CountryFocus: Healthcare, Regulatory and Reimbursement Landscape - India

CountryFocus: Healthcare, Regulatory and Reimbursement Landscape - India

Code: GDHC0056CHR | Published: Jan-2016 | Pages: 235 | GlobalData
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CountryFocus: Healthcare, Regulatory and Reimbursement Landscape - India

Summary

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

India is the second most populated country in the world with a population of approximately 1.24 billion in 2014. The countrys pharmaceutical market was estimated at $24.2 billion in 2014 and is expected to reach approximately $60.5 billion by 2020 at a Compound Annual Growth Rate (CAGR) of 16.5%. The value of the Indian medical device market was $6.6 billion in 2008, and is expected to register a CAGR of 7.7% to reach an estimated $10.3 billion in 2020.

The main growth factors are -
- Increasing coverage of healthcare insurance
- Improving access to medical facilities in both urban and rural areas
- Government initiatives for easy access to healthcare facilities

Scope

The report provides information on the healthcare, regulatory, and reimbursement landscape in India, and includes -
- An overview of the pharmaceutical and medical device markets, comprising market size, segmentation, and key drivers and barriers
- Profiles and SWOT analyses of the major players in the pharmaceutical market: Dr Reddys, Lupin, Cipla, Aurobindo and Cadila; and profiles and SWOT analyses of the major players in the medical device market: Siemens Healthcare, Johnson & Johnson, DePuy, Roche and Philips
- Insightful review of the reimbursement and regulatory landscape, with analysis covering details of the countrys healthcare reimbursement process, regulatory agencies and the approval processes for new drugs and medical devices
- Detailed analysis of the political and economic environment, covering economic indicators, demographics, healthcare infrastructure and healthcare expenditure
- An 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 Indias healthcare market
- Drive revenues by understanding the key trends, reimbursement and regulatory policies, pharmaceutical market segments, and companies likely to affect Indias 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 best opportunities for consolidation, investment, and strategic partnerships
- Identify, understand, and capitalize on the opportunities and challenges in Indias healthcare market
1 Table of Contents
1 Table of Contents 6
1.1 List of Tables 9
1.2 List of Figures 13
2 Introduction 17
2.1 GlobalData Report Guidance 17
3 Overview of the Pharmaceutical and Medical Device Markets 18
3.1 Pharmaceutical Market 18
3.1.1 Market Overview 18
3.1.2 Pharmaceutical Exports and Imports 22
3.1.3 Supply Channels 23
3.1.4 Market Segments 24
3.1.5 Major Therapeutic Areas 26
3.1.6 Major Players 30
3.2 Medical Device Market 57
3.2.1 Market Overview 57
3.2.2 Overview of Top Five Segments 60
3.2.3 Diagnostic market 70
3.2.4 Major Players 72
3.3 Market Drivers and Barriers 101
3.3.1 Drivers 101
3.3.2 Barriers 102
4 Market Access 106
4.1 Reimbursement and Payer Landscape 106
4.1.1 Overview of Healthcare System 106
4.1.2 Reimbursement Process 109
4.1.3 Overview of Insurance Providers 114
4.1.4 Patient Share in Healthcare Spending 118
4.1.5 Drug Price Change 119
4.1.6 Pricing Policies 121
4.2 Regulatory Landscape 123
4.2.1 Overview of Regulatory Agencies 123
4.2.2 New Drug Approval Procedure for Pharmaceutical Products 125
4.2.3 Market Authorization Procedure for Medical Devices 128
4.2.4 Licensing Process for Pharmaceutical and Medical Device Manufacturing 130
4.2.5 Licensing Process for Pharmaceutical Exports and Imports 131
4.2.6 Intellectual Property Rights 132
4.2.7 Clinical Trial Regulations 138
4.2.8 Pharmaceutical Advertising Regulations 140
4.2.9 Pharmacy Regulations 141
4.2.10 Labeling and Packaging Regulations 142
5 Country Analysis 144
5.1 Political Environment 144
5.1.1 Political Structure 144
5.1.2 Analysis of the Current Political Environment 145
5.1.3 Healthcare Policy Initiatives 146
5.2 Economic Landscape 148
5.3 Economic Indicators 149
5.3.1 Gross Domestic Product 149
5.3.2 National Income per Capita 154
5.3.3 Inflation 155
5.3.4 Currency Exchange Rate 158
5.3.5 Foreign Direct Investment 159
5.3.6 Foreign Exchange Reserves 161
5.3.7 Trade Balance 162
5.3.8 Government Structural Balance 164
5.3.9 General Government Gross Debt 166
5.3.10 Major Industries 168
5.4 Demographics 169
5.4.1 Population 169
5.4.2 Education and Literacy 187
5.4.3 Employment 189
5.4.4 Disease Burden 192
5.5 Healthcare Infrastructure 194
5.5.1 Healthcare Facilities 194
5.5.2 Healthcare Parameters 201
5.5.3 Environmental Health 203
5.5.4 Healthcare Personnel 206
5.6 Healthcare Expenditure 209
5.6.1 Overview 209
5.6.2 Components of Healthcare Spending 210
5.6.3 Public and Private Sector Share 212
5.6.4 Spending in Pharmaceutical R&D 213
5.7 Trade Associations 214
5.7.1 Indian Pharmaceutical Association 214
5.7.2 Indian Drug Manufacturer’s Association 214
5.7.3 Organization of Pharmaceutical Producers of India 214
5.7.4 Indian Pharmacy Graduates Association 215
5.8 Trade Fairs 215
6 Opportunities and Challenges 216
6.1 Opportunities 216
6.2 Challenges 217
7 Appendix 219
7.1 Abbreviations 219
7.2 Bibliography 223
7.3 Research Methodology 232
7.3.1 Coverage 232
7.3.2 Secondary Research 233
7.3.3 Forecasts 234
7.3.4 Expert Panel 234
7.4 Disclaimer 234

1.1 List of Tables
Table 1: Pharmaceutical Market, India, Revenue ($bn), 2008-2014 20
Table 2: Pharmaceutical Market, India, Revenue Forecast ($bn), 2014-2020 21
Table 3: Pharmaceutical Market, India, Exports and Imports ($bn), 2008-2013 23
Table 4: Biotechnology Market, India, Market Segments of Bio-technology Industry, Share (%), 2015 25
Table 5: Major Therapeutic Areas, India, Turnover ($m), 2010 27
Table 6: Dr. Reddy’s, Global, Major Products, 2014 31
Table 7: Dr Reddy’s, Global, Late-Stage Pipeline, 2015 31
Table 8: Medical Device Market, India, Revenue ($bn), 2008-2014 58
Table 9: Medical Device Market, India, Revenue Forecast ($bn), 2015-2020 59
Table 10: Medical Device Market, India, Revenue by Segment, 2014 60
Table 11: Medical Device Market, India, Ophthalmic Devices Market ($m), 2008-2014 61
Table 12: Medical Device Market, India, Ophthalmic Devices Market, Market Share for Major Players (%), 2012 62
Table 13: Medical Device Market, India, IVD Market ($bn), 2008-2014 63
Table 14: Medical Device Market, India, IVD Market, Market Share for Major Players (%), 2012 64
Table 15: Medical Device Market, India, Orthopedic Device Market ($bn), 2008-2014 65
Table 16: Medical Device Market, India, Orthopedic Device Market, Market Share for Major Players (%), 2012 66
Table 17: Medical device market, India, Wound Care Management Market ($bn), 2008-2014 67
Table 18: Medical Device Market, India, Wound Care Management Market, Market Share for Major Players (%), 2012 68
Table 19: Medical Device Market, India, Cardiovascular Device Market ($bn), 2008-2014 69
Table 20: Medical Device Market, India, Cardiovascular Device Market, Market Share for Major Players (%), 2012 70
Table 21: Medical Device Market, India, Diagnostic Market, Revenue ($bn), 2008-2014 71
Table 22: Medical Device Market, India, Diagnostic Market, Revenue ($bn), 2014-2020 72
Table 23: Major Public Insurance Schemes, India, 2013 116
Table 24: Insured Population, India, Share ($bn), 2014 116
Table 25: Healthcare Spending, India, Out-of-Pocket Expenditure (% of Private Expenditure on Health), 2008-2013 119
Table 26: Market Access, India, Drug Price Change (%), 2008-2014 120
Table 27: Specific Requirements, New Drug Application, India, 2015 127
Table 28: Market Access, India, Schedule of Patent Fees, 2014 135
Table 29: Market Access, India, Schedule of Trademark Fees, 2014 137
Table 30: Specific Requirements, Clinical Trial Approval, India, 2011 139
Table 31: Economic Indicators, India, GDP per Capita ($), 2008-2014 150
Table 32: Economic Indicators, India, GDP per Capita Forecast ($), 2015-2020 151
Table 33: Economic Indicators, India, GDP Annual Growth (%), 2008-2014 152
Table 34: Economic Indicators, India, GDP Annual Growth Forecast (%), 2015-2020 153
Table 35: Economic Indicators, India, National Income per Capita ($), 2008-2014 154
Table 36: Economic Indicators, India, Average Consumer Price Index Forecast, 2008-2014 156
Table 37: Economic Indicators, India, Average Consumer Price Index Forecast, 2015-2020 156
Table 38: Economic Indicators, India, Average Consumer Price Annual Change (%), 2008-2014 157
Table 39: Economic Indicators, India, Currency Exchange Rate (INR/$), 2008-2014 159
Table 40: Economic Indicators, India, FDI ($bn), 2008-2014 160
Table 41: Economic Indicators, India, Foreign Exchange Reserves ($bn), 2008-2014 161
Table 42: Economic Indicators, India, Imports of Goods and Services ($bn), 2008-2014 163
Table 43: Economic Indicators, India, Exports of Goods and Services ($bn), 2008-2014 164
Table 44: Economic Indicators, India, Government Structural Balance ($bn), 2008-2014 165
Table 45: Economic Indicators, India, General Government Gross Debt (% of GDP), 2008-2014 166
Table 46: Economic Indicators, India, General Government Gross Debt Forecast (% of GDP), 2015-2020 167
Table 47: Economic Indicators, India, Major Industries, National income by Industry ($bn), 2013 169
Table 48: Demographics, India, Population (billion), 2008-2014 170
Table 49: Demographics, India, Population Forecast (billion), 2015-2020 171
Table 50: Demographics, India, Urban-Rural Population (%), 2008-2014 172
Table 51: Demographics, India, Population Distribution by Age Group (%), 2008-2014 173
Table 52: Demographics, India, Population Distribution by Age Group Forecast (%), 2015-2020 174
Table 53: Demographics, India, Births (per 1,000 Population), 2008-2014 175
Table 54: Demographics, India, Mortality (per 1,000 Population), 2008-2014 176
Table 55: Demographics, India, Major Causes of Mortality (%), 2012 177
Table 56: Demographics, India, Children <5 Years Age, Infant Mortality Rate (per 1,000 Live Births), 2008-2014 178
Table 57: Demographics, India, Immunization Rate (%), 2013 180
Table 58: Demographics, India, Major Causes of Male Mortality (‘000), 2008 182
Table 59: Demographics, India, Major Causes of Male Mortality (‘000), 2008 184
Table 60: Demographics, India, Gender Ratio (M/F), 2008-2014 185
Table 61: Demographics, India, Life Expectancy at Birth (Years), 2008-2014 186
Table 62: Demographics, India, Number of students enrolled by level of education (millions), 2013 189
Table 63: Demographics, India, Unemployment Rate (%), 2008-2014 190
Table 64: Demographics, India, Employment by Sector (Number of Employees, Millions), 2013 191
Table 65: Demographics, India, Disease burden, DALYs, 2013 193
Table 66: Healthcare Infrastructure, India, Public Hospitals, 2008-2014 195
Table 67: Major Private Hospitals, India, 2012 196
Table 68: Healthcare Infrastructure, India, Urban-rural share (%), 2008-2014 198
Table 69: Healthcare Infrastructure, India, Healthcare Centers, 2008-2014 199
Table 70: Healthcare Infrastructure, Diagnostic Units (Per 100,000 Population), 2008 200
Table 71: Healthcare Infrastructure, India, Hospital Beds (per 1,000 Population), 2008-2014 201
Table 72: Healthcare Infrastructure, India, Doctors (‘000), 2008-2014 203
Table 73: Healthcare Infrastructure, India, PM10 (ug/m3), 2008-2014 204
Table 74: Healthcare Infrastructure, India, CO2 emissions (mt per Capita), 2008-2014 205
Table 75: Healthcare Infrastructure, India, Nurses (per 1,000 Population), 2008-2014 206
Table 76: Healthcare Infrastructure, India, Pharmacists (per 1,000 Population), 2008-2014 207
Table 77: Healthcare Infrastructure, India, Dentists (per 1,000 Population), 2008-2014 208
Table 78: Healthcare Expenditure, India , Healthcare Expenditure (% of GDP), 2008-2014 209
Table 79: Healthcare Expenditure of Ministry of Health and Family Welfare, India, Share by Department (%), 2014 210
Table 80: Healthcare Expenditure, India, Major Components of Healthcare Spending, Share (%), 2013 211
Table 81: Healthcare Expenditure, India, Public-Private Share (%), 2008-2014 212
Table 82: Healthcare Expenditure, India, Pharmaceutical R&D Expenditure ($m), 2008-2014 214
Table 83: Healthcare Expenditure, India Major Healthcare Trade Fairs, 2015-2016 215

1.2 List of Figures
Figure 1: Pharmaceutical Market, India, Revenue ($bn), 2008-2014 20
Figure 2: Pharmaceutical Market, India, Revenue Forecast ($bn), 2015-2020 21
Figure 3: Pharmaceutical Market, India, Exports and Imports ($bn), 2008-2014 22
Figure 4: Pharmaceutical Market, India, Supply Channels, 2013 23
Figure 5: Biotechnology Market, India, Market Segments of Bio-technology Industry, Share (%), 2015 25
Figure 6: Major Therapeutic Areas, India, Turnover ($m), 2010 26
Figure 7: Medical Device Market, India, Revenue ($bn), 2008-2014 58
Figure 8: Medical Device Market, India, Revenue Forecast ($bn), 2015-2020 59
Figure 9: Medical Device Market, India, Revenue by Segment ($bn), 2014 60
Figure 10: Medical Device Market, India, Ophthalmic Devices Market ($m), 2008-2014 61
Figure 11: Medical Device Market, India, Ophthalmic Devices Market, Market Share for Major Players (%), 2012 62
Figure 12: Medical Device Market, India, IVD Market ($m), 2008-2014 63
Figure 13: Medical Device Market, India, IVD Market, Market Share for Major Players (%), 2012 64
Figure 14: Medical Device Market, India, Orthopedic Device Market ($bn), 2008-2014 65
Figure 15: Medical Device Market, India, Orthopedic Device Market, Market Share for Major Players (%), 2012 66
Figure 16: Medical Device Market, India, Wound Care Management Market ($bn), 2008-2014 67
Figure 17: Medical device market, India, Wound Care Management Market ($m), Market share for Major Players (%), 2012 68
Figure 18: Medical Device Market, India, Cardiovascular Device Market ($bn), 2008-2014 69
Figure 19: Medical Device Market, India, Cardiovascular Device Market, Market Share for Major Players (%), 2012 70
Figure 20: Medical Device Market, India, Diagnostic Market, Revenue ($bn), 2008-2014 71
Figure 21: Medical Device Market, India, Diagnostic Market, Revenue ($bn), 2015-2020 72
Figure 22: Healthcare Market, India, Drivers and Barriers, 2015 105
Figure 23: Milestones of the Insurance Regulatory System, India, 1938-2009 107
Figure 24: Healthcare System, India, Medical Tourism Process, 2008 109
Figure 25: Local Purchase System, Private Hospitals, India, 2013 111
Figure 26: Centralized Purchase System, Private Hospitals, India, 2013 112
Figure 27: Tender Purchase System, Private Hospitals, India, 2013 113
Figure 28: Local and Centralized Purchase System, Private Hospitals, India, 2013 114
Figure 29: Healthcare Spending, India, Out-of-Pocket Expenditure (% of Private Expenditure on Health), 2008-2014 119
Figure 30: Market Access, India, Drug Price Change (%), 2008-2014 120
Figure 31: Market Access, India, Structure of the Central Drugs Standard Control Organization, 2015 124
Figure 32: Market Access, India, New Drug Evaluation Process, 2014 128
Figure 33: Organizational Structure of the Controller General of Patents, Designs and Trade Marks, India, 2015 133
Figure 34: Patent Approval Process, India, 2015 135
Figure 35: Trademark Registration Process, India, 2015 137
Figure 36: Clinical Trial Approval Process, India, 2013 140
Figure 37: Economic Indicators, India, GDP per Capita ($), 2008-2014 150
Figure 38: Economic Indicators, India, GDP per Capita Forecast ($), 2015-2020 151
Figure 39: Economic Indicators, India, GDP Annual Growth (%), 2008-2014 152
Figure 40: Economic Indicators, India, GDP Annual Growth Forecast (%), 2015-2020 153
Figure 41: Economic Indicators, India, National Income per Capita ($),2008-2014 154
Figure 42: Economic Indicators, India, Average Consumer Price Index, 2008-2014 155
Figure 43: Economic Indicators, India, Average Consumer Price Index, 2015-2020 156
Figure 44: Economic Indicators, India, Average Consumer Price Annual Change (%), 2008-2014 157
Figure 45: Economic Indicators, India, Currency Exchange Rate (INR/$), 2008-2014 158
Figure 46: Economic Indicators, India, FDI ($bn), 2008-2014 160
Figure 47: Economic Indicators, India, Foreign Exchange Reserves ($bn), 2008-2014 161
Figure 48: Economic Indicators, India, Imports of Goods and Services ($bn), 2008-2014 162
Figure 49: Economic Indicators, India, Exports of Goods and Services ($bn), 2008-2014 164
Figure 50: Economic Indicators, India, Government Structural Balance ($bn), 2008-2014 165
Figure 51: Economic Indicators, India, General Government Gross Debt (% of GDP), 2008-2014 166
Figure 52: Economic Indicators, India, General Government Gross Debt Forecast (% of GDP), 2015-2020 167
Figure 53: Economic Indicators, India, Major Industries, National Income by Industry ($bn), 2013 168
Figure 54: Demographics, India, Population (billion), 2008-2014 170
Figure 55: Demographics, India, Population Forecast (billion), 2015-2020 171
Figure 56: Demographics, India, Urban-Rural Population (%), 2008-2014 172
Figure 57: Demographics, India, Population Distribution by Age Group (%), 2008-2014 173
Figure 58: Demographics, India, Population Distribution by Age Group Forecast (%), 2015-2020 174
Figure 59: Demographics, India, Births (per 1,000 Population), 2008-2014 175
Figure 60: Demographics, India, Mortality (per 1,000 Population), 2008-2014 176
Figure 61: Demographics, India, Major Causes of Mortality (%), 2012 177
Figure 62: Demographics, India, Infant Mortality Rate (per 1,000 Live Births), 2008-2014 178
Figure 63: Demographics, India, Immunization Rate (%), 2013 180
Figure 64: Demographics, India, Major Causes of Male Mortality (‘000), 2008 181
Figure 65: Demographics, India, Major Causes of Female Mortality (‘000), 2008 183
Figure 66: Demographics, India, Gender Ratio (M/F), 2008-2014 185
Figure 67: Demographics, India, Life Expectancy at Birth (Years), 2008-2014 186
Figure 68: Demographics, India, Number of Students Enrolled by Level of Education (millions), 2013 188
Figure 69: Demographics, India, Unemployment Rate (%), 2008-2014 190
Figure 70: Demographics, India, Employment by Sector (Number of Employees, Millions), 2013 191
Figure 71: Demographics, India, Disease burden, DALYs (per 100,000 Population), 2013 193
Figure 72: Healthcare Infrastructure, India, Public Hospitals, 2008-2014 195
Figure 73: Healthcare Infrastructure, India, Urban rural share (%), 2008-2014 198
Figure 74: Healthcare Infrastructure, India, Healthcare centers, 2008-2014 199
Figure 75: Healthcare Infrastructure, India, Diagnostic Equipment (per 100,000 population), 2008 200
Figure 76: Healthcare Infrastructure, India, Hospital Beds (per 1,000 Population), 2008-2014 201
Figure 77: Healthcare Infrastructure, India, Doctors (‘000), 2008-2014 202
Figure 78: Healthcare Infrastructure, India, PM10 (µg/m3), 2008-2014 204
Figure 79: Healthcare Infrastructure, India, CO2 emissions (mt per capita), 2008-2014 205
Figure 80: Healthcare Infrastructure, India, Nurses (per 1,000 Population), 2008-2014 206
Figure 81: Healthcare Infrastructure, India, Pharmacists (per 1,000 Population), 2008-2014 207
Figure 82: Healthcare Infrastructure, Dentists (per 1,000 Population), 2008-2014 208
Figure 83: Healthcare Expenditure, India, Healthcare Expenditure (% of GDP), 2008-2014 209
Figure 84: Healthcare Expenditure of Ministry of Health and Family Welfare, India, Share by Department (%), 2014 210
Figure 85: Healthcare Expenditure, India, Major Components of Healthcare Spending, Share (%), 2013 211
Figure 86: Healthcare Expenditure, India, Public-Private Share (%), 2008-2014 212
Figure 87: Healthcare Expenditure, India, Pharmaceutical R&D Expenditure ($m), 2008-2014 213
Figure 88: Healthcare Market, India, Opportunities and Challenges, 2015 218

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