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Companion diagnostic Market

Companion diagnostic is a term used to describe the proposed diagnostic for patients – to tailor a treatment, to take a suitable treatment based on results from companion diagnostic. According to the FDA, in companion diagnostics in vitro devices used to provide information for safe and effective use of drugs or any biological product. Devices used in companion diagnostic are used in both therapeutic and diagnostic process. Polymerase chain reaction, in situ hybridization, immunohistochemistry and next generation sequencing (NGS) are some technologies used in the process of companion diagnostic. Moreover, NGS plays a significant role in testing and treatment area.

As per the Frontiers Media SA, companion diagnostics is majorly used to improve the predictability of oncology drug development process.As per the American Cancer Society, ~14.1 million cancer cases were observed (with ~8.2 million cancer deaths) across the globe in 2012, and this cancer burden is expected to increase upto ~21.7 million (with approximately 13 million cancer deaths) by the end of 2030. Hence, increasing incidences of cancer has supported the adoption of companion diagnostics to develop drugs in cancer treatment. Companion diagnostics helps in developing drug, targeting specific area of cancer type with more efficacy thus, driving the global companion diagnostics market growth during the forecast period.

Regional Analysis

China would account for the largest share in the companion diagnostics market, owing to various factors such as high prevalence of cancer in region, focus of companies to adopt partnership as their major strategic initiative to develop companion diagnostics and government funding on precision medicines. In China, companies are adopting various strategies to develop companion diagnostics tools. For instance, Simcere Diagnostics and Agena Bioscience collaborated to commercialize and develop companion diagnostics in China by using Agena’sMassARRAY System. Also, CANbridge Life Sciences and Amoy Diagnostics collaborated to develop companion diagnostics assay to treat glioblastoma multiforme (GBM) patient. Moreover, according to the World Economic Forum, in 2016, the Chinese government announced a 15 year “Precision Medicine Initiative” with $9.2 billion investment for R&D for precision medicine. Hence, these initiatives cumulatively contribute in a business growth of a region.

Status of new market entrants

The intensity of threat of new entrants in the companion diagnostics market is expected as high, owing to growing prevalence of diseases such as neurological, cancer and other infectious diseases. These diseases are expected to create opportunities for new companies to develop treatment methods, medicines, and related technologies. The companion diagnostics market is lucrative to attract new companies and government support from different countries, as companion diagnostics technology can help to reduce the overall cost and time of treatment and medicine.

Some interesting market strategies:

  • In 2018, Loxo Oncology and Illumina signed a partnership agreement to develop NGS-Based Pan-Cancer Companion Diagnostics. This partnership will support the development of a multi-gene panel for tumor profiling through NGS based on companion diagnostic with pan-cancer indication. This strategic initiative is expected to boost company’s revenue in future.
  • In 2018, BRIEF, Bristol-Myers Squibb and Illumina announced a collaboration, that is focused upon development of companion diagnostics for oncology immunotherapies.
  • In 2018, Qiagen N.V. collaborated with SRL Inc. to introduce novel companion diagnostics.


Companion diagnostics increases trials success and reduce the cost of clinical trial through targeted approach. Biotechnology and Pharmaceutical companies, and clinical research organizations are incorporating companion diagnostics into their trial study to mitigate risk with R&D expenditure.Companion diagnostics highly contribute in decision making by physicians to assess appropriate treatment method or technology for patient.

Considering key buying criteria in the companion diagnostics market include price, specifications, availability, sensitivity and efficacy of companion diagnostics products (not necessarily in same order).



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