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The Indian Pharmaceutical Industry 2013: Coming of Age in a Global Market

  • January 2013
  • -
  • Espicom Business Intelligence
  • -
  • 164 pages

The 20 companies examined in this report had combined sales of more than US$17.4 billion in their most recently reported fiscal year, which generally concluded on 31st March 2012. Ranbaxy reported revenue of Rs.99,769 million (US$2,145 million) for the calendar year ended 31st December 2011, making it the leading company in terms of revenue. Of the companies listed, 18 reported improved sales over 2010/11.

New Guidance on Biosimilar Manufacture
In 2012, new “Guidelines on Similar Biologics” were published. The Guidelines were prepared by the Central Drugs Standard Control Organisation and the Department of Biotechnology, and lay down the regulatory pathway for a biologic claiming to be similar to an already authorised reference biologic. The Guidelines apply to both locally-developed and imported products, although the precise approval process differs in each case. The document notes that a reduction in testing and data requirements at the preclinical and clinical level is likely to be possible for a biosimilar, however, ‘it is essential that the testing of the similar biologic be sufficient to ensure that the product meets acceptable levels of safety, efficacy and quality to ensure public health’.

A number of Indian companies are active in the biologics segment of the pharmaceutical market. Leading indigenous biotechnology companies include Biocon and Panacea Biotech, which ranked first and third in terms of revenue in the BioSpectrum-ABLE Biotech Industry Survey 2010. The Serum Institute of India was in second place. Unsurprisingly, the Indian biotech industry has its sights set on the regulated biosimilars markets of the EU and US. However, no Indian company has yet achieved a biosimilar approval in the EU and the US market remains in its infancy. A more realistic target for most companies, at least for the time being, is the domestic and emerging markets for biosimilars.

Where have all the outbound mergers gone?
Many Indian companies have pursued an aggressive acquisition policy in order to accelerate market growth or acquire manufacturing capacity. Prior to the economic downturn in 2008, this policy could be clearly seen with 10 acquisition/controlling stake deals announced in the year. Pressure on prices and variable performance have firmly put a lid on this activity, Sun Pharma’s eventual control of Taro being one of the few deals to go through since. Inward investment has equally been affected as interest in Indian companies has cooled. Matrix – one of the more acquisitive companies – was purchased in 2007 by Mylan. Now rebranded Mylan Laboratories, one of the better known names in India pharma has now gone.

Focus on...current and future markets
India’s domestic market: not achieving necessary growth
With a population of over one billion and a growing middle class in excess of 300 million people with disposable income and increasing healthcare expectations, the domestic formulations market has enormous potential for growth. But India is a country of wide economic divide and while a growing number of people can afford to pay for good quality private healthcare, for the bulk of its vast rural population all but basic healthcare provision will remain out of reach for the foreseeable future. However, domestic pharmaceutical companies are reporting increased penetration in smaller towns and rural areas. Rising household income and improvements in health infrastructure and delivery systems will continue to support long-term growth in the pharmaceutical market. Nevertheless, India’s domestic market will not grow at the required rate to sustain the industry’s revenue needs and production capacity and so Indian pharma companies will remain export focused in the medium term.

INTERNATIONAL DEVELOPMENTS

US Market: the prize market for Indian companies
The USA remains the largest generic market and the most sought after target for Indian companies involved in the generic business, and market growth has been sustained in recent years by a large number of patent expirations. As the Indian majors have gained experience in the US, they have been able to exploit opportunities provided by Paragraph IV filings and specialty generics with fewer competitors. Over the last decade the number of ANDAs approved increased dramatically. During the three year period between January 2002 and December 2004, the FDA approved 72 ANDAs for Indian pharmaceutical companies and their US subsidiaries and the numbers have increased year-on-year, to peak at 132 in 2008. Since then, the number of annual approvals has dropped slightly, to 119 in 2011 and 127 in 2012.

UK: One of Europe’s strongest generics markets
Over 80% of prescriptions in the mature UK market are fulfilled generically. The UK has always been a focus for Indian companies with nine companies running 11 manufacturing sites. Between January 2009 and January 2010, Indian companies had more than 260 marketing authorisations approved by the UK’s Medicines and Healthcare Regulatory Agency (MHRA) for a wide range of products. During this period, Ranbaxy received 55 approvals; Dr Reddy’s received 54; Aurobindo received 39; and Lupin received 25.

Europe: wider generic adoption is good news for Indian companies
The UK and Germany have been promoting generic use as a way of containing healthcare costs for years and a number of Indian companies are active in these markets. Others, such as France, Italy and Spain, have more recently begun to explore the use of generics to curtail burgeoning drug bills. Government initiatives have been introduced to increase the use of generics and reduce prices as part of wider austerity measures. These generic markets are still relatively small but growing and there are a number of Indian companies currently monitoring them. When will they act and will prevaricating harm their long-term potential?

Russia: an import dependent market which is to the advantage of Indian companies
Russia is an important market for India’s pharmaceutical industry. In 2012, the Russian pharmaceutical market was estimated at US$26,551 million at retail prices. The market is characterised by strong import growth which rose
by a CAGR of 18.7% in US dollar terms over the 2007-11 period. The heavy reliance on imports has been to Indian companies’ benefit and India’s pharmaceutical exports to Russia amounted to US$534 million in 2011, of which
US$517 million were retail formulations – this makes Russia India’s second most important export market after the USA. Among the leaders in this trade were Dr Reddy’s in gastrointestinal, cardiovascular and anti-infective drugs,
while the leading areas for the company with biosimilars are immunology and oncology. Glenmark Russia is among the top 20 pharmaceutical companies in the dermatology segment and one of the fastest growing pharmaceutical
companies in Russia.

South Africa
The generics market in South Africa has grown markedly in recent years as the government has continued to promote the low-cost sector as a means of improving access to medicines for the country's vast poor population. India’s
exports to South Africa amounted to US$310 million in 2011, of which US$267 million were retail formulations. To illustrate Indian company success, Lupin stated in its 2012 annual report that it was one of the fastest growing of
the top ten companies in South Africa, recording growth of 40% in revenues to Rs.2,554 million (US$55 million) from its subsidiary, Pharma Dynamics. The company ranked fifth among generic pharmaceutical companies in South Africa.

India as a research base: balancing need and research investment
India’s acknowledged strengths make it an ideal regional base, particularly for R&D and for commercialisation in select markets in which India already has a significant presence. With its vast population, comparatively low cost, fast turnaround and expertise in statistical analysis, India is also an attractive base for Phase III clinical trials.

Several multinationals are already using or plan to use India as a base for clinical research, particularly for specific diseases with a significant local patient base, such as tuberculosis. Companies such as GSK and Eli Lilly have been collaborating with domestic companies for R&D, while others have been utilising Indian contract research organisations. In the future, it is likely that an increasing number of companies will set up research centres in India and use the country as a hub for multi-centric global trials. Others will take advantage of the services offered by India’s emerging CROs.

The Foreign Direct Investment (FDI) policy, introduced in 2001, allows 100% FDI in the pharmaceutical industry. By 2011, however, the move aimed at encouraging foreign investment had become a cause for concern and the FDI policy was placed under review.

The Ministry of Health fears that continued takeover of Indian pharmaceutical companies by multinationals will adversely affect the domestic industry and push prices up, leading to essential medicines becoming more expensive. This could impact public health programmes, including the Universal Immunisation Programme.

According to a September 2011 report in the online version of The Hindu, the Ministry has recommended that prior approval of the Foreign Investment Promotion Board be made mandatory and that steps should be taken to channel foreign investment into green-field projects. The report states that, since 2001 when 100% FDI was first allowed in the pharmaceutical sector, just 10% has gone to green-field projects. At the government’s request, Ernst & Young is conducting a study on the impact of the recent takeover of Indian pharmaceutical companies, and its report is deemed likely to be placed before the Economic Advisory Council to the Prime Minister.


Table Of Contents

The Indian Pharmaceutical Industry 2013: Coming of Age in a Global Market
Contents

FOREWORD 1
THE INDIAN PHARMACEUTICAL INDUSTRY 3
Overview 3
Indian Operations 4
Sales Revenue 4
Generic development: a natural progression born out of necessity? 5
Domestic Market 6
Biotechnology and Biosimilars 7
Regulation 7
Biotechnology Industry Partnership Programme 8
India announces plans to establish a National Biosimilar Centre 8
Biosimilars and Indian Companies 8
International Markets 10
The United States 10
Authorised generics 11
Indian Companies' FDA ANDA Approvals 12
Europe 19
Emerging Markets 21
Brazil 21
Russia 25
South Africa 25
Global Exports 26
Foreign Acquisitions 31
COMPANY PROFILES 37
ALEMBIC 37
Corporate Strategy 37
Manufacturing Capabilities 37
RandD 38
Key Markets 38
Products 39
Domestic Formulations 39
APIs 39
International Formulations 39
Generics 39
Financial Performance 41
AUROBINDO PHARMA 42
Corporate Strategy 42
Manufacturing Capabilities 42
Licensing and Supply Agreements 43
RandD 44
Key Markets 44
Products 45
APIs 45
Domestic Formulations 45
International Generics 45
Financial Performance 50
BIOCON 51
Corporate Strategy 51
Manufacturing 51
RandD 52
Insugen 52
Biosimilar insulin glargine 53
Oral insulin development 53
Monoclonal Antibodies 53
Recent Company News 54
Biocon and BMS sign option agreement for IN-105 54
Biocon and Pfizer conclude commercialisation agreement 54
Products 55
APIs 55
Domestic Formulations 55
International Formulations 55
Financial Performance 56
CIPLA 57
Corporate Strategy 57
Manufacturing 57
RandD 58
Key Markets 58
Recent Company News 58
Cipla reduces prices of some cancer drugs 58
Cipla proposes to buy stake in Cipla Medpro 59
DNDi enters antiretroviral collaboration with Cipla 59
Products 61
APIs 61
Domestic Formulations 61
International Generics 63
Financial Performance 64
CLARIS LIFESCIENCES 65
Corporate Strategy 65
Manufacturing 65
RandD 65
Key Markets 66
Recent Company News 66
Claris Lifesciences enters into a joint venture with Otsuka and Mitsui 66
Claris Lifesciences receives FDA response to Warning Letter; intends to supply itself in US 66
Products 67
Domestic Formulations 67
International Generics 68
Financial Performance 68
DR REDDY'S 69
Corporate Strategy 69
Manufacturing 69
RandD 70
Key Markets 71
Recent Company News 71
Dr Reddy's launches Pamorelin LA in India 71
Dr Reddy's makes public offer for OctoPlus 71
Merck and Dr Reddy's enter biosimilars collaboration 72
Products 72
APIs 72
Domestic Formulations 72
International Generics 73
Financial Performance 76
ELDER PHARMACEUTICALS 77
Corporate Strategy 77
Manufacturing 77
RandD 77
Products 78
Financial Performance 78
GLENMARK 79
Corporate Strategy 79
Manufacturing 80
RandD 81
New Chemical Entities 81
Biologics 82
Key Markets 82
Recent Company News 83
Glenmark settles OC litigation with Janssen 83
ICDR rules in favour of Glenmark regarding crofelemer agreement 83
Products 84
APIs 84
Domestic Formulations 84
International Generics 84
Financial Performance 87
JUBILANT LIFE SCIENCES 88
Corporate Strategy 88
Manufacturing 89
RandD 89
Recent Company News 89
JDI/Positron strategic tie-up set to boost PET scanner capabilities 89
Jubilant SEZ facility is inaugurated 90
Jubilant/Mnemosyne enter drug-discovery collaboration 90
Early milestones delivered in Jubilant/Endo collaborative discovery programme 90
Products 90
APIs 90
International Generics 91
Financial Performance 92
LUPIN 93
Corporate Strategy 93
Manufacturing 94
RandD 95
Key Markets 95
Recent Company News 96
Santarus/Depomed enter Glumetza settlement arrangement with Lupin 96
Lupin and Eli Lilly collaborate on diabetes products 96
Products 96
APIs 96
Domestic Formulations 96
International Formulations 97
Financial Performance 99
NATCO PHARMA 100
Corporate Strategy 100
Manufacturing 100
RandD 101
Key Markets 101
Recent Company News 101
IPAB dismisses AstraZeneca's patent plea 101
Natco granted sorafenib compulsory licence 102
Natco signs biosimilars agreement with Mabxience 104
Products 104
Domestic Formulations 104
International Generics 105
Financial Performance 106
ORCHID CHEMICALS and PHARMACEUTICALS 107
Corporate Strategy 107
Manufacturing 108
RandD 108
Key Markets 109
Recent Company News 109
Orchid exits its China joint venture 109
Hospira to acquire API and RandD facilities from Orchid 109
Orchid's drug-discovery initiative with Merck advances 110
Products 110
APIs 110
Domestic Formulations 111
International Generics 111
Financial Performance 112
PANACEA BIOTEC 113
Corporate Strategy 113
Manufacturing 113
RandD 113
Key Markets 114
Recent Company News 114
Panacea enters US generic alliance with Kremers Urban 114
Osmotica and Panacea sign strategic alliance agreement 115
Panacea inaugurates oncology production unit 115
Products 115
Financial Performance 115
PIRAMAL ENTERPRISES 117
Corporate Strategy 117
Manufacturing 118
RandD 118
Key Markets 119
Recent Company News 119
Strategic alliance with Fujifilm Diosynth Biotechnologies 119
Piramal/Baxter settle patent litigation over generic Suprane 119
Products 120
APIs 120
Domestic Formulations 120
International Formulations 120
Financial Performance 120
RANBAXY 122
Corporate Strategy 122
Manufacturing 122
RandD 123
Key Markets 123
Recent Company News 124
Ranbaxy approved to set up new manufacturing facility in Malaysia 124
Ranbaxy requests withdrawal of 27 ANDAs 124
Daiichi Sankyo/Ranbaxy launch hybrid business in Venezuela 125
Synriam launched in India 125
Products 126
APIs 126
Domestic Formulations 126
Ranbaxy/Daiichi Sankyo Global Partnership 127
International Generics 127
Financial Performance 132
STRIDES ARCOLAB 133
Corporate Strategy 133
Manufacturing 133
RandD 134
Key Markets 134
Recent Company News 135
Lilly/Strides collaborate to deliver branded generic cancer drugs in emerging markets 135
Phosphagenics licenses injectable antibiotic to Agila 135
Strides' Polish sterile injectable facility gains US FDA approval 135
Agila to enter the Canadian injectable market 135
Strides acquires FDA-approved sterile formulations facility 136
Products 136
Domestic Formulations 136
International Generics 137
Financial Performance 138
SUN PHARMA 139
Corporate Strategy 139
Manufacturing 140
RandD 141
Key Markets 141
Recent Company News 142
Caraco to acquire URL Pharma 142
DUSA to be acquired by Sun 142
Sun to take Taro private 142
Products 143
APIs 143
Domestic Formulations 143
International Generics 144
Financial Performance 148
TORRENT PHARMACEUTICALS 149
Corporate Strategy 149
Manufacturing 149
RandD 150
Key Markets 150
Products 151
Domestic Formulations 151
International Generics 151
Financial Performance 153
WOCKHARDT 154
Corporate Strategy 154
Manufacturing 155
RandD 155
Key Markets 156
Products 156
APIs 156
Domestic Formulations 157
International Generics 157
Financial Performance 160
ZYDUS CADILA 161
Corporate Strategy 161
Manufacturing 162
RandD 163
Key Markets 163
Recent Company News 164
Microbix licenses Kinlytic rights to Zydus to aid North American re-launch 164
Karo Bio/Zydus Cadila collaboration expires 164
Zydus Cadila acquires Biochem 165
Products 165
APIs 165
Domestic Formulations 165
International Generics 166
Financial Performance 169
SOURCES 170
Espicom Sources 170
Others 170



List of Tables

Company Sales, 2010/11-2011/12 5
FDA ANDA Approvals, 2002-2012 (Number) 10
Indian Pharmaceutical Companies' US Subsidiaries 11
FDA ANDA Approvals, 2011-2012 12
Indian Pharmaceutical Companies' EU Subsidiaries 20
Indian Companies' EMA Authorisations 21
Indian Company Registrations of Generic Medicines in Brazil, October 2012 21
Pharmaceutical Exports Summary, 1995-2011 (US$000s) 26
Retail Medicament Exports, 2001-2011 (US$000s) 29
Indian Companies' Foreign Acquisitions 33
Foreign Acquisitions of Indian Pharmaceutical Companies, 2007-2012 36
Alembic Manufacturing Facilities 38
Alembic FDA ANDA Approvals, 2009-2012 40
Alembic Financial Results 2008-2012 41
Aurobindo Pharma Key Manufacturing Facilities 43
Aurobindo Pharma Key Subsidiaries 44
Aurobindo Pharma Regulatory Filing Status 46
Aurobindo Pharma ANDA Approvals, 2004-2012 46
Cephazone Pharma FDA ANDA Approval, 2007 49
Aurobindo ANVISA Registrations, October 2012 49
Aurobindo Pharma Financial Results, 2008-2012 50
Biocon Financial Results from Continuing Operations, 2008-2012 56
Cipla Manufacturing Facilities 58
Cipla FDA ANDA Approvals 63
Cipla Financial Results, 2008-2012 64
Claris Lifesciences Key Subsidiaries 66
Claris Lifesciences: FDA ANDA Approvals, 2008 68
Claris Lifesciences Financial Results, 2009-2011 68
Dr Reddy's Manufacturing Facilities 70
Dr Reddy's: Regional Headquarters and Key Subsidiaries 71
Top 10 Brands in India, 2011-2012 73
Dr Reddy's FDA ANDA Approvals, 2002-2012 74
Dr Reddy's Financial Results, 2008-2012 76
Elder Pharmaceuticals Manufacturing Facilities 77
Elder Pharmaceuticals Financial Results, 2008-2012 78
Glenmark Pharmaceuticals Manufacturing Facilities 80
Glenmark Generics Manufacturing Facilities 80
Glenmark Key Subsidiaries 82
Glenmark FDA ANDA Approvals, 2006-2012 85
Glenmark EMA Approvals 86
Glenmark ANVISA Registrations, October 2012 87
Glenmark Financial Results, 2008-2012 87
Jubilant Life Sciences Manufacturing Facilities 89
Jubilant Cadista FDA ANDA Approvals 2004-2012 92
Jubilant Life Sciences Financial Results, 2011-2012 92
Lupin Manufacturing Facilities 94
Lupin FDA ANDA Approvals, 2003-2012 97
Lupin Financial Results, 2008-2012 99
Natco Pharma Manufacturing Facilities 100
Natco Pharma FDA ANDA Approvals 105
Natco Pharma Financial Results, 2008-2012 106
Orchid Manufacturing Facilities 108
Orchid Key Subsidiaries 109
Orchid Leading Brands 111
Orchid FDA ANDA Approvals, 2005-2012 111
Orchid Financial Results 2008-2012 112
Panacea Biotec Financial Results, 2008-2012 116
Piramal Healthcare Manufacturing Facilities 118
Piramal Enterprises Financial Results, 2011-2012 121
Ranbaxy Manufacturing Facilities 123
Ranbaxy Regional Headquarters and Key Subsidiaries 124
Ranbaxy Laboratories FDA ANDA Approvals, 2002-2012 128
Ranbaxy ANVISA Registrations, October 2012 130
Ranbaxy Financial Results, 2007-2011 132
Strides Arcolab Manufacturing Facilities 134
Strides Arcolab Key Subsidiaries 135
Sagent Strides FDA ANDA Approvals 137
Strides Arcolab FDA ANDA Approvals 137
Strides Arcolab Financial Results, 2007-2011 138
Sun Pharma Manufacturing Facilities 140
Sun Pharma Key Subsidiaries 141
Sun Pharma FDA ANDA Approvals, 2006-2012 145
Caraco Pharmaceutical ANDA Approvals, 2002-2008 147
Sun Pharma EMA Marketing Authorisations 148
Sun Pharma Financial Results, 2008-2012 148
Torrent Manufacturing Facilities 150
Torrent Key Subsidiaries 151
Torrent FDA ANDA Approvals, 2007-2012 152
Torrent ANVISA Registrations, October 2012 153
Torrent Financial Results, 2008-2012 153
Wockhardt Manufacturing Facilities 155
Wockhardt Key Subsidiaries 156
Wockhardt FDA ANDA Approvals, 2003-2012 158
Wockhardt Financial Results, 2010-2012 160
Zydus Cadila Manufacturing Facilities 163
Zydus Cadila Key Subsidiaries 164
Zydus ANDA Approvals, 2005-2012 166
Zydus ANVISA Registrations, October 2012 168
Zydus Cadila Financial Results, 2008-2012 169



List of Figures

Total Pharmaceutical Exports, 1995-2011 (US$000s) 27
Exports of Raw Materials, 1995-2011 (US$000s) 27
Exports of Retail Medicaments, 1995-2011 (US$000s) 28
Pharmaceutical Exports by Destination, 2011 (%) 28
Exports of Retail Medicaments by Category, 2001 (%) 29
Exports of Retail Medicaments by Category, 2011 (%) 30

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