Alzheimer’s Disease Therapeutics And Diagnostics Market By Product (Diagnostics [Biomarker Analysis, Imaging Techniques (MRI, PET), Genetic Testing, Digital Diagnostics, Blood-Based Assays], Therapeutics [Cholinesterase Inhibitors, NMDA Receptor Antagonists, Anti-Amyloid Monoclonal Antibodies, Tau Aggregation Inhibitors, Disease-Modifying Therapies]); By Geography, Segment Revenue Estimation, Forecast, 2024–2032.

Alzheimer’s Disease Therapeutics And Diagnostics Market Size

The Global Alzheimer’s Disease Therapeutics & Diagnostics Market is on the cusp of a transformative decade. In 2024, the market was valued at USD 11.40 billion, and by 2030, it is projected to surge to USD 19.44 billion, expanding at a robust CAGR of 9.3%. This growth is driven by a paradigm shift from symptomatic management to early-stage, disease-modifying interventions & precision diagnostics.

 

Alzheimer’s Disease Therapeutics And Diagnostics Market Dynamics:

Market Drivers

• Rising Alzheimer's prevalence

Alzheimer’s disease (AD) is an age-related condition, affecting approximately 5% of individuals aged 65–74, 13.1% of those aged 75–84 & 33.3% of people aged 85 and older. The global aging trend has contributed to a notable rise in cases & signals an impending surge in affected individuals. Worldwide, the estimated numbers of individuals with AD dementia, prodromal AD, and preclinical AD were 32 million, 69 million, and 315 million, respectively. Collectively, they accounted for 416 million across the AD continuum. In 2021, an estimated 57 million people worldwide were living with dementia, with over 60% residing in low- and middle-income countries. Alzheimer's disease, the most prevalent form of dementia, may account for 60–70% of cases. Mild cognitive impairment (MCI) affects around 22% of individuals over the age of 65, with Alzheimer's disease (AD) being the underlying cause in approximately half of these cases. According to the European Brain Council, approximately 7 million individuals in Europe are affected by Alzheimer's disease.  In Spain, more than 0.8 million people are living with the disease. In 2024, an estimated 6.9 Mn Americans aged 65 and older lived with Alzheimer's dementia, with 73% of them being 75 or older. Recent estimates indicate that global dementia-related care expenses exceed $818 billion annually, with costs projected to surpass $2 trillion by 2028.

 

Market Opportunities

• Technological advancements in diagnostics

The use of artificial intelligence (AI) in neurodegenerative disease management is expanding, presenting new opportunities to enhance the accuracy of dementia diagnostics & treating complex neurological disorders. Scientists investigating Alzheimer’s diagnostics are leveraging AI-driven databases to streamline drug discovery, enabling more efficient analysis of extensive biomedical data. AI research spans multiple fields, with a primary focus on machine learning (ML) & deep learning (DL). Businesses are utilizing knowledge graphs in combination with retrieval-augmented generation (RAG) to refine general-purpose AI models from companies like Anthropic and OpenAI. Additionally, AI models can integrate with vector databases, which store data in a format that represents information as "vectors." Healtcare and life sciences organizations can gain significant advantages by structuring their diverse data sources into a map-like relationship instead of relying on traditional relational databases. Deep learning (DL) technology can assess drug efficacy by analyzing drug-inhibitor interactions, facilitating personalized treatment. Moving forward, more advanced and portable methods are expected to enhance the prediction, detection, and treatment of Alzheimer's disease (AD).

 

 

 

• Increased R&D investments

Investor / Funder	Recipient / Program	Investment Amount	Purpose / Focus Area	Date
Novo Holdings	Asceneuron (Switzerland)	$100 million	Phase 2 development of ASN51, an O-GlcNAcase inhibitor targeting tau pathology in AD	July 2024
Alzheimer’s Drug Discovery Foundation (ADDF)	C2N Diagnostics (USA)	$7 million+	Development of scalable blood-based p-Tau217 biomarker tests for early AD detection	September 2024
UK Government	National Neurodegeneration Initiative	£160 million/year	Expansion of dementia research funding; aims to recruit 500,000 volunteers for clinical trials	Ongoing through 2025
Eisai & Biogen	Global rollout of Leqembi (lecanemab)	Undisclosed	Commercial launch and infrastructure development for anti-amyloid therapy in multiple regions	2024–2025
Eli Lilly	Development of donanemab and remternetug	Undisclosed	Clinical trials and regulatory submissions for anti-amyloid monoclonal antibodies	2024–2025
Roche & Quanterix	Collaboration on plasma amyloid beta testing	Undisclosed	Development and validation of blood-based biomarkers to replace costly PET/CSF tests	2024–2025
C2N Diagnostics	Partnership with Alector & Eisai	Undisclosed	Commercialization of FDA breakthrough-designated plasma amyloid beta 42/40 ratio test	2024–2025

 

Alzheimer’s Disease Drug Development Pipeline

As of January 2024, a total of 164 clinical trials for Alzheimer's disease (AD), including prevention, mild cognitive impairment (MCI), and AD dementia, were underway, evaluating 127 different drugs. Among these, 48 trials were testing 32 drugs in Phase 3, 90 trials were assessing 81 drugs in Phase 2, and 26 trials were examining 25 drugs in Phase 1.

 

 

Over the last five years, the Alzheimer’s clinical trial landscape has entered a powerful resurgence, driven by improved understanding of disease mechanisms, greater biomarker integration, and stronger regulatory and investor support for disease-modifying therapies (DMTs).

As of April 2025, the global Alzheimer’s pipeline features:

•           495 active clinical trials, up from 470 in early 2024

•           127 drug candidates in various stages of development

•           Trials spanning over two dozen countries, with increasing emphasis on diverse patient populations and earlier disease stages

Despite historically high failure rates of ~98–99.6%, this surge reflects a critical turning point where therapeutic approaches have become more targeted, and trial designs more adaptive

 

 

Regulatory Approvals : FDA Approved Alzheimer’s Disease Therapies

Product Name	Generic Name	Company	Mechanism of Action	Approval Type	Approval Year	Status (Apr 2025)	Key Notes
Leqembi	Lecanemab	Eisai / Biogen	Anti-amyloid beta mAb	Accelerated + Full	2023	Approved & marketed	First FDA-approved fully approved anti-amyloid DMT
Kisunla	Donanemab	Eli Lilly	Anti-amyloid beta mAb	Full	2024	Approved & marketed	Shows ~29% cognitive slowing; approved for early-stage AD
Aduhelm	Aducanumab	Biogen	Anti-amyloid beta mAb	Accelerated	2021	Withdrawn (2024)	Approval withdrawn due to limited uptake and controversy

 

Alzheimer’s Disease Therapeutics And Diagnostics Market: Recent Developments

• On April 15, 2025, Eisai Co., Ltd. and Biogen Inc. announced that the European Commission (EC) had granted Marketing Authorization (MA) in the European Union (EU) for the amyloid-beta (Aβ) monoclonal antibody Leqembi® (lecanemab). This approval marks the first time a therapy targeting an underlying cause of Alzheimer’s disease (AD) has received MA in the EU.

• On March 28, 2025, the EU medicines regulator declined approval for Eli Lilly's Alzheimer's drug, Kisunla, citing that its ability to slow cognitive decline did not sufficiently outweigh the risk of severe brain swelling in patients. Experts have expressed concerns about the broader adoption of Leqembi in cost-conscious European countries due to its high price. In the U.S., the treatment costs $26,500 per year.

• A recent study from Northwestern University reveals that NU-9, an experimental small-molecule drug approved by the U.S. FDA for clinical trials in treating amyotrophic lateral sclerosis (ALS), also enhances neuron health in animal models of Alzheimer’s disease. The research was featured in the Proceedings of the National Academy of Sciences.

• On July 2, 2024, the U.S. FDA approved Kisunla™, Eli Lilly and Company's treatment for Alzheimer's disease (AD) in adults with early symptomatic stages. This includes individuals with mild cognitive impairment (MCI) & those in the mild dementia phase of AD, confirmed to have amyloid pathology. Kisunla, administered as a monthly infusion, has an annual U.S. list price of approximately $32,000 and generated $9.3 million in sales in 2024.

 

Alzheimer’s Disease Therapeutics And Diagnostics Market Segmentation: A Comprehensive Overview

By Product

• Diagnostics

  • Biomarker analysis

  • Imaging techniques (MRI, PET)

  • Genetic testing

  • Digital diagnostics

  • Blood-based assays

 

• Therapeutics

  • Cholinesterase inhibitors

  • NMDA receptor antagonists

  • Anti-amyloid monoclonal antibodies

  • Tau aggregation inhibitors

  • Disease-modifying therapies?

 

By Region

• North America

• Asia-Pacific

• Europe

• Latin America

• Middle East Africa

 

Regional Analysis – Alzheimer’s Disease Therapeutics And Diagnostics Market

• North America Market Trends

In 2024, North America dominated the global Alzheimer’s disease therapeutics and diagnostics market, representing around USD 5.8 billion—over half of the total market share.

The US  has one of the highest Alzheimer’s patient burdens globally, with an estimated 6.7 million individuals affected by the disease. A strong R&D ecosystem, combined with an efficient regulatory framework, has facilitated rapid FDA approvals & enhanced clinical trial capabilities. Government support, particularly through Medicare & CMS reimbursement expansions for PET imaging & cognitive screening, further strengthens the healthcare infrastructure. Additionally, the presence of major biopharmaceutical companies like Biogen, Eli Lilly & Eisai ensures continuous advancements in therapeutics and diagnostics. High levels of awareness and improved diagnostic accessibility contribute to early detection efforts, with initiatives focused on blood-based biomarker development & cognitive health programs leading the way.

 

• Europe Market Developments

Approximately 7 million people in Europe currently live with Alzheimer’s disease, and as the population ages, it has become an increasing global public health concern. This figure is expected to double, reaching 14 million by 2030. The societal & economic impact of dementia in Europe is substantial, with costs projected to exceed EUR 250 billion by 2030, over half of which will stem from informal care expenses. Currently, healthcare systems across Europe face limitations in effectively detecting, diagnosing, and treating AD. During Brain Awareness Week 2023, the European Brain Council (EBC) & the European Federation of Pharmaceutical Industries and Associations (EFPIA) introduced the Rethinking Alzheimer’s Disease White Paper, advocating for improvements in Alzheimer’s detection and diagnosis. The European Federation of Pharmaceutical Industries & Associations (EFPIA) supports the RETHINKING Alzheimer’s Disease.

 

• Asia-pacific Growth Opportunities

According to the Alzheimer’s International study, the number of people with dementia in the APAC region is projected to triple by 2050. By mid-century, this region will account for more than half of the global dementia population. Across Asian regions, East Asia has the highest estimated number of individuals with Aβ-positive Alzheimer's disease dementia at 6.6 million, followed by South Asia with 3.9 million, high-income Asia Pacific regions with 2.5 million, and Southeast Asia with 2.4 million. With over 20 million individuals affected by dementia in the region and a rapidly aging population, the healthcare burden is immense. Addressing this challenge will require focused research and workforce education to enhance prevention strategies through health promotion.

 

• Emerging markets in Latin America

Latin American countries face rising prevalence & incidence of Alzheimer's disease and related dementias (ADRD), driven by a rapid demographic transition & the accelerated growth of their aging populations. In 2023, the Alzheimer's Association held its eighth satellite symposium in Mexico, showcasing advancements in dementia research, key priorities, and challenges across Latin America. Acknowledging both the challenges and scientific opportunities in the region, the Alzheimer's Association allocated funding in 2023 to support 41 active research grants across Latin America, amounting to over $4 million.

 

• Middle East & Africa diagnostics expansion

Alzheimer's disease (AD) imposes a significant economic burden on societies, leading to rising healthcare expenses, long-term care costs & diminished productivity. A 2019 study estimated that dementia care in the MENA region amounted to approximately $2.1 billion, with expenditures growing at an annual rate of 8.2% since 2000. By 2050, costs are projected to surge to $57.9 billion.

 

A heat map illustrates the varying prevalence of dementia across African countries over the past 25 years. Studies on dementia prevalence have also been conducted in Senegal and Kenya, though the findings have yet to be published.

 

 

 

Key Players in the Alzheimer’s Disease Therapeutics And Diagnostics Market

• Biogen

• Pfizer

• Eisai Co., Ltd.

• Eli Lilly

• Roche

• Grifols

• Johnson & Johnson

• TauRx Therapeutics

• Novartis

• Novo Nordisk

 

Alzheimer’s Disease Therapeutics and Diagnostics Market Report Coverage

Report Attribute	Details
Forecast Period	2024 – 2032
Market Size Value in 2024	USD 11.40 Billion
Revenue Forecast in 2030	USD 19.44 Billion
Overall Growth Rate	CAGR of 9.3% (2024 – 2030)
Base Year for Estimation	2023
Historical Data	2017 – 2021
Unit	USD Million, CAGR (2024 – 2030)
Segmentation	By Product, By Geography
By Product	Diagnostics: Biomarker Analysis, Imaging Techniques (MRI, PET), Genetic Testing, Digital Diagnostics, Blood-Based Assays Therapeutics: Cholinesterase Inhibitors, NMDA Receptor Antagonists, Anti-Amyloid Monoclonal Antibodies, Tau Aggregation Inhibitors, Disease-Modifying Therapies
By Region	North America, Europe, Asia-Pacific, Latin America, Middle East & Africa
Country Scope	U.S., Germany, China, Japan, India, UK, Brazil, etc.
Market Drivers	Aging population, advancements in diagnostic technologies, increasing R&D investment
Pricing and Purchase Options	Customization available upon request