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NOVEMBER
Pharmaceuticals                                       2011




For updated information, please visit www.ibef.org              1
NOVEMBER
Pharmaceuticals                                       2011




                                 Contents
                                Advantage India

                                Market overview and trends

                                Growth drivers

                                Opportunities

                                Success story: Sun Pharma

                                Useful information




For updated information, please visit www.ibef.org


                                                                2
NOVEMBER
Pharmaceuticals                                            2011



Advantage India

                                                                                                                                    2020F
                                Cost Efficiency                                 Economic Drivers
                                                                                                                                Market size:
                    •   Low cost of production and R&D                    •   Economic prosperity to                              USD55
                        boosts efficiency of Indian pharma                    improve affordability of drugs                      billion
                        companies
                                                                          •   Increasing penetration of
                    •   Comparative cost advantage                            health insurance
                        enhances Indian pharma exports



                                                           Advantage
                                                             India
                             Diversified Portfolio                             Policy Support
                    •   Accounts for over 8 per cent of           •    Government unveiled ‘Pharma Vision
                        global pharmaceutical production               2020’ aimed at making India a global
                                                                       leader in end-to-end drug
                    •   Over 60,000 generic brands across              manufacture
                        60 therapeutic categories
                                                                  •    Reduced approval time for new
    2010            •   Manufactures more than 500                     facilities to boost investments
                        different APIs
 Market size:
  USD18.8
   billion                                                                                                          Source: BMI, Aranca Research
                                                                               2015 revenue forecasts are estimates of BMI, United States Food
                                                                                and Drug Association (USFDA), BMI stands for Business Monitor
                                                                                 International, API stands for Active Pharmaceutical Ingredients

For updated information, please visit www.ibef.org                                                                        ADVANTAGE INDIA          3
NOVEMBER
Pharmaceuticals                                       2011




                                 Contents
                                Advantage India

                                Market overview and trends

                                Growth drivers

                                Opportunities

                                Success story: Sun Pharma

                                Useful information




For updated information, please visit www.ibef.org


                                                                4
NOVEMBER
  Pharmaceuticals                                              2011


Evolution of the Indian pharmaceutical
sector


                                                                                             2005 onwards



                                                                 1990–2005




                                   1970–1990                                                        • Indian companies
                                                                                                      increasingly
                                                                      • Liberalised market            launch operations
                                                                      • Domestic players              in foreign
                                                                        expand                        countries
                                                                        aggressively                • India a major
                                               • Indian Patent Act
                                                                      • Increased                     destination for
          Before 1970                            passed in 1970
                                                                        propensity for                generic drug
                                               • Several domestic
                                                                        R&D                           manufacture
                                                 companies start
                                                                                                    • Higher spending
                                                 operations
                        • Market                                                                      on R&D due to the
                                               • Development of
                          dominated by                                                                introduction of
                                                 production
                          foreign                                                                     product patents
                                                 infrastructure
                          companies, with      • Export initiatives
                          little domestic        taken
                          participation



  For updated information, please visit www.ibef.org                                                        MARKET OVERVIEW AND TRENDS   5
NOVEMBER
Pharmaceuticals                                      2011


API is the largest segment of the Indian
pharma industry
                                                                   • Market Size: USD4.8 billion as of 2010
                                         Active pharmaceutical
                                                                   • India is expected to supplant Italy as the second
                                              ingredients
                                                                      largest producer of APIs globally
                                                 (APIs)


                                                                   • Market size: USD2.5 billion as of 2009
                                        Contract research and
                                                                   • Fragmented market with more than 1000 players
                                        manufacturing services
                                              (CRAMS)              • Expected market size of over USD7 billion by 2012

 Pharmaceutical
    industry                                                       • Market size: USD2.3 billion as of 2007
                                                                   • The formulation market consists of prescription and
                                             Formulations
                                                                      OTC drugs; it is expected to expand more than 13
                                                                      per cent annually over the next three years

                                                                   • Market size: USD200 million as of 2008
                                                                   • The government plans to allocate USD70 million for
                                              Biosimilars
                                                                      local players to develop biosimilars


                                                                 Source: BMI, Datamonitor, Various industry estimates, Aranca Research
                                                                                               Note: OTC stands for Over The Counter


For updated information, please visit www.ibef.org                                             MARKET OVERVIEW AND TRENDS                6
NOVEMBER
Pharmaceuticals                                      2011


Fast growth to continue in both
domestic, export segments … (1/2)


→   The Indian pharma market was estimated at USD21.7          Revenue of Indian pharma industry (USD billion)
    billion during 2011
                                                            2015F                                                              36.7
→   It is forecasted to double in five years reaching       2014F                                                       32.4
    USD36.7 billion by 2015
                                                            2013F                                                28.4
                                                            2012F                                         24.7
                                                            2011F                                  21.5
                                                            2010E                           18.4            CAGR:
                                                            2009                         15.6               15.6%

                                                            2008                    13.4
                                                            2007                  11.5



                                                                                              Source: BMI, Aranca Research
                                                                        Note: E stands for Estimates, F stands for Forecasts




For updated information, please visit www.ibef.org                                       MARKET OVERVIEW AND TRENDS                   7
NOVEMBER
Pharmaceuticals                                      2011


Fast growth to continue in both
domestic, export segments … (2/2)


→   Pharma exports from India are forecasted to increase     Trade data of Indian pharma industry (USD billion)
    more than two folds over the next five years
                                                                                                                                     16.7

→   The trade surplus in the pharma sector is likely to                                                                       13.5
                                                                                                                                        12.8
    expand to USD12.8 billion by 2015
                                                                                                                     10.5        10.5
                                                                                                            8.3         8.2
                                                                                                  7.2
                                                                                         6.1            5.6    6.5
                                                                     4.9         4.9
                                                            3.7            4.1              4.8
                                                               3.0                 3.9



                                                            2007 2008 2009 2010 2011E 2012F 2013F 2014F 2015F

                                                                                         Exports         Net exports


                                                                                                 Source: BMI, Aranca Research
                                                                           Note: E stands for Estimates, F stands for Forecasts




For updated information, please visit www.ibef.org                                                  MARKET OVERVIEW AND TRENDS                 8
NOVEMBER
Pharmaceuticals                                      2011


Alimentary drugs lead the market; India
is third in Asia-Pacific … (1/2)


→   Alimentary drugs command the largest share (over 13        Indian pharmaceutical market segments by value
    per cent) in the Indian pharma market                                         (2010E)


→   The cardiovascular segment represents 10 per cent of                                            Other therapeutic
    the market share; its contribution is likely to rise due              6% 3%
                                                                                                    purposes
    to the growing number of cardiac cases in India                                                 Alimentary/metabolism
                                                                     9%

                                                                                                    Cardiovascular
                                                               10%
                                                                                                    Respiratory
                                                                                         59%

                                                                 13%                                Central Nervous
                                                                                                    System
                                                                                                    Oncology



                                                                                  Source: Datamonitor, Aranca Research




For updated information, please visit www.ibef.org                                    MARKET OVERVIEW AND TRENDS            9
NOVEMBER
Pharmaceuticals                                      2011


Alimentary drugs lead the market; India
is third in Asia-Pacific … (2/2)


→   Japan accounts for over 50 per cent of pharmaceutical   Market share by value in Asia-Pacific (2010)
    sales in Asia-Pacific, followed by China which is a
    distant second with 19 per cent
                                                                        10%                        Japan
→   India, with a little over 10 per cent market share,
    ranks third by market size                                9%
                                                                                                   China

                                                            10%                                    India
                                                                                        52%

                                                                                                   South Korea
                                                                  19%
                                                                                                   Rest of Asia-Pacific




                                                                              Source: Datamonitor, Aranca Research




For updated information, please visit www.ibef.org                                MARKET OVERVIEW AND TRENDS              10
NOVEMBER
Pharmaceuticals                                         2011


Competitive market; top 4 firms account
for over 20 per cent


→   Piramal has the largest share (6.2 per cent) in the                             8%
    Indian pharma market with revenues of USD717 million
                                                                                    7%                                                     Piramal
    during FY10
                                                                                    6%                      717                            Cipla
→   During FY10, Lupin posted the highest growth in                                                                      654
                                                                                                                                           GSK
    revenue among the major players                                                 5%




                                                                     Market share
                                                                                                   524     544
                                                                                                                   449     514             Ranbaxy
                                                                                    4%
→   Ranbaxy, with a revenue base of USD524 million,                                                                  383       379         Sun
    ranks fourth in the market                                                      3%
                                                                                                                                           Zydus Cadila
                                                                                    2%
→   The top four firms account for just over one-fifth of                                                                                  Alkem
    the market share                                                                1%
                                                                                                                                           Lupin
                                                                                    0%
                                     Source: BMI, Aranca Research                        0%   5%     10%     15%     20%       25%   30%
                               Market share is in terms of revenue                                 Revenue growth (FY10)
                                                                                     The bubbles denote revenue earned during FY10 in USD
                                                                                     million




For updated information, please visit www.ibef.org                                                                MARKET OVERVIEW AND TRENDS          11
NOVEMBER
Pharmaceuticals                                      2011


Notable trends in the Indian
pharmaceuticals sector

                                     • Indian pharma companies spend 2 per cent of their total turnover on R&D
      Research and
                                     • Expenditure on R&D is likely to increase due to the introduction of product patents;
      development
                                       companies need to develop new drugs to boost sales


                                     • Due to its cost advantage, India is increasingly becoming a hub for clinical trials. Clinical
      Clinical trials
                                       trials market is estimated to be worth USD400 million in 2009



                                     • The pharmaceutical export market in India is thriving due to strong presence in the generic
      Export revenue
                                       space


                                     • Several multinational companies are collaborating with Indian pharma firms to develop
      Joint ventures                   new drugs
                                     • Pfizer partnered with Aurobindo Pharma to develop generic medicines


                                     • The introduction of product patents in India in 2005 has boosted the discovery of new
                                       drugs
      Product patents
                                     • India has reiterated its commitment to IP protection following the introduction of product
                                       patents




For updated information, please visit www.ibef.org                                                  MARKET OVERVIEW AND TRENDS         12
NOVEMBER
Pharmaceuticals                                       2011




                                 Contents
                                Advantage India

                                Market overview and trends

                                Growth drivers

                                Opportunities

                                Success story: Sun Pharma

                                Useful information




For updated information, please visit www.ibef.org


                                                                13
NOVEMBER
Pharmaceuticals                                      2011


Sector driven by confluence of - demand,
capabilities, policy                                                 •   Accessibility of drugs to
                                                                         greatly improve
                                                                     •   Increasing penetration of
                                                                         health insurance

                                                       Demand-       •   Growing number of stress-
                                                                         related diseases due to
                                                      side drivers       change in lifestyle




                                                       Growth
                                                       drivers


                                 Supply-side                              Policy            •   Reduction in approval time
•   Cost advantage                 drivers                               support                for new facilities

•   India a major hub for the                                                               •   Focus on specialised pharma
    manufacture of generics                                                                     education

•   Over 120 USFDA-approved                                                                 •   Improved accessibility for
    facilities                                                                                  BPL people


                                                                                          Notes: BPL means Below Poverty Line
For updated information, please visit www.ibef.org                                                       GROWTH DRIVERS       14
NOVEMBER
Pharmaceuticals                                      2011


Supply-side drivers of Indian pharma
industry
                                       • Following the introduction of product patents, several multinational companies are
       Launch of patented                expected to launch patented drugs in India
       drugs                           • Growth in the number of lifestyle related diseases in India could boost the sale of
                                         drugs in this segment

                                       • Due to its cost advantage, India has emerged as a major producer of generic drugs
       Scope in generics                 with several companies focussing on this sector
       market                          • With an expected market size of USD35 billion in 2015 vis-à-vis USD15 billion
                                         currently, there is immense potential for growth in India’s generic market



       Medical                         • Pharma companies have increased spending to tap rural markets and develop
       infrastructure                    better medical infrastructure




                                       • Increased penetration of chemists, especially in the rural parts of India would
       OTC drugs
                                         make OTC drugs easily available




For updated information, please visit www.ibef.org                                                           GROWTH DRIVERS    15
NOVEMBER
Pharmaceuticals                                             2011


Competency and cost efficiency
continue to be India’s forte … (1/2)


→   India has over 120 USFDA-approved and 84 UK MHRA-                       Number of USFDA-approved facilities in different
    approved manufacturing facilities                                                        countries


→   These facilities significantly support the companies                 Hungary    5
    involved in CRAMS
                                                                           Israel   8

                                                                          Taiwan        10
            Notes: USFDA is United States Food and Drug Administration
                      CRAMS is Contract Research and Medical Services
                                                                           Spain             25

                                                                           China             27

                                                                            Italy                 55

                                                                           India                                         120



                                                                                                       Source: BMI, Aranca Research




For updated information, please visit www.ibef.org                                                                GROWTH DRIVERS      16
NOVEMBER
Pharmaceuticals                                      2011


Competency and cost efficiency
continue to be India’s forte … (2/2)


→   The manufacturing cost of Indian pharma companies            Relative cost of production with US cost as base
    is up to 65 per cent lower than that of US firms and
    almost half of that of European manufacturers
                                                             India              40
→   Cost efficiency continues to create opportunities for
    Indian companies in emerging markets and Africa

                                                            Europe                              85




                                                               US                                    100




                                                                                           Source: BMI, Aranca Research




For updated information, please visit www.ibef.org                                                    GROWTH DRIVERS      17
NOVEMBER
  Pharmaceuticals                                           2011



Demand drivers of Indian pharma industry

                              Accessibility                                                    Acceptability
          • Over USD200 billion to be spent on medical infrastructure              • Rising levels of education to increase the
            in the next decade                                                       acceptability of pharmaceuticals

          • New business models expected to penetrate tier-2 and 3                 • Patients to show greater propensity to self
            cities                                                                   medicate, boosting the OTC market

          • Over 160,000 hospital beds expected to be added each                   • Acceptance of biologics and preventive
            year in the next decade                                                  medicines to rise

                                                                                   • Vaccine market could grow 20 per cent per year
                                                                     Demand          in the next decade
                                                                      drivers
                              Affordability                                               Epidemiological factors
          • Rising income could drive 73 million households to the         • Patient pool expected to increase over 20 per cent in
            middle class over the next ten years                             the next ten years mainly due to a rise in population

          • Over 650 million people expected to be covered by health       • Newer diseases and changes in lifestyle to boost
            insurance by 2020                                                demand

          • Government-sponsored programmes expected to provide
            health benefits to over 380 million BPL people




                                                                                     Source: Mckinsey pharma report 2020, Aranca Research

  For updated information, please visit www.ibef.org                                                                      GROWTH DRIVERS    18
NOVEMBER
Pharmaceuticals                                      2011


Anticipated steep growth in expenditure
on pharmaceuticals … (1/2)


→   From 28 per cent in 2007, expenditure on                   Expenditure on pharma as a % of expense on
    pharmaceuticals is likely to increase to over 40 per                       healthcare
    cent of the total spending on healthcare by
                                                                                                                      40.1
    households by 2015                                                                                         38.8
                                                                                                 35.7   37.3
                                                                                        34.1
                                                                          30.3   32.0
                                                            28.0   28.6




                                                            2007 2008 2009 2010E 2011F 2012F 2013F 2014F 2015F


                                                                                               Source: BMI, Aranca Research




For updated information, please visit www.ibef.org                                                        GROWTH DRIVERS      19
NOVEMBER
Pharmaceuticals                                      2011


Anticipated steep growth in expenditure
on pharmaceuticals … (2/2)


→   Growing per capita expenditure on pharmaceuticals                Per capita expenditure on pharmaceuticals
    in India offers ample opportunities for players in this                         (USD billion)
    market
                                                                                                                        35.3

                                                                                                                 29.9
                                                                                           CAGR:
                                                                                           15.7%          24.3

                                                                                            18.3   20.3
                                                                                    16.1
                                                                             13.5
                                                              11.0    12.0




                                                              2007 2008 2009 2010E 2011F 2012F 2013F 2014F 2015F


                                                                                              Source: BMI, Aranca Research




For updated information, please visit www.ibef.org                                                        GROWTH DRIVERS       20
NOVEMBER
Pharmaceuticals                                      2011


Favourable policy measures support
growth

      Reduction in approval          • Steps taken to reduce approval time for new facilities
      time for new facilities        • NOC for export license issued in two weeks compared to 12 weeks earlier



                                     • MOUs with USFDA, WHO, Health Canada, etc. to boost growth of the Indian
      Collaborations
                                        Pharma sector by benefiting from their expertise



      Support for                    • Zero duty for technology upgrades in the pharmaceutical sector through the Export
      technology upgrades               Promotion Capital Goods (EPCG) Scheme
      and FDIs                       • The automatic route to facilitate 100 per cent foreign direct investment (FDI)



                                     • Government of India plans to set up a USD640 million VC fund to boost drug
      Industry infrastructure
                                        discovery and strengthen the pharma infrastructure



                                     • Pharma Vision 2020 by the government’s Department of Pharmaceuticals aims to
      Pharma vision 2020
                                        make India a major hub for end-to-end drug discovery

                                                                           Notes: NOC – No objection certificate; VC – Venture Capital
                                                                                            MOU – Memorandum of Understanding

For updated information, please visit www.ibef.org                                                                GROWTH DRIVERS         21
NOVEMBER
Pharmaceuticals                                      2011


Government-led initiatives aim at better
availability of drugs … (1/2)


→   Government spending on healthcare expanded at a                    Government spending on healthcare
    CAGR of 18 per cent during 2005–09                                          (USD billion)


→   Increased government expenditure on healthcare
                                                                                      CAGR:
    could create an over USD4.5 billion market for
                                                                                      18.0%                     3.3
    pharmaceuticals in the next few years
                                                                                                  2.8
                                                                                    2.1
                                                                        1.8
                                                                                                                8.4
                                                                                    5.6           6.4
                                                                        4.9



                                                            Share of   FY06         FY07         FY08          FY09
                                                              GDP      0.84%        0.84%        0.88%        0.93%
                                                                                   State    Central

                                                                               Source: Mckinsey estimates, Aranca Research




For updated information, please visit www.ibef.org                                                    GROWTH DRIVERS         22
NOVEMBER
Pharmaceuticals                                               2011


Government-led initiatives aim at better
availability of drugs … (2/2)


→   Penetration of health insurance is expected to more                     Population covered by health insurance
    than double by 2020                                                                  (in million)

                                                                                                            525
→   Increasing penetration of health insurance is likely to
    be driven by government-sponsored initiatives such as
    RSBY and ESIC
                                                                            265
     Note: RSBY stands for Rashtriya Swastha Bima Yojna; ESIC stands for
                                   Employees State Insurance Corporation                                                   130

                                                                                          35


                                                                                  2010                             2020F

                                                                           Government-sponsored Insurance         Private Insurance


                                                                                         Source: Mckinsey estimates, Aranca Research




For updated information, please visit www.ibef.org                                                                GROWTH DRIVERS       23
NOVEMBER
Pharmaceuticals                                      2011


Investments, JVs infusing superior
capabilities in Indian firms
→   In recent years, several foreign players have made acquisitions in India to get a foothold in the country’s pharma
    market and leverage on the technical and cost efficiency of Indian companies

→   Increasing number of companies are forming JVs to benefit from research and development; large firms from
    developed markets are venturing with Indian majors to develop new medicines
                                                                                                  Notes: JV is joint venture

           Indian company                Foreign Company            Value (USD million)               Type
           Aurobindo Pharma                   OJSC Diod                Not disclosed      Sell pharma products in Russia
                                                                                          Marketing and manufacturing
              Sun Pharma                       Merck                   Not disclosed
                                                                                                      JV
                 Cadila                         Bayer                  Not disclosed             Marketing JV
                Biocon                         Pfizer                      350                Insulin marketing deal
             Paras Pharma                 Reckitt Benckiser                726                     Acquisition
               Piramal                         Abbot                       3720                  Business buyout
           Orchid Chemicals                   Hospira                      400                   Business buyout
                                                                                            Generic development and
          Aurobindo Pharma                     Pfizer                  Not disclosed
                                                                                                     supply
            Shantha Biotech                Sanofi Aventis                  783                     Acquisition
            Ranbaxy Labs                   Daiichi Sankyo                  4600                    Acquisition
            Dabur Pharma                   Fresenius Kabi                   219                    Acquisition
                                                                                              Source: BMI, Aranca Research
For updated information, please visit www.ibef.org                                                   GROWTH DRIVERS            24
NOVEMBER
Pharmaceuticals                                       2011




                                 Contents
                                Advantage India

                                Market overview and trends

                                Growth drivers

                                Opportunities

                                Success story: Sun Pharma

                                Useful information




For updated information, please visit www.ibef.org


                                                                25
NOVEMBER
Pharmaceuticals                                      2011


Opportunities abound in clinical trials
and high-end drugs

           Clinical trial market                     High-end drugs            Penetration in rural market


      • The Indian clinical trial            • Due to increasing population   • With 70 per cent of India’s
        market is estimated to be              and income levels, demand        population residing in rural
        worth USD1.5 billion                   for high-end drugs is            areas, there are immense
                                               expected to rise                 opportunities for pharma
      • According to various studies,                                           companies to tap this
        India is among the leaders           • Demand for high-end drugs        market
        in the clinical trial market           could reach USD8 billion by
                                               2015                           • Demand for generic
      • Due to a genetically-diverse                                            medicines in rural markets
        population and availability          • Growing demand could             has grown sharply. Various
        of skilled doctors, India has          open up the market for the       companies investing in the
        the potential to attract huge          production of high-end           distribution network in rural
        investments to its clinical            drugs in India                   areas
        trial market




                                                                                      Source: BMI, Aranca Research


For updated information, please visit www.ibef.org                                                    OPPORTUNITIES   26
NOVEMBER
Pharmaceuticals                                      2011


Drug sales to more than double by 2015
across segments … (1/2)


→   The share of generic drugs is expected to continue to     Share of patented and generic drugs in overall market
    increase; it could represent 90 per cent of the                               (USD billion)
    prescription drug market by 2015
                                                                                                                       35.3
→   Due to their competence in generic drugs, growth in                                                         29.7
    this market offers a great opportunity for Indian firms
                                                                                                         23.9
                                                                                                  19.7
                                                                                          17.5
                                                                                   15.1
                                                                            12.6
                                                               9.9   10.9

                                                                                                          2.6   3.2    4.0
                                                               1.0   1.1    1.2    1.6    1.8      2.1

                                                              2007 2008 2009 2010 2011F 2012F 2013F 2014F 2015F

                                                                        Patented drug sales       Generic drug sales


                                                                                                 Source: BMI, Aranca Research




For updated information, please visit www.ibef.org                                                           OPPORTUNITIES      27
NOVEMBER
Pharmaceuticals                                      2011


Drug sales to more than double by 2015
across segments … (2/2)


→   The OTC market is forecasted to be worth USD4.7                 OTC drug market (USD billion)
    billion by 2015
                                                            2015F                                                 4.7
→   The inclusion of various other drugs and cosmetics      2014F                                           3.9
    under the OTC market may provide a further boost to
                                                            2013F                                  3.2
    this sector
                                                            2012F                           2.6
                                                            2011F                          2.4
                                                            2010                     2.1
                                                            2009                   1.8
                                                            2008             1.6
                                                            2007            1.5




                                                                                           Source: BMI, Aranca Research




For updated information, please visit www.ibef.org                                                       OPPORTUNITIES    28
NOVEMBER
Pharmaceuticals                                       2011




                                 Contents
                                Advantage India

                                Market overview and trends

                                Growth drivers

                                Opportunities

                                Success story: Sun Pharma

                                Useful information




For updated information, please visit www.ibef.org


                                                                29
NOVEMBER
Pharmaceuticals                                       2011


Sun Pharma: Leveraging its generic
market capabilities
                                                                                    Focus on R&D

  Revenue base of over
                                                                                                                    Acquisitions across
      USD500 million                                                                                                    the globe



  Market capitalisation of
       USD1 billion


                                   Organic growth
  Over half the sales from
                                       phase
      North America

                                                             All-India operations
                                                                    begin
    Strong presence in
     generics market

                                                                                                         First
                                                  Nationwide
   Among the top five        Commenced                                                              international             Acquired
                                                   marketing             Built the first API
      Indian pharma          operations in                                                           acquisition:          controlling stake
                                                operations rolled               plant
        companies              Calcutta                                                            Niche Brand in               in Taro
                                                       out
                                                                                                       the US

                                1983                  1987                      1995                  2004                        2010
                                                                                                                    Source: Sun Pharma website
For updated information, please visit www.ibef.org                                                      SUCCESS STORY: SUN PHARMA           30
NOVEMBER
Pharmaceuticals                                       2011




                                 Contents
                                Advantage India

                                Market overview and trends

                                Growth drivers

                                Opportunities

                                Success story: Sun Pharma

                                Useful information




For updated information, please visit www.ibef.org


                                                                31
NOVEMBER
Pharmaceuticals                                      2011



Industry Associations

The Indian Pharmaceutical Association                       Organisation of Pharmaceutical Producers of India
Kalina, Santacruz (E),                                      Peninsula Chambers, Ground Floor,
Mumbai – 400 098                                            Ganpatrao Kadam Marg, Lower Parel,
Phone: 91-22-2667 1072                                      Mumbai – 400 013
Fax: 91 22 2667 0744                                        Phone: 9122 24918123, 24912486, 66627007
E-mail: ipacentre@ipapharma.org                             Fax: 9122 24915168
www.ipapharma.org                                           E-mail: indiaoppi@vsnl.com
                                                            www.indiaoppi.com
Indian Drug Manufacturers' Association
102-B, Poonam Chambers, Dr A.B. Road                        Bulk Drug Manufacturers Association
Worli, Mumbai – 400 018                                     C-25, Industrial Estate, Sanath Nagar
Phone: 91-22-2494 4624/2497 4308                            Hyderabad – 500018
Fax: 9122 24950723                                          Phone: 91 40 23703910/23706718
E-mail: idma1@idmaindia.com                                 Fax: 91 40 23704804
www.idma-assn.org                                           E-mail: info@bdmai.org
                                                            www.bdmai.org




For updated information, please visit www.ibef.org                                         USEFUL INFORMATION   32
NOVEMBER
Pharmaceuticals                                      2011



Glossary

→   CRAMS: Contract Research and Manufacturing Services

→   API: Active Pharmaceutical Ingredients

→   FDI: Foreign Direct Investment

→   GOI: Government of India

→   INR: Indian Rupee

→   USD: US Dollar

→   BPL: Below Poverty Line

→   RSBY: Rashtriya Swastha Bima Yojna

→   ESIC: Employees State Insurance Corporation

→   Wherever applicable, numbers have been rounded off to the nearest whole number




For updated information, please visit www.ibef.org                                   USEFUL INFORMATION   33
NOVEMBER
Pharmaceuticals                                      2011



Disclaimer


  India Brand Equity Foundation (IBEF) engaged Aranca to        presentation to ensure that the information is accurate to
  prepare this presentation and the same has been               the best of Aranca and IBEF’s knowledge and belief, the
  prepared by Aranca in consultation with IBEF.                 content is not to be construed in any manner whatsoever
                                                                as a substitute for professional advice.
  All rights reserved. All copyright in this presentation and
  related works is solely and exclusively owned by IBEF.        Aranca and IBEF neither recommend nor endorse any
  The same may not be reproduced, wholly or in part in          specific products or services that may have been
  any material form (including photocopying or storing it in    mentioned in this presentation and nor do they assume
  any medium by electronic means and whether or not             any liability or responsibility for the outcome of decisions
  transiently or incidentally to some other use of this         taken as a result of any reliance placed on this
  presentation), modified or in any manner communicated         presentation.
  to any third party except with the written approval of
  IBEF.                                                         Neither Aranca nor IBEF shall be liable for any direct or
                                                                indirect damages that may arise due to any act or
  This presentation is for information purposes only. While     omission on the part of the user due to any reliance
  due care has been taken during the compilation of this        placed or guidance taken from any portion of this
                                                                presentation.




For updated information, please visit www.ibef.org                                                            DISCLAIMER   34

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Indian Pharmaceutical Industry

  • 1. NOVEMBER Pharmaceuticals 2011 For updated information, please visit www.ibef.org 1
  • 2. NOVEMBER Pharmaceuticals 2011 Contents  Advantage India  Market overview and trends  Growth drivers  Opportunities  Success story: Sun Pharma  Useful information For updated information, please visit www.ibef.org 2
  • 3. NOVEMBER Pharmaceuticals 2011 Advantage India 2020F Cost Efficiency Economic Drivers Market size: • Low cost of production and R&D • Economic prosperity to USD55 boosts efficiency of Indian pharma improve affordability of drugs billion companies • Increasing penetration of • Comparative cost advantage health insurance enhances Indian pharma exports Advantage India Diversified Portfolio Policy Support • Accounts for over 8 per cent of • Government unveiled ‘Pharma Vision global pharmaceutical production 2020’ aimed at making India a global leader in end-to-end drug • Over 60,000 generic brands across manufacture 60 therapeutic categories • Reduced approval time for new 2010 • Manufactures more than 500 facilities to boost investments different APIs Market size: USD18.8 billion Source: BMI, Aranca Research 2015 revenue forecasts are estimates of BMI, United States Food and Drug Association (USFDA), BMI stands for Business Monitor International, API stands for Active Pharmaceutical Ingredients For updated information, please visit www.ibef.org ADVANTAGE INDIA 3
  • 4. NOVEMBER Pharmaceuticals 2011 Contents  Advantage India  Market overview and trends  Growth drivers  Opportunities  Success story: Sun Pharma  Useful information For updated information, please visit www.ibef.org 4
  • 5. NOVEMBER Pharmaceuticals 2011 Evolution of the Indian pharmaceutical sector 2005 onwards 1990–2005 1970–1990 • Indian companies increasingly • Liberalised market launch operations • Domestic players in foreign expand countries aggressively • India a major • Indian Patent Act • Increased destination for Before 1970 passed in 1970 propensity for generic drug • Several domestic R&D manufacture companies start • Higher spending operations • Market on R&D due to the • Development of dominated by introduction of production foreign product patents infrastructure companies, with • Export initiatives little domestic taken participation For updated information, please visit www.ibef.org MARKET OVERVIEW AND TRENDS 5
  • 6. NOVEMBER Pharmaceuticals 2011 API is the largest segment of the Indian pharma industry • Market Size: USD4.8 billion as of 2010 Active pharmaceutical • India is expected to supplant Italy as the second ingredients largest producer of APIs globally (APIs) • Market size: USD2.5 billion as of 2009 Contract research and • Fragmented market with more than 1000 players manufacturing services (CRAMS) • Expected market size of over USD7 billion by 2012 Pharmaceutical industry • Market size: USD2.3 billion as of 2007 • The formulation market consists of prescription and Formulations OTC drugs; it is expected to expand more than 13 per cent annually over the next three years • Market size: USD200 million as of 2008 • The government plans to allocate USD70 million for Biosimilars local players to develop biosimilars Source: BMI, Datamonitor, Various industry estimates, Aranca Research Note: OTC stands for Over The Counter For updated information, please visit www.ibef.org MARKET OVERVIEW AND TRENDS 6
  • 7. NOVEMBER Pharmaceuticals 2011 Fast growth to continue in both domestic, export segments … (1/2) → The Indian pharma market was estimated at USD21.7 Revenue of Indian pharma industry (USD billion) billion during 2011 2015F 36.7 → It is forecasted to double in five years reaching 2014F 32.4 USD36.7 billion by 2015 2013F 28.4 2012F 24.7 2011F 21.5 2010E 18.4 CAGR: 2009 15.6 15.6% 2008 13.4 2007 11.5 Source: BMI, Aranca Research Note: E stands for Estimates, F stands for Forecasts For updated information, please visit www.ibef.org MARKET OVERVIEW AND TRENDS 7
  • 8. NOVEMBER Pharmaceuticals 2011 Fast growth to continue in both domestic, export segments … (2/2) → Pharma exports from India are forecasted to increase Trade data of Indian pharma industry (USD billion) more than two folds over the next five years 16.7 → The trade surplus in the pharma sector is likely to 13.5 12.8 expand to USD12.8 billion by 2015 10.5 10.5 8.3 8.2 7.2 6.1 5.6 6.5 4.9 4.9 3.7 4.1 4.8 3.0 3.9 2007 2008 2009 2010 2011E 2012F 2013F 2014F 2015F Exports Net exports Source: BMI, Aranca Research Note: E stands for Estimates, F stands for Forecasts For updated information, please visit www.ibef.org MARKET OVERVIEW AND TRENDS 8
  • 9. NOVEMBER Pharmaceuticals 2011 Alimentary drugs lead the market; India is third in Asia-Pacific … (1/2) → Alimentary drugs command the largest share (over 13 Indian pharmaceutical market segments by value per cent) in the Indian pharma market (2010E) → The cardiovascular segment represents 10 per cent of Other therapeutic the market share; its contribution is likely to rise due 6% 3% purposes to the growing number of cardiac cases in India Alimentary/metabolism 9% Cardiovascular 10% Respiratory 59% 13% Central Nervous System Oncology Source: Datamonitor, Aranca Research For updated information, please visit www.ibef.org MARKET OVERVIEW AND TRENDS 9
  • 10. NOVEMBER Pharmaceuticals 2011 Alimentary drugs lead the market; India is third in Asia-Pacific … (2/2) → Japan accounts for over 50 per cent of pharmaceutical Market share by value in Asia-Pacific (2010) sales in Asia-Pacific, followed by China which is a distant second with 19 per cent 10% Japan → India, with a little over 10 per cent market share, ranks third by market size 9% China 10% India 52% South Korea 19% Rest of Asia-Pacific Source: Datamonitor, Aranca Research For updated information, please visit www.ibef.org MARKET OVERVIEW AND TRENDS 10
  • 11. NOVEMBER Pharmaceuticals 2011 Competitive market; top 4 firms account for over 20 per cent → Piramal has the largest share (6.2 per cent) in the 8% Indian pharma market with revenues of USD717 million 7% Piramal during FY10 6% 717 Cipla → During FY10, Lupin posted the highest growth in 654 GSK revenue among the major players 5% Market share 524 544 449 514 Ranbaxy 4% → Ranbaxy, with a revenue base of USD524 million, 383 379 Sun ranks fourth in the market 3% Zydus Cadila 2% → The top four firms account for just over one-fifth of Alkem the market share 1% Lupin 0% Source: BMI, Aranca Research 0% 5% 10% 15% 20% 25% 30% Market share is in terms of revenue Revenue growth (FY10) The bubbles denote revenue earned during FY10 in USD million For updated information, please visit www.ibef.org MARKET OVERVIEW AND TRENDS 11
  • 12. NOVEMBER Pharmaceuticals 2011 Notable trends in the Indian pharmaceuticals sector • Indian pharma companies spend 2 per cent of their total turnover on R&D Research and • Expenditure on R&D is likely to increase due to the introduction of product patents; development companies need to develop new drugs to boost sales • Due to its cost advantage, India is increasingly becoming a hub for clinical trials. Clinical Clinical trials trials market is estimated to be worth USD400 million in 2009 • The pharmaceutical export market in India is thriving due to strong presence in the generic Export revenue space • Several multinational companies are collaborating with Indian pharma firms to develop Joint ventures new drugs • Pfizer partnered with Aurobindo Pharma to develop generic medicines • The introduction of product patents in India in 2005 has boosted the discovery of new drugs Product patents • India has reiterated its commitment to IP protection following the introduction of product patents For updated information, please visit www.ibef.org MARKET OVERVIEW AND TRENDS 12
  • 13. NOVEMBER Pharmaceuticals 2011 Contents  Advantage India  Market overview and trends  Growth drivers  Opportunities  Success story: Sun Pharma  Useful information For updated information, please visit www.ibef.org 13
  • 14. NOVEMBER Pharmaceuticals 2011 Sector driven by confluence of - demand, capabilities, policy • Accessibility of drugs to greatly improve • Increasing penetration of health insurance Demand- • Growing number of stress- related diseases due to side drivers change in lifestyle Growth drivers Supply-side Policy • Reduction in approval time • Cost advantage drivers support for new facilities • India a major hub for the • Focus on specialised pharma manufacture of generics education • Over 120 USFDA-approved • Improved accessibility for facilities BPL people Notes: BPL means Below Poverty Line For updated information, please visit www.ibef.org GROWTH DRIVERS 14
  • 15. NOVEMBER Pharmaceuticals 2011 Supply-side drivers of Indian pharma industry • Following the introduction of product patents, several multinational companies are Launch of patented expected to launch patented drugs in India drugs • Growth in the number of lifestyle related diseases in India could boost the sale of drugs in this segment • Due to its cost advantage, India has emerged as a major producer of generic drugs Scope in generics with several companies focussing on this sector market • With an expected market size of USD35 billion in 2015 vis-à-vis USD15 billion currently, there is immense potential for growth in India’s generic market Medical • Pharma companies have increased spending to tap rural markets and develop infrastructure better medical infrastructure • Increased penetration of chemists, especially in the rural parts of India would OTC drugs make OTC drugs easily available For updated information, please visit www.ibef.org GROWTH DRIVERS 15
  • 16. NOVEMBER Pharmaceuticals 2011 Competency and cost efficiency continue to be India’s forte … (1/2) → India has over 120 USFDA-approved and 84 UK MHRA- Number of USFDA-approved facilities in different approved manufacturing facilities countries → These facilities significantly support the companies Hungary 5 involved in CRAMS Israel 8 Taiwan 10 Notes: USFDA is United States Food and Drug Administration CRAMS is Contract Research and Medical Services Spain 25 China 27 Italy 55 India 120 Source: BMI, Aranca Research For updated information, please visit www.ibef.org GROWTH DRIVERS 16
  • 17. NOVEMBER Pharmaceuticals 2011 Competency and cost efficiency continue to be India’s forte … (2/2) → The manufacturing cost of Indian pharma companies Relative cost of production with US cost as base is up to 65 per cent lower than that of US firms and almost half of that of European manufacturers India 40 → Cost efficiency continues to create opportunities for Indian companies in emerging markets and Africa Europe 85 US 100 Source: BMI, Aranca Research For updated information, please visit www.ibef.org GROWTH DRIVERS 17
  • 18. NOVEMBER Pharmaceuticals 2011 Demand drivers of Indian pharma industry Accessibility Acceptability • Over USD200 billion to be spent on medical infrastructure • Rising levels of education to increase the in the next decade acceptability of pharmaceuticals • New business models expected to penetrate tier-2 and 3 • Patients to show greater propensity to self cities medicate, boosting the OTC market • Over 160,000 hospital beds expected to be added each • Acceptance of biologics and preventive year in the next decade medicines to rise • Vaccine market could grow 20 per cent per year Demand in the next decade drivers Affordability Epidemiological factors • Rising income could drive 73 million households to the • Patient pool expected to increase over 20 per cent in middle class over the next ten years the next ten years mainly due to a rise in population • Over 650 million people expected to be covered by health • Newer diseases and changes in lifestyle to boost insurance by 2020 demand • Government-sponsored programmes expected to provide health benefits to over 380 million BPL people Source: Mckinsey pharma report 2020, Aranca Research For updated information, please visit www.ibef.org GROWTH DRIVERS 18
  • 19. NOVEMBER Pharmaceuticals 2011 Anticipated steep growth in expenditure on pharmaceuticals … (1/2) → From 28 per cent in 2007, expenditure on Expenditure on pharma as a % of expense on pharmaceuticals is likely to increase to over 40 per healthcare cent of the total spending on healthcare by 40.1 households by 2015 38.8 35.7 37.3 34.1 30.3 32.0 28.0 28.6 2007 2008 2009 2010E 2011F 2012F 2013F 2014F 2015F Source: BMI, Aranca Research For updated information, please visit www.ibef.org GROWTH DRIVERS 19
  • 20. NOVEMBER Pharmaceuticals 2011 Anticipated steep growth in expenditure on pharmaceuticals … (2/2) → Growing per capita expenditure on pharmaceuticals Per capita expenditure on pharmaceuticals in India offers ample opportunities for players in this (USD billion) market 35.3 29.9 CAGR: 15.7% 24.3 18.3 20.3 16.1 13.5 11.0 12.0 2007 2008 2009 2010E 2011F 2012F 2013F 2014F 2015F Source: BMI, Aranca Research For updated information, please visit www.ibef.org GROWTH DRIVERS 20
  • 21. NOVEMBER Pharmaceuticals 2011 Favourable policy measures support growth Reduction in approval • Steps taken to reduce approval time for new facilities time for new facilities • NOC for export license issued in two weeks compared to 12 weeks earlier • MOUs with USFDA, WHO, Health Canada, etc. to boost growth of the Indian Collaborations Pharma sector by benefiting from their expertise Support for • Zero duty for technology upgrades in the pharmaceutical sector through the Export technology upgrades Promotion Capital Goods (EPCG) Scheme and FDIs • The automatic route to facilitate 100 per cent foreign direct investment (FDI) • Government of India plans to set up a USD640 million VC fund to boost drug Industry infrastructure discovery and strengthen the pharma infrastructure • Pharma Vision 2020 by the government’s Department of Pharmaceuticals aims to Pharma vision 2020 make India a major hub for end-to-end drug discovery Notes: NOC – No objection certificate; VC – Venture Capital MOU – Memorandum of Understanding For updated information, please visit www.ibef.org GROWTH DRIVERS 21
  • 22. NOVEMBER Pharmaceuticals 2011 Government-led initiatives aim at better availability of drugs … (1/2) → Government spending on healthcare expanded at a Government spending on healthcare CAGR of 18 per cent during 2005–09 (USD billion) → Increased government expenditure on healthcare CAGR: could create an over USD4.5 billion market for 18.0% 3.3 pharmaceuticals in the next few years 2.8 2.1 1.8 8.4 5.6 6.4 4.9 Share of FY06 FY07 FY08 FY09 GDP 0.84% 0.84% 0.88% 0.93% State Central Source: Mckinsey estimates, Aranca Research For updated information, please visit www.ibef.org GROWTH DRIVERS 22
  • 23. NOVEMBER Pharmaceuticals 2011 Government-led initiatives aim at better availability of drugs … (2/2) → Penetration of health insurance is expected to more Population covered by health insurance than double by 2020 (in million) 525 → Increasing penetration of health insurance is likely to be driven by government-sponsored initiatives such as RSBY and ESIC 265 Note: RSBY stands for Rashtriya Swastha Bima Yojna; ESIC stands for Employees State Insurance Corporation 130 35 2010 2020F Government-sponsored Insurance Private Insurance Source: Mckinsey estimates, Aranca Research For updated information, please visit www.ibef.org GROWTH DRIVERS 23
  • 24. NOVEMBER Pharmaceuticals 2011 Investments, JVs infusing superior capabilities in Indian firms → In recent years, several foreign players have made acquisitions in India to get a foothold in the country’s pharma market and leverage on the technical and cost efficiency of Indian companies → Increasing number of companies are forming JVs to benefit from research and development; large firms from developed markets are venturing with Indian majors to develop new medicines Notes: JV is joint venture Indian company Foreign Company Value (USD million) Type Aurobindo Pharma OJSC Diod Not disclosed Sell pharma products in Russia Marketing and manufacturing Sun Pharma Merck Not disclosed JV Cadila Bayer Not disclosed Marketing JV Biocon Pfizer 350 Insulin marketing deal Paras Pharma Reckitt Benckiser 726 Acquisition Piramal Abbot 3720 Business buyout Orchid Chemicals Hospira 400 Business buyout Generic development and Aurobindo Pharma Pfizer Not disclosed supply Shantha Biotech Sanofi Aventis 783 Acquisition Ranbaxy Labs Daiichi Sankyo 4600 Acquisition Dabur Pharma Fresenius Kabi 219 Acquisition Source: BMI, Aranca Research For updated information, please visit www.ibef.org GROWTH DRIVERS 24
  • 25. NOVEMBER Pharmaceuticals 2011 Contents  Advantage India  Market overview and trends  Growth drivers  Opportunities  Success story: Sun Pharma  Useful information For updated information, please visit www.ibef.org 25
  • 26. NOVEMBER Pharmaceuticals 2011 Opportunities abound in clinical trials and high-end drugs Clinical trial market High-end drugs Penetration in rural market • The Indian clinical trial • Due to increasing population • With 70 per cent of India’s market is estimated to be and income levels, demand population residing in rural worth USD1.5 billion for high-end drugs is areas, there are immense expected to rise opportunities for pharma • According to various studies, companies to tap this India is among the leaders • Demand for high-end drugs market in the clinical trial market could reach USD8 billion by 2015 • Demand for generic • Due to a genetically-diverse medicines in rural markets population and availability • Growing demand could has grown sharply. Various of skilled doctors, India has open up the market for the companies investing in the the potential to attract huge production of high-end distribution network in rural investments to its clinical drugs in India areas trial market Source: BMI, Aranca Research For updated information, please visit www.ibef.org OPPORTUNITIES 26
  • 27. NOVEMBER Pharmaceuticals 2011 Drug sales to more than double by 2015 across segments … (1/2) → The share of generic drugs is expected to continue to Share of patented and generic drugs in overall market increase; it could represent 90 per cent of the (USD billion) prescription drug market by 2015 35.3 → Due to their competence in generic drugs, growth in 29.7 this market offers a great opportunity for Indian firms 23.9 19.7 17.5 15.1 12.6 9.9 10.9 2.6 3.2 4.0 1.0 1.1 1.2 1.6 1.8 2.1 2007 2008 2009 2010 2011F 2012F 2013F 2014F 2015F Patented drug sales Generic drug sales Source: BMI, Aranca Research For updated information, please visit www.ibef.org OPPORTUNITIES 27
  • 28. NOVEMBER Pharmaceuticals 2011 Drug sales to more than double by 2015 across segments … (2/2) → The OTC market is forecasted to be worth USD4.7 OTC drug market (USD billion) billion by 2015 2015F 4.7 → The inclusion of various other drugs and cosmetics 2014F 3.9 under the OTC market may provide a further boost to 2013F 3.2 this sector 2012F 2.6 2011F 2.4 2010 2.1 2009 1.8 2008 1.6 2007 1.5 Source: BMI, Aranca Research For updated information, please visit www.ibef.org OPPORTUNITIES 28
  • 29. NOVEMBER Pharmaceuticals 2011 Contents  Advantage India  Market overview and trends  Growth drivers  Opportunities  Success story: Sun Pharma  Useful information For updated information, please visit www.ibef.org 29
  • 30. NOVEMBER Pharmaceuticals 2011 Sun Pharma: Leveraging its generic market capabilities Focus on R&D Revenue base of over Acquisitions across USD500 million the globe Market capitalisation of USD1 billion Organic growth Over half the sales from phase North America All-India operations begin Strong presence in generics market First Nationwide Among the top five Commenced international Acquired marketing Built the first API Indian pharma operations in acquisition: controlling stake operations rolled plant companies Calcutta Niche Brand in in Taro out the US 1983 1987 1995 2004 2010 Source: Sun Pharma website For updated information, please visit www.ibef.org SUCCESS STORY: SUN PHARMA 30
  • 31. NOVEMBER Pharmaceuticals 2011 Contents  Advantage India  Market overview and trends  Growth drivers  Opportunities  Success story: Sun Pharma  Useful information For updated information, please visit www.ibef.org 31
  • 32. NOVEMBER Pharmaceuticals 2011 Industry Associations The Indian Pharmaceutical Association Organisation of Pharmaceutical Producers of India Kalina, Santacruz (E), Peninsula Chambers, Ground Floor, Mumbai – 400 098 Ganpatrao Kadam Marg, Lower Parel, Phone: 91-22-2667 1072 Mumbai – 400 013 Fax: 91 22 2667 0744 Phone: 9122 24918123, 24912486, 66627007 E-mail: ipacentre@ipapharma.org Fax: 9122 24915168 www.ipapharma.org E-mail: indiaoppi@vsnl.com www.indiaoppi.com Indian Drug Manufacturers' Association 102-B, Poonam Chambers, Dr A.B. Road Bulk Drug Manufacturers Association Worli, Mumbai – 400 018 C-25, Industrial Estate, Sanath Nagar Phone: 91-22-2494 4624/2497 4308 Hyderabad – 500018 Fax: 9122 24950723 Phone: 91 40 23703910/23706718 E-mail: idma1@idmaindia.com Fax: 91 40 23704804 www.idma-assn.org E-mail: info@bdmai.org www.bdmai.org For updated information, please visit www.ibef.org USEFUL INFORMATION 32
  • 33. NOVEMBER Pharmaceuticals 2011 Glossary → CRAMS: Contract Research and Manufacturing Services → API: Active Pharmaceutical Ingredients → FDI: Foreign Direct Investment → GOI: Government of India → INR: Indian Rupee → USD: US Dollar → BPL: Below Poverty Line → RSBY: Rashtriya Swastha Bima Yojna → ESIC: Employees State Insurance Corporation → Wherever applicable, numbers have been rounded off to the nearest whole number For updated information, please visit www.ibef.org USEFUL INFORMATION 33
  • 34. NOVEMBER Pharmaceuticals 2011 Disclaimer India Brand Equity Foundation (IBEF) engaged Aranca to presentation to ensure that the information is accurate to prepare this presentation and the same has been the best of Aranca and IBEF’s knowledge and belief, the prepared by Aranca in consultation with IBEF. content is not to be construed in any manner whatsoever as a substitute for professional advice. All rights reserved. All copyright in this presentation and related works is solely and exclusively owned by IBEF. Aranca and IBEF neither recommend nor endorse any The same may not be reproduced, wholly or in part in specific products or services that may have been any material form (including photocopying or storing it in mentioned in this presentation and nor do they assume any medium by electronic means and whether or not any liability or responsibility for the outcome of decisions transiently or incidentally to some other use of this taken as a result of any reliance placed on this presentation), modified or in any manner communicated presentation. to any third party except with the written approval of IBEF. Neither Aranca nor IBEF shall be liable for any direct or indirect damages that may arise due to any act or This presentation is for information purposes only. While omission on the part of the user due to any reliance due care has been taken during the compilation of this placed or guidance taken from any portion of this presentation. For updated information, please visit www.ibef.org DISCLAIMER 34