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Partnering with clients to create innovative growth strategies




Diagnostics Market Outlook – ASIA 2009




                                                                           Frost & Sullivan
                                                                           Healthcare Practice APAC
                                                                           May 2009

                                                                      “We Accelerate Growth”
Partnering with clients to create innovative growth strategies




        Key take away from Diagnostics & Devices Industry:
                                                                OUTLOOK 2009

Prepared by
Frost & Sullivan
Health Care Consulting Practice

May 2009
© 2009 Frost & Sullivan. All rights reserved. This document contains
highly confidential information and is the sole property of Frost & Sullivan.
No part of it may be circulated, quoted, copied or otherwise reproduced
without the written approval of Frost & Sullivan.




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       Contents
  Industry Overview

                    1.   Market & Products Segmentation

                    2.   Socio-economic Status

                    3.   Total APAC Diagnostics Market & Outlook
  Diagnostics
                    4.   Regional Diagnostics Market & Outlook
Industry Overview   5.   Diagnostics Market Age Vs. CAGR
                    6.   Diagnostics Market Revenue by Segment & CAGR




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  Industry Overview
Market & Products
                      • The In Vitro Diagnostics (IVD) Market includes instruments, reagents and services that
     In-vitro           analyze human body fluids in order to evaluate diseases and other medical conditions under
                        various stages
  Diagnostics
                      • IVDs improve patient management and success rates by accurately diagnosing disease,
  Identification of a   monitoring treatments, and detecting predispositions to diseases and conditions and helps in
  disease, disorder,
                        nearly 80 per cent of clinical decisions.
  or syndrome
  through a method
  of consistent       • The importance and clinical relevance of these diagnostic tests are important factors for the
  analysis.             popularity of these tests amongst patients and healthcare providers that are driving the
                        growth of the IVD market.



  Classification based on Application:
      • Central Lab
                  •   Clinical chemistry
                  •   Immunoassay
                  •   Hematology
                  •   Coagulation
                  •   Microbiology

      • Molecular Diagnostics

      • Point-of-care testing (POCT)


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  Industry Overview
Socio-economic Status
                                  Total Healthcare Expenditure (APAC),
                                               2007-2008                                                                               Global HC Expenditure = US$ 4,981 bil
                                                                                                              Facts                    APAC = 54% of the world population
                                                                               889.1                                                   One-third of the world’s GDP
                                 890
                                                                                                                                       High population growth
                                 880                                                                          Demands                  Increasing affluence
                                             CAGR : 6.2%
  HC Expenditure (USD billion)




                                                                                                                                       Ageing population
                                 870
                                                                                                                                       Auto - immune diseases, infectious
                                 860                                                                                                   diseases, neurological disorders
                                                                                                              Diseases                 Chronic diseases, e.g. diabetes, cancers,
                                 850                                                                                                   obesity, cardiovascular diseases.
                                                   836.8
                                 840
                                                                                                                                       Increasing investment in healthcare
                                 830
                                                                                                                                       infrastructure and expenditure
                                 820                                                                                                   Strengthening of private sector
                                                                                                              Outlook                  healthcare.
                                 810                                                                                                   Continued growth in outsourcing as
                                                2007                        2008                                                       the clinical research and manufacturing
                                                                                                                                       shift away from U.S. and Europe.

                                  Source: Decision Support Database, Frost & Sullivan.



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       Industry Overview
Socio-economic Status
Healthcare Spending Growth Rate (APAC),
                  2007                                                                                 Percentage of Population Over 65 Year Old

      Japan        1.3
                                                                                                Philippines
  Indonesia                  5.7
                                                                                                  Malaysia
  Singapore                    6.5
                                                                                                      India
 Hong Kong                              9
                                                                                                Indonesia
     Taiwan                                 9.4                                                                                                   2010
                                                                                                  Thailand
   Thailand                                       10.9                                                                                            2006
                                                                                                Singapore
New Zealand                                         11.7
                                                                                                     China
   Australia                                         11.9

   Malaysia
                                                                                             South Korea
                                                         12.9

 Philippines                                                  14.1
                                                                                                    Taiwan

      India                                                       15.1
                                                                                               Hong Kong

South Korea                                                          15.9                         Australia

      China                                                                 17.8                     Japan

               0         5                  10                  15                 20                         0              5     10        15          20      25

                                   Percentage (%)                                                                                 Percentage(%)

 China, South Korea and India have the highest growth rate in healthcare                                             Aging populations correlate to the increase in
 spending. Together with the large population, these 3 countries are the                                             medical expenditure associated with old age.
 most attractive market in healthcare industry.

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                        Industry Overview
APAC Diagnostics Market & Outlook
                                                                Laboratory Automation Outlook
                                                                Total Laboratory Automation (TLA) is increasingly being favored by large hospital
                            Clinical Diagnostics Market
                                                                clusters and pathology chains as a solution to rising diagnostic test costs.
                            Revenue ( APAC) 2007-2008
                       7
                                                                Home Care Monitoring Outlook
                      6.8                                       Increased usage of home care monitoring devices in Asia Pacific for blood
                      6.6                                       pressure and blood glucose monitoring as patients volume rises.
Revenue US$ Billion




                                                    6.36
                      6.4
                      6.2               CAGR 8.5%                Industry Outlook
                       6                                         The fastest growth was recorded by the molecular
                                  5.8
                      5.8                                        biology segment followed by coagulation and point of
                                                                 care (POC).
                      5.6
                                                                 Increased adoption of nucleic acid testing-(NAT) based
                      5.4                                        infectious diseases and viral assays (molecular
                      5.2
                                                                 diagnostics), blood glucose testing (POC), cardiac
                                                                 markers and glucose (clinical chemistry), coagulation
                       5                                         self-monitoring and bacteriology culture (microbiology)
                                  2007              2008         supported a compound annual growth rate of almost 9%
                                                                 for the overall IVD market between 2007 and 2008.




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        Industry Overview
Regional Diagnostics Market & Outlook
                                                                                                              Korea
                                                               China
                                                                                                              ~US$ 265 m CAGR of 13.5%

India                                                          ~US$ 1.4 B CAGR of 14.5%
                                                                                                              Steadily increasing growth rate for Diabetes
                                                                                                              & Hemostatis. POC gaining market
~US$ 340 M CAGR of 12.1%                                       Highest growth expected in POC,
                                                               Diabetes,   histology, molecular
Stromg Performance in POC,Diabetes                             assay & rapid test.                                     Japan
Molecular, Histopathology & Cytology
                                                                                                                       ~US$ 3.8 Bn CAGR of 4.0%

                                                                                                                       Moderate growth of Hemostasis & POC
                                                                                                                       segment
 Malaysia

 ~US$ 45 m CAGR of 10.5%                                                                                           Taiwan

 POC, Immunoassay & Molecular                                                                                      ~US$ 229 M CAGR of 9.8%
 is driving the growth
                                                                                                                   Growth dominated by Diabetes

                                                                                                               Philippines
        Indonesia
                                                                                                               ~US$ 45.5 M CAGR of 8%
        ~US$ 79 M CAGR of 11%
                                                                                                               Focus on Hematology, Clinical
        POC, Immunoassay & Molecular is
                                                                                                               Chemistry
        driving the growth


                        Singapore                                                                         Others

                        ~US$ 24 M CAGR of 5.5%                                                            ~US$150 m

                        Focus     on     Immuno-Assay,                                                    Including Thailand, Bangladesh, Cambodia,
                        Histology, POC, Hematology                                                        Pakistan, Sri Lanka, and Vietnam



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     Industry Overview
Regional Diagnostics Market & Outlook
                                                                                                                      China
                                                                                                                      ~US$ 1.4 B ; CAGR of 14.5%(06-10)
India
                                                                                                                      Highest growth expected in POC, Diabetes,
~US$ 340 M CAGR of 12.1%(06-10)                                                                                       histology, molecular assay & rapid test.
                                                                                                                      Influencers are
Strong     Performance      in     POC,Diabetes   Molecular,                                                          • MOH projects in Drug discovery & Infectious
Histopathology & Cytology                                                                                             diseases prevention. Allocation of US$ 440 m
Influencers are                                                                                                       going to 25 activities. 6 of them is to develop
• Govt. focused budget on Disease prevention & care,                                                                  advanced IVD.
Access to rural population and Expanding Insurance                                                                    • 1/5th of total ageing population in world requiring
coverage                                                                                                              more medical care.
• Increasing no. of healthcare providers targeting affluent                                                           • More affluent middle class Chinese capable of
middle class.                                                                                                         out-of- pocket expenses.
• Massive growth in private clinical laboratory due to                                                                Regulation:
increase in health awareness & demand for quality care.                                                               • Evolving SFDA regulatory policies. 3 classes of
• approx 50% of total 26,000 labs are manual and in the                                                               diagnostics devices & reagents. Class II and III
process of replacing it with Semi-fully automated labs.                                                               products are required to have completed in-China
Regulation:                                                                                                           clinical studies and reports prior to registration. In
NIB/NICD evolving regulatory policies of Critical or Non-                                                             addition, these products must undergo type
critical devices. The critical ones are those used in HIV,                                                            testing at SFDA authorized laboratories
HBsAg, HCV, Blood grouping reagents, Malaria tests.                                                                   Outlook
Other tests are considered to be non-critical. For critical                                                           • The fastest growing market in APAC with 20-25%
devices product evaluation from NIB(National institute of                                                             in 2007. Expected CAGR 14.5% by 2012. Around
biologicals) or NICD ( National institute of communicable                                                             40% sales comes form other than indigenous IVD
diseases) is mandatory For non critical ones central                   Taiwan                                         companies making it potential import driven
evaluation not required. State drug offices can give the                                                              market.
approval for non critical devices.                                     ~US$ 229 M CAGR of
                                                                       9.8%
Outlook:
Promising market with an expected CAGR of 16% till 2012.               Growth dominated by
Above 65% of total sales is imported and is expected to                Diabetes, Point of care
remain up to a level of 50% by 2012.                                   and      Self   testing
                                                                       devices.



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    Industry Overview
Regional Diagnostics Market & Outlook
                                                                                                                         Japan

                                                                                                                         ~US$ 3.8 Bn CAGR of 4.0%
 Korea
                                                                                                                         Moderate growth of Hemostasis & POC segment
                                                                                                                         Influencers are
 ~US$ 265 m      CAGR of 13.5%
                                                                                                                         • Old age population with highest life expectancy
                                                                                                                         in Asia. Govt increasing Healthcare spending
 Steadily increasing growth rate       for   Diabetes    &
                                                                                                                         • Growing no. of smaller to mid size Healthcare
 Hemostatis. POC gaining market
                                                                                                                         facilities and private labs.
                                                                                                                         Regulation:
 Influencers are
                                                                                                                         April 2005, implemented the Pharmaceutical
 • 100% import driven for instruments & 60% for the
                                                                                                                         Affairs Law. Three of the law’s main reforms that
 reagents
                                                                                                                         apply to IVD products
 • Diabetes a mature market, growing popularity for
                                                                                                                         1. Adopting international standards such as good
 point of care
                                                                                                                         manufacturing practices (GMPs),         2. Allowing
 • focus area would be molecular assays & histology
                                                                                                                         third-party certification instead of requiring direct
 Regulation:
                                                                                                                         MHLW (Ministry of health and labour welfare)
 KFDA viewed as pragmatic though faced with limited
                                                                                                                         approval, 3. Developing a market authorization
 resources.
                                                                                                                         holder (MAH) system – Distributors or a
 Three processes required to get a device registered in
                                                                                                                         independent 3rd party or the company itself
 Korea: 1. Product license (Valid permanently) 2.
                                                                                                                         having a office in Japan
 Korean     Good    Manufacturing      Practice   (KGMP)
                                                                                                                         Today, application forms and certification
 renewable after every 3 yrs and 3. Device Business
                                                                                                                         processes for IVD products differ slightly from
 License (Valid permanently)
                                                                                                                         other medical devices
 Devices are divided into four classes
                                                                                                                         MHLW is considered an established agency
 Class I being lowest risk - Class IV being highest risk.
                                                                                                                         Outlook
 Agency is evolving though still in phase of improving
                                                                                                                         Growing clinical trials industry will positively
 experience and expertise
                                                                                                                         impact the growth of diagnostics instruments &
 Outlook
                                                                                                                         reagents.
 Govt would be consolidating the healthcare industry by
 increasing private & public partnership model giving
 more focus on preventative tools rather than spending
 almost a third of total healthcare spending on
 pharmaceuticals




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      Industry Overview
Regional Diagnostics Market & Outlook
                                                                                   Singapore
Malaysia                                                                           ~US$ 24 M CAGR of 5.5%
~US$ 45 m CAGR of 10.5%
                                                                                   Focus on Immuno-Assay, Histology, POC, Hematology
POC, Immunoassay & Molecular is driving the growth                                 Influencers are
Influencers are                                                                    • Need to improve the process automation of most of the labs
• A sum of RM13.7 billion (USD 3.86 bil) is allocated for the                      • Increase in Healthcare budget to SG$ 3.7 b in 2009
provision of health facilities and equipments, to increase supply of               • Country focus on strengthening its biomedical niche
medicines, develop human resources, intensify research and                         • Increasing deaths by Heart failure, Heart failure, respiratory infection,
enforcement activities, as well as build more hospitals, clinics and               cerebrovascular disease, lung cancer and diabetes bringing noticeable demand
quarters in 2009                                                                   for preventative diagnostics tools & technologies.
• Healthcare sector in Malaysia is growing at 2.7% in Feb 2009                     Outlook
compared to 2.2% in Feb 2008                                                       • Mature market but high acceptance of superior technologies. Expected CAGR
Outlook                                                                            growth around 4% by 2012.
Growing market with potential low cost R&D and manufacturing
facilities. Halal Certification will bring noticeable advantage.
                                                                                                           Philippines
                                                                                                           ~US$ 45.5 M CAGR of 8%

                                                                                                           Focus on Hematology, Clinical Chemistry, infectious
                                                                                                           diseases related test
 Indonesia                                                                                                 Influencers are
 ~US$ 79 M CAGR of 11%                                                                                     High clinical test requirement from insurance companies,
                                                                                                           schools, companies (for the employees), as well as
 POC, Immunoassay & Molecular is driving the growth                                                        equipment replacements,
 Influencers are                                                                                           Increasing number of population 65 and older (current
 • A huge population with more than 10 million above 65                                                    count is 5.5 million)
 years                                                                                                     Cause of death : respiratory infection, ischemic heart
 • Lower quality of healthcare & lab services getting notable                                              disease, TB, hypertension heart disease creating demand
 attention from the ministry of health & private players.                                                  for POCT
 Outlook                                                                                                   Outlook
 Overcoming barriers to growth would be important for the                                                  One of the growing regional market with high potential of
 country. Although self care diagnostics instruments and                                                   growth by replacement market & new products introduction
 reagents for clinical diagnostics would have a remarkable
 growth.




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     Industry Overview
Market Revenue by Products Segment & CAGR
       In-Vitro Diagnostics Market Revenue by Segment, 2008
                 Clinical                                Immuno
                Chemistry                               Chemistry
                  21%                                      23%                  • Three of the segments make up to 68% of the total diagnostics market
                                                                                i.e. Immuno-Chemistry, Clinical Chemistry, and SMBG

                                                            Microbiology        • Growing demand of SMBG devices is due to increasing old age
                                                                6%              population of most of the Asian countries and prevalence of diabetes.

     SMBG                                             Hematology
      24%        Molecular                     POC       6%
                 Diagnosis     Hemostasis       7%
                    8%            5%                                                        CAGR for IVD Segments (APAC), 2006-2010

                                                                        Molecular Diagnostics                                                                  18.0%
• The market growth of Molecular diagnostics is driven by the                            SMBG                                           10.9%
Majority of population with Sexually transmitted diseases,
                                                                                           POC                                          10.8%
growing popularity of Thyroid & other Autoimmune diseases,
Usage of molecular tests in drug discovery clinical trials and                     Hemostasis                                                         15.0%

Need for quantitative, real-time monitoring of viral loads.                       Microbiology                                       10.0%

                                                                                   Hematology                                    9.0%
• Technological advancement in whole blood analyzer would
spur the growth in coagulation/Hemostasis market.                           Clinical Chemistry                       6.0%

                                                                           Immuno-Chemistry                                   8.0%
• Most of the segments are expected to grow fairly due to
emerging focus on preventative medicines in Asia.                                                0%    2%      4%   6%      8%   10%     12%    14%   16%     18%   20%

                                                                                                         CAGR 2006-2010 (%)


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             Industry Overview
Products Market Age Vs. CAGR
          Market Age Vs. CAGR of Diagnostics Market (Global), 2006-2010.

          22.0

          20.0                                                                                          • Though the IVD market is reaching maturity stage, the
                                     Molecular                                                            genomics revolution combined with developments in
                                    Diagnostics
          18.0                                                                                            automation, integration and miniaturization technology
                                                                                                          have definitely set the pace in the market.
          16.0
                           Coagulation
          14.0                                                                                          • Today with well established segments in the IVD
                                                   SMBG
                                                                                                          market moving towards maturity, advancements in the
                               POCT
CAGR %




          12.0                                                                                            above two fields along with popularity for point-of-care
                                                                                                          testing (POCT) is balancing the growth in the IVD
          10.0                                               Microbiology
                                                                                                          market.
           8.0                        Hematology
                                                   Immunoassay
                                                                                                        • Major participants in the IVD market are well adapted to
           6.0                                                    Clinical Chemistry                      these changes and are focusing on high growth
                                                                                                          potential areas to strengthen their position in the
           4.0
                                                                                                          market.
           2.0

           0.0
                 Infancy            Early Growth          Late Growth                  Maturity



         Bubble size indicates the relative projected revenues of different segments in Yr 2010

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      Contents
  Market Dynamics


                  1.   Mega trends & Paradigm Shift

                  2.   Current Industry Challenge
Market Dynamics   3.   Drivers & Restraints

                  4.   Competitive Structure

                  5.   Market Players & Positioning




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 Market Dynamics
Mega trends & Paradigm Shift
                Rise of the Consumer
                                                                        Figure below illustrate various dimensions and market trends shaping the direction of
New era of proactive medicine and empowerment of the                    Healthcare industry form Therapeutic to Preventative medication era. This paradigm shift
consumer. Patients demand more information from healthcare              highlights equal contribution of patients together with clinicians & suppliers. The outlook
providers                                                               based on this shift will bring noticeable changes to the way Healthcare providers deliver
                                                                              their services.
            Evidence based Healthcare
Increase in evidence-based healthcare or the illustration
(providing evidence) of the effectiveness of a test in order to                                          Disease management programs
justify its use, e.g. cardiac risk markers.
                                                                               More information
                                                                                                                                     Adherence, compliance programs
                                                                             resources available to
              Personalized Medicines                                                                                                     push + reward patients
                                                                                    patients
In particular, advances in genomics, proteomics,
pharmacogenetics and theranostics are anticipated to result
in the optimization of diagnosis and therapy tailored to the
individual                                                              More educated ‘power                            Healthcare             Direct-to-consumer
                                                                        patients’ seek info,                                Vs.                marketing of drugs,
                 Integrated Solution                                    want more control.                               Sickcare              clinical diagnostics
From bench top instruments with innovative assays to larger
systems, which are integrated with different software and
automation components
                                                                          Employers becoming more                                       Consumer directed health plans
        Expanding capabilities- Alliances
                  capabilities-                                             aggressive in pushing                                       force consumers to pay more
                                                                              preventative care                                         attention to HC choices
By investing in R&D and Collaboration & partnership with
smaller companies across the world to overcome the vast gap                                                      Wellness movement
of different geographical differences


                Upsurge in IVD Tests                                    Source: Frost & Sullivan Growth Consulting Practice Healthcare APAC Copyright @2009
Key role in improving patient outcomes and cost-savings due
to earlier and more precise diagnoses and patient monitoring



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 Market Dynamics
Current Industry Challenge




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  Market Dynamics
Drivers & Restraints APAC (2008-10)
          Increased private participation of Healthcare providers &                                  Lack of health care facilities in rural areas.
          Insurance companies


          Changing the profile of diseases – from therapeutic to                                     Low level of R&D from local manufacturers
          preventative; from general profile to premium priced
          lifestyle tests
                                                                                                     Lack of proper coverage under health care insurance in
                                                                                                     most developing countries.
          Increasing expenditure on health care as total outgo.
                                                                                                     Lack of awareness by health care professionals of range
                                                                                                     and utility of sophisticated IVD tests.
Drivers                                                                         Restraints
          Increasing affluence of the people who demand better
          medical services.                                                                          Public plays a passive role in health care -
                                                                                                     low expectations from providers.

          Largest pool of Ageing population.
                                                                                                     Fragmented information delivery to patients encumbers
          Newer premium-priced assays replacing conventional                                         patient’s realization of overall importance of IVD testing
          tests.

                                                                                                     Lack of a universal connectivity standard lead to higher
          Government funded disease prevention programs.                                             equipment and management costs at POC


          Strengthening IP law in Asia, Harmonizing the regulations                                  Industry consolidation suppress the future of small to
          across the region (among ASEAN region)                                                     medium participants in the value chain



                                                                                           Source:     Frost & Sullivan analysis, mass media, market expert interviews,
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 Market Dynamics
Competitive Structure
                                                                                                      Threat Level: HIGH
                                                                          SUPPLIERS                   Asian market remains competitive with presence of
                                                                                                      global companies as well as local giants esp. in Japan,
 Threat Level: HIGH                                                                                   Korea & Taiwan. The distributors look for high quality
                                                                                                      products with reasonable margins. In those regions
 The recent acquisition activities, especially of
                                                                                                      where products are supplied / distributed by the
 Bayer diagnostics by Siemens indicates the
                                                                                                      importers, distributors for local companies have a high
 potential growth & possibilities of Capitalized
                                                                                                      margin and hence inclined to supply the products
 companies to have a grand entry to the
                                                                                                      procured locally.
 diagnostics market. The consolidation by
 pharmaceutical companies into this market
 would bring the competition to a new height.                  INDUSTRY COMPETITORS
                                                                                                                                     ALTERNATIVE
           POTENTIAL                                                                                                                 TECHNOLOGY
           ENTRANTS
                                                                  Intensive Rivalry among
                                                                       existing firms                                          Threat Level: MEDIUM
                                                                                                                Technological advanced companies would
                                                                                                            have advantage as trends are moving towards
                                                                                                                   capital-intensive instruments & facilities.
                                                                                                            Strategic Alliances brings added capabilities to
                                           Threat Level: Medium                                                  the market players to remain competitive.

                       The Vast application of diagnostics products &
                     frequent usage gives low to medium bargaining
                        power to the buyers to substitute with. Cost &      BUYERS
                      quality remains a sensitive issue for the buyers.




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 Market Dynamics
Market Players & Positioning
 Characterised by many consolidation activities, current market reflects a very strong bonding with Life sciences players. As
 seen in the diagram, most of the global players believe in integration of Diagnostics products as a vital aspect to sustain
 their healthy growth.
                                                                                                        Market Share of Players –APAC 2008
       High

                                  Qiagen               Roche
                                                                                                                                             Bechman Coulter,
              AffyMetrix                                                                                  Local Companies,
                                                    Abbott                                                      45%                               6%


                           Gen-Probe                       Siemens                   Bio-Merieux, 4%
                                                           Medical Solutions
  Degree of                   Bio-Merieux                  Diagnostics
  Innovation                                                                             Bio-rad, 4%                                                 Sysmex, 5%

                                                                                               Others, 7%
                                                                                                                Abbott         Roche, 11%
                Sysmex             Bio-Rad     Becton            Beckman                                                                       Siemens, 13%
                                                                                                            Diagnostics, 5%
                                               Dickinson         Coulter
                                  GE
                                  Healthcare
                                                 OCD                                       Peculiar to Asian region only, indigenous market players hold a
         Low
                                                                      High                 very substantial market share of close to 45% especially in
                             Breadth of Current Applications                               China, Japan & India.


                Medical Equipment Vendors with Diagnostic Divisions

                 Pharmaceutical Companies with Diagnostic Divisions

                 Biotechnology Companies developing Diagnostics Tests

                 Diagnostics Companies



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       Contents
   Market Outlook & Future Trend



                   1.   Transformation of Medical Device Industry

                   2.   Translating Technological Advancement
Market Outlook &   3.   Key Areas of Alliance and Partnership
Future Trend
                   4.    Key Opportunities Prioritized




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       Market Outlook & Future Trend
Transformation of Medical Device Industry
    IVD Market: Key Technologies Evolution, 2006-2012
                                                                                                                 Transformation of Medtech Device
10     Established   Development          Future                Polymerase Chain
9                                                               Reaction (PCR)
                                                                                                                        Enhanced Performance and Feature
8                                                                Chemiluminescence
                                                                                                                        - Better specifications
7                                                                Microarray                                             - Networking ability: LAN
6                                                                                                                       - Wireless solution: Bluetooth, Wifi
                                                                 Miniaturisation
5
                                                                 Non-Invasive Technology                                Zero Defect Reliability
4
                                                                                                                        - Device failure    death to patient
                                                                 Information Technology
3                                                                                                                       - Failure Mode and Effects Analysis (FMEA)
2                                                                Genomics/Proteomics                                    - Flexible circuits > rigid circuits
                                                                                                                        - Process validatio and control
1                                                                Automation
0
                                                                                                                       Miniaturization
                                                                                                                       - Pacemaker: size of pack of cards    size of
                                                                                                                         stopwatch
Major areas where the industry is currently focusing upon.                                                             - Printed circuits denser and thinner.
                                                                                                                       - Infusion pump: single chip, micro-fluidic
- Identification of new biomarkers, Developing new diagnostic assays and                                                 pumps?
  detection technologies, Improvement in instrument capabilities,
  Analytical performance, Assay sensitivity, Connectivity and Software                                                Improved Power Sources
  solutions                                                                                                           - Rechargeable battery in neuro-stimulator
                                                                                                                        extends its lifespan by 10 years.
Most significant trends in clinical laboratory is workstation integration and                                         - Biothermal battery – using body heat to
consolidation. Most large IVD companies, like Siemens Medical Solutions Diagnostics                                     create a low current source of power.
and Beckman Coulter, are focusing to consolidate or integrate systems and data.                                       - Nuclear microbatteries is in development.



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  Market Outlook & Future Trend
Translating Technological Advancement

           Advancement in                               Translation into                                   Benefits to the
             Technology                              Clinical Applications                                   Patients


            Nanotechnology

                                                          Diagnosis
        Molecular and Gene-based              - Early detection
               Diagnostics                                                                               Affordability
                                              - Reduce false diagnosis                                   AIO device – one device,
                                                                                                         multiple tests
         Information Technology                                                                          Easy to use
                                                           Treatment
                                                                                                         Long term monitoring
                                              - Improved treatment: higher
                                                                                                         Cater to specialized needs
                                                efficacy, target specific.
            Artificial Organs                                                                            Self testing
                                              - Non-invasive
                                                                                                         More options available
                                              - Broadening treatment options
           Tissue Engineering



                 Medtech device is a                           Manufacturers must have strong                Key concerns in R&D would be:
                 technologically inclined industry:            collaborations with different
 Driving the                                                   institutes to carry out the R&D:
                                                                                                             •Leveraging core knowledge of
                 •Short product life cycle                                                                   technology
 Technology                                                    •Medical institutions, Academic
                 •Heavy investment in R&D                                                                    •Lowering the costs
Advancement                                                    institutions
                 •Constant innovation to release
                                                               •Hospitals
                 new products



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Partnering with clients to create innovative growth strategies


   Market Outlook & Future Trend
Key Areas of Alliance and Partnership
                                                             Oncology
                                                             Companies are joining together to move to the forefront of diagnostic
  Key Areas of Alliances within                              technology and provide a full range of solutions between diagnostics
  Diagnostic Companies                                       and therapy.
                                                             These novel oncology management tools are designated to cross over
                                                             from cancer, screening, diagnosis, prognosis to monitoring Clinical reality,
                                                             assisting physicians with a more holistic understanding of disease and treatment
                                                             management

                                                             Automation
    Partnerships within diagnostic                           Companies are entering into alliances as a step forward to combine quality control
                                                                  products and data management solutions to ensure reliability and precision to
   companies expand menus along
                                                                  customers.
 with increasing the sales of systems                        Providing diagnostic customers with cost effective solutions like the need to
 while combining expertise will allow                             generate the best and most reliable data while reducing capital costs
  the respective companies to make                           The segment includes
       significant contributions to                          1.   Automated Analyzers
     diagnostics and patient care                            2.   Stand-alone automation of Pre & Post Analytical process
                                                             3.   Total Laboratory Automation


                                                             Molecular Diagnostics
                                                             Diagnostic companies are able to join their cutting edge, life-saving technologies
                                                             and superior customer service through alliances while complementing automated
                                                             diagnostic solutions for hospitals to provide clinicians with quicker and more
                                                             accurate results.
                                                             IVD manufacturers are strengthening partnerships between themselves
                                                             representing their combined dedication to add significant value to labs and
                                                             becoming market leaders in the industry



                                                                                                                                                  22
Partnering with clients to create innovative growth strategies


  Market Outlook & Future Trend
Key Opportunities Prioritized
                                            Growth Rate ( High)


                                           Molecular
                                          Diagnostics                                                                 Penetration rate is defined as
                                                                                                                      the maturity of the product
                                           POCT                                                                       segment and its application. The
                                                          SMBG                                                        lower penetration rate means
                                                                                                                      higher untapped market
                                                                                                                      potential for growth.
                                        Coagulation
    Penetration                                                                                        Penetration
    Rate ( Low)                                                                                        Rate ( High)   Growth rate is considered as
                                                                                                                      the future projected CAGR till
                                                       Hematology                                                     year 2012. A high growth rate is
                                                                                                                      any rate above 10% vis-à-vis
                                                                                                                      industry average of 8.5%.
                                                                         Microbiology



                                                                                   Clinical Chemistry
                                                              Immunoassay




                                                 Growth Rate (Low)
          The positioning of various product lines indicate the potential opportunity in products based on growth in Asian
          market & its penetration status. Choosing a mixed profile would depend on the company’s objective to grow in
          specific product line and country of interest as displayed on next slide.



                                                                                                                                                     23
Partnering with clients to create innovative growth strategies


  Market Outlook & Future Trend
Key Opportunities Prioritized
                                                                                                                               The Current Attractiveness of
                                                                                     High                                      Market is defined in terms of overall
                                                                                                                               size, historical growth rates,
                                                                                                                               competitive structure, legal &
                                                                                                                               regulatory requirements and




                                                                                               Current Market Attractiveness
                                                                                                                               acceptance rate of various IVD
                                                                                                                               technologies.

                                                                                     Med
                                                                                                                               The Future Growth Opportunity is
                                                                                                                               defined as the overall future IVD
                                                                                                                               market favourability on the same
                                                                                                                               dimensions as explained above.
                                                                                                                               In addition, factors which decide the
                                                                                                                               growth potential are socio-economic
                                                                                     Low
                                                                                                                               drivers & restrains in that particular
                                                                                                                               country, forecasted market size, and
                                                                                                                               expected technological advancement
                                                                                                                               in diagnostics industry.
                     Strong                 Med                            Weak
                              IVD Future Growth Opportunity


        The objective of this diagram is for illustrative purpose only which positions various Asian countries on two
        dimension i.e. Current & Future opportunities available in market.
        The notable argument of this diagram could be to highlight the markets depending on its maturity( in
        terms of current acceptance rate of IVD devices & reagents) and how the country is developing to bring
        growth for the same.



                                                                                                                                                                        24
Partnering with clients to create innovative growth strategies




                                      Diagnostics & Devices Industry:
                                                                OUTLOOK 2009


                                                                                                                                 Name
                                                                                                                                 Account Executive
                                                                                                                                 Healthcare Asia Pacific,
                                                                                                                                 +65.xxxx.xxxx
                                                                                                                                 xxxx @frost.com
Prepared by
Frost & Sullivan
Health Care Consulting Practice
APAC
                                                                                                                                 Siddharth Singh
May 2009                                                                                                                         Consultant
                                                                                                                                 Healthcare Asia Pacific,
                                                                                                                                 +60.6204.5685
© 2009 Frost & Sullivan. All rights reserved. This document contains
highly confidential information and is the sole property of Frost & Sullivan.                                                    siddharth.singh@frost.com
No part of it may be circulated, quoted, copied or otherwise reproduced
without the written approval of Frost & Sullivan.



                                                                                                                                                             25
                                                                                                                                                              1

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Diagnostics Industry Outlook Asia 2009.

  • 1. Partnering with clients to create innovative growth strategies Diagnostics Market Outlook – ASIA 2009 Frost & Sullivan Healthcare Practice APAC May 2009 “We Accelerate Growth”
  • 2. Partnering with clients to create innovative growth strategies Key take away from Diagnostics & Devices Industry: OUTLOOK 2009 Prepared by Frost & Sullivan Health Care Consulting Practice May 2009 © 2009 Frost & Sullivan. All rights reserved. This document contains highly confidential information and is the sole property of Frost & Sullivan. No part of it may be circulated, quoted, copied or otherwise reproduced without the written approval of Frost & Sullivan. 11
  • 3. Partnering with clients to create innovative growth strategies Contents Industry Overview 1. Market & Products Segmentation 2. Socio-economic Status 3. Total APAC Diagnostics Market & Outlook Diagnostics 4. Regional Diagnostics Market & Outlook Industry Overview 5. Diagnostics Market Age Vs. CAGR 6. Diagnostics Market Revenue by Segment & CAGR 2
  • 4. Partnering with clients to create innovative growth strategies Industry Overview Market & Products • The In Vitro Diagnostics (IVD) Market includes instruments, reagents and services that In-vitro analyze human body fluids in order to evaluate diseases and other medical conditions under various stages Diagnostics • IVDs improve patient management and success rates by accurately diagnosing disease, Identification of a monitoring treatments, and detecting predispositions to diseases and conditions and helps in disease, disorder, nearly 80 per cent of clinical decisions. or syndrome through a method of consistent • The importance and clinical relevance of these diagnostic tests are important factors for the analysis. popularity of these tests amongst patients and healthcare providers that are driving the growth of the IVD market. Classification based on Application: • Central Lab • Clinical chemistry • Immunoassay • Hematology • Coagulation • Microbiology • Molecular Diagnostics • Point-of-care testing (POCT) 3
  • 5. Partnering with clients to create innovative growth strategies Industry Overview Socio-economic Status Total Healthcare Expenditure (APAC), 2007-2008 Global HC Expenditure = US$ 4,981 bil Facts APAC = 54% of the world population 889.1 One-third of the world’s GDP 890 High population growth 880 Demands Increasing affluence CAGR : 6.2% HC Expenditure (USD billion) Ageing population 870 Auto - immune diseases, infectious 860 diseases, neurological disorders Diseases Chronic diseases, e.g. diabetes, cancers, 850 obesity, cardiovascular diseases. 836.8 840 Increasing investment in healthcare 830 infrastructure and expenditure 820 Strengthening of private sector Outlook healthcare. 810 Continued growth in outsourcing as 2007 2008 the clinical research and manufacturing shift away from U.S. and Europe. Source: Decision Support Database, Frost & Sullivan. 4
  • 6. Partnering with clients to create innovative growth strategies Industry Overview Socio-economic Status Healthcare Spending Growth Rate (APAC), 2007 Percentage of Population Over 65 Year Old Japan 1.3 Philippines Indonesia 5.7 Malaysia Singapore 6.5 India Hong Kong 9 Indonesia Taiwan 9.4 2010 Thailand Thailand 10.9 2006 Singapore New Zealand 11.7 China Australia 11.9 Malaysia South Korea 12.9 Philippines 14.1 Taiwan India 15.1 Hong Kong South Korea 15.9 Australia China 17.8 Japan 0 5 10 15 20 0 5 10 15 20 25 Percentage (%) Percentage(%) China, South Korea and India have the highest growth rate in healthcare Aging populations correlate to the increase in spending. Together with the large population, these 3 countries are the medical expenditure associated with old age. most attractive market in healthcare industry. 5
  • 7. Partnering with clients to create innovative growth strategies Industry Overview APAC Diagnostics Market & Outlook Laboratory Automation Outlook Total Laboratory Automation (TLA) is increasingly being favored by large hospital Clinical Diagnostics Market clusters and pathology chains as a solution to rising diagnostic test costs. Revenue ( APAC) 2007-2008 7 Home Care Monitoring Outlook 6.8 Increased usage of home care monitoring devices in Asia Pacific for blood 6.6 pressure and blood glucose monitoring as patients volume rises. Revenue US$ Billion 6.36 6.4 6.2 CAGR 8.5% Industry Outlook 6 The fastest growth was recorded by the molecular 5.8 5.8 biology segment followed by coagulation and point of care (POC). 5.6 Increased adoption of nucleic acid testing-(NAT) based 5.4 infectious diseases and viral assays (molecular 5.2 diagnostics), blood glucose testing (POC), cardiac markers and glucose (clinical chemistry), coagulation 5 self-monitoring and bacteriology culture (microbiology) 2007 2008 supported a compound annual growth rate of almost 9% for the overall IVD market between 2007 and 2008. 6
  • 8. Partnering with clients to create innovative growth strategies Industry Overview Regional Diagnostics Market & Outlook Korea China ~US$ 265 m CAGR of 13.5% India ~US$ 1.4 B CAGR of 14.5% Steadily increasing growth rate for Diabetes & Hemostatis. POC gaining market ~US$ 340 M CAGR of 12.1% Highest growth expected in POC, Diabetes, histology, molecular Stromg Performance in POC,Diabetes assay & rapid test. Japan Molecular, Histopathology & Cytology ~US$ 3.8 Bn CAGR of 4.0% Moderate growth of Hemostasis & POC segment Malaysia ~US$ 45 m CAGR of 10.5% Taiwan POC, Immunoassay & Molecular ~US$ 229 M CAGR of 9.8% is driving the growth Growth dominated by Diabetes Philippines Indonesia ~US$ 45.5 M CAGR of 8% ~US$ 79 M CAGR of 11% Focus on Hematology, Clinical POC, Immunoassay & Molecular is Chemistry driving the growth Singapore Others ~US$ 24 M CAGR of 5.5% ~US$150 m Focus on Immuno-Assay, Including Thailand, Bangladesh, Cambodia, Histology, POC, Hematology Pakistan, Sri Lanka, and Vietnam 7
  • 9. Partnering with clients to create innovative growth strategies Industry Overview Regional Diagnostics Market & Outlook China ~US$ 1.4 B ; CAGR of 14.5%(06-10) India Highest growth expected in POC, Diabetes, ~US$ 340 M CAGR of 12.1%(06-10) histology, molecular assay & rapid test. Influencers are Strong Performance in POC,Diabetes Molecular, • MOH projects in Drug discovery & Infectious Histopathology & Cytology diseases prevention. Allocation of US$ 440 m Influencers are going to 25 activities. 6 of them is to develop • Govt. focused budget on Disease prevention & care, advanced IVD. Access to rural population and Expanding Insurance • 1/5th of total ageing population in world requiring coverage more medical care. • Increasing no. of healthcare providers targeting affluent • More affluent middle class Chinese capable of middle class. out-of- pocket expenses. • Massive growth in private clinical laboratory due to Regulation: increase in health awareness & demand for quality care. • Evolving SFDA regulatory policies. 3 classes of • approx 50% of total 26,000 labs are manual and in the diagnostics devices & reagents. Class II and III process of replacing it with Semi-fully automated labs. products are required to have completed in-China Regulation: clinical studies and reports prior to registration. In NIB/NICD evolving regulatory policies of Critical or Non- addition, these products must undergo type critical devices. The critical ones are those used in HIV, testing at SFDA authorized laboratories HBsAg, HCV, Blood grouping reagents, Malaria tests. Outlook Other tests are considered to be non-critical. For critical • The fastest growing market in APAC with 20-25% devices product evaluation from NIB(National institute of in 2007. Expected CAGR 14.5% by 2012. Around biologicals) or NICD ( National institute of communicable 40% sales comes form other than indigenous IVD diseases) is mandatory For non critical ones central Taiwan companies making it potential import driven evaluation not required. State drug offices can give the market. approval for non critical devices. ~US$ 229 M CAGR of 9.8% Outlook: Promising market with an expected CAGR of 16% till 2012. Growth dominated by Above 65% of total sales is imported and is expected to Diabetes, Point of care remain up to a level of 50% by 2012. and Self testing devices. Back to the 8 main
  • 10. Partnering with clients to create innovative growth strategies Industry Overview Regional Diagnostics Market & Outlook Japan ~US$ 3.8 Bn CAGR of 4.0% Korea Moderate growth of Hemostasis & POC segment Influencers are ~US$ 265 m CAGR of 13.5% • Old age population with highest life expectancy in Asia. Govt increasing Healthcare spending Steadily increasing growth rate for Diabetes & • Growing no. of smaller to mid size Healthcare Hemostatis. POC gaining market facilities and private labs. Regulation: Influencers are April 2005, implemented the Pharmaceutical • 100% import driven for instruments & 60% for the Affairs Law. Three of the law’s main reforms that reagents apply to IVD products • Diabetes a mature market, growing popularity for 1. Adopting international standards such as good point of care manufacturing practices (GMPs), 2. Allowing • focus area would be molecular assays & histology third-party certification instead of requiring direct Regulation: MHLW (Ministry of health and labour welfare) KFDA viewed as pragmatic though faced with limited approval, 3. Developing a market authorization resources. holder (MAH) system – Distributors or a Three processes required to get a device registered in independent 3rd party or the company itself Korea: 1. Product license (Valid permanently) 2. having a office in Japan Korean Good Manufacturing Practice (KGMP) Today, application forms and certification renewable after every 3 yrs and 3. Device Business processes for IVD products differ slightly from License (Valid permanently) other medical devices Devices are divided into four classes MHLW is considered an established agency Class I being lowest risk - Class IV being highest risk. Outlook Agency is evolving though still in phase of improving Growing clinical trials industry will positively experience and expertise impact the growth of diagnostics instruments & Outlook reagents. Govt would be consolidating the healthcare industry by increasing private & public partnership model giving more focus on preventative tools rather than spending almost a third of total healthcare spending on pharmaceuticals Back to the 9 main
  • 11. Partnering with clients to create innovative growth strategies Industry Overview Regional Diagnostics Market & Outlook Singapore Malaysia ~US$ 24 M CAGR of 5.5% ~US$ 45 m CAGR of 10.5% Focus on Immuno-Assay, Histology, POC, Hematology POC, Immunoassay & Molecular is driving the growth Influencers are Influencers are • Need to improve the process automation of most of the labs • A sum of RM13.7 billion (USD 3.86 bil) is allocated for the • Increase in Healthcare budget to SG$ 3.7 b in 2009 provision of health facilities and equipments, to increase supply of • Country focus on strengthening its biomedical niche medicines, develop human resources, intensify research and • Increasing deaths by Heart failure, Heart failure, respiratory infection, enforcement activities, as well as build more hospitals, clinics and cerebrovascular disease, lung cancer and diabetes bringing noticeable demand quarters in 2009 for preventative diagnostics tools & technologies. • Healthcare sector in Malaysia is growing at 2.7% in Feb 2009 Outlook compared to 2.2% in Feb 2008 • Mature market but high acceptance of superior technologies. Expected CAGR Outlook growth around 4% by 2012. Growing market with potential low cost R&D and manufacturing facilities. Halal Certification will bring noticeable advantage. Philippines ~US$ 45.5 M CAGR of 8% Focus on Hematology, Clinical Chemistry, infectious diseases related test Indonesia Influencers are ~US$ 79 M CAGR of 11% High clinical test requirement from insurance companies, schools, companies (for the employees), as well as POC, Immunoassay & Molecular is driving the growth equipment replacements, Influencers are Increasing number of population 65 and older (current • A huge population with more than 10 million above 65 count is 5.5 million) years Cause of death : respiratory infection, ischemic heart • Lower quality of healthcare & lab services getting notable disease, TB, hypertension heart disease creating demand attention from the ministry of health & private players. for POCT Outlook Outlook Overcoming barriers to growth would be important for the One of the growing regional market with high potential of country. Although self care diagnostics instruments and growth by replacement market & new products introduction reagents for clinical diagnostics would have a remarkable growth. Back to the 10 main
  • 12. Partnering with clients to create innovative growth strategies Industry Overview Market Revenue by Products Segment & CAGR In-Vitro Diagnostics Market Revenue by Segment, 2008 Clinical Immuno Chemistry Chemistry 21% 23% • Three of the segments make up to 68% of the total diagnostics market i.e. Immuno-Chemistry, Clinical Chemistry, and SMBG Microbiology • Growing demand of SMBG devices is due to increasing old age 6% population of most of the Asian countries and prevalence of diabetes. SMBG Hematology 24% Molecular POC 6% Diagnosis Hemostasis 7% 8% 5% CAGR for IVD Segments (APAC), 2006-2010 Molecular Diagnostics 18.0% • The market growth of Molecular diagnostics is driven by the SMBG 10.9% Majority of population with Sexually transmitted diseases, POC 10.8% growing popularity of Thyroid & other Autoimmune diseases, Usage of molecular tests in drug discovery clinical trials and Hemostasis 15.0% Need for quantitative, real-time monitoring of viral loads. Microbiology 10.0% Hematology 9.0% • Technological advancement in whole blood analyzer would spur the growth in coagulation/Hemostasis market. Clinical Chemistry 6.0% Immuno-Chemistry 8.0% • Most of the segments are expected to grow fairly due to emerging focus on preventative medicines in Asia. 0% 2% 4% 6% 8% 10% 12% 14% 16% 18% 20% CAGR 2006-2010 (%) 11
  • 13. Partnering with clients to create innovative growth strategies Industry Overview Products Market Age Vs. CAGR Market Age Vs. CAGR of Diagnostics Market (Global), 2006-2010. 22.0 20.0 • Though the IVD market is reaching maturity stage, the Molecular genomics revolution combined with developments in Diagnostics 18.0 automation, integration and miniaturization technology have definitely set the pace in the market. 16.0 Coagulation 14.0 • Today with well established segments in the IVD SMBG market moving towards maturity, advancements in the POCT CAGR % 12.0 above two fields along with popularity for point-of-care testing (POCT) is balancing the growth in the IVD 10.0 Microbiology market. 8.0 Hematology Immunoassay • Major participants in the IVD market are well adapted to 6.0 Clinical Chemistry these changes and are focusing on high growth potential areas to strengthen their position in the 4.0 market. 2.0 0.0 Infancy Early Growth Late Growth Maturity Bubble size indicates the relative projected revenues of different segments in Yr 2010 12
  • 14. Partnering with clients to create innovative growth strategies Contents Market Dynamics 1. Mega trends & Paradigm Shift 2. Current Industry Challenge Market Dynamics 3. Drivers & Restraints 4. Competitive Structure 5. Market Players & Positioning 13
  • 15. Partnering with clients to create innovative growth strategies Market Dynamics Mega trends & Paradigm Shift Rise of the Consumer Figure below illustrate various dimensions and market trends shaping the direction of New era of proactive medicine and empowerment of the Healthcare industry form Therapeutic to Preventative medication era. This paradigm shift consumer. Patients demand more information from healthcare highlights equal contribution of patients together with clinicians & suppliers. The outlook providers based on this shift will bring noticeable changes to the way Healthcare providers deliver their services. Evidence based Healthcare Increase in evidence-based healthcare or the illustration (providing evidence) of the effectiveness of a test in order to Disease management programs justify its use, e.g. cardiac risk markers. More information Adherence, compliance programs resources available to Personalized Medicines push + reward patients patients In particular, advances in genomics, proteomics, pharmacogenetics and theranostics are anticipated to result in the optimization of diagnosis and therapy tailored to the individual More educated ‘power Healthcare Direct-to-consumer patients’ seek info, Vs. marketing of drugs, Integrated Solution want more control. Sickcare clinical diagnostics From bench top instruments with innovative assays to larger systems, which are integrated with different software and automation components Employers becoming more Consumer directed health plans Expanding capabilities- Alliances capabilities- aggressive in pushing force consumers to pay more preventative care attention to HC choices By investing in R&D and Collaboration & partnership with smaller companies across the world to overcome the vast gap Wellness movement of different geographical differences Upsurge in IVD Tests Source: Frost & Sullivan Growth Consulting Practice Healthcare APAC Copyright @2009 Key role in improving patient outcomes and cost-savings due to earlier and more precise diagnoses and patient monitoring 14
  • 16. Partnering with clients to create innovative growth strategies Market Dynamics Current Industry Challenge 15
  • 17. Partnering with clients to create innovative growth strategies Market Dynamics Drivers & Restraints APAC (2008-10) Increased private participation of Healthcare providers & Lack of health care facilities in rural areas. Insurance companies Changing the profile of diseases – from therapeutic to Low level of R&D from local manufacturers preventative; from general profile to premium priced lifestyle tests Lack of proper coverage under health care insurance in most developing countries. Increasing expenditure on health care as total outgo. Lack of awareness by health care professionals of range and utility of sophisticated IVD tests. Drivers Restraints Increasing affluence of the people who demand better medical services. Public plays a passive role in health care - low expectations from providers. Largest pool of Ageing population. Fragmented information delivery to patients encumbers Newer premium-priced assays replacing conventional patient’s realization of overall importance of IVD testing tests. Lack of a universal connectivity standard lead to higher Government funded disease prevention programs. equipment and management costs at POC Strengthening IP law in Asia, Harmonizing the regulations Industry consolidation suppress the future of small to across the region (among ASEAN region) medium participants in the value chain Source: Frost & Sullivan analysis, mass media, market expert interviews, 16
  • 18. Partnering with clients to create innovative growth strategies Market Dynamics Competitive Structure Threat Level: HIGH SUPPLIERS Asian market remains competitive with presence of global companies as well as local giants esp. in Japan, Threat Level: HIGH Korea & Taiwan. The distributors look for high quality products with reasonable margins. In those regions The recent acquisition activities, especially of where products are supplied / distributed by the Bayer diagnostics by Siemens indicates the importers, distributors for local companies have a high potential growth & possibilities of Capitalized margin and hence inclined to supply the products companies to have a grand entry to the procured locally. diagnostics market. The consolidation by pharmaceutical companies into this market would bring the competition to a new height. INDUSTRY COMPETITORS ALTERNATIVE POTENTIAL TECHNOLOGY ENTRANTS Intensive Rivalry among existing firms Threat Level: MEDIUM Technological advanced companies would have advantage as trends are moving towards capital-intensive instruments & facilities. Strategic Alliances brings added capabilities to Threat Level: Medium the market players to remain competitive. The Vast application of diagnostics products & frequent usage gives low to medium bargaining power to the buyers to substitute with. Cost & BUYERS quality remains a sensitive issue for the buyers. 17
  • 19. Partnering with clients to create innovative growth strategies Market Dynamics Market Players & Positioning Characterised by many consolidation activities, current market reflects a very strong bonding with Life sciences players. As seen in the diagram, most of the global players believe in integration of Diagnostics products as a vital aspect to sustain their healthy growth. Market Share of Players –APAC 2008 High Qiagen Roche Bechman Coulter, AffyMetrix Local Companies, Abbott 45% 6% Gen-Probe Siemens Bio-Merieux, 4% Medical Solutions Degree of Bio-Merieux Diagnostics Innovation Bio-rad, 4% Sysmex, 5% Others, 7% Abbott Roche, 11% Sysmex Bio-Rad Becton Beckman Siemens, 13% Diagnostics, 5% Dickinson Coulter GE Healthcare OCD Peculiar to Asian region only, indigenous market players hold a Low High very substantial market share of close to 45% especially in Breadth of Current Applications China, Japan & India. Medical Equipment Vendors with Diagnostic Divisions Pharmaceutical Companies with Diagnostic Divisions Biotechnology Companies developing Diagnostics Tests Diagnostics Companies 18
  • 20. Partnering with clients to create innovative growth strategies Contents Market Outlook & Future Trend 1. Transformation of Medical Device Industry 2. Translating Technological Advancement Market Outlook & 3. Key Areas of Alliance and Partnership Future Trend 4. Key Opportunities Prioritized 19
  • 21. Partnering with clients to create innovative growth strategies Market Outlook & Future Trend Transformation of Medical Device Industry IVD Market: Key Technologies Evolution, 2006-2012 Transformation of Medtech Device 10 Established Development Future Polymerase Chain 9 Reaction (PCR) Enhanced Performance and Feature 8 Chemiluminescence - Better specifications 7 Microarray - Networking ability: LAN 6 - Wireless solution: Bluetooth, Wifi Miniaturisation 5 Non-Invasive Technology Zero Defect Reliability 4 - Device failure death to patient Information Technology 3 - Failure Mode and Effects Analysis (FMEA) 2 Genomics/Proteomics - Flexible circuits > rigid circuits - Process validatio and control 1 Automation 0 Miniaturization - Pacemaker: size of pack of cards size of stopwatch Major areas where the industry is currently focusing upon. - Printed circuits denser and thinner. - Infusion pump: single chip, micro-fluidic - Identification of new biomarkers, Developing new diagnostic assays and pumps? detection technologies, Improvement in instrument capabilities, Analytical performance, Assay sensitivity, Connectivity and Software Improved Power Sources solutions - Rechargeable battery in neuro-stimulator extends its lifespan by 10 years. Most significant trends in clinical laboratory is workstation integration and - Biothermal battery – using body heat to consolidation. Most large IVD companies, like Siemens Medical Solutions Diagnostics create a low current source of power. and Beckman Coulter, are focusing to consolidate or integrate systems and data. - Nuclear microbatteries is in development. 20
  • 22. Partnering with clients to create innovative growth strategies Market Outlook & Future Trend Translating Technological Advancement Advancement in Translation into Benefits to the Technology Clinical Applications Patients Nanotechnology Diagnosis Molecular and Gene-based - Early detection Diagnostics Affordability - Reduce false diagnosis AIO device – one device, multiple tests Information Technology Easy to use Treatment Long term monitoring - Improved treatment: higher Cater to specialized needs efficacy, target specific. Artificial Organs Self testing - Non-invasive More options available - Broadening treatment options Tissue Engineering Medtech device is a Manufacturers must have strong Key concerns in R&D would be: technologically inclined industry: collaborations with different Driving the institutes to carry out the R&D: •Leveraging core knowledge of •Short product life cycle technology Technology •Medical institutions, Academic •Heavy investment in R&D •Lowering the costs Advancement institutions •Constant innovation to release •Hospitals new products 21
  • 23. Partnering with clients to create innovative growth strategies Market Outlook & Future Trend Key Areas of Alliance and Partnership Oncology Companies are joining together to move to the forefront of diagnostic Key Areas of Alliances within technology and provide a full range of solutions between diagnostics Diagnostic Companies and therapy. These novel oncology management tools are designated to cross over from cancer, screening, diagnosis, prognosis to monitoring Clinical reality, assisting physicians with a more holistic understanding of disease and treatment management Automation Partnerships within diagnostic Companies are entering into alliances as a step forward to combine quality control products and data management solutions to ensure reliability and precision to companies expand menus along customers. with increasing the sales of systems Providing diagnostic customers with cost effective solutions like the need to while combining expertise will allow generate the best and most reliable data while reducing capital costs the respective companies to make The segment includes significant contributions to 1. Automated Analyzers diagnostics and patient care 2. Stand-alone automation of Pre & Post Analytical process 3. Total Laboratory Automation Molecular Diagnostics Diagnostic companies are able to join their cutting edge, life-saving technologies and superior customer service through alliances while complementing automated diagnostic solutions for hospitals to provide clinicians with quicker and more accurate results. IVD manufacturers are strengthening partnerships between themselves representing their combined dedication to add significant value to labs and becoming market leaders in the industry 22
  • 24. Partnering with clients to create innovative growth strategies Market Outlook & Future Trend Key Opportunities Prioritized Growth Rate ( High) Molecular Diagnostics Penetration rate is defined as the maturity of the product POCT segment and its application. The SMBG lower penetration rate means higher untapped market potential for growth. Coagulation Penetration Penetration Rate ( Low) Rate ( High) Growth rate is considered as the future projected CAGR till Hematology year 2012. A high growth rate is any rate above 10% vis-à-vis industry average of 8.5%. Microbiology Clinical Chemistry Immunoassay Growth Rate (Low) The positioning of various product lines indicate the potential opportunity in products based on growth in Asian market & its penetration status. Choosing a mixed profile would depend on the company’s objective to grow in specific product line and country of interest as displayed on next slide. 23
  • 25. Partnering with clients to create innovative growth strategies Market Outlook & Future Trend Key Opportunities Prioritized The Current Attractiveness of High Market is defined in terms of overall size, historical growth rates, competitive structure, legal & regulatory requirements and Current Market Attractiveness acceptance rate of various IVD technologies. Med The Future Growth Opportunity is defined as the overall future IVD market favourability on the same dimensions as explained above. In addition, factors which decide the growth potential are socio-economic Low drivers & restrains in that particular country, forecasted market size, and expected technological advancement in diagnostics industry. Strong Med Weak IVD Future Growth Opportunity The objective of this diagram is for illustrative purpose only which positions various Asian countries on two dimension i.e. Current & Future opportunities available in market. The notable argument of this diagram could be to highlight the markets depending on its maturity( in terms of current acceptance rate of IVD devices & reagents) and how the country is developing to bring growth for the same. 24
  • 26. Partnering with clients to create innovative growth strategies Diagnostics & Devices Industry: OUTLOOK 2009 Name Account Executive Healthcare Asia Pacific, +65.xxxx.xxxx xxxx @frost.com Prepared by Frost & Sullivan Health Care Consulting Practice APAC Siddharth Singh May 2009 Consultant Healthcare Asia Pacific, +60.6204.5685 © 2009 Frost & Sullivan. All rights reserved. This document contains highly confidential information and is the sole property of Frost & Sullivan. siddharth.singh@frost.com No part of it may be circulated, quoted, copied or otherwise reproduced without the written approval of Frost & Sullivan. 25 1