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Companion Diagnostics Benefit from Fewer Regulatory Barriers in Europe

Published: Thursday, June 26, 2014
Last Updated: Thursday, June 26, 2014
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Future revisions to in-vitro diagnostics laws will offset the launch of new tests, in a market expected to soar to $1,295.1 million in 2018.

With the growth in personalized medicine, there is an increased interest in developing companion diagnostics (CDx) tests or tests that match the right therapy to the patient. In fact, over the past few years, market participants have been entering pharmaceutical and diagnostic partnerships in a bid to develop and commercialize CDx tests for drugs that already exist in the market.

Currently, the oncology segment is the focus among players in the CDx market but it is envisioned that non-oncology segments - such as central nervous system, infectious disease, and cardiovascular conditions - will receive immense attention in the years to come.

New analysis from Frost & Sullivan, Western European Companion Diagnostics Market, finds that the market earned revenues of $457 million in 2013 and estimates this to reach $1,295.1 million in 2018 at a compound annual growth rate of 23.2 percent.

The study covers the oncology areas such as breast cancer, colorectal cancer, and lung cancer panel segments and non oncology areas such as infectious, CNS and cardio vascular diseases for Western Europe, including the United Kingdom, Germany, Italy, France, Spain, Benelux and Scandinavia.

“Limited regulatory barriers for drug and diagnostic combination products, which the current in-vitro diagnostic directive classifies under the low-risk category, are easing market access,” said Frost & Sullivan Healthcare Senior Industry Analyst Divyaa Ravishankar. “As nearly all diagnostic tests in Europe belong to the low risk category, they are exempt from pre-market evaluation. Consequently, manufacturers tend to self-assess conformity, self-certify CDx products, and CE mark them before sale in the European market. This laid-back process has resulted in a higher rate of approval of new CDx tests and products.”

However, intense competition from laboratory-developed test (LDT) manufacturers - who offer tests through reference laboratories across Europe and the rest of the world - is hampering market growth.

The entry of foreign LDT companies into the market through partnership with local companies, as well as the inclination of companies across Western Europe to promote the use of LDT over manufactured and approved CDx tests, is exacerbating the situation.

Further, the variation in reimbursement policies across Western Europe is creating an unpredictable environment, adversely affecting the uptake of new CDx test technologies. Along with the lack of a robust coverage and payment process, this is denting the prospects of CDx manufacturers in the region.

“CDx manufacturers should partner with regulatory bodies from the early stages of solution development to gain an advantage over drug companies,” advised Ravishankar. “Diagnostics companies should also devise effective business models that rest on shortening the drug development time and earning royalties for future sales.”


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