CountryFocus: Healthcare, Regulatory and Reimbursement Landscape - India

Summary

GlobalData, the industry analysis specialist, has released its new report, “CountryFocus: Healthcare, Regulatory and Reimbursement Landscape - India”. The report is an essential source of information and analysis on India’s healthcare, regulatory and reimbursement landscape. It identifies the key trends in the healthcare market and provides insights into the demographic, regulatory and reimbursement landscape and healthcare infrastructure. Most importantly, it provides valuable insights into the trends and segmentation of the pharmaceutical and medical device markets. The report is built using data and information sourced from proprietary databases, secondary research and in-house analysis by GlobalData’s team of industry experts.

India is the second most populated country in the world with a population of approximately 1.22 billion in 2012, although the growth rate of the population is declining due to a decrease in the birth rate and an increase in net emigration. Unlike China and Japan, the working-age population accounts for the majority of the overall population. In order to derive maximum benefit, the government is currently working to develop human capital by increasing its spending on health and education. The country’s pharmaceutical market was estimated at $18.4 billion in 2012 and is expected to reach approximately $56 billion by 2020 at a Compound Annual Growth Rate (CAGR) of 15%, primarily attributed to -
- Increasing coverage of healthcare insurance
- Improving access to healthcare facilities
- Government initiatives for the prevention and management of communicable diseases

Scope

The report provides information on India’s healthcare, regulatory and reimbursement landscape, and includes -
- Overview of the pharmaceutical and medical devices markets, comprising market size, segmentation and key drivers and barriers
- Profiles and SWOT analysis of the major players in the pharmaceutical and medical devices market. The major players covered for the pharmaceutical market are Cipla, Sun Pharmaceuticals, Lupin, Ranbaxy Laboratories and Dr. Reddy’s Laboratories. The major players covered for the medical devices market are Siemens Healthcare, GE Healthcare, Essilor International, Johnson & Johnson Vision Care and F. Hoffmann-La Roche.
- Insightful review of the reimbursement and regulatory landscape, including details of the healthcare reimbursement process, regulatory agencies and approval processes for new drugs
- Detailed analysis of the political and economic environment, including economic indicators, demographics, and healthcare infrastructure and expenditure
- Overview of the opportunities for and challenges to growth in the healthcare market.

Reasons to buy

This report will enhance your decision-making capability by allowing you to -
- Develop business strategies by understanding the trends shaping and driving India’s healthcare market.
- Drive revenues by understanding the key trends, reimbursement and regulatory policies, pharmaceutical market segments and companies likely to impact the Indian healthcare market in the future.
- Formulate effective sales and marketing strategies by understanding the competitive landscape and analyzing the performance of various competitors.
- Organize your sales and marketing efforts by identifying the market categories and segments that present the most opportunities for consolidation, investment and strategic partnership
- Identify, understand and capitalize on the opportunities and challenges in India’s healthcare market.

Table Of Contents

Table of Contents

1 Table of Contents 7
1.1 List of Tables 10
1.2 List of Figures 14
2 Introduction 19
2.1 Report Guidance 19
3 Overview of the Pharmaceutical and Medical Device Markets 20
3.1 Pharmaceutical Market 20
3.1.1 Market Overview 20
3.1.2 Pharmaceutical Imports and Exports 25
3.1.3 Supply Channels 26
3.1.4 Market Segments 29
3.1.5 Major Therapeutic Areas 35
3.1.6 Major Players 39
3.2 Medical Device Market 73
3.2.1 Market Overview 73
3.2.2 Overview of Top Five Segments 76
3.2.3 Diagnostics Market 87
3.2.4 Major Players 89
3.3 Market Drivers and Barriers 124
3.3.1 Drivers 124
3.3.2 Barriers 125
4 Market Access 128
4.1 Reimbursement and Payer Landscape 128
4.1.1 Overview of Healthcare System 128
4.1.2 Reimbursement Process 132
4.1.3 Overview of Insurance Providers 140
4.1.4 Patient Share of Healthcare Spending 143
4.1.5 Drug Price Trends 144
4.1.6 Pricing Policies 145
4.2 Regulatory Landscape 147
4.2.1 Overview of Regulatory Agencies 147
4.2.2 New Drug Approval Procedure for Pharmaceutical Products 149
4.2.3 New Medical Device Approval Process 153
4.2.4 Licensing Process for Pharmaceutical and Medical Device Manufacturing 155
4.2.5 Licensing Process for Pharmaceutical Exports and Imports 156
4.2.6 Intellectual Property Rights 157
4.2.7 Clinical Trial Regulations 164
4.2.8 Pharmaceutical Advertising Regulations 167
4.2.9 Pharmacy Regulations 168
4.2.10 Labeling and Packaging Regulations 169
5 Country Analysis 171
5.1 Political Environment 171
5.1.1 Political Structure 171
5.1.2 Analysis of the Current Political Environment 172
5.1.3 Healthcare Policy Initiatives 174
5.2 Economic Landscape 176
5.3 Economic Indicators 181
5.3.1 Gross Domestic Product 181
5.3.2 Gross National Income 184
5.3.3 Inflation 185
5.3.4 Currency Exchange Rate 189
5.3.5 Foreign Direct Investment 190
5.3.6 Foreign Exchange Reserves 192
5.3.7 Trade Balance 193
5.3.8 Gross Fiscal Deficit 195
5.3.9 External Gross Debt 196
5.3.10 Major Industries 197
5.4 Demographics 199
5.4.1 Population 199
5.4.2 Education and Literacy 215
5.4.3 Employment 218
5.4.4 Disease Burden 219
5.5 Healthcare Infrastructure 222
5.5.1 Healthcare Facilities 222
5.5.2 Healthcare Parameters 231
5.5.3 Environmental Health 233
5.5.4 Healthcare Personnel 238
5.6 Healthcare Expenditure 240
5.6.1 Components of Healthcare Spending 241
5.6.2 Share of Public and Private Sectors 242
5.6.3 Spending in Pharmaceutical RandD 243
5.7 Trade Associations 245
5.7.1 Indian Pharmaceutical Association 245
5.7.2 Indian Drug Manufacturer’s Association 245
5.7.3 Organization of Pharmaceutical Producers of India 245
5.7.4 Indian Pharmacy Graduates Association 246
5.8 Trade Fairs 247
6 Opportunities and Challenges 248
6.1 Opportunities 248
6.2 Challenges 249
7 Appendix 252
7.1 Abbreviations 252
7.2 Bibliography 259
7.3 Methodology 271
7.3.1 Coverage 271
7.3.2 Secondary Research 271
7.3.3 Forecasting 272
7.3.4 Expert Panel Validation 272
7.4 Disclaimer 273




List of Tables

Table 1: Pharmaceutical Market, India, Revenue ($bn), 2007-2012 23
Table 2: Pharmaceutical Market, India, Revenue ($bn), Forecast, 2013-2020 24
Table 3: Pharmaceutical Market, India, Imports and Exports ($bn), 2007-2012 25
Table 4: Pharmaceutical Market, India, Price Margins of Distribution Channel (%), 2007 27
Table 5: Pharmaceutical Market, Global, Drugs Going Off-patent, Revenue ($m), 2011-2015 31
Table 6: Pharmaceutical Market, India, Biologics Market, Revenue ($bn), 2007-2012 33
Table 7: Pharmaceutical Market, India, Major Therapeutic Areas, Turnover ($m), 2010 35
Table 8: Cipla, Global, Major Products, 2013 40
Table 9: Sun Pharma, Global, Major Product Segments, Revenues ($m), 2011 46
Table 10: Lupin, India, Major Products, 2013 53
Table 11: Dr. Reddy’s Laboratories, India, Major Products, 2012 66
Table 12: Medical Device Market, India, Revenue ($bn), 2007-2012 74
Table 13: Medical Device Market, India, Revenue ($bn), Forecast, 2013-2020 75
Table 14: Medical Device Market, India, Revenue by Segments ($m), 2012 76
Table 15: Medical Device Market, India, Ophthalmic Devices Market, Revenue ($bn), 2007-2012 77
Table 16: Medical Device Market, India, Ophthalmic Devices, Sales Trend for Major Players ($m), 2011 78
Table 17: Medical Device Market, India, In Vitro Diagnostics Market, Revenue ($m), 2007-2012 80
Table 18: Medical Device Market, India, In Vitro Diagnostic Devices, Sales Trend for Major Players ($m), 2011 80
Table 19: Medical Device Market, India, Hospital Supplies Market, Revenue ($m), 2007-2012 81
Table 20: Medical Device Market, India, Hospital Supplies, Sales Trend for Major Players ($m), 2011 82
Table 21: Medical Device Market, India, Cardiovascular Devices, Revenue ($m), 2007-2012 84
Table 22: Medical Device Market, India, Cardiovascular Devices, Sales Trend for Major Players ($m), 2011 84
Table 23: Medical Device Market, India, Diagnostic Imaging Devices, Revenue ($m), 2007-2012 86
Table 24: Medical Device Market, India, Diagnostic Imaging Devices, Sales Trend for Major Players ($m), 2011 86
Table 25: Medical Device Market, India, Diagnostics Market, Revenue ($bn), 2007-2012 87
Table 26: Medical Device Market, India, Diagnostics Market, Revenue ($bn), Forecast, 2013-2020 88
Table 27: Medical Device Market, India, Major Medical Device Companies, Revenue ($m), 2011 90
Table 28: Siemens, Global, Major Products, Revenue ($m), 2012 91
Table 29: Essilor International, Global, Major Segments, Revenue ($m), 2011 102
Table 30: Johnson and Johnson Vision Care, Global, Major Products, 2012 108
Table 31: Roche, Global, Major Products, Revenues ($m), 2012 117
Table 32: Healthcare System, India, Surgical Procedure Cost ($’000), 2011 132
Table 33: Healthcare System, India, Major Public Insurance Schemes, 2012 140
Table 34: Healthcare System, India, Insured Population, Share (million), 2012 141
Table 35: Healthcare System, India, Health Insurers, Accounts ($m), 2012 143
Table 36: Healthcare Spending, India, Patient`s Share (%), 2007-2012 144
Table 37: Drug Price Change (%), India, 2007-2012 145
Table 38: Healthcare System, India, New Drug Application, Specific Requirements, 2013 151
Table 39: Healthcare System, India, Clinical Trial Approval, Specific Requirements, 2013 165
Table 40: Economic Landscape, India, Major Sectors, GDP Growth (%), 2012-2013 178
Table 41: Economic Indicators, India, GDP Per Capita ($), 2007-2012 182
Table 42: Economic Indicators, India, GDP Per Capita ($), Forecast, 2013-2020 182
Table 43: Economic Indicators, India, GDP, Annual Growth (%), 2007-2012 183
Table 44: Economic Indicators, India, GDP, Annual Growth (%), Forecast, 2013-2020 184
Table 45: Economic Indicators, India, GNI Per Capita ($), 2007-2012 185
Table 46: Economic Indicators, India, Average Consumer Price Index, 2007-2012 186
Table 47: Economic Indicators, India, Average Consumer Price Index, Forecast, 2013-2020 187
Table 48: Economic Indicators, India, Average Consumer Price, Annual Change (%), 2007-2012 188
Table 49: Economic Indicators, India, Average Consumer Price, Annual Change (%), Forecast, 2013-2020 189
Table 50: Economic Indicators, India, Currency Exchange Rate (INR/$), 2007-2012 190
Table 51: Economic Indicators, India, Foreign Direct Investment ($bn), 2007-2012 191
Table 52: Economic Indicators, India, Foreign Exchange Reserves ($bn), 2007-2012 192
Table 53: Economic Indicators, India, Imports of Goods and Services ($bn), 2007-2012 193
Table 54: Economic Indicators, India, Exports of Goods and Services ($bn), 2007-2012 194
Table 55: Economic Indicators, India, Gross Fiscal Deficit (% of GDP), 2007-2012 195
Table 56: Economic Indicators, India, External Government Gross Debt ($bn), 2007-2012 196
Table 57: Economic Indicators, India, Major Industries, GDP ($bn), 2012 198
Table 58: Demographics, India, Population (million), 2007-2012 200
Table 59: Demographics, India, Population (million), Forecast, 2013-2020 200
Table 60: Demographics, India, Urban and Rural Population, Share (%), 2007-2012 201
Table 61: Demographics, India, Age Groups, Population Distribution (%), 2007-2012 203
Table 62: Demographics, India, Age Groups, Population Distribution (%), Forecast, 2013-2020 203
Table 63: Demographics, India, Births (Per 1,000 Population), 2007-2012 205
Table 64: Demographics, India, Mortality (Per 1,000 Population), 2007-2012 206
Table 65: Demographics, India, Major Causes of Mortality (‘000), 2008 207
Table 66: Demographics, India, Children Table 67: Demographics, India, Immunization Rate (%), 2007-2012 209
Table 68: Demographics, India, Major Causes of Male Mortality (‘000), 2008 210
Table 69: Demographics, India, Major Causes of Female Mortality (‘000), 2008 211
Table 70: Demographics, India, Gender Ratio (Females Per 1,000 Males), 2007-2012 213
Table 71: Demographics, India, Life Expectancy at Birth (Years), 2007-2012 214
Table 72: Demographics, India, Literacy Rate (%), 2007-2012 216
Table 73: Demographics, India, Levels of Education, Students Enrollment (million), 2011 217
Table 74: Demographics, India, Unemployment Rate (%), 2007-2012 218
Table 75: Demographics, India, Major Communicable Diseases, Prevalence (million), 2011 220
Table 76: Demographics, India, Major Causes of Illness, DALY (Per 100,000 Population), 2009 222
Table 77: Healthcare Infrastructure, India, Public Hospitals, 2007-2012 223
Table 78: Healthcare Infrastructure, India, Major Private Hospitals, 2012 225
Table 79: Healthcare Infrastructure, India, Upcoming Health Cities, 2012 226
Table 80: Healthcare Infrastructure, India, Health Centers (‘000), 2007-2012 227
Table 81: Healthcare Infrastructure, India, Hospitals by Bed Size, Share (%), 2010 228
Table 82: Healthcare Infrastructure, India, Urban-Rural Public Hospital Beds (‘000), 2007-2012 229
Table 83: Healthcare Infrastructure, Diagnostic Units (Per 100,000 Population), 2008 231
Table 84: Healthcare Infrastructure, India, Hospital Beds (Per 1,000 Population), 2007-2012 232
Table 85: Healthcare Infrastructure, India, Physicians (Per 1,000 Population), 2007-2012 233
Table 86: Environmental Health, India, CO2 Emissions (Million Tons), 2007-2012 234
Table 87: Environmental Health, India, PM-10 Emissions (µg/cubic meter), 2007-2012 235
Table 88: Environmental Health, India, Waste Generation Per Capita (kg), 2007-2012 237
Table 89: Healthcare Personnel, India, Nurses (Per 1,000 Population), 2007-2012 239
Table 90: Healthcare Personnel, India, Pharmacists (Per 1,000 Population), 2007-2012 239
Table 91: Healthcare Expenditure, India, Healthcare Expenditure (% of GDP), 2007-2012 241
Table 92: Healthcare Expenditure, India, Healthcare Expenditure of Ministry of Health and Family Welfare, Share of Departments (%), 2011 242
Table 93: Healthcare Expenditure, India, Public-Private Share (%), 2007-2012 243
Table 94: Healthcare Expenditure, India, RandD Expenditure ($m), 2007-2012 245
Table 95: Major Healthcare Trade Fairs, India, 2013-2014 247

1.2 List of Figures
Figure 1: Pharmaceutical Market, India, Revenue ($bn), 2007-2012 23
Figure 2: Pharmaceutical Market, India, Revenue ($bn), Forecast, 2013-2020 24
Figure 3: Pharmaceutical Market, India, Imports and Exports ($bn), 2007-2012 25
Figure 4: Pharmaceutical Market, India, Distribution Channel, 2013 27
Figure 5: Pharmaceutical Market, India, Drug Procurement System in Government Hospitals and Institutions, 2013 28
Figure 6: Pharmaceutical Market, India, Biologics Market, Revenue ($bn), 2007-2012 33
Figure 7: Pharmaceutical Market, India, Major Therapeutic Areas, Turnover ($m), 2010 35
Figure 8: Medical Device Market, India, Revenue ($bn), 2007-2012 74
Figure 9: Medical Device Market, India, Revenue ($bn), Forecast, 2013-2020 75
Figure 10: Medical Device Market, India, Revenue by Segments ($m), 2012 76
Figure 11: Medical Device Market, India, Ophthalmic Devices Market, Revenue ($bn), 2007-2012 77
Figure 12: Medical Device Market, India, Ophthalmic Devices, Sales Trend for Major Players ($m), 2007-2011 78
Figure 13: Medical Device Market, India, In Vitro Diagnostics Market, Revenue ($m), 2007-2012 79
Figure 14: Medical Device Market, India, In Vitro Diagnostic Devices, Sales Trend for Major Players ($m), 2007-2011 80
Figure 15: Medical Device Market, India, Hospital Supplies Market, Revenue ($m), 2007-2012 81
Figure 16: Medical Device Market, India, Hospital Supplies, Sales Trend for Major Players ($m), 2007-2011 82
Figure 17: Medical Device Market, India, Cardiovascular Devices, Revenue ($m), 2007-2012 83
Figure 18: Medical Device Market, India, Cardiovascular Devices, Sales Trend for Major Players ($m), 2007-2011 84
Figure 19: Medical Device Market, India, Diagnostic Imaging Devices, Revenue ($m), 2007-2012 85
Figure 20: Medical Device Market, India, Diagnostic Imaging Devices, Sales Trend for Major Players ($m), 2007-2011 86
Figure 21: Medical Device Market, India, Diagnostics Market, Revenue ($bn), 2007-2012 87
Figure 22: Medical Device Market, India, Diagnostics Market, Revenue ($bn), Forecast, 2013-2020 88
Figure 23: Medical Device Market, India, Major Medical Device Companies, Revenue ($m), 2011 89
Figure 24: Healthcare Market, India, Drivers and Barriers, 2013 127
Figure 25: Healthcare System, India, Milestones of the Insurance Regulatory System, 1938-2009 129
Figure 26: Healthcare System, India, Surgical Procedure Cost ($’000), 2011 131
Figure 27: Healthcare System, India, Local Purchase System, Private Hospitals, 2013 134
Figure 28: Healthcare System, India, Centralized Purchase System, Private Hospitals, 2013 135
Figure 29: Healthcare System, India, Tender Purchase System, Private Hospitals, 2013 136
Figure 30: Healthcare System, India, Local and Centralized Purchase System, Private Hospitals, 2013 137
Figure 31: Healthcare System, India, Purchase Channels, Private Hospitals, 2013 138
Figure 32: Healthcare System, India, Addition to a Hospital Drug Formulary, 2013 139
Figure 33: Healthcare Spending, India, Patient`s Share (%), 2007-2012 144
Figure 34: Drug Price Change (%), India, 2007-2012 145
Figure 35: Healthcare System, India, Structure of the Central Drugs Standard Control Organization, 2013 149
Figure 36: Healthcare System, India, New Drug Application Process, 2013 152
Figure 37: Healthcare System, India, Licensing Process for Manufacturing, 2013 156
Figure 38: Healthcare System, India, Organizational Structure of the Controller General of Patents, Designs and Trade Marks, 2013 159
Figure 39: Healthcare System, India, Patent Approval Process, 2013 161
Figure 40: Healthcare System, India, Trademark Registration Process, 2013 163
Figure 41: Healthcare System, India, Clinical Trial Approval Process, 2013 166
Figure 42: Economic Indicators, India, GDP Per Capita ($), 2007-2012 181
Figure 43: Economic Indicators, India, GDP Per Capita ($), Forecast, 2013-2020 182
Figure 44: Economic Indicators, India, GDP, Annual Growth (%), 2007-2012 183
Figure 45: Economic Indicators, India, GDP, Annual Growth (%), Forecast, 2013-2020 184
Figure 46: Economic Indicators, India, GNI Per Capita ($), 2007-2012 185
Figure 47: Economic Indicators, India, Average Consumer Price Index, 2007-2012 186
Figure 48: Economic Indicators, India, Average Consumer Price Index, Forecast, 2013-2020 187
Figure 49: Economic Indicators, India, Average Consumer Price, Annual Change (%), 2007-2012 188
Figure 50: Economic Indicators, India, Average Consumer Price, Annual Change (%), Forecast, 2013-2020 189
Figure 51: Economic Indicators, India, Currency Exchange Rate (INR/$), 2007-2012 190
Figure 52: Economic Indicators, India, Foreign Direct Investment ($bn), 2007-2012 191
Figure 53: Economic Indicators, India, Foreign Exchange Reserves ($bn), 2007-2012 192
Figure 54: Economic Indicators, India, Imports of Goods and Services ($bn), 2007-2012 193
Figure 55: Economic Indicators, India, Exports of Goods and Services ($bn), 2007-2012 194
Figure 56: Economic Indicators, India, Gross Fiscal Deficit (% of GDP), 2007-2012 195
Figure 57: Economic Indicators, India, External Government Gross Debt ($bn), 2007-2012 196
Figure 58: Economic Indicators, India, Major Industries, GDP ($bn), 2012 198
Figure 59: Demographics, India, Population (million), 2007-2012 199
Figure 60: Demographics, India, Population (million), Forecast, 2013-2020 200
Figure 61: Demographics, India, Urban and Rural Population, Share (%), 2007-2012 201
Figure 62: Demographics, India, Age Groups, Population Distribution (%), 2007-2012 202
Figure 63: Demographics, India, Age Groups, Population Distribution (%), Forecast, 2013-2020 203
Figure 64: Demographics, India, Births (Per 1,000 Population), 2007-2012 204
Figure 65: Demographics, India, Mortality (Per 1,000 Population), 2007-2012 205
Figure 66: Demographics, India, Major Causes of Mortality (‘000), 2008 206
Figure 67: Demographics, India, Children Figure 68: Demographics, India, Immunization Rate (%), 2007-2012 209
Figure 69: Demographics, India, Major Causes of Male Mortality (‘000), 2008 210
Figure 70: Demographics, India, Major Causes of Female Mortality (‘000), 2008 211
Figure 71: Demographics, India, Gender Ratio (Females Per 1,000 Males), 2007-2012 213
Figure 72: Demographics, India, Life Expectancy at Birth (Years), 2007-2012 214
Figure 73: Demographics, India, Literacy Rate (%), 2007-2012 216
Figure 74: Demographics, India, Levels of Education, Students Enrollment (million), 2011 217
Figure 75: Demographics, India, Unemployment Rate (%), 2007-2012 218
Figure 76: Demographics, India, Major Communicable Diseases, Prevalence (million), 2011 220
Figure 77: Demographics, India, Major Causes of Illness, DALY (Per 100,000 Population), 2009 221
Figure 78: Healthcare Infrastructure, India, Public Hospitals, 2007-2012 223
Figure 79: Healthcare Infrastructure, India, Health Centers (‘000), 2007-2012 227
Figure 80: Healthcare Infrastructure, India, Hospitals by Bed Size, Share (%), 2010 228
Figure 81: Healthcare Infrastructure, India, Urban-Rural Public Hospital Beds (‘000), 2007-2012 229
Figure 82: Healthcare Infrastructure, Diagnostic Units (Per 100,000 Population), 2008 230
Figure 83: Healthcare Infrastructure, India, Hospital Beds (Per 1,000 Population), 2007-2012 231
Figure 84: Healthcare Infrastructure, India, Physicians (Per 1,000 Population), 2007-2012 232
Figure 85: Environmental Health, India, CO2 Emissions (Million Tons), 2007-2012 234
Figure 86: Environmental Health, India, PM-10 Emissions (µg/cubic meter), 2007-2012 235
Figure 87: Environmental Health, India, Waste Generation Per Capita (kg), 2007-2012 237
Figure 88: Healthcare Personnel, India, Nurses (Per 1,000 Population), 2007-2012 238
Figure 89: Healthcare Personnel, India, Pharmacists (Per 1,000 Population), 2007-2012 239
Figure 90: Healthcare Expenditure, India, Healthcare Expenditure (% of GDP), 2007-2012 240
Figure 91: Healthcare Expenditure, India, Healthcare Expenditure of Ministry of Health and Family Welfare, Share of Departments (%), 2011 242
Figure 92: Healthcare Expenditure, India, Public-Private Share (%), 2007-2012 243
Figure 93: Healthcare Expenditure, India, RandD Expenditure ($m), 2007-2012 244
Figure 94: Healthcare Market, India, Opportunities and Challenges, 2013 251

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