Alzheimer’s Disease Diagnostics Market Size, Share, Growth, Trends, and Global Industry Analysis: By Diagnostic Techniques (Biomarker, CSF Biomarker, blood- Based Biomarker, Imaging Technique, Genetic Testing, Cognitive Assessment Tests), By Type (Triage, Diagnosis, Screening), By End Use (Hospitals, Diagnostic Laboratories, Academic & Research Institutes), and Region Forecast 2020-2031

Alzheimer’s Disease Diagnostics Market size was valued at US$ 5.2 billion in 2024 and is projected to reach US$ 9.1 billion by 2031, growing at an 8.1% from 2025–2031. Moreover, the U.S. Alzheimer’s Diagnostics Market is projected to grow significantly, reaching an estimated value of US$ 3,600 million (US$ 3.6 billion) by 2031.

The market is poised at the intersection of clinical demand and technological advancement. With the world's population growing older, early and precise diagnosis of Alzheimer's disease is becoming an imperative rather than a decision. Diagnosis has moved beyond clinical observation to utilizing sophisticated tools such as PET imaging, cerebrospinal fluid biomarkers, and AI-based cognitive tests. What was once a slow and uncertain process is being re-scripted by precision medicine, making intervention on time and better-informed care planning possible. This shift is not merely technical it's deeply human. It's a move away from reactive care and toward proactive understanding, giving people and families a longer window of time to adapt, respond, and live with dignity.

The course of this sector appears to be one of increased cooperation between pharma, diagnostic companies, and tech entrepreneurs looking for non-invasive, scalable, and affordable diagnostic machines. Liquid biopsies and panels of blood-based biomarkers—formerly in the realm of experimentation—are now moving to clinical trials with real-world applications. Regulators are beginning to move faster to approve new test platforms, and even payers are demonstrating early signs of coverage for pre-symptomatic testing. These advancements aren't only shaping the market; they're upsetting the conventional care continuum. As early-stage detection becomes the norm and not the exception, Alzheimer's diagnosis is transforming from a specialist research issue to an integral component of neurological care systems globally.

Facts & Figures

• The median time from onset of symptoms to definitive diagnosis of Alzheimer's disease remains more than 2.5 years worldwide, representing delays in diagnosis and suboptimal use of early testing assays-considering the added publicity.
• In clinical trials, minimally invasive blood-based biomarker tests such as phosphorylated tau (p-tau) assays had more than 85% concordance with PET imaging, a paradigm-shifting transition toward minimally invasive diagnostics.
• More than 20 AI systems are under trial to help diagnose Alzheimer's diverse including speech pattern analysis, online cognitive testing, and computer-aided neuroimaging interpretation
• Higher numbers of U.S. and EU payors are demonstrating early diagnosis reimbursement for Alzheimer's, particularly blood and cognitive tests, under mounting pressure to intervene early and limit healthcare expenditure.

Key Developments

• In May 2025, The FDA approved marketing of the first-ever blood-based in vitro diagnostic to aid Alzheimer's diagnosis: the Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio. The test is a major step forward toward early, non-invasive detection of amyloid plaque buildup in symptomatic patients age 55 and older.
• In April 2025, Labcorp launched its national pTau-217/Beta Amyloid 42 Ratio test as part of its menu of Alzheimer's blood biomarkers. The test enables more scalable, earlier-stage detection of Alzheimer's in outpatient and ambulatory care settings.
• In April 2025, Lantheus Holdings announced that its clinical-stage PET imaging drug candidate MK-6240 (F18-florquinitau) met significant endpoints in milestone trials. Such success paves the way for a pending New Drug Application (NDA) filing with the FDA in Q3 2025.

Alzheimers Disease Diagnostics Market Segmentation

Based on the Diagnostics Technique

• Biomarkers
  • CSF Biomarkers
  • Blood-Based Biomarkers
• Imaging Techniques
• Genetic Testing
• Cognitive Assessment Tests

Among the new diagnostic tools, blood-based biomarkers are revolutionizing the affordability and availability of Alzheimer's testing. Unlike cerebrospinal fluid sampling or imaging, these tests draw from easily accessible blood samples to measure first pathological changes e.g., beta-amyloid and phosphorylated tau levels with the result of being able to screen on a routine basis even in non-specialist centers. Their very minimally invasive character eliminates the psychological and logistical hurdles commonly linked to conventional diagnostics. In addition, their scalability matches the growing focus on early population-level screening. Laboratories and firms are competing to bring these tests to market, aided by favourable trial outcomes and regulatory fast-track mechanisms. With precision medicine development, diagnostics based on blood will be the foundation of Alzheimer's risk assessment and disease surveillance.

Based on the type

• Triage
• Diagnosis
• Screening

The diagnostic segment commands the Alzheimer's diagnostics market based on clinical demand for precise, stage-specific diagnosis of the disease. Unlike screening or triage, which is initial, diagnostic devices affirm the presence and progression of Alzheimer's through a combination of imaging, mental status examination, and biomarker testing. Hospitals and specialty clinics utilize this level to create patient-specific treatment plans, address comorbidities, and trigger proper caregiver planning. The arrival of novel therapeutics and disease-altering drugs has placed precise diagnosis in the spotlight. Payors and regulatory bodies are ever more making coverage decisions based on confirmed diagnostic markers, even more positioning this segment as the cornerstone to the entire diagnostic process.

Based on the end user

• Hospital
• Diagnostic Laboratories
• Academic and Research Institutes

Hospitals represent the most important end-use environment for diagnosing Alzheimer's, in large part because they contain the entire array of test technology—MRI, PET, blood tests, and neuropsychology staff—all under one roof. Multidisciplinary geriatrics and neuroscience teams will be in a better position to unravel difficult results and orchestrate what comes next. For most patients, hospitals also are the initial point of contact after cognitive decline, putting them at the front of timely care. Also, hospital funding and teaching affiliations enable the hospitals to be involved in clinical trials for new diagnostic technology, and they become privy to innovative solutions ahead of the curve. As early diagnosis becomes the norm, hospitals are in a dual role: first-line caregivers and research centres for Alzheimer's diagnosis.