Biomarker Testing Services Market By Biomarker Type (Safety Biomarkers, Efficacy Biomarkers, Validation Biomarkers), By Technology (Polymerase Chain Reaction (PCR), Next-Generation Sequencing (NGS), Immunoassays, Chromatography, Mass Spectrometry, Others), By Application (Oncology, Cardiology, Neurology, Infectious Diseases, Immunology, Others), By End User (Hospitals & Clinics, Diagnostic Laboratories, Academic & Research Institutions, Biopharmaceutical & Biotechnology Companies, Others), Global Market Size, Segmental analysis, Regional Overview, Company share analysis, Leading Company Profiles And Market Forecast, 2025 – 2035

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What trends will shape the Biomarker Testing Services Market in the coming years?

The Biomarker Testing Services Market accounted for USD 652.30 Million in 2024 and USD 709.05 Million in 2025 is expected to reach USD 1632.95 Million by 2035, growing at a CAGR of around 8.70% between 2025 and 2035. The Biomarker Testing Services Market focuses on the delivery of diagnostic services that determine and examine biomarkers, which are biological signs of normal or abnormal processes, disease status, or medication reactions. Such services can play a crucial role in the development of precision medicine because they allow for diagnosis, prognosis, and planning personal interventions at an early stage. Biomarker testing is heavily utilized-especially in oncology, cardiology, neurology, and the area of infectious diseases, with cancer biomarker testing in particular playing a critical role by informing targeted therapies.

Recent adoption of sophisticated technologies such as next-generation sequencing, polymerase chain reaction, and immunoassays has improved the accuracy and efficiency of testing. Biomarker testing services are also essential to pharmaceutical firms in drug discovery processes and in drug clinical trials to determine which patient groups are suitable and how they respond to treatment. The increasing rate of chronic disease, along with the rising level of expenditure on healthcare, as well as the regulatory backing of companion diagnostics, further catalyzes market growth. Also, artificial intelligence is linked with bioinformatics, enhancing data analysis and accelerating the delivery.  

What do industry experts say about the Biomarker Testing Services Market trends?

“As awareness around trauma and body-based healing increases, Biomarker Testing Services is gaining momentum as a transformative approach to mental health care.”

• Dr. Bessel van der Kolk, MD, Professor of Psychiatry at Boston University School of Medicine

Which segments and geographies does the report analyze?

What are the key drivers and challenges shaping the Biomarker Testing Services Market?

How is the rising demand for precision medicine influencing biomarker testing services?

One of the dynamos behind the Biomarker Testing Services Market is the increased move towards precision medicine, which will allow therapies to be personalized to an individual instead of a one-size-fits-all paradigm. Diagnostic biomarker testing is very important in determining the unique disease processes in the patient and directing selective treatment strategies, especially in oncological and rare diseases. Besides enhancing treatment outcomes, this shift will also result in a decreased risk of adverse drug response because patients will get the therapies most suitable to them. Expansion of precision medicine is complemented by government agendas that put a spotlight on biomarker-based diagnostics.

Researchers say that precision medicine applications in treating cancer are increasingly becoming part of the clinical management of the disease, with 2 of 3 drugs approved by the FDA between 2017 and 2022 necessitating the testing of biomarkers that determine how to use the drug. These statistics underscore the importance of biomarker testing in the promotion of precision medicine, which encourages its implementation in hospitals, diagnostic laboratories, and the development of pharmaceutical research, which consequently stimulates the development of the market as a whole.

In what ways does the growing prevalence of cancer and chronic diseases drive the adoption of biomarker testing?

The rising rates of cancer and long-term conditions are one of the key factors that will boost the Biomarker Testing Services Market, since these diseases need early diagnosis, reliable prognosis, and individualized treatment methods. Biomarker testing helps clinicians to identify diseases at their onset, how the disease is progressing, and effective therapeutic interventions that should be used. In oncology, biomarkers are especially important in determining genetic mutations that can be treated with precision medicine, whereas in chronic diseases such as cardiovascular and neurological problems, they are used to determine risk assessment and response to the treatment.

The increasing load of these diseases in the world is escalating the need for sophisticated diagnosis solutions. Noncommunicable diseases represent enormous health burdens; according to the World Health Organization (WHO), noncommunicable diseases are increasingly becoming the number one cause of deaths all over the world; estimates show that noncommunicable diseases are taking close to 74 percent of all deaths occurring in the world, with an estimate of 10 million in 2020 alone being resulted by cancer. These alarming statistics demonstrate the high demand to introduce biomarker-driven methods to patient clinical practice to enhance patient results and survival and mitigate mortality rates.

Why does the high cost of biomarker testing technologies limit accessibility in developing regions?

A major limiting factor to the Biomarker Testing Services Market is the high cost of analyzing those biomarkers through advanced biomarker testing technology, which mainly affects the developing world due to tight healthcare budgets and resource allocation. Newer technologies such as next-generation sequencing, mass spectrometry, and dedicated immunoassays are costly to perform using specialized equipment and trained specialists, and more generally, the testing process can be very pricey. In low- and middle-income countries, such expenses would mean that few patients are in a position to access biomarker-driven tests - a factor that disadvantages efficiency in connection to disease diagnosis and patient-specific treatment.

Besides, most of the costs incurred are direct to the patients, because there is no comprehensive insurance coverage and poor reimbursement rates in these regions, which further limit the use. WHO reports that nearly 50 per cent of the population globally does not receive essential health services, and primary among the obstacles is its affordability. Such a fiscal burden not only causes disparity in healthcare access but also limits the growth of biomarker testing to the rest of the world, as cost remains a significant factor to its slow growth, as well.

How does the expansion of liquid biopsy-based biomarker testing create new opportunities in cancer diagnostics?

The growth in cancer diagnosis with the use of liquid biopsy-based biomarker testing is an immense opportunity, as it is a less invasive, faster, and more patient-friendly cancer diagnostic alternative to the conventional tissue biopsy. Liquid biopsies are based on DNA in the blood (circulating tumor DNA, ctDNA), exosomes, or other components in the blood that enable identification of cancer early, the stage of disease, and response to treatment in real-time. This method mitigates the pain and complications of surgical biopsy and permits repeat practice across time, which is crucial to monitoring tumor progression and therapeutic resistance.

This capability, which enables it to give exhaustive information on tumor heterogeneity, makes it very useful in personalized cancer treatment. The National Cancer Institute (NCI) notes that liquid biopsies are starting to be used as potent methods of identifying genetic changes and molecular alterations associated with cancer, and there is current research on their benefits in early screening. The acceleration is leading to new growth opportunities in biomarker testing services, as liquid biopsy, a hot trend in cancer care as well as clinical research, is creating the need for more innovative and permissive diagnostic applications.

In what ways can AI and machine learning integration enhance biomarker data interpretation?

The convergence of AI and machine learning (ML) poses a significant opportunity to the Biomarker Testing Services Market because it can improve the analysis of complicated biomarker data. The result of biomarker testing is typically characterised by large amounts of genomic, proteomic, and metabolomic data that cannot be managed efficiently with traditional systems. Having ML and AI can assist in finding obscure patterns, correlations, and predictive variables with high accuracy, allowing faster and more accurate diagnosis. In oncology, the technologies aid in providing information on the way patients will react to treatment and in indicating disease recurrence earlier.

They also facilitate the process of drug discovery by speeding up the target identification and stratification of patients. In addition, AI-driven customer service tools can help make better decisions, minimizing diagnostic mistakes and increasing the personalization of treatment. The National Library of Medicine (NIH) of the United States reports that applications of AI and ML to the field of healthcare research are becoming more commonplace, where research has demonstrated a major benefit of enhancing the efficiency of diagnosis and predictive analysis in biomarker-based tests. This opens up a robust growth channel in biomarker testing services as the integration of AI increases their clinical utility and accessibility.

What are the key market segments in the Biomarker Testing Services industry?

Based on the Biomarker Type, the Biomarker Testing Services Market has been classified into Safety Biomarkers, Efficacy Biomarkers, and Validation Biomarkers. In the Biomarker Testing Services Market, the Efficacy Biomarkers segment forms the largest of them all since they are commonly used to indicate the effectiveness of a drug/treatment in patients. These are important markers in clinical practice and clinical trials to monitor responses to therapeutic actions and make adjustments in treatment. In oncology, efficacy biomarkers are critical to predict which patients will respond well to a targeted therapy, thus an important component to the success of precision medicine.

Pharmaceutical and biotechnology enterprises depend much on the performance of efficacy biomarker tests when developing their drugs because they want to measure the performance of their drug and fast-track regulatory approvals. The growing use of personalized medicine and the necessity to monitor the results of treatment in real-time contribute to the superiority of the segment. As the number of chronic and complex diseases increases, efficacy biomarkers offer practical information to be used in managing patients and increasing the effectiveness of their treatment.

Based on the Technology, the Biomarker Testing Services Market has been classified into Polymerase Chain Reaction (PCR), Next-Generation Sequencing (NGS), Immunoassays, Chromatography, Mass Spectrometry, and Others. Next-Generation Sequencing (NGS) is the single-dominant technological segment of the Biomarker Testing Services Market because of its low error rates, scaling efficiency, and multiple biomarker analysis capacity. Overall, due to the extensive genomic profiling capabilities offered by GS, the testing of biomarkers has largely changed and, in particular, is utilized effectively in oncology to identify genetic mutations and accordingly direct therapy. The speed and sparse resource absorption needed to produce inordinate data quantities make it a necessary tool in clinical diagnostic and research purposes.

Drug discovery and development is another area heavily dependent upon NGS by pharmaceutical companies, as is patient stratification and the learning of treatment responses. NGS has a more comprehensive coverage, a faster turnaround time, and is more sensitive in detecting rare variants compared to the classical methods. The increase in the use of precision medicine and its companion diagnostics has also added momentum to the biomarker testing through the NGS requirement by hospitals, diagnostic laboratories, and research facilities.

Which regions are leading the Biomarker Testing Services Market, and why?

In North America, the Biomarker Testing Services Market is performing strongly due to the presence of an advanced healthcare system in the region, high adoption of precision medicine, and substantial investment in research and development. The US is the dominant market because of intensive attention to the oncology-related biomarker test, since cancer incidence is high, and companion diagnostics are being adopted in the decision-making process. Favorable regulatory environments by government agencies such as the U.S. FDA have fast-tracked the approval of diagnostics based on biomarkers to increase clinical acceptance.

Canada is also affected positively by increasing healthcare expenditures and increasing access to modern molecular testing. The availability of established laboratories, research institutions, and biopharmaceutical companies to provide innovation in biomarker development and testing services helps promote innovation and collaboration. Besides that, the utilization of next-generation sequencing and digital health technologies is rising, which makes the process of performing tests related to the identification of biomarkers more efficient and accurate in the region.

The Asia Pacific Biomarker Testing Services Market is growing at a brisk rate, fuelled by the surging rates of chronic ailments, burgeoning interest in personalized medicine, and amplified healthcare spending among key economies. China, Japan, and India are leading the world in this area with considerable investments in molecular diagnostics, clinical trials, and biotechnology research. The region is characterized by a large population of patients, and the demand for cancer biomarker testing is increasing due to the current rapid increase in the prevalence of cancer. The modernization of healthcare is also supported by governments, whereby there are plans to enhance diagnostic infrastructure and the use of precision medicine practices.

Led by a robust research environment and early adoption of genomic testing in the healthcare system, Japan has been ahead in the use of advanced biomarkers, whereas China is on a growth spurt with an increasing number of biopharmaceutical research and local diagnostic service provider establishments. India is shaping up as a major contributor with an upsurge in clinical trial activities and adoption of cost-effective testing solutions. Moreover, there are technological innovations, such as next-generation sequencing and the analytics powered by AI, increasing the testing capacities around the region.  

What does the competitive landscape of the Biomarker Testing Services Market look like?

The Biomarker Testing Services Market is highly fragmented with the presence of global diagnostic players, dedicated labs, and biotechnology companies competing to enhance their service-based value. Key players are working to increase their biomarker portfolio in oncology, neurology, cardiology, and infectious diseases, to target a broader clinical domain. Innovation in next-generation sequencing, polymerase chain reaction, and digital immunoassays has since become a potential differentiator, with companies able to produce faster and more accurate results.

Strategic alliances between diagnostic providers, pharmaceutical companies, and research institutions are on the rise as a way of promoting companion diagnostics and precision medicine solutions. Mergers and acquisitions have also been relevant and have assisted companies in increasing their geographic presence and improving their testing ability. Also, service providers are spending a lot on bioinformatics or AI-based platforms to enhance data analysis and better clinical decision-making support. The global nature of the marketplace that has advanced infrastructure players and regional providers who offer cost-effective services is also present in the market and thus competes.

Biomarker Testing Services Market, Company Shares Analysis, 2024

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Which recent mergers, acquisitions, or product launches are shaping the Biomarker Testing Services industry?

• In June 2024, Thermo Fisher Scientific Inc. expanded its clinical research laboratory in Wisconsin, aiming to strengthen its services in emerging and novel therapeutic areas.
• In April 2024, Labcorp enhanced its precision oncology portfolio to better support biopharma, clinical research, and pharmaceutical companies, thereby accelerating drug development programs and broadening its offerings in this important market.

Report Coverage:

By Biomarker Type

• Safety Biomarkers
• Efficacy Biomarkers
• Validation Biomarkers

By Technology

• Polymerase Chain Reaction (PCR)
• Next-Generation Sequencing (NGS)
• Immunoassays
• Chromatography
• Mass Spectrometry
• Others

By Application

• Oncology
• Cardiology
• Neurology
• Infectious Diseases
• Immunology
• Others

By End User

• Hospitals & Clinics
• Diagnostic Laboratories
• Academic & Research Institutions
• Biopharmaceutical & Biotechnology Companies
• Others

By Region

North America

• U.S.
• Canada

Europe

• U.K.
• France
• Germany
• Italy
• Spain
• Rest of Europe

Asia Pacific

• China
• Japan
• India
• Australia
• South Korea
• Singapore
• Rest of Asia Pacific

Latin America

• Brazil
• Argentina
• Mexico
• Rest of Latin America

Middle East & Africa

• GCC Countries
• South Africa
• Rest of Middle East & Africa

List of Companies:

• QIAGEN N.V.
• Thermo Fisher Scientific Inc.
• Illumina Inc.
• F. Hoffmann-La Roche Ltd.
• Agilent Technologies Inc.
• Bio-Rad Laboratories Inc.
• PerkinElmer Inc.
• Abbott Laboratories
• Charles River Laboratories International Inc.
• Quest Diagnostics Incorporated
• NeoGenomics Laboratories Inc.
• Sysmex Corporation
• Laboratory Corporation of America Holdings (LabCorp)
• Biocartis Group NV
• Genomic Health Inc.

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