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

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.

Scope

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

List of Tables

Table 1: Requirements by Supply Partner, US, 2020

Table 2: Top Generic Drugs by Savings, US, 2019

Table 3: Generic Drug Fee Rates, US, 2020–2021

Table 4: Major Biologics License Approvals, US, 2020

Table 5: Biosimilar Price at Launch vs. Reference Product, US, 2020

Table 6: COVID-19 Indicators (Number of cases), US and Global, 2020–2021

Table 7: COVID-19-Related Travel Restrictions, US, 2020–2021

Table 8: Medical Devices Market, US, Major Segments ($B), 2020

Table 9: Orthopedic Devices Market, US, Revenue ($B) and Market Share (%) of Major Companies, 2019

Table 10: General Surgery Devices Market, US, Revenue ($B) and Market Share (%) of Major Companies, 2019

Table 11: Cardiovascular Devices Market, US, Revenue ($B) and Market Share (%) of Major Companies, 2019

Table 12: Healthcare IT Market, US, Revenue ($B) and Market Share (%) of Major Companies, 2017

Table 13: Wound Care Management Market, US, Revenue ($B) and Market Share (%) of Major Companies, 2019

Table 14: Medicare Part A Deductible and Coinsurance Amounts by Cost Sharing, US, 2020—2021

Table 15: Medicare Part B Deductible and Coinsurance Amounts by Cost Sharing, US, 2021

Table 16: Urgent Care Copay Rates, US, 2021

Table 17: Poverty Guidelines, US, 2020

Table 18: Metal Plans, US, 2020

Table 19: Metal Plans, US, 2020

Table 20: NDA Approval vs. OTC Monograph, US, 2020

Table 21: Medical Device User Fee Amendments (MDUFA) Fees, US, 2020–2021

Table 22: Patent Fees, US, 2020

Table 23: Trademark Fees, US, 2020

Table 24: Label of a Pharmaceutical Product, US, 2020

Table 25: Label of a Radiopharmaceutical Product, US, 2020

Table 26: Labeling of Small Packages, US, 2020

Table 27: Labeling and Packaging Leaflet, US, 2020

Table 28: Conferences and Trade Fairs, US, 2021

List of Figures

Figure 1: Pharmaceutical Market, US, Revenue ($B), 2011–2019

Figure 2: Medical Devices Market, US, Revenue ($B), 2015–2020

Figure 3: Healthcare Start-ups in the US, 2020

Figure 4: Country Profile, US, 2020

Figure 5: Pharmaceutical Market, US, Revenue ($B), 2011–2019

Figure 6: Pharmaceutical Market, US, Revenue Forecast ($B), 2020–2025

Figure 7: Novel Drug Approvals (Number), US, 2011–2021

Figure 8: Pharmaceutical Exports ($B), US, 2010–2019

Figure 9: Top Export Partners, US, 2019

Figure 10: Pharmaceutical Imports ($B), US, 2010–2019

Figure 11: Top Import Partners, US, 2019

Figure 12: Pharmaceutical Supply Channel Breakdown, US, 2019

Figure 13: Pharmaceutical Supply Channel Flow of Funds and Drugs, US, 2019

Figure 14: Annual Savings from Generic Drugs ($B), US, 2010–2019

Figure 15: Savings by Patient Condition ($B), US, 2019

Figure 16: Major Generic Drug Launches, US, 2020

Figure 17: Generic Drug Approvals, US, 2016–2020

Figure 18: Number of Biosimilars Approved, US, 2015–2020

Figure 19: Major Biosimilars Approval and Launch Dates, US, 2015–2020

Figure 20: OTC Medicines Market, Major Categories ($B), US, 2019

Figure 21: OTC Medicines Market, Revenue ($B), US, 2013–2020

Figure 22: OTC Medicines Market, Major Distribution Channels ($B), US, 2017

Figure 23: Total Expenditure by Therapeutic Class ($B), US, 2018

Figure 24: Major Therapeutic Areas by Household Consumption (million units), US, 2016–2018

Figure 25: COVID-19 (Number of cases), US, 2020–2021

Figure 26: COVID-19 (Number of deaths), US, 2020–2021

Figure 27: COVID-19 Fiscal Stimulus Timeline, US, 2020–2021

Figure 28: Goals of the Biden-Harris Plan to Beat COVID-19, US, 2021

Figure 29: COVID-19 Vaccine Distribution Process, US, 2020–2021

Figure 30: COVID-19 Vaccine Administration, Number of People, US, 2020–2021

Figure 31: Total Vaccine Administration by Type, US, 2020–2021

Figure 32: Top COVID-19 Healthcare IT Products by Application (Number of available marketed products), US, 2020–2021

Figure 33: Top COVID-19 Healthcare IT Products by Type (Number of available marketed products), US, 2020–2021

Figure 34: Top COVID-19 In Vitro Diagnostic (IVD) Products by Type (Number of available marketed products), US, 2020–2021

Figure 35: Top COVID-19 IVD Products by Manufacturer (Number of available marketed products), US, 2020–2021

Figure 36: Top COVID-19 IVD Products by Application (Number of available marketed products), US, 2020–2021

Figure 37: Top COVID-19 IVD Products by Device Class (Number of available marketed products), US, 2020–2021

Figure 38: COVID-19 Clinical Trials Count by Phase, US, 2020–2021

Figure 39: COVID-19 Clinical Trials Count by Trial Status, US, 2020–2021

Figure 40: Top Five COVID-19 Clinical Trials Sponsors by Count, US, 2020–2021

Figure 41: Pharmaceutical Market, Major Players, 2020

Figure 42: Medical Devices Market, US, Revenue ($B), 2015–2020

Figure 43: Medical Devices Market, US, Revenue Forecast ($B), 2021–2025

Figure 44: Medical Devices Market, Major Segments (%), US, 2020

Figure 45: Orthopedic Devices Market, US, Revenue ($B), 2017–2025

Figure 46: Orthopedic Devices Market, US, Market Share of Major Players (%), 2019

Figure 47: General Surgery Devices Market, US, Revenue ($B), 2017–2025

Figure 48: General Surgery Devices Market, US, Market Share of Major Players (%), 2019

Figure 49: Cardiovascular Devices Market, US, Revenue ($B), 2017–2025

Figure 50: Cardiovascular Devices Market, US, Market Share of Major Players (%), 2019

Figure 51: Healthcare IT Market, US, Revenue ($B), 2017–2025

Figure 52: Healthcare IT Market, US, Market Share of Major Players (%), 2017

Figure 53: Wound Care Management Market, US, Revenue ($B), 2017–2025

Figure 54: Wound Care Management Market, US, Market Share of Major Players (%), 2019

Figure 55: Diagnostic Market, US, Revenue ($B), 2015–2020

Figure 56: Diagnostic Market, US, Revenue ($B), 2021–2025

Figure 57: Medical Devices Market, US, Revenue ($B) of Major Companies, 2019

Figure 58: Deal Value and Deal Count, Pharmaceutical Market, US, 2020–2021

Figure 59: Deal Value and Deal Count, Quarterly, Pharmaceutical Market, US, 2020–2021

Figure 60: Deal Value and Deal Count Sub-types, Pharmaceutical Market, US, 2020–2021

Figure 61: Top Therapy Areas by Deal Value ($B), Pharmaceutical Market, US, 2020–2021

Figure 62: Top Therapy Areas by Deal Count, Pharmaceutical Market, US, 2020–2021

Figure 63: M&A Deals by Quarter, Pharmaceutical Market, US, 2020–2021 (by value and by number)

Figure 64: VC Deals by Quarter, Pharmaceutical Market, US, 2020–2021 (by value and by number)

Figure 65: Deal Value and Deal Count, Medical Devices Market, US, 2020–2021

Figure 66: Deal Value and Deal Count, Quarterly, Medical Devices Market, US, 2020–2021

Figure 67: Deal Value and Deal Count Sub-types, Medical Devices Market, US, 2020–2021

Figure 68: Top Equipment Areas by Deal Value ($B), Medical Devices Market, US, 2020–2021

Figure 69: Top Equipment Areas by Deal Count, Medical Devices Market, US, 2020–2021

Figure 70: M&A Deals by Quarter, Medical Devices Market, US, 2020–2021 (by value and by number)

Figure 71: VC Deals by Quarter, Medical Devices Market, US, 2020–2021 (by value and by number)

Figure 72: HHS Information Technology (IT) Strategic Plan, US, 2017–2020

Figure 73: Federal Health IT Strategic Plan Objectives, US, 2020–2025

Figure 74: Deal Value ($B), HealthTech, US, 2019–2020

Figure 75: Deal Count (Number of deals), HealthTech, US, 2019–2020

Figure 76: Proposed Key Components of a Future Pre-Cert Program, US, 2020

Figure 77: Primary Actions, Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) Action Plan, US, 2021

Figure 78: Overview of Healthcare System, US, 2020

Figure 79: Types of Health Insurance, US, 2020

Figure 80: Medicare Plan Types, US, 2020

Figure 81: Medicare Part D Donut Hole, US, 2020

Figure 82: Part D Percentage Coverage, US, 2015–2020

Figure 83: Features of Medicare and Medicaid, US, 2020

Figure 84: CHIP Timeline, US, 1997–2017

Figure 85: VA Priority Groups, US, 2020

Figure 86: Private Health Insurance Contribution (%), US, 2019

Figure 87: Managed Care Plans, US, 2020

Figure 88: Health Insurance Coverage by Type (% of total population), US, 2019

Figure 89: Out-of-Pocket Spending ($ per capita), US, 2012–2019

Figure 90: Out-of-Pocket Expenditure by Consumption, US, 2018

Figure 91: Prescription Drug Consumer Price Index (CPI) (% change), US, 2010–2020

Figure 92: Pricing at Different Supply Chain Levels, US, 2018

Figure 93: Price Transparency Initiative Timeline, US, 2021–2024

Figure 94: CMS Actions to Promote Price Transparency, US, 2021

Figure 95: FDA, Organization Chart, 2020

Figure 96: Investigational New Drug Application Procedure, US, 2020

Figure 97: New Drug Application Procedure, US, 2020

Figure 98: Abbreviated New Drug Application Procedure, US, 2020

Figure 99: Totality of Evidence Biosimilars, US, 2020

Figure 100: Medical Device Approval Process, US, 2020

Figure 101: Patent Approval Process, US, 2020

Figure 102: Trademark Approval Process, US, 2020

Figure 103: Clinical Trial Approval Process, US, 2020

Figure 104: Pharmaceutical Clinical Trials Count by Trial Status, US, 2019–2021

Figure 105: Pharmaceutical Clinical Trials Count by Phase, US, 2019–2021

Figure 106: Pharmaceutical Clinical Trials Count by Indication, US, 2019–2021

Figure 107: Top Five Pharmaceutical Clinical Trials Sponsors by Count, US, 2019–2021

Figure 108: Medical Devices Clinical Trials Count by Trial Status, US, 2019–2021

Figure 109: Medical Devices Clinical Trials Count by Device Category, US, 2019–2021

Figure 110: Medical Devices Clinical Trials Count by Indication, US, 2019–2021

Figure 111: Top Five Medical Devices Clinical Trials Sponsors by Count, US, 2019–2021

Figure 112: Development of Healthy People 2030, US, 2020

Figure 113: Social Determinants of Health – Healthy People 2030, US, 2020

Figure 114: Opioid Crisis Timeline, US, 1995–2020

Figure 115: Opioid Crisis Five-Point Strategy, US, 2017

Figure 116: Number of Hospitals, US, 2010–2018

Figure 117: Number of Diagnostic Equipment Units (per million population), US, 2012–2019

Figure 118: Number of Hospital Beds (per 1,000 population), US, 2011–2018

Figure 119: Number of Acute Care Beds (per 1,000 population), US, 2011–2018

Figure 120: Number of Psychiatric Care Beds (per 1,000 population), US, 2011–2018

Figure 121: Life Expectancy at Birth (years), US, 2010–2018

Figure 122: Immunization Rate (% of children immunized), US, 2010–2017

Figure 123: PM2.5 (µg per m3), US, 2010–2019

Figure 124: CO2 Emissions (Mt CO2), US, 2010–2019

Figure 125: Physicians (per 1,000 population), US, 2010–2018

Figure 126: Nurses (per 1,000 population), US, 2010–2018

Figure 127: Dentists (per 1,000 population), US, 2010–2019

Figure 128: Pharmacists (per 1,000 population), US, 2010–2018

Figure 129: Major Causes of Mortality (number of deaths per 100,000 population), US, 2019

Figure 130: Major Causes of Male Mortality (number of deaths per 100,000 population) US, 2019

Figure 131: Major Causes of Female Mortality (number of deaths per 100,000 population) US, 2019

Figure 132: Disability-Adjusted Life Years by Major Disease (DALYS per 100,000 population), US, 2019

Figure 133: Healthcare Expenditure as Percentage of GDP (%), US, 2010–2019

Figure 134: Healthcare Spending (government vs. private), US, 2010–2019

Figure 135: Healthcare Expenditure Components by Function (% of total health expenditure), US, 2018

Figure 136: Pharmaceutical Spending ($ per capita), US, 2010–2018

Figure 137: Opportunities and Challenges

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