U.S. Companion Diagnostics (CDx) Development Market Size Worth USD 872.89 Million by 2034 | CAGR: 7.8%

The U.S. companion diagnostics (CDx) development market size is expected to reach USD 872.89 million by 2034, according to a new study by Polaris Market Research. The report “U.S. Companion Diagnostics (CDx) Development Market Size, Share, Trends, Industry Analysis Report By Type of Service (Feasibility Studies, Assay Development), By Analytical Technique, By Target Therapeutic Area, By End User – Market Forecast, 2025–2034” gives a detailed insight into current market dynamics and provides analysis on future market growth.

The U.S. companion diagnostics (CDx) development market focuses on creating and gaining approval for specialized diagnostic tests that are directly linked to the safe and effective use of specific medicines. These tests are vital for personalized medicine, helping healthcare professionals identify patients who are most likely to benefit from a particular drug, those who might face serious side effects, or to monitor how well a treatment is working. This co-development of drugs and their accompanying diagnostics ensures that therapies are precisely targeted, leading to better patient outcomes and more efficient treatment strategies.

The U.S. companion diagnostics development market is growing steadily, primarily driven by the increasing shift toward personalized medicine and the rising global burden of complex diseases such as cancer. Technological advancements in areas such as genomics and molecular biology are enabling the discovery of new biomarkers, which fuels the development of more precise and sophisticated CDx tests. Additionally, the supportive regulatory environment in the U.S., including clear guidelines from agencies such as the FDA, encourages companies to invest in the research, development, and commercialization of these essential diagnostic tools. This combination of scientific innovation, medical need, and regulatory facilitation paints a promising outlook for the continued expansion of the market.

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U.S. Companion Diagnostics (CDx) Development Market Report Highlights

• By type of service, the clinical validation segment held the largest share in 2024 as it represents the crucial final stage of CDx development where the diagnostic's effectiveness and reliability are thoroughly proven in real patient settings.
• By analytical technique, the PCR segment held the largest share in 2024 due to its established history in clinical diagnostics, particularly for detecting infectious diseases and genetic conditions. Its high sensitivity, specificity, and relatively faster turnaround times make it a go-to method for detecting specific genetic markers vital for guiding targeted therapies, especially in oncology, securing its prominent market position.
• By target therapeutic area, the oncological disorders segment held the largest share in 2024, as cancer's complex and diverse nature heavily relies on oncology companion diagnostics to identify specific biomarkers for targeted drug therapies.
• By end user, the industry players segment, primarily pharmaceutical and biotechnology companies, held the largest share in 2024, as they are the main drivers of new drug development, particularly targeted therapies, which often require co-developed companion diagnostics.
• A few key players in the market include F. Hoffmann-La Roche Ltd.; Thermo Fisher Scientific Inc.; QIAGEN; Abbott Laboratories; Illumina; Myriad Genetics, Inc.; Agilent Technologies, Inc.; Guardant Health, Inc.; bioMérieux, Inc.; and Sysmex Corporation.

Polaris Market Research has segmented the U.S. companion diagnostics (CDx) development market report based on type of service, analytical technique, target therapeutic area, and end user:

By Type of Service Outlook (Revenue – USD Million, 2020–2034)

• Feasibility Studies
• Assay Development
• Analytical Validation
• Clinical Validation
• Manufacturing

By Analytical Technique Outlook (Revenue – USD Million, 2020–2034)

• NGS
• PCR
• IHC
• Flow Cytometry
• Others

By Target Therapeutic Area Outlook (Revenue – USD Million, 2020–2034)

• Oncological Disorders
• Non-oncological Disorders

By End User Outlook (Revenue – USD Million, 2020–2034)

• Industry Players
• Non-Industry Players