Companion Diagnostics Market - Overview and Key Trends

The Companion Diagnostics Market was valued at USD 4,865.60 million in 2020 and is expected to reach USD 14,920.22 million by 2026, registering a CAGR of 20.24% during the forecast period.

Early diagnosis of COVID-19 is becoming more essential in the market, as it has the potential to find the right treatment for the patients impacted with the virus. The most commonly used and reliable test for diagnosis of COVID-19 has been the polymerase chain reaction (PCR) test performed using nasopharyngeal swabs or other upper respiratory tract specimens, including throat swabss. Thus, the disease diagnosis using polymerase chain reaction (PCR) emerged as a major focus for the management of the disease.​​ In November 2020, TScan Therapeutics signed a research license and option agreement with Qiagen to develop a COVID-19 immune response test.


The companion diagnostics market is expected to experience substantial growth due to the development of new biomarkers for various diseases, a rise in R&D of targeted therapies, an increase in demand for customized medicine with increased recognition in developing markets and a higher number of unmet cancer care needs. For instance, in September 2020, Roche introduced a highly effective SARS-CoV-2 antibody test that provided fast results. The introduction of such highly effective diagnostic tests is expected to boost the market growth.

The growth of the global companion diagnostics market can be attributed to the rising focus on personalized medicine and the co-development of drug and diagnostic technologies. Additionally, rising cases of adverse drug reactions related to drugs, due to the lack of efficacy, drive the need for companion diagnostics. In addition, globally, the rising burden of cancer increasing demand for personalized medicines and awareness about the same, among the population. With companies increasing their collaborations for better biomarkers and diagnostics, in order to focus on cost regulations, there has been a significant number of opportunities for its applications in indications, like cancer, cardiovascular, and neurological disorders. For instance, in April 2019, Myriad Genetics, Inc. and AstraZeneca plc and Merck Group entered into a partnership, to identify unmet medical needs in men related to metastatic castration-resistant prostate cancer and expand the company's patient access in the market.

Overall, the rising R&D activities in the development of novel diagnostic test for various chronic diseases is anticipated to drive the global companion diagnostics market growth.




Key Market Trends

Under Indication Lung Cancer Segment is Expected to Dominate the Market over the Forecast Period

  • Companion diagnostic tests (CDXs) are considered mandatory in decision-making for treatment with targeted therapies in lung cancer. Patients with lung cancer who received a companion diagnostic as part of their initial treatment have a greater survival benefit than those who were not tested.
  • In 2020, the outbreak of SARS-CoV-2 (COVID-19) was one of the greatest public health crises faced by the society. Moreover, lung cancer patients represented a great challenge in clinical diagnosis and treatment decision-making in the context of the highly contagious COVID-19 pandemic. For instance, according to a research article by Zhou Sha et al., published in Annals of Pallative Medicine Journal 2020, study results found that there was a significant impact of the COVID-19 crisis on oncological care, indicating the need for appropriate change of treatment decisions and continued follow-up and psycho-oncological support during the pandemic.
  • Globally, high incidence rate of non-small cell lung cancer (NSCLC) coupled with a rise in the development of oncology companion diagnostic tests for the disease is expected to boost the market growth. For instance, in May 2020, US FDA approved FoundationOne CDx assay for use with Capmatinib for the treatment of metastatic non-small cell lung cancer (NSCLC). In addition, in 2018, Roche Molecular Systems, Inc received US FDA approval for cobas EFGR mutation test v2, a polymerase chain reaction (PCR) test used in diagnosis of mutation in epidermal growth factor receptor gene in non-small cell lung cancer.
  • The emergence of immunotherapy has also given rise to the development of CDXs. Therascreen EGFR RGQ PCR Kit (Qiagen) and Cobas EGFR Mutation Test v2 (Roche Molecular Systems) are some of the many companion diagnostics available for lung cancer therapies.
  • Moreover, lung cancer is the most common form of cancer, and causes most cancer-related deaths, globally, as per the 2020 data by the Globocan, there were around 2,206,771 (11.4%) new lung cancer cases and 1,796,144 (18%) deaths due to lung cancer in 2020. This translates to more demand for lung cancer companion diagnostics, which is expected to help the market growth over the forecast period

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