CountryFocus: Healthcare, Regulatory and

Reimbursement Landscape - US
Released On 18th November 2015

Summary
CountryFocus: Healthcare, Regulatory and Reimbursement Landscape - US report is an essential
source of information on and analysis of the healthcare, regulatory and reimbursement landscape in
the US. It identifies 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 devices markets. It uses data and information sourced from proprietary
databases, secondary research, and in-house analysis by GlobalDatas team of industry experts.
The population of the US in 2013 amounted to 316.1 million, having grown at a Compound Annual
Growth Rate (CAGR) of 0.8% from 2008. The countrys increasingly elderly population and
corresponding increase in the incidence of chronic diseases will help to boost the growth of the
pharmaceutical market, which was worth $326.9 billion in 2008, a value that is expected to have
reached $548.4 billion by 2020 at a CAGR of 4.4%. Approximately 86.6% of the US population
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has healthcare coverage, which has helped to create an efficient healthcare system. New initiatives
taken by the Food and Drug Administration (FDA) have strengthened the review and approval
process. The value of the US medical device market was $116.2 billion in 2008, and is expected to
register a CAGR of 5.0% to reach an estimated $209.7 billion in 2020.
These growth trends can be primarily attributed to
- Sedentary lifestyles, leading to a high chronic disease burden
- High public healthcare expenditure by the Centers for Medicare and Medicaid Services (CMS)
- Increased R&D expenditure
- Easily accessible diagnostic technologies
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, including market size,
segmentation, and key drivers and barriers
- Profiles and SWOT analyses of the major players in the pharmaceuticals market: Pfizer, Merck,
Novartis, Sanofi and Abbott; and profiles and SWOT analyses of the major players in the medical
device market: Medtronic, DePuy, Siemens Healthcare, Abbott Laboratories, and Stryker
- 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 JSB Market Research Pvt. Ltd.

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- Develop business strategies by understanding the trends shaping and driving the US healthcare
market
- Drive revenue by understanding the key trends, reimbursement and regulatory policies,
pharmaceutical market segments, and companies likely to affect the US 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 the US healthcare
market

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Table of Contents
1.1 List of Tables 11
1.2 List of Figures 15
2 Introduction 19
2.1 GlobalData Report Guidance 19

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3 Overview of Pharmaceutical and Medical Device Markets 20

3.1 Pharmaceutical Market 20
3.1.1 Market Overview 20
3.1.2 Pharmaceutical Exports and Imports 25
3.1.3 Supply Channels 27
3.1.4 Market Segments 28
3.1.5 Overview of Top Five Disease Areas 32
3.1.6 Major Players 35
3.2 Medical Device Market 75
3.2.1 Market Overview 75
3.2.2 Overview of the Top Five Segments 77
3.2.3 Diagnostic Market 90
3.2.4 Major Players 91
3.3 Market Drivers and Barriers 127
3.3.1 Drivers 127
3.3.2 Barriers 128
4 Market Access 130
4.1 Reimbursement and Payer Landscape 130
4.1.1 Overview of Healthcare system 130
4.1.2 Overview of Insurance Providers 134
4.1.3 Patient Share in Healthcare Spending 144
4.1.4 Prescription Drug Price Trend 145
4.1.5 Pricing Policies 146
4.2 Regulatory Landscape 147
4.2.1 Overview of Regulatory Agencies 147
4.2.2 New Drug Approval Process 149
4.2.3 Approval Process of Biological Products as Biosimilar or Interchangeable 155
4.2.4 New Medical Device Approval Process 157
4.2.5 Licensing Process for Pharmaceutical and Medical Device Manufacturing 158
4.2.6 Licensing Process for Pharmaceutical Exports and Imports 164
4.2.7 Intellectual Property Rights 170
4.2.8 Clinical Trial Regulations 173
4.2.9 Pharmaceutical Advertising Regulations 174
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4.2.10 Pharmacy Regulations 175

4.2.11 Labeling and Packaging Regulations 177
5 Country Analysis 181
5.1 Political Environment 181
5.1.1 Political Structure 181
5.1.2 Analysis of the Current Political Environment 182
5.1.3 Healthcare Policy Initiatives 185
5.2 Economic Landscape 192
5.3 Economic Indicators 197
5.3.1 Gross Domestic Product 197
5.3.2 Gross National Income 201
5.3.3 Inflation 202
5.3.4 Currency Exchange Rate 205
5.3.5 Foreign Direct Investment 208
5.3.6 Foreign Exchange Reserves 210
5.3.7 Trade Balance 211
5.3.8 General Government Structural Balance 215
5.3.9 General Government Net Debt 217
5.3.10 Major Industries 219
5.4 Demographics 221
5.4.1 Population 221
5.4.2 Education and Literacy 238
5.4.3 Employment 239
5.4.4 Disease Burden 241
5.5 Healthcare Infrastructure 242
5.5.1 Hospitals 242
5.5.2 Healthcare Facilities 244
5.5.3 Healthcare Parameters 246
5.5.4 Environmental Health 248
5.5.5 Healthcare Personnel 252
5.6 Healthcare Expenditure 255
5.6.1 Overview 255
5.6.2 Major Components of Healthcare Spending 256
5.6.3 Public and Private Sector Share 258
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5.6.4 Spending in Pharmaceutical Research and Development 259

5.7 Trade Associations 260
5.7.1 Pharmaceutical Research and Manufacturers of America 260
5.7.2 Consumer Healthcare Products Association 260
5.7.3 International Pharmaceutical Excipients Council 260
5.7.4 Advanced Medical Technology Association 261
5.7.5 National Association for Home Care & Hospices 261
5.7.6 Biotech Industry Association 261
5.7.7 The Society of Chemical Manufacturers and Affiliates 262
5.8 Trade Fairs 263
6 Opportunities and Challenges 264
6.1 Opportunities 264
6.2 Challenges 265
7 Appendix 268
7.1 Abbreviations 268
7.2 Bibliography 273
7.3 Research Methodology 289
7.3.1 Secondary Research 289
7.3.2 Primary Research 289
7.3.3 Models 290
7.3.4 Forecasts 291
7.3.5 Expert Panel 291
7.4 Disclaimer 291

List of Tables
Table 1: Pharmaceutical Market*, US, Revenue ($bn), 2008-2013 24
Table 2: Pharmaceutical Market*, US, Revenue Forecast ($bn), 2014-2020 25
Table 3: Pharmaceutical Market, US, Exports and Imports ($bn), 2008-2013 26
Table 4: Drugs Going Off-Patent, Global, 2013-2014 30
Table 5: Pharmaceutical Market, US, Top Five Therapeutic Areas, Overview, 2012 33
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Table 6: Pharmaceutical Market, Pfizer, Global, Major Products, Revenue ($bn) and Annual
Growth (%), 2013 36
Table 7: Pharmaceutical Market, Pfizer, Global, Late-Stage Pipeline, 2014 37
Table 8: Pharmaceutical Market, Merck, Global, Major Products, Revenue ($bn) and Annual
Growth (%), 2013 44
Table 9: Pharmaceutical Market, Merck, Global, Late-Stage Pipeline, 2014 45
Table 10: Pharmaceutical Market, Novartis, Global, Major Products, Revenue ($bn) and Annual
Growth (%), 2013 52
Table 11: Pharmaceutical Market, Novartis, Global, Planned Filings, 2014-2018 53
Table 12: Pharmaceutical Market, Sanofi, Global, Major Products, Revenue ($bn), 2013 62
Table 13: Pharmaceutical Market, Sanofi, Global, Late-stage Pipeline, 2014 63
Table 14: Medical Device Market, US, Revenue ($bn), 2008-2013 76
Table 15: Medical Device Market, US, Revenue Forecast ($bn), 2014-2020 77
Table 16: Medical Device Market, US, Revenue by Segment, 2013 78
Table 17: Medical Device Market, US, Orthopedic Devices Market, Revenue ($bn), 2008-2013 80
Table 18: Medical Device Market, US, Orthopedic Devices Market, Sales Trends for Major
Players, 2012 81
Table 19: Medical Device Market, US, In Vitro Diagnostics Market, Revenue ($bn), 2008-2013 82
Table 20: Medical Device Market, US, In Vitro Diagnostics Market, Sales Trends for Major
Players, 2012 83
Table 21: Medical Device Market, US, Cardiovascular Devices Market, Revenue ($bn), 2008-2013
84
Table 22: Medical Device Market, US, Cardiovascular Devices Market, Sales Trends for Major
Players, 2012 85
Table 23: Medical Device Market, US, Ophthalmic Devices Market, Revenue ($bn), 2008-2013 86
Table 24: Medical Device Market, US, Ophthalmic Devices Market, Sales Trends for Major
Players, 2012 87
Table 25: Medical Device Market, US, Healthcare IT Market ($bn), 2008-2013 88
Table 26: Medical Device Market, US, Healthcare IT Market, Sales Trends for Major Players, 2012
89
Table 27: Medical Device Market, US, Diagnostic Market, Revenue ($bn), 2008-2013 90
Table 28: Medical Device Market, US, Diagnostic Market, Revenue Forecast ($bn), 2014-2020 91
Table 29: Medical Device Market, US, Major Medical Device Companies Revenue, 2012 92
Table 30: Medical Device Market, Medtronic, Global, Major Products, Revenue ($bn), 2013 94
Table 31: Medical Device Market, Abbott, Global, Major Products, 2014 114
Table 32: Medical Device Market, Abbott, Global, Late-Stage Pipeline, 2014 115
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Table 33: Total Medicare Income, US, Expenditure and Trust Fund Assets ($bn), 20082023 138
Table 34: Market Access, US, Poverty Guidelines, 2014 142
Table 35: Market Access, US, Metal Plans, 2014 143
Table 36: Market Access, US, Coverage by Type of Health Insurance (%), 2013 143
Table 37: Healthcare Spending, US, Out-of-Pocket Expenditure (%), 2008-2013 144
Table 38: Market Access, US, Annual Price Change (%), 2008-2013 145
Table 39: Market Access, US, Clinical Trial Phases, 2014 154
Table 40: Economic Landscape, US, American Jobs Act, Cost ($bn), 2011 194
Table 41: Economic Landscape, US, Major Payments ($bn), 2013 196
Table 42: Economic Indicators, US, GDP per Capita ($), 2008-2013 198
Table 43: Economic Indicators, US, GDP per Capita Forecast ($), 2014-2020 199
Table 44: Economic Indicators, US, GDP Annual Growth (%), 2008-2013 200
Table 45: Economic Indicators, US, GDP Annual Growth Forecast (%), 2014-2020 201
Table 46: Economic Indicators, US, Gross National Income per Capita ($bn), 2008-2013 202
Table 47: Economic Indicators, US, Average Consumer Price Index, 2008-2013 203
Table 48: Economic Indicators, US, Average Consumer Price Index Forecast, 2014-2020 204
Table 49: Economic Indicators, US, Average Consumer Price Annual Change (%), 2008-2013 205
Table 50: Economic Indicators, US, Currency Exchange Rate (JPY/$), 2008-2013 206
Table 51: Economic Indicators, US, Currency Exchange Rate (/$), 2008-2013 207
Table 52: Economic Indicators, US, Currency Exchange Rate (/$), 2008-2013 208
Table 53: Economic Indicators, US, Foreign Direct Investment ($bn), 2008-2013 209
Table 54: Economic Indicators, US, Foreign Exchange Reserves ($bn), 2008-2013 210
Table 55: Economic Indicators, US, Trade of Goods ($bn), 2008-2013 211
Table 56: Economic Indicators, US, Trade of Services ($bn), 2008-2013 212
Table 57: Economic Indicators, US, Imports of Goods and Services ($bn), 2008-2013 213
Table 58: Economic Indicators, US, Exports of Goods and Services ($bn), 2008-2013 214
Table 59: Economic Indicators, US, Government Structural Balance ($bn), 2008-2013 216
Table 60: Economic Indicators, US, Government Structural Balance Forecast ($bn), 2014-2020 216
Table 61: Economic Indicators, US, General Government Net Debt ($tr), 2008-2013 218
Table 62: Economic Indicators, US, General Government Net Debt Forecast ($tr), 2014-2020 218
Table 63: Economic Indicators, US, Major Industries, GDP ($tr), 2013 221
Table 64: Demographics, US, Population (million), 2008-2013 222
Table 65: Demographics, US, Population Forecast (million), 2014-2020 223
Table 66: Demographics, US, Population, Urban and Rural Population (%), 2008-2013 224
Table 67: Demographics, US, Population Distribution by Age Group (%), 2008-2013 225
Table 68: Demographics, US, Population Distribution by Age Group Forecast (%), 2014-2020 226
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Table 69: Demographics, US, Births (per 1,000 Population), 2008-2013 227
Table 70: Demographics, US, Mortality (per 1,000 Population), 2008-2013 228
Table 71: Demographics, US, Major Causes of Mortality (000), 2011 230
Table 72: Demographics, US, Children 5 Years, Mortality Rate (per 1,000 Live Births), 20082013 231
Table 73: Demographics, US, Immunization Rate (%), 2008-2013 232
Table 74: Demographics, US, Major Causes of Male Mortality (000), 2011 233
Table 75: Demographics, US, Major Causes of Female Mortality (000), 2011 235
Table 76: Demographics, US, Gender Ratio (M/F), 2008-2013 236
Table 77: Demographics, US, Life Expectancy at Birth (Years), 2008-2013 237
Table 78: Demographics, US, Student Enrollment by Level of Education (%), 2013 239
Table 79: Demographics, US, Unemployment Rate (%), 2008-2013 240
Table 80: Demographics, US, Major Diseases, DALYs (per 100,000 Population), 2004 242
Table 81: Healthcare Infrastructure, US, Hospitals, 2008-2013 243
Table 82: Healthcare Infrastructure, US, Federal and Non-federal Hospitals, 2008-2013 244
Table 83: Healthcare Infrastructure, US, Diagnostic Equipment (per Million Population), 20082013 245
Table 84: Healthcare Infrastructure, US, Hospital Beds (per 1,000 Population), 2008-2013 247
Table 85: Healthcare Infrastructure, US, Doctors (per 1,000 Population), 2008-2013 248
Table 86: Healthcare Infrastructure, US, CO2 Emissions (Million Metric Tons), 2008-2013 249
Table 87: Healthcare Infrastructure, US, N2O Emissions (Million Metric Tons), 2008-2013 250
Table 88: Healthcare Infrastructure, US, PM10 Emissions (g/m3), 2008-2013 251
Table 89: Healthcare Infrastructure, US, Nurses (per 1,000 Population), 2008-2013 252
Table 90: Healthcare Infrastructure, US, Pharmacists (per 1,000 Population), 2008-2013 253
Table 91: Healthcare Infrastructure, US, Dentists (per 1,000 Population), 2008-2013 254
Table 92: Healthcare Expenditure, US, Healthcare Expenditure (% of GDP), 2008-2013 256
Table 93: Healthcare Expenditure, US, Healthcare Expenditure, Share of Major Components (%),
2012 257
Table 94: Healthcare Expenditure, US, Healthcare Expenditure, Public-Private Share (%), 20082013 258
Table 95: Healthcare Expenditure, US, Research and Development Expenditure ($bn), 2008-2013
259
Table 96: Trade Fairs, US, Major Healthcare Trade Fairs, 2015 263

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List of Figures
Figure 1: Pharmaceutical Market*, US, Revenue ($bn), 2008-2013 24
Figure 2: Pharmaceutical Market*, US, Revenue Forecast ($bn), 2014-2020 25
Figure 3: Pharmaceutical Market, US, Exports and Imports ($bn), 2008-2013 26
Figure 4: Pharmaceutical Distribution Channels, US, 2011 28
Figure 5: Pharmaceutical Market, US, Top Five Therapeutic Areas, Pharmaceutical Expenditure
($bn), 2012 32
Figure 6: Medical Device Market, US, Revenue ($bn), 2008-2013 76
Figure 7: Medical Device Market, US, Revenue Forecast ($bn), 2014-2020 77
Figure 8: Medical Device Market, US, Revenue by Segment ($bn), 2013 78
Figure 9: Medical Device Market, US, Orthopedic Devices Market, Revenue ($bn), 2008-2013 80
Figure 10: Medical Device Market, US, Orthopedic Devices Market, Sales Trends for Major
Players, 2008-2012 81
Figure 11: Medical Device Market, US, In Vitro Diagnostics Market, Revenue ($bn), 2008-2013 82
Figure 12: Medical Device Market, US, In Vitro Diagnostics Market, Sales Trends for Major
Players, 2008-2012 83
Figure 13: Medical Device Market, US, Cardiovascular Devices Market, Revenue ($bn), 20082013 84
Figure 14: Medical Device Market, US, Cardiovascular Devices Market, Sales Trends for Major
Players, 2008-2012 85
Figure 15: Medical Device Market, US, Ophthalmic Devices Market, Revenue ($bn), 2008-2013 86
Figure 16: Medical Device Market, US, Ophthalmic Devices Market, Sales Trends for Major
Players, 2008-2012 87
Figure 17: Medical Device Market, US, Healthcare IT Market, Revenue ($bn), 2008-2013 88
Figure 18: Medical Device Market, US, Healthcare IT Market, Sales Trends for Major Players,
2008-2012 89
Figure 19: Medical Device Market, US, Diagnostic Market, Revenue ($bn), 2008-2013 90
Figure 20: Medical Device Market, US, Diagnostic Market, Revenue Forecast ($bn), 2014-2020 91
Figure 21: Medical Device Market, US, Major Medical Device Companies Revenue ($bn), 2012 92
Figure 22: Healthcare Market, US, Drivers and Barriers, 2014 129
Figure 23: Healthcare Spending, US, Out-of-Pocket Expenditure (%), 2008-2013 144
Figure 24: Market Access, US, Annual Price Change (%), 2008-2013 145
Figure 25: Market Access, US, Structure of Food and Drug Administration, 2014 148
Figure 26: Market Access, US, Outline of the Clinical Development Process for a New Drug, 2012
155
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Figure 27: Market Access, US, Medical Device Approval Process, 2014 158
Figure 28: Market Access, US, Registration Fees for Medical Devices, 2013-2017 163
Figure 29: Market Access, US, Patent Approval Process, 2013 172
Figure 30: Economic Indicators, US, GDP per Capita ($), 2008-2013 198
Figure 31: Economic Indicators, US, GDP per Capita Forecast ($), 2014-2020 199
Figure 32: Economic Indicators, US, GDP Annual Growth (%), 2008-2013 200
Figure 33: Economic Indicators, US, GDP Annual Growth Forecast (%), 2014-2020 201
Figure 34: Economic Indicators, US, Gross National Income per Capita ($tr), 2008-2013 202
Figure 35: Economic Indicators, US, Average Consumer Price Index, 2008-2013 203
Figure 36: Economic Indicators, US, Average Consumer Price Index Forecast, 2014-2020 204
Figure 37: Economic Indicators, US, Average Consumer Price Annual Change (%), 2008-2013 205
Figure 38: Economic Indicators, US, Currency Exchange Rate (JPY/$), 2008-2013 206
Figure 39: Economic Indicators, US, Currency Exchange Rate (/$), 2008-2013 207
Figure 40: Economic Indicators, US, Currency Exchange Rate (/$), 2008-2013 208
Figure 41: Economic Indicators, US, Foreign Direct Investment ($bn), 2008-2013 209
Figure 42: Economic Indicators, US, Foreign Exchange Reserves ($bn), 2008-2013 210
Figure 43: Economic Indicators, US, Trade of Goods ($bn), 2008-2013 211
Figure 44: Economic Indicators, US, Trade of Services ($bn), 2008-2013 212
Figure 45: Economic Indicators, US, Imports of Goods and Services ($bn), 2008-2013 213
Figure 46: Economic Indicators, US, Exports of Goods and Services ($bn), 2008-2013 214
Figure 47: Economic Indicators, US, Government Structural Balance ($bn), 2008-2013 215
Figure 48: Economic Indicators, US, Government Structural Balance Forecast ($bn), 2014-2020
216
Figure 49: Economic Indicators, US, General Government Net Debt ($tr), 2008-2013 217
Figure 50: Economic Indicators, US, General Government Net Debt Forecast ($tr), 2014-2020 218
Figure 51: Economic Indicators, US, Major Industries, GDP ($tr), 2014 220
Figure 52: Demographics, US, Population (million), 2008-2013 222
Figure 53: Demographics, US, Population Forecast (million), 2014-2020 223
Figure 54: Demographics, US, Population, Urban and Rural Population (%), 2008-2013 224
Figure 55: Demographics, US, Population Distribution by Age Group (%), 2008-2013 225
Figure 56: Demographics, US, Population Distribution by Age Group Forecast (%), 2014-2020 226
Figure 57: Demographics, US, Births (per 1,000 Population), 2008-2013 227
Figure 58: Demographics, US, Mortality (per 1,000 Population), 2008-2013 228
Figure 59: Demographics, US, Major Causes of Mortality (000), 2011 229
Figure 60: Demographics, US, Children 5 Years, Mortality Rate (per 1,000 Live Births), 20082013 231
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Figure 61: Demographics, US, Immunization Rate (%), 2008-2013 232

Figure 62: Demographics, US, Major Causes of Male Mortality (000), 2011 233
Figure 63: Demographics, US, Major Causes of Female Mortality (000), 2011 234
Figure 64: Demographics, US, Gender Ratio (M/F), 2008-2013 236
Figure 65: Demographics, US, Life Expectancy at Birth (Years), 2008-2013 237
Figure 66: Demographics, US, Student Enrollment by Level of Education (%), 2013 238
Figure 67: Demographics, US, Unemployment Rate (%), 2008-2013 240
Figure 68: Demographics, US, Major Diseases, DALYs (per 100,000 Population), 2004 241
Figure 69: Healthcare Infrastructure, US, Hospitals, 2008-2013 243
Figure 70: Healthcare Infrastructure, US, Federal and Non-federal Hospitals, 2008-2013 244
Figure 71: Healthcare Infrastructure, US, Diagnostic Equipment (per Million Population), 20082013 245
Figure 72: Healthcare Infrastructure, US, Total Hospital Beds (per 1,000 Population), 2008-2013
246
Figure 73: Healthcare Infrastructure, US, Doctors (per 1,000 Population), 2008-2013 247
Figure 74: Healthcare Infrastructure, US, CO2 Emissions (Million Metric Tons), 2008-2013 248
Figure 75: Healthcare Infrastructure, US, N2O Emissions (Million Metric Tons), 2008-2013 249
Figure 76: Healthcare Infrastructure, US, PM10 Emissions (g/m3), 2008-2013 251
Figure 77: Healthcare Infrastructure, US, Nurses (per 1,000 Population), 2008-2013 252
Figure 78: Healthcare Infrastructure, US, Pharmacists (per 1,000 Population), 2008-2013 253
Figure 79: Healthcare Infrastructure, US, Dentists (per 1,000 Population), 2008-2013 254
Figure 80: Healthcare Expenditure, US, Healthcare Expenditure (% of GDP), 2008-2013 255
Figure 81: Healthcare Expenditure, US, Healthcare Expenditure, Major Components (%), 2012 256
Figure 82: Healthcare Expenditure, US, Healthcare Expenditure, Public-Private Share (%), 20082013 258
Figure 83: Healthcare Expenditure, US, Research and Development Expenditure ($bn), 2008-2013
259
Figure 84: Healthcare Market, US, Opportunities and Challenges, 2014 267

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