Companion Diagnostics (CDx) Market - Forecasts from 2024 to 2029

The companion diagnostics (CDx) market is predicted to grow at a CAGR of 11.54%, increasing from US$7.120 billion in 2024 to US$12.293 billion in 2029.

A companion diagnostic (CDx) device is a medical device that enables the user to receive crucial information regarding the use of corresponding drugs or biological products. The prime reason driving the market growth is the rising prevalence of cancer and other chronic diseases, which is increasing the market adoption of companion diagnostics. Furthermore, increasing innovations in cancer treatment therapies and available technology, coupled with the demand for precision medicine, have created notable opportunities for companion diagnostic devices.

Based on geography, the companion diagnostics market is segmented into North America, South America, Europe, the Middle East and Africa, and the Asia Pacific.  The Asia Pacific region is forecasted to hold a substantial market share owing to a surge in medical tourism and advancement in the medical sector. The North American and European regions are also projected to hold the largest market share with increased healthcare spending.

Companion Diagnostics (CDx) Market Drivers:

Rising cancer prevalence has propelled the companion diagnostics market growth.

Companion diagnosis notably helps in cancer diagnosis and treatment as the device facilitates identifying a specific therapeutic solution for an individual based on his/her cancer profile.  CDx establishes certain parameters that assist in analyzing treatment efficacy and its side effects on the patient’s health. The booming cancer prevalence globally is expected to drive notable demand for companion diagnostic devices.

According to the World Health Organization’s data, in 2022, nearly 20 million new cancer cases were reported globally, with death cases reaching up to 9.7 million. The same sources specified that by 2050, the frequency of new cancer cases will reach up to 35 million, thereby showcasing a massive 77% jump in comparison to 2022. The rise in cancer cases is expected to surge the demand for diagnosis and treatment, supporting the companion diagnostics market.

Ongoing innovations in CDx to bolster cancer treatment have provided new growth prospects for the market.

Cancer has become one of the major causes of death globally. With the constant rise in the strength of new cases, the demand for more precise and effective treatment is also growing, providing new scope for modern approaches and technological innovations.

Hence, CDx provides the medium for identifying such innovations and measuring their effectiveness in cancer treatment. Various companies are observing such ongoing trends and investing in innovations, strategic collaborations, and launches.

For instance, in July 2024, Foundation Medicine Inc. received the Food and Drug Administration’s approval for its “FoundationOne®Liquid CDx,” which would be used for the treatment of BRCA-mutated metastatic castration-resistant prostate cancer patients. Likewise, in March 2024, Bayer AG and Thermo Fisher Scientific collaborated to develop next-generation sequencing-based CDx assays, which would assist in identifying precision cancer therapies. 

Companion Diagnostics (CDx) Market Segment Analysis

A next-generation sequencing companion diagnostic is expected to hold a notable market share.

Based on technology, the companion diagnostic market can be distinguished into polymerase chain reaction, immunohistochemistry, in-situ hybridization, and next-generation sequencing. A next-generation sequencing companion diagnostic is expected to hold a significant market share, owing to its technological effectiveness and better market prospects.

Lung and Breast Cancer indication is expected to dominate the market for companion diagnostics.

By indication, the companion diagnostic market can be segmented into lung, breast, and colorectal cancer. Lung cancer indication is expected to dominate the companion diagnostic market owing to a higher number of cases. As per the data provided by the World Health Organization, in 2022, lung cancer accounted for 12.4% of the new cancer cases reported globally and was also the leading cause of death.

Breast cancer and colorectal cancer are expected to show positive growth during the given timeframe. As per the same source, in 2022, breast cancer-related new cases stood at 2.3 million, which accounted for 11.6% of the total new cases. Likewise, colorectal cancer constituted 9.6% of new cases.

North America is anticipated to account for a considerable market share.

Geography-wise, the North American market is projected to constitute a considerable market share fueled by the growing prevalence of cancer in major regional economies, namely the United States. For instance, according to the American Cancer Society, in 2023, the estimated number of new cancer cases in the USA stood at 1,958,310, which signified a 2.1% increase in new cases, and the number of deaths reached 609,820. Major cancer breast cancer witnessed a 3.4% growth in comparison to new cases reported in 2022.

Likewise, the ongoing development in therapeutic therapies and precision medicine followed by the well-established presence of market players. For instance, Abbott, Illumina Inc., and Thermofisher Scientific, which have actively participated in CDx development, are also driving the regional market expansion.

The European and Asia Pacific regions are poised for steady growth, which is attributable to ongoing investments in cancer detection and treatment. Hence, major governing authorities and cancer research institutes are collaborating on this front, which has provided new growth prospects for the regional markets.

Companion Diagnostics (CDx) Key Market Development:

• In January 2024, Labcorp received approval from the U.S. Food and Drug Administration for the company’s companion diagnostics product, “nAbCyte™ Anti-AAVRh74var HB-FE Assay”. It is designed to determine the patient’s eligibility for treatment with Pfizer’s FDA-approved hemophilia B gene therapy product “BEQVEZ.”
• In January 2024, Agilent Technologies formed an agreement with Incyte to leverage the former’s technical expertise and global regulatory approvals to support the development and commercialization of companion diagnostics (CDx) for oncology and Hematology in the European and US markets. The collaboration has furthered the development of precision medicine products. 
• In November 2023, Foundation Medicine Inc. received FDA approval for its “FoundationOne®CDx,” which would be used along with “Truqap™” to treat hormone receptor-positive breast cancer patients. The approval has supported the development of new targeted treatment options for these specific cancer patients.
• In May 2022, Illumina Inc. launched its new pan-cancer CDx that detects multiple tumor genes, thereby identifying patients who are positive for the NTRK (Neurotrophic Tyrosine Receptor Kinase) gene fusion, which includes NTRK1, NTRK2, and NTRK3.

The Companion Diagnostics (CDx) market is segmented and analyzed as follows:

By Technology

• Polymerase Chain Reaction (PCR)
• Immunohistochemistry (HC)
• In-Situ Hybridization (ISH)
• Next Generation Sequencing (NGS)

By Indication

• Lung Cancer
• Breast Cancer
• Colorectal Cancer
• Others

By Geography

• North America
• United States
• Canada
• Mexico
• South America
• Brazil
• Argentina
• Others
• Europe
• Germany
• France
• United Kingdom
• Italy
• Others
• Middle East and Africa
• Saudi Arabia
• Israel
• Others
• Asia Pacific
• China
• India
• Japan
• South Korea
• Others