United States and Japan Lead Recent Developments in Biomarker Testing Innovation | Top Companies are QIAGEN N.V., Bio-Rad Laboratories, Inc., Illumina, Inc.

Global Biomarker Testing Market is expected to reach at a Significant CAGR during the forecast period 2024-2031.

The Biomarker Testing market involves diagnostic tests that identify molecular, genetic, or protein markers for disease detection, prognosis, and therapeutic decisions. Rising adoption of precision medicine and personalized therapies drives growth. Innovations in liquid biopsy, genomic profiling, and multiplex assays enhance accuracy. Increasing prevalence of chronic diseases and cancers supports market expansion. Regulatory approvals and healthcare investments further fuel adoption globally.

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☛ Biomarker Testing Market Recent Developments 2025:

United States: Recent Industry Developments
✅ In September 2025, Exact Sciences launched Cancerguard, the first multi-cancer early detection blood test commercially available that analyzes multiple biomarker classes to help detect a wide range of cancers, including those that often go undiagnosed until later stages when treatment options are limited.

✅ In July 2025, Illumina enhanced its TruSightTM Oncology 500 v2 research assay to include built-in homologous recombination deficiency (HRD) biomarker detection, offering faster turnaround times and requiring lower tissue sample inputs, thereby accelerating access to comprehensive tumor profiling.

✅ In May 2025, the National Institutes of Health (NIH) reported advancements in Alzheimer's Disease and Related Dementias research, including the development of new dementia screening approaches and diagnostics, such as enhanced biomarkers, contributing to improved early detection and treatment strategies.

Japan: Recent Industry Developments
✅ In September 2025, Otsuka Pharmaceutical's Diagnostic Division inaugurated a new laboratory in Tokyo, focusing on biomarker and digital biomarker research to strengthen connections with users and enhance diagnostic capabilities.

✅ In May 2025, Illumina received approval from Japan's Ministry of Health, Labour and Welfare for its TruSightTM Oncology Comprehensive test, enabling clinicians to profile over 500 genes in solid tumors, thereby expanding access to precision oncology options for patients in Japan.

✅ In July 2025, Mirxes Japan, in collaboration with Nagawa Pharmaceutical, launched a nationwide public health initiative focused on gastric health and early detection of gastric cancer, utilizing the GASTROClearTM microRNA-based blood test to offer free screening to 10,000 residents across Japan.

☛ Biomarker Testing Market Trends:

The Biomarker Testing Market is experiencing significant growth as personalized medicine and targeted therapies gain momentum. Biomarkers-biological molecules indicating normal or abnormal processes or diseases-are increasingly used for early diagnosis, prognosis, and monitoring treatment efficacy across oncology, cardiovascular, neurological, and infectious diseases. Rising demand for precision medicine, coupled with advancements in genomics, proteomics, and molecular diagnostics, is driving the adoption of biomarker testing globally.

Technological innovations, including high-throughput sequencing, liquid biopsies, multiplex assays, and AI-driven data analysis, are improving the accuracy, speed, and cost-effectiveness of biomarker testing. Increasing collaboration between diagnostic companies, research institutions, and healthcare providers is accelerating product development and clinical applications. Additionally, supportive regulatory frameworks and growing awareness among physicians and patients about early disease detection and personalized treatment are further boosting market growth.

☛ Biomarker Testing Market Competitve Landscape:

QIAGEN N.V., Bio-Rad Laboratories, Inc., Illumina, Inc., Labcorp Drug Development, IQVIA, Inc., Quanterix Corporation, Merck KGaA, Abbott Laboratories, Thermo Fisher Scientific Inc., and Q2 Solutions among others.

Research Methodology

We follow a hybrid research approach, combining qualitative insights with rigorous quantitative analysis to deliver reliable and comprehensive market intelligence. Our process begins with extensive secondary research, drawing on trusted industry reports, proprietary databases, and credible market sources. This is then reinforced through targeted primary research, including structured surveys and in-depth interviews with industry leaders, subject matter experts, and key market participants.

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☛ Segment Covered in the Biomarker Testing Market:

By Biomarker Type: Diagnostic Biomarkers, Prognostic Biomarkers, Predictive Biomarkers.

By Application: Drug Discovery and Development, Disease Diagnostics, Disease Risk Assessment, Personalized Medicine, Others.

By End-User: Hospitals, Clinical Laboratoratories, Academic and Research Institutes, Others.

☛ This Report Includes:

✔ Comprehensive go-to-market strategies with actionable insights.

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✔ Deep-dive analysis into development trends, competitive landscape, supply-demand dynamics, YoY growth, benchmarking, vendor mapping, market access, and overall progress.

✔ Tailored regional and country-level reports with detailed localized analysis available on request.

✔ Identification of niche segments and high-growth regions presenting strong opportunities.

✔ Accurate regional forecasts using both top-down and bottom-up approaches.

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☛ Regional Analysis for Biomarker Testing Market:

⇥ North America (U.S., Canada, Mexico)

⇥ Europe (U.K., Italy, Germany, Russia, France, Spain, The Netherlands and Rest of Europe)

⇥ Asia-Pacific (India, Japan, China, South Korea, Australia, Indonesia Rest of Asia Pacific)

⇥ South America (Colombia, Brazil, Argentina, Rest of South America)

⇥ Middle East & Africa (Saudi Arabia, U.A.E., South Africa, Rest of Middle East & Africa)

☛ Frequently asked questions:

➠ What is the global sales, production, consumption, import, and export value of the Biomarker Testing Market?
➠ Who are the key global manufacturers, and what is their operational performance?
➠ What are the major opportunities and threats in the global Biomarker Testing Market?
➠ Which product types or end-users show the most growth potential and market share?
➠ What challenges and constraints are impacting the Biomarker Testing Market?
➠ What sales, marketing, and distribution channels are used globally?

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