Alzheimer’s Disease – Landscape & Forecast – Disease Landscape & Forecast
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.
Table of contents
- Alzheimer's Disease - Landscape & Forecast - Disease Landscape & Forecast
- Key findings
- Alzheimer's disease key findings - November 2022
- Key updates
- March 2023
- Q4 2022
- December 2022
- Q3 2022
- August 2022
- Q2 2022
- June 2022
- May 2022
- April 2022
- Q1 2022
- March 2022
- February 2022
- Market outlook
- Key findings
- Market share of Alzheimer's disease drug classes: 2021
- Market share of Alzheimer's disease drug classes: 2031
- Alzheimer's disease SWOT analysis
- Market drivers and constraints
- What factors are driving the market for Alzheimer's disease?
- What factors are constraining the market for Alzheimer's disease?
- Major-market sales of Alzheimer's disease therapies by disease subtype: 2021-2031
- Major-market drug-treated Alzheimer's disease patient populations: 2021-2031
- Drug-class-specific trends
- 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
- Key findings
- 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
- Disease overview
- 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)
- Key findings
- 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
- Key findings
- 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
- Key findings
- 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
- Region-specific reimbursement practices
- Appendix
- Alzheimer's disease bibliography
- Abbreviations
- Key findings
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, 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.