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

Mar 28, 2013, 14:53 ET from Reportlinker

NEW YORK, March 28, 2013 /PRNewswire/ -- announces that a new market research report is available in its catalogue:

The Indian Pharmaceutical Industry 2013: Coming of Age in a Global Market .html#utm_source=prnewswire&utm_medium=pr&utm_campaign=Generic_Drug

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 roseby 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 whichUS$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 pharmaceuticalcompanies 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.

Contents FOREWORD 1


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



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


Corporate Strategy 42

Manufacturing Capabilities 42

Licensing and Supply Agreements 43

R&D 44

Key Markets 44

Products 45

APIs 45

Domestic Formulations 45

International Generics 45

Financial Performance 50


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


Corporate Strategy 57

Manufacturing 57

R&D 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


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


Corporate Strategy 69

Manufacturing 69

R&D 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


Corporate Strategy 77

Manufacturing 77

R&D 77

Products 78

Financial Performance 78


Corporate Strategy 79

Manufacturing 80

R&D 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


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


Corporate Strategy 93

Manufacturing 94

R&D 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


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


Corporate Strategy 107

Manufacturing 108

R&D 108

Key Markets 109

Recent Company News 109

Orchid exits its China joint venture 109

Hospira to acquire API and R&D 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


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


Corporate Strategy 117

Manufacturing 118

R&D 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


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


Corporate Strategy 133

Manufacturing 133

R&D 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


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


Corporate Strategy 149

Manufacturing 149

R&D 150

Key Markets 150

Products 151

Domestic Formulations 151

International Generics 151

Financial Performance 153


Corporate Strategy 154

Manufacturing 155

R&D 155

Key Markets 156

Products 156

APIs 156

Domestic Formulations 157

International Generics 157

Financial Performance 160


Corporate Strategy 161

Manufacturing 162

R&D 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


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 & 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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