The Market for Pharmaceuticals in Brazil, Russia, India & China

These leading emerging economies represent a combined pharmaceutical market of US$132.2 billion. How have they emerged from the economic downturn? Where do commercial opportunities exist for pharmaceutical companies over the 2011-16 forecast period?

Putting things in perspective...

With strong economic growth, a combined population of 2.9 billion people and significant unmet healthcare needs, challenges and opportunities remain in BRIC pharmaceutical markets. Their combined market, including pharmacy and hospital sales, is valued at US$132.2 billion at retail prices. This market is collectively lower than the USA and just higher than Japan, but impressive growth rates mean that pharmaceutical companies ought to have long-term interests in these markets. China, in fact, is expected to become the second leading worldwide pharmaceutical market by 2016.

Sizeable opportunities exist …

There are wide regional health expenditure differences within the BRIC markets, far more than in developed countries where health systems provide a more uniform coverage level. These four countries, however, have a relatively wealthy urban population with a far greater spending power than their respective national average. In the case of China and India, these urban populations have grown rapidly, and number hundreds of millions. The challenge for these countries is to extend this level of wealth to the rest of the population, so that better levels of healthcare become affordable. China, for instance, plans to create a solid platform for universal healthcare access for all by 2020.

A long haul...

Pharmaceutical market growth has been impressive in recent years. Market change, however, is expected to be incremental. Short-term opportunities exist to meet the health demands of the burgeoning middle classes, whilst future prospects are bright, fuelled by strong economic performance. A high pharmaceutical market growth projected in BRIC markets is expected to erode some of the commercial differences with the established, but more sluggish, pharmaceutical markets in North America, Japan and Europe. Only Brazil is expected to have a low market CAGR in US dollar terms over the 2011-2016 period, as the Economist Intelligence Unit projects a strong exchange rate of the US dollar against the local currency.

Current and accurate decision support intelligence is vital

Effective planning is vital and that is why Espicom, the leading provider of pharmaceutical market intelligence, has issued this report collection The Outlook for Pharmaceuticals in Brazil, Russia, India & China. For each country there is a comprehensive examination of the pharmaceutical market that covers all aspects of the operating environment, from the regulatory situation through health provision/expenditure to domestic production. Importantly, each market evaluation includes five-year growth forecasts and SWOT analysis. An additional benefit – and at no additional cost – is that these reports are updated and issued quarterly and include an annually updated statistical report packed with hard-to-source health market facts and figures.

HIGHLIGHTS FROM THE REGION...

BRAZIL

The government aims to encourage the development of biosimilar drugs. In 2012, ANVISA is expected to publish specific guidelines for the development of biosimilars of monoclonal antibodies. In October 2011, ANVISA published four guidelines for biosimilars. Along with these guidelines, ANVISA created a technical chamber for biologics and posted the main regulations, including those for the registration and post-registration, on its website in 2011. The Ministry of Health is very keen to encourage the local production of biosimilars. As part of these efforts, for instance, the Ministry of Health and the government of Sao Paulo signed an agreement with Instituto Butantan in December 2011. Local companies also consider the biosimilar sector very attractive, therefore a number of initiatives are in the pipeline. Foreign companies have also shown interest. Amgen, for example, acquired the local producer Bergamo in April 2011, and reacquired a number of products previously licensed to Mantercorp, which was acquired by Hypermarcas in January 2011. Novartis has confirmed its plans to build a plant for the production of vaccines against meningococcal B within three years.

RUSSIA

The Russian pharmaceutical market is the largest in Central & Eastern Europe (CEE) and accounts for two-fifths of the total CEE pharmaceutical market, due to its large economy and population. However, Russia has one of the smallest per capita pharmaceutical spending, comparable to Romania. The Russian pharmaceutical market is projected to expand at a double-digit CAGR in US dollar terms between 2011 and 2016. It will continue to be driven by import growth; imports registered a double-digit CAGR between 2006 and 2010. In fact, a heavy reliance on imports has resulted from the lack of locally-manufactured innovative pharmaceuticals. A strategy for encouraging growth in the Russian pharmaceutical industry for the period up to 2020 envisages the government helping local producers to cover the costs of the R&D that is required to boost production of innovative pharmaceuticals.

INDIA

The need to maintain low prices for essential medicines has been addressed in the government’s draft National Pharmaceutical Pricing Policy (NPPP), released in 2011. The proposed NPPP focuses on the National List of Essential Medicines (NLEM), which is periodically revised. The headline major change is a move from the principle of cost-based pricing to a market-based pricing model. The Department of Pharmaceuticals argues that market-based pricing would result in more transparent and fair pricing, as well as increasing competition in the marketplace. Price regulation will encompass all drugs listed in the NLEM, as well as formulations containing combinations of drugs listed in the NLEM; this will include combinations comprising listed drugs and unlisted drugs. If the NPPP is implemented, around 60% of the drugs currently available in India will come under price control.

CHINA

The Ministry of Health (MoH) has made lowering drug prices a top priority for health authorities in 2011. The National Development and Reform Commission (NDRC) implemented two rounds of drug price reductions in 2011, one in March and the other in September. Most of the drugs reduced were manufactured by multinationals, which had previously not been subject to pricing controls. In terms of regulatory developments, the SFDA started to inspect overseas manufacturing facilities in November 2011, as the agency seeks to align its practices with international standards. In July 2011, the MoH revealed that it may introduce mandatory licensing policy to secure cheaper drugs for HIV/AIDS patients, as part of the country’s universal health coverage programme. In January 2011, the MoH announced that the Essential Drugs List would be further expanded to cover nearly all government-sponsored grass-roots health institutions.

Use these original and insightful reports to...

• Assess future market values with our unique and regularly reviewed independent 5-year market forecasts.
• Track the latest developments with the news service that is included for every country.
• Understand the critical issues and drivers which are shaping the market.
• Evaluate the environment for branded and generic operators and stay in touch with the fast growing biologic sector.
• Shape and support business plans and decisions with reliable business data.
• Benchmark key market performance with Espicom’s standardised data.

Table Of Contents

Brazil

EXECUTIVE SUMMARY 1
Snapshot: Strategic Espicom Analysis2
Snapshot: Key Data Projections 3

MACROENVIRONMENT  4
POLITICAL4
ECONOMIC5
Projections5
LEGAL6
Patent Rejection of Tenofovir6
Compulsory Licence for Efavirenz 7
DEMOGRAPHIC8
Projections8
Demographic Indicators9
Birth Rate 9
Death Rate 9
Infant Mortality 9
Life Expectancy at Birth 9

EPIDEMIOLOGY 10
DISEASE BURDEN10
DISEASE PREVALENCE11
Communicable Diseases11
HIV/AIDS 11
Malaria 12
Non-Communicable Diseases12
Anaemia  12
Cancer 12
Vaccination13

HEALTHCARE - ACCOMPANYING HEALTH STATISTICS 14
ORGANISATION14
Main World Bank Health-Related Projects14
National AIDS/SUS Programme  14
QUALISUS-REDE Brazil Health Network Formation and Quality Improvement Project 14
Second Family Health Extension Adaptable Lending Project 14
INSURANCE15
EXPENDITURE16
Projections16
Public Health Expenditure17
Federal Health Expenditure 17
INFRASTRUCTURE18
Healthcare Establishments18
SERVICES19
Inpatient Care Analysis19
Ambulatory Care Analysis20
WORKFORCE21
Physician Projections21
Other Workforce21

REGULATORY AFFAIRS 22
INTERNATIONAL DEVELOPMENTS 22
MERCOSUR Regulation22
Agreement with the FDA22
NATIONAL REGULATION 22
MARKETING REGISTRATION 23
Registration of APIs23
Exemptions24
IMPORTS24
CLINICAL TRIALS24
LABELLING & PACKAGING 25
QUALITY CONTROL26
ADVERTISING26
TRACEABILITY26
PHARMACY REGULATION27
Regulation of Technical Responsibilities27
Regulation of Antibiotic Drug Data27
Regulation of Dispensing Practices27

PRICING & REIMBURSEMENT 28
Drug Price Authority28
Drug Price Readjustments28
Drug Price Control29
The Tax Substitution System30
REIMBURSEMENT 30
PFPB31

DISTRIBUTION CHANNELS 32
DRUG WHOLESALING32
Distribution Trade Associations32
ABAFARMA 32
ABRADILAN33
Distributors35
Athos Farma35
Panpharma35
Profarma36
Santa Cruz 37
DRUG RETAILING 38
Pharmacy & Drug Store Chains38
Pharmacy Chain Associations41
ABRAFARMA 41
ASSIFARMA 42
FEBRAFAR43
Pharmacy Chains44
Brazil Pharma44
Droga Raia45
Drogaria Araújo45
Drogaria Sao Paulo45
Drogarias Pacheco45
Drogasil46
Drogasmil46
Farmácias Pague Menos 47
Panvel Farmácias48
Hypermarkets48

MARKET ANALYSIS 49
SIZE 49
Projections49
Historical Figures51
Structure53
Pharmacy Sales 53
Public Sales54
PRODUCT DEVELOPMENT55
Private Product Development55
Public Product Development55
MANUFACTURING 56
Manufacturing Using CNAE 2056
Manufacturing Using CNAE 1061
TRADE 65
Exports65
Imports67
Balance of Trade72

COMPETITION 73
TRADE ASSOCIATIONS 73
ALANAC 73
ALFOB 74
INTERFARMA 75
SINDUSFARMA 76
TRADE FAIRS76
ABRADILAN FARMA & HPC 76
ECONOFARMA 76
EXPO FARMÁCIA 76
EXPO PHARMA 76
FCE PHARMA 76
Pharmanager 76
COMPANY INTELLIGENCE 77
Foreign Producers77
Abbott77
AstraZeneca77
Bayer78
Boehringer Ingelheim78
Daiichi-Sankyo79
GlaxoSmithKline80
Johnson & Johnson80
Merck  81
Merck Sharp & Dohme82
Novartis83
Novo Nordisk84
Nycomed84
Pfizer85
Roche86
Sanofi87
Servier88
Zambon88
Local Producers89
Aché89
Apsen90
Biolab 91
Cimed  91
Cristália 92
EMS 93
Eurofarma95
Hypermarcas98
Libbs Farmacêutica100
União Química101
Competitive Strategies102

OTC PHARMACEUTICALS 105
MARKET SIZE 105
COMPETITION 105
Trade Association105
ABIMIP105
Competitive Strategies106

GENERIC PHARMACEUTICALS 107
REGULATION 107
Registration of Generic Medicines108
MARKET SIZE 108
Private Pharmacy Sector108
Patent Expiries109
COMPETITION110
Trade Association110
Pró-Genéricos 110
Competitive Strategies110

BIOLOGICS & BIOSIMILARS 113
MACROENVIRONMENT113
REGULATION113
RDC No 53/2011 114
RDC No 55/2010 114
MARKET114
Public Vaccine Sector 114
COMPETITION115
Trade Association 115
BrBiotec 115
Foreign Company Intelligence116
Amgen 116
GlaxoSmithKline 116
Novartis 116
Local Company Intelligence116
CPPI 116
Biomm 116
Blau 117
Cristália 117
Eurofarma 117
Hebron 117
Hemobrás 117
Instituto Butantan 118
PharmaPraxis 118
Competitive Strategies 118

CONCLUSIONS: OPPORTUNITIES & CHALLENGES 120
Strategic Espicom Analysis120
MACROENVIRONMENT120
EPIDEMIOLOGY120
HEALTHCARE120
REGULATORY AFFAIRS121
PRICING & REIMBURSEMENT122
DISTRIBUTION CHANNELS122
MARKET122
COMPETITION 123
OTC PHARMACEUTICALS123
GENERIC PHARMACEUTICALS123
BIOLOGICS & BIOSIMILARS124
Radar Analysis126
SWOT Analysis126

DIRECTORY 127
COMPETITION127
Foreign Biologic Companies127
Foreign Pharmaceutical Companies127
Local Biologic Companies127
Local Pharmaceutical Companies127
GOVERNMENT ORGANISATIONS 128
TRADE ASSOCIATIONS 128

List of Tables

Espicom Analysis of the Pharmaceutical Market, 2011 2
Key Data Projections, 2011-2016 3
Political Landscape, 2011 4
Regional Ranking of Projected Economies, 2016 5
Projected Economy, 2011-2016 5
Regional Ranking of Projected Demographics, 2016 8
Projected Demographics, 2011-2016 8
Projected Demographic Indicators, 2010-2016 9
Deaths by Selected Cause, 2000-2008 10
Infectious Diseases, 2001-200911
Health Insurers, 2000-June 201015
Beneficiaries with Medical Services (With/Without Odontology) by Contract Type,2000-June 2010 15
Regional Ranking of Projected Health Expenditure, 2016 16
Projected Health Expenditure, 2011-2016 16
Healthcare Establishments by Type, 2005-September 2010 18
SUS Hospital Admissions by Specialty, 2000-2009 19
SUS Ambulatory Procedures by Type, 2009 20
Approved SUS Ambulatory Procedures by Provider, 2000-2009 20
Regional Ranking of Projected Physicians, 2016 21
Projected Physicians, 2011-2016 21
Members of ABAFARMA, 2011 32
Members of ABRADILAN, 2010 33
Profarma’s Gross Sales by Type, QIII 2010 vs QIII 2011 (R$ Million) 36
Profarma’s Net & Gross Sales, 2005-2010 (R$ Million) 36
Profarma’s Distribution Centres by Location, 2011 37
ABRAFARMA’s Ranking of Pharmacy Chains by Sales, 2008-2010 39
ABRAFARMA’s Ranking of Pharmacy Chains by Number of Outlets, 2008-201040
ABRAFARMA’s Financial Indicators, 2008-2010 41
Members of ABRAFARMA, 2011 42
Members of ASSIFARMA, 2011 42
Members of FEBRAFAR by Region, 2011 43
Drogasil’s Financial Indicators, 2004-2010 (R$ Million)46
Pague Menos’ Sales, 2000-2011 47
Regional Ranking of Projected Pharmaceutical Markets at Retail Prices, 2016 49
Projected Pharmaceutical Market at Retail Prices, 2011-2016 50
Historical Pharmaceutical Market at Retail Prices, 1995-2010 51
Historical Pharmaceutical Market at Manufacturers’ Prices, 1997-2009 52
Pharmacy Sales Value & Volume at Manufacturers’ Prices, 2006-2010 53
Pharmacy Sales by Leading Company, 2010 53
Pharmaceutical Production Indicators by Company Size, 2007-2009 57
Pharmaceutical Production Indicators by Manufacturing Unit Size, 2007-2009 58
State Pharmaceutical Production Indicators by Manufacturing Units with 5+ Employees, 2009 59
State Pharmaceutical Production Indicators by Manufacturing Units with 5+ Employees, 2009 (%) 60
Pharmaceutical Manufacturing Units by Leading State, 2002-2007 61
Pharmaceutical Workforce by Leading State, 2002-2007 62
Pharmaceutical Gross Production by Leading State, 2002-2007 (R$ Million) 63
Pharmaceutical Gross Production by Companies with 30+ Employees, 2007 (R$ 000s) 63
Pharmaceutical Gross Production by Manufacturing Units with 30+ Employees, 2007 (R$ 000s) 64
Pharmaceutical Exports by Category, 1995-2010 (US$000s) 65
Pharmaceutical Exports by Country/Region, 2010 (US$000s)66
Pharmaceutical Imports by Category, 1995-2010 (US$000s) 67
Imports of Raw Materials by Country/Region, 2010 (US$000s) 69
Imports of Antisera & Vaccines by Country/Region, 2010 (US$000s) 70
Imports of Medicaments by Country/Region, 2010 (US$000s) 71
Balance of Pharmaceutical Trade, 1995-2010 (US$000s) 72
Members of ALANAC, 2011 73
Members of ALFOB, 201174
Members of INTERFARMA, 2011 75
Hypermarcas’ Major Acquisitions, 2005-201199
Hypermarcas’ Net Sales by Division, 2009-2010 (R$ Million)99
Members of ABIMIP, 2011 105
Cumulative Active Ingredients, Registrations & Presentations of Generics, 2000-April 2011 108
Pharmacy Generic Sales by Value & Volume, 2006-2010109
Top-12 Leading Brands Losing Patent, 2012 109
Members of Pró-Genéricos, 2011110
Espicom Analysis of the Pharmaceutical Market, 2011125
SWOT Analysis of the Pharmaceutical Market, 2011126

List of Charts

Regional Comparison of Top 4 Projected Pharmaceutical Markets at Retail Prices, 2016  49
Regional Comparison of Projected Pharmaceutical Market Share at Retail Prices, 2016  50
Historical Pharmaceutical Market at Retail Prices, 1995-2010 51
Historical Pharmaceutical Market at Manufacturers’ Prices, 1997-2009 52
Pharmaceutical Monthly Production Index, January 2008-August 2011 56
Number of Pharmaceutical Producers, 1997-2007 61
Pharmaceutical Workforce, 1997-2007 62
Pharmaceutical Gross Production, 1997-2007 63
Pharmaceutical Gross Production by Manufacturing Type, 2007 (%)64
Pharmaceutical Exports, 1995-2010 (US$ Millions) 65
Pharmaceutical Imports, 1995-2010 (US$ Millions) 67
Pharmaceutical Imports by Country/Region, 2010 (%)68
Balance of Pharmaceutical Trade, 1995-2010 (US$ Millions) 72
Radar Graph of the Pharmaceutical Market, 2011126

Russia

EXECUTIVE SUMMARY 1
Snapshot: Strategic Espicom Analysis2
Snapshot: Key Data Projections 3

MACROENVIRONMENT  4
POLITICAL4
ECONOMIC6
Projections6
LEGAL7
DEMOGRAPHIC8
Projections8
Demographic Indicators9
Births 9
Deaths 9
Infant Deaths 9
Life Expectancy at Birth 9

EPIDEMIOLOGY 10
DISEASE BURDEN10
Leading Causes of Mortality10
DISEASE PREVALENCE11
Communicable Diseases11
HIV/AIDS 11
Non-Communicable Diseases12

HEALTHCARE - ACCOMPANYING HEALTH STATISTICS 13
ORGANISATION13
Fundamentals of Protection of Public Health in the Russian Federation Bill 13
Regional Healthcare Modernisation Programme14
Concept for the Development of the Healthcare Sector until 2020 14
National Health Project 14
EXPENDITURE15
Projections15
Social Security16
New Legislation ‘Concerning the Obligatory Medical Insurance’ 16
INFRASTRUCTURE17
Hospital Infrastructure17
Outpatient Infrastructure18
SERVICES19
Hospital Inpatient Services19
Outpatient Services20
WORKFORCE21
Projections21
Physicians22

REGULATORY AFFAIRS 23
NATIONAL AUTHORITY 23
REGULATORY DEVELOPMENTS 23
MARKETING REGISTRATION24
IMPORT REGULATIONS  25
PROMOTION 25
Advertising 25

PRICING & REIMBURSEMENT 26
PRICING 26
New Methods for Setting Retail Prices of Medicines Explored 27
Registration of Maximum Prices27
Price Freezes27
REIMBURSEMENT 28
Procurement of Pharmaceuticals for the DLO29
Future of the DLO29
Subsidising of Prescription Medicines29
List of Vitally Important Drugs for 201129

DISTRIBUTION CHANNELS 30
DRUG WHOLESALING 30
Leading Wholesalers30
Protek30
Shreya Corporation30
SIA International30
DRUG RETAILING31
Leading Pharmacy Chains31
Pharmacy Chain 366 31
Rigla 31

MARKET ANALYSIS 32
SIZE32
Projections32
Historical Figures34
Current Structure35
Pharmacy Market35
Hospital Market 37
PRODUCT DEVELOPMENT39
Clinical Trials39
MANUFACTURING 40
Government Programme for the Development of the Pharmaceutical Industry 40
TRADE43
Exports43
Imports46
Balance of Trade50

COMPETITION 51
TRADE ASSOCIATION51
AIPM 51
TRADE FAIRS52
Hospital 52
Pharmtech 201252
COMPANY INTELLIGENCE53
Foreign Producers53
KRKA 53
Sanofi 53
STADA CIS 54
Local Producers54
Akrikhin54
JSC Farmacon54
Pharmstandard55
Pharm-Sintez58
Valenta58
Veropharm58
Yugrafarm58
Competitive Strategies59
AstraZeneca59
Aurospharma Company59
Chemical Diversity Research Institute (CDRI)60
Dr Reddy’s60
Incuron60
JB Chemicals & Pharmaceuticals60
Maxwell Biotech Group 61
Neuralstem 61
Novartis 61
Nycomed 61
Panacela Labs62
Pfizer62
Pro Bono Bio62
Ranbaxy63
Teva63

OTC PHARMACEUTICALS64
MARKET SIZE 64
COMPETITION 64

GENERIC PHARMACEUTICALS 65
MARKET SIZE 65
COMPETITION 65

BIOLOGICS & BIOSIMILARS  66
COMPETITION 66
Binnopharm66
Biocad66
Generium 67
Pushchino Scientific Centre 67

CONCLUSIONS: OPPORTUNITIES & CHALLENGES 68
Strategic Espicom Analysis 68
MACROENVIRONMENT68
EPIDEMIOLOGY68
HEALTHCARE68
REGULATORY AFFAIRS69
PRICING & REIMBURSEMENT69
DISTRIBUTION CHANNELS70
MARKET70
COMPETITION71
OTC PHARMACEUTICALS71
GENERIC PHARMACEUTICALS71
BIOLOGICS & BIOSIMILARS71
Radar Analysis 73
SWOT Analysis 73

DIRECTORY 74
GOVERNMENT ORGANISATIONS74
PHARMACEUTICAL PRODUCERS74
Foreign Pharmaceutical Producers74
Local Pharmaceutical Producers74
Biologic & Biosimilar Producers74
TRADE ASSOCIATIONS74

List of Tables

Espicom Analysis of the Pharmaceutical Market, 20112
Key Data Projections, 2011-20163
Political Landscape, 20115
Regional Ranking of Projected Economies, 20166
Projected Economy, 2011-20166
Regional Ranking of Projected Demographics, 20168
Projected Demographics, 2011-20168
Demographic Indicators, 2001-20099
Leading Causes of Death, 2007-200910
HIV & AIDS Trends, 1986-200611
Incidence of Morbidity by Diagnosis, 2007-2009 (000s)12
Regional Ranking of Projected Health Expenditure, 201615
Projected Health Expenditure, 2011-201615
Total Hospitals & Beds, 1990-200917
Outpatient Care Facilities, 1995-200818
Public Inpatient Activity, 2002-200819
Public Hospital Discharges by Group of Diseases, 2005-200819
Day Surgery Discharges by Group of Diseases, 2005-200820
Regional Ranking of Projected Physicians, 201621
Projected Physicians, 2011-201621
Pharmacy Chain 366 Financial Results, 2002-2010 (US$ Millions)31
Regional Ranking of Projected Pharmaceutical Markets at Retail Prices, 201632
Projected Pharmaceutical Market at Retail Prices, 2011-201634
Historical Pharmaceutical Market at Retail Prices, 1995-201034
Pharmacy Sales at Retail Prices, 2003-201135
Pharmacy Sales at Wholesale Prices, 2003-201135
Pharmacy Sales Volume, 2003-201135
Moscow City Pharmacy Sales at Retail Prices, 2004-201136
Moscow City Pharmacy Sales at Wholesale Prices, 2004-201136
Moscow City Pharmacy Sales Volume, 2004-201136
St Petersburg City Pharmacy Sales at Retail Prices, 2004-201136
St Petersburg City Pharmacy Sales at Wholesale Prices, 2004-201137
St Petersburg City Pharmacy Sales Volume, 2004-201137
Hospital Purchases at Wholesale Prices, 2003-201137
Hospital Purchases Volume, 2003-201137
Moscow City Hospital Purchases at Wholesale Prices, 2004-201137
Moscow City Hospital Purchases Volume, 2004-201138
St Petersburg City Hospital Purchases at Wholesale Prices, 2004-201138
St Petersburg City Hospital Purchases Volume, 2004-201138
APS Sales at Wholesale Prices, 2006-201138
APS Sales Volume, 2006-201138
Production Value at Manufacturers' Prices, 2004-201140
Pharmaceutical Exports by Category, 1995-2010 (US$000s)43
Pharmaceutical Exports by Country/Region, 2010 (US$000s)45
Pharmaceutical Imports by Category, 1995-2010 (US$000s)46
Imports of Raw Materials by Country/Region, 2010 (US$000s)48
Imports of Antisera & Vaccines by Country/Region, 2010 (US$000s)48
Imports of Medicaments by Country/Region, 2010 (US$000s) 49
Balance of Pharmaceutical Trade, 1995-2010 (US$000s) 50
AIPM Members, 2011 51
Top Pharmaceutical Companies by Sales, 2009-2010 (%) 53
Pharmstandard Financial Results, 2004-2010 (R Millions) 55
Pharmstandard Pharmaceutical Sales, 2007-2010 (R Millions) 55
Pharmstandard Top 10 OTCs, 2009 56
Pharmstandard Production by Facility, 2009-2010 57
Top Ten Manufacturers, Trade Names and ATG Groups in the OTC Market, 2009 64
Espicom Analysis of the Pharmaceutical Market, 2011 72
SWOT Analysis of the Pharmaceutical Market, 2011 73

List of Charts

Regional Comparison of Top 6 Projected Pharmaceutical Markets at Retail Prices, 2016 33
Regional Comparison of Projected Pharmaceutical Market Share at Retail Prices, 2016 33
Historical Pharmaceutical Market at Retail Prices, 1995-2010 35
Pharmaceutical Exports, 1995-2010 (US$ Millions)44
Pharmaceutical Imports, 1995-2010 (US$ Millions)46
Pharmaceutical Imports by Country/Region, 2010 (%) 47
Balance of Pharmaceutical Trade, 1995-2010 (US$ Millions) 50
Radar Graph of the Pharmaceutical Market, 2011 73

India

EXECUTIVE SUMMARY 1
Snapshot: Strategic Espicom Analysis2
Snapshot: Key Data Projections3

MACROENVIRONMENT 4
POLITICAL4
ECONOMIC5
Projections5
LEGAL6
Background to Pharmaceutical Patents6
Mashelkar Committee Report, December 20066
The Patents (Amendments) Bill, 20057
Compulsory Licensing 7
Pre- & Post-Grant Opposition 8
Mailbox Applications 8
Other Issues 9
The Patents (Amendment) Rules, 20069
Previous Patents Act Amendments and Exclusive Marketing Rights 10
Challenges and Patent Decisions in the Indian High Courts 10
Novartis Once Again Challenges the Indian Patents Act 10
Bayer’s Nexavar Patent Challenged by Compulsory Licence Application 11
US Special 301 Report - India Remains on Priority Watch List 12
DEMOGRAPHIC13
Population13
Demographic Indicators15
Births 15
Deaths 15
Infant Mortality 15
Life Expectancy at Birth 16

EPIDEMIOLOGY 17
DISEASE BURDEN17
Leading Causes of Mortality17
DISEASE PREVALENCE18
Communicable Diseases18
HIV/AIDS20
Leprosy 21
Tuberculosis 21
Vector Borne Diseases22
Non-Communicable Diseases22
Blindness22
Cancer23
Diabetes, Cardiovascular Disease and Stroke24
National Rural Health Mission24

HEALTHCARE - ACCOMPANYING HEALTH STATISTICS 26
ORGANISATION26
Public Sector26
Department of Health and Family Welfare26
Department of AYUSH27
Private Sector27
Health Insurance28
EXPENDITURE 29
Projections29
Latest Figures30
INFRASTRUCTURE31
Hospital Infrastructure31
Private Hospitals and Clinics32
Apollo Hospitals Group 32
Fortis Healthcare33
Max Healthcare33
Wockhardt Hospitals34
Other Commercial Providers34
Ambulatory Infrastructure35
Primary Care35
First Aid and Disaster Relief35
Healthcare for the Underprivileged, Scheduled Castes and Scheduled Tribes 36
WORKFORCE37
Projections37
Latest Figures38

REGULATORY AFFAIRS40
NATIONAL AUTHORITY 40
REGULATORY DEVELOPMENTS41
New Drug Advisory Committees41
MARKETING REGISTRATION42
DGCI Set to Co-ordinate Drug Approvals43
PROMOTION43

PRICING 44
Drugs (Prices Control) Amendment Order and Second Amendment Order, 2006 44
Draft National Pharmaceuticals Pricing Policy, 201145

DISTRIBUTION CHANNELS 47
Medical Stores Organisation47
Pharmacy Chains47
Apollo Pharmacy 47
Guardian Pharmacy 47
Religare Wellness 47
984 47

MARKET ANALYSIS48
SIZE 48
Projections48
Historical Figures51
Current Structure52
PRODUCT DEVELOPMENT53
Traditional Indian Medicines54
MANUFACTURING 56
TRADE57
Exports57
Imports59
Balance of Trade63

COMPETITION64
Foreign Direct Investment in the Pharmaceutical Industry under Review 64
TRADE ASSOCIATIONS 65
TRADE FAIRS 65
Bangalore Bio 201265
India Chem 201265
Pharma World EXPO65
COMPANY INTELLIGENCE 66
Foreign Private Producers66
Abbott66
Actavis66
Bayer Healthcare66
Daiichi Sankyo 67
GlaxoSmithKline 67
Mylan 67
Pfizer India68
Reckitt Benkiser68
Sanofi68
Local Private Producers69
Alembic Ltd69
Aurobindo Pharma71
Cipla Ltd73
Claris Lifesciences 76
Dr Reddy’s Laboratories Ltd77
Glenmark Pharmaceuticals80
Jubilant Life Sciences83
Lupin Limited84
Natco Pharma87
Orchid Chemicals & Pharmaceuticals Ltd89
Piramal Healthcare 92
Ranbaxy Laboratories94
Strides Arcolab97
Sun Pharma99
Torrent Pharmaceuticals102
Wockhardt Ltd104
Zydus Cadila107
COMPETITIVE STRATEGIES111
Recent Acquisitions & Divestitures111
Agreements 111

BIOLOGICS & BIOSIMILARS113
COMPETITION113
Company Intelligence 113
Avesthagen 113
BCG Vaccine Laboratory, Chennai 114
Biocon 114
Cipla 116
Claris Lifesciences 116
Dr Reddy’s 116
Glenmark Pharmaceuticals 117
Lupin 117
Panacea Biotec 118
Ranbaxy/Daiichi Sankyo 118
Wockhardt 119
Zydus Cadila 119
COMPETITIVE STRATEGIES120

CONCLUSIONS: OPPORTUNITIES & CHALLENGES 121
Strategic Espicom Analysis121
MACROENVIRONMENT121
EPIDEMIOLOGY121
HEALTHCARE122
REGULATORY AFFAIRS122
PRICING & REIMBURSEMENT122
DISTRIBUTION CHANNELS123
MARKET123
COMPETITION123
OTC PHARMACEUTICALS123
GENERICS123
BIOLOGICS & BIOSIMILARS124
Radar & SWOT Analysis126

DIRECTORY 127
GOVERNMENT ORGANISATIONS127
PHARMACEUTICAL COMPANIES 128
TRADE ASSOCIATIONS 128

List of Tables

Espicom Analysis of the Pharmaceutical Market, 2012 2
Key Data Projections, 2011-2016 3
Political Landscape, 2012 4
Regional Ranking of Projected Economies, 2016 5
Projected Economy, 2011-2016 5
Regional Ranking of Projected Demographics, 2016 14
Projected Demographics, 2011-2016 14
Summary of Demographic Data 16
Demographic Indicators, 2000-2009 16
Reported Incidence of Communicable Diseases, 2005-2009 18
Reported Incidence of Vaccine Preventable Diseases, 2008-2010 19
Regional Ranking of Projected Health Expenditure, 2016 29
Projected Health Expenditure, 2011-2016 29
Health Expenditure, 201030
Regional Ranking of Projected Physicians, 2016 37
Projected Physicians, 2011-2016 37
Physicians Registered with State Medical Councils, 2007-2009 38
Regional Ranking of Projected Pharmaceutical Markets, 201648
Projected Pharmaceutical Market at Retail Prices, 2011-2016 50
Historical Pharmaceutical Market at Retail Prices, 1995-2010 (US$ Milllion) 51
Pharmaceutical Exports by Category, 1995-2010 (US$000s) 57
Pharmaceutical Exports by Country/Region, 2010 (US$000s) 58
Pharmaceutical Imports by Category, 1995-2010 (US$000s) 59
Imports of Raw Materials by Country/Region, 2010 (US$000s)60
Imports of Antisera & Vaccines by Country/Region, 2010 (US$000s) 61
Imports of Medicaments by Country/Region, 2010 (US$000s) 62
Balance of Pharmaceutical Trade, 1995-2010 (US$000s) 63
Foreign Acquisitions of Indian Pharmaceutical Companies, 2007-201164
Alembic: Financial Results, 2007-2011 69
Alembic: Manufacturing Facilities 70
Aurobindo Pharma: Financial Results, 2007-2011 71
Aurobindo Pharma: Manufacturing Facilities 72
Cipla: Financial Results, 2007-2011 73
Cipla: Manufacturing Facilities 75
Dr Reddy’s: Financial Summary, 2007-2011 78
Dr Reddy’s: Manufacturing Facilities 79
Glenmark: Financial Results, 2007-201180
Glenmark: Manufacturing Facilities 82
Jubilant Life Sciences: Financial Results, 2010-2011 83
Lupin: Financial Results, 2007-2011 85
Lupin: Manufacturing Facilities86
Natco Pharma Financial Results, 2007-2011 87
Orchid: Financial Results, 2007-201190
Orchid’s Top-10 Brands90
Orchid: Manufacturing Facilities 91
Piramal Healthcare: Financial Results, 2007-2011 92
Piramal Healthcare: Manufacturing Facilities 93
Ranbaxy: Financial Results, 2006-201094
Ranbaxy: Manufacturing Facilities96
Strides: Financial Results, 2006-2010 97
Sun Pharma: Financial Results, 2007-201199
Sun Pharma: Manufacturing Facilities 101
Torrent Pharma: Financial Results, 2007-2017 102
Wockhardt: Financial Results, 2006-2011104
Wockhardt Manufacturing Facilities106
Zydus Cadila: Financial Results, 2007-2011108
Zydus Cadila: Manufacturing Facilities110
Biocon: Financial Results, 2007-2011115
Panacea Biotec: Financial Results, 2007-2011118
Espicom Analysis of the Pharmaceutical Market, 2012125
SWOT Analysis of the Pharmaceutical Market, 2012126

List of Charts

Population by Age Group (%)13
Regional Comparison of Top 5 Projected Pharmaceutical Markets at Retail Prices, 2016 49
Regional Comparison of Projected Pharmaceutical Market Share, 2016 49
Historical Pharmaceutical Market at Retail Prices, 1995-2010 52
Pharmaceutical Exports, 1995-2010 (US$ Millions) 57
Pharmaceutical Imports, 1995-2010 (US$ Millions) 59
Pharmaceutical Imports by Country/Region, 2010 (%)60
Balance of Pharmaceutical Trade, 1995-2010 (US$ Millions) 63
Radar Graph of the Pharmaceutical Market, 2012126

China

EXECUTIVE SUMMARY 1
Snapshot: Strategic Espicom Analysis2
Snapshot: Key Data Projections3

MACROENVIRONMENT  4
POLITICAL4
ECONOMIC5
Projections5
Government’s Revaluation of CNY6
LEGAL6
Administrative Protection7
USTR Status7
DEMOGRAPHIC8
Projections8
Current Figures9
Demographic Indicators9
Births 9
Deaths 9
Infant Deaths 9
Life Expectancy at Birth 9

EPIDEMIOLOGY 10
DISEASE BURDEN10
Leading Causes of Mortality10
DISEASE PREVALENCE11
Communicable Diseases11
HIV/AIDS 12
Non-communicable Diseases12
Diabetes 12

HEALTHCARE - ACCOMPANYING HEALTH STATISTICS 13
ORGANISATION13
Healthcare Reform Plan 13
Ministry of Health13
Hospitals 13
Rural Healthcare 14
Red Cross Society of China14
EXPENDITURE15
Projections15
Latest Figures16
Health Insurance16
Public Health Insurance 16
Private Health Insurance 18
INFRASTRUCTURE18
Hospital Infrastructure18
Outpatient Infrastructure19
SERVICES 20
Inpatient Analysis20
Outpatient Analysis21
WORKFORCE 22
Projections22
Current State23

REGULATORY AFFAIRS 24
NATIONAL AUTHORITY24
Department of Drug Registration24
REGULATORY DEVELOPMENTS 25
SFDA Starts Overseas Factory Inspections25
Revised GMP Regulations25
Revised Antibiotic Regulations25
MARKETING REGISTRATION26
Department of Drug Safety & Inspection27
Department of Drug Market Compliance27
Drug Classification27
Regulatory Legislation28
2001 DAL Amendments28
Drug Import Regulation28
GMP Regulations29
Drug Approval Process29
Clinical Trials29
Quality Tests29
Certification30
PACKAGING 30
POST-MARKETING SURVEILLANCE31
Revoked Licences31
Bribery Cases31
PROMOTION31
Advertising 31

PRICING & REIMBURSEMENT 32
PRICING 32
National Pricing32
REIMBURSEMENT 33

DISTRIBUTION CHANNELS 35
DRUG WHOLESALING35
Selected Wholesalers36
Alliance Boots36
China Medical System36
Chindex36
First China Pharmaceutical Group 37
Global Pharm Holdings Group 37
Hainan Kangtong Pharmaceutical 37
Huazhong Pharmaceutical 37
Hunan Provincial Medicines & Health Products Import & Export Corp 37
Hutchison China MediTech38
Jiangbo Pharmaceuticals38
Jointown Pharmaceutical Group38
Nanjing Medical Company38
Shandong Medicines & Health Products Import & Export Corp  38
Shanghai Pharmaceutical Group39
Sincer Pharmchem39
Sinochem Jiangsu Suzhou Import Export Corp39
Sinopharm39
Tianjin Medicines & Health Products Import & Export Corp 40
Yong Yu40
DRUG RETAILING41
Selected Pharmacy Chains41
China BCT Pharmacy Group 41
ShenZhen Nepstar 41

MARKET ANALYSIS 42
SIZE42
Projections42
Historical Figures44
Current Structure45
PRODUCT DEVELOPMENT47
12th Five-Year Plan 2011-201547
Mega New Drug Development Programme47
SFDA R&D Initiatives47
Beijing Economic-Technological Development Area48
Zhangjiang Hi-Tech Park48
MANUFACTURING 49
China to Turn Five Companies into International Producers 51
TRADE51
Exports51
Imports54
Balance of Trade58

COMPETITION 59
TRADE ASSOCIATIONS59
CAPC59
CCCMHPIE59
CPIA59
RDPAC60
TRADE FAIRS61
Interphex China 61
PharmChina 61
COMPANY INTELLIGENCE 62
Foreign Manufacturers62
Abbott62
Astellas Pharma62
AstraZeneca62
Bayer62
Boehringer Ingelheim63
Bristol-Myers Squibb63
Daiichi Sankyo63
Dainippon Sumitomo Pharma64
Dragon Pharmaceuticals64
Eisai64
Eli Lilly65
GlaxoSmithKline65
Hovione65
Johnson & Johnson66
Merck Sharp & Dohme66
Mitsubishi Tanabe Pharma 67
Novartis 67
Novo Nordisk 67
Pfizer68
Roche69
Sanofi69
SciClone70
Servier70
Shionogi70
Takeda71
Competitive Strategies71
Local Manufacturers72
Aida Pharmaceuticals 72
Beijing Four Ring Biopharmaceutical72
Beijing Union Pharmaceutical Factory72
Changzhou Siyao Pharmaceuticals72
China Meheco Corporation73
China Pharmaceutical Group 73
CSPC Weisheng Pharmaceutical Company73
Fuzhou Antibiotic Group Corp73
Haizhou Pharmaceutical73
Heshuo Ephedrine Factory73
Huazhong Pharmaceutical 74
Jiangbo Pharmaceuticals 74
Jiangsu Jiangan Pharmaceutical 74
Lansen Pharmaceutical 74
Ningbo Jierfu Pharmaceutical 74
North China Pharmaceutical Huasheng 74
Shanghai Pharmaceutical Group 75
Shenzhen Salubris Pharmaceuticals 75
Shenzhen Taitai Pharmaceutical Company 75
Shenzhen Zhijun Pharmaceutical Company 75
Sihuan Pharmaceutical Group  75
Sinobiopharma 76
 76
Sinochem Group 76
Sinopharm 76
Simcere77
Wenzhou Pharmaceutical Factory77
Xiamen No2 Pharmaceutical Factory77
Xinhua Pharma77
YiYuan Pharmaceutical78
Zhejiang Jingxin78
Zhejiang Jinhua Lixin Fine Chemicals78
Zhejiang Medicine Company78

TRADITIONAL CHINESE MEDICINES 79

OTC PHARMACEUTICALS 80
REGULATION 80
MARKET SIZE 80
COMPETITION81
Trade Association81
CNMA 81
Company Intelligence81
China Sky One Medical  81
Harbin Pharmaceutical Group 81
Sanofi82

GENERIC PHARMACEUTICALS 83
REGULATION 83
Prescribing Regulation83
MARKET SIZE 83
COMPETITION 84
Foreign Company Intelligence84
Desano84
Mylan84
Ranbaxy84
Sandoz84
Watson84
Local Company Intelligence85
China Pharma Holdings85
Qilu Pharmaceutical85
Shanghai Fosun Pharmaceutical Company85
Zhejiang Hisun86
Competitive Strategies86

BIOLOGICS & BIOSIMILARS  87
REGULATION87
MARKET SIZE87
PRODUCT DEVELOPMENT87
COMPETITION 88
Foreign Company Intelligence88
Agenix88
AutekBio88
Avid Bioservices88
Genzyme89
GlaxoSmithKline89
Merck Millipore89
Merck Serono89
Microbix90
NeoStem90
Novartis90
OriGene90
Sanofi90
Local Company Intelligence91
3SBIO 91
Anhui Anke Biotech 91
China Biologic Products 91
China National Biotech Group 91
GeneScience 92
Guangdong Techpool Bio-Pharma 92
Harbin Gloria Pharmaceuticals 92
Kun Run Biotechnology 92
Lanzhou Institute of Biological Products 92
Livzon Pharmaceutical93
Nuokang Bio-Pharmaceutical93
Shenzhen Hepalink93
Shenzhen Kexing Biotech93
Simcere94
Sinopharm94
Sinovac Biotech94
Walvax Biotechnology94
WuXi AppTec95
Wuyi JiuYuan95
Zhejiang Tianyuan Bio-Pharmaceutical Company95
Zhuhai United Laboratories96
Competitive Strategies96

CONCLUSIONS: OPPORTUNITIES & CHALLENGES 97
Strategic Espicom Analysis97
MACROENVIRONMENT97
EPIDEMIOLOGY97
HEALTHCARE98
REGULATORY AFFAIRS98
PRICING & REIMBURSEMENT99
DISTRIBUTION CHANNELS99
MARKET99
COMPETITION 100
OTC PHARMACEUTICALS100
GENERIC PHARMACEUTICALS101
BIOLOGICS & BIOSIMILARS101
Radar Analysis 103
SWOT Analysis 103

DIRECTORY 104
GOVERNMENT ORGANISATIONS 104
PHARMACEUTICAL COMPANIES 104
Foreign Pharmaceutical Companies104
Local Pharmaceutical Companies105
TRADE ORGANISATIONS 106

List of Tables

Espicom Analysis of the Pharmaceutical Market, 20112
Key Data Projections, 2011-20163
Political Landscape, 20114
Regional Ranking of Projected Economies, 20165
Projected Economy, 2011-20165
Regional Ranking of Projected Demographics, 20168
Projected Demographics, 2011-20168
Demographic Indicators, 2002-20089
Leading Causes of Death, 200810
Reported Infectious Diseases, 2001-2008 (Rate/100,000 Population)11
Regional Ranking of Projected Health Expenditure, 201615
Projected Health Expenditure, 2011-201615
Healthcare Expenditure by Type, 1999-2008 (CNY Billions)16
Hospitals, 2000-200818
Hospitals by Region & Municipality, 200818
Outpatient Institutions by Type, 2001-200819
Health Centres & Clinics by Region & Municipality, 200819
Inpatient Admissions, 2002-2008 (Millions)20
Inpatient Admissions by Type & Institution, 2008 (10,000s)20
Outpatient Visits, 1999-2008 (Millions)21
Outpatient Visits by Type & Institution, 2008 (Millions)21
Regional Ranking of Projected Physicians, 201622
Projected Physicians, 2011-201622
Medical Personnel by Type, 2008 (000s)23
Physicians by Region & Municipality, 2008 (000s) 23
ShenZhen Nepstar Drug Stores by City, 2008-2010 41
Regional Ranking of Projected Pharmaceutical Markets, 2016 42
Projected Pharmaceutical Market at Retail Prices, 2011-201644
Historical Pharmaceutical Market at Retail Prices, 1995-201044
Pharmaceutical Sales at Retail Prices, 2000-2011 (CNY Billions) 45
Pharmaceutical Sales by Sector, 2009-2010 (CNY Billions)46
Pharmaceutical & Medical Device Output, 1998-2011 (CNY Billions) 49
Pharmaceutical & Medical Device Output by Type, 2010 (CNY Billions) 50
Pharmaceutical Exports by Category, 1995-2010 (US$000s) 51
Pharmaceutical Exports by Country/Region, 2010 (US$000s) 53
Pharmaceutical Imports by Category, 1995-2010 (US$000s) 54
Imports of Raw Materials by Country/Region, 2010 (US$000s) 56
Imports of Antisera & Vaccines by Country/Region, 2010 (US$000s) 56
Imports of Medicaments by Country/Region, 2010 (US$000s) 57
RDPAC Members, 201160
OTC Pharmaceutical Sales, 2005-2009 (CNY Billions)80
Espicom Analysis of the Pharmaceutical Market, 2011 102
SWOT Analysis of the Pharmaceutical Market, 2011 103

List of Charts

Regional Comparison of Top 5 Projected Pharmaceutical Markets at Retail Prices, 2016  43
Regional Comparison of Projected Pharmaceutical Market Share, 2016 43
Historical Pharmaceutical Market at Retail Prices, 1995-2010 45
Pharmaceutical Sales at Retail Prices, 2000-2011 (CNY Billions)46
Pharmaceutical & Medical Device Output, 1998-2011 (CNY Billions) 49
Pharmaceutical Exports, 1995-2010 (US$ Billions) 52
Pharmaceutical Imports, 1995-2010 (US$ Billions) 54
Pharmaceutical Imports by Country/Region, 2010 (%) 55
Pharmaceutical Balance of Trade, 1995-2010 (US$ Billions) 58
OTC Pharmaceutical Sales, 2005-2009 (CNY Billions)80
Radar Graph of the Pharmaceutical Market, 2011 103