The global Alzheimer's disease therapeutics market was valued at USD 3.59 billion in 2022 and is expected to reach USD 7.16 billion by 2028, growing at a CAGR of 12.19% from 2022-2028. With the growing prevalence of Alzheimer's worldwide, government and non-government entities are investing heavily in developing therapeutics for the disease, which may augment the market's growth. R&D investments are further expected to propel the Alzheimer's disease therapeutics market growth.
According to Arizton's estimates, the prevalence of Alzheimer's disease was high in China, followed by U.S. and Japan in 2021. In the 8MM, the total prevalent cases increased from 29,460,996 in 2021 to 36,009,144 cases in 2028. The increasing prevalence of Alzheimer's disease is driving the growth of the global Alzheimer's disease therapeutics market. According to the estimates, approximately 900,000 new patients are diagnosed annually in the US alone.
Alzheimer's disease (AD) is a progressive neurodegenerative disease characterized by memory loss, cognitive impairment, and functional decline. During the early stages of the disease, sleep disturbances and forgetfulness are generally the first presenting symptoms. In the severe stages, patients with AD require permanent observation, either by a home care professional or a family member. With rapidly increasing worldwide prevalence, the international medical community has identified Alzheimer's disease as a major global health threat. Significant efforts have been made to develop a new treatment, as current pharmacologic management is known only temporarily to improve symptoms. Without therapies that effectively stop or reverse the course of the disease, a large area of opportunity exists for developing an effective pharmacologic approach in the global Alzheimer's disease therapeutics market.
The most significant known risk factor is increasing age; most people with Alzheimer's are 65 and older. Alzheimer's disease is considered younger-onset Alzheimer's if it affects a person under 65. Younger-onset can also be referred to as early-onset Alzheimer's. Further, Alzheimer's disease is the most common type of dementia and affected approximately 5.8 million people in the United States in 2020, and the prevalence is expected to double by 2050. According to estimates, approximately 35 million people are affected with Alzheimer's disease globally. In Europe alone, as of 2018, 9.7 million people have Alzheimer's disease and other forms of dementia. By 2030, the number of patients will rise to 14 million. According to estimates, Japan has the highest total prevalence of AD, with 23.88% in women and 11.93% in men, with the total prevalent cases in those 60 years and older forecast to increase from 4.2 million in 2022 to 5.1 million in 2028, at an annual growth rate of 3.5%. Such a growing number of Alzheimer's disease gives significant growth opportunities for the Alzheimer's disease therapeutics market.
Alzheimer's Disease Diagnosis
Several laboratory tests can diagnose Alzheimer's disease to assess memory impairment and other thinking skills, judge functional abilities, and identify behavior changes. The brain-imaging technologies most often used are Magnetic resonance imaging (MRI), Computerized tomography (CT), and Positron emission tomography (PET).
Alzheimer's Disease Treatment
The current competitive landscape in AD consists only of symptomatic treatments, of which there are currently seven approved medications: three ChEIs (donepezil, rivastigmine, and galantamine), one NMDA-R antagonist (memantine), one combination therapy (memantine/donepezil), and two Aβ A4 protein inhibitor (aducanumab and sodium oligomannate). In the global Alzheimer's disease therapeutics market, cholinesterase inhibitors are the major drugs available for Alzheimer's because the enzyme cholinesterase is a significant therapeutic target for Alzheimer's. Improvements to the approved therapies, such as easier routes of administration and reduced dosing frequencies, along with the developments expected to occur within the next decade, could significantly affect how the disease is managed. Earlier disease detection may render the currently available therapies more useful, but until disease-modifying agents are introduced, the landscape will not change significantly.
ALZHEIMER'S DISEASE: CLINICAL TRIALS SCENARIO
The Alzheimer's disease therapeutics market portfolio contains a total of 151+ assets in various development phases. Most industry-sponsored drugs in active clinical development for Alzheimer's Disease are in the Phase II stage.
The clinical trial portfolio contains 139+ trials in various development phases. Most industry-sponsored drugs in active clinical development for Alzheimer's Disease are in the Phase II stage. The global pharmaceutical industry is steadily developing new drugs for Alzheimer's Disease, a Central Nervous System disorder. Moreover, North America boasts the highest number of ongoing clinical trials involving Alzheimer's Disease. Asia-Pacific and Europe are the other prominent regions involved in Alzheimer's Disease-related drug trials. Further, Eli Lilly and Company is the leading ongoing Alzheimer's Disease-related clinical trials sponsor in the Alzheimer's disease therapeutics market. Eisai Co Ltd, Roche Ltd, Cognition Therapeutics Inc, and Cassava Sciences Inc are a few other notable sponsors involving Alzheimer's Disease.
MARKET TRENDS & DRIVERS
Launch of New Therapies
The USFDA approved biological drug candidates such as Aducanumab (Aduhelm) in 2021 for treating early Alzheimer's Disease. With Aduhelm being the biologic approved for Alzheimer's disease in 2021, there is a demand for biological therapies with novel MOAs, and many new classes of therapies are looking to enter the Alzheimer's disease therapeutics market over the next few years. The biologics such as amyloid beta inhibitors are making inroads into the Alzheimer's disease market owing to better clinical profiles and convenient patient dosing. Launching approved small molecules, and further uptake in biological therapies will lead to significant growth in the Alzheimer's Disease therapeutics market.
Increasing Prevalence of Alzheimer's Disease
The Alzheimer's disease therapeutics market has been witnessing considerable growth, which is attributed to the increasing prevalence of Alzheimer's Disease worldwide. According to the estimates, the prevalence of Alzheimer's Disease patients was 6.5 million in the United States in 2022.
High Investment in R&D Activities
Major players in the Alzheimer's disease therapeutics market are developing novel products and spending significantly on research and development, along with major acquisitions and collaborations to achieve a competitive edge over their counterparts. High investments in R&D capabilities and infrastructure by the industry and governments are anticipated to create lucrative opportunities in the market.
- Drug Class: The ACE inhibitors are expected to account for a significant share of the global Alzheimer's disease therapeutics market by drug class. However, the other class of drugs is expected to be the fastest-growing segment during the forecast period. Recently approved biologic such as Aducanumab (Aduhelm) is expected to drive the global Alzheimer's disease therapeutics market during the forecast period.
- Gender Type: Among the gender type, women were expected to account for a significant share of the global Alzheimer's disease therapeutics market. The majority of the share is due to women's longer life expectancy.
- Age Group: The global Alzheimer's disease therapeutics market by age group people is expected to be dominated by the 85 years & above age group. However, people 65 years & above are expected to be the fastest-growing segment during the study period.
- Severity Type: Among the severity type, People with mild form are expected to account for a significant share of the global Alzheimer's Disease therapeutics market. In 2021, the incidence of Alzheimer's disease was 229,385 in the U.S., projected to grow significantly during the forecast period. However, people with moderate form are expected to be the fastest-growing segment during the forecast period.
The U.S. dominates the global Alzheimer's disease therapeutics market by geography due to the rise in healthcare affordability in the U.S., the rise in knowledge and awareness amongst the people, and technological advancement in this region. However, China is expected to grow at a faster rate with a high CAGR in the global Alzheimer's disease therapeutics market due to the geriatric population's rise, awareness about disease management, and rising healthcare expenditure in the APAC region.
The current competitive landscape in AD consists only of symptomatic treatments, of which there are currently seven approved medications. The global Alzheimer's disease therapeutics market is dominated by many companies offering generic drugs and selective pharma/biotech companies offering patented/commercial drugs for treating Alzheimer's Disease. The U.S. Food and Drug Administration (FDA) approved the amyloid beta antibody Adehulm (Adecanumab) for treating Alzheimer's Disease in 2021. This marked the arrival of biologics in this treatment landscape. Although generic products continue to capture significant Alzheimer's disease therapeutics market share, the arrival of biologics and other targeted therapies indicates a paradigm shift in this therapeutic space through the forecast period.
The global Alzheimer's disease therapeutics market contains 151+ assets in various development phases. The emerging therapeutics being developed for Alzheimer's Disease include Lecanemab, Nilotinib, Remternetug, NE-3107, Bepranemab, Vafidemstat, Seltorexant, and many others. Launching these novel emerging drugs will shift the Alzheimer's Disease therapeutics paradigm shortly. With more than 151 molecules in various stages of development, it is expected that new vendors are likely to enter the market with a novel mechanism of action and better safety and efficacy profiles compared to the existing patented commercial drugs for treating Alzheimer's Disease.
Companies such as Eisai Co., Ltd., Novartis, Biogen, AbbVie, Janssen Pharmaceuticals, and Shanghai Green Valley Pharmaceuticals are the major players in the global Alzheimer's disease therapeutics market. These players adopt organic and inorganic growth strategies to strengthen their product portfolio. These companies have adopted strategies such as collaborations & acquisitions, expansion of geographical footprint, investments in research & development, and manufacture of novel drugs to compete in the global Alzheimer's disease therapeutics market. The other prominent emerging players operating in the global Alzheimer's disease market include KeifeRx LLC, BioVie Inc, Eli Lilly and Company, UCB SA, Oryzon Genomics, Denali Therapeutics, and many others.
Key Milestones in The Alzheimer's Disease Therapeutics Market:
- In April 2022, Biogen Announced that the European Medicines Agency (EMA) had withdrawn its Marketing Authorization Application (MAA) for aducanumab to treat the early stages of Alzheimer's disease due to a lack of sufficient data.
- In March 2022, Corium, Inc. announced that the U.S. Food and Drug Administration (FDA) had approved Adlarity (donepezil transdermal system) as a treatment for patients with mild, moderate, or severe dementia of Alzheimer's Disease.
- In June 2021, Biogen Announced that the U.S. Food and Drug Administration (FDA) had granted accelerated approval for Aduhelm (aducanumab-avwa) to treat early Alzheimer's disease. The approval is based on two Phase 3 clinical trials—EMERGE (Study 1) and ENGAGE (Study 2)—in patients with early stages of Alzheimer's disease (mild cognitive impairment and mild dementia) with confirmed presence of amyloid pathology.
- Detailed overview of Alzheimer's Disease, including disease definition, classification, diagnosis, and treatment pattern
- Overview of the global trends of Alzheimer's Disease in the eight major markets (8MM)
- Historical, current, and projected patient pool of Alzheimer's Disease in the eight major markets (8MM) for the 2019 – 2028 period
- Gender type, Drug Class, Age group, Severity type, and Geography type segmentations of Alzheimer's Disease in the eight major markets (8MM)
- Historical, current, and projected market size of Alzheimer's Disease in the eight major markets (8MM) for the 2019 – 2028 period
- In-depth analysis of the market segments, which includes products, treatment, and competitor analysis
- Market share of the market players, company profiles, product specifications, and competitive landscape
- Comprehensive data on emerging trends, market drivers, growth opportunities, and restraints
- Detailed overview of marketed drugs with key coverage of developmental activities, including sponsor name, approved indication, territory, collaborations, licensing, mergers and acquisitions, regulatory designations, and other product-related activities.
- Detailed overview of therapeutic pipeline activity and therapeutic assessment of the products by development stage, product type, route of administration, molecule type, and MOA type for Alzheimer's Disease across the complete product development cycle, including all clinical and non-clinical stages
- Detailed overview of clinical trial activity and therapeutic assessment of the products by development stage, product type, route of administration, molecule type, and geography type for Alzheimer's Disease across all clinical stages
- Coverage of dormant and discontinued pipeline projects along with the reasons across Alzheimer's Disease
- Coverage of major milestones (product approvals/launches timelines, clinical trial result publications, regulatory designations, licensing & collaborations, research & development progress of pipeline assets) in the Alzheimer's Disease space.