Companion Diagnostics Market - Growth, Trends, COVID-19 Impact, and Forecast (2022 - 2027)

Companion Diagnostics Market - Growth, Trends, COVID-19 Impact, and Forecast (2022 - 2027)

The companion diagnostics market was valued at USD 5,936.4 million in 2021, and it is projected to register a CAGR of 20.40% during the forecast period (2022-2027).

Early diagnosis of COVID-19 is becoming essential in the market, as it can help find the right treatment for patients impacted by the virus. The most commonly used and reliable test for the diagnosis of COVID-19 is the polymerase chain reaction (PCR) test performed using nasopharyngeal swabs or other upper respiratory tract specimens, including throat swabs. Thus, diagnosis using polymerase chain reaction (PCR) has emerged as a major focus for managing the disease. For instance, in November 2020, TScan Therapeutics signed a research license and option agreement with Qiagen to develop a COVID-19 immune response test. This led to increased adoption of companion diagnostics, thereby driving the growth of the market during the pandemic. Moreover, the companion diagnostics market is expected to experience substantial growth due to the rise in product launches; the development of new biomarkers for various diseases; a rise in research and development 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 provides fast results. The introduction of such highly effective diagnostic tests is expected to boost the market's growth.

Furthermore, 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. Moreover, the rising cases of adverse drug reactions related to drugs due to the lack of efficacy drive the need for companion diagnostics.

Globally, the rising burden of cancer increases the demand and awareness for personalized medicines among the population. With companies expanding their collaborations for better biomarkers and diagnostics to focus on cost regulations, there have been a significant number of opportunities for applications in indications like cancer, cardiovascular, and neurological disorders. For instance, in June 2020, Thermo Fisher Scientific Inc. and Agios Pharmaceuticals entered into a strategic partnership to co-develop a second companion diagnostics platform for oncology.

Thus, the growing R&D activities in the development of novel diagnostic tests for various chronic diseases are anticipated to drive the growth of the global companion diagnostics market. However, the high cost of drug development and associated clinical trials and reimbursement issues in many countries are expected to constrain the market's growth.

Key Market TrendsThe Lung Cancer Segment is Expected to Hold a Significant Share in 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 receive companion diagnostics as part of their initial treatment have greater survival benefits than those not tested.

Globally, the 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 segment growth. For instance, in May 2020, the United States Food and Drug Administration approved the FoundationOne CDx assay for use with Capmatinib to treat metastatic non-small cell lung cancer (NSCLC). In addition, in July 2021, Labcorp launched Therascreen KRAS PCR Mutation Analysis, a companion diagnostic to identify patients with non-small cell lung cancer (NSCLC) who are eligible for therapy with LUMAKRAS (sotorasib), a novel therapeutic option developed by Amgen.

The emergence of immunotherapy has 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 it causes the most cancer-related deaths globally. As per the 2020 data by 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, leading to more demand for lung cancer companion diagnostics, which is expected to help the market growth over the forecast period.

Therefore, the rising prevalence of lung cancers and product launches for lung cancer companion diagnostics are expected to drive the growth of this segment.

North America is Expected to Hold a Major Market Share Over the Forecast Period

North America dominated the overall companion diagnostics market, with the United States emerging as the major contributor to the market. The use of companion diagnostics is considered an important treatment decision tool for various oncology drugs, which is also reflected in how the FDA classifies these assays concerning risk.

Companion diagnostics clinical trials have come to the forefront in the pharmaceutical industry, despite the COVID-19 outbreak, as it helps boost the chances of clinical success. The testing kit has been in high demand for identifying those infected with SARS-CoV-2. The novel coronavirus remained the main focus for diagnostic test makers in terms of research and development. In May 2020, in the United States, MiraDx set up its lab to provide COVID-19-based test services. The company claims that the lab has been able to analyze more than 9,000 tests accurately.

The increasing burden of cancer in the United States is also expected to drive market growth. According to the data published by the American Cancer Society Inc., in January 2020 in the United States, there were around 1.8 million new cancer cases diagnosed and 606,520 cancer deaths.

In addition, the favorable reimbursement scenario for breast cancer diagnostic solutions in the United States is anticipated to facilitate their adoption. For instance, in January 2020, the Centers for Medicare & Medicaid Services (CMS) expanded its coverage of next-generation sequencing as a diagnostic tool for patients with germline (inherited) breast cancer.

Moreover, in October 2021, the United States Food and Drug Administration approved Agilent's Ki-67 IHC MIB-1 pharmDx (Dako Omnis), which aids in identifying patients with early breast cancer (EBC) at high risk of disease recurrence. This will further drive the market growth over the forecast period in North America.

Due to the above-mentioned factors, North America is expected to hold a major share in the global companion diagnostics market.

Competitive Landscape

The companion diagnostics market is moderately fragmented and highly competitive with several major players. The rising focus of companies toward personalized medicine, co-development activities, and increased cases of adverse drug reactions are expected to boost the competitive rivalry in the market studied. The major market players, such as Abbott Laboratories Inc., Agilent Technologies Inc., F Hoffmann-La Roche Ltd, Biomerieux SA, and Qiagen NV, are increasing the overall competitive rivalry of the market studied.

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