Blood-based Biomarker for Alzheimer’s Disease Market to Reach US$ 554.2 Mn by 2035 at 14.3% CAGR - TMR

Global Blood-based Biomarker for Alzheimer’s Market to Reach USD 554.2 Mn by 2035 at 14.3% CAGR Driven by Early Diagnosis Demand-TMR

WILMINGTON, DE, UNITED STATES, February 24, 2026 /EINPresswire.com/ -- The global blood-based biomarker for Alzheimer’s disease market was valued at US$ 127.4 Mn in 2024 and is projected to reach US$ 554.2 Mn by 2035, expanding at a CAGR of 14.3% from 2025 to 2035. Market growth is primarily driven by the rising prevalence of Alzheimer’s disease, increasing demand for non-invasive and accessible diagnostic solutions, and rapid technological advancements in ultra-sensitive detection platforms.

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The market has gained significant traction as healthcare systems transition toward early diagnosis and precision medicine approaches in neurodegenerative disorders. In revenue terms, growing regulatory clarity, improved reimbursement frameworks, and expanding clinical validation studies are accelerating commercialization of blood-based biomarker assays.

North America dominated the market in 2024, holding 48.2% of total revenue share, while the Plasma Tau-related Biomarkers segment accounted for 35.8%, reinforcing its clinical relevance in early disease detection and differential diagnosis.

Analysts’ Viewpoint

Regulatory clarity and evolving reimbursement models have significantly strengthened market confidence. Clearer regulatory pathways for in vitro diagnostic (IVD) tests have reduced uncertainty around commercialization, encouraging capital allocation and strategic investments.

Health-economic studies demonstrating cost-effectiveness of biomarker-based patient stratification have convinced payers and healthcare systems to support coverage models. Furthermore, venture capital and private equity investments are accelerating assay platform scalability, manufacturing expansion, and commercialization infrastructure.

The industry is increasingly focused on:
• Large multicenter validation trials
• Standardized reference materials and cut-off values
• Cross-platform comparability
• Multiplex panels integrating proteomic and genomic data
• AI-driven analytical algorithms

Key Market Growth Drivers

1. Rising Prevalence of Alzheimer’s Disease
The global increase in aging populations is driving a substantial rise in Alzheimer’s disease incidence. As healthcare systems face growing diagnostic demand, scalable and affordable tools are becoming essential.

Traditional diagnostic tools such as CSF testing and PET imaging are:
• Expensive
• Invasive
• Limited in accessibility
• Operationally complex

Blood-based biomarkers provide a patient-friendly, cost-effective alternative suitable for large-scale screening and monitoring.

Early detection enables:
• Timely therapeutic intervention
• Personalized treatment planning
• Delayed disease progression
• Reduced long-term care costs
• Improved quality of life

Increased disease burden has also intensified R&D investments and clinical trial activity, fostering collaborations between pharmaceutical companies, academic institutions, and diagnostic developers.

2. Growing Demand for Early and Non-Invasive Diagnosis
Early-stage diagnosis, including identification at pre-symptomatic or mild cognitive impairment (MCI) stages, is critical for effective disease management.

Healthcare providers and patients increasingly prefer non-invasive diagnostic options that:
• Reduce procedural discomfort
• Minimize clinical risks
• Offer rapid turnaround times
• Support community-based screening

Advancements in ultra-sensitive immunoassays, digital signal processing, and high-resolution mass spectrometry have improved analytical sensitivity and specificity, overcoming historical limitations of blood-based detection.

Plasma Tau-related Biomarkers – Leading Segment

The Plasma Tau-related Biomarkers segment held 35.8% of total market share in 2024, making it the dominant biomarker category.

Phosphorylated tau (p-tau) biomarkers are highly correlated with neurofibrillary tangle pathology, a defining feature of Alzheimer’s disease progression. Their ability to distinguish Alzheimer’s disease from other neurodegenerative disorders makes them clinically valuable.

Key advantages include:
• High specificity for Alzheimer’s pathology
• Strong correlation with PET and CSF biomarkers
• Reliable differentiation from other dementias
• Compatibility with ultra-sensitive detection platforms

Technological innovations have enabled accurate quantification of tau proteins even at extremely low plasma concentrations, enhancing diagnostic reliability and clinical adoption.

Regional Outlook

North America accounted for 48.2% of global market revenue in 2024. The region benefits from:
• Advanced healthcare infrastructure
• Strong research ecosystem
• Early adoption of innovative diagnostic technologies
• Robust funding from government and private agencies

The presence of leading biotechnology firms, academic research institutions, and well-established clinical trial networks facilitates rapid commercialization and regulatory approvals.

Europe
Europe represents a significant share of the global market, supported by growing Alzheimer’s awareness programs, government-backed research initiatives, and structured reimbursement pathways.

Asia Pacific
Asia Pacific is emerging as a high-growth region due to expanding healthcare access, increasing elderly population, and rising investments in neurodegenerative disease research.

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Analysis of Key Players – Competitive Landscape

The competitive environment is innovation-driven, with companies emphasizing clinical validation, regulatory approvals, strategic partnerships, and companion diagnostic development.

Leading players include:
• Biogen Inc.
• Beckman Coulter, Inc. (a subsidiary of Danaher Corporation)
• F. Hoffmann-La Roche AG
• Fujirebio
• C2N Diagnostics
• Quest Diagnostics
• ALZpath Inc.
• Quanterix
• Sysmex Corporation
• Shimadzu Corporation
• Alamar Biosciences, Inc.
• BGI Genomics
• Diadem srl

Recent Developments

• In October 2025, Roche announced that its Elecsys pTau181 test received approval from the U.S. Food and Drug Administration (FDA). The test is indicated as an adjunct tool in early evaluation of Alzheimer’s disease and detects phosphorylated Tau (pTau) 181 protein in plasma.

• In July 2024, Biogen Inc., Beckman Coulter, Inc., and Fujirebio entered into a collaboration to develop and commercialize blood-based biomarkers for tau pathology in Alzheimer’s disease. The initiative aims to quantify tau burden and support development of next-generation tau-targeted therapies.

Market Challenges & Opportunities

Challenges
• Need for large-scale clinical validation
• Standardization of reference materials and cut-offs
• Regulatory variability across regions
• Reimbursement uncertainties in emerging markets

Opportunities
• Expansion of early screening programs
• Integration with digital health platforms
• Growth in precision medicine initiatives
• AI-driven biomarker analytics
• Companion diagnostics for disease-modifying therapies

Market Segmentation

By Biomarker Type
• Plasma Tau-related Biomarkers (35.8% share in 2024)
• Amyloid-beta Biomarkers
• Neurofilament Light Chain (NfL)
• Others

By Application
• Early Diagnosis
• Disease Monitoring
• Clinical Trial Screening

By End User
• Hospitals
• Diagnostic Laboratories
• Research Institutes
• Pharmaceutical Companies

By Region
• North America (48.2% share, leading region)
• Europe
• Asia Pacific
• Latin America
• Middle East & Africa

Why Buy This Report?

• Detailed market sizing and 2035 forecast
• Comprehensive biomarker-type analysis
• Competitive landscape profiling
• Regulatory and reimbursement insights
• Clinical validation assessment
• Investment and ROI outlook
• Strategic recommendations for stakeholders

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FAQs

1. What is the projected size of the blood-based biomarker for Alzheimer’s disease market by 2035?
The market is expected to reach US$ 554.2 Mn by 2035.

2. What is the CAGR during 2025–2035?
The market is projected to expand at a CAGR of 14.3%.

3. Which region leads the market?
North America leads with a 48.2% revenue share.

4. Which biomarker segment dominates?
Plasma Tau-related Biomarkers held 35.8% share in 2024.

5. What are the key growth drivers?
Rising Alzheimer’s prevalence and increasing demand for early, non-invasive diagnostic solutions.

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