The document provides an overview of the diagnostics market in Asia. It notes that the market is expected to grow at a CAGR of 8.5% between 2007-2008 due to factors such as increasing healthcare spending, aging populations, and demand for preventative healthcare tools. The largest regional markets are China, India, and Japan, though all markets are expected to see steady growth. The largest product segments are clinical chemistry, immuno-chemistry, and self-monitoring blood glucose devices.
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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”
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
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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
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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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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
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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.
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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.
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