Diagnostic Biomarkers Global Market Report 2025

The diagnostic biomarkers market size has grown rapidly in recent years. It will grow from $65.25 billion in 2024 to $75.67 billion in 2025 at a compound annual growth rate (CAGR) of 16%. The growth during the historic period was driven by factors such as the increasing prevalence of chronic diseases, advancements in omics technologies, rising demand for personalized medicine, greater awareness of early disease detection, and the expanding use of non-invasive diagnostic methods.

The diagnostic biomarkers market size is expected to see rapid growth in the next few years. It will grow to $136.57 billion in 2029 at a compound annual growth rate (CAGR) of 15.9%. The growth in the forecast period is expected to be driven by the increasing adoption of liquid biopsy techniques, rising investments in biomarker research, a growing focus on precision medicine, and expanding applications in neurodegenerative diseases. Key trends include advancements in artificial intelligence and machine learning, the integration of multi-omics approaches, the development of point-of-care diagnostic tools, the shift toward digital biomarkers, the growing use of wearable health monitoring devices, and a heightened emphasis on biomarker validation and standardization.

The increasing incidence of cancer is driving the expansion of the diagnostic biomarkers market. Various factors, including an aging population, lifestyle changes, environmental exposures, and advancements in diagnostic technology, contribute to the rising prevalence of cancer. Diagnostic biomarkers play a vital role in cancer detection by enabling early identification, accurate diagnosis, and personalized treatment approaches, ultimately improving patient outcomes. For example, in January 2024, the American Cancer Society, a US-based nonprofit cancer advocacy organization, reported that the number of cancer cases had risen to 2,001,140 from 1,958,310 in 2023, marking a 2.19% increase. This growing prevalence of cancer continues to fuel the demand for diagnostic biomarkers.

Leading companies in the diagnostic biomarkers market are prioritizing the development of non-invasive testing methods, such as blood-based biomarker tests, to improve patient comfort and accessibility while facilitating personalized treatment approaches. A blood-based biomarker test is a diagnostic tool that examines specific biological markers in the blood to detect or monitor diseases, including Alzheimer's, in a minimally invasive manner. For instance, in July 2023, Quanterix Corporation, a US-based life sciences company, introduced LucentAD, a blood-based biomarker test designed to assist healthcare professionals in diagnosing Alzheimer's disease (AD) in patients with early cognitive symptoms. The test measures plasma levels of phosphorylated tau protein at the 181 residue (p-Tau 181), a biomarker linked to amyloid pathology in the brain, a key indicator of AD. By offering a less invasive and more accessible alternative to traditional diagnostic methods such as cerebrospinal fluid analysis or amyloid positron emission tomography, LucentAD aims to streamline the assessment process for suspected Alzheimer's patients.

In September 2024, Trinity Biotech, an Ireland-based clinical diagnostics company, acquired Metabolomics Diagnostics for approximately $1.3 million. This acquisition enhances Trinity Biotech’s capabilities by integrating a strategically significant mass spectrometry platform with machine learning-driven bioinformatics. Metabolomics Diagnostics, also based in Ireland, specializes in developing novel biomarker-based diagnostic solutions for complex diseases.

Major players in the diagnostic biomarkers market are Johnson & Johnson Services Inc., F. Hoffmann-La Roche AG, Thermo Fisher Scientific Inc., Abbott Laboratories, PerkinElmer Inc., Siemens Healthineers AG, Merck KGaA, Agilent Technologies Inc., Charles River Laboratories International Inc., Bio-Rad Laboratories Inc., Bruker Corporation, Qiagen N.V., Myriad Genetics Inc., Meso Scale Diagnostics LLC, EKF Diagnostics Holdings Plc, Sino Biological Inc., Enzo Biochem Inc., Biomarker Technologies Inc., Cisbio Bioassays, Signosis Inc., Epigenomics AG, LifeSign LLC, Banyan Biomarkers Inc., Biosims Technologies SAS.

North America was the largest region in the diagnostic biomarkers market in 2024. The regions covered in diagnostic biomarkers report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East and Africa.

The countries covered in the diagnostic biomarkers market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA, Canada, Italy, Spain.

A diagnostic biomarker is a biological indicator that aids in identifying a disease, distinguishing it from other conditions. This can include various types of findings, such as laboratory test results, radiological imaging, genetic markers, and physiological changes. Additionally, diagnostic biomarkers can offer insights into disease progression and the effectiveness of treatments.

The primary product types in diagnostic biomarkers include safety biomarkers, efficacy biomarkers, and validation biomarkers. Safety biomarkers are measurable indicators used to evaluate the potential risk of toxicity or adverse effects linked to medical treatments or environmental exposures. They help determine the safety of a therapy by monitoring biological responses that may signal harm. These biomarkers are applied in fields such as oncology, metabolic diseases, and neurological disorders, serving end users such as hospitals, cancer research institutes, and diagnostic laboratories.

The diagnostic biomarkers market research report is one of a series of new reports that provides diagnostic biomarkers market statistics, including diagnostic biomarkers industry global market size, regional shares, competitors with a diagnostic biomarkers market share, detailed diagnostic biomarkers market segments, market trends and opportunities, and any further data you may need to thrive in the diagnostic biomarkers industry. This diagnostic biomarkers market research report delivers a complete perspective of everything you need, with an in-depth analysis of the current and future scenario of the industry.

The diagnostic biomarkers market consists of revenues earned by entities by providing services such as biomarker assay development and validation, biomarker-based diagnostic testing services, clinical trial support services, and data management services. The market value includes the value of related goods sold by the service provider or included within the service offering. The diagnostic biomarkers market also includes sales of biomarker assays, liquid biopsy kits, digital biomarkers, and genetic testing kits. Values in this market are ‘factory gate’ values, that is the value of goods sold by the manufacturers or creators of the goods, whether to other entities (including downstream manufacturers, wholesalers, distributors and retailers) or directly to end customers. The value of goods in this market includes related services sold by the creators of the goods.

The market value is defined as the revenues that enterprises gain from the sale of goods and/or services within the specified market and geography through sales, grants, or donations in terms of the currency (in USD, unless otherwise specified).

The revenues for a specified geography are consumption values that are revenues generated by organizations in the specified geography within the market, irrespective of where they are produced. It does not include revenues from resales along the supply chain, either further along the supply chain or as part of other products.

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