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

NEW YORK, Jan. 30, 2013 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue:

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

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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 FOREWORD 1THE 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

R&D . 38

Key Markets . 38

Products . 39

Domestic Formulations 39

APIs . 39

International Formulations 39

Generics 39

Financial Performance 41

AUROBINDO PHARMA . 42Corporate Strategy 42Manufacturing Capabilities . 42Licensing and Supply Agreements . 43R&D . 44Key Markets . 44Products . 45APIs . 45Domestic Formulations . 45International Generics 45Financial Performance 50

BIOCON 51

Corporate Strategy 51

Manufacturing 51

R&D . 52

Insugen 52

Biosimilar insulin glargine . 53

Oral insulin development . 53

Monoclonal Antibodies 53

Recent Company News 54

Biocon & BMS sign option agreement for IN-105 . 54

Biocon & Pfizer conclude commercialisation agreement . 54

Products . 55

APIs . 55

Domestic Formulations . 55

International Formulations 55

Financial Performance 56

CIPLA 57Corporate Strategy 57Manufacturing 57R&D . 58Key Markets . 58Recent Company News 58Cipla reduces prices of some cancer drugs . 58Cipla proposes to buy stake in Cipla Medpro 59DNDi enters antiretroviral collaboration with Cipla 59Products . 61APIs . 61Domestic Formulations . 61International Generics 63Financial Performance 64

CLARIS LIFESCIENCES . 65

Corporate Strategy 65

Manufacturing . 65

R&D . 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 69Corporate Strategy 69Manufacturing . 69R&D . 70Key Markets . 71Recent Company News 71Dr Reddy's launches Pamorelin LA in India .71Dr Reddy's makes public offer for OctoPlus .71Merck and Dr Reddy's enter biosimilars collaboration 72Products . 72APIs . 72Domestic Formulations 72International Generics 73Financial Performance 76

ELDER PHARMACEUTICALS . 77

Corporate Strategy 77

Manufacturing . 77

R&D . 77

Products . 78

Financial Performance 78

GLENMARK . 79Corporate Strategy 79Manufacturing . 80R&D . 81New Chemical Entities .81Biologics 82Key Markets . 82Recent Company News 83Glenmark settles OC litigation with Janssen .83 ICDR rules in favour of Glenmark regarding crofelemer agreement 83Products . 84APIs . 84Domestic Formulations . 84International Generics 84Financial Performance 87

JUBILANT LIFE SCIENCES 88

Corporate Strategy 88

Manufacturing 89

R&D . 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 93Corporate Strategy 93Manufacturing 94R&D . 95Key Markets . 95Recent Company News 96Santarus/Depomed enter Glumetza settlement arrangement with Lupin 96Lupin and Eli Lilly collaborate on diabetes products . 96Products . 96APIs . 96Domestic Formulations . 96International Formulations 97Financial Performance 99

NATCO PHARMA . 100

Corporate Strategy 100

Manufacturing 100

R&D . 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 & PHARMACEUTICALS 107Corporate Strategy 107Manufacturing 108R&D 108Key Markets . 109Recent Company News 109Orchid exits its China joint venture 109Hospira to acquire API and R&D facilities from Orchid . 109Orchid's drug-discovery initiative with Merck advances 110Products . 110APIs 110Domestic Formulations 111International Generics . 111Financial Performance 112

PANACEA BIOTEC 113

Corporate Strategy 113

Manufacturing 113

R&D 113

Key Markets . 114

Recent Company News 114

Panacea enters US generic alliance with Kremers Urban . 114

Osmotica & Panacea sign strategic alliance agreement 115

Panacea inaugurates oncology production unit . 115

Products . 115

Financial Performance 115

PIRAMAL ENTERPRISES 117Corporate Strategy . 117Manufacturing 118R&D 118Key Markets . 119Recent Company News 119Strategic alliance with Fujifilm Diosynth Biotechnologies . 119Piramal/Baxter settle patent litigation over generic Suprane 119Products . 120APIs 120 Domestic Formulations 120International Formulations 120Financial Performance 120

RANBAXY 122

Corporate Strategy 122

Manufacturing 122

R&D . 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 133Corporate Strategy 133Manufacturing 133R&D . 134Key Markets 134Recent Company News 135Lilly/Strides collaborate to deliver branded generic cancer drugs in emerging markets . 135Phosphagenics licenses injectable antibiotic to Agila . 135Strides' Polish sterile injectable facility gains US FDA approval . 135Agila to enter the Canadian injectable market . 135Strides acquires FDA-approved sterile formulations facility . 136Products . 136Domestic Formulations 136International Generics 137Financial Performance 138

SUN PHARMA 139

Corporate Strategy 139

Manufacturing 140

R&D . 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 . 149Corporate Strategy 149Manufacturing 149R&D 150Key Markets . 150Products . 151Domestic Formulations 151International Generics . 151Financial Performance 153

WOCKHARDT . 154

Corporate Strategy 154

Manufacturing 155

R&D 155

Key Markets . 156

Products . 156

APIs 156

Domestic Formulations 157

International Generics . 157

Financial Performance 160

ZYDUS CADILA 161Corporate Strategy 161Manufacturing 162R&D 163Key Markets . 163Recent Company News 164Microbix licenses Kinlytic rights to Zydus to aid North American re-launch 164Karo Bio/Zydus Cadila collaboration expires 164Zydus Cadila acquires Biochem 165Products . 165APIs 165Domestic Formulations 165International Generics . 166 Financial Performance 169

SOURCES 170

Espicom Sources . 170Others 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 & 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

Companies Mentioned Alembic

Auribindo Pharma

Biocon

Cipla

Claris Lifesciences

Dr Reddy's

Elder Pharmaceuticals

Glenmark Pharmaceuticals

Jubilant Life Sciences

Lupin

Natco Pharma

Orchid

Panacea Biotec

Piramal Enterprises

Ranbaxy

Strides Arcolab

Sun Pharma

Torrent Pharmaceuticals

Wockhardt

Zydus Cadila

To order this report:Generic_Drug Industry: The Indian Pharmaceutical Industry 2013: Coming of Age in a Global Market

Nicolas Bombourg
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