Companion Diagnostics Market to Reach $14.7 billion by 2035

Companion diagnostics market was valued at $5.5 billion in 2025 and is projected to reach $14.7 billion by 2035, growing at a CAGR of 10.5% from 2026 to 2035. The market is expanding due to the increasing adoption of precision medicine and targeted therapeutic approaches. According to the Personalized Medicine Coalition, its Personalized Medicine at FDA 2024 report highlights that a substantial proportion of newly approved drugs are personalized therapies that rely on biomarker-based testing. In 2024, personalized medicines accounted for nearly 38% of all FDA approvals, reflecting a strong shift toward individualized treatment strategies. This growing dependence on biomarker-driven therapies is significantly increasing the demand for companion diagnostics. Additionally, the rising use of next-generation sequencing (NGS) technologies is enhancing the accuracy of disease detection and treatment selection. These advancements are improving clinical outcomes while supporting broader adoption of precision diagnostics across healthcare systems.

Browse the full report description of “Companion Diagnostics Market Size, Share & Trends Analysis Report by Technology (PCR, NGS, IHC, ISH, Others), by Product Type (Assay Kits & Reagents, Instruments/Analyzers, Software & Bioinformatics Platforms), by Indication (Oncology, Infectious Diseases, Neurological Disorders, Cardiovascular Diseases, Others), and Forecast Period (2026–2035)” at https://www.omrglobal.com/industry-reports/companion-diagnostics-market

Innovation Leaders Transforming the Companion Diagnostics Market

The key players in the companion diagnostics market include top companies such as Roche, Thermo Fisher Scientific, Abbott Laboratories, Danaher, and Siemens Healthineers, among others. The market is witnessing strong growth due to increasing adoption of biomarker-based diagnostics and integration of advanced genomic technologies into clinical workflows. Pharmaceutical companies are increasingly co-developing drugs with companion diagnostics to enhance treatment efficacy and regulatory approval success rates. Additionally, healthcare providers are expanding molecular testing capabilities to support personalized oncology treatments.

• In March 2026, Roche announced that its Ionify steroid assays for mass spectrometry received CLIA moderate complexity classification, expanding access to advanced diagnostic testing in routine clinical laboratories. The assays, used for hormone analysis, run on the cobas platform and enable standardized, automated workflows. This development enhances the adoption of high-precision diagnostic technologies, supporting broader advancements in clinical diagnostics.

• In January 2026, Thermo Fisher Scientific announced a strategic collaboration with NVIDIA to integrate AI into scientific instruments and laboratory workflows. The partnership focuses on enhancing automation, accuracy, and speed of laboratory operations by connecting instruments, data, and AI platforms.

Market Coverage

• The market number available for – 2025–2035
• Base year- 2025
• Forecast period- 2026–2035
• Segment Covered-
• By Product Type
• By Technology
• By Indication
• Regions Covered-
• North America
• Europe
• Asia-Pacific
• Rest of the World
• Competitive Landscape: Roche, Thermo Fisher Scientific, Abbott Laboratories, Danaher, and Siemens Healthineers, among others.

Key questions addressed by the report

• What is the market growth rate?
• Which segment and region dominate the market in the base year?
• Which segment and region will project the fastest growth in the market?
• Who is the leader in the market?
• How are players addressing challenges to sustain growth?
• Where is the investment opportunity?

Global Companion Diagnostics Market Report Segment

By Product Type

• Assay Kits & Reagents
• Instruments/Analyzers
• Software & Bioinformatics Platforms

By Technology

• Polymerase Chain Reaction (PCR)
• Next-Generation Sequencing (NGS)
• Immunohistochemistry (IHC)
• In Situ Hybridization (ISH)
• Others

By Indication

• Oncology
• Infectious Diseases
• Neurological Disorders
• Cardiovascular Diseases
• Others

Global Companion Diagnostics Market Report Segment by Region

North America

• United States
• Canada

Europe

• UK
• Germany
• Italy
• Spain
• France
• Russia
• Rest of Europe

Asia-Pacific

• China
• India
• Japan
• South Korea
• Australia and New Zealand
• ASEAN Economies
• Rest of Asia-Pacific

Rest of the World

• Latin America
• Middle East & Africa

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