Keywords : generics, biosimilars, Generic Pharmaceuticals
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 Man...
More »
Search ReportLinker
The Largest Collection of Market Research Reports
» 1.2 Million Industry Reports
» 450,000 Company Profiles
» 850,000 Market Briefings
» 40,000 Country Guides
From +200,000 authoritative sources
- Publication date: January 2013
- Report size: 164 pages
- Report price: $ 1 391
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.
Generic Drug Industry in India
Table of 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
R&D . 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
R&D . 44
Key Markets . 44
Products . 45
APIs . 45
Domestic Formulations . 45
International Generics 45
Financial 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 57
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
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 69
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
ELDER PHARMACEUTICALS . 77
Corporate Strategy 77
Manufacturing . 77
R&D . 77
Products . 78
Financial Performance 78
GLENMARK . 79
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
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 93
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
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 107
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
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 117
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
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 133
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
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 . 149
Corporate Strategy 149
Manufacturing 149
R&D 150
Key Markets . 150
Products . 151
Domestic Formulations 151
International Generics . 151
Financial 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 161
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
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 & 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
Generic Drug in India
- $ 250
- Industry data
- January 2013
Yearly, From 2006 To 2021
By Business Monitor International
Source: AIOCD Pharmasofttech AWACS, Organisation of Pharmaceutical Producers of India (OPPI), BMI
- Industries : Generic Drug
- Countries : India
- $ 250
- Industry data
- January 2013
Yearly, From 2005 To 2021
By Business Monitor International
Source: AIOCD Pharmasofttech AWACS, Organisation of Pharmaceutical Producers of India (OPPI), BMI
- Industries : Generic Drug
- Countries : India
- $ 250
- Industry data
- January 2013
Yearly, From January 01, 2012 To January 01, 2012
By Business Monitor International
Source: AIOCD Pharmasofttech AWACS, Organisation of Pharmaceutical Producers of India (OPPI), BMI
- Industries : Generic Drug
- Countries : India
- $ 250
- Industry data
- January 2013
Yearly, From January 01, 2012 To January 01, 2012
By Business Monitor International
Source: AIOCD Pharmasofttech AWACS, Organisation of Pharmaceutical Producers of India (OPPI), BMI
- Industries : Generic Drug
- Countries : India
- $ 250
- Industry data
- January 2013
Yearly, From January 01, 2012 To January 01, 2012
By Business Monitor International
Source: AIOCD Pharmasofttech AWACS, Organisation of Pharmaceutical Producers of India (OPPI), BMI
- Industries : Generic Drug
- Countries : India
- Publication date: January 2013
- Report size: 164 pages
- Report price: $ 1 391
