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

Market Overview

The U.S. companion diagnostics (CDx) development market was valued at USD 412.84 million in 2024 and is anticipated to register a CAGR of 7.8% from 2025 to 2034. The market is mainly driven by the increasing demand for personalized medicine due to the rising prevalence of cancer and other chronic diseases.

Key Insights

• 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 amplifying DNA sequences, widespread use in detecting infectious diseases, and inherent reliability in molecular diagnostics across clinical, research, and forensic applications. 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, oncological disorders 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.

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The U.S. companion diagnostics development market involves the creation and approval of specialized diagnostic tests that are essential for the safe and effective use of particular medicines. These tests help doctors determine which patients will benefit most from a specific drug, identify those who may be at risk for serious side effects, or track how well a treatment is working.

Rapid advancements in genomic and molecular biology technologies are a primary force propelling the U.S. CDx development market expansion. These innovations include high-throughput sequencing methods such as Next-Generation Sequencing (NGS), advanced digital PCR techniques, and improved bioinformatics tools for data analysis. These technologies allow researchers to identify and understand disease-specific biomarkers with unprecedented precision and speed. The ability to comprehensively profile a patient's genetic and molecular makeup enables the development of highly targeted diagnostic tests that can pinpoint the exact molecular alterations driving a disease, leading to more effective and personalized treatment strategies. This continuous innovation makes it possible to discover new biomarkers and develop more sophisticated CDx.

A supportive and evolving regulatory landscape, particularly from the U.S. Food and Drug Administration (FDA), is a critical driver for the U.S. companion diagnostics development market. The FDA has established clear guidelines and processes for the co-development and approval of companion diagnostics alongside therapeutic products. This structured approach provides clarity and predictability for diagnostic and pharmaceutical companies, encouraging them to invest in CDx development. The agency's commitment to expediting the review of these essential tools, especially for conditions with unmet medical needs, helps bring innovative CDx to patients faster. This regulatory support ensures the safety and effectiveness of CDx and facilitates their integration into clinical practice.

Industry Dynamics

• The growing adoption of personalized medicine is significantly driving the demand for companion diagnostics development, as they enable targeted and effective treatment approaches.
• The rising prevalence of cancer and other chronic diseases is increasing the need for diagnostic tools that can guide therapy selection and improve patient outcomes.
• Technological advancements in genomics and molecular biology are enhancing the development and precision of companion diagnostic tests.
• A favorable regulatory landscape and increased support from health authorities are facilitating the development and approval of companion diagnostics in the U.S. market.

Rising Prevalence of Cancer and Chronic Diseases: The increasing incidence of cancer and other chronic diseases is a significant driver for the U.S. companion diagnostics development market. As more individuals are diagnosed with these complex conditions, there is a growing need for treatments that are effective and highly specific to the patient's unique biological makeup. CDx plays a critical role in this by helping doctors select therapies that are most likely to work and avoid those that might be ineffective or cause harmful side effects. This tailored approach leads to better patient outcomes and more efficient use of healthcare resources.

The National Cancer Institute (NCI) stated in their "Cancer Statistics" overview, updated in May 2025, that the rate of new cancer cases in the U.S. was 445.8 per 100,000 men and women per year, based on data from 2018 to 2022. This consistent high rate of cancer diagnoses highlights the continuous and urgent demand for advanced diagnostic tools such as CDx to guide treatment decisions for a growing patient population. The ongoing rise in cancer cases globally is therefore a key factor driving the demand and development in the companion diagnostics market.

Advancements in Genomic and Molecular Biology Technologies: Significant advancements in genomic and molecular biology technologies are driving the U.S. companion diagnostics development market growth. These technological leaps allow for a much deeper understanding of diseases at a molecular level, enabling the identification of specific biomarkers that can predict how a patient will respond to certain medications. Techniques such as next-generation sequencing (NGS) can analyze multiple genes quickly and affordably, paving the way for more precise diagnostic tests. This ability to uncover intricate genetic information is vital for the design and validation of new companion diagnostics.

A publication in the National Center for Biotechnology Information (NCBI) titled "Genomic Sequencing and the Impact of Molecular Diagnosis on Patient Care," published in 2015, noted that evolving sequencing technologies allow for more accurate, efficient, and affordable genomic analysis, becoming increasingly available for molecular diagnoses in patients with suspected genetic disorders. Such technological progress in genetic sequencing directly supports the development of more sophisticated CDx by making it feasible to discover and validate the specific genetic markers needed for targeted therapies. This continuous innovation in genomic and molecular biology is therefore a crucial factor boosting the growth and capabilities of the market.

Segmental Insights

Type of Service Analysis

Based on type of service, the U.S. companion diagnostics development market segmentation includes feasibility studies, assay development, analytical validation, clinical validation, and manufacturing. The clinical validation segment held the largest share in 2024. This dominance is attributed to its critical role in the final stages of CDx development, where the diagnostic's accuracy, reliability, and clinical utility are rigorously proven. Before a companion diagnostic can be approved and widely used, extensive clinical studies are required to show that it accurately identifies patients who will benefit from a specific therapy and those who might experience adverse reactions. This process involves testing the diagnostic in real-world patient populations, comparing its results with patient outcomes, and gathering substantial data to support its claims. The high regulatory hurdles and the need for robust evidence to ensure patient safety and treatment efficacy contribute significantly to the substantial investment and activity within this service area.

The analytical validation segment is anticipated to register the highest growth rate during the forecast period. This anticipated surge is driven by several factors, including the increasing complexity of new biomarkers and diagnostic technologies, especially those involving advanced genomic and proteomic analyses. As personalized medicine evolves, the diagnostics being developed are becoming more intricate, requiring more rigorous and sophisticated analytical validation to ensure their precision, sensitivity, and specificity. This stage involves confirming that the test accurately measures the intended biomarker, is reproducible, and performs consistently under various conditions.

Analytical Technique Analysis

Based on analytical technique, the U.S. companion diagnostics development market segmentation includes NGS, PCR, IHC, flow cytometry, and others. The PCR segment held the largest share in 2024 due to PCR's long-standing history, widespread use, and established reliability in molecular diagnostics. PCR-based tests are extensively used in clinical diagnostics, particularly for detecting infectious diseases, genetic disorders, and cancer biomarkers. In oncology, PCR helps identify specific gene mutations or expressions that guide personalized treatment strategies. It is also widely applied in research laboratories, forensic science, and public health surveillance. Its high sensitivity, specificity, relatively low cost, and quick results make it a preferred technique across various healthcare and scientific applications.

The Next-Generation Sequencing (NGS) segment is anticipated to witness the highest growth rate during the forecast period. This rapid growth is fueled by NGS's ability to analyze multiple genes simultaneously and efficiently, providing a comprehensive genomic profile of a patient's disease. As personalized medicine advances, there is a rising need to identify a broader range of biomarkers and genetic alterations that influence treatment response across various diseases, not just single mutations. NGS offers the capability to detect low-frequency variants and to explore novel biomarkers, which is essential for developing next-generation targeted therapies.

Target Therapeutic Area Analysis

Based on target therapeutic area, the U.S. companion diagnostics development market segmentation includes oncological disorders and non-oncological disorders. The oncological disorders segment held the largest share in 2024. This is primarily due to the complex and heterogeneous nature of cancer, which often requires highly specific and personalized treatment approaches. Companion diagnostics are essential in oncology for identifying particular genetic mutations, protein expressions, or other biomarkers in a tumor that indicate how a patient will respond to certain targeted cancer therapies. The development of numerous targeted oncology drugs, each requiring a specific diagnostic test to ensure efficacy and minimize adverse effects, has driven significant investments and innovation in this area.

The non-oncological disorders segment is anticipated to register the highest growth rate during the forecast period. While oncology has historically been the primary focus for CDx, there is a growing recognition of the value of personalized medicine in other therapeutic areas. This expansion is driven by advancements in understanding the molecular basis of diseases beyond cancer, such as neurological disorders, cardiovascular diseases, and infectious diseases. As researchers identify more predictive biomarkers for these conditions, the need for companion diagnostics to guide treatment decisions in non-oncological areas will increase significantly.

End User Analysis

Based on end user, the segmentation includes industry players and non-industry players. The industry players segment held a larger share in 2024. These companies are at the forefront of developing new drugs, especially targeted therapies, and CDx is an integral part of their drug development process. The co-development of a drug and its companion diagnostic ensures that the right patients receive the right treatment, which is crucial for regulatory approval and market success. Pharmaceutical and biotech firms invest heavily in research and development to discover new biomarkers and create associated diagnostic tests, often collaborating with specialized diagnostic companies.

The non-industry players segment, which includes hospitals, academic research centers, and reference laboratories, is anticipated to register the highest growth rate during the forecast period. This growth is driven by the increasing adoption of personalized medicine in routine clinical practice and the rising demand for in-house testing capabilities. As more CDx receive regulatory approval and become available, hospitals and reference laboratories are expanding their infrastructure and expertise to perform these tests themselves, rather than solely relying on external services. Academic centers also contribute to this growth through their research initiatives in biomarker discovery outsourcing and validation.

Key Players and Competitive Insights

The U.S. companion diagnostics development market is characterized by a mix of established diagnostic companies, large pharmaceutical firms, and specialized biotech companies. A few major players in this space include Roche Diagnostics, Thermo Fisher Scientific, QIAGEN, Abbott Laboratories, Illumina, Myriad Genetics, and Foundation Medicine. These companies compete based on factors such as technological innovation, the breadth of their diagnostic portfolios, strategic partnerships with drug developers, and regulatory approvals. The competitive landscape is dynamic, with ongoing collaborations between diagnostic and pharmaceutical companies to co-develop CDx alongside new drug therapies. Companies are also investing heavily in advanced technologies such as next-generation sequencing (NGS) to offer more comprehensive genomic profiling solutions, which are becoming increasingly vital for personalized medicine.

A few prominent companies in the industry 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.

Key Players

• Abbott Laboratories
• Agilent Technologies, Inc.
• bioMérieux, Inc.
• F. Hoffmann-La Roche Ltd.
• Guardant Health, Inc.
• Illumina, Inc.
• Myriad Genetics, Inc.
• QIAGEN
• Sysmex Corporation

Industry Developments

May 2025: Roche's Itovebi received a positive recommendation from the Committee for Medicinal Products for Human Use (CHMP) for EU approval for PIK3CA-mutated, ER-positive, HER2-negative advanced breast cancer.

U.S. Companion Diagnostics Development Market Segmentation

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

U.S. Companion Diagnostics Development Market Report Scope: