PUBLISHER: MarketsandMarkets | PRODUCT CODE: 2096352
PUBLISHER: MarketsandMarkets | PRODUCT CODE: 2096352
The global biomarkers market is expected to reach USD 112.10 billion by 2031 from USD 67.95 billion in 2026, at a CAGR of 10.5% from 2026 to 2031. This growth is driven by the increasing integration of artificial intelligence, digital pathology, and bioinformatics, as well as the rising adoption of precision medicine and companion diagnostics.
| Scope of the Report | |
|---|---|
| Years Considered for the Study | 2026-2031 |
| Base Year | 2025 |
| Forecast Period | 2026-2031 |
| Units Considered | Value (USD billion) |
| Segments | Offering, Type, Research Area, Technology, Disease Indication, Application, and End User |
| Regions covered | North America, Europe, the Asia Pacific, Latin America, the Middle East, and Africa |
In 2025, the predictive biomarkers segment accounted for the largest share of the efficacy biomarkers market.
The biomarkers market is categorized by type into three segments: safety, efficacy, and validation biomarkers. The efficacy biomarkers segment is further divided into predictive, surrogate, pharmacodynamic, and prognostic biomarkers. In 2024, predictive biomarkers accounted for the largest share globally in the efficacy biomarkers segment. This dominance is primarily due to their crucial role in facilitating personalized treatment by identifying patients most likely to respond to specific therapies. This capability ultimately improves treatment outcomes and enhances clinical decision-making.

The use of predictive biomarkers has gained significant traction in fields such as oncology, autoimmune diseases, and infectious diseases. Additionally, the increasing number of companion diagnostic approvals for predictive biomarkers is driving market adoption. For instance, in June 2026, the FDA approved Roche's first companion diagnostic to assess the PTEN protein in prostate cancer. The VENTANA PTEN assay enables the identification of patients eligible for more targeted treatment decisions.
By technology, the immunoassays segment held the largest share of the biomarkers market in 2025.
The biomarkers market is divided into several technologies, including immunoassays, NGS (next-generation sequencing), PCR (polymerase chain reaction), mass spectrometry, chromatography, and others. In 2025, immunoassays are expected to hold the largest share of the biomarker market due to their high specificity and ability to detect a wide range of biomarkers across various disease areas, particularly in oncology, cardiology, and infectious diseases.
Immunoassays are favored for biomarker detection because they are compatible with both clinical diagnostics and research applications. Additionally, their scalability and automation capabilities enable high-throughput testing, which is essential for meeting the increasing demand for precision diagnostics.
Major companies are actively enhancing their immunoassay platforms to improve their diagnostic offerings. For instance, Roche provides the Elecsys Anti-p53 immunoassay for cancer diagnostics, while Abbott is expanding its ARCHITECT and Alinity immunoassay systems to test for infectious diseases and monitor chronic conditions.
APAC is the fastest-growing regional segment in the global biomarkers market from 2026 to 2031.
The biomarkers market is divided into several regions: North America, Europe, Asia Pacific, Latin America, the Middle East, and Africa. The Asia Pacific region is expected to experience the highest CAGR during the forecast period. This growth is primarily driven by the expanding healthcare infrastructure in countries such as China, India, and Japan, along with increasing investments in precision medicine, genomic research, and diagnostic innovation.
The rising prevalence of chronic diseases, including cancer, cardiovascular disorders, metabolic diseases, and infectious diseases, is accelerating the demand for biomarker-based diagnostics and personalized treatment approaches. Additionally, the growth of clinical trial activities, the increasing adoption of companion diagnostics, supportive government initiatives for biotechnology and life sciences research, and the rapid integration of genomics, proteomics, and AI-enabled analytics are all contributing to the regional market growth.
Furthermore, expanding local biopharmaceutical manufacturing capabilities and improving regulatory frameworks are enhancing commercialization opportunities, establishing the Asia Pacific region as a significant hub for growth and innovation in the biomarkers market.
This research report categorizes the global biomarkers market by offering, type, research area, technology, disease indication, and end user.
The report provides comprehensive information about the key factors influencing the growth of the biomarkers market, including drivers, restraints, challenges, and opportunities. It also includes a detailed analysis of major industry players, offering insights into their business overviews, products, solutions, key strategies, collaborations, partnerships, and agreements. Additionally, the report covers new approvals and product launches, as well as recent collaborations, acquisitions, and developments within the global biomarkers market.
The report will help market leaders and new entrants by providing the closest approximations of revenue numbers for the overall biomarkers market and its subsegments. It will also help stakeholders better understand the competitive landscape and gain insights to position their businesses more effectively and develop suitable go-to-market strategies. This report will enable stakeholders to understand the market's pulse and provide information on the key drivers, restraints, opportunities, and challenges.
4.2.3 OPPORTUNITIES
7 SUSTAINABILITY & REGULATORY LANDSCAPE
12.6 CHROMATOGRAPHY
14.3.2 HEPATITIS (B & C)
15.3 HOSPITALS & DIAGNOSTIC LABORATORIES
16.5 LATIN AMERICA
18.1.4 MERCK KGAA
18.1.9 REVVITY INC.