The landmark FDA approval of Biogen / Eisai’s aducanumab (Aduhelm) in 2021 has had a minimal effect on treatment dynamics in AD owing to the lack of reimbursement and the controversy surrounding its approval. Eisai / Biogen’s lecanemab (Leqembi) became the second FDA-approved anti-Aβ MAb in January 2023, following its accelerated approval for early AD; applications for traditional FDA approval as well as for approval in Europe and Japan have been accepted by regulators. Other DMTs may soon follow in the United States and potentially other markets (Eli Lilly’s donanemab, and Novo Nordisk’s semaglutide). Meanwhile, Lundbeck / Otsuka’s Rexulti could become the first therapy to receive FDA approval for AD agitation (PDUFA date: May 10, 2023). That said, therapies from Otsuka, BioXcel, and Axsome are progressing through late-phase development to treat key neuropsychiatric symptoms associated with AD. The launch of these potential blockbusters could meaningfully alter the dynamics of this market, driven by clear need, strong market demand, and premium pricing.
QUESTIONS ANSWERED
How large is the treatable AD population? What will be the impact of future anti-Aβ MAbs on diagnosis / drug treatment rates if these agents become available and accessible for the treatment of early AD?
What are KOLs’ opinions of recently launched therapies (e.g., Corium’s Adlarity) and other key symptomatic and disease-modifying therapies in development for AD?
What commercial uptake can Rexulti, AVP -786, Auvelity (AXS-05) expect if they launch for AD agitation?
What are the drivers and constrainers of the AD market, and how might they change over the forecast period as premium-priced agents enter the market?
PRODUCT DESCRIPTION
Disease Landscape & Forecast provides comprehensive market intelligence with world-class epidemiology, keen insight into current treatment paradigms, in-depth pipeline assessments, and drug forecasts supported by detailed primary and secondary research.
SOLUTION ENHANCEMENT
Disease Landscape & Forecast features will feature continual updates in 2022 to provide timely insights and analyses as meaningful indication-specific news and events unfold.
Major-market patient share of behavioral therapies in Alzheimer's disease: 2021-2031
Anti-Au03b2 monoclonal antibodies
Major-market sales and patient share of disease-modifying therapies in MCI due to AD: 2021-2031
Major-market sales and patient share of disease-modifying therapies in mild AD: 2021-2031
Major-market sales in Alzheimer's disease, by therapeutic group: 2021-2031
Alternative market scenarios
Alternative scenarios for the AD market through 2031
Forecast
Market forecast assumptions
Market forecast dashboard
Etiology and pathophysiology
Disease overview
Amyloid plaques and neurofibrillary tangles in Alzheimeru2019su00a0disease
Etiology
Genetic risk factors for Alzheimeru2019s disease
Genes associated with familial Alzheimeru2019s disease
Nongenetic risk factors for Alzheimeru2019s disease
Pathophysiology
Leading pathophysiologicalu00a0hypotheses in Alzheimeru2019s disease
Normal and pathogenic cleavage of amyloid precursor protein
Disease progression / natural history
Brain atrophy in Alzheimeru2019s disease
Key pathways and drug targets
Key drug targets
Key strategies and drug targets in Alzheimeru2019s disease
Epidemiology
Key findings
Epidemiology populations
2020 model update
Disease definition, methods, and sources used
Total asymptomatic Alzheimeru2019s disease prevalent cases: 2021-2031 (thousands)
Disease definition, methods, and sources used
Total MCI due to AD prevalent cases: 2021-2031 (thousands)
Disease definition, methods, and sources used
Total Alzheimer's disease prevalent cases: 2021-2031 (thousands)
Multistate model of the progression of Alzheimer's disease
Disease definition, methods, and sources used
Total Alzheimer's disease prevalent cases by severity: 2021-2031 (thousands)
Disease definition
Methods
Sources used for diagnosed prevalent cases of Alzheimer's disease by symptom status
Diagnosed prevalent cases of Alzheimer's disease by symptom status: 2020-2030 (thousands)
Diagnosed prevalent cases of MCI due to AD in the mature pharmaceutical markets: 2021-2031 (thousands)
Diagnosed prevalent cases of Alzheimer's disease by severity in the mature pharmaceutical markets: 2021-2031 (thousands)
Drug-treated prevalent cases of MCI due to AD in the mature pharmaceutical markets: 2021-2031 (thousands)
Drug-treated prevalent cases of Alzheimer's disease by severity in the mature pharmaceutical markets: 2021-2031 (thousands)
Current treatment
Key findings
Treatment goals
Key endpoints used in clinical trials for Alzheimer's disease
Key current therapies
Overview of Alzheimer's disease drug classification
Mechanism of action of key current drug classes used for Alzheimeru2019s disease
Current treatments used for Alzheimeru2019s disease
Market events impacting the use of key current therapies in Alzheimer's disease
Advantages and disadvantages of donepezil
Advantages and disadvantages of Adlarity
Key results from select clinical trials of Adlarity for the treatment of Alzheimer's disease
Expert insight: Adlarity
Advantages and disadvantages of rivastigmine
Advantages and disadvantages of galantamine
Advantages and disadvantages of memantine
Advantages and disadvantages of antipsychotics
Advantages and disadvantages of antidepressants
Advantages and disadvantages of Aduhelm
Key results from select clinical trials of Aduhelm for the treatment of Alzheimer's disease
Ongoing clinical development of Aduhelm
Expert insight: Aduhelm
Advantages and disadvantages of Leqembi
Key results from select clinical trials investigating Leqembi for the treatment of Alzheimer's disease
Ongoing clinical development of Leqembi
Expert insight: lecanemab
Revised diagnostic guidelines
Summary of diagnostic guidelines for Alzheimeru2019s disease and subsequent revisions
Diagnostic biomarkers
Non-PET-imaging-related diagnostic biomarkers
PET imaging
Factors influencing the use of PET imaging biomarkers
Medical practice
Overview
Factors influencing drug selection in Alzheimeru2019s disease
Region-specific treatment practices
Treatment decision tree for Alzheimer's disease: United States
Treatment decision tree for Alzheimer's disease: Europe
Treatment decision tree for Alzheimer's disease: Japan
Unmet need overview
Current and future attainment of unmet needs in Alzheimer's disease
Top unmet needs in Alzheimer's disease: current and future attainment
Drug Pipeline
Pipeline
Regulatory Milestones
Indication Comparison
Emerging therapies
Key findings
Key emerging therapies
Key therapies in development for Alzheimer's disease
Estimated launch dates of key emerging therapies for the treatment of Alzheimer's disease
Drug development and regulatory hurdles
Drug development and regulatory hurdles in Alzheimer's disease
Select ongoing clinical trials of disease-modifying therapies in the treatment of Alzheimer's disease
Select ongoing prevention trials in Alzheimeru2019s disease
Key results from select clinical trials investigating donanemab for the treatment of Alzheimer's disease
Analysis of the clinical development program for donanemab
Expert insight: donanemab
Expectations for launch and sales opportunity of donanemab in Alzheimer's disease
Analysis of the clinical development program for semaglutide
Expert insight: semaglutide
Expectations for launch and sales opportunity of semaglutide in Alzheimer's disease
Rexulti profile
Analysis of the clinical development program of Rexulti
Expert insight: Rexulti
Expectations for launch and sales opportunity of Rexulti in Alzheimer's disease
AVP-786 profile
Analysis of the clinical development program for AVP-786
Expert insight: AVP-786
Expectations for launch and sales opportunity of AVP-786 in Alzheimer's disease
Auvelity profile
Analysis of the clinical development program of Auvelity
Expert insight: Auvelity
Expectations for launch and sales opportunity of Auvelity in Alzheimer's disease
Igalmi profile
Analysis of the clinical development program for Igalmi
Expert insight: Igalmi
Expectations for launch and sales opportunity of Igalmi in Alzheimer's disease
Recent late-phase DMT failures in AD
Early-phase pipeline analysis
Select disease-modifying compounds in Phase II development for Alzheimer's disease
Select symptomatic compounds in Phase II development for Alzheimer's disease
Access & reimbursement overview
Region-specific reimbursement practices
Key market-access considerations in Alzheimer's disease: United States
General reimbursement environment: United States
Key market-access considerations in Alzheimer's disease: EU5
General reimbursement environment: EU5
Key market-access considerations in Alzheimer's disease: Japan
General reimbursement environment: Japan
Appendix
Alzheimer's disease bibliography
Abbreviations
Meher Baba Kumar Nakka
Meher Baba Kumar Nakka, M.S.(Pharm.), is a senior healthcare research & data analyst on the CNS/Ophthalmology Disorders team at Clarivate. In this capacity, he works on a range of neurological indications, such as pain and migraine, and neurodegenerative disorders, such as Alzheimer’s disease. He holds a bachelor’s degree in pharmacy from Jawaharlal Nehru Technological University in Hyderabad and a master’s degree in pharmacoinformatics from the National Institute of Pharmaceutical Education and Research in Mohali.
Latashree Goswami
Latashree Goswami, M.P.H., is an associate epidemiologist at Clarivate. Her areas of interest include oncology and autoimmune disorders. She holds an M.P.H. from the Indian Institute of Public Health, where she specialized in health economics, financing, and policy, and a B.D.S. from India’s ITS Dental College.