Corporate Banner
Satellite Banner
Technology
Networks
Scientific Communities
 
Become a Member | Sign in
Home>News>This Article
  News
Return

Companion Diagnostics Benefit from Fewer Regulatory Barriers in Europe

Published: Thursday, June 26, 2014
Last Updated: Thursday, June 26, 2014
Bookmark and Share
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.”


Further Information

Join For Free

Access to this exclusive content is for Technology Networks Premium members only.

Join Technology Networks Premium for free access to:

  • Exclusive articles
  • Presentations from international conferences
  • Over 3,200+ scientific posters on ePosters
  • More Than 4,700+ scientific videos on LabTube
  • 35 community eNewsletters


Sign In



Forgotten your details? Click Here
If you are not a member you can join here

*Please note: By logging into TechnologyNetworks.com you agree to accept the use of cookies. To find out more about the cookies we use and how to delete them, see our privacy policy.

Related Content

Disruptive Technologies Transforming the Growing Biologic Manufacturing Market
Single use technologies are paving the future of biopharmaceutical manufacturing.
Wednesday, June 22, 2016
Increased Public Private Partnerships to Drive Cutting Edge Innovation and Business Growth
Faced with increasing challenges such as costly treatments and treatments that are palliative rather than symptomatic, the global healthcare industry today is gradually transforming itself.
Thursday, October 08, 2015
The Changing Tides of the In Vitro Diagnostics Market
With the increasing focus in personalized medicine, diagnostics plays a crucial role in patient monitoring.
Monday, August 24, 2015
Changing Phase of Biomarkers
Discover the current scenario and changing business models of the biomarkers field.
Monday, April 13, 2015
Can Regenerative Medicine be the Cure for Cancer and Other Deadly Diseases?
Change in regulatory frameworks and standards are essential to expedite approval and release of innovative products.
Thursday, June 19, 2014
Gene Expression Profiling Drives Personalized Medicine Worldwide
Large amounts of information generated by gene expression profiling will increase implementation of data management tools.
Tuesday, June 10, 2014
Personalized Medicine Drives Uptake of Next-generation Sequencing in Europe
Future of DNA sequencing will shift from a laboratory-based setup to point of care testing in the next 5 years.
Saturday, May 31, 2014
Emerging Technologies Redefine Infectious Disease Diagnostics
The largest opportunities lie in the developing regions of Asia, Africa and Latin America.
Wednesday, April 23, 2014
Drug Developers Drawn to Orphan Drugs Market
Breakthrough therapies for rare diseases command premium pricing, particularly if no alternatives exist.
Thursday, March 27, 2014
Next-Generation Therapeutics for Infectious Diseases Conquer the Global Spotlight
Resistance to current drugs spurs treatment innovation in influenza, respiratory syncytial virus, chlamydia and gonorrhea.
Thursday, March 27, 2014
Live Cell Imaging Revolutionizes Disease Diagnostics and Drug Discovery
Stakeholder collaboration will be crucial to convert these developments into clinically meaningful tests.
Friday, March 21, 2014
Automated Anatomic Pathology Labs Transform Global Tissue Diagnostics Market
Offering attractive procurement strategies will boost adoption of high-end tools.
Thursday, February 06, 2014
Strong Pipeline of mAbs Biosimilars in the US and Europe Lends Impetus to Global Market
The market is expected to soar from $1.2 billion of 2013 to $24 billion in 2019.
Tuesday, February 04, 2014
Predictions for the Global Chemicals, Materials and Food Industry
New insights based on Frost & Sullivan's ‘2013 Search for Growth’ survey.
Wednesday, December 11, 2013
CMOs Can Reduce Vendor Switching with Informational Marketing Efforts
Frost & Sullivan: Companies opt for CMOs offering high-quality services, confidentiality and clean regulatory track records.
Tuesday, November 26, 2013
Scientific News
Platelets are the Pathfinders for Leukocyte Extravasation During Inflammation
Findings from the study could help in the prevention and treatment of inflammatory pathologies.
ASMS 2016: Targeting Mass Spectrometry Tools for the Masses
The expanding application range of MS in life sciences, food, energy, and health sciences research was highlighted at this year's ASMS meeting in San Antonio, Texas.
Benchtop Automation Trends
Gain a better understanding of current interest in and future deployment of benchtop automated systems.
Some Women With PCOS May Have Adrenal Disorder
Researchers at NIH have found that a subgroup of women with PCOS, a leading cause of infertility, may produce excess adrenal hormones.
Alzheimer's Genetics Point To New Research Direction
A University of Adelaide analysis of genetic mutations which cause early-onset Alzheimer’s disease suggests a new focus for research into the causes of the disease.
Penn State, TB Alliance, and GSK Partner To Discover New Treatments For TB
A new collaboration between TB Alliance, GSK, and scientists in the Eberly College of Science seeks to find new small molecules that can be used to create antibiotics in the fight against tuberculosis (TB).
Manufactured Stem Cells To Advance Clinical Research
Clinical-grade cell line will enable development of new therapies and accelerate early-stage clinical research.
Faster Detection of Pathogens in the Lungs
Thanks to new molecular-based methods, mycobacterial pathogens that cause pulmonary infections or tuberculosis can now be detected much more quickly.
Contagious Cancers Are Spreading in Shellfish
Direct transmission of cancer among some marine animals may be more common than once thought, suggests a new study published in Nature by researchers at Columbia University Medical Center (CUMC).
Contagious Cancers Are Spreading in Shellfish
Direct transmission of cancer among some marine animals may be more common than once thought, suggests a new study published in Nature by researchers at Columbia University Medical Center (CUMC).
Scroll Up
Scroll Down
Skyscraper Banner

Skyscraper Banner
Go to LabTube
Go to eposters
 
Access to the latest scientific news
Exclusive articles
Upload and share your posters on ePosters
Latest presentations and webinars
View a library of 1,800+ scientific and medical posters
3,200+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
4,700+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FOR FREE!