Predictive Biomarkers Market Size, Share & Segmentation By Indication (Cancer, Cardiovascular Diseases, Neurological Diseases, Immunological Diseases, and Others), Technology (Diagnostics, Drug Discovery & Development, Personalized Medicine, Disease Risk Assessment, and Others), End-User (Pharmaceutical & Biotechnology Companies, Diagnostics & Research Laboratories, Hospitals & Specialty Clinics, and Others), and Region | Global Forecast 2025-2032

Predictive Biomarkers Market Report Scope & Overview:

Predictive biomarkers market size was valued at USD 24.31 billion in 2024 and is expected to reach USD 94.16 billion by 2032, growing at a CAGR of 18.47% over the forecast period of 2025-2032. 

Increasing demand for precision and personalized medicine is driving the predictive biomarkers market trend. Predictive biomarkers assist in identifying how patients will respond to particular treatments, so that physicians can customize treatments according to genetic, proteomic, or metabolic patterns. The personalized approach is contributing to a higher success rate in treatment and minimizes side effects, and saves wasted medication. In cancer, where biomarkers (HER2, EGFR, and PD-L1) are already influencing targeted therapies, the inclusion of these tools is a clinical necessity. The urgency to develop predictive biomarkers is increasing sharply as the healthcare paradigm moves away from a one-size-fits-all approach and embraces precision medicine. Growing integration with companion diagnostics, along with advancements in targeted drug discovery, will continue to drive demand in hospitals, labs, and pharmaceutical companies.

For instance, Sept 2024, LAURA is a randomised, double-blind, placebo-controlled, multi-centre, global Phase III trial in patients with unresectable, Stage III EGFRm NSCLC whose disease has not progressed following definitive platinum-based CRT. 

The U.S. predictive biomarkers market was valued at USD 7.96 billion in 2024 and is expected to reach USD 30.59 billion by 2032, growing at a CAGR of 18.36% over 2025-2032.  

The U.S. is at the forefront of precision medicine n hence a major driving force for the market for predictive biomarkers. Tracelery medicine targets treatment to a patient’s genetic, biological, and lifestyle characteristics. Predictive biomarkers are critical to this strategy as they are able to tell us in which patients a certain therapy will be beneficial. Biomarker-driven treatments are already widely used in the U.S., particularly in oncology, with markers such as HER2, EGFR, and PD-L1. Societal efforts, such as the All of Us Research Program, are driving the collection and use of biomarker data. Further, companion diagnostics are now a part of the everyday care in U.S. hospitals and clinics, which has equally contributed to high demand. This deep integration makes the U.S. the indisputable global leader in this area.

For instance, in May 2024, A predictive, blood-based cancer screening tool used widely in U.S. hospitals, demonstrating real-world integration of biomarkers in routine clinical practice.

Market Dynamics:

Drivers

• Increased Use in Drug Development & Companion Diagnostics is Driving the Predictive Biomarkers Market

Predictive biomarkers are an emerging component in drug discovery and development and serve as an essential criterion for increasing the efficiency and success of new therapies. These biomarkers are being increasingly used by pharmaceuticals and biotechnology companies to select patients, predict drug response, and decrease toxicity. This aids in the development of more focused and efficient clinical trials, often facilitating acceleration in regulatory approval timelines. The biomarker-driven tests, also known as companion diagnostics, are being adopted as the standard of care in oncology and other therapeutic areas. This integration is driving a dramatic reduction in R&D costs, an improvement in indices for precision medicine, and an increase in the need for predictive biomarkers along the drug development process.

For instance, on January 31, 2025, Roche receives FDA approval for the first companion diagnostic to identify patients with HER2-ultralow metastatic breast cancer eligible for ENHERTU.

• Integration With Clinical Practice & Digital Health Tools Is Significantly Propelling the Growth of the Predictive Biomarkers Market

The incorporation of predictive biomarkers into clinical routines and in digital health systems has driven such predictive biomarkers real-world clinical application. Biomarker-based assessments to inform treatment decision-making have become an increasingly important part of the hospital, clinic, and diagnostic lab, with a focus on the challenges of oncology and chronic disease. These assays have been incorporated into the EHR now, and the results of the biomarkers are immediately available for personalized therapy considerations. Furthermore, the emergence of AI and machine learning applications reflects on biomarker data for predicting patient outcomes and treatment response. By integrating these findings digitally, you can provide an improved diagnostic utility, quicker time to clinical conclusion, and efficient, evidence-based care, which leads to market growth.

Restraints:

• Lack of Standardization & Regulatory Complexity are Restraining the Predictive Biomarkers Market Growth

Lack of uniform test protocols and regulatory uniformity among countries are a significant limitation to the predictive biomarkers market. Biomarker tests differ considerably with respect to sensitivity, specificity, and interpretation, which results in inhomogeneous clinical findings. This presents a major problem for doctors attempting to trust test results. There are also very different routes to companion diagnostic regulations, such as the U.S., Europe, and Asia, which leads to delays in launching the product globally. These challenges raise development costs, pose barriers to market entry, and hinder the adoption of predictive biomarkers in research and in the clinic, especially in the global framework of multi-national drug development.

For instance, in February 2025, Bridging Gaps in Oncology: Comparative Analysis of Development and Approval Pathways for Anticancer Drugs and Companion Diagnostics in the U.S. and Japan.

Segmentation Analysis:

By Indication

Cancer was the dominant segment in the global predictive biomarkers market, with a 62.52% market share in 2024 owing to the high prevalence of cancer worldwide, and an increasing requirement for targeted, individualized therapy. Predictive biomarkers, including HER2, EGFR, BRCA, and PD-L1, have been extensively recognized in order to compensate for treatment strategy, including breast, lung, and colorectal cancers. These biomarkers enable doctors to recognize patients who are most likely to benefit from particular drugs, leading to better outcomes and fewer side effects. Growing penetration of companion diagnostics, an increase in the number of cancer research studies, and regulatory support for biomarker-based therapies also contribute to the growth of the market. Whilst precision oncology progresses, cancer is still the leading sector for predictive biomarkers internationally.

The immunological diseases segment is emerging as the fastest growing in the Global Predictive Biomarkers Market with the highest CAGR of 19.54% owing to the increasing incidence of diseases, such as rheumatoid arthritis, lupus, and multiple sclerosis.” These are life-long autoimmune diseases with variable responses to different biologic treatments. Predictive biomarkers allow for the selection of patients based on who will respond to individual immunomodulators or biologics, resulting in improved efficacy and less trial-and-error prescribing. Progress in cytokine profiling, genomics, and companion diagnostics has improved biomarker-based immunological decision-making. While rising investment in autoimmune research and the surge in demand for customized immunotherapies continue to shape the market in developed and emerging markets alike, the uptake of predictive biomarkers in this segment is also gaining traction.

By Technology

In 2024, the drug discovery & development segment dominated the predictive biomarkers market share with a 34.42%. Owing to its important role in enhancing the efficacy, safety, and success rate of drug approval. Predictive biomarkers are candidates early in the drug development process that may predict a given drug’s target, responsive patient population, or a novel clinical trial endpoint. It lowers the time, cost, and risk to bring new treatments to market. The emergence of personalized medicine and companion diagnostics has further accelerated the incorporation of biomarkers in pharmaceutical pipelines. Moreover, government regulatory bodies, such as the FDA, are in favor of biomarker-driven drug development, promoting broad acceptance throughout the biotechnology and pharmaceutical institutions globally.

The diagnostics segment is the fastest-growing in the predictive biomarkers market analysis, due to increasing requirements for early diagnosis, non-invasive testing, and treatment individualization. Predictive biomarkers facilitate physicians in assessing the risk of disease and the response to treatments, which is expected to occur much before the onset of symptoms, especially in cancer, cardiovascular, and autoimmune diseases. Molecular-based testing is now becoming more precise, accessible, and affordable through continued advances in technology, including next-generation sequencing (NGS), liquid biopsy, and molecular diagnostics. Rising adoption of companion diagnostics and incorporation into clinical workflows are in turn accelerating the pace. Furthermore, clinicians and patients are increasingly becoming aware of diagnostic biomarkers that are being used more frequently both in the hospital and the outpatient context.

By End-User

The pharmaceutical & biotechnology companies hold the largest share in the predictive biomarkers industry owing to their extensive use of biomarkers in drug discovery, development, and trials. These companies apply predictive biomarkers to patient identification, improve drug targeting, lessen side effects, and increase clinical trial efficiency. This focused strategy significantly raises the likelihood of drug approval and reduces development costs. Increasing prevalence of companion diagnostics, regulations supporting the use of biomarker-associated therapies, and growing R&D investment by pharmaceutical and biotechnology companies are also contributing to the increasing demand for personalized medicine. With precision medicine helping to drive drug development, predictive biomarker technologies are being heavily utilized by pharma and biotech companies around the world.

Hospitals & Specialty Clinics is the fastest-growing segment in the predictive biomarkers industry, with the highest CAGR of 19.08%. More biomarker testing is being incorporated into routine clinical care. Such places are now using predictive biomarkers to tailor treatment regimens, notably in oncology, cardiology, and autoimmune disorders. Developments in molecular diagnostics, point-of-care testing, and relative access to companion diagnostics make an accurate bedside decision faster and more feasible. Furthermore, an increase in patient consciousness, augmenting requirements for personalized therapies, and the availability of enhanced medical insurance for biomarker tests are accelerating adoption across the hospital segment. The transition to value-based care is also more actively motivating hospitals to employ predictive biomarkers to improve outcomes while decreasing costs.

Regional Analysis:

In 2024, the North American region dominated the predictive biomarkers market and accounted for 42.30% of the overall revenue share owing to a highly advanced healthcare infrastructure, significant presence of pharmaceutical and biotechnology companies, and early adoption of precision medicine. The region, and specifically the U.S., has broad availability of advanced technologies, such as next-generation sequencing (NGS), molecular diagnostics, and AI-enabled analytics that are critical to biomarker discovery and use. Regulatory backing from organisations, such as the FDA, in conjunction with mature companion diagnostic models, reduces product approval timeframes and time to clinical implementation. Moreover, positive reimbursement policies and awareness among the patients have fuelled the demand for personalized therapeutics across cancer, cardiovascular, and autoimmune diseases. Key companies, including Thermo Fisher, Guardant Health, and Roche, have established their strong presence in the North America region, which also provides fuel to the innovativeness.

Europe holds the second-largest market share in the predictive biomarkers market due to strong healthcare infrastructure, increasing focus on precision medicine, and a favorable regulatory scenario. The EMA is taking an active stance to foster the development and acceptance of biomarker-targeted therapies and companion diagnostics to maximize utility. Countries, such as Germany, the U.K., and France are pouring funds into research for personal medicine strategies, national screening, particularly in the area of oncology and chronic diseases, for those who are starting to merge and try to accelerate the discovery of diagnostic treatments. Also, the existence of a number of top biotech companies and research institutes promotes innovation in biomarker identification. Rising public patient awareness and government funding, and EU-backed cross-border healthcare collaborations continue to drive the market.

The Asia Pacific region is projected to grow with the fastest CAGR of 19.98% over the forecast period. Catapulted by a fast-paced evolution of the health care systems, growing disease burden, and intensified funding of precision medicine. Shifting Dynamics in Emerging Economies Developing countries, such as China, India, Japan, and South Korea, are seeing greater demand for personalized medicine, especially in oncology, neurology, and autoimmune diseases. This is driving demand for predictive biomarkers that can help to inform early diagnosis, treatment selection, and risk stratification. Genomics research and clinical innovation are actively supported by governments in the region via national programs and public–private partnerships. For instance, China’s Precision Medicine Initiative and India’s focus on spreading biotech hubs are contributing to the development of biomarkers. Furthermore, the expansion of multinational pharmaceutical and diagnostics companies is increasing accessibility to sophisticated molecular testing tools.

Moreover, the availability of genomic testing at affordable prices and rising numbers for private clinics and hospitals are contributing to the predictive biomarkers market growth in the Asia Pacific region. Further increasing adoption are a large patient pool, increasing healthcare expenditure, and an increasing awareness regarding the benefits of predictive diagnostics. Regulatory hurdles persist, but continued movement toward harmonization and collaboration is likely to drive further growth, with Asia-Pacific undeniably at the heart of the global predictive biomarkers market.

The Middle East & Africa account for a relatively low market share in predictive biomarkers owing to poor health care infrastructure and less adoption of advanced diagnostics. Lack of funding, lack of trained medical personnel, and inadequate access to next-generation sequencing and molecular diagnostic testing needed for pharmacogenomic testing are challenges that many countries in MEA are addressing. Furthermore, a lack of knowledge about personalized medicine and biomarkers among clinicians and patients limits market growth. Regulations are still in flux, which has resulted in slower approval and disjointed healthcare policies across the region. In addition to this difference in infrastructure, economic disparities and a focus on basic healthcare demands rather than sophisticated diagnostics are also reasons for a smaller market size. Nevertheless, the rising investments, growing accessibility of healthcare, and rising interest in precision medicine indicate incremental opportunities for the predictive biomarkers market in MEA over the forecast period.

The predictive biomarkers market in Latin America is expected to progress at a moderate pace, fueled by a rising number of investments in healthcare, increasing prevalence of diseases, such as cancer and others, and rising awareness about the benefits of personalized medicine. The volumes of market opening up in countries including Brazil, Mexico, and Argentina, which are scaling their healthcare infrastructure and conforming with best global practices by embracing advanced diagnostic modalities, including next-generation sequencing and molecular testing. Public- and private-sector programs are working to increase access to biomarker-based diagnostics, especially in oncology and cardiovascular diseases. However, the speed of market penetration remains hindered by barriers such as reimbursement restrictions, regulatory complexity, and economic disparity. However, growing government interventions, higher patient awareness, and the penetration of the global pharmaceutical and diagnostic players will help keep the Latin American predictive biomarkers market afloat in the next few years.

Key Players:

Predictive Biomarkers Market companies include Thermo Fisher Scientific, Inc., Roche Diagnostics, Illumina, Inc., Guardant Health, Inc., Pfizer Inc., AstraZeneca plc, Abbott Laboratories, Qiagen N.V., Myriad Genetics, Inc., Agilent Technologies, Inc., and other players.

Recent Developments:

• In May 2025, Guardant Health, Inc., a leading precision oncology company, announced major new features for the Guardant 360 Liquid test that greatly expand its biomarker identification and cancer subtyping capabilities to help oncologists identify optimal treatment plans. 

• In March 2024, Venlo, the Netherlands, QIAGEN announced the release of the QIAstat-Dx Analyzer 2.0, including the Software 1.6 upgrade, a significant enhancement to the widely-used QIAstat-Dx Analyzer 1.0 for reliable, fast, and cost-effective diagnosis of complex syndromes.