Companion Diagnostics Market Size 2025 | Growth, Trends & Forecast by 2033
The global companion diagnostics market size reached USD 7.6 Billion in 2024. Looking forward, IMARC Group expects the market to reach USD 22.3 Billion by 2033, exhibiting a growth rate (CAGR) of 12.11% during 2025-2033.b

Market Overview:
The companion diagnostics market is experiencing rapid growth, driven by rising demand for personalized medicine, increasing prevalence of chronic diseases and advancements in diagnostic technologies. According to IMARC Group’s latest research publication, “Companion Diagnostics Market Report by Product & Service (Assays, Kits and Reagents, Software and Services), Technology (Immunohistochemistry (IHC), Polymerase Chain Reaction (PCR), In-situ Hybridization (ISH), Real-time PCR (RT-PCR), Gene Sequencing, and Others), Indication (Cancer, Neurological Diseases, Infectious Diseases, Cardiovascular Diseases, and Others), End User (Pharmaceutical & Biopharmaceutical Companies, Reference Laboratories, Contract Research Organizations, and Others), and Region 2025-2033.” The global companion diagnostics market size reached USD 7.6 Billion in 2024. Looking forward, IMARC Group expects the market to reach USD 22.3 Billion by 2033, exhibiting a growth rate (CAGR) of 12.11% during 2025-2033.
This detailed analysis primarily encompasses industry size, business trends, market share, key growth factors, and regional forecasts. The report offers a comprehensive overview and integrates research findings, market assessments, and data from different sources. It also includes pivotal market dynamics like drivers and challenges, while also highlighting growth opportunities, financial insights, technological improvements, emerging trends, and innovations. Besides this, the report provides regional market evaluation, along with a competitive landscape analysis.
Grab a sample PDF of this report: https://www.imarcgroup.com/companion-diagnostics-market/requestsample
Our report includes:
- Market Dynamics
- Market Trends and Market Outlook
- Competitive Analysis
- Industry Segmentation
- Strategic Recommendations
Growth Factors in the Companion Diagnostics Market
-
Rising Demand for Personalized Medicine:
The increasing emphasis on personalized medicine is likely a major contributor to the expansion of the companion diagnostics market. Personalized medicine allows for specificity in treatment for individual patients genetic & biological attributes from a better understanding of the molecular makeup of their own cancer, and can lead to the best outcome while decreasing complications from treatment. Companion diagnostics are crucial to personalized medicine because they define specific biomarkers to help ascertain whether a patient will benefit from specific targeted therapy in lieu of taking a more generalized treatment approach. An example through the FDA approach in 2020 that has illustrated this approach, is a timely companion diagnostic identified in the Guardant360 timed or "liquid biopsy" that helps identify EGFR mutations, to optimize targeted therapy support the individualized nature of cancer treatment. With the shift to more individualized health care, the companion diagnostics market should continue to expand increasing demand, and expansion of the companion diagnostics market..
-
Increasing Prevalence of Chronic Diseases:
The global rise of chronic diseases, and especially cancer, greatly increases the companion diagnostics market. Companion diagnostics provides important information to clinicians prescribing treatment for the complex disease processes patients experience. For example, the HER2 companion diagnostic test, the diagnostic test used for breast cancer patients to determine eligibility for therapies such as Herceptin, contributes to more favourable patient outcomes. Given the anticipated increase in the number of cancer cases diagnosed around the world, coupled with the rising demand for diagnostic tools related to the treatment directed at appropriate targeted treatments, this trend is likely to continue. This trend is supported by ongoing research efforts related to potential biomarkers for other conditions categorized as chronic, such as cardiovascular diseases and neurological diseases (to name a few).
-
Advancements in Diagnostic Technologies
Technological advances like polymerase chain reaction (PCR) and next-generation sequencing (NGS) are driving growth in the companion diagnostics market. These tools provide improved sensitivity, expedited sample processing, and the ability to assay several biomarkers concurrently. A prominent example is the 2022 CE approved Illumina’s TruSight Oncology test, which is used to profile solid tumors in 500 genes to assist the physician in making precise therapy choices. These technologies provide increased diagnostic accuracy and patient management capabilities and support the use of companion diagnostics in modern healthcare. With each technological evolution, manufacturers continue to invest heavily in research and development (R&D) to deliver more advanced offerings, creating overall growth in the companion diagnostic market space.
Key Trends in the Companion Diagnostics Market
-
Expansion Beyond Oncology:
While oncology remains the dominant application, companion diagnostics are increasingly being developed for non-cancer conditions, such as cardiovascular, neurological, and infectious diseases. This trend reflects the broader adoption of precision medicine across medical specialties. For instance, in 2024, Labcorp received FDA approval for a companion diagnostic for hemophilia B, designed to guide gene therapy decisions. This expansion diversifies the market and opens new revenue streams for manufacturers. As research uncovers biomarkers for various diseases, the application of companion diagnostics is expected to grow, transforming treatment approaches in multiple therapeutic areas.
-
Integration of Artificial Intelligence:
The incorporation of artificial intelligence (AI) into companion diagnostics is revolutionizing the market by enhancing data analysis and diagnostic precision. AI algorithms can process vast amounts of genomic and clinical data to identify patterns and predict treatment responses. For example, Roche has invested in AI-driven platforms to improve the development of companion diagnostics, enabling faster biomarker discovery. This trend streamlines drug development and diagnostic processes, reducing costs and time-to-market. As AI technology advances, its integration into companion diagnostics will likely become standard, driving innovation and improving patient outcomes.
-
Collaborative Partnerships:
Strategic collaborations between diagnostic companies, pharmaceutical firms, and research institutions are shaping the companion diagnostics market. These partnerships accelerate the co-development of drugs and diagnostics, ensuring seamless integration into clinical practice. A notable case is the 2022 collaboration between GRAIL and AstraZeneca, which focused on developing companion diagnostics for early-stage cancer detection, leveraging GRAIL’s multi-cancer detection technology. Such alliances enhance innovation, expand market reach, and address regulatory challenges. As the demand for targeted therapies grows, collaborative efforts will remain a key trend, fostering advancements in personalized medicine.
The companion diagnostics market report provides a comprehensive overview of the industry. This analysis is essential for stakeholders aiming to navigate the complexities of the biochar market and capitalize on emerging opportunities.
Leading Companies Operating in the Companion Diagnostics Industry:

- Abbott Laboratories
- Agilent Technologies
- BioMerieux
- Danaher Corporation
- Roche Holding AG
- Myriad Genetics Inc.
- Siemens Healthcare
- Thermo Fisher Scientific Inc.
Companion Diagnostics Market Report Segmentation:
By Product & Service:

- Assays, Kits and Reagents
- Software and Services
Assays, kits, and reagents dominate the market due to their critical role in biomarker detection and enabling targeted therapies.
By Technology:
- Immunohistochemistry (IHC)
- Polymerase Chain Reaction (PCR)
- In-situ Hybridization (ISH)
- Real-time PCR (RT-PCR)
- Gene Sequencing
- Others
Polymerase chain reaction (PCR) leads the segment owing to its widespread use in mutation detection and easy availability of diagnostic kits.
By Indication:
- Cancer
- Lung Cancer
- Breast Cancer
- Colorectal Cancer
- Gastric Cancer
- Melanoma
- Others
- Neurological Diseases
- Infectious Diseases
- Cardiovascular Diseases
- Others
Cancer holds the largest share, driven by high disease prevalence and increasing approvals of companion diagnostics for oncology treatments.
By End User:
- Pharmaceutical & Biopharmaceutical Companies
- Reference Laboratories
- Contract Research Organizations
- Others
Pharmaceutical & biopharmaceutical companies account for the highest demand as they integrate companion diagnostics into drug development.
Regional Insights:
- North America (United States, Canada)
- Asia Pacific (China, Japan, India, South Korea, Australia, Indonesia, Others)
- Europe (Germany, France, United Kingdom, Italy, Spain, Russia, Others)
- Latin America (Brazil, Mexico, Others)
- Middle East and Africa
North America leads the market, supported by advanced healthcare infrastructure, strong regulatory support, and high adoption of precision medicine.
Research Methodology:
The report employs a comprehensive research methodology, combining primary and secondary data sources to validate findings. It includes market assessments, surveys, expert opinions, and data triangulation techniques to ensure accuracy and reliability.
Note: If you require specific details, data, or insights that are not currently included in the scope of this report, we are happy to accommodate your request. As part of our customization service, we will gather and provide the additional information you need, tailored to your specific requirements. Please let us know your exact needs, and we will ensure the report is updated accordingly to meet your expectations.
About Us:
IMARC Group is a global management consulting firm that helps the world’s most ambitious changemakers to create a lasting impact. The company provide a comprehensive suite of market entry and expansion services. IMARC offerings include thorough market assessment, feasibility studies, company incorporation assistance, factory setup support, regulatory approvals and licensing navigation, branding, marketing and sales strategies, competitive landscape and benchmarking analyses, pricing and cost research, and procurement research.
Contact Us:
IMARC Group
134 N 4th St. Brooklyn, NY 11249, USA
Email: sales@imarcgroup.com
Tel No:(D) +91 120 433 0800
United States: +1-631-791-1145