Dublin, Nov. 12, 2025 (GLOBE NEWSWIRE) -- The "U.S. Blood-based Biomarker for Alzheimer's Disease Diagnostics Market Size, Share & Trends Analysis by Type (Amyloid-related Markers, Tau-related markers, Neurodegeneration), by Technology, by End Use, and Segment Forecasts, 2025-2033" report has been added to ResearchAndMarkets.com's offering.
The U.S. blood-based biomarker for alzheimer's disease diagnostics market size was estimated at USD 59.64 million in 2024 and is expected to grow at a CAGR of 14.60% from 2025 to 2033
This growth is fueled by rising Alzheimer's prevalence, increasing demand for non-invasive diagnostics, and regulatory approvals such as the FDA's clearance of blood-based IVD assays. Technological advancements in ultrasensitive immunoassays and multiplex testing further support adoption, positioning blood biomarkers as essential tools in early detection and treatment pathways.
One of the most significant growth drivers for the U.S. blood-based biomarker market is the approval of FDA-cleared IVD assays. A prime example is the Lumipulse G pTau217/Amyloid 1-42 Plasma Ratio, which gained marketing authorization in 2025. Regulatory recognition not only lowers clinical adoption barriers but also validates the reliability of blood-based tests in practice.
At the same time, advances in ultra-sensitive immunoassays and AI-powered multiplex testing are enhancing diagnostic accuracy. These technologies help reduce dependence on costly, invasive methods such as PET imaging and lumbar punctures. The combination of regulatory approval and innovation is creating strong momentum, boosting confidence among healthcare providers, payers, and patients alike
Demographic trends are another critical driver. As the U.S. population ages, the prevalence of dementia is rising rapidly-about 4% of individuals aged 65+ are affected, and the rate climbs to 13% among those over 85. This has created an urgent need for scalable, early diagnostic solutions. Blood-based biomarkers address this gap by offering less invasive testing, enabling earlier intervention, and streamlining patient care pathways. They also support the shift toward precision medicine, where biologically driven diagnostics guide therapy selection and monitoring. Importantly, anti-amyloid drugs now require biomarker confirmation of pathology, making blood tests an essential first-line triage tool for patients being evaluated for treatment.
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Market Dynamics
Market Drivers Analysis
- Regulatory approvals and clinical validation
- Rising demand for early and non-invasive diagnosis
- Integration with disease-modifying therapies (DMTS)
Market Restraint Analysis
- Reimbursement and coverage challenges
- Standardization and validation barriers
Porter's Five Forces Analysis
PESTLE Analysis
Pipeline Analysis
U.S. Blood-based Biomarker For Alzheimer's Disease Diagnostics Market Report Segmentation
Type Outlook (USD Million, 2021-2033)
- Amyloid-related markers
- Tau-related markers
- Neurodegeneration
- Others
Technology Outlook (USD Million, 2021-2033)
- Immunoassays
- Mass spectrometry-based assays
- Next-generation platforms
- Others
End Use Outlook (USD Million, 2021-2033)
- Clinical laboratories & hospital labs
- Pharma & biotech
- Academic & research institutes
- Others
Companies Featured
- F. Hoffmann-La Roche Ltd
- Quanterix
- Fujirebio
- C2N Diagnostics
- Labcorp
- Quest Diagnostics Incorporated
- Siemens Healthineers
- Diadem srl
- Abbott
- BioArctic
- Grifols
For more information about this report visit https://www.researchandmarkets.com/r/xar7ny
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