CountryFocus: Healthcare, Regulatory and Reimbursement Landscape - US

  • ID: 2559940
  • Report
  • Region: United States
  • 267 pages
  • GlobalData
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Despite Uncertainty Surrounding Future Healthcare Policy, the US Pharmaceutical Market Will Approach $500 Billion by 2020
CountryFocus: Healthcare, Regulatory and Reimbursement Landscape - US

Summary

The author, who is an industry analysis specialist, has released their 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 a 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
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1.1 List of Tables

1.2 List of Figures

2 Introduction

2.1 Report Guidance

3 Overview of the Pharmaceutical and Medical Device Markets

3.1 Pharmaceutical Market

3.1.1 Market Overview

3.1.2 Pharmaceutical Exports and Imports

3.1.3 Supply Channels

3.1.4 Market Segments

3.1.5 Major Disease Areas

3.1.6 Major Companies

3.2 Medical Device Market

3.2.1 Overview of the Top Five Segments

3.2.2 Diagnostic Market

3.2.3 Major Players

3.3 Market Drivers and Barriers

3.3.1 Drivers

3.3.2 Barriers

4 Market Access

4.1 Reimbursement and Payer Landscape

4.1.1 Overview of Healthcare System

4.1.2 Reimbursement Process

4.1.3 Overview of Insurance Providers

4.1.4 Patient Share in Healthcare Spending

4.1.5 Price Trends in the Healthcare Sector

4.1.6 Pricing Policies

4.2 Regulatory Landscape

4.2.1 Overview of Regulatory Agencies

4.2.2 New Drug Approval Process

4.2.3 Approval Process of Biological Products as Biosimilar or Interchangeable

4.2.4 New Medical Device Approval Process

4.2.5 Intellectual Property Rights

4.2.6 Clinical Trial Regulations

4.2.7 Pharmaceutical Advertising Regulations

4.2.8 Pharmacy Regulations

4.2.9 Labeling and Packaging Regulations

5 Country Analysis

5.1 Political Environment

5.1.1 Political Structure

5.1.2 Analysis of the Current Political Environment

5.1.3 Healthcare Policy Initiatives

5.2 Economic Landscape

5.3 Economic Indicators

5.3.1 Gross Domestic Product

5.3.2 Gross National Income

5.3.3 Inflation

5.3.4 Currency Exchange Rate

5.3.5 Foreign Direct Investment

5.3.6 Foreign Exchange Reserves

5.3.7 Trade Balance

5.3.8 General Government Structural Balance

5.3.9 General Government Net Debt

5.3.10 Major Industries

5.4 Demographics

5.4.1 Population

5.4.2 Education and Literacy

5.4.3 Employment

5.4.4 Disease Burden

5.5 Healthcare Infrastructure

5.5.1 Healthcare Facilities

5.5.2 Healthcare Parameters

5.5.3 Environmental Health

5.5.4 Healthcare Personnel

5.6 Healthcare Expenditure

5.6.1 Overview

5.6.2 Major Components of Healthcare Spending

5.6.3 Public and Private Sector Share

5.6.4 Spending in Healthcare R&D

5.7 Trade Associations

5.7.1 Pharmaceutical Research and Manufacturers of America

5.7.2 Consumer Healthcare Products Association

5.7.3 International Pharmaceutical Excipients Council

5.7.4 Advanced Medical Technology Association

5.7.5 National Association for Home Care & Hospices

5.7.6 Biotech Innovation Organization

5.7.7 The Society of Chemical Manufacturers and Affiliates

5.8 Trade Fairs

6 Opportunities and Challenges

6.1 Opportunities

6.2 Challenges

7 Appendix

7.1 Abbreviations

7.2 Bibliography

7.3 Research Methodology

7.3.1 Coverage

7.3.2 Secondary Research

7.3.3 Forecasts

7.3.4 Expert Panel

7.4 Disclaimer

1.1 List of Tables

Table 1: Pharmaceutical Market, US, Revenue ($bn), 2008-2015

Table 2: Pharmaceutical Market, US, Revenue ($bn), 2016-2020

Table 3: Pharmaceutical Market, US, Exports and Imports ($bn), 2008-2015

Table 4: Pharmaceutical Market, Biologics Approvals, US, 2014-2016

Table 5: Pharmaceutical market, Approved biosimilars, US, 2016

Table 6: Pharmaceutical Market, US, Top Five Therapeutic Areas, 2014

Table 7: Pharmaceutical Market, Johnson & Johnson, Major Products, 2016

Table 8: Pharmaceutical Market, Johnson & Johnson, Global, Late-Stage Pipeline, 2016

Table 9: Pharmaceutical Market, Pfizer, Late-Stage Pipeline, 2016

Table 10: Pharmaceutical Market, Merck & Co., Global, Major Products, 2015

Table 11: Pharmaceutical Market, Merck & Co., Global, Late-Stage Pipeline, 2016

Table 12: Medical Device Market, Gilead Sciences, Major Products, 2016

Table 13: Pharmaceutical Market, Gilead Sciences, Global, Late-Stage Pipeline, 2016

Table 14: Pharmaceutical Market, Amgen, Global, Late-Stage Pipeline, 2016

Table 15: Medical Device Market, US, Revenue ($bn), 2008-2015

Table 16: Medical Device Market, US, Revenue ($bn), 2016-2020

Table 17: Medical Device Market, US, Revenue and Market Share by Segment, 2015

Table 18: Orthopedic Devices Market, US, Revenue ($bn), 2008-2015

Table 19: Orthopedic Devices Market, US, Revenue and Market Share by Company, 2015

Table 20: IVD Market, US, Revenue ($bn), 2008-2015

Table 21: IVD Market, US, Revenue and Market Share by Company, 2014

Table 22: Cardiovascular Device Market, US, Revenue ($bn), 2008-2015

Table 23: Cardiovascular Device Market, US, Revenue and Market Share by Segment, 2015

Table 24: Ophthalmic Device Market, US, Revenue ($bn), 2008-2015

Table 25: Ophthalmic Device Market, US, Revenue and Market Share by Company, 2015

Table 26: Healthcare IT Market, US, Revenue ($bn), 2008-2015

Table 27: Healthcare IT Market, US, Revenue and Market Share by Company, 2015

Table 28: Medical Device Market, US Diagnostic Market, Revenue ($bn), 2008-2015

Table 29: Medical Device Market, US, Diagnostic Market, Revenue ($bn), 2016-2020

Table 30: Medical Device Market, GE Healthcare, Global, Major Products, 2015

Table 31: Medical Device Market, Medtronic, Global, Major Products, 2015

Table 32: Medical Device Market, Siemens Healthineers, Global, Major Products, 2015

Table 33: Medical Device Market, Philips Healthcare, Global, Major Products, 2015

Table 34: Total Medicare Income, US, Expenditure and Trust Fund Assets ($bn), 2008-2025

Table 35: Market Access, US, Poverty Guidelines, 2016

Table 36: Market Access, US, Value of Metal Plans, 2016

Table 37: Market Access, US, Metal Plans , 2016

Table 38: Market Access, US, Coverage by Type of Health Insurance (%), 2015

Table 39: Market Access, US, Out-of-Pocket Expenditure (annual percentage change), 2008-2015

Table 40: Market Access, Price of Healthcare Products, US, Change in Average Price of Prescription Drugs (%), 2008-2015

Table 41: Regulatory Landscape, US, Patent Fees ($), 2016

Table 42: Regulatory Landscape, US, Trademark Fees ($), 2016

Table 43: Economic Indicators, US, Gross Domestic Product per Capita ($), 2008-2015

Table 44: Economic Indicators, US, Gross Domestic Product per Capita ($), 2016-2020

Table 45: Economic Indicators, US, Gross Domestic Product Annual Growth (%), 2008-2015

Table 46: Economic Indicators, US, Gross Domestic Product Annual Growth (%), 2016-2020

Table 47: Economic Indicators, US, Gross National Income per Capita ($), 2008-2015

Table 48: Economic Indicators, US, Consumer Price Index, 2008-2015

Table 49: Economic Indicators, US, Consumer Price Index, 2016-2020

Table 50: Economic Indicators, US, Consumer Price Annual Change (%), 2008-2015

Table 51: Economic Indicators, US Currency Exchange Rate ($/€), 2008-2015

Table 52: Economic Indicators, US Currency Exchange Rate ($/£), 2008-2015

Table 53: Economic Indicators, US Currency Exchange Rate ($/¥) 2008-2015

Table 54: Economic Indicators, US, Foreign Direct Investment ($bn), 2008-2015

Table 55: Economic Indicators, US, Foreign Exchange Reserves ($bn), 2008-2015

Table 56: Economic Indicators, US, Imports of Goods and Services ($bn), 2008-2015

Table 57: Economic Indicators, US, Exports of Goods and Services ($bn), 2008-2015

Table 58: Economic Indicators, US, Government Structural Balance ($bn), 2008-2015

Table 59: Economic Indicators, US, General Government Net Debt ($tn), 2008-2015

Table 60: Economic Indicators, US, General Government Net Debt ($tn), 2016-2020

Table 61: Economic Indicators, US, Major Industries, GDP ($bn), 2015

Table 62: Demographics, US, Population (million), 2008-2015

Table 63: Demographics, US, Population (million), 2016-2020

Table 64: Demographics, US, Population, Urban-Rural Population Share (%), 2008-2015

Table 65: Demographics, US, Population, Urban-Rural Population Share (%), 2016-2020

Table 66: Demographics, US, Population Distribution by Age Group (%), 2008-2015

Table 67: Demographics, US, Population Distribution by Age Group Forecast (%), 2016-2020

Table 68: Demographics, US, Births (per 1,000 population), 2008-2015

Table 69: Demographics, US, Mortality (per 1,000 population), 2008-2015

Table 70: Demographics, US, Number of Deaths (‘000), 2015

Table 71: Demographics, US, Mortality Rate in Children under Five (per 1,000 live births), 2008-2015

Table 72: Demographics, US, Immunization Rate (%), 2008-2015

Table 73: Demographics, US, Major Causes of Mortality in Males (Deaths ‘000), 2015

Table 74: Demographics, US, Major Causes of Mortality in Females (Deaths ‘000), 2015

Table 75: Demographics, US, Gender Ratio (M/F), 2008-2015

Table 76: Demographics, US, Life Expectancy at Birth (years), 2008-2015

Table 77: Demographics, US, Gross Enrollment by Level of Education (%), 2008-2015

Table 78: Demographics, US, Unemployment Rate (%), 2008-2015

Table 79: Demographics, US, Disability-Adjusted Life Years by Major Disease (millions), 2012

Table 80: Healthcare Infrastructure, US, Hospitals, 2008-2015

Table 81: Healthcare Infrastructure, US, Public and Private Hospitals, 2008-2015

Table 82: Healthcare Infrastructure, US, Diagnostic Units (per million population), 2008-2015

Table 83: Healthcare Infrastructure, US, Hospital Beds (per 1,000 population), 2008-2015

Table 84: Healthcare Infrastructure, US, Doctors (per 1,000 population), 2008-2015

Table 85: Healthcare Infrastructure, US, PM2.5 (µg/m3), 2008-2015

Table 86: Healthcare Infrastructure, US, CO2 Emissions (metric tons per capita), 2008-2015

Table 87: Healthcare Infrastructure, US, Nurses (per 1,000 population), 2008-2015

Table 88: Healthcare Infrastructure, US, Dentists (per 1,000 population), 2008-2015

Table 89: Healthcare Infrastructure, US, Pharmacists (per 1,000 population), 2008-2015

Table 90: Healthcare Expenditure, US, Healthcare Expenditure (% of GDP), 2008-2015

Table 91: Public Healthcare Expenditure, US, Share of Major Components (%), 2015

Table 92: Healthcare Expenditure, US, Healthcare Expenditure, Public-Private Share (%), 2008-2015

Table 93: Healthcare Expenditure, US, R&D expenditure ($bn), 2008-2015

Table 94: Healthcare Expenditure, US, Major Healthcare Trade Fairs, 2017

1.2 List of Figures

Figure 1: Pharmaceutical Market, US, Revenue ($bn), 2008-2015

Figure 2: Pharmaceutical Market, US, Revenue ($bn), 2016-2020

Figure 3: Pharmaceutical Market, US, Exports and Imports ($bn), 2008-2015

Figure 4: Pharmaceutical Market, US, Supply Channels, 2016

Figure 5: Pharmaceutical Market, US, Top Five Therapeutic Areas ($bn), 2014

Figure 6: Medical Device Market, US, Revenue ($bn), 2008-2015

Figure 7: Medical Device Market, US, Revenue ($bn), 2016-2020

Figure 8: Medical Device Market, US, Revenue by Segment ($bn), 2015

Figure 9: Orthopedic Devices Market, US, Revenue ($bn), 2008-2015

Figure 10: Orthopedic Devices Market, US, Market Share by Company (%), 2015

Figure 11: IVD Market, US, Revenue ($bn), 2008-2015

Figure 12: IVD Market, US, Market Share by Company (%), 2014

Figure 13: Cardiovascular Device Market, US, Revenue ($bn), 2008-2015

Figure 14: Cardiovascular Device Market, US, Revenue and Market Share by Segment, 2015

Figure 15: Ophthalmic Device Market, US, Revenue ($bn), 2008-2015

Figure 16: Ophthalmic Device Market, US, Market Share by Company (%), 2012

Figure 17: Healthcare IT Market, US, Revenue ($bn), 2008-2015

Figure 18: Healthcare IT Market, US, Market Share by Company (%), 2015

Figure 19: Medical Device Market, US, Diagnostic Market, Revenue ($bn), 2008-2015

Figure 20: Medical Device Market, US, Diagnostic Market, Revenue ($bn), 2016-2020

Figure 21: Healthcare Market, US, Drivers and Barriers, 2016

Figure 22: Healthcare System, Flow of Funds, US, 2016

Figure 23: Market Access, US, Out-of-Pocket Expenditure (annual percentage change), 2008-2015

Figure 24: Market Access, Price of Healthcare Products, US, Change in Average Price of Prescription Drugs (%), 2008-2015

Figure 25: Market Access, US, Structure of Food and Drug Administration, 2016

Figure 26: Market Access, US, Outline of the Clinical Development Process for a New Drug, 2016

Figure 27: Market Access, US, Outline of the Clinical Development Process for a Generic Drug, 2016

Figure 28: Market Access, US, Medical Device Approval Process, 2016

Figure 29: Market Access, US, Patent Approval Process, 2016

Figure 30: Economic Indicators, US, Gross Domestic Product per Capita ($), 2008-2015

Figure 31: Economic Indicators, US, Gross Domestic Product per Capita ($), 2016-2020

Figure 32: Economic Indicators, US, Gross Domestic Product Annual Growth (%), 2008-2015

Figure 33: Economic Indicators, US, Gross Domestic Product Annual Growth (%), 2016-2020

Figure 34: Economic Indicators, US, Gross National Income per Capita ($), 2008-2015

Figure 35: Economic Indicators, US, Consumer Price Index, 2008-2015

Figure 36: Economic Indicators, US, Consumer Price Index, 2016-2020

Figure 37: Economic Indicators, US, Consumer Price Annual Change (%), 2008-2015

Figure 38: Economic Indicators, US, Currency Exchange Rate ($/€), 2008-2015

Figure 39: Economic Indicators, US, Currency Exchange Rate ($/£), 2008-2015

Figure 40: Economic Indicators, US, Currency Exchange Rate ($/¥) 2008-2015

Figure 41: Economic Indicators, US, Foreign Direct Investment ($bn), 2008-2015

Figure 42: Economic Indicators, US, Foreign Exchange Reserves ($bn), 2008-2015

Figure 43: Economic Indicators, US, Imports of Goods and Services ($bn), 2008-2015

Figure 44: Economic Indicators, US, Exports of Goods and Services ($bn), 2008-2015

Figure 45: Economic Indicators, US, Government Structural Balance ($bn), 2008-2015

Figure 46: Economic Indicators, US, General Government Net Debt ($tn), 2008-2015

Figure 47: Economic Indicators, US, General Government Net Debt ($tn), 2016-2020

Figure 48: Economic Indicators, US, Major Industries, GDP ($bn), 2015

Figure 49: Demographics, US, Population (million), 2008-2015

Figure 50: Demographics, US, Population (million), 2016-2020

Figure 51: Demographics, US, Population, Urban-Rural Population Share (%), 2008-2015

Figure 52: Demographics, US, Population, Urban-Rural Population Share (%), 2016-2020

Figure 53: Demographics, US, Population Distribution by Age Group (%), 2008-2015

Figure 54: Demographics, US, Population Distribution by Age Group (%), 2016-2020

Figure 55: Demographics, US, Births (per 1,000 population), 2008-2015

Figure 56: Demographics, US, Mortality (per 1,000 population), 2008-2015

Figure 57: Demographics, US, Number of Deaths (‘000), 2015

Figure 58: Demographics, US, Mortality Rate in Children under Five (per 1,000 live births), 2008-2015

Figure 59: Demographics, US, Immunization Rate (%), 2008-2015

Figure 60: Demographics, US, Major Causes of Mortality in Males (Deaths ‘000), 2015

Figure 61: Demographics, US, Major Causes of Mortality in Females (Deaths ‘000), 2015

Figure 62: Demographics, US, Gender Ratio (M/F), 2008-2015

Figure 63: Demographics, US, Life Expectancy at Birth (years), 2008-2015

Figure 64: Demographics, US, Gross Enrollment by Level of Education (%), 2008-2015

Figure 65: Demographics, US, Unemployment Rate (%), 2008-2015

Figure 66: Demographics, US, Disability-Adjusted Life Years by Major Disease (millions), 2012

Figure 67: Healthcare Infrastructure, US, Hospitals, 2008-2015

Figure 68: Healthcare Infrastructure, US, Public and Private Hospitals, 2008-2015

Figure 69: Healthcare Infrastructure, US, Diagnostic Units (per million population), 2008-2015

Figure 70: Healthcare Infrastructure, US, Hospital Beds (per 1,000 population), 2008-2015

Figure 71: Healthcare Infrastructure, US, Doctors (per 1,000 population), 2008-2015

Figure 72: Healthcare Infrastructure, US, PM2.5 (µg/m3), 2008-2015

Figure 73: Healthcare Infrastructure, US, CO2 Emissions (metric tons per capita), 2008-2015

Figure 74: Healthcare Infrastructure, US, Nurses (per 1,000 population), 2008-2015

Figure 75: Healthcare Infrastructure, US, Dentists (per 1,000 population), 2008-2015

Figure 76: Healthcare Infrastructure, US, Pharmacists (per 1,000 population), 2008-2015

Figure 77: Healthcare Expenditure, US, Healthcare Expenditure (% of GDP), 2008-2015

Figure 78: Public Healthcare Expenditure, US, Share of Major Components (%), 2015

Figure 79: Healthcare Expenditure, US, Public-Private Share of Healthcare Expenditure (%), 2008-2015

Figure 80: Healthcare Expenditure, US, R&D expenditure ($bn), 2008-2015

Figure 81: Healthcare Market, US, Opportunities and Challenges, 2016
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