Companion Diagnostics: Pharma’s Doorway to Truly Personalized Therapies
Its been more than 20 years since the first companion diagnostic test hit the market. Two decades later, these tests have become an industry norm and are being widely utilized to identify eligible patients.
Given the influx of novel technologies and growing demand for personalized medicine, companion diagnostics have gradually become a necessity for modern pharmacological interventions — Ishita Nanda, Roots Analysis
I recently followed a presentation by Biodesix, one of the leading lung cancer diagnostic company at the RAS-Targeted Drug Discovery meeting. The company’s chief development officer presented a case study based review of their companion diagnostic capabilities. One of the key thing that really caught my attention was the presentation of real world data by Dr. Yishan Chuang ( Director of Scientific & Medical Affairs) on the importance of monitoring KRAS mutations in blood.
Now, if you followed the ASCO 2019 meeting, you would realize the reason I’m so excited about a company having the capability to effectively detect KRAS mutations. KRAS is one of those biomarkers that has got everyone excited in recent years. The presence of companies, such as Biodesix, that can help in effectively detect / monitor such patients is a big step forward in overcoming high unmet need in these patients.
With the exciting development of KRAS targeted therapy in clinical studies, there is an increasing need for swift mutation testing with liquid biopsy — Dr. Chuan
The example that I just quoted above shows a relationship that pharma players have built so well in last two decades. The beginning of this relationship was back in 1998 when the first companion diagnostic for Herceptin was approved. The approval showed pharma companies that diagnostic tests and drug development can and should go hand in hand.
Effective use of companion diagnostics is an important component of our oncology development strategy focused on targeted therapies — Head of Oncology Research, Merck
Currently, more than 130 companion diagnostic tests are either already available on the market or being developed by various companies across the world. Given the fact that a number of patients do not respond to different therapies (as shown in exhibit 1), the success of these companion diagnostic tests will be vital improve overall patient care.
One of the best thing that can happen to any research area in the healthcare space is the show of interest from big pharma players. Companion diagnostics has been one of those areas that has always been a priority for big pharma. In fact, as per a market research report by Roots Analysis, in last few years alone, more than 300 clinical trials have been initiated by top 20 pharma players, in which they are evaluating various biomarkers and majority of these biomarker based trials require a companion diagnostic test for identification of eligible patients.
Pharma is ready to Partner
With more than 150 deals in last 5 years, pharma players have accepted the role that companion diagnostic service provides play in the overall drug development paradigm.
We have a unique strategy of pursuing a small number of strategic partnerships with global players — and those partners are genuine strategic partners. Dako scientists are working alongside our scientists, in a way which is completely the opposite to a fee-for-service arrangement — AstraZeneca
Given the large pipeline of personalized drugs that are currently under development, you can expect companion diagnostic developers to become an integral part of the drug development process
Real Opportunity Yet to be Realized
Now at AstraZeneca, about 85% of our pipeline has personalized care embedded in our development programs. We follow the science to identify if a patient population will respond better. The reason is very simple, “Having good biomarkers decreases the chances of a drug’s failure. It means that the pivotal trials have a greater chance of succeeding, which is good for everyone.” — AstraZeneca
Companion diagnostic not just improves the chances of drug approval, it is also a highly lucrative market. As per market reports, the companion diagnostics market is expected to grow at a CAGR of more than 7 percent in the coming decade.
