Alzheimers Disease Biomarkers Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Type (CSF Biomarkers, Amyloid Beta, Tau Protein, Genetic Biomarkers, Apolipoprotein E, Blood Biomarkers, Others), By Detection Technique (Molecular Diagnostics, Immunoassays), By End user (Hospitals & Clinics, Diagnostic Laboratories, Others), By Region and Competition 2021-2031F

Forecast Period	2027-2031
Market Size (2025)	USD 0.91 Billion
CAGR (2026-2031)	7.82%
Fastest Growing Segment	Hospitals & Clinics
Largest Market	North America
Market Size (2031)	USD 1.43 Billion

Market Overview

The Global Alzheimer’s Disease Biomarkers Market will grow from USD 0.91 Billion in 2025 to USD 1.43 Billion by 2031 at a 7.82% CAGR. Alzheimer’s disease biomarkers are measurable biological indicators detectable in cerebrospinal fluid, blood plasma, or via imaging technologies that identify pathological changes such as amyloid beta plaques and tau protein tangles. The market trajectory is primarily supported by the expanding global geriatric population and the critical clinical imperative for early detection to optimize the efficacy of emerging therapeutic interventions. Furthermore, the rapid evolution of noninvasive blood based diagnostic tools is enhancing market access by mitigating the procedural invasiveness and patient burden associated with traditional lumbar punctures.

However, the market encounters significant impediments due to the high development costs of diagnostic assays and inconsistent reimbursement coverage which restrict widespread accessibility in cost sensitive regions. This economic friction is particularly problematic given the escalating burden of the condition which necessitates scalable diagnostic solutions. According to the Alzheimer's Association, in 2025, an estimated 7.2 million Americans aged 65 and older are living with Alzheimer's dementia. This rising prevalence underscores the urgent industrial necessity for affordable and accessible biomarker platforms to facilitate timely patient management.

Key Market Drivers

The proliferation of disease-modifying therapies (DMTs) is fundamentally restructuring the market by mandating precise companion diagnostics for patient eligibility and treatment monitoring. As regulatory bodies approve novel monoclonal antibodies targeting amyloid-beta, clinical workflows are rapidly integrating biomarker testing to confirm amyloid pathology prior to therapeutic intervention. This linkage transforms diagnostics from a passive screening tool into a critical gatekeeper for pharmaceutical access, directly fueling volume growth for FDA-cleared assays. Highlighting the clinical efficacy driving this demand, according to Eli Lilly and Company, July 2024, in the 'FDA Approval Press Release', results from the Phase 3 TRAILBLAZER-ALZ 2 study pivotal for the approval of Kisunla demonstrated that the treatment slowed clinical decline by 35% in participants with confirmed amyloid and intermediate tau pathology. Consequently, the adoption of these therapies creates an immediate, scalable requirement for diagnostic platforms capable of identifying these specific biological markers.

Simultaneously, the rapid emergence and commercialization of minimally invasive blood-based biomarkers is dismantling the accessibility barriers associated with traditional PET scans and cerebrospinal fluid analysis. The integration of high-performance plasma assays, specifically those measuring phosphorylated tau (p-tau), enables cost-effective prescreening in primary care settings, effectively triaging patients for confirmatory testing. This technological shift is validated by recent performance data; according to the American Medical Association, January 2024, in the 'JAMA Neurology' published article, a study evaluating a commercial p-tau217 blood assay revealed a diagnostic accuracy of 96% in identifying elevated brain amyloid. Such precision supports broader adoption, which is vital given the financial stakes of the disease; according to the Alzheimer's Association, in 2024, the total national cost for caring for individuals with Alzheimer's and other dementias was projected to reach $360 billion.

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Key Market Challenges

The high development costs of diagnostic assays coupled with inconsistent reimbursement coverage constitute a primary impediment to the growth of the market. Manufacturers face substantial financial requirements to validate and produce these tests, resulting in premium pricing that restricts accessibility for many healthcare providers and patients. When insurance payers fail to provide standardized or adequate coverage for these procedures, the financial burden shifts to the individual or the medical institution. This economic uncertainty creates hesitation among healthcare systems to adopt biomarker testing as a routine standard of care, thereby limiting the volume of tests administered and stalling revenue generation for market players.

This financial friction is particularly impactful given the broader economic context of dementia care, where resources are already heavily allocated to long-term management rather than diagnostics. The competition for limited healthcare funds makes it difficult for expensive diagnostic tools to gain traction without guaranteed payment models. According to the Alzheimer's Association, in 2024, the total estimated payments for health care, long-term care, and hospice services for people aged 65 and older with dementia were $360 billion. This massive existing expenditure on care delivery crowds out the budget available for adopting new diagnostic technologies, directly hampering the scalability of the biomarkers market.

Key Market Trends

The Integration of Artificial Intelligence (AI) in Biomarker Discovery is fundamentally reshaping the market by enabling the identification of novel pathological signatures from complex, multi-modal datasets. Unlike traditional singular assay validation, AI algorithms can analyze vast repositories of genomic, proteomic, and imaging data to detect subtle, non-linear patterns that precede clinical symptoms. This capability accelerates the development of precision diagnostics by uncovering latent biological factors that correlate with disease progression, thereby enhancing the stratification of patients for clinical trials. Validating the potential of this technological convergence, according to Premier Science, January 2025, in the article 'Revolutionizing Alzheimer’s Diagnostics: AI Tool Shows Superior Accuracy Over Traditional Methods', a newly developed AI model achieved a prediction accuracy of nearly 90% on independent datasets by identifying latent metabolic and physiological factors associated with cognitive decline.

Simultaneously, the Emergence of Digital Biomarkers for Remote Monitoring is creating a new paradigm for accessible and scalable patient assessment. This trend moves diagnostic capture away from invasive clinical procedures toward continuous, non-intrusive data collection using consumer-grade sensors and specialized peripherals to track oculomotor, vocal, and behavioral metrics. These digital tools are particularly valuable for identifying preclinical neurodegenerative changes that episodic clinical exams often miss, offering a cost-effective solution for mass population screening. Demonstrating the high precision of these non-invasive modalities, according to the University of Strathclyde, October 2025, in a research announcement regarding the 'ViewMind Atlas' system, the platform's integration of eye-tracking technology with machine learning analysis demonstrated a 96% accuracy rate in identifying asymptomatic carriers of a genetic mutation linked to Alzheimer’s disease.

Segmental Insights

The Hospitals and Clinics segment is projected to emerge as the fastest-growing category within the Global Alzheimer’s Disease Biomarkers Market. This expansion is primarily driven by the increasing integration of diagnostic evaluations into routine clinical care for the early detection of cognitive decline. These facilities possess the specialized infrastructure required to conduct complex assessments, including cerebrospinal fluid analysis and positron emission tomography scans. Furthermore, recent approvals of disease-modifying therapies by the U.S. Food and Drug Administration have mandated rigorous biomarker testing to verify patient eligibility, significantly increasing the reliance on hospital-based settings for these essential diagnostic procedures.

Regional Insights

North America maintains a dominant position in the global Alzheimer’s disease biomarkers market due to the high prevalence of neurodegenerative conditions and an established healthcare infrastructure. The region benefits from substantial investment in research and development by major pharmaceutical companies and academic institutions. Additionally, the U.S. Food and Drug Administration provides a supportive regulatory environment that facilitates the approval of diagnostic agents. This market leadership is further bolstered by funding from the National Institute on Aging and favorable reimbursement structures, creating a conducive environment for the adoption of biomarker technologies.

Recent Developments

• In May 2025, the U.S. Food and Drug Administration granted 510(k) clearance to the first blood-based in vitro diagnostic test intended to aid in the assessment of Alzheimer's disease. Manufactured by a subsidiary of Fujirebio Holdings, the Lumipulse G pTau217/β-Amyloid 1-42 Plasma Ratio assay was authorized for use in adult patients aged 55 and older presenting with cognitive impairment. This clearance marked a significant regulatory milestone in the Global Alzheimer’s Disease Biomarkers Market, offering a less invasive and potentially more accessible alternative to traditional cerebrospinal fluid testing or positron emission tomography scans for detecting amyloid pathology.
• In February 2025, C2N Diagnostics achieved a key international regulatory milestone by receiving medical device registration from the United Kingdom's Medicines and Healthcare products Regulatory Agency for its advanced blood test. The PrecivityAD2 assay, which identifies the likelihood of brain amyloid plaques, became the first blood biomarker test of its kind to obtain this certification in the UK. This development expanded the commercial reach of the company's portfolio in the Global Alzheimer’s Disease Biomarkers Market, aiming to address diagnostic bottlenecks in regions with aging populations and facilitate earlier intervention strategies.
• In April 2024, Roche announced that its Elecsys pTau217 plasma biomarker assay had received Breakthrough Device Designation from the U.S. Food and Drug Administration. This diagnostic tool was developed through a strategic collaboration with Eli Lilly and Company to enhance the early and accurate identification of amyloid pathology. The partnership highlighted the growing trend of cooperation between diagnostic leaders and pharmaceutical firms in the Global Alzheimer’s Disease Biomarkers Market. The test was designed to broaden access to timely diagnosis and facilitate participation in clinical trials for disease-modifying therapies by leveraging Roche's extensive installed base of diagnostic systems.
• In March 2024, Labcorp announced the commercial launch of a new blood-based test designed to detect phosphorylated tau 217, a pivotal biomarker associated with Alzheimer's disease. This standalone assay was made available for physicians to order for use in clinical diagnosis and patient monitoring, as well as for biopharmaceutical partners conducting clinical trials. The introduction of this test expanded the company's neurological portfolio in the Global Alzheimer’s Disease Biomarkers Market, providing a scalable and accessible tool to assist in the evaluation of patients with cognitive symptoms and suspected neurodegenerative conditions without requiring more invasive procedures.

Key Market Players

• Enzo Life Sciences Inc.
• Thermo Fisher Scientific Inc.
• AnaSpec Inc.
• Merck KGaA
• Cell Signaling Technology Inc.
• Fujirebio Diagnostics Inc
• 23andMe Inc.
• NanoSomiX Inc.
• QIAGEN NV
• Quest Diagnostics

By Type	By Detection Technique	By End user	By Region
CSF Biomarkers Amyloid Beta Tau Protein Genetic Biomarkers Apolipoprotein E Blood Biomarkers Others	Molecular Diagnostics Immunoassays	Hospitals & Clinics Diagnostic Laboratories Others	North America Europe Asia Pacific South America Middle East & Africa

Report Scope:

In this report, the Global Alzheimer’s Disease Biomarkers Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

• Alzheimer’s Disease Biomarkers Market, By Type:

• CSF Biomarkers
• Amyloid Beta
• Tau Protein
• Genetic Biomarkers
• Apolipoprotein E
• Blood Biomarkers
• Others

• Alzheimer’s Disease Biomarkers Market, By Detection Technique:

• Molecular Diagnostics
• Immunoassays

• Alzheimer’s Disease Biomarkers Market, By End user:

• Hospitals & Clinics
• Diagnostic Laboratories
• Others

• Alzheimer’s Disease Biomarkers Market, By Region:

• North America
• United States
• Canada
• Mexico
• Europe
• France
• United Kingdom
• Italy
• Germany
• Spain
• Asia Pacific
• China
• India
• Japan
• Australia
• South Korea
• South America
• Brazil
• Argentina
• Colombia
• Middle East & Africa
• South Africa
• Saudi Arabia
• UAE