Despite growing demand, varied reimbursement and regulatory policies could impede market momentum 

The European genetic testing and screening services market is poised to be driven by the increasing availability of tests covering a wider range of disease areas, paralleled by a rapidly expanding pool of potential consumers. Testing for genetic diseases has swiftly moved from the laboratory into medical practice. In this process, issues related to quality have not received adequate attention.

New analysis from Frost & Sullivan European Genetic Testing and Screening Services Market, finds that the market earned revenues of $896.2 million in 2011 and estimates this to reach $1908.8 million in 2018. The research covers diagnostic testing/screening, relationship testing and predictive testing. Heightened awareness, primarily due to widespread genetic counselling groups and the availability of direct-to-consumer (DTC) tests will boost market prospects.

"Demand for genetic testing will receive further impetus when accompanied by consultation, counselling physician's advice and proper reimbursement," noted Frost & Sullivan Senior Research Analyst Divyaa Ravishankar. "There is a rising interest in predictive testing, which is seen as the highest growth area within genetic testing."

Genetic testing and screening are the next big focus in molecular diagnostics. The molecular diagnostics market in Western Europe is worth $1,352.4 million, and genetic testing contributed almost 66 per cent of its revenue in 2011.

The cost of sequencing a genome is reducing, with new, efficient next-generation sequencing platforms. This will create fierce competition for faster turn-around times and will have a positive impact on the genetic testing and screening market.

Varying reimbursement procedures across Europe, however, loom as a major concern to market participants. When samples are being shipped across international boundaries, inadequate reimbursement can result in uneven access to genetic testing services.

"There are potential gaps that exist in the regulatory and normative framework which need to be addressed," cautioned Ravishankar. "Currently, there is no legal requirement on quality assurance, specifically for diagnostic laboratories in different member states of the EU."

Obtaining accreditation and certification is entirely voluntary. Only a few European labs have obtained them. Moreover, the definitions of ‘accreditation' and ‘certification' are still not universally accepted in EU member states.

"Defining a framework for reimbursement related to cross-border exchange of samples for genetic testing and data is critical," advised Ravishankar. "Proper rules should be framed for reimbursement when samples are tested in other nations; pan-European co-operation will be essential to streamlining cross-border shipping."

If you are interested in more information on this study, please send an e-mail with your contact details to Janique Morvan, Corporate Communications, at janique.morvan@frost.com.


European Genetic Testing and Screening Services Market is part of the Clinical Diagnostics Growth Partnership Services programme, which also includes research in the following markets: Western European In Vitro Diagnostics (IVD) Market, European Molecular Diagnostics Market and Strategic Analysis of the European Stem Cell Research Tools Market. All research included in subscriptions provide detailed market opportunities and industry trends that have been evaluated following extensive interviews with market participants.