Companion Diagnostics Market Worth USD 15.6 Bn by 2030 Growing at 12.4% CAGR, says Mordor Intelligence

HYDERABAD, India, Nov. 5, 2025 /PRNewswire/ -- According to Mordor Intelligence, the global companion diagnostics market is valued at USD 8.70 billion in 2025 and is projected to surpass USD 15.62 billion by 2030, growing at a CAGR of 12.42% during the forecast period (2025–2030). The market is primarily driven by the growing applications of precision medicine in oncology and rare diseases, and the increasing need for biomarker-based testing to improve drug efficacy and safety.

Regional Segment Insights

North America continues to dominate the companion diagnostics market, supported by a robust pharmaceutical pipeline, favorable reimbursement policies, and early adoption of molecular testing technologies. The region's regulatory clarity from the FDA for co-development of drugs and diagnostics has also streamlined commercialization pathways.

Asia-Pacific is emerging as the fastest-growing region, driven by an increasing cancer burden, expansion of genetic testing services, and the rapid development of localized diagnostic solutions in China, Japan, and India. National initiatives to integrate precision medicine into healthcare systems are further strengthening regional demand.

Major Trends Shaping Market Dynamics

Rising Demand for Precision and Targeted Therapies
The growing emphasis on personalized medicine is reshaping treatment paradigms. Pharmaceutical companies increasingly rely on companion diagnostics to identify patient subgroups based on genetic or molecular profiles. This trend is particularly evident in oncology, where companion diagnostics guide the use of targeted therapies such as EGFR, HER2, and PD-L1 inhibitors.

Integration of Next-Generation Sequencing (NGS) Technologies
The use of NGS-based testing platforms is transforming how we discover biomarkers and perform multiplex testing. By enabling comprehensive genomic profiling across multiple mutations, NGS helps reduce both turnaround time and cost per sample. This technology is also moving beyond oncology, finding new applications in infectious diseases, neurology, and cardiovascular research.

Strategic Collaborations Between Pharma and Diagnostic Developers
Pharmaceutical and diagnostic firms are increasingly forming strategic alliances to co-develop companion diagnostics alongside drug pipelines. These collaborations help align regulatory submissions and accelerate market entry timelines. Additionally, the integration of AI and bioinformatics tools is improving the interpretation of complex genomic data, supporting faster clinical decision-making.

Comprehensive Segmental Overview

By Technology

• Polymerase Chain Reaction (PCR)
• Immunohistochemistry (IHC)
• Real-Time PCR (RT-PCR)
• In Situ Hybridization (ISH)
• Next-Generation Sequencing (NGS)
• Other Technologies

By Indication

• Lung Cancer
• Breast Cancer
• Colorectal Cancer
• Leukemia
• Melanoma
• Gastric Cancer
• Prostate Cancer
• Other Indications

By Product & Service 

• Assays & Kits
• Instruments & Analyzers
• Software & Services

By Sample Type 

• Tissue Biopsy
• Liquid Biopsy
• Cytology Smears

By End User

• Pharmaceutical & Biotechnology Companies
• Clinical Reference Laboratories
• Contract Research Organizations (CROs)
• Hospitals & Cancer Centers

By Geography

• North America
• Europe
• Asia-Pacific
• Middle East & Africa
• South America

For a full breakdown of market size, segmentation data, and competitive intelligence, access the details of the Mordor Intelligence report:
 https://www.mordorintelligence.com/industry-reports/companion-diagnostics-market?utm_source=prnewswire

Strategic Market Landscape

The companion diagnostics market is moderately consolidated, with global diagnostics manufacturers, biotechnology companies, and technology providers actively advancing co-development partnerships and multiplex testing solutions. Market leaders focus on expanding companion tests across multiple cancer indications and investing in regulatory-approved NGS panels.

Leading Companion Diagnostics Companies

• Qiagen NV
• Agilent Technologies Inc.
• Abbott
• bioMérieux
• F. Hoffmann-La Roche Ltd

Check out related reports published by Mordor Intelligence:

Oncology Molecular Diagnostics Market : The Oncology Molecular Diagnostics Market Report is Segmented by Product Type (Instrument), Technology (Polymerase Chain Reaction), Cancer Type (Breast Cancer), Sample Type (Tissue Biopsy, and More), End User (Hospitals), and Geography (North America, Europe, Asia-Pacific, Middle East & Africa, South America).

Illumina, QIAGEN, Roche, Thermo Fisher Scientific and Danaher are the major companies operating in this market.

Read more about companies active in Oncology Molecular Diagnostics : https://www.mordorintelligence.com/industry-reports/global-oncology-molecular-diagnostics-market/companies?utm_source=prnewswire

Companion Animal Diagnostic Market : The Companion Animal Diagnostics Market report segments the industry into By Animals (Cats, Dogs, Other Animals), By Application (Bacteriology, Parasitology, Clinical Pathology, Other Applications), By Technology (Immunodiagnostic Tests, Molecular Diagnostics, Diagnostic Imaging, Other Diagnostics), and Geography (North America, Europe, Asia-Pacific, Middle East and Africa, South America).

Heska, Neogen, Zoetis, IDEXX and Innovative Diagnostics are the major companies operating in this market.

Read more about companies active in Companion Animal Diagnostic : https://www.mordorintelligence.com/industry-reports/companion-animal-diagnostic-market/companies?utm_source=prnewswire

Anatomic Pathology Market : The Anatomic Pathology Market Report is Segmented by Product & Services (Instruments, Consumables, and Services), Application (Disease Diagnosis, Drug Discovery & Development, and Other Applications), End User (Hospitals, Diagnostic Laboratories), Geography (North America, Europe, Asia-Pacific, The Middle East and Africa, and South America).

Thermo Fisher Scientific, Quest Diagnostics, Roche, LabCorp and Agilent Technologies are the major companies operating in this market.

Read more about companies active in Anatomic Pathology : https://www.mordorintelligence.com/industry-reports/anatomic-pathology-market/companies?utm_source=prnewswire

About Mordor Intelligence:

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SOURCE Mordor Intelligence Private Limited