Last Updated 1 October 2014
The market for Alzheimer’s disease (AD) pharmacotherapies continues to offer compelling commercial opportunities driven by considerable unmet need. The AD population is poised to grow rapidly over the next ten years as the baby boomer generation ages, meaningfully increasing the treatable patient pool. Moreover, treatment options for AD remain limited to four approved therapies, all of which are symptomatic and offer only modest efficacy of limited duration. Two critical unmet needs are routinely cited by interviewed experts: disease-modifying therapies (DMTs) that are capable of slowing disease progression (especially needed for patients with early AD) and improved symptomatic therapies (which will be welcomed for all patients). Despite high pipeline 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 three potential DMTs targeting the amyloid cascade—Eli Lilly’s solanezumab, Roche/Chugai/MorphoSys’s gantenerumab, and Merck’s MK-8931—which will dramatically expand the AD market, despite reaching relatively few patients. Additionally, we forecast the launch of a novel symptomatic alternative: Lundbeck/Otsuka’s Lu-AE58054. However, owing to as-yet uncertain clinical benefits for any emerging candidates, we expect investigational products will only partially fulfill the need for therapeutic advances, leaving ample room for others to enjoy commercial success.

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 potential 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 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?

Scope:

Markets covered: United States, France, Germany, Italy, Spain, United Kingdom, Japan.

Primary research: 27 country-specific interviews with thought leaders.

Epidemiology: Prevalence of 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.

Population segments in market forecast: AD, segmented into mild, moderate, and severe AD and the pre-AD one- to two-year population.

Emerging therapies: Phase II: 27 drugs; Phase III: 11 drugs; coverage of 18 preclinical and Phase I products; coverage of one preregistered drug.

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 2013 to 2023.

Alternative market scenarios: Forum Pharmaceuticals/Mitsubishi Tanabe Pharma’s nicotinic receptor agonist encenicline is approved for the treatment of mild to moderate AD; Lundbeck/Otsuka’s brexpiprazole is approved for the treatment of agitation associated with AD; AstraZeneca’s AZD-3239 is approved for the treatment of AD.

Author(s): Alana K. Simorellis, Ph.D.
Anouchka Seesaghur, M.B.B.S., M.P.H.
Jonathan W. Searles

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