Next Generation Tissue Biomarkers Market Report 2025

The next generation tissue biomarkers market size has grown rapidly in recent years. It will grow from $2.68 billion in 2024 to $3.03 billion in 2025 at a compound annual growth rate (CAGR) of 13.1%. The growth during the historic period can be attributed to increasing demand for personalized medicine, expanding adoption of immunohistochemistry techniques, a growing emphasis on early disease detection, rising healthcare expenditure, advancements in diagnostic imaging technologies, heightened awareness of biomarker-based diagnostics, and an increasing focus on companion diagnostics.

The next generation tissue biomarkers market size is expected to see rapid growth in the next few years. It will grow to $4.89 billion in 2029 at a compound annual growth rate (CAGR) of 12.7%. The growth in the forecast period can be attributed to rising demand for multiplex biomarker assays, increasing adoption of next-generation sequencing, growing investment in cancer research, expanding applications of digital pathology, enhanced use of AI in diagnostics, a surge in clinical trials for targeted therapies, and broader availability of tissue-based genomic data. Major trends during the forecast period include advancements in next-generation sequencing, integration of artificial intelligence (AI) in digital pathology, development of advanced mass spectrometry-based proteomics, improvements in ribonucleic acid biomarker detection technologies, and integration with cloud-based data platforms.

The rising demand for personalized medicine is driving growth in the next-generation tissue biomarkers market. Personalized medicine tailors treatments based on an individual’s genetic profile, lifestyle, and environmental factors. Its adoption is increasing due to advancements in genomic technologies, which enable highly specific and individualized treatment strategies. Next-generation tissue biomarkers support personalized medicine by providing precise information on a patient’s tissue profile, guiding tailored therapies. For example, according to the Personalized Medicine Coalition, in 2023, the FDA approved 16 new personalized treatments for rare disease patients, up from six in 2022, including seven cancer drugs and three for other conditions. This rising demand for personalized medicine is therefore fueling the growth of the next-generation tissue biomarkers market.

Companies in this market are focusing on genomic-based diagnostic assays and sequencing solutions to improve precision and efficiency in cancer diagnostics and treatment. These tools examine genetic information to identify disease-related biomarkers, enabling more personalized diagnostic and therapeutic approaches. For instance, in August 2024, Illumina Inc., a US-based biotechnology company, received FDA approval for its TruSight Oncology Comprehensive test and two companion diagnostics. The test profiles over 500 genes from a single tissue sample, automates biomarker detection, and supports 24/7 deployment, significantly reducing turnaround times and improving clinical efficiency for targeted cancer therapies.

In July 2025, Quanterix Corporation, a US-based life sciences company, acquired Akoya Biosciences Inc. This acquisition aims to integrate Akoya’s spatial biology capabilities into Quanterix’s blood-based biomarker platform, enhancing tissue-to-blood precision diagnostics. Akoya Biosciences provides advanced solutions for analyzing next-generation tissue biomarkers, and this partnership strengthens Quanterix’s technological depth in precision diagnostics.

Major players in the next generation tissue biomarkers market are Roche Diagnostics, Thermo Fisher Scientific Inc., LabCorp., Quest Diagnostics Incorporated, Agilent Technologies Inc., Illumina Inc., Bio-Rad Laboratories Inc., QIAGEN N.V., Bio-Techne Corporation, Myriad Genetics Inc., NeoGenomics Laboratories Inc., Guardant Health Inc., Foundation Medicine Inc., NanoString Technologies Inc., PathAI Inc., Biocartis Group NV, Personalis Inc., Ultivue Inc., Indica Labs Inc., Strata Oncology Inc., Genialis Inc., Alida Biosciences Inc., and Biofidelity Ltd.

North America was the largest region in the next generation tissue biomarkers market in 2024. Asia-Pacific is expected to be the fastest-growing region in the forecast period. The regions covered in next generation tissue biomarkers market report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East and Africa. The countries covered in the next generation tissue biomarkers market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA, Canada, Italy, Spain.

Note that the outlook for this market is being affected by rapid changes in trade relations and tariffs globally. The report will be updated prior to delivery to reflect the latest status, including revised forecasts and quantified impact analysis. The report’s Recommendations and Conclusions sections will be updated to give strategies for entities dealing with the fast-moving international environment.

The sudden escalation of U.S. tariffs and the consequent trade frictions in spring 2025 are severely impacting the pharmaceutical companies contend with tariffs on APIs, glass vials, and lab equipment inputs with few alternative sources. Generic drug makers, operating on razor-thin margins, are especially vulnerable, with some reducing production of low-profit medicines. Biotech firms face delays in clinical trials due to tariff-related shortages of specialized reagents. In response, the industry is expanding API production in India and Europe, increasing inventory stockpiles, and pushing for trade exemptions for essential medicines.

Next-generation tissue biomarkers are sophisticated biological indicators derived from tissue samples that provide highly detailed and accurate insights into biological conditions. They capture subtle molecular and cellular changes within tissues, enabling a deeper understanding of physiological and pathological processes. These biomarkers are identified using advanced analytical techniques that allow for comprehensive examination of tissue characteristics.

The primary types of next-generation tissue biomarkers include genomic biomarkers, proteomic biomarkers, epigenetic biomarkers, transcriptomic biomarkers, and metabolomic biomarkers. Genomic biomarkers, based on DNA or RNA, help detect, diagnose, or predict disease risk and treatment responses by analyzing genetic mutations or expression patterns. Supporting technologies for these biomarkers include immunohistochemistry, next-generation sequencing, mass spectrometry-based proteomics, spatial biology platforms, digital pathology integrated with artificial intelligence, and others. These biomarkers find applications in areas such as oncology, companion diagnostics, drug discovery and development, neurology, and more, serving end users including hospitals, reference laboratories, pharmaceutical and biotechnology companies, academic and research institutions, and contract research organizations.

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

The next generation tissue biomarkers market consists of revenues earned by entities by providing services such as epigenomics analysis, single-cell analysis, and multiplex immunofluorescence. The market value includes the value of related goods sold by the service provider or included within the service offering. The next generation tissue biomarkers market also includes sales of diagnostic assays, reagents and antibodies, sequencing kits, imaging and staining systems, multiplex analysis platforms, and spatial biology instruments. 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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