Companion Diagnostics Market (2026 - 2033) Size, Share & Trends Analysis Report By product And service (Assays, Kits, And Reagents, Instruments And Systems, Software And Services), By Indication, By Technology, By Sample Type, By End-use, By Region, And Segment Forecasts

Companion Diagnostics Market Summary

The global companion diagnostics market size was estimated at USD 9.56 billion in 2025 and is projected to reach USD 20.05 billion by 2033, growing at a CAGR of 10.07% from 2026 to 2033. Growth is supported by increasing demand for precision medicine and the rising prevalence of cancer, cardiovascular diseases, and autoimmune disorders, which are contributing to the need for targeted therapies.

The transition from a one-size-fits-all treatment approach to personalized medicine continues to support the expansion of the companion diagnostics market. In addition, pharmaceutical companies are increasingly integrating companion diagnostics into drug development pipelines to improve the success rate of novel therapeutics, further contributing to the growth of the companion diagnostics industry.

Rapid advancements in diagnostic technologies are supporting the expansion of the companion diagnostics industry. Innovations in next-generation sequencing (NGS), polymerase chain reaction (PCR), and digital pathology have improved the accuracy and efficiency of biomarker identification. These technologies enable faster and more precise detection of genetic mutations and protein expression, which are essential for personalized treatment decisions. In addition, artificial intelligence (AI) and machine learning (ML) are enhancing diagnostic accuracy and data interpretation, supporting more informed clinical decision-making. The growing adoption of these advanced diagnostic tools across research laboratories and healthcare institutions is contributing to market growth, as providers increasingly focus on delivering precise and data-driven patient care.

Regulatory support and favorable reimbursement policies are also contributing to the market growth. Government agencies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have established clear regulatory pathways to facilitate the approval of companion diagnostic tests alongside targeted therapies. The increasing number of FDA-approved companion diagnostics is indicative of the growing acceptance of personalized medicine. For instance, in October 2024, Roche announced that its VENTANA Assay had become the first immunohistochemistry (IHC) companion diagnostic approved by the U.S. Food and Drug Administration (FDA) for assessing CLDN18 protein expression in tumors of patients with gastric or gastroesophageal junction adenocarcinoma. This approval enables eligible patients to receive treatment with Astellas' targeted therapy, VYLOY. Additionally, reimbursement policies are evolving to accommodate the cost of these advanced diagnostics, making them more accessible to patients. As regulatory bodies continue to support the co-development of drugs and diagnostics, pharmaceutical and biotech companies are investing heavily in developing new companion diagnostic tests to enhance treatment precision and market penetration.

The rising prevalence of oncology-related diseases is another significant factor driving the growth of the companion diagnostics industry. Cancer remains one of the leading causes of death worldwide, and companion diagnostics play a vital role in oncology treatment by identifying genetic mutations that guide the selection of targeted therapies. Cancer remains a significant health challenge and a leading cause of mortality in the 21st century. According to a study published in The Lancet in September 2025, findings from the Global Burden of Disease (GBD) 2023 study indicate that cancer burden was assessed across 47 cancer types in 204 countries and territories from 1990 to 2023, with projections extending to 2050. Cancer was estimated to be the second leading cause of death globally in 2023, following cardiovascular diseases, with total cancer-related deaths projected to exceed 18 million by 2050.

Companies such as Roche Diagnostics, Thermo Fisher Scientific, and Qiagen are actively investing in companion diagnostics for various cancer types, including lung, breast, and colorectal cancer. The increasing incidence of these cancers has driven a greater demand for early and accurate diagnosis, prompting healthcare providers to integrate companion diagnostics into routine clinical practice. As precision oncology continues to gain traction, the market for companion diagnostics is expected to expand further, driven by the need for better treatment outcomes and reduced healthcare costs.

List of Cleared or Approved Companion Diagnostic Devices

Market Concentration & Characteristics

The companion diagnostics market is witnessing continuous innovation, supported by advancements in genomics, proteomics, and precision medicine. Technologies such as next-generation sequencing (NGS), artificial intelligence (AI), digital PCR (dPCR), and multiplex PCR are improving diagnostic accuracy and enabling comprehensive biomarker detection. Liquid biopsy is gaining adoption for non-invasive analysis of circulating tumor DNA (ctDNA) and real-time disease monitoring. For instance, in September 2025, Guardant Health received approval from the U.S. Food and Drug Administration for Guardant360 CDx, enabling liquid biopsy-based detection of ESR1 mutations and targeted breast cancer therapy selection. In addition, bioinformatics and advanced analytics are accelerating biomarker discovery and validation. The expanding use of companion diagnostics in immuno-oncology, along with their integration into clinical trials and drug development, is enhancing patient stratification, improving treatment precision, and contributing to better clinical outcomes.

Mergers and acquisitions (M&A) are shaping the companion diagnostics industry as companies seek to expand their technological capabilities and market reach. Pharmaceutical and diagnostics firms are increasingly acquiring biotech companies to integrate novel biomarker technologies. Collaborations between diagnostic companies and pharmaceutical firms are also increasing, with a focus on developing co-approved therapies. These strategic initiatives strengthen market positioning and accelerate the development of advanced diagnostic solutions. For instance, in December 2025, Guardant Health acquired MetaSight Diagnostics Ltd for approximately USD 149 million, strengthening its capabilities in advanced cancer diagnostics and biomarker analysis. This acquisition enhances Guardant’s liquid biopsy and data analytics platform, which are directly applied in the development of companion diagnostics for targeted therapies. The integration of MetaSight’s technology supports improved genomic profiling and patient stratification, reinforcing the role of precision diagnostics in oncology and accelerating the advancement of companion diagnostics solutions.

Regulatory frameworks significantly influence the growth of the companion diagnostics market. Stringent approval processes by agencies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) ensure the safety and efficacy of diagnostics associated with targeted therapies. The regulatory landscape continues to evolve to accommodate innovative diagnostic solutions, with more streamlined approval pathways being introduced. Compliance with these regulatory requirements remains essential for market entry, influencing product development strategies and maintaining high standards in precision medicine.

The global adoption of companion diagnostics is increasing, with emerging markets such as Asia Pacific and Latin America witnessing notable growth. Rising healthcare investments, improving regulatory frameworks, and growing awareness of precision medicine are supporting this expansion. Key players are establishing partnerships and research collaborations in these regions to strengthen their presence. As access to advanced diagnostic technologies continues to improve globally, the market is expected to experience sustained geographical expansion.

Product And Service Insights

The assays, kits, and reagents segment led the companion diagnostics market with a 59.17% share in 2025, supported by increasing demand for personalized medicine and targeted therapies. These components play a crucial role in detecting specific biomarkers that determine patient eligibility for precision treatments, particularly in oncology, cardiovascular diseases, and rare genetic disorders. The expansion of next-generation sequencing (NGS) and polymerase chain reaction (PCR)-based assays has further supported market growth by enabling rapid, accurate, and high-throughput testing. Pharmaceutical and biotechnology companies are increasing investments in companion diagnostics to support regulatory approvals and improve treatment outcomes. The growing adoption of in vitro diagnostics (IVD) and immunohistochemistry (IHC) assays is also driving market expansion. Additionally, regulatory agencies such as the U.S. Food and Drug Administration and the European Medicines Agency continue to approve new CDx assays, supporting market penetration.

The software and services segment is projected to grow at the fastest CAGR over the forecast period, driven by the increasing need for advanced data analysis, regulatory compliance, and test development support. Companies such as Labcorp and Q2 Solutions offer specialized services for companion diagnostics development, assisting pharmaceutical companies in designing, validating, and commercializing diagnostic tests. These providers play a critical role in ensuring regulatory compliance while enabling efficient biomarker identification and clinical trial integration. For instance, in March 2026, GenDx collaborated with Treos Bio to develop an integrated HLA-based companion diagnostic for cancer immunotherapy. This collaboration combines NGS-based HLA typing software with predictive analytics platforms to support accurate patient stratification and response prediction. Such developments highlight the growing importance of bioinformatics, AI-driven analytics, and integrated software solutions in advancing companion diagnostics and precision oncology workflows.

Indication Insights

The oncology segment dominated the companion diagnostics industry with a 56.46% share in 2025, supported by the increasing global cancer burden and growing demand for personalized medicine. Companion diagnostics play a critical role in identifying biomarkers that guide targeted therapy selection, improving clinical outcomes for cancer patients. Advancements in next-generation sequencing (NGS), immunohistochemistry (IHC), and liquid biopsy technologies are further supporting market expansion by enabling precise and minimally invasive detection of genetic alterations. According to data published by the World Health Organization in March 2026, approximately 400,000 children develop cancer annually worldwide, while overall cancer incidence remains high, reinforcing the need for effective diagnostic solutions. The continued development of targeted therapies across major cancer types, including lung, breast, and colorectal cancers, is increasing the demand for companion diagnostics. In addition, rising regulatory approvals are supporting market expansion. For instance, in December 2025, Foundation Medicine achieved a milestone of 100 approved companion diagnostic indications across its FoundationOne CDx and FoundationOne Liquid CDx platforms in the United States and Japan, highlighting the expanding role of NGS-based companion diagnostics in biomarker-driven therapy selection and precision oncology.

The cardiovascular disease segment is expected to grow at the fastest CAGR over the forecast period, supported by the increasing global burden of cardiovascular disorders and a growing focus on precision medicine-based treatment strategies. Companion diagnostics in cardiovascular care are being increasingly explored to guide therapy selection, optimize drug response, and support risk stratification through biomarker-driven approaches. Advances in genomic profiling, pharmacogenomics, and molecular diagnostics are enabling the identification of clinically actionable biomarkers associated with conditions such as thrombosis, cardiomyopathies, and heart failure. As per an article on pharmacogenomics in cardiovascular therapy, genetic testing for drugs such as clopidogrel (CYP2C19 genotype) and warfarin (CYP2C9 and VKORC1 genotypes) is increasingly being incorporated into clinical decision-making to guide therapy selection and optimize dosing. These biomarker-based approaches support personalized treatment strategies, reduce adverse drug reactions, and improve clinical outcomes.

Technology Insights

The Polymerase Chain Reaction (PCR) segment dominated the companion diagnostics market in 2025, holding a 27.67% share. Real-time PCR assays are widely used for their high specificity and sensitivity, making them a preferred method for detecting cancer biomarkers. In clinical laboratories, real-time PCR enables simultaneous gene analysis, cost-effective reagent use, internal controls, and sample preservation for tumor profiling. For instance, in November 2025, Thermo Fisher Scientific received approval from the U.S. Food and Drug Administration (FDA) for its Oncomine Dx Express Test as a companion diagnostic for non-small cell lung cancer, supporting rapid biomarker detection and targeted therapy selection. This development highlights the growing adoption of advanced molecular assay-based companion diagnostics in clinical settings.

The Next-Generation Sequencing (NGS) segment is projected to grow at the fastest CAGR during the forecast period. The adoption of NGS technology has significantly advanced cancer biomarker discovery, supporting tumor genomics, transcriptomics, and epigenomics research. NGS enables the detection of low-frequency mutations, the simultaneous identification of single nucleotide polymorphisms (SNPs) and structural variants, high-throughput analysis, and rapid turnaround times, driving its increasing use in companion diagnostics. These capabilities position NGS as a critical tool for tumor stratification and precision oncology. For instance, in September 2025, Illumina partnered with multiple pharmaceutical companies to develop companion diagnostics based on its TruSight Oncology comprehensive genomic profiling platform, focusing on KRAS biomarker detection to support targeted therapy selection and clinical trial matching.

Sample Type Insights

Tissue samples held the largest market share of 62.58% in 2025, supported by the widespread adoption of biomarker-based tissue testing for targeted therapies. Tissue samples play a critical role in identifying genetic mutations and protein expression in solid tumors, guiding precision medicine in oncology. Techniques such as immunohistochemistry (IHC), in situ hybridization (ISH), and polymerase chain reaction (PCR) are widely used to analyze tissue specimens, ensuring accurate diagnosis and treatment selection. Regulatory approvals for tissue-based companion diagnostics continue to support market expansion. For instance, in 2025, Roche expanded its VENTANA immunohistochemistry-based companion diagnostic portfolio to support the detection of CLDN18.2 protein expression in gastric cancer, enabling targeted therapy selection. The increasing prevalence of cancer and chronic diseases, along with advancements in molecular pathology, is further driving demand for tissue-based companion diagnostics. As precision medicine continues to expand, the tissue sample segment is expected to maintain its dominant position in the market.

The blood samples segment is expected to grow at the fastest CAGR over the forecast period, supported by the increasing adoption of liquid biopsy techniques for non-invasive cancer diagnostics. Blood-based companion diagnostics enable the detection of circulating tumor DNA (ctDNA), circulating tumor cells (CTCs), and other biomarkers, providing a minimally invasive alternative to traditional tissue biopsies. This approach is particularly beneficial for patients who are unable to undergo invasive procedures due to tumor location or underlying health conditions. Advancements in next-generation sequencing (NGS) and polymerase chain reaction (PCR) technologies are enhancing the sensitivity and accuracy of blood-based testing, enabling real-time disease monitoring and assessment of therapy response. In addition, the rising prevalence of cancer and chronic diseases is further supporting the demand for blood-based companion diagnostics.

End Use Insights

In 2025, the hospitals and physician laboratories segment dominated the companion diagnostics industry, holding a 38.76% share. Hospitals typically offer a comprehensive range of cancer diagnostic tests to address the increasing cancer burden and aging populations. As companion diagnostics gain traction, hospitals are increasingly adopting advanced technologies to enhance early cancer detection and personalized treatment strategies. The evolution of hospital laboratories is supporting changing patient needs, prompting healthcare facilities to expand their diagnostic capabilities. Additionally, hospitals are investing in advanced diagnostic platforms and establishing collaborations with pharmaceutical companies to strengthen precision oncology services. For instance, in 2025, Northwestern Medicine collaborated with Tempus to expand genomic testing access for oncology patients, enabling broader integration of biomarker-driven insights into clinical decision-making and supporting the adoption of companion diagnostics in hospital settings.

The pharmaceutical and biotechnology companies segment is projected to grow at the fastest CAGR over the forecast period, supported by increasing investments in targeted therapies and precision medicine. These organizations are actively engaged in research and development, focusing on biomarker-driven drug discovery that requires accurate and reliable companion diagnostics. Companion diagnostics play a critical role in clinical trial design by enabling effective patient stratification, improving trial success rates, and supporting the development of safer and more efficacious therapies. Furthermore, the growing emphasis on co-development strategies has led pharmaceutical companies to collaborate with diagnostic manufacturers or establish in-house diagnostic capabilities to accelerate product development timelines. Regulatory agencies such as the U.S. Food and Drug Administration and the European Medicines Agency are also supporting integrated drug-diagnostic development through streamlined approval pathways. As partnerships, licensing agreements, and biomarker-focused R&D initiatives continue to expand, pharmaceutical and biotechnology companies are expected to play a key role in driving sustained market growth.

Regional Insights

North America dominated the global companion diagnostics market, accounting for a 39.92% share in 2025, supported by advanced healthcare infrastructure, strong adoption of precision medicine, and a well-established regulatory environment. The region benefits from the presence of leading pharmaceutical and biotechnology companies and extensive clinical research. The high prevalence of cancer and increasing demand for targeted therapies are supporting the integration of companion diagnostics into routine clinical practice. Favorable reimbursement frameworks and early adoption of advanced technologies such as next-generation sequencing (NGS) and liquid biopsy further strengthen market expansion. In addition, ongoing collaborations between diagnostic developers and drug manufacturers continue to accelerate the co-development of therapies and companion diagnostics.

U.S. Companion Diagnostics Market Trends

The U.S. accounts for the largest share of the North America companion diagnostics industry, driven by strong regulatory support from the U.S. Food and Drug Administration and widespread adoption of precision oncology. The country benefits from advanced laboratory infrastructure, high healthcare expenditure, and significant investments in research and development. Increasing cancer prevalence and growing demand for personalized therapies are encouraging the use of biomarker-based diagnostic approaches. The integration of companion diagnostics into clinical trials and drug approval pathways is strengthening their role in treatment decision-making. In addition, favorable reimbursement policies and continuous technological advancements are supporting sustained market growth.

Europe Companion Diagnostics Market Trends

The Europe companion diagnostics industry is witnessing steady growth, supported by increasing adoption of personalized medicine and strong healthcare systems. Regulatory oversight from the European Medicines Agency ensures the safety and performance of diagnostic and therapeutic products. The implementation of the In Vitro Diagnostic Regulation (IVDR) is strengthening requirements for clinical evidence and validation. Rising cancer incidence and growing awareness of targeted therapies are encouraging the use of companion diagnostics in clinical practice. In addition, collaborations between research institutions, healthcare providers, and industry participants are supporting innovation and improving access to advanced diagnostic technologies across the region.

The companion diagnostics market in the UK is expanding steadily, supported by strong public healthcare infrastructure and increasing focus on genomics-based medicine. Initiatives led by the National Health Service (NHS) are promoting the adoption of genomic testing and personalized treatment approaches. National sequencing programs are enabling early disease detection and improved patient stratification. The country’s focus on integrating diagnostics into clinical pathways is strengthening the role of companion diagnostics, particularly in oncology. In addition, collaborations between academic institutions and industry players are fostering innovation and supporting the development of biomarker-driven diagnostic solutions.

The Germany companion diagnostics market is growing steadily, supported by advanced healthcare infrastructure and a strong emphasis on medical research. The country benefits from a well-established network of diagnostic laboratories and high adoption of precision medicine approaches. Government support and favorable reimbursement policies are facilitating access to advanced diagnostic technologies. Increasing cancer prevalence and the growing use of targeted therapies are encouraging adoption in clinical settings. In addition, Germany’s strong pharmaceutical and biotechnology industry presence supports research collaborations and the development of innovative biomarker-based diagnostic solutions, contributing to overall market expansion.

Asia Pacific Companion Diagnostics Market Trends

The Asia Pacific companion diagnostics industry is witnessing rapid growth, driven by expanding healthcare infrastructure, increasing healthcare expenditure, and rising awareness of precision medicine. Countries across the region are investing in advanced diagnostic technologies and improving regulatory frameworks to support market development. The growing burden of cancer and chronic diseases is increasing demand for targeted therapies and associated diagnostics. In addition, the presence of a large patient population and the growing clinical research landscape are attracting global market players. Strategic partnerships and investments in genomics and molecular diagnostics are further supporting market expansion.

The companion diagnostics market in China is experiencing significant growth, driven by rapid healthcare modernization and increasing investments in biotechnology and precision medicine. Government initiatives supporting genomic research and local manufacturing are accelerating market development. The rising prevalence of cancer and improving access to healthcare services are increasing the demand for advanced diagnostic solutions. In addition, the presence of a large patient population and a growing number of clinical trials are attracting domestic and international companies. Regulatory reforms aimed at streamlining approval processes are further supporting market expansion.

Latin America Companion Diagnostics Market Trends

The Latin America companion diagnostics industry is growing gradually, supported by improving healthcare infrastructure and increasing awareness of precision medicine. Countries in the region are focusing on enhancing diagnostic capabilities and expanding access to advanced healthcare services. The rising burden of cancer and chronic diseases is driving demand for targeted therapies and companion diagnostics. Although challenges such as limited reimbursement and regulatory variability remain, increasing investments and collaborations with global players are supporting market development. The gradual adoption of molecular diagnostic technologies is contributing to market growth.

Middle East & Africa Companion Diagnostics Market Trends

The Middle East & Africa companion diagnostics industry is witnessing emerging growth, driven by increasing healthcare investments and efforts to modernize healthcare systems. Governments in several countries are focusing on improving access to advanced diagnostic technologies and strengthening healthcare infrastructure. The rising prevalence of cancer and chronic diseases is creating demand for targeted therapies and precision diagnostics. While the market is still developing, increasing collaborations with international companies and the establishment of specialized diagnostic centers are supporting growth. Additionally, growing awareness of personalized medicine is contributing to the gradual adoption of companion diagnostics across the region.

Key Companion Diagnostics Company Insights

Leading players in the market, such as Agilent Technologies, Inc., Illumina Inc., and Merck KGaA, are actively developing innovative Next-Generation Sequencing (NGS) products, panels, kits, and IHC systems that emphasize portability and sequencing efficiency. They invest heavily in research and development, often collaborating with pharmaceutical and biotechnology organizations to introduce new technologies. These companies boast robust product portfolios and consistently expand their R&D efforts. Emerging participants like Biosystems, Guardant Health, Inc., and EntroGen, Inc. are also making their mark. They are partnering with both major and local players to secure a competitive advantage, focusing on regional expansion and developing companion diagnostics, NGS platforms, and laboratory services to enhance clinical testing capabilities.

Recent Developments

• In September 2025, Thermo Fisher Scientific received approval from the FDA for the Oncomine Dx Express Test as a companion diagnostic to identify patients with EGFR exon 20 insertion mutations in non-small cell lung cancer. The test delivers rapid next-generation sequencing (NGS) results in approximately 24 hours, enabling faster and more accurate patient selection for targeted therapies. This advancement supports timely clinical decision-making and expands access to precision oncology by enabling decentralized testing across a broader range of clinical settings.

• In December 2025, Guardant Health acquired MetaSight Diagnostics Ltd for up to USD 149 million, strengthening its capabilities in genomic profiling, liquid biopsy, and biomarker analysis that directly support companion diagnostics development. This acquisition enhances Guardant Health’s ability to detect and interpret complex genomic alterations through advanced data analytics, improving the identification of clinically actionable biomarkers. It also supports the expansion of liquid biopsy applications for non-invasive cancer detection and real-time treatment monitoring. 

• In January 2025, Roche revealed that the FDA granted approval for a label expansion of the PATHWAY anti-Rabbit Monoclonal Primary Antibody*. This update enables the detection of patients with HR-positive, HER2-ultralow metastatic breast cancer who could qualify for treatment.

• In August 2024, the FDA approved Illumina's cancer biomarker test, featuring two companion diagnostics to swiftly match patients with targeted therapies. This test analyzes 500 genes to profile solid tumors, increasing the likelihood of identifying immunotherapy- or clinically actionable biomarkers. TSO Comprehensive is FDA-approved as a CDx for detecting NTRK gene fusions in solid tumors, aiding treatment with Bayer’s VITRAKVI (larotrectinib).

• In April 2024, Labcorp, a global provider of innovative laboratory services, announced that the FDA had approved its nAbCte Anti-AAVRh74var HB-FE Assay. This companion diagnostic (CDx) is designed to assess patient eligibility for treatment with BEQVZ™, Pfizer's newly FDA-approved gene therapy for hemophilia B.

Companion Diagnostics Market Report Scope

Global Companion Diagnostics Market Report Segmentation

This report forecasts revenue growth at the global, regional, and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2021 to 2033. For this study, Grand View Research has segmented the global companion diagnostics market report based on product & service, indication, technology, sample type, end use, and region:

• Product and Service Outlook (Revenue, USD Million, 2021 - 2033)

  • Assays, Kits, & Reagents

  • Instruments and Systems

  • Software and Services

• Indication Outlook (Revenue, USD Million, 2021 - 2033)

  • Oncology

  • Infectious Diseases

  • Cardiovascular Diseases

  • Neurological Disorders

  • Other Indications

• Technology Outlook (Revenue, USD Million, 2021 - 2033)

  • Polymerase Chain Reaction (PCR)

  • Next-generation Sequencing (NGS)

  • In-situ Hybridization (ISH)

  • Immunohistochemistry (IHC)

  • Magnetic Resonance Imaging (MRI)

  • Other Technology

• Sample Type Outlook (Revenue, USD Million, 2021 - 2033)

  • Tissue Samples

  • Blood Samples

  • Other Sample Types

• End Use Outlook (Revenue, USD Million, 2021 - 2033)

  • Academic & Research Centers

  • Hospitals & Physician Laboratories

  • CROs

  • Reference Laboratories

  • Pharmaceutical & Biotechnology Companies

  • Other End-use

• Regional Outlook (Revenue, USD Million, 2021 - 2033)

  • North America

    • U.S.

    • Canada

    • Mexico

  • Europe

    • UK

    • Germany

    • France

    • Italy

    • Spain

    • Denmark

    • Sweden

    • Norway

  • Asia Pacific

    • China

    • Japan

    • India

    • Australia

    • South Korea

    • Thailand

  • Latin America

    • Brazil

    • Argentina

  • Middle East and Africa (MEA)

    • South Africa

    • Saudi Arabia

    • UAE

    • Kuwait