Companion Diagnostics: The Road Ahead for Personalized Therapies

It is estimated that nearly 50% of prescribed drugs / therapies fail to show adequate clinical benefits. It is also worth highlighting that companion diagnostic guided drug development efforts have been estimated to help reduce clinical trial costs by almost 60%. Since the approval of the HercepTest (in 1998) for identifying patients for treatment with trastuzumab, over 50 companion diagnostics have been developed for various drugs. Several companies have undertaken initiatives to develop biomarker-based therapeutics for other disease indications, such as infectious diseases, neurological disorders and metabolic disorders.

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The adoption of companion diagnostics in pharmaceutical R&D has led to marked improvement in clinical trial success rates, resulting in reduced mortality due to drug side effects and more precise treatment-related decision making.

Presently, over 130 companion diagnostic tests, designed to enable better treatment related decisions, are either already available in the market, or under development by various companies across the world

Based on validated disease-specific biomarkers, these diagnostic tests are known to utilize a variety of analytical tools and techniques for assessing therapeutic compatibility across diverse disease indications

Several companies in this domain have already established strong brand positions in the global market, and are expected to continue to innovate in terms of improving assay techniques and upgrading analytical paradigms

This field is characterized by a value chain, involving drug and diagnostics developers, along with other important stakeholders, each having a discrete set of priorities and requirements

Increase in partnership activity reflects the growing interest of stakeholders; over 70% of reported deals were focused on oncological disorders, involving both international and indigenous stakeholders

With potential applications across a myriad of disease indications, the companion diagnostics market is expected to witness a double digit growth; the opportunity is likely to be distributed across different regions and techniques

In the long-term, the growth momentum will be driven by the niche tumour hotspots which have been identified as promising biological targets for development of companion diagnostics

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