CountryFocus: Healthcare, Regulatory and Reimbursement Landscape - US
October 2018
169
About the Report
About the Report
CountryFocus: Healthcare, Regulatory and Reimbursement Landscape-US
Summary
GlobalData, the industry analysis specialist, has released its latest report, "CountryFocus: Healthcare, Regulatory and Reimbursement Landscape-US". The report is an essential source of information and analysis on the healthcare, regulatory and reimbursement landscape in the US. It identifies the key trends in the healthcare market and provides insights into the demographic, regulatory, reimbursement landscape and healthcare infrastructure of the US. Most importantly, the report provides valuable insights into the trends and segmentation of the pharmaceutical and medical device markets. It is built using data and information sourced from proprietary databases, secondary research, and in-house analysis by GlobalData's team of industry experts.
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, Amgen, Merck, and Abbvie) and profiles and SWOT analyses of the major players in the medical device market (Abbott, GE Healthcare, DePuy, Zimmer and Edwards)
- Detailed analysis about recent completed deals in the pharmaceutical and medical device market of the US
- Porter's five forces analysis for pharmaceutical and medical devices market of the US
- An insightful review of the reimbursement and regulatory landscape, of which analysis includes details of the healthcare reimbursement process, the regulatory agencies and the approval processes for new drugs and medical devices
- Information regarding recent healthcare policies along with 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 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 most opportunities for consolidation, investment, and strategic partnership
- Identify, understand, and capitalize on the opportunities and challenges in the US healthcare market.
Products
Products
US, Pharmaceutical Market, Medical Devices, Drivers and Barriers, Major Players, Regulatory landscape, Reimbursement landscape, Deals, Porter Five Forces,Opportunities and Challenges
Table of Contents
Table of Contents
Table of Contents
Executive Summary
Overview of Pharmaceutical Market
Overview of Medical Device Market
Deals Analysis
Porter's Five Forces Model
Market Access
Country Healthcare Landscape
Opportunities and Challenges
Appendix
List of Figure
List of Figures
Figure 1: Pharmaceutical Market, US, Revenue, 2015-2022 8
Figure 2: Medical Device Market, US, Revenue, 2015-2020 8
Figure 3: Number of Deals (2017-2018) 12
Figure 4: 2017-2018 Deal Overview By Region 12
Figure 5: Country Profile, US, 2018 14
Figure 6: Pharmaceutical Market, US, Revenue, 2010-2017 16
Figure 7: Pharmaceutical Market, US, Revenue Forecast, 2018-2022 16
Figure 8: Pharmaceutical Market, US, Pharmaceutical Exports 17
Figure 9: Pharmaceutical Market, US, Top Export Partners 17
Figure 10: Pharmaceutical Market, US, Pharmaceutical Imports 18
Figure 11: Pharmaceutical Market, US, Top Import Partners 18
Figure 12: Pharmaceutical Market, US, Supply Channels 21
Figure 13: Pharmaceutical Market, US, Drug Supply Chain Security Act: Implementation Timeline, 2013-2023 22
Figure 14: Pharmaceutical industry: Supply Chain Vulnerability, US 22
Figure 15: Pharmaceutical Market, US, Major Drugs Going Off-Patent, US, 2018-2022 24
Figure 16: Pharmaceutical Market, US, Generic Full Drug Approvals, US, 2013-2018* 25
Figure 17: Pharmaceutical Market, US, Key Generic Drug Approvals (Jan 18-Aug 18), 2018 26
Figure 18: Pharmaceutical Market, US, Top Selling Biologics Drugs, Sales, 2017 27
Figure 19: Pharmaceutical Market, US, Patent Expirations of Major Biologics, US, 2013-2028 28
Figure 20: Pharmaceutical Market, US Sales (Current and Forecast), Biologics Drugs Going Off-Patent, 2019-2021 29
Figure 21: Pharmaceutical Market, US, Number of Biosimilars Drug Approvals by EMA and USFDA, 2012-2018 30
Figure 22: Pharmaceutical Market, US, Key Events: Biosimilars Breakthroughs and Drug Approvals by EMA and FDA, 2001-2018 30
Figure 23: Pharmaceutical Market, US, Number of Biologics and Biosimilars Drug Approvals, USA, 2012-2018 (June 18) 31
Figure 24: Pharmaceutical Market, US, Biosimilars Approvals, 2017-2018 32
Figure 25: Pharmaceutical Market, Sales of OTC Products Based on Therapeutic Areas by Value and Volume (USD million), US, 2016 33
Figure 26: Pharmaceutical Market, US, Sales of Patented Drug Products by Major Therapeutic Class, 2015 34
Figure 27: Pharmaceutical Market, US, Major Players 36
Figure 28: Medical Device Market, US, Revenue, 2015-2020 53
Figure 29: Medical Device Market, US, Revenue Forecast, 2021-2025 53
Figure 30: Medical Device Market, US, Revenue by Segment, 2017 54
Figure 31: Orthopedic Devices Market, US, Revenue 55
Figure 32: Orthopedic Devices Market, US, Market Share of Major Players 55
Figure 33: Cardiovascular Devices Market, US, Revenue 56
Figure 34: Cardiovascular Devices Market, US, Market Share of Major Players 56
Figure 35: In Vitro Diagnostics Devices Market, US, Revenue 57
Figure 36: In Vitro Diagnostics Devices Market, US, Market Share of Major Players 57
Figure 37: Healthcare IT Market, US, Revenue 58
Figure 38: Healthcare IT Market, US, Market Share of Major Players 58
Figure 39: Ophthalmic Devices Market, US, Revenue 59
Figure 40: Ophthalmic Devices Market, US, Market Share of Major Players 59
Figure 41: Diagnostic Market, US, Revenue (USD bn), 2010-2017 60
Figure 42: Diagnostic Market, US, Revenue Forecast (USD bn), 2018-2022 60
Figure 43: Medical Device Market, US, Revenue of Major Players, 2016 60
Figure 44: Deal Value and Deal Count, Pharmaceutical Market, US, 2017-2018 82
Figure 45: Deal Value and Deal Count Quarterly, Pharmaceutical Market, US, 2017-2018 82
Figure 46: Deal Value and Deal Count Sub-types, Pharmaceutical Market, US, 2017-2018 82
Figure 47: Top Five Therapy Area by Deal Value, Pharmaceutical Market, US, 2017-2018 83
Figure 48: Top Five Therapy Area by Deal number, Pharmaceutical Market, US, 2017-2018 83
Figure 49: M&A Deals by Therapy Area, Pharmaceutical Market, US, 2017-2018 83
Figure 50: Venture Financing Deals by Therapy Area, Pharmaceutical Market, US, 2017-2018 83
Figure 51: Private Equity Deals by Therapy Area, Pharmaceutical Market, US, 2017-2018 83
Figure 52: Medical Device Market Deals, US, 2017-2018 (by deal value, USD m) 84
Figure 53: Medical Device Market Deals, US, 2017- 2018 (by deal count) 84
Figure 54: Medical Device Market Deals Share (by deal count), US, 2017-2018 84
Figure 55: Medical Device Market Deals Share (by deal value), US, 2017-2018 84
Figure 56: Medical Device, Top Therapy Area by Deal Value, US, 2017-2018 85
Figure 57: Medical Device, Top Therapy Area by Deal Number, US, 2017-2018 85
Figure 58: M&A Deals by Therapy Area, Medical Device, US, 2017-2018 (by value and by number) 85
Figure 59: Venture Financing Deals by Therapy Area, Medical Device, US, 2017-2018 (by value and by number) 85
Figure 60: Private Equity Deals by Therapy Area, Medical Device US, 2017-2018 (by value and by number) 85
Figure 61: Healthcare System, Structure and Flow of Funds, US, 2018 90
Figure 62: Overview of Public and Private Insurance Provider, US, 2018 91
Figure 63: Components of Medicare Plan, Public Insurance, US, 2018 93
Figure 64: Doughnut Hole and Medicare Part D Coverage Gap, US, 2018 94
Figure 65: Premiums and Deductibles, Medicare, US, 2018 95
Figure 66: Features of Medicare and Medicaid Plan, US, 2018 96
Figure 67: Recent Advancements in Healthcare, DVA, US, 2016-2018 98
Figure 68: Overview of Private Insurance Plans, US, 2018 101
Figure 69: Various Types of Managed Care Plans, US, 2018 102
Figure 70: Major Components of National Health Expenditure (%), US, 2016 103
Figure 71: Overview of Affordable Care Act and American Health Care Act, US 105
Figure 72: Uninsured Rate, US, 2013-2018 106
Figure 73: OOP Expenditure (% of Total Expenditure on Health), US, 2010-2017 107
Figure 74: OOP Expenditure (OOP Expenditure per Capita), US, 2010-2017 107
Figure 75: Annual Rate of Change (%), Average Price of Prescription Drugs, US, 2010-2017 108
Figure 76: Pricing List at Different supply Chain Levels, US, 2018 109
Figure 77: FDA, Organizational Structure, US, 2018 111
Figure 78: Outline of the Clinical Development Process for a New Drug, US, 2017 112
Figure 79: Outline of Clinical Development Process for Generic Drug, US 117
Figure 80: Outline of Biological Products Licensure Process, US, 2018 119
Figure 81: Medical Device Approval Process, US, 2016 121
Figure 82: Patent Approval Process, US, 2018 125
Figure 83: Trademark Approval Process, US, 2018 126
Figure 84: Number of Hospitals, US, 2010-2017 133
Figure 85: Number of Ambulatory Surgery Centers (ASCs), US, 2010-2017 133
Figure 86: CT Scanners and MRI Units (per million population), US, 2010-2017 134
Figure 87: Mammography Units (per million population), US, 2010-2017 134
Figure 88: Hospital Beds (per 1,000 population), US 135
Figure 89: Acute Care Hospital Beds (per 1,000 population), US 135
Figure 90: Psychiatric Hospital Beds (per 1,000 population), US 135
Figure 91: Life Expectancy, 2010-2017, US 136
Figure 92: Elderly population (% of total population), 2010-2017, US 136
Figure 93: Immunization Rate (%), DPT, 2010-2017, US 137
Figure 94: Immunization Rate (%), Measles, 2010-2017, US 137
Figure 95: PM2.5 (?g per m3), US, 2010-2016 138
Figure 96: CO2 Emissions (million tons), US, 2010-2016 138
Figure 97: Physicians (per 1,000 population), US, 2010-2016 139
Figure 98: Nurses (per 1,000 population), US, 2010-2016 139
Figure 99: Dentists (per 1,000 population), US, 2010-2016 139
Figure 100: Pharmacists (per 1,000 population), US, 2010-2016 139
Figure 101: Major Causes of Mortality (per 1,000 population), US, 2015 140
Figure 102: Major Causes of Male Mortality, US, 2015 140
Figure 103: Major Causes of Female Mortality, US, 2015 140
Figure 104: Disability-Adjusted Life Years by Major Disease (�000), US, 2016 140
Figure 105: Healthcare Expenditure as Percentage of GDP (%), US, 2010-2017 141
Figure 106: Public-Private Share (%), US, 2010-2017 141
Figure 107: Major Components of Healthcare Spending (%), US, 2016 142
Figure 108: Opportunities and Challenges, US 146
List of Table
List of Tables
Table 1: Average Gross Margin (%) on Various Drug Categories for Each Sector, Weighted by US Sales, 2015 21
Table 2: Pharmaceutical Market, Major Drugs Going Off-Patent, US Sales, 2017 24
Table 3: Pharmaceutical Market, Key Biologics Approval, US, 2018 (Jan 18-Aug 18) 27
Table 4: Pharmaceutical Market, US, Sales of Patented Drug Products by Major Therapeutic Class (USD bn), 2015 34
Table 5: Medical Device Market, US, Revenue by Segment 54
Table 6: Orthopedic Devices Market, US, Revenue and Market Share of Major Players 55
Table 7: Cardiovascular Devices Market, US, Revenue and Market Share of Major Players 56
Table 8: In Vitro Diagnostics Devices Market, US, Revenue and Market Share of Major Players 57
Table 9: Healthcare IT Market, US, Revenue and Market Share of Major Players 58
Table 10: Ophthalmic Devices Market, US, Revenue and Market Share of Major Players 59
Table11: Overview of Public Insurance Providers, Federal Poverty Plans, US, 2018 99
Table 12: Overview of Public Insurance Providers, Metal Plans, US, 2018 100
Table 13: Overview of Public Insurance Providers, Value of Metal Plans, US, 2018 100
Table 14: Market Authorization for Biopharmaceutical Products, Biosimilar User Fee Act (BsUFA) Fees, 2018-2019, US 120
Table 15: Market Authorization for Medical Devices, Medical Device User Fee Amendments (MDUFA) Fees, 2018-2019, US 122
Table 16: Patent Fees, 2018, US 124
Table 17: Trade Associations, US 143
Table 18: Trade Fairs, US 144
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