Companion Diagnostics Market Trends: AI-Powered Testing, Data-Driven Decisions & Industry Outlook to 2033

The global companion diagnostics market is experiencing robust growth, fueled by personalized medicine, technological innovation, and the widespread adoption of targeted therapies. According to IMARC Group's recent analysis, the market reached USD 7.6 Billion in 2024. Looking ahead, IMARC Group projects the market will reach USD 22.3 Billion by 2033, demonstrating steady expansion during 2025-2033.

Companion diagnostics have become a cornerstone of precision medicine, allowing healthcare providers to identify which patients will respond most favorably to specific treatments. These diagnostic tools detect biomarkers, genetic mutations, and protein expressions that directly influence therapeutic outcomes. This targeted approach dramatically reduces trial-and-error prescribing while minimizing adverse effects. The pharmaceutical industry increasingly relies on companion diagnostics during drug development cycles to demonstrate treatment efficacy and secure regulatory approval. Meanwhile, healthcare systems worldwide recognize that matching therapies to patient genetics improves clinical results while controlling overall treatment costs through more efficient resource allocation.

Explore Key Insights with a Free “Companion Diagnostics Market” Sample

Companion Diagnostics Market Growth Drivers:

• Advancements in Gene Therapy

Gene therapies targeting genetic disorders are creating unprecedented demand for sophisticated diagnostic solutions. Companion diagnostics verify whether patients meet specific biomarker criteria before gene therapy administration, ensuring both safety and optimal treatment response. For rare genetic conditions, these diagnostics identify antibodies or genetic factors that could compromise therapy effectiveness. In 2024, Labcorp secured FDA approval for its nAbCyte™ Anti-AAVRh74var HB-FE Assay, a companion diagnostic supporting Pfizer's BEQVEZ™ gene therapy for hemophilia B. The test identifies patients with preexisting antibodies, enabling clinicians to determine safe treatment eligibility and representing a significant breakthrough in gene therapy diagnostics for rare diseases.

• Integration of Artificial Intelligence in Diagnostics

Artificial intelligence is revolutionizing diagnostic precision by analyzing massive datasets to identify biomarkers with exceptional accuracy. AI algorithms predict patient responses to specific treatments, enabling truly personalized therapy selection. In oncology and complex disease management, AI streamlines patient selection for clinical trials, ensuring only candidates most likely to benefit participate. Strategic industry partnerships underscore this transformation—in 2024, ABION and Deep Bio established collaboration in Seoul focused on AI-powered companion diagnostics and cancer trials. The partnership integrates Deep Bio's AI pathology tools into ABION's drug development pipeline, enhancing patient selection precision and accelerating trial efficiency for lung cancer combination therapies.

• Increased Healthcare Investments

Healthcare investment worldwide increasingly prioritizes precision medicine, which fundamentally relies on companion diagnostics. Governments, private investors, and healthcare organizations recognize that identifying optimal treatments upfront eliminates wasteful trial-and-error approaches common in traditional medicine. This precision reduces overall healthcare costs while improving patient outcomes. The shift toward value-based healthcare where reimbursement depends on patient results rather than service volume aligns perfectly with companion diagnostics' ability to target effective treatments. Under mounting economic pressure, healthcare systems invest strategically in tools that deliver both efficiency and effectiveness, positioning companion diagnostics as essential infrastructure for sustainable healthcare delivery.

Companion Diagnostics Market Trends:

• Next-Generation Sequencing (NGS) Expansion

Next-generation sequencing technologies are transforming companion diagnostics through comprehensive genetic profiling capabilities. Unlike traditional single-biomarker tests, NGS platforms simultaneously analyze hundreds of genes, identifying multiple actionable mutations in one diagnostic procedure. This comprehensive approach proves particularly valuable in oncology, where tumor genetics often involve complex mutation patterns. NGS-based companion diagnostics enable oncologists to select optimal targeted therapies or immunotherapies based on complete genomic profiles. As sequencing costs continue declining and analysis speeds improve, NGS adoption accelerates across clinical settings.

Liquid Biopsy Advancement

Liquid biopsy technology represents a paradigm shift in companion diagnostics, enabling genetic testing through simple blood draws rather than invasive tissue biopsies. These minimally invasive tests detect circulating tumor DNA, providing real-time insights into disease progression and treatment response. Liquid biopsies prove especially valuable for monitoring therapy effectiveness and identifying emerging resistance mutations, allowing timely treatment adjustments. The convenience and repeatability of blood-based testing facilitates longitudinal patient monitoring impossible with traditional tissue sampling.

• Expansion Beyond Oncology

While oncology remains the primary application area, companion diagnostics are rapidly expanding into cardiovascular disease, neurological disorders, and infectious diseases. Cardiovascular companion diagnostics guide anticoagulation therapy and identify patients benefiting from specific cholesterol-lowering medications. In neurology, genetic testing determines optimal treatments for Alzheimer's disease and multiple sclerosis. Infectious disease companion diagnostics personalize antiviral and antibiotic therapies, addressing antimicrobial resistance challenges. This therapeutic diversification reflects growing recognition that precision medicine principles apply across disease categories.

Recent News and Developments in Companion Diagnostics Market

• July 2025: Thermo Fisher Scientific secured FDA approval for the Oncomine™ Dx Express Test as a companion diagnostic for Dizal's ZEGFROVY® (sunvozertinib) in non-small cell lung cancer. The test identifies patients with EGFR exon 20 insertion mutations while delivering genomic results within 24 hours, enhancing precision oncology through rapid, decentralized tumor profiling in clinical environments.
• May 2025: Roche announced FDA approval for the VENTANA MET (SP44) RxDx Assay, the first companion diagnostic identifying non-squamous non-small cell lung cancer patients eligible for AbbVie's Emrelis™ (telisotuzumab vedotin) treatment. The assay detects MET protein expression crucial for determining c-Met-targeted therapy response, supporting customized treatment options for advanced lung cancer patients.
• May 2025: NeoGenomics launched its c-MET CDx companion diagnostic assay for advanced non-small cell lung cancer, featuring a 48-hour turnaround time. The test detects c-Met protein overexpression guiding treatment decisions, including the newly approved EMRELIS™ therapy, enhancing personalized treatment options for eligible patients.

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.