United States of America (USA) – Healthcare, Regulatory and Reimbursement Landscape

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GlobalData, the industry analysis specialist, has released its latest report, “United States of America (USA) – Healthcare, Regulatory and Reimbursement Landscape”. The report is an essential source of information on analysis of the healthcare, regulatory and reimbursement landscape in 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 US pharmaceutical market is the largest by value in the world. It grew from $305B in 2011 at a Compound Annual Growth Rate (CAGR) of 2.7% to $377B in 2019. It is forecast to reach about $441B in 2025. The growth is due to the rising elderly population, increased access to healthcare services, high disease burden, and launch of innovative drugs. However, introduction of drug cost controls and increased focus on generic drugs pose barriers to the pharmaceutical industry. The economic impact of the COVID-19 pandemic is also expected to affect consumers’ purchasing power. The US medical devices market was estimated to be $142B in 2015, which increased at a CAGR of 4.8% to reach $170B in 2019. The market is expected to grow at a CAGR of 4.8% from $179B in 2020 to reach $226B in 2025.


The report provides information on the healthcare, regulatory, and reimbursement landscape in 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: Abbvie, Amgen, Gilead, Johnson & Johnson, and Pfizer.

Profiles and SWOT analyses of the major players in the medical device market: Abbott, Alcon, GE Healthcare, Fresenius, and Roche Diagnostics

An insightful review of the COVID-19 epidemiology, COVID-19 impact and developments in healthcare market, HealthTech landscape, 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 healthcare policy highlights, 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 US healthcare market

Drive revenues by understanding the key trends, reimbursement and regulatory policies, pharmaceutical market segments and companies likely to impact 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

1. Table of Contents

1.1List of Figures

1.2 List of Tables

2. Executive Summary

2.1 Executive Summary

2.2 Key Highlights – Facts about the US Healthcare Market

2.3 Key Highlights: Healthcare Startups in US

2.4 Key Events: US Healthcare Timeline, 2014–2020

2.5 Key Events: US Pharmaceutical Market

2.6 Key Events: M&As, VC & PE Deals, Global Pharmaceutical Market, 2019–2020

2.7 Key Events: Mergers and Acquisitions

2.8 Country Profile, US, 2020

3. Overview of Pharmaceutical Market

3.1 Pharmaceutical Market – Overview

3.2 Pharmaceutical Market – Novel Drug Approvals

3.3 Pharmaceutical Market – Exports

3.4 Pharmaceutical Market – Imports

3.5 Pharmaceutical Market – Supply Channels, US

3.6 Pharmaceutical Market – Market Segments

3.7 Major Therapeutic Areas, US

3.8 COVID-19 Epidemiology, US

3.9 COVID-19 Impact and Developments, US

3.10 COVID-19 Clinical Trials Landscape, US

3.11 Pharmaceutical Market – Major Players

4. Overview of Medical Devices Market

4.1 Medical Device Market – Overview

4.2 Medical Devices Market – Major Players

5. Pharmaceutical and Medical Devices Market – Drivers and Barriers

5.1 Drivers

5.2 Barriers

6. Deal Analysis

6.1 Deal Analysis: Pharmaceutical Market, US, 2020–2021

6.2 Deal Analysis: Medical Device Market, US, 2020–2021

7. HealthTech Landscape

7.1 HealthTech Landscape, US

7.2 Adoption of Technology in Healthcare, US

7.3 HealthTech Deals Landscape, US

7.4 Key HealthTech Deals, US

7.5 Digital Health Regulations, US

7.6 HealthTech Landscape: Benefits and Risks, US

8. Market Access

8.1 Overview of Healthcare System, US

8.2 Overview of Insurance Providers, US

8.3 Overview of the Affordable Care Act and American Health Care Act, US

8.4 Impact of 2020 Presidential Elections on Healthcare System, US

8.5 Drug Reimbursement Process, US

8.6 Out-of-Pocket Spending, US

8.7 Prescription Drug Price Trend, US

8.8 Pricing Policies, US

8.6 Regulatory Landscape, US

8.6.1 Overview of Regulatory Agencies, US

8.6.2 Market Authorization for Investigational New Drug, US

8.6.3 Market Authorization for New Drug, US

8.6.4 Market Authorization for Abbreviated New Drug Application, US

8.6.5 Marketing Authorization for Biosimilars, US

8.6.6 Marketing Authorization for Over-the-Counter Drugs, US

8.6.7 Marketing Authorization for Medical Devices, US

8.6.8 Import Regulations, US

8.6.9 Intellectual Property Rights, Patent, US

8.6.10 Intellectual Property Rights, Trademark, US

8.6.11 Clinical Trial Regulation Process, US

8.6.12 Pharmaceutical Clinical Trials Landscape, US

8.6.13 Medical Devices Clinical Trials Landscape, US

8.6.10 Pharmacy License Regulations, US

8.6.11 Pharmaceutical Advertisement Regulations, US

8.6.12 Labeling and Packaging Regulations, US

9. Country Healthcare Landscape

9.1 Healthcare Policy Highlights, US

9.2 Healthcare Facilities, US

9.3 Healthcare Parameters, US

9.4 Life Expectancy and Immunization Rate, US

9.5 Environmental Health, US

9.6 Healthcare Personnel, US

9.7 Disease Burden, US

9.8 Healthcare Expenditure, US

9.9 Healthcare Spending Components and Pharmaceutical Spending, US

10 Trade Associations, US

11 Trade Fairs, US

12 Opportunities and Challenges

13 Appendix

13.1 Research Methodology

13.1.1 Coverage

13.1.2 Secondary Research

13.1.3 Forecasts

13.2 Bibliography

13.3 About GlobalData

13.4 Contact Us

13.5 Disclaimer

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