Last Updated 28 September 2015
The market for Alzheimer’s disease (AD) pharmacotherapies offers enormous commercial opportunity driven by considerable unmet need and looming societal burden. The AD population is poised to grow rapidly over the next ten years as the baby boomer generation ages, simultaneously increasing the treatable patient pool and straining healthcare resources. Moreover, approved treatments today comprise a handful of symptomatic therapies that offer only modest efficacy of limited duration. Two critical unmet needs in AD treatment remain: the development of bona fide disease-modifying therapies (DMTs) that are capable of slowing disease progression, and the launch of improved symptomatic adjuncts, including those for behavioral deficits. Despite a perennially high rate of attrition, the late-stage pipeline in AD remains full and diverse, comprising a range of promising symptomatic and disease-modifying candidates. We forecast the launch of four potential DMTs targeting the amyloid cascade—Eli Lilly’s solanezumab, Roche/Chugai/MorphoSys’s gantenerumab, Biogen/Neurimmune’s aducanumab, and Merck’s verubecestat—which will dramatically expand the AD market, despite reaching relatively few patients. Additionally, we forecast the launch of a novel symptomatic alternative to enhance cognition, Lundbeck/Otsuka’s idalopirdine, and the launch of a novel behavioral therapy, Lundbeck/Otsuka’s brexpiprazole (Rexulti) for the treatment of AD associated agitation. However, owing to as-yet uncertain clinical benefits for any emerging candidates, and lingering questions about the clinical efficacy (and safety) of putative DMTs, we expect investigational products will only partially fulfill the need for therapeutic advances should they launch, leaving ample room for superior alternatives.
Questions Answered in This Report:
- The AD population is large and heterogeneous; patients in different stages of the disease require different therapeutic strategies. This report subdivides the AD market into four clinical segments: pre-AD 1-2 years (a proprietary epidemiological category) and mild, moderate, and severe AD. What are the current differences in treatment patterns across the four market segments? Which of the AD market segments will experience the greatest growth over the forecast period? In which segment will novel therapies see the greatest uptake?
- The approval of the first DMT will be a watershed moment in the management of AD. What are thought leaders’ opinions regarding the therapeutic promise of late-stage pipeline DMTs in light of ongoing questions about the amyloid hypothesis? In which subpopulations will neurologists prescribe emerging DMTs? What is the market potential for these sought-after products?
- The launch of improved symptomatic interventions that target cognitive and/or behavioral deficits also will be welcome. How will current and future symptomatic agents be used following the launch of the first DMTs? What percentage of AD patients suffer depression, agitation, and psychosis? What factors will drive sales growth among symptomatic agents in the face of increasing generic competition? What are thought leaders’ opinions of investigational symptomatic alternatives and their mechanisms of action?
Markets covered: United States, France, Germany, Italy, Spain, United Kingdom, Japan.
Primary research: 34 country-specific interviews with thought leaders.
Epidemiology: Prevalence of AD (segmented by mild, moderate, and severe AD) and pre-AD (a population of patients who will likely convert to AD, segmented into patients who will likely convert to AD within two years and patients likely to convert in three to five years) by region. Diagnosed prevalence of comorbid depression, agitation, and pyschosis also presented.
Population segments in market forecast: AD, segmented into mild, moderate, and severe AD and the pre-AD 1-2 years population.
Emerging therapies: Phase II: 28 drugs; Phase III: 13 drugs; coverage of 26 preclinical and Phase I products.
Market forecast features: We forecast annualized drug use and sales for prescription drugs that treat primary (e.g., cognitive) and secondary (e.g., behavioral) symptoms for the four clinical populations from 2014 to 2024.
Alternative market scenarios: Forum Pharmaceuticals/Mitsubishi Tanabe Pharma’s nicotinic receptor agonist encenicline is approved for the treatment of mild to moderate AD; Otsuka/Avanir’s AVP-923/AVP-786 is approved for the treatment of agitation associated with AD; AstraZeneca/Astex Pharmaceuticals/Eli Lilly’s AZD-3293 is approved for the treatment of early AD.
Nishant Kumar, M.P.H.
Jonathan W. Searles