United States Biomarkers Market 2032 | Growth Drivers, Key Players & Investment Opportunities

Market Size and Growth

The global Biomarkers market reached US$ 60.76 billion in 2024 and is expected to reach US$ 148.88 billion by 2032, growing at a CAGR of 11.9% during the forecast period 2025-2032.

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Key Development:

United States: Recent Biomarkers Developments

✅ In December 2025, U.S. oncology clinical trials expanded the use of wearable‐derived digital biomarkers to monitor patient fatigue, mobility and treatment response in real time, enhancing continuous data capture and late‐stage cancer trial performance.

✅ In November 2025, several FDA‐supported oncology studies broadened the integration of AI‐driven digital biomarkers for early toxicity detection and treatment response assessment, reducing patient dropouts and improving safety monitoring.

✅ In October 2025, major U.S. cancer research programs incorporated digital biomarkers into decentralized clinical trial models using smartphone‐based assessments and ePROs, accelerating recruitment and enhancing real‐world outcomes data collection.

✅ In October 2025, CND Life Sciences was granted FDA Breakthrough Device Designation for its Syn‐One Test®, a skin‐biopsy‐based diagnostic that measures alpha‐synuclein biomarkers to aid diagnosis of neurodegenerative synucleinopathies.

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Japan: Recent Biomarkers Developments

✅ In December 2025, Japanese oncology research centers expanded the use of mobile health apps to collect digital symptom and activity biomarkers in cancer trials, supporting continuous monitoring during chemotherapy and immunotherapy.

✅ In November 2025, Japan‐based oncology trials increasingly leveraged AI‐enabled digital pathology biomarkers, using high‐resolution imaging for more precise tumor characterization and response evaluation in clinical studies.

✅ In October 2025, academic‐industry collaborations in Japan integrated wearable sensors into oncology clinical trials to assess physical function and treatment tolerance with digital biomarker endpoints, improving endpoint consistency.

✅ In September 2025, AMI株式会社 (AMI Co., Ltd.) received regulatory approval in Japan for its digital biomarker DNP‐HF program for non‐invasive heart sound analysis, advancing digital biomarkers in cardiovascular diagnostics.

Key Players:

=> Thermo Fisher Scientific Inc., QIAGEN NV, Merck KGaA, BRUKER CORPORATION, Bio-Rad Laboratories, Inc., Siemens Healthineers AG, Abbott Laboratories, Agilent Technologies Inc., Myriad Genetics and Somru BioScience Inc. among others.

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Key Segments:

By Product Type

Diagnostic Biomarkers - ~25% share

Widely used for early disease detection, clinical diagnosis, and laboratory testing across multiple therapeutic areas.

Monitoring Biomarkers - ~15% share

Adopted for tracking disease progression, treatment response, and therapeutic efficacy in clinical settings.

Predictive Biomarkers - ~10% share

Increasing demand in precision medicine and oncology for predicting patient response to therapies.

Susceptibility/Risk Biomarkers - ~10% share

Growing focus in preventive medicine and disease risk stratification studies.

Prognostic Biomarkers - ~10% share

Used to forecast disease outcomes and survival rates, particularly in oncology and chronic diseases.

Pharmacodynamic/Response Biomarkers - ~10% share

Critical in drug development for assessing pharmacological effects in clinical trials.

Safety Biomarkers - ~10% share

Important for evaluating drug toxicity and adverse reactions during preclinical and clinical studies.

Others - ~10% share

Includes emerging biomarkers for novel applications and niche research areas.

By Application

Drug Discovery and Development - ~30% share

Primary driver of biomarker adoption; helps in target identification, drug response monitoring, and clinical trial optimization.

Disease Diagnostics - ~25% share

Key application in hospitals and diagnostics laboratories for early and accurate disease detection.

Disease Risk Assessment - ~15% share

Increasing use in preventive healthcare and personalized screening programs.

Personalized Medicine - ~20% share

Adoption growing rapidly in oncology, cardiology, and rare disease management.

Others - ~10% share

Includes research, epidemiological studies, and companion diagnostic development.

By End-User

Pharmaceutical Companies - ~35% share

Major adopters for biomarker-driven drug development and clinical trials.

Biotechnology Companies - ~25% share

Leveraging biomarkers for novel therapeutic development and precision medicine solutions.

Research Centers and Institutes - ~25% share

Extensive use in academic research, preclinical studies, and translational medicine.

Others - ~15% share

Includes diagnostic laboratories, contract research organizations (CROs), and hospitals involved in R&D.

By Region

North America - ~35% share

Dominates due to advanced pharmaceutical infrastructure, strong R&D investment, and regulatory support for biomarker-driven therapies.

Europe - ~25% share

Growth supported by precision medicine initiatives, clinical trial networks, and government-backed research programs.

South America - ~5% share

Emerging market driven by clinical research expansion and diagnostic adoption.

Asia Pacific - ~30% share

Fastest growing region with increasing biotech investment, growing pharmaceutical sector, and rising awareness of personalized medicine.

Middle East & Africa - ~5% share

Moderate growth driven by healthcare modernization and partnerships with global pharmaceutical firms.

FAQ

What is the current size of the Biomarkers Market?

A: In 2024, the Biomarkers Market was valued at US$ 60.76 billion, reflecting its strong industry presence.

Q2: How large is the Biomarkers Market expected to be by 2032?

A: By 2032, industry forecasts suggest the Biomarkers Market will grow to around US$ 148.88 billion, demonstrating significant expansion.

Q3: What is the growth rate of the Biomarkers Market?

A: The market is projected to expand at a compound annual growth rate (CAGR) of 11.9% during the forecast period from 2025 to 2032.

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