Table of Contents
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.
-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.
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