On Dec 13, 2018 AstraZeneca, a global research based biopharmaceutical company, partnered with Guardant Health (US) for the development of CDx tests to commercialize AstraZeneca’s oncology portfolio including Tagrisso and Imfinzi. The CDx test is based on liquid biopsy platform supported by Guardant’s proprietary Digital Sequencing technology.
The multi-year agreement involves obtaining FDA approval for Guardant360 CDx liquid biopsy test and development of plasma-based CDx test using the GuardantOMNI assay. Guardant360 CDx liquid biopsy test enables stratifying non-small cell lung cancer (NSCLC) patients for treatment with Tagrisso, an EGFR inhibitor. GuardantOMNI assay scores tumor mutational burden (TMB) that will help in predicting responses to AstraZeneca’s immunotherapies and targeted drugs. The TMB test is currently under clinical development in phase 3 clinical trial of Imfinzi (durvalumab)¬, with or without tremelimumab, in NSCLC. In February 2018, USFDA granted GuardantOMNI assay as the first breakthrough device designation.
MarketsandMarkets™ View Point:
Rajiv Kalia - Associate Vice President : Healthcare Research, at MarketsandMarkets™, shares his Point of View as mentioned below:
BAstraZeneca is among the leading manufacturer and distributor of pharmaceutical products. The company was incorporated in 1999 and is headquartered in UK. The company offers products in the areas of oncology, anesthesia and pain control, cardiovascular disease, central nervous system, gastrointestinal disease, infection and respiratory diseases. The company operates in Europe, the Americas, Africa and Asia. With the partnership, AstraZeneca will continue to hold a strong position in the development of liquid biopsy based CDx tests.
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 liquid biopsy 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 based on non-invasive liquid biopsy, precision medicine stands at the forefront of medical innovation.
Partnership between AstraZeneca and Guardant Health will have a positive impact on the cancer diagnostics industry. For the diagnostics industry, companion diagnostics represent a major opportunity to enter precision medicine. With this FDA approval, the use of liquid biopsies to run a traditional companion diagnostics test, cancer diagnostics industry is expected to grow leaps and bounds.
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 CDx tests based on liquid biopsy to capitalize the enormous opportunity currently available.
Impact of AstraZeneca and Guardant Health on Top Competitors
The partnership will not only have an impact on the competition but also on the environment. AstraZeneca will be able to cater more demand worldwide with the expansion of its production capacities. This expansion will give AstraZeneca an advantage over its competitors such as Merck, Novartis, Amgen, and others. Moreover, in August 2018, FDA granted a new indication to Roche’s cobas EGFR Mutation Test v2, clearing its use as a noninvasive companion diagnostic for AstraZeneca’s Iressa (gefitinib) in first-line non-small cell lung cancer.
With increasing research and development in the field of liquid biopsy and CDx, more cancer indications will be targeted, which in turn gives better opportunities to companies to increase their product pipeline. However, uncertain reimbursement scenario may restrict the rising demand.
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.