CRISIL Ratings Indian Pharma Booklet Apr10

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     April 2010

    Sound Fundamentals DespiteIncreasing ChallengesSound Fundamentals DespiteIncreasing Challenges

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    MANAGING DIRECTOR AND CHIEF EXECUTIVE OFFICER, CRISIL

    & REGION HEAD, SOUTH ASIA, STANDARD & POOR'S

    Roopa Kudva

    SENIOR DIRECTOR

    Raman Uberoi

    CORPORATE AND GOVERNMENT RATINGS

    Pawan Agrawal Director [email protected]

    CORPORATE SECTOR RATINGS

    Sudip Sural  Head [email protected]

    Aparna Karnik Sr. Manager [email protected]

    Ateesh Chaudhary Manager [email protected]

    Manita Agarwal Analyst [email protected]

    Saurabh Piplani [email protected]

    T K Mahesh [email protected]

    BUSINESS DEVELOPMENT

    Maya Vengurlekar Head [email protected]

    Sachin Gupta Head [email protected] Chakraborti Head [email protected]

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    ForewordCRISIL is pleased to present its publication, Pharma Sector Outlook: Sound Fundamentals Despite

    Increasing Challenges. This publication is part of CRISIL's endeavour to provide market participants with CRISIL's

    credit outlook for India's pharmaceuticals (pharma) industry. This publication also includes three additional

    commentaries on the key trends that CRISIL believes will shape the future of the Indian pharma industry, and a list of its

    outstanding ratings, along with company-specific rating drivers.

    CRISIL has rated 100 companies, spanning the breadth of the Indian pharma industry. The rated entities include large

    players as well as small and medium enterprises, with operations in the domestic market, and the regulated and semi-

    regulated markets. These companies manufacture formulations, active pharmaceutical ingredients, and intermediates,

    and are also engaged in contract research and manufacturing.

    CRISIL believes that the global generics markets continue to offer sizeable growth opportunities to Indian companies.

    However, the risks associated with these markets are increasing as healthcare regulations in these markets are

    evolving; this is expected to pose a challenge for Indian players. As Indian pharma players derive more than half their

    total revenues from global markets and because these revenues are expected to increase faster than revenues from the

    domestic market, the need to manage risks associated with global markets prudently has never been more

    pronounced.

    Contract manufacturing also provides Indian players the opportunity to participate in the global generics growth story,

    while limiting exposure to some of the risks associated with global markets. India, with its low cost structure and

    abundant talent pool, has an advantage as a manufacturing hub for the global pharma industry. Several global

    pharma majors are gradually increasing their presence in India with a view to gain cost advantages as well as to gain

    access to the domestic market. CRISIL believes that this trend will accelerate.

    The domestic pharma market, although competitive, has remained relatively stable and has strongly supported the

    credit quality of players by balancing exposure to risks in the global markets. The domestic market allows stability in

    cash flows and provides the necessary scale for pharma companies. Local players have a competitive edge over

    multinational companies in the domestic formulations market, despite the implementation of the product patent

    regime in 2005.

    Indian companies are investing conservatively in new drug research and are curbing ambitions in research and

    development (R&D) because of the high resource intensity and longer timeframes for returns in this segment. However,

    several Indian companies are undertaking research for global innovator pharma companies on a fixed-fee basis. The

    nascent contract research outsourcing sector in India is expected to grow rapidly.

    We hope this publication provides useful analytical insights into the Indian pharma sector. We welcome your feedback.

    Pawan Agrawal

    Director – Corporate & Government Ratings

    [email protected]

    April 2010

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    Contents

    Pharma sector credit outlook stable despite increasing risks

    Regulated markets: Increasing challenges for Indian players

    Attractive opportunities in contract manufacturing for Indianpharma industry

    Home-grown players retain edge in domestic pharma market

    Rating distribution and brief profile of CRISIL rated pharmaceuticalcompanies

    Glossary of terms

    Rating changes over the 12 months through January, 2010

    01

    07

    11

    13

    16

    57

    58

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    1CRISIL's ratings on most large and mid-sized Indian

    pharmaceutical (pharma) companies have remained

    stable in the recent past, despite a significant increase in

    the companies' business risks. While the increase in

    business risks has been largely on account of the

    companies' rapid global expansions, their ratings have

    remained stable, backed by strong domestic operations,

    and conservative financial policies. The credit risk

    profiles of some domestic players have also been

    supported by strong parentage by global pharma majorslooking to increase their presence in India. Nevertheless,

    there have been a few rating downgrades in the sector

    in recent months—of companies that have faced

    refinancing pressure in repayment of substantial debt

    contracted to fund expansions.

    India's pharma players continue to expand globally, to

    capitalise on the large generics opportunity in the

    regulated and semi-regulated markets. The regulated

    generics markets have witnessed severe pricing pressure

    as a result of government-led cost-containment

    measures, and intense competition. Moreover, the

    regulatory environment in the generics market has

    become increasingly stringent, with players'

    manufacturing processes coming under greater scrutiny,

    and the sale of some products being banned. Players

    operating in the semi-regulated markets, on the other

    hand, have been exposed to risks such as sharp currency

    movements, stretched working capital cycles, and

    higher incidence of bad debt.

    Going forward, India's pharma players will remain

    focused on the international markets to drive growth,

    despite the associated risks and challenges. Hence, the

    proportion of international revenues in the overallrevenue mix of the players is expected to increase.

    However, CRISIL believes that pharma companies will

    contain risks from international business by adopting a

    mix of the following strategies, and thus maintain stable

    ratings:

    • Seeking collaborations with strong global players

    • Focusing on contract manufacturing options that

    lend stability to revenues

    • Maintaining healthy financial risk profiles and

    strengthening risk management policies

    • Curbing ambitions in research and development

    (R&D) to avoid drain on resources

    • Precluding costly litigations: by reducing focus on

    launches of blockbuster drugs 'at risk', since these

    invite litigations from innovators

    Business risks on the ascendant

    Over the past few years, India's pharma companies havefaced increasing business risks because of their

    expanding global operations. These players have

    aggressively scaled up operations in the regulated and

    semi-regulated generics markets through a spate of

    debt-funded acquisitions. Graphs 1 & 2 indicate the

    increasing revenues of large and mid-sized CRISIL-rated

    players from the international markets. Graph 1 shows

    that the international markets contributed around 60

    per cent to these players' overall revenues in 2008-09

    (refers to financial year, April 1 to March 31). In addition,

    while revenues from the global markets increased at a

    compound annual growth rate (CAGR) of 39 per cent

    between 2005-06 and 2008-09, those from the

    domestic market grew at a CAGR of 21 per cent.

    As Graph 2 indicates, the global markets have

    contributed more than 75 per cent to the overall

    revenues of some large companies such as Dr. Reddy's

    Laboratories Ltd (DRL), Ranbaxy Laboratories Ltd

    (Ranbaxy), and Matrix Laboratories Ltd (Matrix Labs).

    Graph 1: Shift in revenue mix of large and mid-

    sized CRISIL-rated players

    (Source: Annual reports of players, and CRISIL estimates)

     

    243.8

    152.2

    90.086.6

    2008-092005-06

    Domestic Overseas

    300.0

    250.0

    200.0

    150.0

    100.0

    50.0

    0.0

       R  s .   B   i   l   l   i  o  n

    Pharma sector credit outlook stable despiteincreasing risks

    1  Pharma companies with annual revenues of more than Rs.5 billion

     Aparna Karnik Senior Manager, Corporate Sector Ratings

    Email: [email protected]: 022- 3342 3456

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    0702

    India's pharma players have entered the international

    generics market to capitalise on the significant

    opportunities it offers, given the large market size (the

    global generics market was estimated at USD90 billion

    in 2008, while the domestic formulations market was

    estimated at USD6-7 billion) and imminent substitution

    of drugs accounting for annual revenues of more than

    USD100 billion with low-cost generic versions following

    patent expiries over the next three years (refer to Graph3).

    Key business segments and their risk profiles

    CRISIL believes that the different markets and segments

    within the pharma industry have dissimilar risk

    characteristics (as Table 1 indicates). The international

    generics markets, for instance, pose higher risks for

    India's pharma players than the domestic market .

    (Source: CRISIL estimates)

    (Source: Annual reports of players)

    Graph 2: Estimated revenue from international markets for large and mid-sized companies in 2008-09

     

    Graph 3: Global generics opportunity: Regulated

    markets account for more than 70 per cent of the

    total market

       B   i   l   l   i  o  n   U   S   D

    3346

    28

    364

    623

    41

    0

    20

    40

    60

    80

    100

    120

    140

    2008 E 2013 P

    ROW Japan Europe North America

    Regulated generics markets

    (Refer to commentary 'Regulated Markets - Increasing

    challenges for Indian players')

    Regulated generics markets such as the US, Europe, and

    Japan comprise more than 70 per cent of the global

    generics markets by value, and contribute around 40 per

    cent to the revenues of large and mid-sized CRISIL-rated

    Indian pharma companies. These markets are highlycommoditised; the large number of generics players in

    these markets limits their pricing flexibility. On account

    of the competition over a period of time, drug prices fall

    by up to 90 per cent after the patent of the innovator

    drug expires. Hence, the generic drugs market accounts

    for about 50 per cent of the market by volume, but only

    around 10 per cent by value. This leads to volatility in

    revenues and profit margins for India's pharma players.

    Generics manufacturers launching products in

    regulated markets face litigation risks in case their

    products are perceived as infringing upon the patents

    held by innovator drug manufacturers—this leads tohigh legal costs for the former. Regulatory norms are

    very stringent in the regulated markets: quality issues

    can lead to high reputation risks for players. The key

    buyers and decision makers in these markets are few in

    number, and consolidated, thereby skewing the

    purchasing power in their own favour. Typically,

    decision makers are few, and consist of large public and

    private health insurance funds, since these markets have

    a wide health insurance coverage and social security net.

    Buyers such as large retail chains are also highly

    consolidated.

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       B  r  a  n   d  e   d  m  a  r   k  e   t ,   h   i  g   h  e  r  p  r   i  c  e  s   t  a   b   i   l   i   t  y

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       t   h  e

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       i  p  s

      a  n   d

      n  e   t  w  o  r   k  s .   P   l  a  y  e  r  s  n  e  e   d   t  o   i  n  v  e  s   t   l  a  r  g  e

      s  u  m  s

      o  n

      m  a  r   k  e   t   i  n  g

      a  n   d

       b  r  a  n   d

       b  u   i   l   d   i  n  g

       C  o  m  m  o   d   i   t   i  s  e   d  m  a  r   k  e   t  s ,   l  o  w

      p  r  o   d  u  c   t

       d   i   f   f  e  r  e  n   t   i  a   t   i  o  n

       N  o

      p  r   i  c   i  n  g

       f   l  e  x   i   b   i   l   i   t  y ,

      s   h  a  r  p

      p  r   i  c  e

      e  r  o  s   i  o  n  s

       I  n  c  r  e  a  s   i  n  g  c  o  n  c  e  n   t  r  a   t   i  o  n

       i  n   b  u  y  e  r   b  a  s  e  ;

      a   f  e  w

       l  a  r  g  e   d  e  c   i  s   i  o  n  m

      a   k  e  r  s ,  n  a  m  e   l  y

      g  o  v  e  r  n  m  e  n   t

       h  e

      a   l   t   h

      c  a  r  e

      p  r  o  g  r  a  m  s   /   l  a  r  g  e   h  e  a   l   t   h   i  n

      s  u  r  a  n  c  e   f  u  n   d  s

       d   i  c   t  a   t  e  p  r   i  c   i  n  g

       G  o  v  e  r  n  m  e  n   t

       f  o  c  u  s

      o  n

      c  o  s   t  -

      c  o  n   t  a   i  n  m  e  n   t   d  r   i  v  e  s  p  r   i  c  e

      s   d  o  w  n

       G  r  e  a   t  e  r  r  e  g  u   l  a   t  o  r  y  r  e  q  u   i  r  e  m  e  n   t  s ,   h   i  g   h

      c  a  p   i   t  a   l   i  n   t  e  n  s   i   t  y

       H   i  g   h   l   i   t   i  g  a   t   i  o  n  r   i  s   k ,   i  n  n

      o  v  a   t  o  r  s   t  r  y   t  o

      p  r  o   t  e  c   t  p  a   t  e  n   t  s   f  o  r   b   l  o  c   k   b  u  s   t  e  r   d  r  u  g  s  ;

      w  e   l   l  -  e  s   t  a   b   l   i  s   h  e   d  p  a   t  e  n   t   l  a  w  s

       L  a  c   k

      o   f   l  o  c  a   l  r  e   l  a   t   i  o  n  s   h   i  p  s

      a  n   d

      n  e   t  w  o  r   k  s .   P   l  a  y  e  r  s  n  e  e   d   t  o   i  n  v  e  s   t   l  a  r  g  e

      s  u  m  s  o  n  m  a  r   k  e   t   i  n  g  a  n   d   d

       i  s   t  r   i   b  u   t   i  o  n

       I  n   t  e  n  s  e

      c  o  m  p  e   t   i   t   i  o  n

       f  r  o  m

      g   l  o   b  a   l

      g  e  n  e  r   i  c  s  g   i  a  n   t  s  w   i   t   h   d  e  e  p  p  o  c   k  e   t  s

       D  o  m  e  s   t   i  c  m  a  r   k  e   t

       C  o  n   t  r  a  c   t  m  a  n  u   f  a  c   t  u  r   i  n  g

       S  e  m   i  -  r  e  g  u   l  a   t  e   d  g  e  n  e  r   i  c  s  m

      a  r   k  e   t  s

       R  e  g  u   l  a   t  e   d  g  e  n  e  r   i  c  s

      m  a  r   k  e   t  s

       T  a   b   l  e   1  :   K  e  y   b  u  s   i  n  e  s  s  s  e  g

      m  e  n   t  s  a  n   d   h  o  w   t   h  e  y   f  a  r  e  o  n

      r   i  s   k

       L  o

      w  e  r   R   i  s   k

       H   i  g   h  e  r   R   i  s   k

    7

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    04

    Over the past few years, pricing pressures have

    intensified for India's generics players in regulated

    markets. This is because governments have introduced

    stringent cost-containment measures to control

    unsustainably high healthcare costs (see Box 1).

    Box 1: Impact of cost-containment measures

    by the governments in Europe

    DRL and Matrix Labs made large acquisitions in

    Germany (Betapharm Arzneimittel GmbH) and

    Belgium (Docpharma), respectively. The

    performances of the acquired entities deteriorated

    significantly because of regulatory changes in the

    markets where they operate. Both DRL and Matrix

    Labs subsequently made large write-offs to account

    for the reduced value of their investments, resulting

    in reported losses in 2008-09 and 2007-08,respectively.

    Large retailers and drug store chains also exert pressure

    on prices, constraining the profitability of drug

    manufacturers (see Box 2).

    Box 2: Impact of generics drug price

    competition in US 

    In 2006, large retailers such as Wal-Mart Stores, Inc.,

    Kmart Corp, and Target Corp began offering

    commonly prescribed generic drugs at USD4-5 per

    month, as a strategy to attract shoppers to their

    stores. By 2008, the large drug store chains were

    forced to respond and launch their own low-cost

    generics drugs. Pricing pressures have pushed sales

    of generic drugs in the US down by 2.7 per cent in

    the 12 months ended September 30, 2008, even

    though the number of generic prescriptions filled

    increased by 5.4 per cent during the period (Source:

    IMS Health).

    Increasing competition from the rapidly consolidating

    global generics giants has resulted in these companies

    clearly superseding their small and mid-sized Indian

    counterparts in terms of negotiating power over

    product pricing. Market regulators such as the US Food

    and Drug Administration (FDA) have tightened their

    scrutiny of issues relating to quality and compliance with

    Good Manufacturing Practices (GMP). Several Indian

    companies have faced actions ranging from warning

    letters, to ban on manufacture of drugs (see Box 3).

    Box 3: Impact of stringent US FDA action on

    players

    The US FDA has banned some of Ranbaxy's drugs in

    the US because of alleged manufacturing norm

    violations and falsification of data and results of

    tests held at the company's plants in India.

    Ranbaxy's US sales declined by 53 per cent in the

    third quarter of 2009 (refers to calendar year,

    January 1 to December 31) over the corresponding

    quarter of the previous year. Also, inventory write-

    offs resulted in a decline in profits for the company

    in preceding quarters. Sun Pharmaceuticals

    Industries Ltd's (Sun Pharma's) subsidiary in Detroit,

    Caraco Pharmaceutical Laboratories Ltd (Caraco),

    was found to be violating Current Good

    Manufacturing Practices (cGMP) norms; US FDA

    seized Caraco's inventory in June 2009 from the

    manufacturing unit premises. As a result, Sun

    Pharma's export sales declined by about 12 per cent

    in the first half of 2009-10, over the corresponding

    period in the previous year.

    Semi-regulated generics markets

    Semi-regulated markets such as Russia, the

    Commonwealth of Independent States (CIS), Latin

    America, Africa, and South East Asia (excluding India)

    comprise about 25 per cent of the global generics

    markets, and contribute around 20 per cent to the

    revenues of large and mid-sized Indian pharma

    companies. These markets are structurally similar to the

    Indian markets as 'branded' generics markets. Brands

    enhance players' pricing flexibility; however, they

    require substantial outlay in marketing and brand-

    building expenses. The markets are far more

    fragmented than the regulated markets are in terms of

    buyers. This is because there is lower penetration ofhealth insurance and lack of social security net; this leads

    to customers paying out of their own pockets for a large

    part of the cost of drugs. Also, entry barriers are lower

    because of less stringent regulations.

    The working capital requirements of India's pharma

    companies operating in the semi-regulated markets are

    higher than that in the regulated markets. Companies

    are exposed to risks relating to long payment periods

    and bad debt. Moreover, the semi-regulated markets

    have higher risk of currency movements than the

    regulated markets—this exposes the operations of

    companies operating in these markets to risks relating tovolatility in margins.

    Post September 2008, the local currencies in Russia, CIS,

    and Latin America depreciated by more than 20 per cent

    against the US dollar. High dependence on imports for

    pharmaceuticals in these markets led to sharp increase

    in drug costs, and therefore, a fall in consumer spending.

    Drug retailers faced not only an increase in servicing

    costs on foreign-currency-denominated loans as well as

    an increase in creditors. This resulted in re-negotiation

    of prices, extension of credit terms, and some write-offs

    for rated companies (see Box 4)

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    Box 4: Impact of currency devaluation in semi-

    regulated markets

    The CRISIL-rated pharma companies with large

    exposures to semi-regulated markets include DRL,

    Ranbaxy, Glenmark Pharmaceuticals Ltd(Glenmark), and JB Chemicals and Pharmaceuticals

    Ltd (JB Chemicals). Glenmark saw a sharp increase

    in receivables and inventory; Ranbaxy's revenues in

    Russia and Latin America saw de-growth of 18 per

    cent for the first half of 2009. JB Chemicals wrote-

    off bad loans of Rs.110 million in 2008-09.

    Contract manufacturing: an attractive option

    (refer to CRISIL's commentary, 'Attractive opportunities

    in contract manufacturing for Indian pharma industry').

    The pressing need to reduce healthcare costs is forcing

    global pharma majors to outsource manufacturing to

    low-cost destinations, such as India. India's pharma

    companies, with their low labour costs and strong skills

    in process chemistry, have the advantage of being low-

    cost producers of active pharmaceuticals ingredients

    (APIs) and formulations.

    India has the highest number of manufacturing facilities

    approved by the US FDA outside the US. Indian

    companies are ahead of other countries in receiving

    abbreviated new drug application (ANDA) approvals,

    and drug master files (DMFs).

    Contract manufacturing allows Indian players the

    opportunity to participate in the global generics growth

    story, and benefit from stability in revenues and growth

    in volumes (albeit, at significantly lower profit margins)

    without exposure to risks such as litigation. It also avoids

    the need for the Indian players to make large

    investments in marketing and distribution, and the

    necessity of contracting large debt for funding

    acquisitions in international markets.

    Ratings stable for most players, supported by the

    stability provided by the domestic market and

    healthy financial profiles

    (refer to commentary 'Home-grown players retain edge

    in domestic pharma market').

    Despite the increase in business risks for large and mid-

    sized pharma companies, CRISIL's ratings on most

    companies have remained stable. This is because most

    CRISIL-rated pharma companies continue to derive

    sizeable and steady revenues from the domestic market,

    which has remained largely stable. This has resulted in

    stable cash flows and healthy profit margins for the

    companies. The domestic market still contributes nearly

    40 per cent to these companies' total revenues.

    The domestic formulations market has grown at a

    healthy CAGR of 15 per cent over the past four years.

    This has been supported by increase in the consumers'

    income levels (and therefore, their purchasing power),

    and also by increased awareness about health and well-being. An increasing incidence of lifestyle diseases has

    led to above-average growth and profitability in chronic

    therapeutic segments such as cardiovascular and anti-

    diabetic care; however, the anti-infective segment

    remains the largest therapeutic segment. The 'branded

    generics' Indian pharma market helps bring in stable

    revenues and enhances pricing flexibility. Domestic

    players have retained their edge in the Indian pharma

    market, as there have been few launches of new drugs

    by MNCs. Moreover, domestic players have developed

    strong relationships and good networks, spanning both

    urban and rural areas. However, the domestic

    formulations market continues to be intenselycompetitive, with more than 15,000 players. Hence,

    drug prices in India are among the lowest in the world.

    The operating margins of players in the Indian pharma

    market are healthy and much less volatile than that of

    players in the regulated markets. The operating margins

    of companies are typically in the range of 15 to 25 per

    cent, depending upon the product mix. The domestic

    market has helped Indian companies mitigate risks

    arising from operations in the international generics

    markets.

    Conservative financial policies have also helped playersmaintain overall credit quality, despite their large

    exposures to global markets. Sun Pharma, Biocon Ltd,

    and DRL, for instance, continues to maintain healthy

    gearing (at less than 0.5 times) and strong liquidity.

    Strong parentage has also helped players maintain

    stable ratings. Several global pharma majors have

    increased their presence in India through acquisitions, or

    by setting up manufacturing facilities. For instance,

    Matrix Labs and Ranbaxy have been acquired by Mylan

    Laboratories Inc (Mylan) and Daiichi Sankyo Co Ltd,

    respectively.

    Stable outlook on pharma sector ratings

    The domestic market has thus far mitigated the impact

    of increasing risks from global exposure. As growth

    from international business continues to outpace that

    from the domestic market, players are expected to

    proactively manage risks from global markets through a

    mix of strategies. CRISIL's outlook on the pharma sector,

    therefore, remains stable.

    The risk management strategies adopted by pharma

    players are as follows:

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    06

    • Seeking collaborations with strong global

    players: Strong global pharma players have the large

    resources, strong balance sheets and local expertise

    necessary to ensure long-term success in regulated

    markets. In these collaborations, Indian players willremain focused on manufacturing, while their global

    partners deal with large buyers and manage

    relationships with local authorities (see Box 5)

    • Focusing on contract manufacturing options

    that lend stability to revenues:  Contract

    manufacturing provides Indian players the

    opportunity to participate in the global generics

    growth story, and benefit from stability in revenues

    and growth in volumes (albeit, at significantly lower

    profit margins) without exposure to risks such as

    litigation. It also avoids the need for Indian players to

    make large investments in marketing anddistribution and the necessity of contracting large

    debt for funding acquisitions in international

    markets.

    • Maintaining healthy financial risk profiles and

    strengthening risk management policies: 

    Companies are expected to be cautious in large

    acquisitions of companies and brands, and fund

    growth initiatives and capital expenditure prudently.

    Companies are expected to formalise policies for

    managing foreign exchange and other related risks.

    • Curbing ambitions in R&D to avoid drain onresources: The initial enthusiasm for new chemical

    entity (NCE) research seems to have diminished

    because of high resource intensity and longer

    timeframes for returns. The past 12 months have

    seen few out-licensing deals. Indian pharma

    companies such as Sun Pharma, DRL, and Glenmark

    have actively hived-off their R&D for drug discovery

    and innovation into separate entities in order to de-

    risk the business model. The total R&D expenditure

    for major pharma companies has remained low, in

    the range of 4 to 6 percent. Indian companies are

    also being conservative in investments on new drug

    research.

    • Precluding costly litigations: By reducing focus on

    launches of blockbuster drugs 'at risk', since these

    invite litigations from innovators, companies are

    instead focusing on niche molecules with fewer

    competitors and lower risks of price erosion.

    Box 5: Collaborations between Indian and

    global pharma players 

    In March 2009, Pfizer Inc (Pfizer) entered into a deal

    with Aurobindo Pharma Ltd (Aurobindo) for

    contract manufacturing of 39 drugs to be sold

    across Europe and the US. In June 2009,

    GlaxoSmithKline PLC (GSK), entered into a similar

    alliance with DRL to access the current portfolio and

    future pipeline of more than 100 branded

    pharmaceutical products. The products will be

    manufactured by DRL, and licensed and supplied by

    GSK in various countries in Africa, West Asia, Asia

    Pacific, and Latin America.

    However, industry-level factors such as regulatory

    changes in key markets, change in competitive

    landscape, increasing pricing pressure remain key rating

    sensitivity factors. The growth strategies, financial riskprofile and risk management policies adopted by

    individual players would determine their credit risk

    profiles in future.

    Rating changes

    CRISIL has downgraded its ratings on a few large and

    mid-sized pharma companies. This is because of

    refinancing pressures arising from the repayment of

    substantial debt incurred by these entities to fund

    expansions. Due to the turmoil in the equity markets

    since September 2008, planned initial public offerings

    (IPOs) and conversion of foreign currency convertible

    bonds (FCCBs) did not materialise. Companies with

    large exposure to semi-regulated markets of Russia, CIS,

    and Latin America were faced with significant

    accumulation of inventory and receivables because of

    currency devaluation in these markets; this led to steep

    increase in their debt levels, thereby weakening their

    financial risk profiles. Currency volatility also led to large

    outflows for a number of companies on account of out-

    of-money derivatives contracts, which further

    exacerbated the stretched liquidity position (see Box 6).

    Box 6: Impact of exchange rate volatility

    Depreciation in the value of the Indian rupeeresulted in large forex losses for most CRISIL-rated

    companies in 2008-09. This is because the

    companies had entered into derivative contracts and

    long-term forward contracts with the expectation

    that the rupee would appreciate against the dollar.

    The net impact of these losses (realised and

    unrealised) is estimated at Rs.40 billion for large and

    mid-sized pharma companies rated by CRISIL, which

    was 10 per cent of their revenues in 2008-09.

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    08

    Government-led cost-containment measures have

    impacted player profitability

    Move towards tendering is game-changer in Germany

    and Netherlands

    Germany: As a result of legislative changes introduced

    in 2007 (refers to calendar year, January 1 to December

    31), the German generics market, which is Europe's

    largest generics market, has become increasingly

    tender-driven. With the new legislations, health insurers

    are encouraged to enter into direct rebate agreements

    with pharma companies that offer the most competitive

    prices. Under this system, pharmacists are obliged to sell

    products of only those manufacturers who hold rebate

    contracts with the health insurers of patients. The law

    also provides incentives to doctors to prescribe generic

    drugs covered by such rebate contracts. By May 2008,

    around 66 per cent (by volumes) of generic drugs were

    sold through tenders. Generic drug prices declined by 5

    to 25 per cent after 2007 because of these changes.

    Netherlands:  In 2008, a new tender system was

    introduced, giving pharma manufacturers an incentive

    to reduce prices and become direct and exclusive

    suppliers to health insurance organisations for a period

    of up to one year. This has resulted in a sharp decline in

    generics prices, as companies compete for exclusive

    large orders.

    The companies that benefited through this shift have

    large scale of operations, stronger balance sheets, and

    broader product portfolio to offer. Large global generics

    majors such as Teva Pharmaceutical Industries Ltd (Teva),

    Mylan Laboratories Inc (Mylan), and Sandoz (generic

     pharmaceuticals division of Novartis AG), were able to

     garner a larger share of the tenders by bidding very

    competitively and offering a large basket of products.

    The tender-based approach implemented by Germany

    and Netherlands is likely to be adopted by other nations

    in the European Union (EU) over the medium term, as it

    has proved to be effective in reducing costs.

     Steep cuts in reimbursement prices for generic drugs inUK and France 

    The UK: National Health Service (NHS) is the national

    insurer in the UK's pharma market, where competition is

    intense. In 2007, the UK government initiated reforms in

    pharmacy remuneration. As part of this reform, the

    government reduced the annual reimbursement level

    for generic drugs to pharmacists by USD600 million

    (which is estimated to be more than 10 per cent of the

    UK's generic drugs market). The cut in pharmacist

    reimbursements has resulted in a decline in prices of

    generic drugs. Generics prices are subject to frequent

    reviews.

    France: In 2008, the Government of France mandated

    that the prices of new generic drugs be fixed at 55 per

    cent (as against 50 per cent, earlier) lower than the

    prices of innovator drugs, making it difficult for generics

    players to earn adequate profits.

    Box 1: Impact of government cost-

    containment measures in Europe

    Dr. Reddy's Laboratories Ltd (DRL) and Matrix

    Laboratories Ltd (Matrix Labs) made large

    acquisitions in Germany (betapharm Arzneimittel

    GmbH) and Belgium (Docpharma) respectively. The

    performances of the acquired entities deteriorated

    significantly because of regulatory changes in the

    markets where they operate. Both DRL and Matrix

    subsequently made large write-offs to account for

    the decrease in the value of their investments,resulting in reported losses in 2008-09 and 2007-

    08 respectively.

    Increasing consolidation can impact small and

    mid-sized Indian players

    Generics price competition in the US, triggered by large

    retailers and drug store chains

    There has been consolidation at all levels in the US

    pharma industry—including the pharmacy chains,

    wholesalers, benefit managers, and generic drug

    manufacturers—resulting in fewer, but larger, players

    throughout the supply chain. The top six pharmacies inthe US account for more than 50 per cent of all drug

    prescriptions in the country.

    Since 2006, large retailers, such as Wal-Mart Stores, Inc,

    Kmart Corp, and Target Corp began offering commonly

    prescribed generic drugs at very low prices to attract

    shoppers. For these retailers, pharma sales contribute to

    a small portion of their total revenues; they were,

    therefore, able to absorb the lower margins. By 2008,

    the large drug store chains were forced to respond and

    launch their own low-cost generic drugs. Generic drug

    manufacturers began competing and lowering prices toattract bulk orders from retailers. As a result, generic

    drug sales dropped to USD33 billion in the year ended

    September 2008 from USD34 billion in 2007, a drop of

    2.7 per cent, despite the number of generic drug

    prescriptions increasing by 5.4 per cent during the same

    period.

    The major beneficiaries of these changes have been

    large companies that offer larger product baskets at

    attractive discounts. The retailers prefer to work with a

    few large suppliers who can meet their requirements,

    rather than with a large number of suppliers. The

    adverse effect on the profitability of the US generic

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    drugs manufacturers is likely to be seen over the medium term. US-focused generics companies, such as Mylan and

    Watson Pharmaceuticals, Inc (Watson), are diversifying through acquisitions in other markets as a de-risking strategy.

    Consolidation among generics players continues

    The top three generics companies now account for over 30 per cent of the market (see Chart 4). These large

    companies have been able to compete successfully and increase their market shares in the regulated markets, by

    edging out the smaller and mid-sized players. CRISIL expects more consolidation to take place in the global generics

    industry going forward, which will further increase the degree of competition for Indian players.

    Regulatory environment has become more

    stringent

    The US Food and Drug Administration (FDA) has

    tightened regulatory oversight over the drugs sold in US

    pharma market, especially with regard to compliance.

    This was triggered by several quality-related issues

    including deaths of 149 people in the US in 2008

    following alleged consumption of inferior-quality blood

    thinner, Heparin, sourced from China. The US FDA

    opened its first overseas offices in Beijing, Shanghai, and

    Guangzhou in China in November 2008. In India, the

    regulatory body conducts frequent on-site inspections

    as part of its 'Beyond Our Borders' initiative. Several

    generic drug manufacturers have been cited by US FDA

    for irregularities, including global companies such as

    Sandoz, and a number of Indian players such as Ranbaxy

    Laboratories Ltd (Ranbaxy), Sun Pharmaceuticals

    Industries Ltd's subsidiary in Detroit (Caraco

    Pharmaceutical Laboratories Ltd), Cipla Ltd, and Lupin

    Ltd. This could severely hamper the market reputation of

    the companies under the US FDA scanner and also could

    lead to termination of review of drug applications from

    the site or a complete ban on manufacture and sales.

    Recent regulatory issues raised by US FDA for

    Indian pharma companies

    • Ranbaxy faces ban on some of its drugs in the US

    because of manufacturing violations andfalsification of data and results of tests held at the

    two manufacturing units in India. Ranbaxy's US

    sales declined by 53 per cent in the third quarter of

    2009. Also, inventory write-offs resulted in a

    decline in profits for the company in the earlier

    quarters.

    • Caraco's facility in Detroit was found violating

    current good manufacturing practices (cGMP).

    USFDA seized Caraco's inventory of goods in June

    2009. Sun Pharma's US sales declined by 12 per

    cent in the first half of 2009-10 (refers to financial

    year, April 1 to March 31)

    • US FDA reported several discrepancies in the

    manufacturing processes of Cipla's manufacturing

    unit in Bangalore in April 2009. Recently, however,

    the unit was cleared of alleged violations in cGMP

    norms by US FDA.

    • For Lupin's manufacturing unit at Mandideep, US

    FDA issued warning letters because of significant

    deviations in compliance with cGMP norms in May

    2009.

    Source: CRISIL estimates, company annual reports

    Chart 4: Top 10 generics companies—percentage market share (2008 estimates)

    1.4%

    1.5%

    1.9%

    2.8%

    2.9%

    3.0%

    3.1%

    5.9%

    9.5%.

    16.9%

    0.0% 2.0% 4.0% 6.0% 8.0% 10.0% 12.0% 14.0% 16.0% 18.0%

    Gideon Richter

    Krka

    Ranbaxy (acquired by Daiichi Sankyo)

    Stada

    Ratiopharm

    Actavis

    Watson (acquired Andrx)

    Mylan (acquired Merck KGaA generics)

    Novartis (Sandoz, acquired Hexal)

    Teva (acquired Ivax, Barr)

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    10

    Key success factors in regulated generics markets

    CRISIL believes that the following factors are critical for a

    generics company to succeed in regulated markets:

    Managing relationships with key decision makers(public/private insurance funds): Cost bearers such as

    insurance funds and governments are gaining

    importance as key decision-makers in the regulated

    generics markets. This is particularly true for most of the

    European countries where the majority of healthcare

    expenses are borne by public/private insurance funds.

    These insurance funds are typically institutionalised and

    highly sophisticated and control a large part of the

    market. Therefore, building favourable relationships

    with these entities will be critical for success in the

    market.

     Ability to shift the sales model towards an institutionalfocus:  Promotion of products to doctors and

    pharmacists, which has traditionally been the selling

    norm with drug manufacturers in India, is not effective

    in the current scenario in the regulated markets; this is

    especially true where the markets are becoming

    increasingly tender-driven. The sales focus will have to

    move towards a more institutional focus.

    Gaining critical size and scale: Large scale of operations

    and strong balance sheets provide players with the

    ability to negotiate with large and powerful decision

    makers, benefit from economies of scale, and become

    more competitive through sheer staying power in a

    market. Diversified product portfolio and ability to give

    discounts help players win tenders and gain orders from

    large retailers. Having revenues from across markets

    also helps mitigate risks arising from unfavourable

    changes in regulations in any one market.

    Pharma companies are recognising the need to gain size

    and scale. Several large pharma companies have

    responded with a spate of acquisitions, thereby making

    the industry more consolidated globally.

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    Indian pharma players continue to benefit from the

    increasing push by governments and pharma majors in

    regulated markets to reduce drug prices. The focus on

    cost reduction has led to an increase in outsourcing of

    the manufacturing of drugs/drug intermediates to low-

    cost destinations such as India. Indian players, with their

    inherent cost advantages, skills in process chemistry,

    and large number of manufacturing facilities approved

    by regulators in developed markets are in an

    advantageous position. Contract manufacturingprovides Indian players the opportunity to participate in

    the global generics growth story, and benefit from

    stability in revenues and growth in volumes (albeit, at

    significantly lower profit margins) without exposure to

    risks such as litigation. It also does not require Indian

    players to make large investments in marketing and

    distribution or contract large debt for funding

    acquisitions in international markets.

    Global pharma majors are increasing their presence in

    India by setting up their own manufacturing facilities or

    entering into alliances and tie-ups with Indian

    companies for manufacture of drugs. A number of

    prominent tie-ups have been announced in the recent

    past. CRISIL believes that gaining control over the

    manufacturing base will be seen as a logical step for

    global majors to bring about vertical integration, and to

    ensure that quality standards are met. For this reason, a

    number of Indian companies and/or their

    manufacturing facilities are likely to become targets for

    acquisition in the near future.

    Pressing need to reduce healthcare costs

    Pharma companies, especially in the regulated markets

    where the healthcare costs are as high as 15 per cent ofthe gross domestic product (GDP), are under

    tremendous pressure from the respective countries'

    governments to rationalise pharmaceutical prices in the

    current environment. The regulatory push towards

    reduction of prices is expected to continue, intensify,

    and spread throughout regulated markets over the

    medium term.

    In addition, high research and development (R&D) costs,

    shrinking pipeline of new drugs, and substitution of

    patented drugs (of more than USD100 billion) with

    generics on the back of expected patent expiries over

    the next three years, are adding to pressures on

    profitability for large global pharma companies.

    The India advantage

    Indian pharma companies have the advantage of being

    low-cost producers of active pharmaceuticals

    ingredients (APIs) and formulations because of their low

    labour costs and strong skills in process chemistry.

    CRISIL Research estimates that the cost of

    manufacturing in India in an US FDA-approved plant is

    around 45 to 50 per cent of the cost of manufacturing in

    the US.

    Moreover, India has the highest number of

    manufacturing facilities approved by the US Food and

    Drug Administration (FDA) outside the US. This reflects

    India's ability to meet the most stringent quality norms

    and superior technical expertise. Indian companies are

    ahead of other Eastern European countries and China in

    receiving abbreviated new drug application (ANDA)

    approvals and drug master files (DMFs). Chart 1 shows

    that India has a share of nearly 30 per cent of the total

    ANDA approvals by the USFDA in 2008. Chart 2 shows

    that out of the total number of DMFs in 2008, 45 per

    cent were from India.

     Attractive opportunities in contractmanufacturing for Indian pharma industry 

    26

    49

    72

    96

    92

    6.8%

    14.2%

    19.5%

    24.1%

    27.3%

    0.0%

    5.0%

    10.0%

    15.0%

    20.0%

    25.0%

    30.0%

    0

    20

    40

    60

    80

    100

    120

    2004 2005 2006 2007 2008(till Sept)

    No of approvals % of total approvals (RH axis )

    193

    274306

    310267

    37.3%39.8%

    43.3%45.7% 45.3%

    0.0%

    5.0%

    10.0%

    15.0%

    20.0%

    25.0%

    30.0%

    35.0%

    40.0%

    45.0%

    50.0%

    0

    50

    100

    150

    200

    250

    300

    350

    2004 2005 2006 2007 2008(till Sept)

    N o o f D MFs % of to ta l f il ings (RH axis)

    Source: CRISIL Research

    Source: CRISIL Research

    Chart 1: Number and percentage of total ANDAapprovals

    Chart 2: Number and percentage of total DMF fi lings

     Aparna Karnik Senior Manager, Corporate Sector Ratings

    Email: [email protected]: 022- 3342 3456

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    12

    The significant advantage that a global pharma

    company can achieve by producing in India vis-à-vis in

    regulated markets is indicated by the increasing number

    of collaborations and tie-ups that global companies are

    entering into with Indian pharma companies.

    Contract manufacturing by Indian players: Pharma

    companies such as Dr Reddy's Laboratories Ltd (Dr

    Reddy's), Alembic Ltd (Alembic), Jubilant Organosys,

    and Maneesh Pharma have extended their capabilities

    to offer services in contract manufacturing to global

    pharma companies. These services range from

    manufacturing APIs at competitive cost, to

    manufacturing complex formulations. Companies such

    as Cadila Healthcare Ltd (Cadila) and Strides Arcolabs

    actively enter into joint ventures (JVs) with global

    pharma companies, wherein manufacturing activitiesare performed by the Indian company, while the

    marketing of products is conducted by the JV partner.

    Cadila's JV with Hospira Inc, USA and Nycomed S.C.A.

    SICAR (Denmark) is an example of this practice. The

    benefits accruing to the Indian partner could be based

    either on a cost plus pricing with committed large

    volumes or on a profit-sharing model. Likewise, Alembic

    also manufactures APIs and formulations for global

    pharma majors in the regulated market, from which it

    derives around 25 per cent of its revenues.

    Recent collaborations announced by globalpharma companies

    In March 2009, global pharma giant Pfizer Inc (Pfizer)

    entered into a deal with Aurobindo Pharma Ltd

    (Aurobindo) to contract manufacture 39 drugs to be

    sold across Europe and the US. The scope of the deal

    was later expanded with Pfizer acquiring rights to 55

    solid oral dose products and 5 sterile injectable products

    for several countries emerging countries throughout

    Asia, Latin America, Africa, and the Middle East. Pfizer

    will handle the marketing after licensing each product

    from Aurobindo; Aurobindo will handle all the steps to

    obtain approvals to make generic versions, as well asmanufacture the drugs. The products are in anti-

    infective, cardiovascular (CVS), and central nervous

    system disorders (CNS) therapeutic segments.

    In June 2009, GlaxoSmithKline plc.(GSK), entered into a

    similar alliance with Dr Reddy's to access the current

    portfolio and future pipeline of more than 100 branded

    pharmaceuticals in CVS, diabetes, oncology,

    gastroenterology, and pain management segments.The products will be manufactured by Dr Reddy's, and

    licensed and supplied by GSK in Africa, West Asia, Asia

    Pacific, and Latin America. In some markets, the

    products will be co-marketed by GSK and Dr Reddy's.

    In June 2009, Mylan Inc (Mylan) entered into an

    exclusive collaboration with Biocon Ltd (Biocon) for the

    development, manufactur ing, supply, and

    commercialisation of multiple, high-value generic

    biologic compounds for the global market. Mylan is

    likely to benefit from Biocon's capabilities in research,

    development, and manufacturing of high-quality

    protein therapeutics, including both novel biologics and

    bio-generics. In addition, Mylan's regulatory and

    commercialisation capabilities in the US and Europe

    create a cost-effective model to address an emerging

    opportunity for generic biologics. As part of the

    collaboration, Mylan and Biocon will share development,

    capital, and certain other costs to bring products to

    market.

    A win-win situation

    Collaborations present a win-win situation for both

    parties, since the multi-national companies (MNCs) will

    be able to reduce costs and focus on marketing activities,

    while the Indian players benefit from stable and

    predictable revenues and growth in volumes. Global

    pharma players have also been pursuing acquisitions of

    Indian players for their low-cost manufacturing and

    research capabilities. Deals such as Mylan's acquisition

    of Matrix Laboratories, Sanofi-Aventis's acquisition of

    Shantha Biotechnics Ltd, and Hospira Inc's acquisition of

    Orchid Chemicals and Pharmaceuticals Ltd's injectable

    pharma business are cases in point. CRISIL believes that

    more such acquisitions are likely to occur over the short

    to medium term, as gaining control over the

    manufacturing base will be seen as a logical step for

    global majors to bring about vertical integration in their

    operations, and ensure that quality standards are met.

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    Home-grown players retainedge in domestic pharma market

    Indian players have demonstrated their strength in the

    domestic pharma market by maintaining market

    positions, and reporting healthy growth. The stability

    provided by domestic revenues has helped Indian

    pharma players retain stable credit profiles despite

    increasing risks arising from their growing presence in

    the international markets. The domestic market

    contributes 46 per cent to the total revenues of India’s

    pharma companies.

    The growth story continues…The domestic formulations market, estimated at Rs.341

    billion in 2008, has grown at a healthy compound

    annual growth rate (CAGR) of 15 per cent over the past

    four years. The growth has been driven by increase in

    customer income levels and awareness, augmenting the

    demand for drugs.

    …. backed by buoyant chronic care segment

    An increasing incidence of lifestyle diseases (especially,

    chronic ailments) has led to above-average growth and

    profitability in segments such as diabetic and

    cardiovascular (CVS) care. The anti-diabetic segment

    grew by 17 per cent while the CVS segment grew by 14

    per cent in 2008 as compared to total formulations

    market growth rate of about 10 per cent. The anti-

    infective segment remains the largest revenue earner

    with sales of about Rs.60 billion, which is 18 per cent of

    the total market.

    The Indian formulations market is expected to grow at a

    CAGR of 10-12 per cent over the medium term, backed

    by steady growth in the chronic therapeutic segments.

    Local players retain market positions in domestic

    market

    Local players continue to hold a competitive edge over

    the multinational companies (MNCs) in the formulations

    market, despite the implementation of the product

    patent regime in 2005. As Table 1 indicates a majority of

    Indian players have improved or held on to their market

    positions post 2004 (pre-product patent introduction).

    The few Indian players that have slipped in the rankings

    have lost positions to other Indian players. However,

    most of the MNCs in the top 25 players have been

    superceded by Indian players.

    Table 1: Movement in top 25 players' ranking post the introduction of product patent regime

    Movement in ranking

    Manita Agarwal Analyst, Corporate Sector Ratings

    Email: [email protected]: 022- 3342 3028

    Cipla

    Ranbaxy Laboratories (acquired by MNC)

    Piramal Healthcare

    Cadila Healthcare

    Sun Pharma

    Alkem Laboratories

    Lupin Labs

    Mankind PharmaAristo Pharma

    Dr. Reddy's Laboratories

    Emcure Pharmaceuticals

    Wockhardt

    Torrent Pharma

    Intas Pharmaceuticals

    Alembic Ltd

    FDC

    Micro Labs

    Macleods Pharma

    U S V

    Unichem Laboratories

    Indian Players

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    14

    From CRISIL's rated portfolio, home-grown players such

    as Cadila and Sun Pharma, which have been focused on

    the chronic segment, have been able to maintain their

    market positions among the top seven. Companies such

    as Micro Labs and Alembic, which have a higher

    presence in the acute segments, have lost market

    positions

    Home-grown players have been able to retain their edge

    due to few new product launches by MNCs. Moreover,

    domestic players have strong relationships, and well-

    entrenched networks spanning both the urban and rural

    areas, which help them to retain their market positions.

    Few new product launches by MNCs

    As Table 2 shows, MNCs have launched very few

    patented products in India in the four years since the

    implementation of the new regime. The MNCs cite

    issues relating to the implementation and enforceability

    of Intellectual Property Rights (IPR) in India as a key

    hurdle in launching new drugs, in addition to thelengthy patent application and approval process. MNCs

    Table 2: Patented molecules launched in India (till March 2008)

    Product Company Therapeutic category Launch date Status 

    Vfend Pfizer Anti-Infective Feb-05 On Patent

    Windia (Avandia) GSK Anti-Diabetic May-05 On Patent

    Viagra Pfizer Erectile Dsyfunction Dec-05 On Patent

    Lyrica Pfizer Neuropathic Feb-06 On Patent

    Caduet Pfizer Cardiovascular Feb-06 Off Patent

    Coreg GSK Cardiovascular Mar-06 Off Patent

    Genotropin Pfizer Endocrine Disorders Mar-06 On Patent

    Tamiflu Roche Influenza Apr-06 On Patent

    Pegasys Roche Hepatitis C May-06 On Patent

    Aprovel (Avalide) Sanofi Aventis Cardiovascular Jul-06 On Patent

    Stilnox (Ambien) Sanofi Aventis Insomnia Jan-07 Off Patent

    Arixtra GSK Cardiovascular Mar-08 On Patent

    Champix Pfizer Neuro/CNS Mar-08 On Patent

    Flutivate - E GSK Dermatology n.a On Patent

    Lescol XL Novartis Cardiovascular n.a On Patent

    such as Novartis (India) Ltd, Hoffman La Roche, and

    Bayer have been involved in legal battles alleging

    infringement of patents by Indian players. Issues

    regarding definition of 'invention' and eligibility of

    drugs for patent protection remain a key concern for

    MNCs in India.

    Another strong deterrent for MNCs has been the low

    affordability in the Indian market for expensive new

    treatments: most drugs treating key therapeutic

    diseases are already available in India at reasonable

    prices. Moreover, there have been few new

    breakthrough drugs discovered in the past 3-4 years for

    treatment of ailments where existing proven therapies

    are not adequately effective. Because of these factors,

    only about 15 patented molecules have been launched

    in India since April 2005 with the Government of India

    remaining committed to keeping healthcare affordable

    for the Indian market, MNCs may continue to face

    challenges in capturing a dominant market position.

    CRISIL expects MNCs to focus on niche segments and

    specialty drugs going forward.

    Source: Company Reports, CRISIL Research and CRISIL Ratings

    n.a: Not available; Source: CRISIL Research

    Movement in rankingMNCs

    GlaxoSmithKline Pharmaceuticals

    Abbott India

    Sanofi AventisPfizer

    Novartis India

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    5

    Strong relationships, well entrenched networks,

    and competitive scale

    Indian players have established strong relationships with

    local stakeholders—general practitioners, specialists,

    public and private hospitals, and pharmacists across the

    urban and rural parts of the country. Companies have

    allocated large resources to marketing efforts within the

    medical fraternity and have a track record of delivering

    effective medicines. Indian companies have gradually

    grown to a critical size and scale to meet the drug

    requirements of the domestic market at reasonable

    prices.

    Domestic market provides stability to credit

    profiles

    The branded nature of the domestic market lends

    stability to revenues, and enhances pricing flexibility for

    players. The operating margins and cash flows of the

    players in the Indian pharma market are healthy and

    much less volatile than that of players in the regulated

    markets. The operating margins of companies aretypically in the range of 15 to 25 per cent, depending

    upon the product mix. Healthy performance in the

    domestic market has helped Indian companies mitigate

    risks arising from operations in the international

    generics markets.

    However, the intense competition—the domestic

    market has more than 15,000 players—and the Drug

    Price Control Order (DPCO) have collectively kept drug

    prices in India among the lowest in the world and

    continue to constrain the profitability of players.

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  • 8/20/2019 CRISIL Ratings Indian Pharma Booklet Apr10

    21/64

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