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Healthcare, Regulatory and Reimbursement Landscape - India

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Abstract

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

TOC

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

1.1 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

1.2 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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