CountryFocus: Healthcare, Regulatory and Reimbursement Landscape – UK

GlobalData, the industry analysis specialist, has released its latest report, “CountryFocus: Healthcare, Regulatory and Reimbursement Landscape – UK”. The report is an essential source of information and analysis on the healthcare, regulatory and reimbursement landscape in the UK. It identifies the key trends in the healthcare market and provides insights into the demographic, regulatory, reimbursement landscape and healthcare infrastructure of the UK. 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.

The value of the UK pharmaceutical market increased from £13.2bn ($20.3bn) in 2010 to £19.6bn ($25.9bn) in 2017, at a compound annual growth rate (CAGR) of 5.9% in the terms of GBP and 3.5% in the terms of US$. The market is expected to reach £26.2bn ($30.9bn) in 2022. The increased usage of personalized medicines, incorporating digital technology into drug development and accelerating drug access pathway, high disease burden and rise in elderly population are the main driving factors of pharmaceutical market. In 2015, the medical device market in the UK was worth $17.8 billion, which increased to $19.1 billion in 2017 at a CAGR of 3.6%. It is expected to grow at a CAGR of 4.1% from $19.8 billion in 2018 to $26.3 billion in 2025. The main segments were in vitro diagnostics, ophthalmic devices, cardiovascular devices, wound care devices and orthopedic devices. The development in personalized or precision medicines, incorporation of genetic sequencing and personal genome data, is revolutionizing the approach medical practitioners and pharmaceutical industries are undertaking for the disease treatment.

Scope

The report provides information on the healthcare, regulatory, and reimbursement landscape in the UK, 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 (AstraZeneca, GlaxoSmithKline, Merck, Novartis and Pfizer) and profiles and SWOT analyses of the major players in the medical device market (Siemens, Roche, DePuy, Essilor and Smith & Nephew)

• Detailed analysis about recent completed deals in the pharmaceutical and medical device market of the UK

• Porter’s five forces analysis for pharmaceutical and medical devices market of the UK

• 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 UK 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 UK 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 UK healthcare market

Table of Contents

1 Table of Contents

1.1 List of Figures

1.2 List of Tables

2 Executive Summary

2.1 Executive Summary – Overview

2.2 Key Highlights

2.3 Key Events: UK Pharmaceutical Market

2.4 Key Events: UK Pharmaceutical History, 2012–2019

2.5 Brexit, UK

2.5 Key Events: M&A, VF & PE Deals, Global Pharmaceutical Market, 2017–2018

2.6 Key Events: Mergers and Acquisitions

2.7 Country Profile, UK, 2018

3 Overview of Pharmaceutical Market

3.1 Pharmaceutical Market – Overview

3.2 Pharmaceutical Market – Exports

3.3 Pharmaceutical Market – Imports

3.5 Pharmaceutical Market – Supply Channels

3.6 Pharmaceutical Market – Market Segments

3.7 Pharmaceutical Market – Top Five Disease Areas

3.8 Pharmaceutical Market – Major Players

4 Overview of Medical Devices Market

4.1 Medical Device Market – Overview

4.2 Medical Device Market – Top Five Segments

4.3 Medical Device Market – Diagnostic Market

4.4 Medical Device Market – Major Players

5 Pharmaceutical and Medical Device Market – Drivers and Barriers

5.1 Drivers

5.2 Barriers

6 Deal analysis

6.1 Deal Analysis: M&A, VF and PE Deals, Pharmaceutical Market, UK

6.2 Deal Analysis: M&A, VF and PE Deals, Medical Device Market, UK

7 Pharmaceutical and Medical Device Market – Porter’s Five Forces Analysis

7.1 Pharmaceutical Market, UK – Porter’s Five Forces Analysis

7.2 Medical Device Market, UK – Porter’s Five Forces Analysis

8 Market Access

8.1 Overview of Healthcare System, UK

8.1.1 Key Responsibilities of DHSC (For the year 2018-2019), UK

8.1.2 NHS England, UK

8.1.3 Financing in the NHS, UK

8.1.4 National Institute for Health and Care Excellence (NICE), Clinical Commissioning Groups, UK

8.1.5 NHS Wales, NHS Northern Ireland and NHS Scotland, UK

8.2 Reimbursement Process, UK

8.2.1 Overview of Insurance Providers, UK

8.2.2 Healthcare Spending and Price Trends in the Healthcare Sector, UK

8.2.3 Pricing Policies, UK

8.3 Regulatory Landscape, UK

8.3.1 Market Authorization for Pharmaceutical Products, UK

8.3.2 Market Authorization for Pharmaceutical Products, National Procedure, UK

8.3.3 Market Authorization for Biosimilars, National Procedure, UK

8.3.4 Market Authorization for Pharmaceutical Products, Centralized Procedure, UK

8.3.5 Market Authorization for Pharmaceutical Products, Decentralized Procedure, UK

8.3.6 Market Authorization for Pharmaceutical Products, Mutual Recognition Procedure, UK

8.3.7 Market Authorization for Medical Devices, UK

8.3.8 Licensing Process for Pharmaceutical Manufacturing, UK

8.3.9 Licensing Process for Pharmaceutical Exports and Imports, UK

8.3.10 Intellectual Property Rights, Patent, UK

8.3.11 Intellectual Property Rights, European Patent, UK

8.3.12 Intellectual Property Rights, Unitary Patent, UK

8.3.13 Intellectual Property Rights, Trademark, UK

8.3.14 Clinical Trial Regulation Process, UK

8.3.15 Pharmaceutical Advertising Regulations, UK

8.3.16 Pharmacy Regulation, UK

8.3.17 Labeling and Packaging Regulations, UK

8.3.18 Implications of Brexit, UK

9 Country Healthcare Landscape

9.1 Healthcare Policy Highlights

9.2 Healthcare Facilities

9.3 Healthcare Parameters

9.4 Environmental Health

9.5 Healthcare Personnel

9.6 Disease Burden

9.7 Healthcare Expenditure

9.7.1 Healthcare Expenditure – Overview

9.7.2 Share of Public and Private Sectors

9.7.3 Major Components of Healthcare Expenditure

10 Trade Associations

11 Trade Fairs, UK

12 Opportunities and Challenges

13 Appendix

13.1 Research Methodology

13.1.1 Coverage

13.1.2 Secondary Research

13.1.3 Forecasts

13.1.4 Expert Panel

13.2 Bibliography

13.3 Contact Us

13.4 Disclaimer

List of Tables

Table 1: Pharmaceutical Market, UK, Sales of Patented Drug Products by Major Therapeutic Class ($bn), 2016

Table 2: Medical Device Market, UK, Revenue by Segment ($bn), 2017

Table 3: InVitro Diagnostics Devices Market, UK, Revenue and Market Share of Major Players

Table 4: Ophthalmic Devices Market, UK, Revenue and Market Share of Major Players

Table 5: Cardiovascular Devices Market, UK, Revenue and Market Share of Major Players

Table 6: Wound Care Devices Market, UK, Revenue and Market Share of Major Players

Table 7: Orthopedic Devices Market, UK, Revenue and Market Share of Major Players

Table 8: Market Access, Forecasts and Profile Of Annual Payment Percentages, UK, 2014–2018

Table 9: Patent Fees ($), 2018, UK

Table 10: Trademark Fees ($), 2018, UK

Table11: Clinical Trials Application Fees ($), 2018, UK

Table 12: Clinical Trials Application Fees ($) for Medical Devices, 2018, UK

Table 13: Trade Associations, UK

Table 14: Trade Fairs, UK

List of Figures

Figure 1: Pharmaceutical Market, UK, Revenue, 2015–2022

Figure 2: Medical Device Market, UK, Revenue, 2015–2020

Figure 3: UK Brexit Timeline, UK, 2018

Figure 4: Number of Deals (2017–2018)

Figure 5: 2017–2018 Deal Overview By Region

Figure 6: Country Profile, UK, 2018

Figure 7: Pharmaceutical Market, UK, Revenue, 2010–2017

Figure 8: Pharmaceutical Market, UK, Revenue Forecast, 2018–2022

Figure 9: Pharmaceutical Market, UK, Pharmaceutical Exports

Figure 10: Pharmaceutical Market, UK, Top Export Partners

Figure 11: Pharmaceutical Market, UK, Pharmaceutical Imports

Figure 12: Pharmaceutical Market, UK, Top Import Partners

Figure 13: Pharmaceutical Market, UK, Supply Channels

Figure 14: Pharmaceutical Market, UK, Sales of OTC drugs by Major Therapeutic Segments, 2018

Figure 15: Pharmaceutical Market, UK, Sales of Patented Drug Products by Major Therapeutic Class, 2016

Figure 16: Pharmaceutical Market, UK, Sales of Patented Drug Products by Major Therapeutic Class ($bn), 2016

Figure 17: Pharmaceutical Market, UK, Major Players

Figure 18: Medical Device Market, UK, Revenue, 2015–2020

Figure 19: Medical Device Market, UK, Revenue Forecast, 2021–2025

Figure 20: Medical Device Market, UK, Revenue by Segment, 2017

Figure 21: InVitro Diagnostics Devices Market, UK, Revenue

Figure 22: InVitro Diagnostics Devices Market, UK, Market Share of Major Players

Figure 23: Ophthalmic Devices Market, UK, Revenue

Figure 24: Ophthalmic Devices Market, UK, Market Share of Major Players

Figure 25: Cardiovascular Devices Market, UK, Revenue

Figure 26: Cardiovascular Devices Market, UK, Market Share of Major Players

Figure 27: Wound Care Devices Market, UK, Revenue

Figure 28: Wound Care Devices Market, UK, Market Share of Major Players

Figure 29: Orthopedic Devices Market, UK, Revenue

Figure 30: Orthopedic Devices Market, UK, Market Share of Major Players

Figure 31: Diagnostic Market, UK, Revenue ($bn), 2015–2020

Figure 32: Diagnostic Market, UK, Revenue Forecast ($bn), 2021–2025

Figure 33: Medical Device Market, UK, Revenue of Major Players, 2016

Figure 34: Deal Value and Deal Count, Pharmaceutical Market,UK, 2017–2018

Figure 35: Deal Value and Deal Count Quarterly, Pharmaceutical Market,UK, 2017–2018

Figure 36: Deal Value and Deal Count Sub-types, Pharmaceutical Market,UK, 2017–2018

Figure 37: Top Five Therapy Area by Deal Value, Pharmaceutical Market,UK, 2017–2018

Figure 38: Top Five Therapy Area by Deal Number, Pharmaceutical Market, UK, 2017–2018

Figure 39: M&A Deals by Therapy Area, Pharmaceutical Market, UK, 2017–2018

Figure 40: Venture Financing Deals by Therapy Area, Pharmaceutical Market, UK, 2017–2018

Figure 41: Private Equity Deals by Therapy Area, Pharmaceutical Market, UK, 2017–2018

Figure 42: Medical Device Market Deals, UK, 2017–2018 (by Deal Value, $m)

Figure 43: Medical Device Market Deals, UK, 2017– 2018 (by Deal Count)

Figure 44: Medical Device Market Deals Share (by Deal Count), UK, 2017–2018

Figure 45: Medical Device Market Deals Share (by Deal Value), UK, 2017–2018

Figure 46: Medical Device, Top Therapy Area by Deal Value, UK, 2017–2018

Figure 47: Medical Device, Top Therapy Area by Deal Number, UK, 2017–2018

Figure 48: M&A Deals by Therapy Area, Medical Device, UK, 2017–2018 (by Value and by Number)

Figure 49: Venture Financing Deals by Therapy Area, Medical Device, UK, 2017–2018 (by Value and by Number)

Figure 50: Private Equity Deals by Therapy Area, Medical Device, UK, 2017–2018 (by Value and by Number)

Figure 51: Healthcare Market, UK, Overview of Health System, 2018

Figure 52: Overview of Finance Flow, UK, 2018

Figure 53: NHS Departmental Expenditure Limit ($bn), UK, 2015–2021

Figure 54: Market Access, Reimbursement Schemes, UK, 2016

Figure 55: OOP Expenditure (% of Total Expenditure on Health), UK, 2010–2017

Figure 56: Annual Average Rates of Price Change (%), Medicines Price Index, UK, 2010–2017

Figure 57: Market Access, MHRA Structure, UK, 2018

Figure 58: Centralized Procedure, UK, 2018

Figure 59: Centralized Procedure, EU, 2018

Figure 60: Decentralized Procedure, EU, 2018

Figure 61: Mutual Recognition Procedure, UK, 2018

Figure 62: Life Cycle of Medical Device, UK, 2018

Figure 63: Conformity Assessment of Class I Medical Devices, EU, 2018

Figure 64: Conformity Assessment of Class IIa Medical Devices, EU, 2018

Figure 65: Conformity Assessment of Class IIb Medical Devices, EU, 2018

Figure 66: Conformity Assessment of Class III Medical Devices, EU, 2018

Figure 67: Licensing Procedure for Pharmaceutical Manufacturing, UK, 2018

Figure 68: Patent Approval Process, UK, 2018

Figure 69: European Patent Approval Process, EU, 2017

Figure 70: Unitary Patent Approval Process, EU, 2017

Figure 71: Trademark Approval Process, UK, 2018

Figure 72: Clinical Trial Authorization (CTA) Application Flowchart, 2017, UK

Figure 73: Market Access, UK, Clinical Trial Regulation Process for Medical Devices, 2018

Figure 74: Market Access, Regulatory Changes in the UK Before and After Brexit, 2018

Figure 75: Number of Hospitals, UK, 2010–2017

Figure 76: Diagnostic Equipment (per Million Population), UK, 2010–2017

Figure 77: Hospital Beds (per 1,000 Population), UK

Figure 78: Psychiatric Hospital Beds (per 1,000 Population), UK

Figure 79: Life Expectancy, 2010–2017, UK

Figure 80: Immunization Rate (%), 2010–2017, UK

Figure 81: PM2.5 (µg per m3), UK, 2010–2017

Figure 82: CO2 Emissions (Million Tons), UK, 2010–2017

Figure 83: Physicians (per 1,000 Population), UK, 2010–2016

Figure 84: Nurses (per 1,000 Population), UK, 2010–2016

Figure 85: Dentists (per 1,000 Population), UK, 2010–2016

Figure 86: Pharmacists (per 1,000 Population), UK, 2010–2016

Figure 87: Major Causes of Mortality (per 1,000 Population), UK, 2016

Figure 88: Major Causes of Male Mortality, UK, 2016

Figure 89: Major Causes of Female Mortality, UK, 2016

Figure 90: Disability-Adjusted Life Years by Major Disease (‘000), UK, 2016

Figure 91: Healthcare Expenditure as Percentage of GDP (%), UK, 2010–2017

Figure 92: Public–Private Share (%), UK, 2010–2017

Figure 93: Major Components of Healthcare Spending (%), UK, 2016

Figure 94: Opportunities and Challenges, UK

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