Companion Diagnostics Market: Relevant Developments Overview

Companion Diagnostics Market - Inkwood Research

By Shruti Vanjare

As per Roche’s Personalized Healthcare Brochure, for every 10 patients with cancer treated, only an average of half will actually benefit from it. While some may suffer serious side effects, others will be completely unaffected following the course of the treatment. As a result, leading pharmaceutical companies are collaborating to identify and develop innovative predictive diagnostics, including companion diagnostics, in order to target patients more likely to respond to suitable therapies.

Inkwood Research estimates that the global companion diagnostics market is set to grow with a CAGR of 13.29% from 2022 to 2030, primarily attributed to the increasing number of cancer cases and associated mortalities. The market growth is further fuelled by the rising popularity of precision medicines as well as the surge in adverse drug reaction cases.


Significance of Companion Diagnostics in Oncology

As defined by the United States Food and Drug Administration (FDA), companion diagnostics entail devices that provide data linked to the effective use of a biological product or corresponding drug. Moreover, companion diagnostics also aim to help medical professionals ascertain whether the advantages of a particular treatment outweigh the potential risks and side effects.

According to the World Health Organization (WHO), after cardiovascular conditions, cancer is the second-leading cause of death worldwide, accounting for approximately one in six fatalities. As the field of oncology continues to develop, researchers are dedicating extensive resources to discover innovative drug regimens and companion diagnostics to offer targeted therapies that serve individual patients effectively.

Conversely, with the ongoing evolution of oncology practices, in addition to companion diagnostics, the FDA has also noted a trend toward more advanced tests capable of detecting upto hundreds of genetic mutations within a single test. In this regard, Inkwood Research’s analysis suggests that the oncology segment, under the indication category, is set to grow with the highest CAGR during the forecast period. Moreover, oncology was also the dominating indication in 2021.


Oncology Segment: Developments by Key Players

  • In view of the contribution of leading players, Biocartis, headquartered in the United States, has further expanded its R&D initiatives across the oncology and infectious disease division. The company also witnessed significant growth in the sale of diagnostic devices, on account of the surging number of cancer cases and the spread of the novel coronavirus infection.
  • Similarly, companies such as Myriad Genetics and Roche Diagnostics are actively investing in research and development within the oncology segment. Aligning with this, the VENTANA PD-L1 (SP142) Assay by Roche Diagnostics is specifically designed to develop immune cell staining’s visual contrast in the tumor microenvironment.
  • The diagnostic tests by Arup Laboratories (United States) cover a wide range of clinical specialties, including oncology, cytogenetics, and molecular genetics.


Companion Diagnostics Market: Prominent Technologies

The growth of companion diagnostics beyond oncology has significantly impacted clinical practice as well as the research and development pipeline. While the arena has expanded from a few oncology drugs with corresponding diagnostics to multiple therapeutic areas, several companies are now capitalizing on the demand for personalized treatments by offering various next-generation sequencing (NGS) technologies.

  • Next-Generation Sequencing (NGS): 
    • With the advent of NGS and its prolific use in the clinical realm, relatively older techniques, including immunohistochemistry (IHC) and in situ hybridization (ISH), would observe depreciated demand. Consequently, on account of the increased efficiency, targeted sequencing is set to record increased usage in clinical diagnostics.
    • The importance of polymerase chain reaction (PCR) techniques in targeted NGS sequencing is mainly attributed to the fact that it facilitates the simultaneous generation of multiple NGS libraries. Besides, it also aids the sequencing of various targeted regions. These factors are set to play a pivotal role in positioning next-generation sequencing as the fastest-growing technology during the forecast period, with a CAGR of 13.65%.
  • Polymerase Chain Reaction: 
    • Polymerase chain reaction-based companion diagnostics are expected to continue to dominate the technology segment during the forecast years, with a significant share in neurology as well as novel oncology applications. 
    • The segment’s notable growth is primarily accredited to PCR-based companion diagnostics’ effective detection of biomarkers. In this regard, Qiagen NV’s JAK2 V617F Kit utilizes a real-time PCR for the detection of suspected polycythemia vera (PV) linked to other clinic-pathological variables.

Companion diagnostics offer numerous benefits, especially in advancing personalized medicine as well as improving clinical and pre-clinical targeted drug development. Therefore, the early adoption of companion diagnostics ensures the best prospects for diagnostic pairing, while enabling drugs to reach the market in greatly expedited timelines. Such developments are estimated to positively impact the global companion diagnostics market growth.



What are some of the key restraints challenging the global companion diagnostics market?

Country-specific reimbursement issues and frequent cases of leakage in companion diagnostics for oncology are among the key restraints hindering the growth of the global companion diagnostics market.

What are the end-users considered in the global companion diagnostics market study?

Pharmaceutical and biopharmaceutical companies, reference laboratories, and other end users are considered in the global companion diagnostics market study.