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CountryFocus: Healthcare, Regulatory and Reimbursement Landscape - US

Summary

GlobalData, the industry analysis specialist, has released its latest report, “CountryFocus: Healthcare, Regulatory and Reimbursement Landscape - US”. The report is an essential source of information on and analysis of the healthcare, regulatory and reimbursement landscape in the US. It identifies the key trends in the country’s 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 GlobalData’s team of industry experts.

The population of the US in 2015 was 326 million, having grown at a CAGR of 1% from 2008. In 2015, the government spent 17.5% of GDP in 2015 on medical and health science and exported $32.8 billion of pharmaceutical products. The pharmaceutical market in the US was worth $354 billion in 2015 and is projected to reach $497 billion by 2020, at a Compound Annual Growth Rate (CAGR) of 4.4%. The medical device market was valued at $161 billion in 2015 and is projected to grow at a CAGR of 5.5% to $209 billion by 2020.

These positive growth trends can be primarily attributed to -
- Availability of latest drugs and technologies
- Universal health coverage
- Access to healthcare facilities

Scope

The report provides information on the healthcare, regulatory, and reimbursement landscape in the US, 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: Johnson & Johnson, Pfizer, Merck & Co., Gilead Science and Amgen; and profiles and SWOT analyses of the major players in the medical device market: Johnson and Johnson, GE Healthcare, Siemens, Medtronic, and Philips Healthcare
- An insightful review of the reimbursement and regulatory landscape, with analysis covering details of the country’s healthcare reimbursement process, regulatory agencies and the approval processes for new drugs and medical devices
- Detailed analysis of the country’s 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 US 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 the US healthcare market
- Drive revenues by understanding the key trends, reimbursement and regulatory policies, pharmaceutical market segments and companies likely to impact the US healthcare market in the future
- Formulate effective sales and marketing strategies by understanding the competitive landscape and analyzing competitors’ performance
- Organize your sales and marketing efforts by identifying the market categories and segments that present the most opportunities for consolidation, investment and strategic partnership

Table Of Contents

CountryFocus: Healthcare, Regulatory and Reimbursement Landscape - US
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 Disease Areas 31
3.1.6 Major Companies 33
3.2 Medical Device Market 78
3.2.1 Overview of the Top Five Segments 80
3.2.2 Diagnostic Market 90
3.2.3 Major Players 93
3.3 Market Drivers and Barriers 133
3.3.1 Drivers 133
3.3.2 Barriers 134
4 Market Access 136
4.1 Reimbursement and Payer Landscape 136
4.1.1 Overview of Healthcare System 136
4.1.2 Reimbursement Process 138
4.1.3 Overview of Insurance Providers 140
4.1.4 Patient Share in Healthcare Spending 151
4.1.5 Price Trends in the Healthcare Sector 152
4.1.6 Pricing Policies 153
4.2 Regulatory Landscape 155
4.2.1 Overview of Regulatory Agencies 155
4.2.2 New Drug Approval Process 156
4.2.3 Approval Process of Biological Products as Biosimilar or Interchangeable 163
4.2.4 New Medical Device Approval Process 165
4.2.5 Intellectual Property Rights 166
4.2.6 Clinical Trial Regulations 171
4.2.7 Pharmaceutical Advertising Regulations 172
4.2.8 Pharmacy Regulations 173
4.2.9 Labeling and Packaging Regulations 176
5 Country Analysis 179
5.1 Political Environment 179
5.1.1 Political Structure 179
5.1.2 Analysis of the Current Political Environment 180
5.1.3 Healthcare Policy Initiatives 183
5.2 Economic Landscape 186
5.3 Economic Indicators 188
5.3.1 Gross Domestic Product 188
5.3.2 Gross National Income 192
5.3.3 Inflation 194
5.3.4 Currency Exchange Rate 196
5.3.5 Foreign Direct Investment 199
5.3.6 Foreign Exchange Reserves 200
5.3.7 Trade Balance 202
5.3.8 General Government Structural Balance 204
5.3.9 General Government Net Debt 205
5.3.10 Major Industries 206
5.4 Demographics 208
5.4.1 Population 208
5.4.2 Education and Literacy 224
5.4.3 Employment 226
5.4.4 Disease Burden 227
5.5 Healthcare Infrastructure 228
5.5.1 Healthcare Facilities 228
5.5.2 Healthcare Parameters 232
5.5.3 Environmental Health 234
5.5.4 Healthcare Personnel 236
5.6 Healthcare Expenditure 239
5.6.1 Overview 239
5.6.2 Major Components of Healthcare Spending 240
5.6.3 Public and Private Sector Share 241
5.6.4 Spending in Healthcare RandD 242
5.7 Trade Associations 243
5.7.1 Pharmaceutical Research and Manufacturers of America 243
5.7.2 Consumer Healthcare Products Association 243
5.7.3 International Pharmaceutical Excipients Council 243
5.7.4 Advanced Medical Technology Association 244
5.7.5 National Association for Home Care and Hospices 244
5.7.6 Biotech Innovation Organization 244
5.7.7 The Society of Chemical Manufacturers and Affiliates 245
5.8 Trade Fairs 246
6 Opportunities and Challenges 247
6.1 Opportunities 247
6.2 Challenges 248
7 Appendix 250
7.1 Abbreviations 250
7.2 Bibliography 253
7.3 Research Methodology 264
7.3.1 Coverage 264
7.3.2 Secondary Research 265
7.3.3 Forecasts 265
7.3.4 Expert Panel 266
7.4 Disclaimer 266

1.1 List of Tables
Table 1: Pharmaceutical Market, US, Revenue ($bn), 2008-2015 19
Table 2: Pharmaceutical Market, US, Revenue ($bn), 2016-2020 20
Table 3: Pharmaceutical Market, US, Exports and Imports ($bn), 2008-2015 22
Table 4: Pharmaceutical Market, Biologics Approvals, US, 2014-2016 27
Table 5: Pharmaceutical market, Approved biosimilars, US, 2016 29
Table 6: Pharmaceutical Market, US, Top Five Therapeutic Areas, 2014 32
Table 7: Pharmaceutical Market, Johnson and Johnson, Major Products, 2016 35
Table 8: Pharmaceutical Market, Johnson and Johnson, Global, Late-Stage Pipeline, 2016 36
Table 9: Pharmaceutical Market, Pfizer, Late-Stage Pipeline, 2016 46
Table 10: Pharmaceutical Market, Merck and Co., Global, Major Products, 2015 54
Table 11: Pharmaceutical Market, Merck and Co., Global, Late-Stage Pipeline, 2016 56
Table 12: Medical Device Market, Gilead Sciences, Major Products, 2016 63
Table 13: Pharmaceutical Market, Gilead Sciences, Global, Late-Stage Pipeline, 2016 64
Table 14: Pharmaceutical Market, Amgen, Global, Late-Stage Pipeline, 2016 72
Table 15: Medical Device Market, US, Revenue ($bn), 2008-2015 79
Table 16: Medical Device Market, US, Revenue ($bn), 2016-2020 79
Table 17: Medical Device Market, US, Revenue and Market Share by Segment, 2015 80
Table 18: Orthopedic Devices Market, US, Revenue ($bn), 2008-2015 82
Table 19: Orthopedic Devices Market, US, Revenue and Market Share by Company, 2015 82
Table 20: IVD Market, US, Revenue ($bn), 2008-2015 83
Table 21: IVD Market, US, Revenue and Market Share by Company, 2014 84
Table 22: Cardiovascular Device Market, US, Revenue ($bn), 2008-2015 85
Table 23: Cardiovascular Device Market, US, Revenue and Market Share by Segment, 2015 86
Table 24: Ophthalmic Device Market, US, Revenue ($bn), 2008-2015 87
Table 25: Ophthalmic Device Market, US, Revenue and Market Share by Company, 2015 88
Table 26: Healthcare IT Market, US, Revenue ($bn), 2008-2015 89
Table 27: Healthcare IT Market, US, Revenue and Market Share by Company, 2015 90
Table 28: Medical Device Market, US Diagnostic Market, Revenue ($bn), 2008-2015 91
Table 29: Medical Device Market, US, Diagnostic Market, Revenue ($bn), 2016-2020 92
Table 30: Medical Device Market, GE Healthcare, Global, Major Products, 2015 100
Table 31: Medical Device Market, Medtronic, Global, Major Products, 2015 108
Table 32: Medical Device Market, Siemens Healthineers, Global, Major Products, 2015 119
Table 33: Medical Device Market, Philips Healthcare, Global, Major Products, 2015 126
Table 34: Total Medicare Income, US, Expenditure and Trust Fund Assets ($bn), 2008?2025 144
Table 35: Market Access, US, Poverty Guidelines, 2016 149
Table 36: Market Access, US, Value of Metal Plans, 2016 149
Table 37: Market Access, US, Metal Plans , 2016 150
Table 38: Market Access, US, Coverage by Type of Health Insurance (%), 2015 150
Table 39: Market Access, US, Out-of-Pocket Expenditure (annual percentage change), 2008-2015 152
Table 40: Market Access, Price of Healthcare Products, US, Change in Average Price of Prescription Drugs (%), 2008-2015 153
Table 41: Regulatory Landscape, US, Patent Fees ($), 2016 168
Table 42: Regulatory Landscape, US, Trademark Fees ($), 2016 171
Table 43: Economic Indicators, US, Gross Domestic Product per Capita ($), 2008-2015 189
Table 44: Economic Indicators, US, Gross Domestic Product per Capita ($), 2016-2020 190
Table 45: Economic Indicators, US, Gross Domestic Product Annual Growth (%), 2008-2015 191
Table 46: Economic Indicators, US, Gross Domestic Product Annual Growth (%), 2016-2020 192
Table 47: Economic Indicators, US, Gross National Income per Capita ($), 2008-2015 193
Table 48: Economic Indicators, US, Consumer Price Index, 2008-2015 194
Table 49: Economic Indicators, US, Consumer Price Index, 2016-2020 195
Table 50: Economic Indicators, US, Consumer Price Annual Change (%), 2008-2015 196
Table 51: Economic Indicators, US Currency Exchange Rate ($/€), 2008-2015 197
Table 52: Economic Indicators, US Currency Exchange Rate ($/£), 2008-2015 198
Table 53: Economic Indicators, US Currency Exchange Rate ($/Â¥) 2008-2015 199
Table 54: Economic Indicators, US, Foreign Direct Investment ($bn), 2008-2015 200
Table 55: Economic Indicators, US, Foreign Exchange Reserves ($bn), 2008-2015 201
Table 56: Economic Indicators, US, Imports of Goods and Services ($bn), 2008-2015 202
Table 57: Economic Indicators, US, Exports of Goods and Services ($bn), 2008-2015 203
Table 58: Economic Indicators, US, Government Structural Balance ($bn), 2008-2015 204
Table 59: Economic Indicators, US, General Government Net Debt ($tn), 2008-2015 205
Table 60: Economic Indicators, US, General Government Net Debt ($tn), 2016-2020 206
Table 61: Economic Indicators, US, Major Industries, GDP ($bn), 2015 207
Table 62: Demographics, US, Population (million), 2008-2015 208
Table 63: Demographics, US, Population (million), 2016-2020 209
Table 64: Demographics, US, Population, Urban-Rural Population Share (%), 2008-2015 210
Table 65: Demographics, US, Population, Urban-Rural Population Share (%), 2016-2020 211
Table 66: Demographics, US, Population Distribution by Age Group (%), 2008-2015 212
Table 67: Demographics, US, Population Distribution by Age Group Forecast (%), 2016-2020 213
Table 68: Demographics, US, Births (per 1,000 population), 2008-2015 214
Table 69: Demographics, US, Mortality (per 1,000 population), 2008-2015 215
Table 70: Demographics, US, Number of Deaths (‘000), 2015 217
Table 71: Demographics, US, Mortality Rate in Children under Five (per 1,000 live births), 2008-2015 218
Table 72: Demographics, US, Immunization Rate (%), 2008-2015 219
Table 73: Demographics, US, Major Causes of Mortality in Males (Deaths ‘000), 2015 220
Table 74: Demographics, US, Major Causes of Mortality in Females (Deaths ‘000), 2015 222
Table 75: Demographics, US, Gender Ratio (M/F), 2008-2015 223
Table 76: Demographics, US, Life Expectancy at Birth (years), 2008-2015 224
Table 77: Demographics, US, Gross Enrollment by Level of Education (%), 2008-2015 225
Table 78: Demographics, US, Unemployment Rate (%), 2008-2015 226
Table 79: Demographics, US, Disability-Adjusted Life Years by Major Disease (millions), 2012 228
Table 80: Healthcare Infrastructure, US, Hospitals, 2008-2015 229
Table 81: Healthcare Infrastructure, US, Public and Private Hospitals, 2008-2015 230
Table 82: Healthcare Infrastructure, US, Diagnostic Units (per million population), 2008-2015 231
Table 83: Healthcare Infrastructure, US, Hospital Beds (per 1,000 population), 2008-2015 232
Table 84: Healthcare Infrastructure, US, Doctors (per 1,000 population), 2008-2015 233
Table 85: Healthcare Infrastructure, US, PM2.5 (µg/m3), 2008-2015 234
Table 86: Healthcare Infrastructure, US, CO2 Emissions (metric tons per capita), 2008-2015 236
Table 87: Healthcare Infrastructure, US, Nurses (per 1,000 population), 2008-2015 237
Table 88: Healthcare Infrastructure, US, Dentists (per 1,000 population), 2008-2015 237
Table 89: Healthcare Infrastructure, US, Pharmacists (per 1,000 population), 2008-2015 238
Table 90: Healthcare Expenditure, US, Healthcare Expenditure (% of GDP), 2008-2015 239
Table 91: Public Healthcare Expenditure, US, Share of Major Components (%), 2015 240
Table 92: Healthcare Expenditure, US, Healthcare Expenditure, Public-Private Share (%), 2008-2015 241
Table 93: Healthcare Expenditure, US, RandD expenditure ($bn), 2008-2015 242
Table 94: Healthcare Expenditure, US, Major Healthcare Trade Fairs, 2017 246

1.2 List of Figures
Figure 1: Pharmaceutical Market, US, Revenue ($bn), 2008-2015 19
Figure 2: Pharmaceutical Market, US, Revenue ($bn), 2016-2020 20
Figure 3: Pharmaceutical Market, US, Exports and Imports ($bn), 2008-2015 22
Figure 4: Pharmaceutical Market, US, Supply Channels, 2016 24
Figure 5: Pharmaceutical Market, US, Top Five Therapeutic Areas ($bn), 2014 31
Figure 6: Medical Device Market, US, Revenue ($bn), 2008-2015 78
Figure 7: Medical Device Market, US, Revenue ($bn), 2016-2020 79
Figure 8: Medical Device Market, US, Revenue by Segment ($bn), 2015 80
Figure 9: Orthopedic Devices Market, US, Revenue ($bn), 2008-2015 81
Figure 10: Orthopedic Devices Market, US, Market Share by Company (%), 2015 82
Figure 11: IVD Market, US, Revenue ($bn), 2008-2015 83
Figure 12: IVD Market, US, Market Share by Company (%), 2014 84
Figure 13: Cardiovascular Device Market, US, Revenue ($bn), 2008-2015 85
Figure 14: Cardiovascular Device Market, US, Revenue and Market Share by Segment, 2015 86
Figure 15: Ophthalmic Device Market, US, Revenue ($bn), 2008-2015 87
Figure 16: Ophthalmic Device Market, US, Market Share by Company (%), 2012 88
Figure 17: Healthcare IT Market, US, Revenue ($bn), 2008-2015 89
Figure 18: Healthcare IT Market, US, Market Share by Company (%), 2015 90
Figure 19: Medical Device Market, US, Diagnostic Market, Revenue ($bn), 2008-2015 91
Figure 20: Medical Device Market, US, Diagnostic Market, Revenue ($bn), 2016-2020 92
Figure 21: Healthcare Market, US, Drivers and Barriers, 2016 135
Figure 22: Healthcare System, Flow of Funds, US, 2016 136
Figure 23: Market Access, US, Out-of-Pocket Expenditure (annual percentage change), 2008-2015 151
Figure 24: Market Access, Price of Healthcare Products, US, Change in Average Price of Prescription Drugs (%), 2008-2015 153
Figure 25: Market Access, US, Structure of Food and Drug Administration, 2016 156
Figure 26: Market Access, US, Outline of the Clinical Development Process for a New Drug, 2016 161
Figure 27: Market Access, US, Outline of the Clinical Development Process for a Generic Drug, 2016 162
Figure 28: Market Access, US, Medical Device Approval Process, 2016 166
Figure 29: Market Access, US, Patent Approval Process, 2016 169
Figure 30: Economic Indicators, US, Gross Domestic Product per Capita ($), 2008-2015 189
Figure 31: Economic Indicators, US, Gross Domestic Product per Capita ($), 2016-2020 190
Figure 32: Economic Indicators, US, Gross Domestic Product Annual Growth (%), 2008-2015 191
Figure 33: Economic Indicators, US, Gross Domestic Product Annual Growth (%), 2016-2020 192
Figure 34: Economic Indicators, US, Gross National Income per Capita ($), 2008-2015 193
Figure 35: Economic Indicators, US, Consumer Price Index, 2008-2015 194
Figure 36: Economic Indicators, US, Consumer Price Index, 2016-2020 195
Figure 37: Economic Indicators, US, Consumer Price Annual Change (%), 2008-2015 196
Figure 38: Economic Indicators, US, Currency Exchange Rate ($/€), 2008-2015 197
Figure 39: Economic Indicators, US, Currency Exchange Rate ($/£), 2008-2015 198
Figure 40: Economic Indicators, US, Currency Exchange Rate ($/Â¥) 2008-2015 199
Figure 41: Economic Indicators, US, Foreign Direct Investment ($bn), 2008-2015 200
Figure 42: Economic Indicators, US, Foreign Exchange Reserves ($bn), 2008-2015 201
Figure 43: Economic Indicators, US, Imports of Goods and Services ($bn), 2008-2015 202
Figure 44: Economic Indicators, US, Exports of Goods and Services ($bn), 2008-2015 203
Figure 45: Economic Indicators, US, Government Structural Balance ($bn), 2008-2015 204
Figure 46: Economic Indicators, US, General Government Net Debt ($tn), 2008-2015 205
Figure 47: Economic Indicators, US, General Government Net Debt ($tn), 2016-2020 206
Figure 48: Economic Indicators, US, Major Industries, GDP ($bn), 2015 207
Figure 49: Demographics, US, Population (million), 2008-2015 208
Figure 50: Demographics, US, Population (million), 2016-2020 209
Figure 51: Demographics, US, Population, Urban-Rural Population Share (%), 2008-2015 210
Figure 52: Demographics, US, Population, Urban-Rural Population Share (%), 2016-2020 211
Figure 53: Demographics, US, Population Distribution by Age Group (%), 2008-2015 212
Figure 54: Demographics, US, Population Distribution by Age Group (%), 2016-2020 213
Figure 55: Demographics, US, Births (per 1,000 population), 2008-2015 214
Figure 56: Demographics, US, Mortality (per 1,000 population), 2008-2015 215
Figure 57: Demographics, US, Number of Deaths (‘000), 2015 216
Figure 58: Demographics, US, Mortality Rate in Children under Five (per 1,000 live births), 2008-2015 218
Figure 59: Demographics, US, Immunization Rate (%), 2008-2015 219
Figure 60: Demographics, US, Major Causes of Mortality in Males (Deaths ‘000), 2015 220
Figure 61: Demographics, US, Major Causes of Mortality in Females (Deaths ‘000), 2015 221
Figure 62: Demographics, US, Gender Ratio (M/F), 2008-2015 223
Figure 63: Demographics, US, Life Expectancy at Birth (years), 2008-2015 224
Figure 64: Demographics, US, Gross Enrollment by Level of Education (%), 2008-2015 225
Figure 65: Demographics, US, Unemployment Rate (%), 2008-2015 226
Figure 66: Demographics, US, Disability-Adjusted Life Years by Major Disease (millions), 2012 227
Figure 67: Healthcare Infrastructure, US, Hospitals, 2008-2015 229
Figure 68: Healthcare Infrastructure, US, Public and Private Hospitals, 2008-2015 230
Figure 69: Healthcare Infrastructure, US, Diagnostic Units (per million population), 2008-2015 231
Figure 70: Healthcare Infrastructure, US, Hospital Beds (per 1,000 population), 2008-2015 232
Figure 71: Healthcare Infrastructure, US, Doctors (per 1,000 population), 2008-2015 233
Figure 72: Healthcare Infrastructure, US, PM2.5 (µg/m3), 2008-2015 234
Figure 73: Healthcare Infrastructure, US, CO2 Emissions (metric tons per capita), 2008-2015 235
Figure 74: Healthcare Infrastructure, US, Nurses (per 1,000 population), 2008-2015 236
Figure 75: Healthcare Infrastructure, US, Dentists (per 1,000 population), 2008-2015 237
Figure 76: Healthcare Infrastructure, US, Pharmacists (per 1,000 population), 2008-2015 238
Figure 77: Healthcare Expenditure, US, Healthcare Expenditure (% of GDP), 2008-2015 239
Figure 78: Public Healthcare Expenditure, US, Share of Major Components (%), 2015 240
Figure 79: Healthcare Expenditure, US, Public-Private Share of Healthcare Expenditure (%), 2008-2015 241
Figure 80: Healthcare Expenditure, US, RandD expenditure ($bn), 2008-2015 242
Figure 81: Healthcare Market, US, Opportunities and Challenges, 2016 249

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