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Healthcare, Regulatory and Reimbursement Landscape - India

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Healthcare, Regulatory and Reimbursement Landscape - India

Publication date: August 2012
Report size: 190 pages

Keywords : diagnostic, Diagnostics, diagnostic device

Healthcare, Regulatory and Reimbursement Landscape - India Summary GlobalData, the industry analysis specialist, has released its new report, “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 i...

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Healthcare, Regulatory and Reimbursement Landscape - India

Summary

GlobalData, the industry analysis specialist, has released its new report, “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 1.21 billion in 2011, 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 valued at $12.9 billion in 2010 and is expected to reach approximately $54 billion by 2020 at a Compound Annual Growth Rate (CAGR) of 15.4%, 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, Hindustan Syringes and Medical Devices, Essilor International 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

Diagnostics Industry in India

1 Table of Contents
1 Table of Contents 5
1.1 List of Tables 7
1.2 List of Figures 9
2 Introduction 11
2.1 Report Guidance 11
3 Overview of the Pharmaceutical and Medical Device Market 12
3.1 Pharmaceutical Market 12
3.1.1 Market Overview 12
3.1.2 Supply Channels 16
3.1.3 Market Segments 19
3.1.4 Major Therapeutic Areas 24
3.1.5 Major Players 27
3.2 Medical Device Market 49
3.2.1 Market Overview 49
3.2.2 Overview of Top Five Segments 51
3.2.3 Major Players 62
3.3 Market Drivers and Barriers 78
3.3.1 Drivers 78
3.3.2 Barriers 78
4 Market Access 81
4.1 Reimbursement and Payer Landscape 81
4.1.1 Overview of Healthcare System 81
4.1.2 Reimbursement Process 84
4.1.3 Overview of Insurance Providers 91
4.1.4 Patient Share of Healthcare Spending 93
4.1.5 Drug Price Trends 94
4.1.6 Pricing Policies 95
4.2 Regulatory Landscape 96
4.2.1 Overview of Regulatory Agencies 96
4.2.2 New Drug Approval Procedure for Pharmaceutical Products 97
4.2.3 New Medical Device Approval Process 100
4.2.4 Licensing Process for Pharmaceutical and Medical Device Manufacturing 101
4.2.5 Licensing Process for Pharmaceutical Exports and Imports 102
4.2.6 Intellectual Property Rights 103
4.2.7 Clinical Trial Regulations 106
4.2.8 Pharmaceutical Advertising Regulations 108
4.2.9 Pharmacy Regulations 108
4.2.10 Labeling and Packaging Regulations 109
5 Country Analysis 110
5.1 Political Environment 110
5.1.1 Political Structure 110
5.1.2 Analysis of the Current Political Environment 110
5.1.3 Healthcare Policy Initiatives 112
5.2 Economic Landscape 113
5.3 Economic Indicators 116
5.3.1 Gross Domestic Product 116
5.3.2 Gross National Income 120
5.3.3 Inflation 121
5.3.4 Currency Exchange Rate 125
5.3.5 Foreign Direct Investment 126
5.3.6 Foreign Exchange Reserves 127
5.3.7 Trade Balance 128
5.3.8 Gross Fiscal Deficit 130
5.3.9 External Gross Debt 131
5.3.10 Major Industries 132
5.4 Demographics 134
5.4.1 Population 134
5.4.2 Education and Literacy 148
5.4.3 Employment 150
5.4.4 Disease Burden 151
5.5 Healthcare Infrastructure 153
5.5.1 Healthcare Facilities 153
5.5.2 Healthcare Parameters 160
5.5.3 Environmental Health 162
5.5.4 Healthcare Personnel 166
5.6 Healthcare Expenditure 168
5.6.1 Components of Healthcare Spending 169
5.6.2 Pharmaceutical Expenditure 171
5.6.3 Share of Public and Private Sectors 172
5.6.4 Spending in Pharmaceutical R&D 173
5.7 Trade Associations 174
5.7.1 Indian Pharmaceutical Association 174
5.7.2 Indian Drug Manufacturer’s Association 174
5.7.3 Organization of Pharmaceutical Producers of India 174
5.7.4 Indian Pharmacy Graduates Association 174
5.8 Trade Fairs 175
6 Opportunities and Challenges 176
6.1 Opportunities 176
6.2 Challenges 177
7 Appendix 180
7.1 Abbreviations 180
7.2 Bibliography 183
7.3 Methodology 188
7.3.1 Coverage 188
7.3.2 Secondary Research 189
7.3.3 Forecasting 189
7.3.4 Primary Research 189
7.3.5 Expert Panel Validation 189
7.4 Contact Us 190
7.5 Disclaimer 190

List of Tables

Table 1: Pharmaceutical Market ($bn), India, 2005–2010 14
Table 2: Pharmaceutical Market ($bn), India, Forecast, 2011–2020 15
Table 3: Price Margins of Distribution Channel (%), India, 2007 17
Table 4: Drugs Going Off-patent, Revenue ($bn), Global, 2011–2014 20
Table 5: Biologics Market ($bn), India, 2005–2010 22
Table 6: Biologics Market, India, Segment Share (%), 2010 23
Table 7: Major Therapeutic Areas, India, Revenue ($m), 2008 24
Table 8: Major Pharmaceutical Companies, India, Revenue ($m), 2011 27
Table 9: Major Products, Cipla, 2010 28
Table 10: Production, Major Products Categories, Cipla, 2010 29
Table 11: Major Product Segments, Sun Pharma, Revenues ($m), Global, 2010 32
Table 12: Major Products, Lupin, India, 2010 37
Table 13: Major Products, Dr. Reddy’s Laboratories, India, Revenue ($m), 2010 45
Table 14: Medical Device Market ($bn), India, 2006–2011 49
Table 15: Medical Device Market ($bn), India, Forecast, 2012–2020 50
Table 16: Medical Device Market, India, Segments, Revenue ($m), 2011 51
Table 17: Ophthalmic Devices Market ($m), India, 2006–2011 52
Table 18: Sales Trend for Major Players*, Ophthalmic Devices, India, 2010 53
Table 19: Hospital Supplies Market ($m), India, 2006–2011 54
Table 20: Sales Trend for Major Players*, Hospital Supplies, India, 2010 55
Table 21: Diagnostic Imaging Devices Market ($m), India, 2006–2011 56
Table 22: Sales Trend for Major Players*, Diagnostic Imaging Devices, India, 2010 57
Table 23: In Vitro Diagnostics Market ($m), India, 2006–2011 58
Table 24: Sales Trend for Major Players*, In Vitro Diagnostic Devices, India, 2010 59
Table 25: Cardiovascular Devices Market ($m), India, 2006–2011 60
Table 26: Sales Trend for Major Players*, Cardiovascular Devices, India, 2010 61
Table 27: Major Medical Device Companies, India, Revenue ($m), 2010 62
Table 28: Major Products, Siemens, Global, Revenue ($m), 2010 63
Table 29: Major Products, Essilor, Global, Revenue ($m), 2010 72
Table 30: Major Products, Roche, Global, Revenue ($m), 2010 75
Table 31: Surgical Procedure Cost ($’000s), 2011 83
Table 32: Major Public Insurance Schemes, India, 2011 91
Table 33: Insured Population, India, Share (m), 2010 91
Table 34: Health Insurers, Accounts ($m), India, 2010 92
Table 35: Healthcare Spending, India, Patient's Share (%), 2005–2010 93
Table 36: Drug Price Change (%), India, 2005–2010 94
Table 37: Specific Requirements, New Drug Application, India, 2011 98
Table 38: Specific Requirements, Clinical Trial Approval, India, 2011 106
Table 39: Impact of Union Budget on Healthcare Sector, India, 2012–2013 112
Table 40: Major Sectors, India, GDP Growth (%), 2011–2012 114
Table 41: GDP Per Capita ($), India, 2005–2010 116
Table 42: GDP Per Capita ($), India, Forecast, 2011–2020 117
Table 43: GDP, India, Annual Growth (%), 2006–2011 118
Table 44: GDP, India, Annual Growth (%), Forecast, 2012–2020 119
Table 45: GNI Per Capita ($), India, 2005–2010 120
Table 46: Average Consumer Price Index, India, 2006–2011 121
Table 47: Average Consumer Price Index, India, Forecast, 2012–2020 122
Table 48: Average Consumer Price, India, Annual Change (%), 2006–2011 123
Table 49: Average Consumer Price, India, Annual Change (%), Forecast, 2012–2020 124
Table 50: Currency Exchange Rate (INR/$), India, 2006–2011 125
Table 51: Foreign Direct Investment ($bn), India, 2005–2010 126
Table 52: Foreign Exchange Reserves ($bn), India, 2005–2010 127
Table 53: Imports of Goods and Services ($bn), India, 2005–2010 128
Table 54: Exports of Goods and Services ($bn), India, 2005–2010 129
Table 55: Gross Fiscal Deficits (% of GDP), India, 2005–2010 130
Table 56: External Government Gross Debt ($bn), India, 2005–2010 131
Table 57: Major Industries, India, GDP ($bn), 2010 133
Table 58: Population (m), India, 2006–2011 134
Table 59: Population (m), India, Forecast, 2012–2020 135
Table 60: Urban and Rural Population, India, Share (%), 2006–2011 136
Table 61: Age Groups, India, Population Distribution (%), 2006–2011 137
Table 62: Age Groups, India, Population Distribution (%), Forecast, 2012–2020 138
Table 63: Births (Per 1,000 Population), India, 2005–2010 139
Table 64: Mortality (Per 1,000 Population), India, 2005–2010 140
Table 65: Major Causes of Mortality (‘000s), India, 2008 141
Table 66: Children <5 Years, India, Mortality Rate (Per 1,000 Live Births), 2005–2010 142
Table 67: Immunization Rate (%), India, 2005–2010 143
Table 68: Major Causes of Male Mortality (‘000s), India, 2008 144
Table 69: Major Causes of Female Mortality (‘000s), India, 2008 145
Table 70: Gender Ratio (Females Per 1,000 Males), India, 2006–2011 146
Table 71: Life Expectancy at Birth (Years), India, 2005–2010 147
Table 72: Literacy Rate (%), India, 2006–2011 148
Table 73: Levels of Education, India, Students Enrollment (m), 2009 149
Table 74: Employees, India, Segment Share (%), 2010 150
Table 75: Major Communicable Diseases, Prevalence (Per 100,000 Population), India, 2010 151
Table 76: Major Diseases, India, DALY (Per 100,000 Population), 2004 152
Table 77: Public Hospitals, India, 2005–2010 153
Table 78: Major Private Hospitals, India, 2012 154
Table 79: Upcoming Health Cities, India, 2012 155
Table 80: Health Centers (‘000s), India, 2005–2010 156
Table 81: Hospitals by Bed Size, India, Share (%), 2010 157
Table 82: Public Hospital Beds (‘000s), India, Urban–Rural, 2005–2010 158
Table 83: Diagnostic Units (Per 100,000 Population), 2008 159
Table 84: Beds (Per 1,000 Population), India, 2005–2010 160
Table 85: Physicians (Per 100,000 Population), India, 2005–2010 161
Table 86: CO2 Emission (MMt), India, 2005–2010 162
Table 87: PM-10 Emissions (µgm/cubic meter), India 2005–2010 163
Table 88: Waste Generation Per Capita (kg), India, 2005–2010 164
Table 89: Composition of Municipal Solid Waste (%), India, 2005 165
Table 90: Nurses (Per 100,000 Population), India, 2005–2010 166
Table 91: Pharmacists (Per 100,000 Population), India, 2005–2010 167
Table 92: Healthcare Expenditure (% of GDP), India, 2005–2010 168
Table 93: Healthcare Expenditure, India, Share of Major Components (%), 2005 169
Table 94: Healthcare Expenditure of Ministry of Health and Family Welfare, India, Share of Departments (%), 2008 170
Table 95: Pharmaceutical Expenditure (% of Total Healthcare Expenditure), India, 2005–2010 171
Table 96: Healthcare Expenditure, India, Share (%), 2005–2010 172
Table 97: R&D Expenditure ($m), India, 2005–2010 173
Table 98: Major Healthcare Trade Fairs, India, 2012 175

List of Figures

Figure 1: Pharmaceutical Market ($bn), India, 2005–2010 14
Figure 2: Pharmaceutical Market ($bn), India, Forecast, 2011–2020 15
Figure 3: Distribution Channels, India, 2011 17
Figure 4: Drug Procurement System in Government Hospitals and Institutions, India, 2011 18
Figure 5: Biologics Market ($bn), India, 2005–2010 22
Figure 6: Biologics Market, India, Segment Share (%), 2010 23
Figure 7: Major Therapeutic Areas, India, Revenue ($m), 2008 24
Figure 8: Major Pharmaceutical Companies, India, Revenue ($m), 2011 27
Figure 9: Medical Device Market ($bn), India, 2006–2011 49
Figure 10: Medical Device Market ($bn), India, Forecast, 2012–2020 50
Figure 11: Medical Device Market, India, Segments, Revenue ($m), 2011 51
Figure 12: Ophthalmic Devices Market ($m), India, 2006–2011 52
Figure 13: Sales Trend for Major Players*, Ophthalmic Devices, India, 2006–2010 53
Figure 14: Hospital Supplies Market ($m), India, 2006–2011 54
Figure 15: Sales Trend for Major Players*, Hospital Supplies, India, 2006–2010 55
Figure 16: Diagnostic Imaging Devices Market ($m), India, 2006–2011 56
Figure 17: Sales Trend for Major Players*, Diagnostic Imaging Devices, India, 2006–2010 57
Figure 18: In Vitro Diagnostics Market ($m), India, 2006–2011 58
Figure 19: Sales Trend for Major Players*, In Vitro Diagnostic Devices, India, 2006–2010 59
Figure 20: Cardiovascular Devices Market ($m), India, 2006–2011 60
Figure 21: Sales Trend for Major Players*, Cardiovascular Devices, India, 2006–2010 61
Figure 22: Major Medical Device Companies, India, Revenue ($m), 2010 62
Figure 23: Drivers and Barriers, Healthcare Market, India, 2011 80
Figure 24: Milestones of the Insurance Regulatory System, India, 1938–2009 82
Figure 25: Surgical Procedure Cost ($’000s), 2011 83
Figure 26: Local Purchase System, Private Hospitals, India, 2012 85
Figure 27: Centralized Purchase System, Private Hospitals, India, 2012 86
Figure 28: Tender Purchase System, Private Hospitals, India, 2012 87
Figure 29: Local and Centralized Purchase System, Private Hospitals, India, 2012 88
Figure 30: Purchase Channels, Private Hospitals, India, 2012 89
Figure 31: Addition to a Hospital Drug Formulary, India, 2011 90
Figure 32: Healthcare Spending, India, Patient's Share (%), 2005–2010 93
Figure 33: Drug Price Change (%), India, 2005–2010 94
Figure 34: Structure of the Central Drugs Standard Control Organization, India, 2011 96
Figure 35: New Drug Application Process, India, 2011 99
Figure 36: Licensing Process for Manufacturing, India, 2011 101
Figure 37: Organizational Structure of the Controller General of Patents, Designs and Trade Marks, India, 2011 103
Figure 38: Patent Approval Process, India, 2011 104
Figure 39: Trademark Registration Process, India, 2011 105
Figure 40: Clinical Trial Approval Process, India, 2011 107
Figure 41: GDP Per Capita ($), India, 2005–2010 116
Figure 42: GDP Per Capita ($), India, Forecast, 2011–2020 117
Figure 43: GDP, India, Annual Growth (%), 2006–2011 118
Figure 44: GDP, India, Annual Growth (%), Forecast, 2012–2020 119
Figure 45: GNI Per Capita ($), India, 2005–2010 120
Figure 46: Average Consumer Price Index, India, 2006–2011 121
Figure 47: Average Consumer Price Index, India, Forecast, 2012–2020 122
Figure 48: Average Consumer Price, India, Annual Change (%), 2006–2011 123
Figure 49: Average Consumer Price, India, Annual Change (%), Forecast, 2012–2020 124
Figure 50: Currency Exchange Rate (INR/$), India, 2006–2011 125
Figure 51: Foreign Direct Investment ($bn), India, 2005–2010 126
Figure 52: Foreign Exchange Reserves ($bn), India, 2005–2010 127
Figure 53: Imports of Goods and Services ($bn), India, 2005–2010 128
Figure 54: Exports of Goods and Services ($bn), India, 2005–2010 129
Figure 55: Gross Fiscal Deficits (% of GDP), India, 2005–2010 130
Figure 56: External Government Gross Debt ($bn), India, 2005–2010 131
Figure 57: Major Industries, India, GDP ($bn), 2010 133
Figure 58: Population (m), India, 2006–2011 134
Figure 59: Population (m), India, Forecast, 2012–2020 135
Figure 60: Urban and Rural Population, India, Share (%), 2006–2011 136
Figure 61: Age Groups, India, Population Distribution (%), 2006–2011 137
Figure 62: Age Groups, India, Population Distribution (%), Forecast, 2012–2020 138
Figure 63: Births (Per 1,000 Population), India, 2005–2010 139
Figure 64: Mortality (Per 1,000 Population), India, 2005–2010 140
Figure 65: Major Causes of Mortality (‘000s), India, 2008 141
Figure 66: Children <5 Years, India, Mortality Rate (Per 1,000 Live Births), 2005–2010 142
Figure 67: Immunization Rate (%), India, 2005–2010 143
Figure 68: Major Causes of Male Mortality (‘000s), India, 2008 144
Figure 69: Major Causes of Female Mortality (‘000s), India, 2008 145
Figure 70: Gender Ratio (Females Per 1,000 Males), India, 2006–2011 146
Figure 71: Life Expectancy at Birth (Years), India, 2005–2010 147
Figure 72: Literacy Rate (%), India, 2006–2011 148
Figure 73: Levels of Education, India, Students Enrollment (m), 2009 149
Figure 74: Employees, India, Segment Share (%), 2010 150
Figure 75: Major Communicable Diseases, Prevalence (Per 100,000 Population), India, 2010 151
Figure 76: Major Diseases, India, DALY (Per 100,000 Population), 2004 152
Figure 77: Public Hospitals, India, 2005–2010 153
Figure 78: Health Centers (‘000s), India, 2005–2010 156
Figure 79: Hospitals by Bed Size, India, Share (%), 2010 157
Figure 80: Public Hospital Beds (‘000s), India, Urban–Rural, 2005–2010 158
Figure 81: Diagnostic Units (Per 100,000 Population), 2008 159
Figure 82: Beds (Per 1,000 Population), India, 2005–2010 160
Figure 83: Physicians (Per 100,000 Population), India, 2005–2010 161
Figure 84: CO2 Emission (MMt), India, 2005–2010 162
Figure 85: PM-10 Emissions (µgm/cubic meter), India 2005–2010 163
Figure 86: Waste Generation Per Capita (kg), India, 2005–2010 164
Figure 87: Composition of Municipal Solid Waste (%), India, 2005 165
Figure 88: Nurses (Per 100,000 Population), India, 2005–2010 166
Figure 89: Pharmacists (Per 100,000 Population), India, 2005–2010 167
Figure 90: Healthcare Expenditure (% of GDP), India, 2005–2010 168
Figure 91: Healthcare Expenditure, India, Share of Major Components (%), 2005 169
Figure 92: Healthcare Expenditure of Ministry of Health and Family Welfare, India, Share of Departments (%), 2008 170
Figure 93: Pharmaceutical Expenditure (% of Total Healthcare Expenditure), India, 2005–2010 171
Figure 94: Healthcare Expenditure, India, Share (%), 2005–2010 172
Figure 95: R&D Expenditure ($m), India, 2005–2010 173
Figure 96: Opportunities and Challenges, Healthcare Market, India, 2011 179

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