Global Alzheimer’s Disease Therapeutics & Diagnostics Market Forecast 2024-2032
The global Alzheimer’s disease therapeutics & diagnostics market was valued at $7366.84 million in 2023 and is expected to reach $12302.40 million by 2032, growing at a CAGR of 5.81% during the forecast period 2024-2032. The base year considered for the study is 2023, and the estimated period is between 2024 and 2032. The market study has also analyzed the impact of COVID-19 on the Alzheimer’s disease therapeutics & diagnostics market qualitatively as well as quantitatively.
Alzheimer’s is a progressive neurodegenerative disorder that damages the brain's nerve cells, resulting in memory loss, cognitive decline, and behavioral changes. The Alzheimer's disease therapeutics & diagnostics market is projected to grow, amped by the development of disease-modifying drugs and a strong pipeline of late-stage treatments. The Alzheimer's market size is also influenced by the rising prevalence of Alzheimer's worldwide, which has spurred significant research and development of Alzheimer's disease.
According to a September 2023 report by the WHO, approximately 55 million people worldwide are living with dementia, with nearly 10 million new cases reported each year. Alzheimer's disease is the most common form of dementia, representing 60%-70% of all cases. In parallel, with increased investments in biomarkers for drug development and early detection, the adoption of biomarker-based diagnostics is expected to accelerate. This shift is likely to pave the way for innovative Alzheimer's disease therapies, further contributing to the global market's expansion.
At present, Alzheimer's & dementia diagnosis assessment and disease monitoring largely depend on advanced diagnostic technologies, such as brain imaging studies. However, the future of the Alzheimer’s disease diagnostics market may shift towards blood-based tests, which are less invasive. These tests, designed to identify Alzheimer’s biomarkers, are currently awaiting FDA approval and are expected to be available by the end of the forecast period.
MARKET INSIGHTS
Key growth enablers of the global Alzheimer’s disease therapeutics & diagnostics market:
• Increase in Alzheimer’s disease cases
The global prevalence of Alzheimer’s disease is a key driver of market growth, highlighting the continued need for effective treatments. In the United States, approximately 5.8 million people are currently living with Alzheimer's dementia, with projections indicating this number could reach 13.8 million by mid-century, primarily due to the aging baby boomer generation. Moreover, the substantial burden on caregivers is evident, with more than 16 million family members and unpaid caregivers contributing an estimated 18.5 billion hours of care in 2018 alone.
Notably, women make up about two-thirds of Americans living with Alzheimer’s, and the disease's significant prevalence across all age groups, including those under 65, is expected to drive growth in the Alzheimer’s disease therapeutics & diagnostics market.
• Advancements in diagnostic technologies
• Growth in the number of drugs under development
• Expansion of the elderly population
Key growth restraining factors of the global Alzheimer’s disease therapeutics & diagnostics market:
• Limited availability of surrogate markers
Alzheimer’s disease (AD) is the most prevalent form of dementia in the elderly and ranks as a leading cause of death, following cancer, heart disease, and stroke. Early symptoms of AD, such as aphasia, apraxia, and agnosia, are often mild and can be easily overlooked, making early diagnosis difficult and potentially delaying crucial diagnostic and therapeutic interventions. The lack of definitive diagnostic procedures and surrogate markers further complicates the drug discovery and development process. Unlike biomarkers, a surrogate marker acts as an indirect measure of therapy effectiveness in clinical trials, serving as a substitute for a clinically meaningful endpoint.
Surrogate markers are utilized in controlled trials to demonstrate the effectiveness of new treatments and are especially valuable in the early phases of drug development for gathering preliminary data. The availability of reliable surrogate markers could help accelerate drug development and enhance diagnostic processes. Technologies such as DNA microarrays and emerging proteomics show promise in screening for these markers. However, there are currently no established surrogate markers that consistently predict clinical outcomes in Alzheimer’s disease trials aimed at disease modification, creating challenges for drug development and contributing to the high failure rates in clinical trials.
• Late-stage drug failures
• Strict government regulations
Global Alzheimer’s Disease Therapeutics & Diagnostics Market | Top Market Trends
• A key trend in the global Alzheimer's disease therapeutics & diagnostics market is the growing use of computed tomography (CT) for diagnosis. CT scans are increasingly preferred due to their cost-effectiveness and accessibility, particularly for the elderly, where early detection is critical. MRI scans are approximately 20% more expensive than CT scans, making the latter a more affordable diagnostic option. This affordability, combined with CT's effectiveness in detecting Alzheimer's-related brain changes, is driving the growth of the CT market. As the prevalence of Alzheimer's continues to increase, the demand for CT-based diagnostics is expected to rise, significantly influencing the global market.
• Another significant trend in the market is the advancement of in-vitro diagnostic techniques. These methods, which analyze biological samples such as blood or tissue, are essential for early detection and effective disease management. In-vitro diagnostics help identify specific biomarkers linked to Alzheimer's, enabling timely and targeted interventions. Additionally, these techniques are crucial in precision medicine, allowing treatments to be personalized based on the unique characteristics of each patient. As these diagnostic methods continue to evolve, they are becoming an increasingly important part of the global strategy for managing Alzheimer's disease.
SEGMENTATION ANALYSIS
Market Segmentation – Product –
Market by Product:
• Therapeutics
Cholinesterase Inhibitors
In 2023, cholinesterase inhibitors was the largest therapeutics in the global Alzheimer's disease therapeutics & diagnostics market.
Cholinesterase inhibitors are a commonly used class of medications in managing Alzheimer's disease, particularly targeting the symptoms in the mild to moderate stages of the condition. These drugs work by boosting the levels of acetylcholine in the brain, a neurotransmitter essential for memory and cognitive function, which is often reduced in Alzheimer's patients.
Drugs such as donepezil, rivastigmine, and galantamine are frequently prescribed in clinical settings, with donepezil being one of the most widely used. In this regard, according to the Alzheimer’s Association, approximately 50-70% of patients with mild to moderate Alzheimer's experience some symptom improvement when treated with cholinesterase inhibitors. However, these medications do not impact the disease's progression.
Additionally, the use of cholinesterase inhibitors is widespread globally, with millions of prescriptions issued each year. Donepezil, for example, is commonly prescribed, with over 3 million patients using it worldwide. In Japan, where the aging population is particularly large, donepezil has been prescribed to more than 1 million patients, making it a key therapeutic option for managing Alzheimer's disease. While these inhibitors are widely used, they are associated with side effects such as gastrointestinal issues. They are typically recommended for symptomatic relief rather than altering the course of the disease.
NMDA Receptor Antagonists
Other Therapeutics
• Diagnostics
Brain Imaging
In 2023, brain imaging was the major diagnostics in the global Alzheimer's disease therapeutics & diagnostics market.
The Alzheimer’s disease therapeutics & diagnostics market is evolving with advancements in brain imaging techniques. Brain imaging plays a crucial role in detecting Alzheimer's disease, allowing healthcare professionals to identify amyloid plaques & tau tangles, key hallmarks of the condition. Techniques like positron emission tomography (PET) & magnetic resonance imaging (MRI) are commonly used to observe changes in brain structure & function. These imaging methods are instrumental in early diagnosis, which is essential for managing symptoms & slowing disease progression.
Recent years have seen prominent research focused on improving the sensitivity and specificity of brain imaging technologies. For instance, PET scans now use tracers that specifically bind to amyloid plaques, delivering clearer and more precise images. These advancements are crucial for distinguishing Alzheimer’s disease from other forms of dementia. Additionally, MRI technologies are being enhanced to detect subtle changes in brain volume and white matter, offering valuable insights into disease progression.
The use of these imaging technologies is growing, with an increasing number of healthcare facilities integrating advanced brain imaging into their diagnostic protocols. Given the significant global burden of Alzheimer’s, affecting millions worldwide, there is a pressing need for reliable and early diagnostic tools. Enhanced brain imaging capabilities not only support diagnosis but also play a vital role in assessing treatment effectiveness and gaining a deeper understanding of the disease’s underlying mechanisms, ultimately leading to better patient outcomes.
CSF Test for Alzheimer's Disease
Other Diagnostics
REGIONAL ANALYSIS
Geographical Study based on Four Major Regions:
• North America: The United States and Canada
• Europe: The United Kingdom, Germany, France, Italy, Belgium, Poland, and Rest of Europe
• Asia-Pacific: China, Japan, India, South Korea, Indonesia, Thailand, Vietnam, Australia & New Zealand, and Rest of Asia-Pacific
The Asia-Pacific is estimated to be the leading region over the forecast period.
The Asia-Pacific Alzheimer's disease therapeutics & diagnostics market is experiencing robust growth, fueled by a rapidly aging population and the rising prevalence of Alzheimer's disease. In essence, the World Health Organization (WHO) projects that the number of individuals aged 60 and above in the region will double by 2050, reaching approximately 1.3 billion. This demographic shift is contributing to an increase in Alzheimer's cases, with an estimated 23 million people in the Asia-Pacific expected to be affected by dementia by 2030, a significant portion of them likely to be diagnosed with Alzheimer's disease. In response, governments in countries like Japan, China, and South Korea are investing in healthcare infrastructure and promoting early diagnosis and intervention, which is anticipated to further drive the demand for advanced diagnostic and therapeutic solutions.
Further, in terms of diagnostics, there has been a noticeable increase in the adoption of advanced imaging technologies and biomarker-based tests across the Asia-Pacific. Japan, for example, is leading the way in using PET scans and cerebrospinal fluid analysis for early Alzheimer's detection, with around 4.6 million individuals estimated to be living with dementia in the country.
Additionally, pharmaceutical companies in China have amplified research and development efforts, with over 70 clinical trials related to Alzheimer's disease currently underway, focusing on new treatments and enhancing existing therapeutic approaches. Despite these promising advancements, challenges such as limited healthcare access in rural areas and the high cost of advanced diagnostics remain, presenting obstacles to achieving wider market penetration across the region.
• Rest of World: Latin America, the Middle East & Africa
COMPETITIVE INSIGHTS
Major players in the global Alzheimer’s disease therapeutics & diagnostics market:
• Baxter International Inc
• Biogen Inc
• Allergan PLC (acquired by AbbVie)
• Cognoptix Inc
• Eli Lilly and Company
Key strategies adopted by some of these companies:
• Fujirebio, a subsidiary of HU Group Holdings Inc, a producer and supplier of in-vitro diagnostic products, announced on May 4, 2022, that its Lumipulse G β-Amyloid Ratio (1-42/1-40) in-vitro diagnostic test had received US Food and Drug Administration (FDA) approval. The test is designed for assessing Alzheimer's disease in the US.
• Quanterix introduced a novel blood-based biomarker test, LucentAD p-Tau 217, in October 2023 for the accurate diagnosis of Alzheimer’s disease. The test boasts an impressive accuracy rate of over 90%, exceeding the stringent criteria set by the Alzheimer's Association.
• Diadem SpA announced a major partnership with Quest Diagnostics in October 2023, establishing an exclusive US licensing agreement for its innovative technology, AlzoSure-R Predict. Designed to predict the onset of Alzheimer’s disease, this collaboration aims to transform early detection and diagnosis efforts in the US market.
• AbbVie Inc signed an agreement in December 2023 to acquire Cerevel Therapeutics, along with its strong neuroscience pipeline of clinical-stage and preclinical candidates targeting diseases such as schizophrenia, Parkinson's disease (PD), and mood disorders. The acquisition includes Emraclidine, a positive allosteric modulator (PAM) of the muscarinic M4 receptor. It is currently undergoing a Phase 1 study in elderly healthy volunteers to support a potential Alzheimer's disease psychosis program.
• Eisai Co Ltd received approval in January 2024 for its humanized anti-soluble aggregated amyloid-beta (Aβ) monoclonal antibody LEQEMBI in China. The approval is for the treatment of patients with Alzheimer’s disease.
Frequently Asked Questions (FAQs):
• What are the common diagnostic methods for Alzheimer's disease?
A: Common diagnostic methods for Alzheimer’s disease include neuroimaging (MRI, PET scans), cerebrospinal fluid analysis, blood tests, and cognitive assessments.
• What are the current therapeutic options for Alzheimer's disease?
A: Current therapies for Alzheimer’s disease include cholinesterase inhibitors, NMDA receptor antagonists, and emerging disease-modifying drugs aimed at slowing disease progression.
• How significant is the role of biomarkers in Alzheimer's diagnostics?
A: Biomarkers are crucial for early diagnosis and tracking disease progression, enabling more precise and personalized treatment strategies.
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