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US Alzheimers Disease Diagnostic Market

ID: MRFR/MED/14705-HCR
100 Pages
Garvit Vyas
October 2025

US Alzheimer's Disease Diagnostic Market Research Report By Type (Early Onset Alzheimers, Late Onset Alzheimers, Familial Alzheimers Disease, Others), By Diagnostic Tests (Genetic Testing, Neurological Exam, Mini Mental State Exam (MMSE), Brain Imaging, Others) and By End User (Clinic, Hospital, Diagnostic Center, Others) - Forecast to 2035

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US Alzheimers Disease Diagnostic Market Summary

As per MRFR analysis, The US Alzheimer's disease diagnostic market size was estimated at 2800.0 USD Million in 2024. The US alzheimers disease-diagnostic market is projected to grow from 3052.84 USD Million in 2025 to 7250.0 USD Million by 2035, exhibiting a compound annual growth rate (CAGR) of 9.03% during the forecast period 2025 - 2035.

Key Market Trends & Highlights

The US Alzheimer's disease-diagnostic market is experiencing robust growth driven by technological advancements and increasing demand for early diagnosis.

  • Technological advancements in diagnostics are enhancing the accuracy and efficiency of Alzheimer's disease detection.
  • The integration of artificial intelligence is revolutionizing diagnostic processes and enabling more personalized patient care.
  • The largest segment in the market is the imaging techniques segment, while the fastest-growing segment is the biomarker-based diagnostics segment.
  • Key market drivers include the rising prevalence of Alzheimer's disease and increased funding for Alzheimer's research.

Market Size & Forecast

2024 Market Size 2800.0 (USD Million)
2035 Market Size 7250.0 (USD Million)
CAGR (2025 - 2035) 9.03%

Major Players

Eli Lilly and Company (US), Biogen Inc. (US), Roche Holding AG (CH), Novartis AG (CH), AstraZeneca PLC (GB), Merck & Co., Inc. (US), Johnson & Johnson (US), AbbVie Inc. (US)

US Alzheimers Disease Diagnostic Market Trends

The Alzheimer's disease diagnostic market is currently experiencing notable shifts driven by advancements in technology and an increasing understanding of the disease. Innovations in diagnostic tools, such as biomarkers and imaging techniques, are enhancing the accuracy and speed of diagnosis. This evolution is crucial, as early detection can significantly impact patient outcomes and treatment options. Furthermore, the growing prevalence of Alzheimer's disease in the aging population is prompting healthcare providers to seek more effective diagnostic solutions. As a result, there is a heightened focus on research and development, leading to the introduction of novel diagnostic methods that may improve the overall management of the disease. In addition, the regulatory landscape is evolving, with agencies emphasizing the need for rigorous validation of diagnostic tests. This trend suggests a shift towards more standardized practices in the alzheimers disease-diagnostic market, which could enhance trust among healthcare professionals and patients alike. Moreover, the integration of artificial intelligence and machine learning into diagnostic processes is emerging as a potential game-changer. These technologies may facilitate more personalized approaches to diagnosis, allowing for tailored treatment plans that align with individual patient needs. Overall, the alzheimers disease-diagnostic market is poised for growth, driven by innovation, regulatory changes, and a deeper understanding of the disease's complexities.

Technological Advancements in Diagnostics

The Alzheimer's disease diagnostic market is witnessing rapid technological advancements that enhance diagnostic accuracy. Innovations such as advanced imaging techniques and biomarker identification are becoming increasingly prevalent. These developments may lead to earlier detection and improved patient outcomes, as healthcare providers gain access to more reliable diagnostic tools.

Regulatory Changes and Standardization

Recent regulatory changes are shaping the alzheimers disease-diagnostic market by promoting standardization in diagnostic practices. Regulatory agencies are emphasizing the importance of rigorous validation for diagnostic tests. This trend may foster greater trust among healthcare professionals and patients, ultimately improving the overall quality of care.

Integration of Artificial Intelligence

The integration of artificial intelligence (AI) into diagnostic processes is emerging as a transformative trend in Alzheimer's disease diagnostics. AI technologies may facilitate personalized diagnostic approaches, allowing for tailored treatment plans. This shift could significantly enhance the management of Alzheimer's disease, aligning care with individual patient needs.

US Alzheimers Disease Diagnostic Market Drivers

Growing Demand for Early Diagnosis

The growing demand for early diagnosis of Alzheimer's disease is a significant driver for the alzheimers disease-diagnostic market. Early detection is crucial for effective management and treatment, as it allows for timely interventions that can improve patient outcomes. Surveys indicate that over 80% of healthcare professionals believe that early diagnosis can lead to better care strategies. This demand is pushing healthcare systems to adopt advanced diagnostic tools, including neuroimaging and biomarker tests. The market for these diagnostic solutions is expected to grow by approximately 12% annually as healthcare providers seek to meet the needs of patients and their families. This trend highlights the importance of developing reliable and accessible diagnostic methods.

Aging Population and Increased Awareness

The aging population in the US is a critical driver for the alzheimers disease-diagnostic market. As the baby boomer generation ages, the number of individuals at risk for Alzheimer's disease is increasing. This demographic shift is accompanied by heightened awareness of Alzheimer's and its impact on families and communities. Educational campaigns and advocacy efforts have contributed to a greater understanding of the disease, leading to increased demand for diagnostic services. It is estimated that by 2030, nearly 20% of the US population will be over 65 years old, further amplifying the need for effective diagnostic solutions. This growing awareness is likely to drive market growth as more individuals seek diagnosis and treatment options.

Rising Prevalence of Alzheimer's Disease

The increasing prevalence of Alzheimer's disease in the US is a primary driver for the alzheimers disease-diagnostic market. According to the Alzheimer's Association, approximately 6.7 million individuals aged 65 and older are living with Alzheimer's in the US as of 2025. This number is projected to rise significantly, potentially reaching 14 million by 2060. The growing patient population necessitates enhanced diagnostic tools and methods, thereby stimulating market growth. As awareness of the disease increases, healthcare providers are more inclined to adopt advanced diagnostic solutions, which could lead to a market expansion of around 10% annually. This trend underscores the urgent need for effective diagnostic strategies to manage the rising burden of Alzheimer's disease.

Increased Funding for Alzheimer's Research

In recent years, there has been a notable increase in funding for Alzheimer's research in the US, which serves as a crucial driver for the alzheimers disease-diagnostic market. The National Institutes of Health (NIH) allocated approximately $3.5 billion for Alzheimer's research in 2025, reflecting a commitment to understanding and diagnosing the disease. This financial support fosters innovation in diagnostic technologies, encouraging the development of novel biomarkers and imaging techniques. As research progresses, new diagnostic tools are likely to emerge, enhancing the accuracy and speed of Alzheimer's diagnosis. This influx of funding not only propels the market forward but also raises public awareness, potentially leading to earlier detection and intervention.

Technological Innovations in Diagnostic Tools

Technological innovations are transforming the landscape of the alzheimers disease-diagnostic market. Advancements in neuroimaging techniques, such as PET scans and MRI, have significantly improved the ability to detect Alzheimer's disease at earlier stages. Additionally, the development of blood-based biomarkers is emerging as a promising area of research, potentially offering less invasive and more cost-effective diagnostic options. The integration of these technologies into clinical practice is expected to enhance diagnostic accuracy and efficiency. As a result, the market is projected to experience a compound annual growth rate (CAGR) of around 11% over the next five years, driven by the continuous evolution of diagnostic tools and methodologies.

Market Segment Insights

By Type: Late Onset Alzheimers (Largest) vs. Early Onset Alzheimers (Fastest-Growing)

The US alzheimers disease-diagnostic market is characterized by a diverse array of segment values. Among these segments, Late Onset Alzheimers holds the largest share, driven by the increasing aging population and a higher prevalence of age-related cognitive decline. Conversely, Early Onset Alzheimers is gaining attention as a rapidly growing segment, fueled by rising awareness and advancements in diagnostic methodologies. Growth trends in the market are largely influenced by research innovations and the healthcare infrastructure in place for the diagnosis of Alzheimer's. Factors such as increased funding for research, public awareness campaigns, and collaborations between healthcare organizations and diagnostic companies play crucial roles in driving growth in both Late and Early Onset Alzheimers segments, ensuring that more individuals receive timely diagnoses and appropriate care.

Late Onset Alzheimers (Dominant) vs. Early Onset Alzheimers (Emerging)

Late Onset Alzheimers is established as the dominant segment in the US alzheimers disease-diagnostic market, characterized by a higher incidence in older adults typically aged 65 and above. This segment benefits from robust diagnostic frameworks and strategies aimed at understanding the complexities of late-stage cognitive decline, which includes comprehensive neuropsychological testing and imaging technologies. On the other hand, Early Onset Alzheimers, often diagnosed in individuals as young as 30s or 40s, represents an emerging segment that is garnering increased attention due to the early onset of symptoms and the significant impact it has on the quality of life. The awareness surrounding early diagnosis is increasing, leading to advancements in diagnostic technologies specifically tailored for younger populations.

By Diagnostic Tests: Genetic Testing (Largest) vs. Neurological Exam (Fastest-Growing)

In the US alzheimers disease-diagnostic market, Genetic Testing holds the largest market share, signifying its pivotal role in early diagnosis and patient management. Neurological Exams, while gaining traction, serve as complementary tools, optimizing diagnostic accuracy. The diversification within these testing methodologies reflects the market's adaptive strategies to cater to evolving healthcare needs. The landscape is witnessing a significant shift as Neurological Exams exhibit rapid growth due to increasing awareness of Alzheimer’s symptoms and advancements in diagnostic technologies. Also, Genetic Testing continues to flourish amidst rising interest in personalized medicine. Factors such as an aging population and enhanced insurance coverage for diagnostic tests contribute to this positive momentum, enabling more patients to seek timely evaluations and results.

Genetic Testing: Dominant vs. Neurological Exam: Emerging

Genetic Testing proves to be the dominant force in the diagnostic process for Alzheimer's, offering insights into hereditary factors and risk assessments which are vital for at-risk populations. Its established methodology appeals to both clinicians and patients, providing a layer of reassurance through scientific validation. On the other hand, Neurological Exams emerge as an essential and growing segment, focusing on physical assessments and cognitive evaluations, which are pivotal in understanding the disease's progression. These exams are increasingly recognized for their role in comprehensive evaluations, thus attracting healthcare providers aiming for a holistic approach to patient care. This dichotomy highlights a rich spectrum of options available in the market, catering to diverse patient needs.

By End User: Hospital (Largest) vs. Clinic (Fastest-Growing)

In the US alzheimers disease-diagnostic market, hospitals account for the largest share among end users, largely due to their capacity to provide comprehensive diagnostic services, advanced technology, and immediate access to specialist care. Clinics, while smaller in market share, are gaining traction and are expected to see significant growth as they offer accessible and specialized services to patients.

Hospital: (Dominant) vs. Clinic (Emerging)

Hospitals hold a dominant position in this market, equipped with extensive resources and multidisciplinary teams that facilitate accurate diagnosis and treatment for Alzheimer's disease. They are often the first point of referral for patients showing symptoms, due to their large-scale operations and integrated healthcare models. On the other hand, clinics are emerging rapidly, driven by an increasing focus on outpatient services and personalized care. They often provide quicker and more convenient access to diagnostic services, catering to a growing patient preference for localized care options. This shift is indicative of a broader trend towards efficiency and specialization in Alzheimer's diagnostics.

Get more detailed insights about US Alzheimers Disease Diagnostic Market

Key Players and Competitive Insights

The alzheimers disease-diagnostic market is characterized by a dynamic competitive landscape, driven by the increasing prevalence of Alzheimer’s disease and the urgent need for effective diagnostic solutions. Key players such as Eli Lilly and Company (US), Biogen Inc. (US), and Roche Holding AG (CH) are at the forefront, each adopting distinct strategies to enhance their market positioning. Eli Lilly (US) focuses on innovation, particularly in developing novel biomarkers for early detection, while Biogen (US) emphasizes partnerships with academic institutions to advance research. Roche (CH) leverages its extensive diagnostic portfolio to integrate digital health solutions, thereby enhancing patient outcomes and operational efficiency. Collectively, these strategies contribute to a competitive environment that is increasingly centered on innovation and collaboration.

In terms of business tactics, companies are localizing manufacturing and optimizing supply chains to enhance responsiveness to market demands. The market structure appears moderately fragmented, with several players vying for market share, yet the influence of major companies remains substantial. This competitive structure fosters an environment where innovation and strategic partnerships are critical for success, as companies seek to differentiate themselves in a crowded marketplace.

In October 2025, Eli Lilly and Company (US) announced a collaboration with a leading tech firm to develop an AI-driven diagnostic tool aimed at improving early detection rates of Alzheimer’s disease. This strategic move is likely to enhance Eli Lilly’s competitive edge by integrating cutting-edge technology into its diagnostic offerings, potentially leading to more accurate and timely diagnoses.

In September 2025, Biogen Inc. (US) launched a new clinical trial focused on a blood-based biomarker for Alzheimer’s detection, in partnership with a prominent research university. This initiative underscores Biogen’s commitment to advancing diagnostic capabilities and may position the company as a leader in the development of non-invasive testing methods, which are increasingly favored by both clinicians and patients.

In August 2025, Roche Holding AG (CH) expanded its diagnostic services by acquiring a startup specializing in digital health solutions for Alzheimer’s care. This acquisition is indicative of Roche’s strategy to enhance its service offerings and integrate technology into its diagnostic processes, thereby improving patient management and outcomes.

As of November 2025, current trends in the alzheimers disease-diagnostic market include a pronounced shift towards digitalization and AI integration, which are reshaping competitive dynamics. Strategic alliances are becoming increasingly vital, as companies recognize the need for collaborative approaches to tackle complex challenges in diagnosis and treatment. Looking ahead, competitive differentiation is expected to evolve, with a greater emphasis on innovation and technology rather than price-based competition. Companies that can reliably integrate advanced technologies into their diagnostic processes are likely to gain a significant advantage in this rapidly evolving market.

Key Companies in the US Alzheimers Disease Diagnostic Market market include

Industry Developments

The US Alzheimer's Disease Diagnostic Market has witnessed significant developments recently, with companies such as Biogen, AbbVie, and Eli Lilly and Company actively advancing their diagnostic capabilities. In September 2023, Biogen announced the successful completion of clinical trials for its latest biomarker tests that aim to improve early detection methods. Meanwhile, in October 2023, AbbVie reported advancements in their imaging techniques associated with Alzheimer’s diagnosis. On the corporate front, Roche and Invitae Corporation both announced collaborative efforts to enhance genetic testing for Alzheimer’s, promoting a broader understanding of the disease's genetic predisposition.

Additionally, in June 2022, Acumen Pharmaceuticals revealed its plan to acquire Neurocrine Biosciences to broaden its pipeline in therapeutic diagnostic solutions for Alzheimer's, a move expected to enhance market competition. The market has seen a rise in valuation, attributed to increasing investments in Research and Development by major firms including Merck and Johnson and Johnson, enhancing existing diagnostic technologies. Public awareness campaigns have also emphasized the importance of early diagnosis, further driving demand within this niche.

Over the past few years, developments in advanced imaging techniques and blood tests have also contributed significantly to diagnostic accuracy, shaping the future of Alzheimer's diagnostics in the US

Future Outlook

US Alzheimers Disease Diagnostic Market Future Outlook

The Alzheimers Disease Diagnostic Market is projected to grow at a 9.03% CAGR from 2024 to 2035, driven by technological advancements, increasing prevalence, and enhanced awareness.

New opportunities lie in:

  • Development of AI-driven diagnostic tools for early detection.
  • Expansion of telehealth services for remote patient monitoring.
  • Partnerships with pharmaceutical companies for integrated diagnostic solutions.

By 2035, the market is expected to achieve substantial growth, reflecting advancements in diagnostics and increased demand.

Market Segmentation

US Alzheimers Disease Diagnostic Market Type Outlook

  • Early Onset Alzheimers
  • Late Onset Alzheimers
  • Familial Alzheimers Disease
  • Others

US Alzheimers Disease Diagnostic Market End User Outlook

  • Clinic
  • Hospital
  • Diagnostic Center
  • Others

US Alzheimers Disease Diagnostic Market Diagnostic Tests Outlook

  • Genetic Testing
  • Neurological Exam
  • Mini Mental State Exam (MMSE)
  • Brain Imaging
  • Others

Report Scope

MARKET SIZE 20242800.0(USD Million)
MARKET SIZE 20253052.84(USD Million)
MARKET SIZE 20357250.0(USD Million)
COMPOUND ANNUAL GROWTH RATE (CAGR)9.03% (2024 - 2035)
REPORT COVERAGERevenue Forecast, Competitive Landscape, Growth Factors, and Trends
BASE YEAR2024
Market Forecast Period2025 - 2035
Historical Data2019 - 2024
Market Forecast UnitsUSD Million
Key Companies Profiled["Eli Lilly and Company (US)", "Biogen Inc. (US)", "Roche Holding AG (CH)", "Novartis AG (CH)", "AstraZeneca PLC (GB)", "Merck & Co., Inc. (US)", "Johnson & Johnson (US)", "AbbVie Inc. (US)"]
Segments CoveredType, Diagnostic Tests, End User
Key Market OpportunitiesAdvancements in biomarker discovery enhance early detection capabilities in the alzheimers disease-diagnostic market.
Key Market DynamicsTechnological advancements in biomarkers enhance diagnostic accuracy, driving competitive dynamics in the Alzheimer's disease-diagnostic market.
Countries CoveredUS

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FAQs

What was the expected market size of the US Alzheimer's Disease Diagnostic Market in 2024?

The U.S. Alzheimer's Disease Diagnostic Market was expected to be valued at 1.2 billion USD in 2024.

What will be the projected market size by 2035?

By 2035, the market is anticipated to reach a value of 2.78 billion USD.

What is the expected CAGR for the US Alzheimer's Disease Diagnostic Market from 2025 to 2035?

The market is expected to experience a CAGR of 7.85% during the forecast period from 2025 to 2035.

Who are the key players in the US Alzheimer's Disease Diagnostic Market?

Major players in the market include AbbVie, Merck, Johnson and Johnson, Biogen, and Eli Lilly and Company, among others.

Which segment of the market has the largest share in 2024?

In 2024, the Late Onset Alzheimer's segment was valued at 0.48 billion USD, making it the largest share of the market.

What is the expected market value for Early Onset Alzheimer's in 2035?

The market value for Early Onset Alzheimer's is projected to reach 0.56 billion USD by 2035.

What challenges might the US Alzheimer's Disease Diagnostic Market face in the coming years?

Key challenges may include regulatory hurdles, technological advancements, and competing diagnostic methods in the market.

What growth drivers are influencing the US Alzheimer's Disease Diagnostic Market?

Factors such as the increasing prevalence of Alzheimer's, advancements in diagnostic technologies, and growing awareness are driving market growth.

What was the market size of the Familial Alzheimer's Disease segment in 2024?

The Familial Alzheimer's Disease segment was valued at 0.12 billion USD in 2024.

How does the market size of the 'Others' segment compare in 2024 and 2035?

In 2024, the 'Others' segment is valued at 0.36 billion USD and is expected to grow to 0.83 billion U.S.D by 2035.

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