Market Trends of Companion Diagnostics Industry
The Lung Cancer Segment is Expected to Witness Significant Growth 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 more survival benefits, such as targeted therapy selection, which helps in providing personalized treatment to the target patient.
The high incidence rate of lung cancer and novel innovations in companion diagnostics by major players are likely to boost the segment's growth over the forecast period.
Globally, the high incidence rate of non-small cell lung cancer (NSCLC), coupled with the growing development of oncology companion diagnostic tests for the disease, is expected to boost the segment's growth. For instance, according to a report published by the American Cancer Society in January 2024, about 10-15% of all lung cancers were observed to be small cell lung cancer (SCLC), and about 80-85% were non-small cell lung cancer (NSCLC). The same source reported an estimated 234,580 new cases of lung cancer in 2024 in the United States, leading to more demand for lung cancer companion diagnostics. Similarly, according to a report published by the American Cancer Society in 2023, about 238,340 people were diagnosed with lung cancer. Such prevalence is expected to fuel the growth of the lung cancer segment in the companion diagnostic market over the forecast period.
The segment is also growing due to the rising number of product approvals and launches. In June 2023, ARUP Laboratories received approval from the US Food and Drug Administration for AAV5 DetectCDx as a companion diagnostic to aid in the selection of adult patients eligible for treatment with ROCTAVIAN (valoctocogene roxaparvovec-rvox).
Companies are also focusing on adopting key collaborative strategies to expand their product portfolios in the market. In July 2023, Tempus collaborated with TScan Therapeutics to develop a companion diagnostic (CDx) test to treat cancer patients. The collaboration supports TScan’s screening protocol for its Phase 1 solid tumor, including non-small cell lung cancer, a clinical trial designed to enable customized mixtures of TCR-Ts to be administered to patients based on tumor antigen positivity and intact HLA expression.
Therefore, the high incidence rate of lung cancer, novel innovations in companion diagnostics by major players, and strategic activities are expected to drive the segment’s growth during the forecast period.
North America is Expected to Hold a Significant Market Share Over the Forecast Period
North America is expected to witness significant growth in the overall companion diagnostics market, with the United States emerging as a key contributor. Companion diagnostics are recognized as pivotal tools for making treatment decisions related to various oncology drugs, as evidenced by the FDA's classification of these assays based on associated risks. This acknowledgment underscores the strategic importance of companion diagnostics in oncology, emphasizing their role as critical elements in informed and risk-assessed treatment decisions.
The increasing burden of cancer in the United States is also expected to drive the market. For instance, according to a report published by the Cancer Journal for Clinicians1 in January 2024, about 313,510 breast cancer cases, 152,810 colorectal cancer cases, and 66,440 pancreatic cancer cases were estimated in the United States in 2024. The incidence of cancer has also been rising in Canada, which is expected to boost the demand for companion diagnostics tests in the market. For instance, according to a report published by Canadian Cancer Statistics in November 2023, about 239,100 new cancer cases were estimated to be diagnosed in Canada in 2023, compared to 233,900 new cancer cases in 2022. This data shows the increasing burden of cancer in the region, which is expected to boost the demand for companion diagnostics.
Product launches, strategic collaborations, partnerships, and product approvals by the government are expected to drive the North American companion diagnostics market over the forecast period. In June 2023, the US FDA initiated a new voluntary pilot program for certain oncology drug products used with certain corresponding in vitro diagnostic tests to help clinicians select appropriate cancer treatments for patients. Similarly, in June 2022, GRAIL LLC, a healthcare company, signed a strategic collaboration with AstraZeneca to develop and commercialize companion diagnostic (CDx) assays for use with AstraZeneca’s therapies. The company focuses on developing companion diagnostic tests to identify patients with high-risk, early-stage disease. Such developments are expected to positively impact the regional market’s growth.
The increasing burden of cancer, rising product launches, and growth strategies by major players are expected to significantly boost the region’s share in the global companion diagnostics market.
