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    The Volatile Alzheimer's Disease (AD) Pipeline Continues to Disappoint, Continually Reshaping Expectations for the Future Market Outlook

    The last six months have seen clinical trial failures for a number of high-profile development programs including Eli Lilly’s disease-modifying therapy (DMT) solanezumab, Lundbeck/Otsuka’s symptomatic therapy idalopirdine, and most recently Merck’s DMT verubecestat in mild to moderate (a trial in prodromal AD continues).

    Despite the seemingly insurmountable challenge of bringing a drug for AD to market, pipeline activity in the space is as strong as ever, given the enormous market potential. DRG’s Disease Landscape & Forecast: Alzheimer’s Disease report projects substantial growth in the AD market, which could eclipse $30 billion in 2025. Our model assumes the launch of a wide range of emerging therapies, including as many as six premium-priced DMTs, though there is no guarantee any of these agents will launch. Indeed, the failure of Merck’s oral BACE inhibitor in the EPOCH study puts its first-to-market launch prospects in jeopardy, and any delay or termination could have meaningful repercussions on future market dynamics.

    Key findings from Disease Landscape & Forecast: Alzheimer’s Disease:

    • The launch of the first DMTs for AD will undoubtedly have a measurable impact on diagnosis and drug treatment, particularly in the pre-AD and mild AD populations; the timing of this inflection point, however, hinges on at least one Phase III DMT delivering on its promise.
    • While the pipeline for procognitive symptomatics has dwindled, there has been an increased focus on the behavioral symptoms of AD, including agitation, which according to DRG’s proprietary epidemiology affects the majority of diagnosed AD patients. Lundbeck/Otsuka’s Rexulti (brexpiprazole) could be the first drug approved for the treatment of agitation in AD, reaching the market as soon as 2018 and driving blockbuster sales. A number of other candidates are also in late-phase development, the most advanced of which is Avanir/Otsuka’s AVP-786.