With a growing population and an enormous clinical need for improved treatments, the market for Alzheimer’s disease (AD) pharmacotherapies represents a massive commercial opportunity that continues to attract widespread industry attention, from small biotechs to large pharma. As a result, the AD pipeline remains vast, despite a perennially high rate of attrition. Disease-modifying therapies (DMTs), especially those targeting Aβ, are a major focus of drug development, but the regulatory pathway for such drugs has yet to be trodden. The launch of one or more among the many mid- and late-phase putative DMTs in development, while far from guaranteed, would be a landmark commercial event in AD, though potentially only a modest clinical advance. That said, the impact of the first DMTs will extend beyond drug treatment and into diagnosis, specifically increasing neurologists’ incorporation of biomarkers in the diagnostic process. While justifiable doubt remains about the approval of any DMTs in the near future, novel procognitive symptomatic adjuncts and behavioral therapies (e.g., for agitation) also are advancing through the pipeline and represent an equally important dimension of future AD treatment—and one that is potentially more attainable. Ultimately, we expect any agent that is judged acceptably safe, reasonably well tolerated, and meaningfully effective would be welcomed by AD patients, caregivers, and physicians in desperate need of more options to maximize patient outcomes and, on balance, improve their overall quality of life.

Table of contents

  • Alzheimer's Disease - Emerging Therapies - Special Topics (US): Emerging Therapies And Biomarkers In Alzheimer’s Disease
    • Introduction
      • Key Findings
      • Efficacy Will Be Top of Mind for Surveyed Physicians When Discussing a New Alzheimer's Disease Drug with Sales Representatives
    • Biomarkers
      • Key Findings
      • Surveyed Neurologists' Opinions on the Use of Biomarkers in the Diagnosis of Alzheimer's Disease
      • Neurologists' Use of Biomarkers in the Diagnosis of Alzheimer's Disease
      • Imaging Agents Used by Neurologists in the Diagnosis of Alzheimer's Disease
      • Mechanisms by Which Patients Gain Access to Amyloid Imaging According to Surveyed Neurologists
      • Neurologists' Anticipated Use of Biomarkers After the Launch of a DMT
    • Physician Insight on Regulatory Guidance
      • Key Findings
      • Neurologists' Insight on Clinical Trials in Early-Stage Alzheimer's Disease Patients
      • Importance of a Claim of Disease Modification in Surveyed Neurologists' Decision to Prescribe a Disease-Modifying Therapy
      • Neurologists' Preferred Primary End Point for Clinical Trials of DMTs in Early-Stage Alzheimer's Disease Patients
    • Disease-Modifying Therapies
      • Key Findings
      • Drug Profile: Eli Lilly's Solanezumab
      • Drug Profile: Biogen/Neurimmune's Aducanumab
      • Drug Profile: Merck's Verubecestat
      • Drug Profile: TauRx Therapeutics' LMTX
      • Percentage of Surveyed Neurologists Familiar with Select Emerging Therapies in Alzheimer's Disease
      • Impact of a DMT on Neurologists' Diagnosis and Treatment Practices
      • Probability of Approval of Select Emerging DMTs for the Treatment of Alzheimer's Disease, According to Surveyed Neurologists
      • Neurologists' Expected Patient Demand for Emerging DMTs
      • Maximum Patient Share for Emerging DMTs, According to Surveyed Neurologists
      • Treatment with DMTs Beyond Mild Alzheimer's Disease
      • Patients to Whom Surveyed Neurologists Would Prescribe DMTs
      • Key Findings
      • Factors That Will Drive the Choice of Disease-Modifying Therapy
      • Differentiating Features of Neurologists' Preferred Disease-Modifying Therapies
      • Reasons Why DMTs Would Not Be Prescribed to More Patients, According to Surveyed Neurologists
      • Most Likely Use Patterns for Emerging DMTs, According to Surveyed Neurologists
      • Key Findings
      • Neurologists' Opinions on Serious Side Effects Associated with DMTs
      • Neurologists' Level of Concern with ARIA and Liver Toxicity
      • Neurologists' Level of Confidence in DMT Mechanisms of Action
      • Neurologists' Willingness to Prescribe DMTs in Combination
      • DMT Drug Classes Surveyed Neurologists Would Consider Prescribing in Combination
    • Procognitive Symptomatic Therapies
      • Key Findings
      • Drug Profile: Lundbeck/Otsuka's Idalopirdine
      • Neurologists' Level of Confidence in the Mechanisms of Action of Emerging Procognitive Symptomatic Therapies
      • Maximum Patient Share for Idalopirdine, According to Surveyed Neurologists
      • Factors Neurologists Indicate May Constrain Prescribing of Idalopirdine
      • Most Likely Use Patterns for Idalopirdine, According to Surveyed Neurologists
      • Neurologists' Perception of Idalopirdine's Place in the Treatment Algorithm for Alzheimer's Disease
      • Factors That Will Drive the Choice of Symptomatic Therapy
    • Behavioral Therapies
      • Key Findings
      • Data Presented to Respondents on Drugs in Development for Agitation Associated with Alzheimer's Disease
      • Drug Classes Currently Used to Treat Key Behavioral Symptoms
      • Surveyed Neurologists' Satisfaction with Current Therapies to Treat Behavioral Symptoms Associated with Alzheimer's Disease
      • Factors That Will Influence Neurologists' Prescribing of Novel Behavioral Therapies
      • Influence of the Black Box Warning on Neurologists' Prescribing of Antipsychotics for Alzheimer's Disease Patients
      • Percentage of Surveyed Neurologists Who Currently Prescribe Rexulti and Nuedexta for Key Behavioral Symptoms in Alzheimer's Disease Patients
      • Maximum Patient Share for Late-Phase Anti-Agitation Therapies, According to Surveyed Neurologists
      • Factors Driving Neurologists' Preference for Late-Stage Anti-Agitation Therapies
      • Influence of the Black Box Warning on Neurologists' Prescribing of Rexulti If Approved for Alzheimer's Disease Patients
      • Influence of Lack of a Black Box Warning on Prescribing of AVP-786
    • Appendix
      • Surveyed Neurologists' Access to PET Imaging Agents and PET Scanners
      • Percentage of Patients with Agitation Who Meet Select Inclusion Criteria for Late-Phase Anti-Agitation Agents
      • Surveyed Neurologists' Willingness to Prescribe Late-Phase Anti-Agitation Therapies to Alzheimer's Disease Patients Outside of Current Clinical Trial Enrollment Criteria

Author(s): Tamara Blutstein, PhD

Tamara Blutstein is a Senior Business Insights Analyst on the Central Nervous System, Pain, and Ophthalmology team. She is responsible for analyzing and forecasting pharmaceutical markets, primarily in Neurology indications, with specific expertise in Alzheimer’s disease, Parkinson’s disease, and ischemic stroke.

Prior to joining the company, Tamara was a postdoctoral fellow at Tufts University School of Medicine, where she studied the role of gliotransmission in the regulation of sleep and sleep homeostasis. She earned a Ph.D. in neuroscience from the University of Maryland School of Medicine where she conducted research on the role of gonadal hormones in modulating neuronal-glial communication. She holds a B.A. in neuroscience from Drew University.


Related Reports

Alzheimer's Disease - Landscape & Forecast - Disease Landscape & Forecast

View Details

Alzheimer's Disease | Disease Landscape and Forecast | G7 | 2020

The Alzheimer’s disease (AD) market comprises a handful of symptomatic options that offer modest efficacy for a limited duration, leaving wide open the opportunity for more-effective alternatives—i...

View Details

Alzheimer's Disease - Epidemiology - Mature Markets

DRG Epidemiology’s coverage of Alzheimer’s disease (AD) comprises epidemiological estimates of key...

View Details