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

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    Report

  • 200 Pages
  • March 2021
  • Region: United States
  • GlobalData
  • ID: 2559940
Summary

The publisher, 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 the publisher’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
1.1 List 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 the Publisher
13.4 Contact
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