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Trends in Biomarkers and CDx

Product Code:
Publication Date:
July 2018

Technical advances are ushering in a new era for companion diagnostics. What does Pharma need know?

The introduction of liquid biopsies and advances in next generation sequencing are just the latest developments driving the companion diagnostics (CDx) sector. Yet despite providing accurate diagnosis for physicians, better outcomes for patients, savings for payers and competitive advantage for companies, CDx are underutilised. What are the obstacles and how can pharma and CDx developers overcome the operational, commercial and regulatory barriers?

Experts scan the biomarker and CDx horizon

  • Does a one-size-fits-all approach to pricing and reimbursement of CDx work or is there a need for a pricing model that suits pharma and diagnostic companies as well as their stakeholders?
  • What is the value proposition that CDx must bring to manufacturers, payers and patients?
  • How significant is the development of liquid biopsy and breath analysers and what does this mean for CDx developers?
  • Can CDx influence market access and product differentiation? If so, how and why?
  • How might next generation screening impact the uptake, use and commercial value of CDx?
  • At what stage should pharma engage with CDx developers?
  • What has the role of pharma-led biomarker consortia been in the identification and commercial development of biomarkers for incorporation into CDx?


What companion diagnostic experts say…

"A companion diagnostic is essential in terms of the utilisation of the drug if it can determine responders and non-responders, whereas a complimentary diagnostic is informative. It is a challenge for reimbursement as manufacturers need to demonstrate the value of a diagnostic in the post market setting, to convince payers."
US Industry Expert

"Oncology will always be the leader, but I am seeing more consideration in the cardiovascular space, Alzheimer's disease and immune-oncology. We would love to bring down the numbers of patients in clinical trials, but the commercial people need to get on board. If you use a diagnostic, you're restricting the number of patients that you're treating, therefore drug sales could be less. They have to get past that. At some point I don't think they will have a choice; reimbursement and the tight healthcare system finances will drive behaviour."
US Industry Expert

"In the last year or two there has been the real push for liquid biopsies. Even though companies have been evaluating them in their own labs, or in collaboration, the next gen sequencing boom and with their higher sensitivities has really opened up that field. Everyone is now interested in moving their testing strategy to next gen sequencing using liquid biopsies. For drug development, it [liquid biopsy] blows the door open on what we can do, because now we can look at a time course and look at earlier responses to therapy versus waiting for a patient to progress. Additionally, we can look at resistance mechanisms much earlier."
US Industry Expert

What to expect

  • A detailed report exploring current trends and the key market access, technology, regulatory and stakeholder issues that are shaping the rapidly growing biomarker and companion diagnostics sector
  • An examination of nine key issues that pharma and CDx developers need to understand and respond to
  • 36 targeted questions put to biomarker and CDx experts
  • Their perceptive responses that yielded 38 current insights supported by 132 directly quoted comments

Expert contributors

The report harnesses critical insights from front line industry experts who completely understand the pressure points in the biomarker and companion diagnostic sector. In order to allow for candid responses, we have agreed to keep some of their names anonymous.

  • Billy Boyle, CEO and Founder, Owlstone Medical Sciences, UK
  • Bill Pignato, WJ Pignato & Associates, USA
  • David Spetzler, MS, PhD, MBA, President and Chief Scientific Officer, Caris Life Sciences, USA
  • Peggy Robinson, Vice President, ANGLE Biosciences, USA
  • Steve M Anderson, PhD, Chief Scientific Officer, Covance and Senior Vice President, LabCorp, USA
  • EU Industry Expert, Leading Pharma Company
  • EU Industry Expert, Leading Pharma Company
  • US Industry Expert, Leading Pharma Company

Why Choose FirstWord?

FirstWord's reports analyse in detail the market trends that pharma executives need to understand if they are to manage the opportunities and challenges that lay ahead. These concise and highly focussed reports:

  • Are based on primary research with experts whose knowledge and current experience is proven
  • Present clear expert insights free from secondary source information and spurious observations
  • Include only latest research and content–we don't reuse or recycle content


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