Companion Diagnostics Market Size & Share 2026-2035

Companion Diagnostics Market Size

The global companion diagnostics market was valued at USD 7.9 billion in 2025 and is projected to grow from USD 8.7 billion in 2026 to USD 22.5 billion by 2035, expanding at a CAGR of 11.2%, according to the latest report published by Global Market Insights Inc. This substantial growth is driven by several key factors, including rising prevalence of cancer, growing incidences of adverse drug reactions, and growth of precision medicine.

Companion diagnostics (CDx) are medical diagnostic tests used to identify patients who are most likely to benefit from a specific targeted therapy or who may be at risk of adverse reactions. These tests detect biomarkers, genetic mutations, or protein expressions that guide treatment selection and support personalized medicine. Companion diagnostics are commonly used in oncology to match patients with the most effective therapies.

Leading companies in the companion diagnostics industry include Guardant Health, Thermo Fisher Scientific Inc., Illumina Inc., F. Hoffmann-La Roche Ltd., and QIAGEN N.V. These companies are strengthening their market presence by advancing companion diagnostics technologies, expanding their molecular diagnostics portfolios, and enhancing comprehensive genomic profiling capabilities. They are focused on improving biomarker detection sensitivity, increasing the accuracy of cancer diagnostics, and broadening the clinical applications of companion diagnostics across cancer screening, treatment selection, and disease monitoring.

The market has increased from USD 6 billion in 2022 and reached USD 7.2 billion in 2024, with a historic growth rate of 9.2%. The rising global burden of cancer is a major driver of the market, as precision medicine becomes increasingly important in oncology treatment. Companion diagnostics are essential for identifying patients who are most likely to benefit from targeted therapies, enabling healthcare providers to deliver personalized treatment strategies and improve clinical outcomes. As the number of cancer cases continues to grow, the demand for accurate biomarker testing and molecular diagnostics is increasing significantly. According to the World Health Organization (WHO), cancer was one of the leading causes of death worldwide, accounting for nearly 10 million deaths in 2022.

The most commonly diagnosed cancers in 2022 were lung cancer (2.5 million cases), breast cancer (2.3 million cases), colorectal cancer (1.9 million cases), prostate cancer (1.5 million cases), non-melanoma skin cancer (1.2 million cases), and stomach cancer (1.0 million cases). The high incidence of these cancers has accelerated the adoption of companion diagnostic tests that help detect specific genetic mutations, biomarkers, and molecular characteristics associated with targeted therapies. Consequently, the growing cancer population is expected to fuel sustained demand for companion diagnostics, supporting market growth over the forecast period.

Additionally, the growing adoption of precision medicine is a key driver of the market, as healthcare systems increasingly shift from a one-size-fits-all approach toward personalized treatment strategies. Precision medicine focuses on tailoring therapies based on an individual's genetic profile, disease characteristics, and biomarker status, enabling more effective and targeted interventions. Companion diagnostics play a crucial role in this approach by identifying specific biomarkers and genetic mutations that help determine the most suitable treatment for each patient. The expanding pipeline of targeted therapies, particularly in oncology, has significantly increased the need for companion diagnostic tests to support treatment selection and optimize clinical outcomes. These diagnostics help improve therapeutic efficacy, reduce adverse drug reactions, and avoid unnecessary treatments, thereby enhancing patient care and healthcare cost efficiency. Furthermore, advances in genomic sequencing technologies, biomarker discovery, and molecular testing have accelerated the integration of precision medicine into routine clinical practice. As pharmaceutical and biotechnology companies continue to develop personalized therapies, the demand for companion diagnostics is expected to rise substantially, making precision medicine a critical factor driving market growth throughout the forecast period.

Companion Diagnostics Market Trends

• The integration of companion diagnostics into drug development has emerged as a significant trend in the market. Pharmaceutical and biotechnology companies are increasingly incorporating biomarker-based diagnostic strategies during the early stages of drug discovery and clinical development. This approach enables the identification of patient populations most likely to respond to specific therapies, improving treatment efficacy and increasing the probability of successful clinical trial outcomes.
• As the pharmaceutical industry continues to focus on targeted therapies, particularly in oncology, companion diagnostics have become an integral component of the drug approval pathway. Companies are increasingly collaborating with diagnostic manufacturers to develop companion tests alongside novel therapeutics. Such co-development strategies help ensure that both the drug and the diagnostic test are available simultaneously upon regulatory approval, facilitating faster market adoption and optimized patient selection.
• The trend is further driven by the growing emphasis on precision medicine and value-based healthcare. By identifying patients who are most likely to benefit from treatment, companion diagnostics help reduce unnecessary drug exposure, minimize adverse events, and improve overall healthcare efficiency. This has encouraged pharmaceutical firms to invest in diagnostic partnerships and biomarker research to strengthen their product portfolios.
• Moreover, regulatory agencies are increasingly supporting the co-development of therapeutics and companion diagnostics, recognizing their role in enhancing treatment safety and effectiveness. As a result, the integration of companion diagnostics into drug development programs is becoming a standard practice across the pharmaceutical industry. This trend is expected to accelerate the commercialization of personalized therapies and drive sustained growth in the market over the coming years.

Companion Diagnostics Market Analysis

Based on the product, the market is segmented into consumables, instruments, and software and services. The consumables segment held a significant market share of 62.1% in 2025.

• Consumables include assay kits, reagents, antibodies, probes, cartridges, and other test-specific materials that are utilized during companion diagnostic procedures. These products form a fundamental component of molecular and genetic testing workflows by enabling the detection of biomarkers, gene mutations, and other disease-specific characteristics used to guide targeted treatment decisions. Their role is particularly critical in oncology and other precision medicine applications where accurate biomarker assessment is required for therapy selection and patient stratification.
• The growing adoption of biomarker-driven therapies, increasing volume of diagnostic testing, and expanding use of next-generation sequencing (NGS), polymerase chain reaction (PCR), and immunohistochemistry (IHC) technologies are contributing to segment growth. Continuous utilization of consumables throughout the testing cycle, coupled with the increasing number of approved companion diagnostic assays and targeted therapies, supports sustained demand across clinical laboratories, hospitals, and diagnostic centers.
• The companion diagnostics market from instruments segment accounted for USD 1.9 billion in 2025 and is projected to expand at a CAGR of 11.5% from 2026 to 2035. Instruments comprise the laboratory systems and analytical platforms used to perform companion diagnostic tests, including sequencing systems, PCR instruments, automated staining platforms, and molecular diagnostic analyzers. These technologies facilitate biomarker identification, genomic analysis, and molecular profiling, enabling healthcare professionals to support precision treatment decisions.
• The adoption of advanced diagnostic instruments has increased alongside the growing implementation of molecular testing in clinical practice. Technological developments in automation, throughput capabilities, and analytical accuracy have enhanced the efficiency of diagnostic workflows. Furthermore, the expanding utilization of precision medicine and biomarker-driven therapies has encouraged healthcare facilities and laboratories to strengthen their diagnostic infrastructure, contributing to the demand for companion diagnostic instruments.
• The software and services segment accounted for USD 1.1 billion in 2025 and is projected to expand to a CAGR of 11.9% from 2026 to 2035. Software and services include bioinformatics platforms, data management solutions, clinical decision-support tools, testing services, assay development, validation support, regulatory consulting, and other specialized offerings associated with companion diagnostics. These solutions assist healthcare providers, diagnostic laboratories, pharmaceutical companies, and research organizations in managing diagnostic workflows, analyzing complex biomarker data, and supporting clinical decision-making. Software platforms are increasingly utilized to process genomic and molecular information, enabling efficient interpretation of diagnostic results and facilitating personalized treatment selection.
• The growing volume of molecular and genomic data has increased the importance of software solutions and specialized services within the companion diagnostics ecosystem. The adoption of advanced analytics, artificial intelligence-based interpretation tools, and cloud-based data management platforms continues to enhance diagnostic efficiency and accuracy.

Based on therapy area, the companion diagnostics market is segmented into cancer, cardiovascular disease, neurological disease, and other therapy areas. The cancer segment held significant market share of 78.7% in 2025.  

• Companion diagnostics are extensively utilized in cancer care to identify specific biomarkers, genetic mutations, and molecular alterations that help determine a patient's eligibility for targeted therapies and immunotherapies. These diagnostics play a vital role in supporting personalized treatment strategies, improving treatment selection, and enhancing clinical outcomes across various cancer types.
• The increasing adoption of precision oncology has strengthened the integration of companion diagnostics into cancer management. Advancements in molecular profiling, biomarker testing, and genomic analysis have enabled a more targeted approach to treatment selection. The expanding availability of targeted therapies and biomarker-based treatment pathways has further increased the utilization of companion diagnostics in oncology.
• The companion diagnostics market from cardiovascular segment accounted for USD 751.9 million in 2025 and is projected to expand at a CAGR of 10.8% from 2026 to 2035. Companion diagnostics support cardiovascular care by enabling the identification of genetic markers, disease-associated biomarkers, and patient-specific characteristics that can influence therapeutic decisions and disease management strategies.
• The growing focus on personalized medicine in cardiovascular healthcare has increased the application of molecular and biomarker-based diagnostics. Continuous advancements in genetic testing technologies and greater emphasis on risk assessment and treatment optimization have contributed to the adoption of companion diagnostic solutions within this therapeutic area. Increasing awareness regarding early diagnosis and individualized treatment approaches further supports their utilization in cardiovascular disease management.
• The neurological diseases segment accounted for USD 490.7 million in 2025 and is projected to expand at a CAGR of 10.2% from 2026 to 2035. Neurological diseases include a wide range of disorders affecting the brain, spinal cord, and nervous system, such as Alzheimer's disease, Parkinson's disease, multiple sclerosis, and other neurodegenerative conditions. Companion diagnostics assist in identifying disease-associated biomarkers and molecular signatures that support diagnosis, patient stratification, and treatment selection.
• The growing emphasis on precision medicine in neurology has increased interest in biomarker-driven diagnostic approaches. Advances in genomic research, molecular testing, and neurodegenerative disease biomarkers have expanded the potential applications of companion diagnostics within this field.

Based on technology, the companion diagnostics market is segmented into immunohistochemistry, in situ hybridization, polymerase chain reaction, next-generation sequencing, and other technologies. The next-generation sequencing (NGS) was worth USD 2.4 billion in 2025.  

• Next-generation sequencing (NGS) is an advanced genomic analysis technology capable of simultaneously examining multiple genes and genetic alterations within a single test. The technology provides comprehensive molecular profiling, allowing healthcare professionals to identify complex biomarker patterns and actionable mutations relevant to targeted therapies. NGS has become an important component of precision medicine initiatives due to its ability to generate extensive genomic insights.
• The increasing focus on comprehensive biomarker assessment and personalized therapeutic approaches has accelerated the incorporation of NGS into companion diagnostic workflows.
• The immunohistochemistry segment accounted for significant revenue in 2025 and is anticipated to grow at a CAGR of 10.2% over the forecast period. Immunohistochemistry (IHC) is a tissue-based diagnostic technique that utilizes antibodies to detect and visualize specific protein biomarkers within tissue samples. Technology is widely employed in companion diagnostics to assess biomarker expression patterns that support patient selection, disease classification, and treatment planning. IHC remains an important tool in precision medicine due to its ability to provide clinically relevant information directly from tumor tissues.
• Its extensive integration into routine pathology workflows and broad applicability across multiple cancer types have strengthened its position within companion diagnostic testing. The technology is commonly utilized alongside targeted therapies to identify eligible patient populations and support treatment decisions.
• The in situ hybridization segment accounted for significant revenue in 2025 and is anticipated to grow at a CAGR of 10% over the forecast period. In situ hybridization (ISH) is a molecular diagnostic technique used to detect specific DNA or RNA sequences within cells and tissues. Technology enables the visualization of genetic alterations at the cellular level, providing valuable insights into biomarker status and disease characteristics. ISH is frequently applied in companion diagnostics for the identification of gene amplifications, translocations, and other molecular abnormalities associated with targeted therapies.
• The continued emphasis on biomarker-driven treatment approaches has encouraged the adoption of ISH in clinical settings. Its ability to combine molecular analysis with tissue morphology assessment makes it a valuable complement to other diagnostic technologies. Growing utilization of precision medicine strategies has further reinforced the relevance of ISH-based testing across therapeutic applications.
• The polymerase chain reaction segment accounted for significant revenue in 2025 and is anticipated to grow at a CAGR of 11.3% over the forecast period. Polymerase chain reaction (PCR) is a molecular testing method designed to amplify and detect specific genetic sequences with high sensitivity and specificity. Within companion diagnostics, PCR is used to identify genetic mutations, genomic variations, and disease-associated biomarkers that may influence therapeutic response. The technology supports personalized treatment decisions by enabling rapid and accurate molecular characterization of patient samples.
• PCR continues to serve as a widely recognized diagnostic platform due to its analytical reliability and broad clinical applicability. The increasing adoption of biomarker testing and molecular diagnostics has expanded its use across healthcare and laboratory environments. Ongoing advancements in assay design and testing capabilities have also enhanced the utility of PCR-based companion diagnostic solutions.

Based on the end use, the companion diagnostics market is segmented into hospitals, pharmaceutical and biopharmaceutical companies, contract research organizations, and diagnostic laboratories. The pharmaceutical and biopharmaceutical companies segment accounted for a significant market share of 38.3% in 2025.

• Pharmaceutical and biopharmaceutical companies utilize companion diagnostics throughout the drug development lifecycle to identify suitable patient populations and support targeted therapy development. These organizations increasingly incorporate biomarker-based strategies into clinical research programs to enhance treatment efficacy, improve clinical trial outcomes, and facilitate regulatory approval processes.
• The growing focus on precision medicine has encouraged greater collaboration between therapeutic and diagnostic developers. Companion diagnostics have become an important component of personalized drug development, enabling companies to align therapies with specific patient populations.
• The companion diagnostics market from hospitals segment accounted for significant revenue in 2025 and is anticipated to grow at a CAGR of 11% over the forecast period. Hospitals represent a major end-use segment for companion diagnostics, as they serve as primary centers for disease diagnosis, treatment planning, and patient management. These healthcare facilities utilize companion diagnostic tests to identify biomarkers, genetic mutations, and molecular characteristics that support informed therapeutic decisions. The integration of precision medicine into hospital settings has enhanced the role of companion diagnostics in selecting targeted therapies and improving clinical outcomes across various disease areas.
• The increasing availability of advanced diagnostic infrastructure, multidisciplinary care teams, and specialized oncology services has strengthened the utilization of companion diagnostics within hospitals. Growing adoption of molecular testing as part of routine clinical workflows, coupled with rising demand for personalized treatment approaches, continues to support the use of these solutions.
• The contract research organizations segment accounted for significant revenue in 2025 and is anticipated to grow at a CAGR of 11.4% over the forecast period. Contract research organizations provide specialized research, clinical trial management, biomarker testing, and regulatory support services for pharmaceutical and biotechnology companies. Within the companion diagnostics ecosystem, CROs assist in evaluating biomarker performance, validating diagnostic assays, and generating clinical evidence required for therapeutic and diagnostic development programs.
• Increasing complexity in clinical trials and a growing emphasis on biomarker-guided therapies have elevated the involvement of CROs in companion diagnostic projects. Their expertise in managing multicenter studies, patient stratification processes, and regulatory requirements enables efficient execution of precision medicine initiatives. The expanding outsourcing of research and development activities has further strengthened the role of CROs in supporting companion diagnostic advancement.

North America Companion Diagnostics Market

The North America region accounted for 33.3% of the market in 2025. The market in North America is experiencing robust expansion.

• The U.S. market was valued at USD 1.9 billion and USD 2.1 billion in 2022 and 2023, respectively. The market size reached USD 2.5 billion in 2025, growing from USD 2.3 billion in 2024, and is anticipated to grow at a CAGR of 10.7% from 2026 to 2035.
• The increasing occurrence of adverse drug reactions (ADRs) is emerging as a significant driver for the North America market. Companion diagnostics help identify patients who are more likely to respond positively to specific therapies while reducing the risk of unwanted drug-related complications. By enabling biomarker-based treatment selection, these diagnostics support safer and more personalized healthcare delivery.
• The growing burden of adverse drug events has intensified the need for precision medicine approaches across the region. According to the U.S. Centers for Disease Control and Prevention (CDC), more than 1.5 million people visit emergency departments for adverse drug events (ADEs) annually in the U.S., with nearly 500,000 cases resulting in hospitalization. Such statistics have increased the emphasis on companion diagnostic testing to assess patient suitability before treatment initiation. As healthcare providers and pharmaceutical companies focus on improving treatment safety, minimizing drug-related complications, and enhancing clinical outcomes, the adoption of companion diagnostics is expected to continue gaining momentum across North America.

Europe Companion Diagnostics Market

Europe market accounted for USD 2.3 billion in 2025 and is anticipated to show lucrative growth over the forecast period.

• The increasing prevalence of cancer across Europe is a key factor supporting the growth of the market. Companion diagnostics enable the identification of specific biomarkers and genetic mutations associated with targeted therapies, helping healthcare providers select the most appropriate treatment for individual patients. Their use has become increasingly important as precision oncology gains wider adoption throughout the region.
• The growing cancer burden continues to create demand for advanced diagnostic solutions. According to the World Health Organization (WHO), Europe records more than 3.7 million new cancer cases and approximately 1.9 million cancer-related deaths annually. The rising number of patients requiring personalized treatment approaches has accelerated the use of biomarker testing and molecular diagnostics. As the development and adoption of targeted cancer therapies continue to expand, companion diagnostics are expected to play an increasingly important role in oncology care across Europe.

Asia Pacific Companion Diagnostics Market

The Asia Pacific region is projected to show a lucrative growth of about 12.1% during the forecast period.

• The growth of precision medicine is a major factor driving the Asia Pacific market. As healthcare systems increasingly adopt targeted treatment approaches, the demand for companion diagnostics is rising to support accurate patient identification and biomarker-based therapy selection. These diagnostic solutions enable healthcare providers to match patients with the most effective treatments, improving clinical outcomes and advancing the implementation of personalized medicine across the region.
• The increasing emphasis on individualized healthcare across Asia Pacific is creating favorable conditions for the adoption of companion diagnostics. Advances in genomic research, rising utilization of molecular testing, and ongoing improvements in healthcare infrastructure are facilitating the broader implementation of precision medicine. In addition, growing investments by governments, healthcare providers, and pharmaceutical companies in biomarker-driven treatment strategies are expanding the use of targeted therapies. These developments continue to reinforce the importance of companion diagnostics in clinical decision-making and patient management across the region.

Latin America Companion Diagnostics Market 

The Latin America market is experiencing robust growth over the analysis timeframe.

• The increasing incidence of adverse drug reactions (ADRs) is contributing to the adoption of companion diagnostics across Latin America. Companion diagnostics assist healthcare providers in identifying patients who are most likely to benefit from specific therapies while minimizing the risk of treatment-related complications. Their role in supporting personalized treatment decisions has become increasingly important as healthcare systems focus on improving patient safety and therapeutic outcomes.
• The growing prevalence of chronic diseases and expanding use of advanced therapeutics have heightened concerns regarding adverse drug reactions in the region. Healthcare providers are increasingly recognizing the value of biomarker-based testing for optimizing treatment selection and reducing the likelihood of ineffective therapies. As awareness of precision medicine continues to increase, companion diagnostics are gaining greater importance in supporting safer and more targeted healthcare approaches across Latin America.

Middle East and Africa Companion Diagnostics Market 

The Middle East and Africa (MEA) market is experiencing robust growth over the analysis timeframe.

• The rising prevalence of cancer is a key factor driving the growth of the market across the Middle East & Africa. Companion diagnostics support the identification of specific biomarkers and genetic alterations, enabling healthcare providers to select targeted therapies and deliver more personalized treatment approaches. Their importance is increasing as precision medicine becomes more widely integrated into cancer care throughout the region.
• The growing burden of cancer, coupled with ongoing investments in healthcare infrastructure and oncology services, is fueling demand for advanced biomarker-based testing solutions. In addition, increasing access to targeted therapies, expanding cancer research initiatives, and greater focus on improving treatment outcomes are supporting the adoption of companion diagnostics across Middle Eastern and African healthcare systems.

Companion Diagnostics Market Share

• The top five players, F. Hoffmann-La Roche Ltd., Agilent Technologies, QIAGEN N.V., Abbott Laboratories, and Thermo Fisher Scientific Inc., collectively account for approximately 55% of the global companion diagnostics industry. Their leadership position is driven by extensive portfolios of approved companion diagnostic assays, strong partnerships with pharmaceutical and biopharmaceutical companies, broad capabilities across PCR, immunohistochemistry (IHC), in situ hybridization (ISH), and next-generation sequencing (NGS) technologies, as well as extensive global commercialization networks.
• Companion diagnostics developers, molecular diagnostics companies, and pharmaceutical manufacturers are increasingly focusing on technological advancements to enhance the accuracy, sensitivity, and clinical utility of biomarker-based testing. Additionally, advancements in bioinformatics, genomic profiling, automated laboratory workflows, and artificial intelligence-enabled data analysis are improving diagnostic efficiency and supporting more precise treatment selection. Continuous investments in molecular diagnostic technologies and precision medicine solutions are facilitating broader adoption of companion diagnostics across hospitals, diagnostic laboratories, and research institutions.
• Market participants, including pharmaceutical companies, biotechnology firms, diagnostic manufacturers, healthcare providers, and research organizations, are increasingly strengthening strategic collaborations to expand the development and commercialization of companion diagnostics. Partnerships between drug developers and diagnostic companies are supporting the co-development of targeted therapies and companion diagnostic assays, enabling more effective patient stratification and treatment selection. Furthermore, collaborations with academic institutions, clinical research centers, and healthcare systems are accelerating biomarker discovery, assay validation, and clinical research activities. These initiatives are enhancing the integration of precision medicine into routine clinical practice, expanding access to personalized therapies, and contributing to the broader adoption of companion diagnostics across global healthcare markets.

Companion Diagnostics Market Companies

Few of the prominent players operating in the companion diagnostics industry include:

• F. Hoffmann-La Roche Ltd
• Foundation Medicine
• QIAGEN
• Agilent Technologies
• Abbott Laboratories
• Illumina
• Thermo Fisher Scientific
• Guardant Health
• Myriad Genetics
• BioMérieux
• Leica Biosystems
• MolecularMD
• ARUP Laboratories
• Bio-Rad Laboratories
• Sysmex Corporation

• Illumina

Illumina is a leading provider of next-generation sequencing technologies that power companion diagnostics testing. Its sequencing platforms and oncology-focused assays facilitate highly sensitive DNA analysis for cancer detection, biomarker identification, and treatment monitoring.

• Abbott Laboratories

Abbott plays an important role in the market through its expertise in molecular diagnostics and genomic testing technologies. The company supports precision medicine initiatives by delivering biomarker detection solutions that assist healthcare providers in identifying appropriate patients for targeted treatments and improving therapeutic decision-making.

Companion Diagnostics industry News:

• In September 2025, Myriad Genetics entered a strategic partnership with SOPHiA GENETICS to co-develop a global companion diagnostic (CDx). The collaboration was centered on MSK-ACCESS powered by SOPHiA DDM, a ctDNA-based test developed with Memorial Sloan Kettering Cancer Center. This hybrid model was aimed at expanding access to precision oncology testing worldwide.
• In April 2025, Guardant Health announced a multi-year global collaboration with Pfizer to integrate its Guardant Infinity smart companion diagnostics platform into Pfizer’s oncology clinical trials. The partnership focused on circulating tumor DNA (ctDNA) monitoring and blood-based epigenomic analyses to advance precision oncology. Additionally, the collaboration extended Guardant’s presence in China through its existing partnership with Adicon Holdings, further strengthening its global footprint in companion diagnostics applications.

The companion diagnostics market research report includes an in-depth coverage of the industry with estimates and forecast in terms of revenue in USD Million and from 2022 – 2035 for the following segments:

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Market, By Product

• Instruments
• Consumables
• Software and services

Market, By Therapy Area

• Cancer
  • Breast cancer
  • Lung cancer
  • Colorectal cancer
  • Skin cancer
  • Other cancers
• Cardiovascular disease
• Neurological diseases
• Other therapy areas

Market, By Technology

• Immunohistochemistry
• In situ hybridization
• Polymerase chain reaction
• Next-generation sequencing
• Other technologies

Market, By End Use

• Hospitals
• Pharmaceutical and biopharmaceutical companies
• Contract research organizations
• Diagnostic laboratories

The above information is provided for the following regions and countries:

• North America
  • U.S.
  • Canada
• Europe
  • Germany
  • UK
  • France
  • Italy
  • Spain
  • Netherlands
• Asia Pacific
  • China
  • India
  • Japan
  • Australia
  • South Korea
• Latin America
  • Brazil
  • Mexico
  • Argentina
• Middle East and Africa
  • Saudi Arabia
  • South Africa
  • UAE