Companion Diagnostics Market Report 2026

Companion Diagnostics Market Overview

• Companion Diagnostics market size has reached to $8.69 billion in 2025 • Expected to grow to $22.7 billion in 2030 at a compound annual growth rate (CAGR) of 21.1% • Growth Driver: The Surge In Targeted Therapies Fueling The Expansion Of Companion Diagnostics • Market Trend: Innovative Companion Diagnostics Transforming Precision Medicine In Non-Small Cell Lung Cancer • North America was the largest region in 2025.

The key promising market opportunities in the companion diagnostics market include: • Assays Kits And Reagents (Segmentation By Product) → Expected gain of $9.12 Billion • Software And Services (Segmentation By Product) → Expected gain of $4.78 Billion

What Is Covered Under Companion Diagnostics Market?

Companion diagnostics is an in vitro diagnostic medical test used to check the safety and effectivity of a corresponding drug or biological product. The test aids a medical expert to match a patient to a specific drug or therapy. The main products and services of companion diagnostics are assays, kits and reagents and software and services. Assays, kits and reagents are used in various life science, environmental, and research labs. An assay is a procedure for examining a substance to ascertain its composition or quality. Kits are a set or collection of equipment, materials, or instruction for a particular use. A reagent is a chemical used in laboratory testing to make, measure, or detect other compounds. Polymerase chain reaction, next-generation sequencing, in situ hybridization and immunohistochemistry are the technologies used in companion diagnostics. The companion diagnostics are used for identifying lung, breast, colorectal, leukemia and melanoma cancer diseases. Pharmaceutical and biopharmaceutical companies, reference laboratories and contract research organizations use companion diagnostics.

What Is The Companion Diagnostics Market Growth Forecast?

The companion diagnostics market size is expected to see exponential growth in the next few years. It will grow to $22.7 billion in 2030 at a compound annual growth rate (CAGR) of 21.1%. The growth in the forecast period can be attributed to increasing demand for personalized treatment selection, rising investments in precision medicine, expansion of immuno-oncology pipelines, growing adoption of ai-driven diagnostic interpretation, increasing regulatory emphasis on diagnostic-drug co-development. Major trends in the forecast period include increasing adoption of precision oncology diagnostics, rising integration of companion diagnostics in drug development, growing use of ngs-based diagnostic platforms, expansion of biomarker-driven therapies, enhanced focus on personalized medicine.

What Is The Driver Of The Companion Diagnostics Market?

The increasing number of targeted therapies is expected to propel the growth of the companion diagnostics market. Targeted therapy is a pharmacological therapy that targets particular characteristics of cancer cells to inhibit the growth and spread of the disease. The medications circulate throughout the body but have a more targeted effect than chemotherapy and frequently have fewer adverse effects. Biological marker-based companion diagnostic testing for targeted cancer therapy is becoming an essential part of personalized cancer care. For instance, in February 2024, according to the Personalized Medicine Coalition, a US-based hospital and health care organization, in 2023, the FDA approved 16 new personalized treatments for rare disease patients, up from 6 in 2022. Therefore, the surge in targeted therapies drives growth in the companion diagnostics industry.

How Will The Drivers Impact Growth In The Global Companion Diagnostics Market?

• Rising Adoption Of Precision Medicine (High) – During the forecast period, the rising adoption of precision medicine is expected to become a key growth driver for the companion diagnostics market by 2030. Healthcare systems are increasingly shifting toward individualized treatment approaches that rely on patient-specific genetic and molecular profiles to guide therapy selection. Companion diagnostics play a critical role in identifying suitable patient populations, improving treatment efficacy, and minimizing adverse drug reactions. This growing emphasis on personalized care is accelerating demand for advanced diagnostic solutions that align with targeted therapies. As clinical practices continue to evolve toward precision-based models, the adoption of companion diagnostics is expected to expand significantly. As a result, the rising adoption of precision medicine is anticipated to contribute approximately 2.5% annual growth to the market. • Growth In Targeted Therapies And Biologics (High) – During the forecast period, the growth in targeted therapies and biologics is expected to emerge as a major factor driving the expansion of the companion diagnostics market by 2030. The increasing development of drugs designed to act on specific molecular targets is creating a strong need for diagnostic tools that can accurately identify eligible patients. Biopharmaceutical companies are focusing on co-development strategies where therapies and diagnostics are developed in parallel to improve clinical outcomes and streamline regulatory approvals. This trend is strengthening the integration of diagnostics into drug development pipelines and enhancing treatment success rates. • Increasing Prevalence Of Chronic And Genetic Diseases (Medium) – During the forecast period, the increasing prevalence of chronic and genetic diseases is expected to act as a key growth catalyst for the companion diagnostics market by 2030. Rising incidence of conditions such as cancer, cardiovascular disorders, and rare genetic diseases is driving the need for more accurate and early diagnostic solutions. Companion diagnostics enable precise disease classification and support timely therapeutic interventions, improving patient outcomes and optimizing healthcare resource utilization. The growing global disease burden is also encouraging healthcare providers to adopt advanced diagnostic technologies for better disease management.

How Will The Restraints Impact Growth In The Global Companion Diagnostics Market?

• High Development And Regulatory Costs (High) – During the forecast period, high development and regulatory costs are significantly restricting the growth of the companion diagnostics market. Extensive R&D requirements, complex validation processes, and stringent regulatory approvals are increasing time-to-market and financial burdens for diagnostic developers, limiting rapid commercialization. • Limited Reimbursement And Pricing Challenges (High) – During the forecast period, limited reimbursement and pricing challenges are significantly restricting the growth of the companion diagnostics market. Inconsistent reimbursement policies across regions and pricing pressures from healthcare payers are reducing adoption rates and limiting profitability for diagnostic test providers. • Complex Co-Development And Integration Issues (Medium) – During the forecast period, complex co-development and integration issues are significantly restricting the growth of the companion diagnostics market. The need for close coordination between pharmaceutical and diagnostic companies, along with challenges in integrating diagnostics into therapeutic development pipelines, is slowing product development and market entry timelines.

Key Players In The Global Companion Diagnostics Market

Major companies operating in the companion diagnostics market are F Hoffmann-La Roche Ltd., Agilent Technologies Inc., Qiagen NV, Thermo Fisher Scientific Inc., Abbott Laboratories Inc., Amoy Diagnostics Co. Ltd., Danaher Corporation, Guardant Health Inc., Illumina Inc., Myriad Genetics Inc., Siemens Healthcare GmbH, Almac Group, Caris Life Sciences, Cepheid Inc., Diaceutics plc, Epic Sciences Inc., Foundation Medicine Inc., Genomic Health Inc., Grail Inc., Hologic Inc., HTG Molecular Diagnostics Inc., Inivata Ltd., Invivoscribe Inc., MolecularMD Corporation, Natera Inc., NeoGenomics Laboratories Inc., Personal Genome Diagnostics Inc., Precision Therapeutics Inc., Prometheus Laboratories Inc., Sysmex Corporation, Ventana Medical Systems

Global Companion Diagnostics Market Trends and Insights

Major companies operating in the companion diagnostics market are collaborating to develop innovative treatment solutions to enhance personalized medicine, improve patient outcomes, and optimize the effectiveness of targeted therapies. Collaboration of the companies will accelerate the development and commercialization of companion diagnostics (CDx) for hematology and oncology treatments. For instance, in January 2024, Agilent Technologies, Inc., a US-based company that provides instruments, software, services, and consumables for laboratories, announced an agreement with Incyte, a US-based pharmaceutical company. This will bring together Agilent’s expertise and proven track record in the development of companion diagnostics (CDx) to support the development and commercialization of Incyte’s hematology and oncology portfolio. This collaboration allows Agilent to expand its CDx portfolio with new biomarkers, while Incyte benefits from Agilent's expertise in assay development, regulatory approvals, and commercialization to support clinical trials and CDx registration in the U.S. and Europe.

What Are Latest Mergers And Acquisitions In The Companion Diagnostics Market?

In September 2023, Exact Sciences, a US-based provider of molecular diagnostics and precision oncology tests, acquired Resolution Bioscience for an undisclosed amount. Through this acquisition, Exact Sciences aims to enhance its companion diagnostic capabilities by integrating Resolution Bioscience’s ctDx FIRST liquid biopsy platform and expanding its portfolio of precision oncology assays. Resolution Bioscience is a US-based company that provides next-generation sequencing (NGS)-based liquid biopsy tests to detect actionable tumor mutations and guide targeted therapy.

What Defines the Companion Diagnostics Market?

The companion diagnostics market includes revenues earned by theranostics and monitoring tests. The market value includes the value of related goods sold by the service provider or included within the service offering. Only goods and services traded between entities or sold to end consumers are included.

How is Market Value Defined and Measured?

The market value is defined as the revenues that enterprises gain from the sale of goods and/or services within the specified market and geography through sales, grants, or donations in terms of the currency (in USD unless otherwise specified). The revenues for a specified geography are consumption values that are revenues generated by organizations in the specified geography within the market, irrespective of where they are produced. It does not include revenues from resales along the supply chain, either further along the supply chain or as part of other products.

What Key Data and Analysis Are Included in the Companion Diagnostics Market Report 2026?

The companion diagnostics market research report is one of a series of new reports from The Business Research Company that provides market statistics, including industry global market size, regional shares, competitors with the market share, detailed market segments, market trends and opportunities, and any further data you may need to thrive in the companion diagnostics industry. The market research report delivers a complete perspective of everything you need, with an in-depth analysis of the current and future state of the industry.