Description

Liquid biopsy (CTCs and ctDNAs) is slowly gaining momentum in clinical care given its advantages over the traditional tissue-based gold standard methods. Short-term applications in cancer care range from risk assessment to cancer recurrence monitoring. Despite the proven advantages, there is still a significant number of barriers to adoption such as high cost of next-generation sequencing (NGS), reimbursement scenario and the establishment of clinical utility of mutation and clinical evidence.

Liquid biopsy remains an interesting business opportunity for several investors and the quest for the most successful company continues. With GRAIL announcing over $1.3 billion in financing, the modality has also garnered interest from several pharma companies vying to capture their share of the market by co-developing drugs and diagnostic products. CTCs and ctDNAs have extended applications across oncology, NIPT (non-invasive prenatal testing), transplant diagnostics and infectious diseases. This report provides a strategic insight into liquid biopsy test makers relating to the challenges they will encounter and lists some of the winning strategies to gain reimbursement and market access. It also highlights growth opportunities where companies can gain the first-mover advantage, and provides a guidance for investment bankers on the most successful and unique disruptive technology.

It is important to identify winning strategies in order to be successful. Given the tricky nature of this market, establishing clinical utility and clinical evidence and getting the test into guidelines are some of the key pathways for success. This report discusses regional challenges, regulatory barriers in the UK, China and the US. Key drivers would include the following: Identifying the area of unmet need; aiming for incorporating the test within guidelines and screening programs; overcoming regulatory and reimbursement barriers; and innovating to draw maximum capital from investors.

Broadly three types of companies form the competitive landscape in this market - liquid biopsy kit providers, liquid biopsy instrument providers. Most activity is sensed within “liquid biopsy as a service model”.

Currently, there are no clear guidelines that provide a definitive regulatory/ reimbursement roadmap in emerging countries such as India where the concept is still in its nascent stages.

Top market trends include:
•     Increasing interest from pharma companies forging partnerships with diagnostic test developers to advance their drug discovery and development activities.
•     Companies are leaning towards biomarkers that are listed in the NCCN guidelines as a low-risk approach and which offer more guaranteed reimbursement.
•     Biomarker tests are focusing on multi-gene or multi-cancer testing rather than a single gene approach.
•     Companies are pushing the boundaries beyond oncology testing.