Companion diagnostics market seen tripling by 2035

The global companion diagnostics market is projected to rise from $9.32 billion in 2025 to $26.83 billion by 2035, driven by regulatory co-development requirements, faster next-generation sequencing adoption and growing use of liquid biopsy. North America leads today, while Asia-Pacific is expected to grow the fastest over the next decade.

Why it matters: - Companion diagnostics are becoming a core part of precision medicine, helping clinicians match patients with therapies based on molecular characteristics. - The market is being pulled higher by stricter regulatory expectations, broader genomic testing and more use of blood-based testing. - Drug developers, labs and diagnostics companies are likely to see more demand for validated tests, validation services and software tools.

What happened: - Market Research Future estimated the global companion diagnostics market at $9.32 billion in 2025. - The market is projected to reach $10.36 billion in 2026 and $26.83 billion by 2035. - The forecast implies an 11.15% compound annual growth rate from 2026 to 2035. - The report said the growth outlook is powered by regulatory co-development requirements, next-generation sequencing expansion and liquid biopsy commercialization. - A free sample is available here. - A customization request is available here. - The full report is available here.

The details: - Regulatory agencies are increasingly requiring validated companion diagnostics alongside targeted therapies where appropriate. - The FDA’s focus on CDx-linked oncology therapies is pushing pharmaceutical companies to plan parallel diagnostic development. - Regulators in Europe and Japan are also creating broader co-submission expectations. - Next-generation sequencing is the fastest-expanding technology segment, with a projected 14.80% CAGR from 2026 to 2035. - Liquid biopsy is projected to grow at a 19.65% CAGR through 2035, making it the fastest-growing sample category. - PCR held a 23.50% share in 2025 and remained the dominant technology for single-gene mutation testing. - IHC generated about $1.72 billion in 2025 and remained important for protein-expression biomarkers such as HER2 and PD-L1. - ISH generated about $0.84 billion in 2025 and stayed relevant for gene rearrangements such as ALK and ROS1. - Lung cancer led indications with about a 20.40% share in 2025. - Breast cancer generated about $1.68 billion in 2025. - Colorectal cancer accounted for about 13.5% of the market. - Melanoma is the fastest-growing indication, with a projected 14.30% CAGR through 2035. - Assays and kits dominated product types with a 70.80% share in 2025. - Instruments and analyzers generated about $1.91 billion in 2025. - Software and services are the fastest-growing product category, with a projected 16.35% CAGR through 2035. - Tissue biopsy held a 72.10% share in 2025. - Pharmaceutical and biotechnology companies were the largest end-user segment, with a 41.20% share in 2025. - Contract research organizations are the fastest-growing end-user group, with a projected 13.85% CAGR through 2035. - Hospitals and reference laboratories generated about $3.18 billion in 2025. - North America led the market with about a 43.15% share in 2025. - The United States accounted for about 82.5% of North American revenue. - Europe held about 27.00% of global revenue in 2025. - Asia-Pacific is the fastest-growing region, with a projected 13.45% CAGR through 2035. - South America generated about $0.61 billion in 2025. - The Middle East and Africa held about 5.35% of global share in 2025. - The market is moderately concentrated, with the top five players controlling an estimated 48% to 55% of global revenue. - Key companies include Roche Diagnostics, Abbott Laboratories, Agilent Technologies, Thermo Fisher Scientific, QIAGEN, Illumina, Guardant Health, Myriad Genetics, bioMérieux and Exact Sciences.

Between the lines: - The report points to a market shift from standalone tests toward diagnostics built into drug development from the start. - Faster sequencing and AI-assisted interpretation are reducing barriers to broader genomic profiling. - Liquid biopsy looks set to expand access for patients who cannot provide adequate tissue samples. - Coverage decisions from payers may matter as much as technical advances because reimbursement can determine how quickly testing spreads.

What's next: - AI-driven interpretation is expected to become more embedded in companion diagnostic workflows by 2030. - Liquid biopsy may move from a backup option to a first-line tool in selected cancers. - Pan-cancer and multi-omic platforms are expected to gain traction as labs combine genomic, transcriptomic and proteomic data. - Companion diagnostics may expand beyond oncology into cardiovascular, psychiatric and autoimmune applications. - Recent milestones cited in the report include Roche Diagnostics’ FDA approval for FoundationOne CDx in October 2024, Guardant Health’s CMS coverage win in August 2024, and the FDA’s March 2024 guidance on real-world data for label expansions.