The companion diagnostics market was valued at USD 4,865.60 million in 2020, and it 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 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 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, the disease diagnosis using polymerase chain reaction (PCR) emerged as a major focus for managing 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 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. 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 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., AstraZeneca PLC, and Merck Group entered 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 tests for various chronic diseases are anticipated to drive the global companion diagnostics market growth.
Key Market Trends
The 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 receive companion diagnostics as part of their initial treatment have greater survival benefits than those not tested.
- In 2020, the outbreak of SARS-CoV-2 (COVID-19) was one of the greatest public health crises faced by society. Moreover, lung cancer patients represented a significant 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 Palliative Medicine Journal 2020, there was a significant impact of the COVID-19 crisis on oncological care, indicating the need for an appropriate change of treatment decisions and continued follow-up and psycho-oncological support during the pandemic.
- 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 market growth. For instance, in May 2020, the US FDA approved the FoundationOne CDx assay for use with Capmatinib to treat metastatic non-small cell lung cancer (NSCLC). In 2018, Roche Molecular Systems Inc. received the US FDA approval for Cobas EFGR mutation test v2, a polymerase chain reaction (PCR) test used to diagnose mutation in epidermal growth factor receptor gene in non-small cell lung cancer.
- 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.
North America is Expected to Hold Significant 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 seeing 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 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 American Cancer Society Inc., in 2020, in the United States, there were around 1.8 million new cancer cases diagnosed and 606,520 cancer deaths.
- The favorable reimbursement scenario for breast cancer diagnostic solutions in the United States is anticipated to facilitate their adoption. 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.
- The evolving role of oncology companion diagnostics in the era of next-generation omics is expected to drive the market. For instance, in August 2020, Guardant Health Inc. received the US FDA approval for Guardant360 CDx, which is a companion diagnostic test that detects genetic mutations found in circulating cell-free DNA (cfDNA) to help doctors identify patients with non-small cell lung cancer who must be treated with TAGRISSO (osimertinib).
- Foundation Medicine Inc. received the US FDA approval for FoundationOne Liquid companion diagnostics, which is the only FDA-approved blood-based test to analyze over 300 genes, making it the most comprehensive FDA-approved liquid biopsy on the market.
- In the United States, companion diagnostic assays are classified as IVD class III products, representing a high-risk category, and consequently, the highest level of regulatory control. Hence, owing to high healthcare technology adoption rates and the increasing demand for personalized medicine, the US companion diagnostics market is expected to register a substantial growth rate during the forecast period.
The companion diagnostics market is moderately fragmented and highly competitive consists of several major players. The presence of major market players, such as Abbott Laboratories Inc., Agilent Technologies Inc., F Hoffmann-La Roche Ltd, Biomerieux SA, and Qiagen NV, is increasing the overall competitive rivalry of the market studied. Moreover, 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.
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