The companion diagnostics market supports personalized medicine by identifying patients most likely to benefit from specific targeted therapies. Regulatory authorities are incorporating guidelines to ensure accuracy, clinical validity, and safe use of diagnostic tests that guide treatment decisions.
The Companion Diagnostics of Key Targets are Tests and Platforms Used to Determine Biomarkers That Predict a Person's Response to a Different Therapeutic Agent. As a result, Companion Diagnostics Play a Central Role in Precision Medicine, immunology, and Treatment for Uncommon Disorders. Companion Diagnostics Aid in Selecting Treatment Regimens, Optimizing Clinical Outcomes and Minimizing Unnecessarily Subjecting Patients To Ineffective Drugs. The Growing Number of Patients with Cancer, Chronic Diseases and Genetic Disorders is Accelerating the Adoption of Biomarker Tests. Agencies such as the FDA (U.S.) Have Developed Regulations to Regulate Both Diagnostic Tests and Their Corresponding Therapeutic Agents to Ensure Their Clinical Effectiveness, Safety and Risk-Benefit Profile. For Example, Regulatory Agencies Have Stressed the Importance of Analytical Validation, Standardization of Tests and Market Monitoring (Post-) to Ensure Diagnostic Reliability and Safety for Patients.
• An Increase in the Use of Biomarker Based Treatments: The increasing use of companion diagnostics to identify patients eligible for targeted therapies based on specific genetic, protein, or other molecular biomarkers will allow for greater precision in the treatment of diseases and, thereby, increase patient response rates while reducing the amount of time patients are subjected to therapies that are unlikely to work. This is particularly true in the field of oncology.
• The Expansion of Companion Diagnostics: While companion diagnostics have been primarily used in cancer diagnosis and treatment, they are moving into other areas, such as cardiology, neurology, and diseases of the immune system. As researchers learn more about disease specific biomarkers, they can develop tailored treatment plans for patients affected by these diseases and/or conditions.
• The Development of New Technologies for the Analysis of Biomarkers: With the advancement of technology in the fields of next generation sequencing and multiplex testing, multiple biomarkers can now be analyzed from a single sample. This will increase the efficiency of determining clinical decisions and the ability to use complex treatment strategies using targeted therapies.
• The Closer Integration of Drug Development with Companion Diagnostic Development: Pharmaceutical manufacturers and diagnostic test manufacturers are increasingly collaborating during the early phases of the drug development process. By using co-development models for drug and companion diagnostic tests, it is possible to have a biomarker test approved at the time the drug is approved. Therefore, the identification of patients who will benefit from targeted therapy will be facilitated much faster.
• Growing prevalence of cancer and demand for Precision Oncology: The increasing global cancer prevalence is a key factor driving the demand for companion diagnostics. Companion tests enable appropriate therapeutic selection for patients by providing accurate biomarker identification for targeted therapies, which are important for effective treatment selection. By aligning molecular profile of the patient's tumor with a specific therapy, companion tests improve therapy outcomes and reduce trial-and-error prescribing.
• Increased targeted drug approval growth: An increasing number of targeted therapies are gaining market access as well as Companion Diagnostics (CD) to help identify eligible patients for each therapy. Therefore, the parallel growth of precision therapeutics creates a demand for the continued validation of testing platforms that detect specific biomarkers.
• Technological advancements in molecular/genomic testing: Advancements in detector technology, including NGS, PCR assays and various multiplex platforms allow rapid detection of biomarkers on a highly sensitive basis; therefore, providing companion diagnostics with improved scalability, accuracy and accessibility in standard clinical practice.
• Regulatory support for co-development models: Regulatory agencies are encouraging drug manufacturers and diagnostics manufacturers to coordinate their development efforts, thus assuring the clinical and patient safety of both the drug and the diagnostics. The continued development of clearer regulatory process for both drug and diagnostics manufacturers is increasing the confidence of drug and diagnostic sponsors to invest funds into the development of co-development strategies.
• Despite experiencing robust growth, companion diagnostics are challenged by many operational and clinical issues. One of these is the high cost of developing and validating diagnostic assays, which often leads to longer timeframes for bringing diagnostic tests to market when aligning with new or evolving targeted therapies. The variability of reimbursement policies for laboratory and physician practices across the world creates additional uncertainty for labs and physicians. In addition, a lack of access to advanced molecular testing infrastructure in developing healthcare systems may limit widespread adoption. Standardisation of biomarker testing methodologies and ensuring consistent assay performance from laboratory to laboratory continues to be a challenge. The integration of genomic information into routine clinical workflow is also influenced by the need for adequate education of clinicians who will be performing genomic testing, as well as adequate support for interpreting genomic results. The growth in interest in precision medicine and personalised oncology is expected to create increased demand for biomarker driven treatment selection. The development of next-generation sequencing technologies and multiplex assays has enabled the ability to analyse multiple biomarkers simultaneously, improving efficiency and clinical utility. The expansion of targeted therapies into non-oncology indications is opening up additional areas for application. The increasing collaboration between pharmaceutical companies and diagnostic manufacturers is strengthening the co-development pipelines within each industry. The growing emphasis on quality of care versus just costs by health systems provides an opportunity for companion diagnostics to be an integral part of optimising the effectiveness of therapy and improving patient survival rates.
• June 2025: Qiagen announced an official global collaboration with Incyte to develop a novel companion diagnostic panel for patients with mutant CALR-expressing myeloproliferative neoplasms (MPNs), a group of rare blood cancers. Under the agreement, QIAGEN will build an NGS-based multimodal panel to detect clinically relevant gene alterations, with validation on the Illumina NextSeq 550Dx platform. This companion diagnostic is intended to support Incyte’s investigational therapies such as INCA033989, guiding treatment decisions for patients with MPNs by identifying key biomarkers associated with disease progression and eligibility for targeted therapy. The collaboration underscores the expanding role of comprehensive genomic profiling in precision oncology and the importance of tailored diagnostic tools that match patients with emerging targeted treatments.
The market is segmented by product type, technology, application and geography.
The assay, kit & reagent segment, which is mostly considered consumables, is a key supplier in the biomarker detection field for targeted therapies. Moreover, these consumables are routinely used for the detection of gene mutations and protein expressions used to determine patient eligibility for targeted therapies through molecular diagnostic laboratories.
NGS is recognized as an effective method of Next Generation Sequencing by allowing for the simultaneous screening of multiple genes across all genes in the human genome. In addition, NGS is an important tool for identifying actionable mutations and is commonly used as part of precision oncology programs that require deep molecular characterization of patient tissue.
As the majority of targeted therapies use biomarker testing to help clinicians select cancer treatments, oncology is the dominant application type for the assay, kit & reagent market at this time. Companion diagnostic tests are the most important form of biomarker based testing in oncology, as they provide clinicians with information regarding genetically altered tumours in order to support and improve treatment decisions and clinical outcomes.
As a result of a high level of acceptance of precision medicine, and a significant number of molecular testing infrastructures available throughout North America, this region leads the market. In particular, the US has an established regulatory framework for the approval of both established companion diagnostic devices, as well as targeted therapies. A combination of these factors creates an incentive for coordinated approval by the pharmaceutical industry through the approval of both the drug and the associated diagnostic test(s). Major oncology centres in North America use biomarker testing routinely to assist in selecting treatment for each individual patient. This consistent use of biomarker tests drives a steady demand for such tests in North America.
South America is an emerging market with growing awareness of personalized oncology. Brazil, Argentina, and Chile are strengthening cancer screening and molecular testing capabilities. Adoption is supported by improving laboratory networks and collaboration with multinational pharmaceutical companies introducing targeted therapies into the region.
Several countries in Europe have been implementing genomic medicine programs over the last several years and have also introduced the In Vitro Diagnostic Regulation to govern the use of genomics within the healthcare system. Examples of countries that have been integrating biomarker testing into national cancer strategies include the UK, Germany, and France, which are all beginning to develop robust systems of reimbursement for targeted therapy-related diagnostic testing by their respective national public health systems.
The Middle East is advancing through healthcare modernization initiatives and establishment of specialized cancer centers. Adoption is strongest in high income countries investing in advanced laboratory capabilities. In Africa, growth remains gradual due to limited infrastructure, though international partnerships and regional oncology programs are expanding access to biomarker testing.
The Asia Pacific region is experiencing a rapid growth rate due to the increasing incidence of cancer, increased healthcare costs, and the investment in molecular diagnostics labs. A number of countries in the Asia Pacific region, including China, Japan, South Korea, and India, are focusing on developing genomic research initiatives and precision oncology strategies. There are numerous collaborations between large multinational pharmaceutical companies and regional diagnostic labs, which are driving the industry's penetration into the Asia Pacific region.
• IBM
• Oracle Health
• SAS Institute
• Cerner Corporation
• Epic Systems
• Siemens Healthineers
• Philips Healthcare
• Tempus
• Flatiron Health
• Palantir Technologies
The industry is in the process of consolidation as players target the provision of " Companion Diagnostics for Targeted Therapies Market” toolchains.
Roche Diagnostics is a globally recognised leader in molecular diagnostic products, tools, and technologies. Within its product offerings, one can find real-time PCR systems, high-throughput testing solutions, and companion diagnostics used for oncological, infectious diseases, and genetic testing. Its diagnostic technology facilitates laboratory automation and collaboration through integration with laboratory information systems, allowing for optimal workflows and data management. Roche also manufactures multiplex assays to enable the simultaneous detection of various pathogens. Furthermore, Roche's continuous investments in new technologies, including next-generation sequencing and biomarker discovery, are helping to solidify its role in the field of precision medicine. The breadth of Roche's portfolio and its global reach establish it as one of the leading diagnostic companies, helping to make it an essential component of clinical and reference labs.
Thermo Fisher Scientific is a manufacturer and distributor of many types of molecular diagnostic technologies, including PCR technology, next-generation sequencing technology, reagents, and bioinformatics software. Thermo Fisher's Applied Biosystems brand manufactures and sells products that relate to genetic analysis, infectious disease identification, and research purposes. Additionally, Thermo Fisher's platforms provide high-throughput workflows, allowing labs to increase their testing capacity. Thermo Fisher also offers package solutions for integrated service/support to help labs achieve optimal assay performance and compliance. Thermo Fisher is well-known for its strong commitment to research and development in order to support ongoing innovation in molecular testing and laboratory automation, positioning it to be a critical partner for clinical and research labs globally.