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  5. > Western European Companion Diagnostics Market

Western European Companion Diagnostics Market

  • May 2014
  • -
  • Frost & Sullivan
  • -
  • 164 pages

Regulatory Hurdles and LDTs Stall the Global and European Market for Companion Diagnostics

The research service aims to give a global outlook of the companion diagnostic market landscape, with a specific focus on Western European countries. The segments related to oncology discussed in this study include breast cancer, lung cancer, colorectal cancer and other cancers, and non-oncology related infectious disease, CNS, and cardiovascular. The forecasts are based on test volumes for these cancers and disease types. Effective analysis of the reimbursement pathway in Germany, the United Kingdom, France, Italy, Spain, Scandinavia, and Benelux, coupled with regulatory approval in Europe, is discussed. A comparative assessment of regulatory scenarios has been performed to assess easy-target markets.

Key Findings

-The molecular diagnostics sector and tissue diagnostics sector form the basis of the companion diagnostics market. Most partnerships are triggered by growth and innovation in these sectors. The companion diagnostics market is valued at $ million and is expected to reach $ billion in 2018. The market is expected to grow at a compound annual growth rate (CAGR) of % from 2013 to 2018.
-Approximately % of the market is focused on oncology-based testing products, while % of the market is focused on non-oncology areas. By 2016 and 2017, Frost and Sullivan expects that the non-oncology sector will gradually experience an increase because many companies such as QIAGEN and Roche have a strong pipeline for infectious diseases and central nervous system (CNS) areas. Many pharmaceutical giants are focusing on developing new treatments for neurodegenerative disorders.
- Within oncology testing, breast cancer, lung cancer, and colorectal cancer represent the major portion of the testing market as more CE IVD companion diagnostic products exist in the European market.
-From 2014 onward, Europe will portray an interesting geography because of the effect of the new revised IVD regulation and clinical trial regulation. Frost & Sullivan anticipates this modification to have both positive and negative effects on companion diagnostics manufacturers.
- The new rule is aligned with the International Medical Device Regulators Forum (IMDRF), formerly known as Global Harmonization Task Force (GHTF), and is expected to address challenges pertaining to laboratory-developed tests (LDT).
- Among the various companion diagnostic products, breast cancer testing has matured, exhibiting an established market space indicated by a moderate growth rate.
- Given the recent approvals for many combination products, lung cancer testing is the most attractive growth market. About % of partnerships worldwide are focused on lung cancer as the therapeutic area, followed by colorectal cancer testing.
- Amidst other types, tests for cancer, melanoma, prostate, and ovarian cancers will experience growth in the upcoming years.

Table Of Contents

Western European Companion Diagnostics Market
1. EXECUTIVE SUMMARY

Executive Summary

Key Findings
Scope and Segmentation
Key Questions This Study Will Answer
Market Engineering Measurements
CEO's Perspective
Key Companies to Watch
Executive Summary—3 Big Predictions

2. MARKET OVERVIEW

Market Overview
Market Background
Market Segmentation
Overall Market Perspective
Defining Healthcare Trends in the Future

3. EUROPEAN REGULATORY OVERVIEW

European Regulatory Overview
Regulatory Overview—Europe
Future IVD Regulation in Europe
Role of EMA
Drug Labels Requiring Biomarker Testing by the EMA
Comparison of FDA and CE Marking
Comparative Analysis of the United States, Europe, and China
Global Regulatory Outlook

4. COMPETITIVE PLAYBOOK

Competitive Playbook
New Market Opportunities
Current Participant Strategies Discussion
Unmet Needs Discussion

5. DRIVERS AND RESTRAINTS—TOTAL COMPANION DIAGNOSTICS MARKET

Drivers and Restraints—Total Companion Diagnostics Market
Market Drivers
Market Restraints
Market Impact of Top Trends

6. FORECASTS AND TRENDS—TOTAL COMPANION DIAGNOSTICS MARKET

Forecasts and Trends—Total Companion Diagnostics Market
Market Engineering Measurements
Snapshot of the European Companion Diagnostics Market
Important Market Characteristics
Forecast Assumptions
Total Companion Diagnostics Market—Revenue Forecast
Total Companion Diagnostics Market—Revenue Forecast by Disease Focus
Revenue Forecast Discussion
PEST Analysis

7. BREAST CANCER TESTING

Breast Cancer Testing
Revenue Forecast for Breast Cancer Testing
Revenue Forecast for Breast Cancer Testing Discussion

8. LUNG CANCER TESTING

Lung Cancer Testing
Revenue Forecast for Lung Cancer Testing
Revenue Forecast for Lung Cancer Testing Discussion

9. COLORECTAL CANCER AND OTHER CANCERS TESTING

Colorectal Cancer and Other Cancers Testing
Revenue Forecast for Colorectal Cancer Testing
Revenue Forecast for Other Cancers Testing
Revenue Forecast for Colorectal Cancer and Other Cancers Testing Discussion

10. INFECTIOUS DISEASE, CNS, AND CARDIOVASCULAR TESTING

Infectious Disease, CNS, and Cardiovascular Testing
Revenue Forecast for Infectious Disease, CNS, and Cardiovascular Testing
Revenue Forecast for Infectious Disease, CNS, and Cardiovascular Testing Discussion
Revenue Forecast Discussion

11. COMPETITIVE ENVIRONMENT

Competitive Environment
Product Analysis
Top Competitors
Market Share by Tier
Merger, Acquisition, and Partnership Assessment
Companion Diagnostic Partners
Therapy Areas for Companion Diagnostic Partnerships
Types of Companion Diagnostic Partnerships
Global Reach of Companion Diagnostic Partnership

12. EUROPEAN REIMBURSEMENT LANDSCAPE

European Reimbursement Landscape
Introduction
Reimbursement Systems Overview
CDx Penetration Across Western Europe

13. GERMANY—REIMBURSEMENT OVERVIEW

Germany—Reimbursement Overview
Germany—Personalized Medicine Overview
Germany—Overview of Reimbursement

14. FRANCE—REIMBURSEMENT OVERVIEW

France—Reimbursement Overview
France—Personalized Medicine Overview
France—Overview of Reimbursement

15. THE UNITED KINGDOM—REIMBURSEMENT OVERVIEW

The United Kingdom—Reimbursement Overview
The United Kingdom—Personalized Medicine Overview
The United Kingdom—Overview of Reimbursement

16. ITALY—REIMBURSEMENT OVERVIEW

Italy—Reimbursement Overview
Italy—Personalized Medicine Overview
Italy—Overview of Reimbursement

17. SPAIN—REIMBURSEMENT OVERVIEW

Spain—Reimbursement Overview
Spain—Personalized Medicine Overview
Spain—Healthcare Payment System
Spain—Pricing and Reimbursement

18. SCANDINAVIA—REIMBURSEMENT OVERVIEW

Scandinavia—Reimbursement Overview
Scandinavia—Personalized Medicine Overview
Scandinavia—Reimbursement Overview

19. BENELUX—REIMBURSEMENT OVERVIEW

Benelux—Reimbursement Overview
Benelux—Personalized Medicine Overview
The Netherlands—Personalized Medicine Overview
The Netherlands—Reimbursement Overview
Belgium—Personalized Medicine Overview
Belgium—Reimbursement Overview

20. THE LAST WORD

The Last Word
The Last Word—3 Big Predictions
The Last Word—Discussion
Legal Disclaimer

21. APPENDIX

Appendix
Europe—Drivers Explained
Europe—Restraints Explained
Decision Support Database
Associated Multimedia
Market Engineering Methodology
Learn More—Next Steps

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