Biomarker Technologies Market

Market Definition

Biomarker technologies encompass a range of scientific tools and methods designed to identify, analyze, and validate biological markers (biomarkers) that indicate physiological or pathological processes, or responses to pharmacological treatment.

The market encompasses as assay systems, imaging technologies, and molecular diagnostics. It supports drug discovery, clinical diagnostics, and disease monitoring by improving biological analysis and medical decision-making.

This report explores the key drivers of market development, a detailed regional analysis, and a comprehensive overview of the competitive landscape shaping future opportunities.

Biomarker Technologies Market Overview

The global biomarker technologies market size was valued at USD 45.23 billion in 2024 and is projected to grow from USD 49.29 billion in 2025 to USD 91.86 billion by 2032, exhibiting a CAGR of 9.21% over the forecast period. 

The market is experiencing significant growth, driven by the increasing demand for early disease detection, personalized treatment approaches, and advancements in genomics and proteomics. Rising investments in biomarker research, coupled with the expanding application of biomarkers in drug discovery and development, are accelerating market expansion.

Major companies operating in the biomarker technologies industry are Quibim, Bio-Rad Laboratories, Inc., Abbott, Revvity, Agilent Technologies, Inc., F. Hoffmann-La Roche Ltd, Thermo Fisher Scientific Inc., Merck KGaA, QIAGEN, Illumina, Inc., DH Life Sciences, LLC, Beckman Coulter, Inc., Bruker, Empatica Inc., and Golden Helix, Inc.

• In October 2024, the Centers for Disease Control and Prevention (CDC) reported that chronic diseases are the leading cause of illness, disability, and death in the U.S. Six in ten adults have at least one chronic condition, while four in ten have two or more, primarily due to smoking, poor nutrition, physical inactivity, and alcohol use.

The rising prevalence of chronic diseases has established the demand for accurate diagnostic tools to enable their early detection and effective management. 

Biomarker technologies address this need by identifying diseases at an early stage, monitoring their progression, and informing targeted treatment decisions. These capabilities improve diagnostic precision and contribute to better patient outcomes.

Key Highlights

1. The biomarker technologies market size was valued at USD 45.23 billion in 2024.
2. The market is projected to grow at a CAGR of 9.21% from 2025 to 2032.
3. North America held a market share of 34.09% in 2024, with a valuation of USD 15.42 billion.
4. The consumables segment garnered USD 26.10 billion in revenue in 2024.
5. The solid biopsy segment is expected to reach USD 54.17 billion by 2032.
6. The polymerase chain reaction (PCR) segment is expected to reach USD 30.24 billion by 2032.
7. The drug discovery segment is expected to reach USD 38.33 billion by 2032.
8. The market in Asia Pacific is anticipated to grow at a CAGR of 10.22% during the forecast period.

Market Driver

High-Throughput Platforms Boosting Adoption in Biomarker Technologies

The market is expanding due to the adoption of high-throughput analytical platforms. Technologies such as next-generation sequencing (NGS), digital PCR, spatial transcriptomics, and mass spectrometry have enhanced the sensitivity, accuracy, and speed of biomarker analysis. 

These platforms enable the detection of multiple biomarkers together, improving workflow efficiency and reducing turnaround time. Their scalability supports large research studies and ensures data consistency. Automation capabilities further reduce manual errors and operational costs. 

These factors are driving product adoption across clinical diagnostics, drug development, and treatment monitoring. As the need for precise and high-volume biomarker analysis continues to grow, high-throughput platforms are becoming integral to market growth.

• In May 2025, Nomic Bio launched Omni 1000, a high-throughput proteomics platform that enables the absolute quantification of 1,000 clinically relevant proteins. The platform is designed to support biomarker discovery and translational research by offering low-cost, scalable, and quantitative proteome-wide analysis. It allows researchers to generate standardized and comparable data across cohorts, facilitating large-scale studies in drug development and clinical diagnostics.

Market Challenge

Low Clinical Trial Success Due to Biomarker Limitations

A significant challenge in the biomarker technologies market is the low success rate of clinical trials. This is primarily due to inadequate patient stratification and the limited clinical applicability of identified biomarkers. 

Many biomarkers do not demonstrate consistent performance across varied patient populations, which results in suboptimal treatment targeting and increased trial failure rates. Therefore, companies are implementing synthetic lethal biomarker identification to enhance alignment between patients and targeted cancer therapies. 

This approach focuses on identifying gene pairs, whose combined loss leads to cancer cell death, allowing for precise targeting of tumor-specific vulnerabilities. It offers improved patient selection, higher clinical trial success rates, and greater efficiency in the drug development process.

• In October 2024, MEDiC Life Sciences collaborated with Hanmi Pharmaceutical to identify cancer biomarkers using MEDiC’s MCAT functional genomics platform. The collaboration aims to discover synthetic lethal biomarkers to enhance the clinical success of Hanmi’s oncology assets, and includes a strategic investment from Hanmi to support the development and application of biomarker-driven cancer therapies.

Market Trend

Integration of Spatial Multi-Omics in Biomarker Discovery

The market is witnessing a key trend with the integration of spatial multi-omics in biomarker discovery. This method combines molecular data such as genomics, proteomics, and transcriptomics with their distribution across tissue samples. 

This spatial context is critical for understanding disease mechanisms, especially in cancer and neurological disorders. By providing deeper insights into cell behavior and molecular pathways, spatial multi-omics supports the identification of more accurate and context-specific biomarkers. 

This improves the relevance and clinical value of biomarker findings. This integrated approach is shaping research priorities and influencing platform development across the market.

• In April 2025, Vizgen, Inc. launched MERFISH 2.0, an advanced spatial transcriptomics technology that enables high-resolution mapping of gene activity within tissue samples, along with updated OmniVUE proteomics panels, which feature validated biomarkers for antibody-drug conjugate (ADC) development. These tools aim to improve biomarker detection and support early-stage research and development of targeted cancer therapies.

Biomarker Technologies Market Report Snapshot

Market Segmentation

• By Component (Consumables (Reagents and Assays) and Instruments): The consumables segment earned USD 26.10 billion in 2024, due to their recurrent use in high-throughput biomarker testing and routine diagnostic workflows.
• By Test (Liquid Biopsy and Solid Biopsy): The solid biopsy segment held 59.94% of the market in 2024, attributed to its higher accuracy and established clinical acceptance across oncology diagnostics.
• By Technology (Polymerase Chain Reaction (PCR), Next Generation Sequencing (NGS), Immunoassay, and Others): The polymerase chain reaction (PCR) segment is projected to reach USD 30.24 billion by 2032, owing to its cost-effectiveness, speed, and widespread adoption in biomarker validation.
• By Application (Drug Discovery, Diagnostics, and Personalized Medicine): The drug discovery segment is projected to reach USD 38.33 billion by 2032, owing to the growing use of biomarkers in target identification, lead optimization, and clinical trial stratification.

Biomarker Technologies Market Regional Analysis

Based on region, the market has been classified into North America, Europe, Asia Pacific, Middle East & Africa, and South America.

North America accounted for 34.09% share of the biomarker technologies market in 2024, with a valuation of USD 15.42 billion. A strong clinical research infrastructure, a dense concentration of pharmaceutical and biotechnology companies, and consistent investment in translational research drive this dominance.

• In January 2025, Quibim secured USD 50 million to expand its AI-powered imaging biomarker solutions, which include QP-Prostate, QP-Brain, and QP-Liver. The funding aims to strengthen the company’s commercial presence in the U.S. through collaborations with leading hospitals and pharmaceutical firms.

This development reflects North America's commitment to innovation in biomarker technologies. The rising use of imaging biomarkers in the U.S. clinical and research settings illustrates the region’s shift toward data-driven, individualized healthcare. 

Institutions are rapidly adopting digital pathology, high-throughput sequencing, and AI analytics to improve early diagnosis, treatment monitoring, and patient stratification.

Asia Pacific is expected to register the fastest growth in the biomarker technologies industry, with a projected CAGR of 10.22% over the forecast period. This growth is primarily attributed to the expanding clinical research activities, increasing precision medicine adoption, and advancements in genomic technologies.

• In May 2025, Illumina, Inc. received approval from Japan’s Ministry of Health, Labour and Welfare for its TruSight Oncology Comprehensive genomic profiling test. By analyzing over 500 genes to identify clinically actionable biomarkers, the test is expected to improve access to targeted cancer therapies and support personalized treatment strategies.

The development emphasizes a broader regional transition toward the integration of biomarker-based diagnostics into routine oncology practice. Japan’s focus on high-throughput genomic testing and the clinical application of molecular profiling continues to influence adoption patterns throughout the region.

• In March 2025, Novotech secured a new investment from GIC and Temasek, with support from Texas Pacific Group (TPG) through its TPG Asia fund. The funding will accelerate the company’s global expansion, support strategic acquisitions, and strengthen its position as a leading biotech-focused clinical research organization (CRO) in Asia Pacific, where demand for clinical trials is rising steadily.

These developments are contributing to the enhancement of the region’s clinical research infrastructure and accelerating the deployment of biomarker technologies. This, in turn, is supporting improvements in early disease detection, treatment selection, and patient stratification across a broad spectrum of therapeutic areas.

Regulatory Frameworks

• In the U.S., the Food and Drug Administration (FDA) is the primary regulatory authority responsible for biomarker qualification and their integration into drug development and regulatory review.
• In Europe, biomarkers are regulated by the European Medicines Agency (EMA) associated with medicinal products, particularly companion diagnostics. The EMA is responsible for the scientific evaluation, supervision, and safety monitoring of medicines across the European Union (EU) and the European Economic Area (EEA).
• In Japan, the Pharmaceuticals and Medical Devices Agency (PMDA) and the Ministry of Health, Labour and Welfare (MHLW) oversee the regulation of biomarker-based diagnostics. Biomarkers intended for clinical use are categorized as in vitro diagnostics (IVDs) and must undergo a thorough evaluation under Japan’s Pharmaceutical and Medical Device Act (PMD Act).
• In India, biomarker technologies used in diagnostics are regulated by the Central Drugs Standard Control Organization (CDSCO). These rules classify diagnostic tools, including biomarker-based assays, as medical devices, requiring registration, clinical evaluation, and performance validation.

Competitive Landscape

The biomarker technologies market is undergoing a strategic shift, driven by increased collaboration and targeted acquisitions aimed at platform integration and market growth. Rising demand for early, accurate, and minimally invasive diagnostics is prompting stakeholders to accelerate the translation of biomarker discoveries into clinical practice. 

Collaborations are playing a critical role in aligning research capabilities with clinical needs, particularly in areas like neurology and oncology. Simultaneously, companies are engaging in mergers and acquisitions to build integrated platforms and expand technological capabilities.

• In July 2024, Biogen Inc., Beckman Coulter, Inc., and Fujirebio collaborated to identify and develop blood-based biomarkers for tau pathology in Alzheimer’s disease. The collaboration aims to advance minimally invasive diagnostic tools to support patient stratification and treatment monitoring in clinical trials and practice.
• In January 2025, Quanterix Corporation entered a merger agreement to acquire Akoya Biosciences, creating the first integrated platform for ultra-sensitive detection of blood- and tissue-based protein biomarkers. The merger aims to accelerate biomarker translation across neurology, oncology, and immunology.

These strategies reflect a shift from fragmented innovation to integrated solutions that offer greater sensitivity, scalability, and readiness for adoption in precision medicine as well as routine clinical care.

List of Key Companies in Biomarker Technologies Market:

• Quibim
• Bio-Rad Laboratories, Inc.
• Abbott
• Revvity
• Agilent Technologies, Inc.
• F. Hoffmann-La Roche Ltd
• Thermo Fisher Scientific Inc.
• Merck KGaA
• QIAGEN
• Illumina, Inc.
• DH Life Sciences, LLC
• Beckman Coulter, Inc.
• Bruker
• Empatica Inc.
• Golden Helix, Inc.

Recent Developments (Merger/Discovery)

• In February 2025, Renovaro Biosciences merged with BioSymetrics to advance AI-driven biomarker discovery and precision medicine. The merger integrates BioSymetrics’ Elion platform into Renovaro’s workflow to accelerate biomarker identification, target validation, and drug development in oncology and related fields.
• In November 2024, MultiOmic Health discovered novel endotypes and proprietary biomarkers for diabetic kidney disease (DKD) using its AI-enabled computational platform. The biomarkers are designed to stratify patients by disease progression and support precision medicine with potential applications in companion diagnostics, clinical trial optimization, and targeted therapy development.