throbber
www.pwc.com/india
`
`India Pharma
`Inc.: Capitalising
`on India’s
`Growth Potential
`
`Exhibit 1135
`IPR2017-00807
`ARGENTUM
`
`000001
`
`

`

`000002
`
`000002
`
`

`

`Foreword
`
`Sujay Shetty
`Director
`India Pharmaceuticals &
`Life sciences leader, PwC
`
`Jai Hiremath
`Chairman,
`CII Pharma Summit 2010 &
`Vice Chairman & Managing
`Director, Hikal Ltd.
`
`The global Pharma industry is under serious pressure from a large number of innovator molecules facing patent expiration,
`a thin pipeline of new drugs, regulatory challenges and pricing pressures. This has led to a directional shift towards the
`emerging markets of Asia, Australia, Africa and Latin America, which are growing three times faster than the current
`growth rates experienced in the industry’s leading markets of North America, Japan and Europe. We expect over 40% of
`the global Pharma industry’s incremental growth over the next decade to come from the emerging markets.
`The Indian Pharma industry is on the threshold of becoming a major global market by 2020. Many experts believe that
`the Industry has the potential to grow at an accelerated 15 to 20% CAGR for the next 10 years to reach between US$49
`billion to US$74 billion in 2020.
`The Indian pharmaceuticals market is witnessing dynamic changing trends such as large acquisitions by multinational
`companies in India, increasing investment by domestic and international players in India, deeper penetration into the rural
`markets, growth and availability of healthcare and incentives for setting up special economic zones (SEZ’s). We believe
`these trends combined with increased purchasing power and access to good quality medical care will continue to propel
`the domestic pharmaceutical industry to new heights.
`Indian Pharma companies are already major outsourcing partners of global Pharma companies. Research & Development
`in India is getting more innovative. Domestic companies have strengthened their position in the world for supplying
`solutions across the pharmaceutical value chain. They are likely to become a competitor of global Pharma in the areas
`of manufacturing and R&D, and a potential partner in others.
`In this report, we look at developments in the branded generics market, over-the-counter products (OTC), vaccines and
`rural markets, and analyse what lies ahead for the industry as it aims to capitalise on the promise of the domestic market
`place. We believe that the domestic Indian pharmaceutical market has a positive growth trajectory but will also face major
`transformational challenges in the next decade. We address some of these challenges and identify key imperatives to
`accelerate the domestic market’s growth.
`
`000003
`
`

`

`Contents
`
`Background
`
`The Indian Domestic Pharma Market
`
`Indian Pharma Market Segments
`
`Rural markets
`
`Vaccines
`
`Changing Tax Environment
`
`Challenges
`
`The Road Ahead - Imperatives for Growth
`
`Profiles
`
`References
`
`About Confederation of Indian Industry
`
`About PricewaterhouseCoopers
`
`Contacts
`
`6
`
`14
`
`18
`
`28
`
`34
`
`38
`
`44
`
`48
`
`52
`
`60
`
`62
`
`63
`
`000004
`
`

`

`Executive Summary
`
`The global pharmaceutical market is
`undergoing rapid transformation. As
`blockbuster drugs come off patent, there
`are fewer new products in the pipeline to
`replace them. This is due to declining
`R&D productivity and rising regulatory
`costs. In PwC Pharma 2020 series of
`reports, we have examined in detail the
`challenges faced by Big Pharma in this
`regard. There has been a dramatic shift
`towards emerging markets as western
`markets slow down. Global Pharma
`multinational corporations are looking
`at new growth drivers such as the Indian
`domestic market to capitalise on the
`growing opportunity.
`The paradigm faced by the leading
`economies of the US, Europe and Japan
`are significantly different from those in
`the emerging markets of India, China,
`South America and Russia. According
`to IMS Health, the emerging markets
`of Asia/Africa/Australia grew at a rate
`of 15.9% in 2009, as compared to much
`slower growth rates in North America
`(5.5%), Japan (7.6%) and Europe
`(4.8%).(1) Emerging markets will be the
`next major growth drivers for the global
`Pharma industry, with more than 40%
`of incremental growth of the industry
`coming from emerging economies in
`the next decade.(2)
`In our report, “Capitalising on India’s
`growth potential”, we analyse the
`immense potential of India’s domestic
`Pharma market, which was valued at
`approximately US$12 billion in 2010,
`and showed a strong growth of 21.3%
`for the twelve months ending September
`2010.(3) PwC estimates that over the next
`10 years, the domestic market will grow
`to US$49 billion - a compounded annual
`growth rate (CAGR) of 15%, with the
`potential to reach US$74 billion – a
`CAGR of 20%, if aggressive growth
`drivers kick in.
`One of the reasons behind this expected
`growth rate is that India’s pharmaceutical
`
`industry has a favourable macro-
`environment to grow in. The Indian
`economy has rebounded from the global
`economic downturn, with real gross
`domestic product (GDP) growth reaching
`9.66% in 2010.(4) The Indian middle
`class is also expanding rapidly, with
`affordability of medicines increasing,
`and an increased percentage of
`disposable income being spent on
`healthcare. The government has made
`public healthcare one of its top priorities
`by launching policies and programmes
`that are aimed at making healthcare
`more affordable and accessible, especially
`in rural markets.
`The industry is witnessing trends
`such as acquisition activity, increasing
`investment, deeper penetration into
`the tier I to tier VI and rural markets,
`growth in insurance coverage and
`innovation in healthcare delivery.
`Taken together, these trends are leading
`to increased affordability of services
`to patients and access to quality medical
`care. We believe these trends, along
`with the favourable macro environment
`will propel the industry to the next level
`of growth.
`At the moment, approximately 90% of
`India’s pharmaceutical market is made
`up of branded generics.(5) We estimate
`that this segment will grow at a CAGR
`of 15% - 20% for the next five years.(5)
`Generic generics’ and patented products’
`contributions to the market as a whole is
`currently very low. Although this is the
`expected model of the future, we do not
`foresee a significant increase in the next
`five years; the market is expected to
`remain comprised predominantly of
`branded generics. By 2020 though,
`patented drug sales are expected to
`increase, owing to an improvement in
`the implementation of patent laws and
`spread of health insurance. We also
`expect the OTC segment to be a strong
`growth driver for the industry.
`
`Currently, around 67% of India’s
`population, or 742 million people live
`in rural areas (6), but rural markets
`contribute to only 17% (7) of the overall
`market’s sales. This represents a huge
`opportunity for pharmaceutical
`companies, as we expect these markets
`to be the future growth drivers for the
`industry. The rural market has several
`challenges, and in order to tap the full
`potential of this opportunity, companies
`should:
`• create demand by increasing
`awareness and education;
`• work with the government through
`public-private partnerships (PPP),
`in order to improve hygiene and
`infrastructure conditions;
`• mobilise primary care givers and
`paramedics through health and
`diagnostic camps;
`• bring specific product solutions to
`the market and use local languages;
`• improve accessibility of medicines
`by innovative distribution channels
`and
`• make products affordable, through
`appropriate pricing and packaging.
`Top Indian and foreign companies will
`look to increase their market share by
`entering into strategic alliances,
`strengthening their sales forces and
`increasing penetration into newer
`markets.
`The potential that the Indian Pharma
`industry holds is unquestionable. India
`is home to approximately 1/6th of the
`world’s population, and is expected to
`become the most populous nation in the
`world by 2050.(8) Demand for
`pharmaceuticals will grow decidedly.
`Government must continue to invest in
`healthcare and medical infrastructure in
`rural markets, raise healthcare spending,
`encourage innovation, contain healthcare
`costs and work with private players to
`take the market to the next level.
`
`000005
`
`

`

`Background
`Strong macroeconomics
`over the next decade
`
`The Growing Indian Economy
`
`Growing Middle Class With Higher Purchasing Power
`
`Changing Disease Profile
`
`Government Policies
`
`Healthcare Insurance
`
`000006
`
`

`

`Figure 1: Emerging markets (Asia/Australia/Africa & Latin
`America) growing faster than developed markets
`
`15.90%
`
`10.60%
`
`7.60%
`
`5.50%
`
`4.80%
`
`North America
`1
`
`Europe
`
`2
`
`3
`
`Japan
`
`4
`
`Asia/Australia/
`5
`Africa
`
`Latin
`America
`
`18.00%
`
`16.00%
`
`14.00%
`
`12.00%
`
`10.00%
`
`8.00%
`
`6.00%
`
`4.00%
`
`2.00%
`
`0.00%
`
`Growth Rate (%)
`
`Source: IMS Health market prognosis, March 2010
`
`Figure 2: Emerging markets drive industry growth
`
`100%
`
`90%
`
`80%
`
`70%
`
`60%
`
`50%
`
`40%
`
`30%
`
`20%
`
`10%
`
`0%
`
`2
`
`32
`
`9
`
`10
`
`37
`
`9
`
`3
`
`35
`
`9
`
`42
`
`12
`
`2
`
`22
`
`9
`
`10
`
`44
`
`12
`
`1
`3
`
`7
`
`11
`
`63
`
`15
`
`2
`
`22
`
`9
`7
`
`48
`
`11
`
`2
`
`23
`
`9
`6
`
`46
`
`12
`
`2009 (f)
`
`2010 (f)
`
`2011 (f)
`
`2012 (f)
`
`2013 (f)
`
`2008-2013 (f)
`
`Rest of World
`
`Emerging markets
`
`South Korea, Canada
`
`Japan
`
`EU
`
`US
`
`Source: IMS Health, Market Prognosis, October 2009
`
`
`
`PwC
`
`7
`
`Large numbers of forthcoming patent
`expiries, a dry pipeline of new drugs,
`regulatory challenges and pricing
`restrictions have collectively contributed
`to low growth rates for prominent global
`pharmaceutical markets. As global
`markets such as North America, Europe
`and Japan continue to slow down (See
`figure 1), pharmaceutical companies are
`scanning markets for new growth
`opportunities to boost drug discovery
`potential, reduce time to market and
`squeeze costs along the value chain. The
`Industry is beginning to realize that some
`of the most promising opportunities will
`come from emerging markets (Asia/
`Australia/Africa & Latin America).
`IMS Health and other sources suggest
`that emerging markets (China, India,
`Brazil, Russia, Turkey, Mexico and South
`Korea) will contribute to over 40% of the
`incremental growth of the global
`Pharmaceutical industry over the next
`decade.(2) In this report, we will look at
`the domestic Indian Pharma market, and
`the opportunities it holds.
`The huge potential of the Indian
`pharmaceutical industry is impossible for
`global Pharma companies to ignore,
`given that India will be one of the top 10
`sales markets in the world by 2020.
`Some of the largest Pharma companies in
`the world have been in the Indian market
`since the 1970s, and 5 out of the top 10
`domestic Pharma companies are already
`foreign owned, with a consolidated share
`of 22 – 23%.
`India’s domestic pharmaceutical market
`has recorded a CAGR of 13.5% over the
`past five years.(5) With considerable
`expertise in manufacturing of generics
`and vaccines, Indian companies have
`now also started significant research
`and development (R&D). India has the
`world’s second biggest pool of English
`speakers and a strong system of higher
`education, all this has well-positioned
`
`000007
`
`

`

`India to become an outsourcing partner
`in manufacturing and R&D, and as a
`location for clinical trials.
`The Indian economy is growing strongly
`and healthcare is expanding to meet the
`needs of a growing population with a
`
`changing disease profile. Increase in
`insurance coverage, aggressive market
`creation, growth in the income of the
`Indian population and steady
`government investment into medical
`infrastructure has further propelled the
`
`growth of the industry, such that it is on
`the threshold of becoming a competitor
`of global Pharma companies in some key
`areas, and a potential partner in others.
`
`Macro factors pushing the industry
`
`Figure 3: India’s strong GDP growth rate
`
`12
`
`10
`
`02468
`
`GDP growth (%)
`
`2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015
`GDP growth % 9.167 9.658 9.886 6.396 5.678 9.668 8.373 7.976 8.174 8.148 8.128
`
`The Growing Indian Economy
`The Indian economy is growing fast,
`and is valued at US$1.430 trillion in
`2010.(4) GDP growth, calculated on
`a Purchasing Power Parity basis has
`reached 9.66% in the year 2010, and
`the International Monetary Fund (IMF)
`expects it to remain consistently above
`8% till 2015. Furthermore, India’s share
`in the world GDP has been steadily
`increasing, and is expected to reach
`6.28% in 2015, up from 4.17% in 2005.(4)
`
`Source: International Monetary Fund, World Economic Outlook, (October 2010)
`
`Figure 4: Growing global share of India’s GDP (%)
`
`4.74
`
`5.276
`
`5.677
`
`5.486
`
`6.074
`
`5.873
`
`6.28
`
`4.544
`
`5.051
`
`4.365
`
`4.173
`
`01234567
`
`India’s share of the World’s GDP (%)
`
`2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015
`
`Source: International Monetary Fund, World Economic Outlook, (October 2010)
`
`8
`
`India Pharma Inc.: Capitalising on India’s Growth Potential
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
` 2010
`
`000008
`
`

`

`Growing middle class with higher purchasing power
`India’s population is currently just
`at 2001-02 prices), which has grown
`over 1.1 billion and is projected to
`rapidly, from 25 million people in 1996
`rise to 1.6 billion by 2050 – a 45.5%
`to 153 million people in 2010.(11) If the
`increase that will see it outstrip China
`economy continues to grow fast and
`as the world’s most populous state.(9)
`literacy rates keep rising, around a third
`Besides, India has a huge middle class
`of the population (34%) is expected
`population (households with annual
`to join the middle class in the near
`incomes of US$4762 to US$23,810
`future. The middle class population
`
`is rapidly acquiring the purchasing
`power necessary to afford quality
`western medicine due to an increase
`in disposable income. The Indian
`population spent 7% of its disposable
`income on healthcare in 2005; this
`number is expected to nearly double, to
`13%, by 2025.(12)
`
`Figure 5: Population growth projections
`
`Figure 6: Ascent of the Indian Middle Class -
`Percentage of the population
`
`13%
`
`• 2009-10
`
`34%
`
`• 2020
`(Forecast)
`
`11.7%
`
`• 2007-08
`
`6%
`• 2001-02
`
`1326.1
`
`1311.6
`
`1296.8
`
`1281.9
`
`1266.9
`
`1251.7
`
`1236.3
`
`1220.8
`
`1205.1
`
`1189.2
`
`Million Persons
`
`2019/20
`
`2018/19
`
`2017/18
`
`2016/17
`
`2015/16
`
`2014/15
`
`2013/14
`
`2012/13
`
`2011/12
`
`2010/11
`
`Source: ISI analytics (2010)
`
`Source: Economic Times (April 2009), PwC analysis
`
`Figure 7: Indian population’s expenditure break up as a % of overall disposable income
`
`4%
`
`100%
`
`7%
`
`9%
`
`13%
`
`Healthcare
`
`Education &
`Recreation
`
`Communication
`
`Tranportation
`
`Personal products
`and services
`
`Household
`products
`
`Housing & utilities
`
`Apparel
`
`Food, beverages
`and tobacco
`
`90%
`
`80%
`
`70%
`
`60%
`
`50%
`
`40%
`
`30%
`
`20%
`
`10%
`
`0%
`
`Percentage spend
`
`1995
`
`2005
`
`2015F
`
`2025F
`
`Year
`Source: IDFC Institutional Securities, Indian Pharma (June 2010)
`
`
`
`PwC
`
`9
`
`000009
`
`

`

`Along with chronic, in the last year there
`has been a rebound in sales in the acute
`diseases segment. This trend is likely to
`continue over the next few years, as we
`see companies widening their reach into
`newer markets, which have a relatively
`higher number of treatment naïve
`patients requiring basic treatment, thus,
`creating new demand for drugs of the
`acute therapies segment.
`
`Changing Disease Profile
`The Indian population is experiencing
`a shift in disease profiles (Figure 8).
`Traditionally, the acute disease segment
`held a significant share of the Indian
`pharmaceutical market. This segment
`will continue to grow at a steady rate,
`due to issues relating to public hygiene
`and sanitation. But, with increase in
`affluence, rise in life expectancy and
`the onset of lifestyle related conditions,
`the disease profile is gradually shifting
`towards a growth in the chronic diseases
`segment. India has the largest pool of
`diabetic patients in the world, with more
`than 41 million people suffering from the
`disease; this is projected to reach 73.5
`million in 2025.(10)
`
`IMS Health indicates that some of the
`fastest growing therapeutic segments
`in the Indian Pharma space today are
`chronic disease-related therapeutic
`segments. The anti-diabetic segment
`grew 29% in the 12 months ending July
`2010. Cardio-vascular medication and
`nervous system disorder medication
`grew at 22% for the same period of time,
`indicating rapid growth.(13)
`The growing size of the Indian geriatric
`population will be a key factor in
`influencing the growth of the chronic
`segment. By 2028, an estimated 199
`million Indians will be age 60 or older,
`up from about 91 million in 2008.(9)
`
`Figure 8: Shift in Disease Profile toward Chronics
`
`Cancer
`
`Heart disease
`
`Other circulatory
`
`CNS Disorders
`
`Diabetes
`
`Asthma
`
`Others
`
`Sense organs
`
`Muscoloskeletal
`
`Accidents
`
`Acute Infections
`
`622542
`
`12
`
`8
`
`21
`
`2
`
`41
`
`1522331
`
`2751
`
`57
`
`100%
`
`90%
`
`80%
`
`70%
`
`60%
`
`50%
`
`40%
`
`30%
`
`20%
`
`10%
`
`0%
`
`Disease Prevalence (%)
`
`2001
`
`2012
`
`Source: IDFC Institutional Securities, Indian Pharma (June 2010)
`
`000010
`
`

`

`Government policies
`The Indian government has been
`making efforts to improve nationwide
`provision of healthcare. It has launched
`policies that are aimed at:
`• building more hospitals,
`• boosting local access to healthcare,
`• improving the quality of medical
`training,
`• increasing public expenditure on
`healthcare to 2-3% of GDP, up from a
`current low of 1%.(14)
`Some of the significant government
`allocations on healthcare spend include
`a five year tax break for opening
`hospitals anywhere in India, with
`an added focus on tier II and tier III
`markets, both in the 2008-09 Union
`Budget.
`
`plans to spend US$293 million on
`the promotion of healthcare through
`programmes for the prevention and
`cure of diseases such as cancer, diabetes,
`heart ailments and stroke in 2011-12.
`Diabetes, hypertension and non-
`communicable disease patients will be
`screened under the National Programme
`for Prevention and Control of Cancer,
`Diabetes, Cardiovascular Diseases and
`Stroke (NPCDCS). The programme is
`likely to cover more than 70 million
`adults across 100 districts in 15 states
`and union territories of the country.(15)
`Healthcare Insurance
`India’s healthcare insurance industry
`is currently very small and limited,
`but is expected to grow at a CAGR of
`15% till 2015. Around 80% of
`
`India’s healthcare expenditure is
`financed out of pocket. This limits
`the propensity of Indians to spend on
`healthcare, particularly in lower and
`middle income groups which comprise
`around 95% of population.(8)
`The small percentage of Indians who
`do have some insurance, the main
`provider is the Government-run
`General Insurance Company (GIC).
`Private insurance only came into the
`market post 2007, when the Insurance
`Regulatory and Development
`Authority (IRDA) eliminated tariffs
`on general insurance. Apollo was
`the first private healthcare insurance
`provider in the country; other private
`entrants are ICICI Lombard, Tata AIG,
`Royal Sundaram, Star Allied Health
`Insurance, Cholamandalam DBS and
`Bajaj Allianz Apollo.
`
`Going forward, the Indian government
`
`000011
`
`

`

`Figure 9: Healthcare expenditure break up 2009
`
`Local
`
`Social Insurance
`
`11%
`
`6%
`
`State
`
`71%
`
`12%
`
`Centre
`
`Government
`
`17%
`
`3%
`
`Insurance
`
`Out of Pocket
`
`80%
`
`Source: ISI Analytics, Healthcare Industry (2010)
`
`Figure 10: Increase in penetration of Healthcare Insurance
`
`No. of People
`covered by
`Health Insurance
`(Million)
`
`70
`
`60
`
`50
`
`40
`
`30
`
`20
`
`10
`
`0
`
`Million Persons
`
`Size of the Healthcare
`Insurance Industry
`
`81000
`
`66000
`
`32090
`
`22220
`
`17320
`
`13540
`
`10040
`
`7610
`
`90000
`
`80000
`
`70000
`
`60000
`
`50000
`
`40000
`
`30000
`
`20000
`
`10000
`
`0
`
`INR Million
`
`2002
`
`2003
`
`2004
`
`2005
`
`2006
`
`2007
`
`2008
`
`2009
`
`2006
`
`2015
`
`Source: ISI Analytics, Healthcare Industry (2010), General Insurance Council of India (2010)
`
`12
`
`India Pharma Inc.: Capitalising on India’s Growth Potential
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
` 2010
`
`000012
`
`

`

`“In terms of factors that could drive the market up,
`I think insurance would be a major factor. Insurance
`penetration numbers should go up dramatically,
`because out of pocket payment for medications is not a
`model anywhere in the world, as it cannot drive a large
`part of the market. A lot of countries have gone through
`this change; it is imperative to take us to the next level.”
`
`– Achin Gupta , Sr. V.P, Corporate Strategy, Glenmark
`
`The government runs a programme
`called the National Rural Health
`Mission (NRHM), for the development
`of the poor, allocating US$2920 million
`in the 2008-09 budget, under the
`NRHM.(16) A health insurance scheme
`called Rashtriya Swasthya Bima Yojna
`(RSBY) that provided US$745 worth
`of cover for every worker was also
`included. The total allocation of this
`inclusion was US$51 million(17), which
`was then increased in the subsequent
`budgets. The latest budget, 2010-11,
`incorporated a further 20% of the
`population covered under the NREGA
`(National Rural employment Guarantee
`Act).(18)
`
`The government, along with many
`in the industry believes that increase in
`insurance coverage is essential
`to take the market forward. But,
`other experts believe that the spread
`of health insurance could lead to
`a market wherein there is minimal
`differentiation between branded
`generics. An important success factor
`for generic makers is differentiation of
`their products. While increased health
`insurance coverage may benefit generic
`drug manufacturers by increasing the
`market’s affordability for medicines,
`it may, in combination with increased
`institutional sales cause a reduction in
`prices, owing to the rising influence of
`insurance companies.
`
`Overall, lack of insurance coverage still
`remains a challenge. Widespread use
`of health insurance could take many
`years, not least because insurance
`companies lack the data they require
`to assess health risks accurately and
`the only products they sell work on
`an indemnity basis – that is, they
`reimburse the patient after he or she
`has paid the healthcare provider’s bill,
`making such policies
`less attractive.
`
`Key takeaways
`
`1. The Indian economy is growing strongly, and will continue
`to provide a conducive macro-environment for the industry
`to grow in.
`
`2. The government is increasing spend on healthcare; and the
`Indian population is spending an increased amount of money
`on healthcare as a percentage of disposable income.
`
`3. The disease profile is changing with an increase in acute
`diseases along side growth of chronics.
`
`4. Health insurance is growing.
`
`
`
`PwC
`
`13
`
`000013
`
`

`

`The Indian Domestic
`Pharma market
`Set for robust growth
`
`Key Players
`
`Industry SWOT
`
`Key Recent Trends
`
`Investment Scenario
`
`000014
`
`

`

`According to IMS Health, in
`September 2010, on a Moving annual
`total (MAT) basis, the Indian Pharma
`market grew at 21.3%, reaching
`a size of US$10.9 billion.(3) Taking
`into account generic medicines sold
`directly to institutions and OTC drugs
`sold through non-pharmacy retailers,
`PwC and IMS Health estimate the
`
`domestic market size to be US$12
`billion. We estimate that by 2020,
`it will grow to US$49 billion - a
`conservative CAGR of 15%, with
`the potential to reach US$74 billion –
`at an aggressive CAGR of 20%, if
`growth drivers kick in.
`
`Key Players
`
`There is a high level of market
`fragmentation. As of 2009, there
`were more than 10,000 firms in the
`market, of which, around 200 of them
`collectively controlled about 70% of
`the market share.(19)
`Most of the top 10 players in the
`market had growth rates of over 18%
`for the 12 months ending July 2010.
`Of these, Cipla continued to have the
`largest market share of 5.2%, followed
`by Ranbaxy (now a subsidiary of
`Daiichi-Sankyo), with a 4.7% share.(13)
`
`Figure 11: India Pharma top 10 players: 12 month growth
`rate ending July 2010 (09/10 Revenues in US$ millions)
`
`Cipla
`
`Ranbaxy
`
`GSK India
`
`Piramal Healthcare
`
`Sun Pharma
`
`Zydus cadila
`
`Alkem Labs
`
`Pfizer India
`
`Mankind Pharma
`
`Abbott
`
`19%
`
`(1276.1)
`
`15.5%
`
`(1125.45)
`
`19%
`
`(445.87)
`
`18.6%
`
`(631.18)
`
`25.7%
`
`(600.65)
`
`24.1%
`
`(436.40)
`
`23.3%
`
`(276.49)
`
`23.6%
`
`(192.59)
`
`37.20%
`(200.06)
`
`25%
`
`(189.07)
`
`Source: Business Standard (October 2010), IMS Health, Capitaline
`
`
`
`PwC
`
`15
`
`000015
`
`

`

`Industry SWOT
`
`Figure 12: Indian Pharma Industry SWOT analysis
`
`Strengths
`• Higher GDP growth leading to increased disposable
` income in the hands of general public and their
` positive attitude towards spending on healthcare
`• Cost Competitiveness
`• Low-cost, highly skilled set of English speaking
` labour force
`• Growing treatment naive patient population
`
`Weaknesses
`• Poor all-round infrastructure is a major challenge
`• Stringent price controls
`• Lack of data protection
`• Poor health insuracnce coverage
`
`Threats
`• Labour shortage
`• Wage inflation
`• Government expanding the umbrella of the Drugs
` Price Control Order (DPCO)
`• Considerable counterfeiting threat
`• Competition from other emerging economies
`
`Opportunities
`• Global demand for generics rising
`• Rapid OTC and generic market growth
`• Increased penetration in the non - metro markets
`• Large demand for quality diagnostic services
`• Increase in healthcare insurance coverage
`• Significant investment from MNCs
`• Public-Private Partnerships for strengthning
` infrastructure
`
`
`
`Source: PwC analysis, Industry & Company interviews
`
`Key Recent Trends
`
`Figure 13: Industry trends and implications
`
`Increase
`Investments
`& MNC
`activity
`
`Shift towards a
`Networked
`business model
`Increasing M&A
`and aliiances
`Consolidation
`in the market
`
`Increasing
`reach in
`Non-Metro
`markets
`
`Seen as the
`next volume
`driver, though
`costs of
`operation is
`high due to
`poor health
`infrastructure
`
`Goods &
`Services Tax
`(GST)
`
`Though
`delayed from
`its April 2010
`implementation
`date, GST will
`add significant
`efficiencies to
`economy and
`lead to an
`overhaul of
`supply chain
`
`Growing
`Insurance
`
`Changing
`disease profile
`
`Healthcare
`innovation
`
`More numbers
`of patients will
`be coming in
`for treatment.
`
`• Use of
`technology &
`IT for innovation
`in healthcare
`delivery
`• e.g. Mobile
` clinics
`
`• Shift towards
`biotech &
`speciality
`therapies,
`• increased
`investment
`in R&D and
` acute disease
`segment will
`sustain strong
`growth
`
`Source: PwC analysis, Industry & Company interviews
`
`16
`
`India Pharma Inc.: Capitalising on India’s Growth Potential
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
` 2010
`
`000016
`
`

`

`Investment Scenario
`
`The Indian Pharma industry has
`attracted US$1707.52 million worth
`of foreign direct investment (FDI) in
`the period between April 2000 and
`April 2010.(20) This FDI is exclusive of
`investments in shares of Indian firms.
`Acquisitions of local players by large
`MNCs illustrate the increasing level
`of interest that they have shown in
`the Indian market.
`MNC acquisitions in the Indian
`Pharma space took off in 2008 with
`the acquisition of Ranbaxy by Japanese
`drug maker, Daiichi Sankyo for US$4.6
`billion.(21) This deal was valued at
`five times Ranbaxy’s sales.(12) Since
`
`then, there has been a trend of higher
`valuations of Indian Pharma companies,
`culminating with a new benchmark: in
`2010, Abbott bought Piramal Healthcare
`in a deal worth US$3.7 billion(22), a
`valuation that was nine times the value
`of Piramal’s sales revenue.(12)
`Partnerships and
`Licensing deals
`Although long-term supply deals
`between innovators and generic-
`producers have been taking place for a
`while now, the frequency of these deals
`has been growing at an increasingly
`
`rapid rate in the recent past. Deals
`between Pfizer and Aurobindo, and
`GlaxoSmithKline and Dr. Reddy’s Labs
`are recent examples of out-licensing
`deals where generic makers are signing
`distribution and marketing contracts,
`so their products reach foreign regulated
`and developing markets. Due to the
`large number of drugs going off-patent
`in the next few years, this trend is
`expected to increase even further.
`
`Table 1: Key recent mergers & acquisitions
`
`Year
`
`2010
`
`Indian Player MNC
`
`Nature of deal
`
`Details
`
`Piramal
`Healthcare
`
`Abbott
`
`Sale of domestic
`branded
`formulations
`
`Abbott acquired Piramal's domestic branded
`formulations division, along with its 350 brands,
`Baddi facility and about 5,200-strong sales force
`for US$3.72 billion
`
`2010
`
`Strides
`Acrolabs
`
`Pfizer
`
`2009
`
`Shantha
`Biotech
`
`Sanofi-
`Aventis
`
`2009 Aurobindo
`
`Pfizer
`
`2009
`
`Biocon
`
`Mylan
`
`Licensing
`and supply
`arrangement
`
`Acquisition
`
`Dossier
`licensing &
`supply contract
`
`Development &
`supply contract
`
`2009 Dr. Reddy’s
`Labs
`
`GSK
`Pharma
`
`Supply contract
`
`2008
`
`Strides-Aspen
`JV
`
`GSK
`Pharma
`
`2008 Ranbaxy
`
`Daiichi
`Sankyo
`
`Upfront
`milestone &
`supply contract
`
`Acquisition
`
`To supply 40 off patent products, mainly oncology
`ingestables that would be commercialised by Pfizer
`
`Acquired for about US$820mn and got access to
`Shantha's vaccines pipeline and access to emerging
`markets
`
`Formulations and injectables for US,EU and ROW
`markets on exclusive and co-exclusive basis
`
`To develop, manufacture, supply and commercialise
`many high-value generic biologic compounds for the
`global markets.
`
`To develop and market more than 100 branded
`products on an exclusive basis across an extensive
`number of emerging markets, excluding India.
`
`To manufacture and supply branded generics to GSK
`which would be marketed in about 80 emerging
`markets.
`
`Daiichi acquired Ranbaxy and got access to Ranbaxy's
`diversified product portfolio and vast geographical
`presence.
`
`Source: Centrum. Pharmaceuticals update, (June 2010).
`
`India’s domestic
`market is poised for
`strong growth on the
`back of increased
`foreign investment
`in the region, an
`increased reach in
`non-metro markets,
`the implementation of
`GST, growing insurance
`coverage, a change in
`the population’s disease
`profile and increase in
`healthcare innovation,
`in combination with
`growth of key segments
`– branded generics,
`OTC, rural markets
`and vaccines.
`
`
`
`PwC
`
`17
`
`000017
`
`

`

`Indian Pharma
`Market Segments
`A market dominated
`by branded generics
`
`Branded Generics
`
`Generic Generics
`
`Over-The-Counter Products
`
`Patented Products
`
`Retail vs. Institutional sales
`
`Road ahead
`
`000018
`
`

`

`It is difficult to track and estimate the
`exact composition of India’s domestic
`Pharma market; but industry experts
`believe that this market is largely
`dominated by branded generics.
`This segment contributes around 90%
`
`of total sales, and represents one
`of the key strengths of the market,
`encompassing the OTC segment as
`well. Only about 10% of the market
`constitutes commodity generics sold
`through institutional sales and innovator
`
`products.(5) The branded generics
`segment is expected to grow at a CAGR
`of 15% - 20% for the next decade.(5)
`
`Figure 14: Indian Pharma market is predominantly a branded generics market
`
`10%
`
`90%
`
`Other drugs: 10%
`
`Branded Generics: 90%
`
`Source: Industry & Company interviews
`
`Branded generics
`
`In the global context, IMS Health,
`which began tracking and reporting
`on branded generics in 2002, defines
`the category as including “prescription
`products that are either novel dosage
`forms of off-patent products produced by
`a manufacturer that is not the originator
`of the molecule, or a molecule copy
`of an off-patent product with a trade
`name.” This definition is used by both
`the United States of America’s Food
`and Drug Administration (FDA) and
`the United Kingdom’s National Health
`Service (NHS). It does not include
`authorized generics, which are drugs
`
`made by or under license from the
`innovator company and sold without a
`brand name.
`In India, any non patented molecule
`with a brand name other than the
`innovator’s name is termed as a
`branded generic. Chemically, branded
`generics are identical, or bioequivalent
`to innovator drugs. It is the share of
`voice the brand commands by getting
`repeatedly prescribed by the physicians,
`due to some degree of recall and
`preference over the other brands. In
`the global context, substitution – when
`
`an innovator product goes off-patent -
`is the key driver for generics. In India,
`it’s about driving a difference using
`the core equity of a brand, over a
`competitor’s product.
`
`Any non patented molecule
`with brand name, which is
`other than the innovator’s
`name, is termed as a
`branded generic.
`
`
`
`PwC
`
`19
`
`000019
`
`

`

`“India has a very large acute
`segment growing at strong double
`digits, which is expected to
`continue. While the chronic market
`is relatively small, it is on a rapid
`growth path due to an ageing
`population and changing lifestyles.
`Therefore, both markets will be
`attractive.”
`- Vivek Mohan, MD, Abbott India
`
`Top Brands
`Table 2 gives the top 20 brands in the
`Indian market, as track

This document is available on Docket Alarm but you must sign up to view it.


Or .

Accessing this document will incur an additional charge of $.

After purchase, you can access this document again without charge.

Accept $ Charge
throbber

Still Working On It

This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.

Give it another minute or two to complete, and then try the refresh button.

throbber

A few More Minutes ... Still Working

It can take up to 5 minutes for us to download a document if the court servers are running slowly.

Thank you for your continued patience.

This document could not be displayed.

We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.

Your account does not support viewing this document.

You need a Paid Account to view this document. Click here to change your account type.

Your account does not support viewing this document.

Set your membership status to view this document.

With a Docket Alarm membership, you'll get a whole lot more, including:

  • Up-to-date information for this case.
  • Email alerts whenever there is an update.
  • Full text search for other cases.
  • Get email alerts whenever a new case matches your search.

Become a Member

One Moment Please

The filing “” is large (MB) and is being downloaded.

Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.

Your document is on its way!

If you do not receive the document in five minutes, contact support at support@docketalarm.com.

Sealed Document

We are unable to display this document, it may be under a court ordered seal.

If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.


Access Government Site

We are redirecting you
to a mobile optimized page.





Document Unreadable or Corrupt

Refresh this Document
Go to the Docket

We are unable to display this document.

Refresh this Document
Go to the Docket