June 30, 2025 | 1 min read
The global alzheimer’s disease diagnostics market size is calculated at USD 8.95 billion in 2024, grows to USD 9.94 billion in 2025, and is projected to reach around USD 25.53 billion by 2034, growing at a CAGR of 11.05% from 2025 to 2034. Rising regulatory approvals, innovative product launches, research funding and increased emphasis on early screening are driving the growth of the Alzheimer’s disease diagnostics market.
Advanced imaging tests can detect particular brain changes caused by Alzheimer’s disease, like amyloid plaques and neurofibrillary tangles. These newer tests are significantly used in major medical centers or clinical trials. Use different diagnostic technologies such as magnetic resonance imaging (MRI), computerized tomography (CT), PET imaging, Amyloid PET imaging, and tau PET imaging. The tests are used with other tools to assist in diagnosing Alzheimer’s disease after symptoms start.
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Alzheimer’s Disease Diagnostics Market Highlights:
• North America dominated the global Alzheimer’s disease diagnostics market in 2024.
• Asia Pacific is expected to grow at the fastest CAGR during the forecast period.
• By diagnostic technique, the imaging techniques segment dominated the market with the largest share in 2024.
• By diagnostic technique, the biomarkers segment is expected to show the fastest growth during the forecast period.
• By type, the diagnostic segment accounted for the biggest market share in 2024.
• By end-use, the academic and research institutes segment held the largest market share in 2024.
• By end-use, the hospitals segment is expected to register the fastest growth during the forecast period.
Market Overview and Industry Potential
The alzheimer’s disease diagnostics market is expanding rapidly due to growing lab tests, neurology imaging tests, and detailed memory testing. These tests offer valuable data for a diagnosis. They also rule out other situations that cause the same symptoms. These tests, the physical exam, and information on age and duration of worsening symptoms are frequently sufficient to diagnose Alzheimer’s dementia.
Explore advanced technologies that enhance diagnostic accuracy while looking at the current diagnostic criteria for AD, like clinical evaluations, biomarker-based techniques, and cognitive testing. Some biomarkers are helpful, like inflammatory, proteomic, olfactory, ocular, and oral, in the early detection of AD. Particularly in person with mild cognitive impairment (MCI). Biomarkers are collected through invasive technology, particularly CSF from lumbar puncture; non-invasive procedures are used in practice to diagnose AD.
• For Instance, In June 2025, the FDA approved a label update for Amyvid, a florbetapir F 18 injection, for intravenous use. The injection is utilized for brain imaging to estimate the density of amyloid plaque in patients with cognitive impairment who are being evaluated for Alzheimer’s disease and other causes of cognitive decline.
What are the Latest Trends in Alzheimer’s Disease Diagnostics Market?
• In May 2025, the U.S. Food and Drug Administration cleared for marketing the first in vitro diagnostic device that tests blood to aid in diagnosing Alzheimer’s disease. The Lumpias G pTau217/ß-Amyloid 1-42 Plasma Ratio is for the early detection of amyloid plaques associated with alzheimer’s disease in adult patients, aged 55 years and older, exhibiting signs and symptoms of the disease.
• In May 2025, the Global Alzheimer’s Platform Foundation applauds the FDA’s clearance of the first blood test to diagnose Alzheimer’s disease. Fujirebio’s Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio in vitro diagnostic (IVD) represents the first blood-based test available to physicians and their patients for early detection of amyloid plaques associated with Alzheimer’s, a significant element in accurately diagnosing Alzheimer’s disease (AD).
• In January 2024, IHI launched a novel interdisciplinary initiative to revolutionise the opportunity for Alzheimer’s disease to be detected, diagnosed, prevented, and treated. Developed by a consortium of 24 partners, the real-world implementation, deployment, and validation of early detection tools and lifestyle enhancement (AD-RIDDLE) project will offer healthcare providers a toolbox platform of validated resources and tailored interventions to help detect, prevent, diagnose, and manage Alzheimer’s disease.
Adoption of Digital Cognitive Testing: Market’s Largest Potential
Increasing adoption of digital cognitive testing as a screening tool for patients at risk of developing Alzheimer’s disease, for recruitment in clinical trials, and longitudinal follow-up performed remotely. Major advantages include growing sensitivity and reliability, and it could add value to a person by increasing engagement, accessibility, and reducing participant burden.
Digital assessments have clinical trial implications by improved screening, enabling case finding, and providing more sensitive clinical results. Severe promising diagnostic tests are presently in development and are undergoing validation; this cognitive testing is beneficial for patients in underserved areas.
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Report Scope of Alzheimer’s Disease Diagnostics Market
| Report Coverage | Details |
| Market Size in 2025 | USD 9.94 Billion |
| Market Size by 2034 | USD 25.53 Billion |
| Growth Rate From 2025 to 2034 | CAGR of 11.05% |
| Base Year | 2024 |
| Forecast Period | 2025-2034 |
| Segments Covered | Diagnostics Technique, Type, End-use, Region |
| Market Analysis (Terms Used) | Value (US$ Million/Billion) or (Volume/Units) |
| Regional scope | North America; Europe; Asia Pacific; Latin America; MEA |
| Key Companies Profiled | C2N diagnostics, Fujirebio, F. Hoffmann-La Roche AG, Labcorb, Lantheus, Quanterix, Quest Diagnostics, Sysmex, Siemens Healthineers AG |
Alzheimer’s Disease Diagnostics Market Segmentation Analysis:
By Diagnostic Technique Analysis:
The imaging techniques segment dominates in the alzheimer’s disease diagnostics market, as imaging technologies mostly used are computerized tomography (CT), magnetic resonance imaging (MRI), positron emission tomography (PET) these techniques offer significant advantages in diagnosing alzheimer’s disease by permitting imagining of brain structure and function, allowing early monitoring and detection of disease progression. Multiple imaging techniques with related biomarkers are used to monitor and identify AD.
On the other hand, the biomarker segment is expected to grow significantly during the forecast period as there are some biomarkers that are supportive, like inflammatory, proteomic, oral, ocular, and olfactory, in the detection of AD. The biomarkers of Alzheimer’s disease are neurochemical indicators applications to assess the challenges or presence of the disease. The biomarkers used to diagnose Alzheimer’s disease (AD) in the early stage also offer objective and reliable measures of disease progression.
By Type Analysis:
The diagnostic segment dominates the alzheimer’s disease diagnostics market, as getting a diagnosis lets patients know what type of dementia they have. It supports planning for the future and access to support and therapy groups. Blood and imaging diagnostics can rule out other effective causes of symptoms. A primary diagnosis enables persons to participate in a wider range of clinical trials, which progress research and may offer medical benefits.
By End-use Analysis:
The academic and research institutes segment accounted for the largest market share in 2024 as researchers learn more related disease development, how lifestyle and behaviour factors may affect medical care, and the effectiveness and safety of involvement. Researchers at these institutes conduct clinical research to enhance care and diagnosis for patients with alzheimer’s disease and their families, and to identify a treatment or risk prevention.
On the other hand, the hospital segment is expected to grow significantly during the forecast period as these diagnostic tests support the diagnosis of other causes of memory problems, like tumor, stroke, side effects of medication, sleep disturbances, Parkinson’s disease, an infection, or another type of AD in the hospital. Regular diagnosis gives advanced care to adjust, prepare, and manage for the future, as well as access to therapy and support for the patient.
Which Region Dominated the Alzheimer’s Disease Diagnostics Market?
North America dominated the global Alzheimer’s Disease Diagnostics Market in 2024 because of the day-to-day growing number of North Americans living with Alzheimer’s. An estimated 6.9 million Americans aged 65 and older are living with Alzheimer’s dementia. This number will grow to 13.8 million by 2060, except for the development of medical breakthroughs to cure or prevent AD. Around 1 in 9 people age 65 and older (11%) have Alzheimer’s in North America, which increases the demand for alzheimer’s disease diagnostics solutions.
• For Instance, In April 2025, Lantheus Holdings, Inc., the leading radiopharmaceutical-focused company committed to enabling clinicians to Find, Fight, and Follow disease to deliver better patient outcomes, announced that its clinical-stage F18-labeled tau Positron Emission Tomography (PET) radiodiagnostic, MK-6240, successfully met its co-primary endpoints in two pivotal studies assessing its sensitivity and specificity. This achievement reinforces the potential of MK-6240 as a valuable diagnostic tool.
In the U.S. growing incidence of Alzheimer’s is directly linked to the aging of the U.S. population. Also, high risk of AD is linked to genetic factors, and increased rates of diabetes and hypertension, obesity, unhealthy meals, lack of exercise, and poor mental health. Every 67 seconds, in the U.S. develops Alzheimer’s. It is expected that approximately 500,000 novel cases of Alzheimer’s disease diagnosed in 2023, which will cause growth in the market.
Asia-Pacific is expected to exhibit the fastest growth during the forecast period. In Asia-Pacific, the increasing old age population in this region and also an increase in cases of people with dementia, burdening the medical systems of countries in the region, particularly those in low and middle-income countries, which increases the demand for Alzheimer’s diagnostic technology. With more than 15 % of the global aging population expected to exist in India by 2050, the burden of AD is projected to increase, which increases the need for increased diagnostic technology.
Alzheimer’s Disease Diagnostics Market Companies:
• F. Hoffmann-La Roche AG
• Labcorb
• Lantheus
• Quest Diagnostics
• Sysmex
What is Going Around the Globe?
• In April 2025, Quest Diagnostics, a leader in diagnostic information services, including advanced diagnostics for brain health, announced the launch of a novel laboratory blood test designed to support physicians in confirming amyloid brain pathology due to Alzheimer’s disease (AD) in patients with mild cognitive impairment (MCI) or dementia.
• In May 2025, Fujirebio Holdings Inc., its wholly-owned subsidiary Fujirebio Diagnostics, Inc., and AriBio Co., Ltd. announced the completion of a prospective sample acquisition as part of the strategic partnership to advance the development of biomarkers for Alzheimer’s disease and other neurodegenerative conditions.
• In March 2025, Splash Clinical, the new standard in trial enrollment, and C2N Diagnostics, LLC, a pioneer in advanced diagnostic testing for brain health, announced a partnership to improve recruitment ef?ciency for Alzheimer’s disease clinical trials throughout the United States and globally.
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Segments Covered in the Report
This report forecasts revenue growth at country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2021 to 2034. For this study, Nova one advisor, Inc. has segmented the Alzheimer’s Disease Diagnostics Market.
By Diagnostics Technique
• Biomarkers
º CSF Biomarkers
º Blood-Based Biomarkers
• Imaging Techniques
• Genetic Testing
• Cognitive Assessment Tests
By Type
• Triage
• Diagnosis
• Screening
By End-use
• Hospitals
• Diagnostic Laboratories
• Academic and Research Institutes
By Regional
• North America
• Europe
• Asia Pacific
• Latin America
• Middle East and Africa (MEA)
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