PUBLISHER: Grand View Research | PRODUCT CODE: 1813897
PUBLISHER: Grand View Research | PRODUCT CODE: 1813897
The global blood-based biomarker for Alzheimer's disease diagnostics market size was estimated at USD 139.69 million in 2024 and is expected to reach USD 429.31 million by 2033, growing at a CAGR of 15.07% from 2025 to 2033. A pivotal catalyst was the U.S. FDA's May 16, 2025, marketing clearance of Fujirebio's Lumipulse G pTau217/B-amyloid 1-42 plasma ratio-the first Alzheimer's blood test cleared to aid diagnosis-quickly followed by Labcorp's nationwide launch on Aug 18, 2025.
These steps lower adoption friction (regulatory clarity, distribution) and are expected to accelerate payer uptake and clinician ordering, intensifying the growth curve for blood tests relative to imaging and CSF. Guidance presented at AAIC 2025 and published by the Alzheimer's Association states that blood-based biomarker (BBM) tests with >=90% sensitivity and >=75-90% specificity can triage-and at higher performance, substitute for-amyloid PET or CSF testing in appropriate patients. p-tau217-containing panels consistently outperform earlier generations (AB42/40 or p-tau181 alone) for detecting amyloid and tau pathology. Real-world product data are converging: Quest's 2025 AD-Detect(TM) reported >90% sensitivity and specificity for Alzheimer's pathology in AAN-presented analyses, while clinical summaries highlight ~92% positive and ~97% negative agreement for the FDA-cleared Lumipulse test. As clinicians gain confidence in rule-in/rule-out accuracy, ordering shifts from specialty memory clinics to broader frontline settings, expanding test volumes and normalizing BBMs as the first diagnostic step.
Technology maturation and clinical validation add momentum. Blood assays targeting phosphorylated tau (especially p-tau217) have received Breakthrough Device designations and now full FDA clearance, reflecting strong clinical validity and utility.
Academic-industry consortia (e.g., UW-Madison, Johns Hopkins, Lund) supplied pivotal data underpinning the cleared IVD. Published reviews conclude that blood-based biomarker tests (BBMTs) bring value by reducing invasiveness and enabling earlier triage-crucial when disease-modifying therapies are most effective in prodromal/mild stages. Market traction examples include reference-lab launches and hospital adoption for memory-clinic pathways, where a positive p-tau217/AB ratio can expedite PET scheduling while a negative result can avoid costly scans. As platforms scale, expect menu expansion (neurofilament light, GFAP, AB42/40), reflex algorithms, and bundled panels, improving sensitivity/specificity and supporting longitudinal monitoring-opening recurring-test revenue beyond one-time diagnosis.
Global Blood-based Biomarker For Alzheimer's Disease Diagnostics Market Report Segmentation
This report forecasts revenue growth at the global, regional and country levels and provides an analysis of the latest trends in each of the sub-segments from 2021 to 2033. For this study, Grand View Research has segmented the global blood-based biomarker for Alzheimer's disease diagnostics market report based on type, technology, end-use, and region: