On May 28 Lunit Inc. announced an abstract presentation of its AI precision medicine research portfolio at the American Society of Clinical Oncology (ASCO) Annual Meeting 2019. The accepted abstract highlights the feasibility of AI-based biomarker in metastatic non-small cell lung cancer, based on the H&E analysis that predicts response to immune checkpoint inhibitors (ICI).
The study evaluated the predictive value of AI versus PD-L1, which is the main biomarker for ICI. According to the research presented by LUNIT INC., within PD-L1(+) patient group, the treatment response and progression-free survival (PFS) significantly differed depending on the AI score. The same results were obtained within the PD-L1(-) group.
Immunotherapy drugs targeting checkpoints are catching attention as a promising cancer treatment. Immune-oncology drugs such as KEYTRUDA, OPDIVO, YERVOY, and among others are recently approved by FDA. KEYTRUDA, and OPDIVO targets PD-1 checkpoint while YERVOY targets CTLA-4 checkpoint to boost immune response against cancer cells. With new biomarkers into development, the overall cancer biomarker market will witness growth in the coming years.
Factors such as increasing prevalence of cancer, increasing preference for noninvasive procedures, initiatives undertaken by government and global health organizations, technological advancements to augment market revenues, rising emphasis on personalized medicine in clinical practice, and increased funding for R&D are driving the growth of the market. According to MarketsandMarkets analysis, new drugs based on specific genetic biomarkers combined with in vitro tests will identify biological markers and provide essential information on the safe and effective use of a corresponding drugs. With increasing development of new targeted therapies and CDx tests, precision medicine stands at the forefront of medical innovation.
The global companion diagnostics market is projected to reach USD 6.51 billion by 2022 from USD 2.61 billion in 2017, at a CAGR of 20.1%. Owing to the advantages of approval processes of drugs based on companion tests, an increasing number of pharmaceutical companies have entered into partnerships and collaborations with different companion diagnostic companies to develop and commercialize companion diagnostics tests for their drugs.
On the regulatory front, regulators are putting further efforts to improve approval guidelines for CDx tests. In 2018, the FDA released numerous guidance especially for sponsers which includes a guide to support early co-development of drugs and companion tests. This flexible regulatory processes are expected to expedite the clinical trial process and help in transiting a clinical trial assay into FDA-approved CDx.
Presently, more than 1,000 oncology products are under various stages out of which approximately 70% include biomarkers. With such regulatory support, large number of players are expected to launch new biomarker based CDx tests to capitalize the enormous opportunity currently available.
With increasing research and development in the field of CDx, more biomarkers will be identified on various cancer indications, which in turn will give better opportunities to companies to increase their product pipeline. However, uncertain reimbursement scenario may restrict the rising demand.
KEY PLAYERS IN COMPANION DIAGNOSTICS
- F. Hoffmann-La Roche AG
- Agilent Technologies, Inc.
- Qiagen N. V.
As regulatory scenario continues to streamline from precision medicine and companion diagnostics perspective, fast and flexible eClinical tools may further boost and maximize the positive impact. As a result, these markets will continue to grow, attracting more competition. However, continued efforts in research will be required in order to maintain a competitive advantage in the market.