Alzheimers Disease and Associated Indications - Exceptional Level of First-in-Class Innovation within AD, and Diverse Range of Therapies in Development for Disorders Such as Anxiety and Depression

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Alzheimer’s disease (AD), the most common form of dementia, is a progressive, neurodegenerative and currently incurable disease characterized by loss of memory and other mental abilities. It has a devastating impact on independence and quality of life, with patients requiring full-time care in the later disease stages. In addition to cognitive impairment, AD is associated with behavioral and psychological changes, which often represent the greatest challenges for patients and caregivers.

The prevalence of AD is escalating rapidly, largely owing to aging populations, as advancing age is the most important epidemiological risk factor for the disease. This will amplify the already substantial societal and economic costs of the disease over the coming years. This has led to high levels of R&D investment over the past two decades, but clinical trial failure rates within the indication are extremely high and treatment options remain limited. There are no disease-modifying therapies for AD, and current approaches can only temporarily slow the worsening of symptoms.

The report focuses on AD alongside four key associated behavioral and psychological indications: anxiety, depression, psychosis and insomnia. These four conditions are highly prevalent in AD and contribute substantially to the disease burden.

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Scope

Unmet need is extremely high in AD, with behavioral and psychological complications contributing significantly to the disease burden

• What are the most important etiological risk factors and pathophysiological processes implicated in AD? 
• What is the current treatment algorithm? 
• How common are anxiety, depression, psychosis and insomnia in AD? 

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The AD pipeline is large and contains a very high proportion of first-in-class product innovation

• Which molecule types and molecular targets are most prominent across AD and its associated indications? 
• What are the connections, in terms of first-in-class innovation, between AD and its associated indications?
• Which first-in-class targets are most promising? 
• How does the level of first-in-class innovation differ between products in development for anxiety, depression, psychosis and insomnia? 
• How does first-in-class target diversity differ by stage of development and molecular target class?

The deals landscape is active and dominated by G-protein coupled receptor (GPCR)-targeting products

• Which indications attract the highest deal values? 
• How has deal activity fluctuated over the past decade? 
• Which first-in-class pipeline products have no prior involvement in licensing or co-development deals?

Reasons to buy

This report will allow you to - 

• Appreciate the current clinical and commercial landscapes by considering disease pathogenesis, etiology, epidemiology, symptoms, diagnosis and treatment options. 
• Identify leading products and key unmet needs within the market. 
• Recognize innovative pipeline trends by analyzing therapies by stage of development, molecule type and molecular target. 
• Assess the therapeutic potential of first-in-class targets. Using proprietary matrix assessments, first-in-class targets in the pipeline have been assessed and ranked according to clinical potential. Individual matrix assessments are provided for targets identified in the pipeline for AD, anxiety, depression, psychosis and insomnia. Promising early-stage first-in-class targets are reviewed in greater detail. 
• Consider first-in-class pipeline products with no prior involvement in licensing and co-development deals that may represent potential investment opportunities.

Alzheimers Disease Market - Global Drug Forecast to See Double-Digit Sales Growth, 2026

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Alzheimers disease (AD) is a progressive neurodegenerative disease that is characterized by impaired memory and thinking (known as dementia), and functional decline. With a rapidly accelerating worldwide prevalence, there is a growing societal pressure for curative treatment for AD patients. The burden of AD encompasses clinical burden to patients as well as economic burden to payers and patients and caregiver burden, adding to the urgent need for improved AD therapy. Significant efforts are being made to develop a new treatment for AD, as current pharmacologic management is known to only provide a temporary improvement in symptoms.

GlobalData estimates the 2016 sales for AD at approximately $3.0B across the 7MM covered in this report.

The AD pipeline activity is strong, with twenty active Phase III (or Phase II/III) pipeline agents, most notable drug classes of which being passive immunotherapies and BACE inhibitors. These late-phase drugs also include those targeted for AD-linked agitation and cognitive impairments. Despite the fierce competition, GlobalData expects AD drug development to continue to see considerable struggles until reliable biomarkers and diagnostics are developed. Nevertheless, the treatment landscape of AD is expected to see a substantial change during the forecast period of 2016-2026.

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Scope
- Overview of AD, including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and disease management.
- Annualized AD market revenue, cost of therapy per patient, and treatment usage patterns in three patient segments (including mild cognitive impairment, mild AD, moderate AD, and severe AD), forecast from 2016 to 2026.
- Key topics covered: strategic competitor assessment, market characterization, unmet needs, clinical trial mapping and implications for the AD therapeutics market
- Pipeline analysis: comprehensive data assessing emerging trends and mechanisms of action under development for AD therapy. The most promising candidate in Phase III (and Phase II/III) development is profiled.
- Analysis of the current and future market competition in the global AD therapeutics market. Insightful review of the key industry drivers, restraints and challenges. Each trend is independently researched to provide qualitative analysis of its implications.

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Reasons to buy
The report will enable you to -
- Develop and design your in-licensing and out-licensing strategies through a review of pipeline products and technologies, and by identifying the companies with the most robust pipeline.
- Develop business strategies by understanding the trends shaping and driving the global AD therapeutics market.
- Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the global AD therapeutics market in the future.
- Formulate effective sales and marketing strategies by understanding the competitive landscape and by analysing the performance of various competitors.
- Identify emerging players with potentially strong product portfolios and create effective counter-strategies to gain a competitive advantage.
- Organize your sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments and strategic partnerships.

Table of Contents

1 Table of Contents

1 Table of Contents 2
1.1 List of Tables 7
1.2 List of Figures 10
2 Executive Summary 12
2.1 Alzheimers Market Forecast to See Double-Digit Sales Growth out to 2026 13
2.2 Allergan, Biogen, and Roche Are Forecast to Lead the AD Market in 2026 14
2.3 Lack of Treatments and Biomarkers Remain As Key Unmet Needs in the AD Market 16
2.4 Opportunities Remain for Disease-Modifying and Symptomatic Drugs Entering the AD Market 16
2.5 Twenty Promising Drugs in Phase II/III or Phase III of Development 17
2.6 What Do Physicians Think? 18              

Detailed Analysis & Symptoms Of Alzheimers Disease | ResearchMoz

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Alzheimers disease (AD) is an irreversible, progressive neurodegenerative disease, characterized by cognitive impairment, memory loss and functional decline. The pathological features of AD comprise a complex set of histopathological changes within the brain. Symptoms typically begin to first appear in patients in their mid-sixties, and appear in varying stages. The effects of AD, particularly at an advanced stage, are devastating to patients and their caregivers, and are associated with significant associated healthcare costs.

Current treatments focus on sustaining the patient?s cognitive function, managing behavioural symptoms and slowing down the rate of disease progression. There is currently no cure for AD, and only six symptomatic treatment therapies have been approved, of which one (Cognex) is no longer available in the US. The current market leaders are suboptimal in terms of efficacy, and there is therefore a large unmet need within AD to develop safer and more efficacious treatments.

There are numerous differences between many of these products due to their mechanisms of action, and these must be understood fully by companies seeking to position a novel drug in this market. This tabular heatmap framework, designed to provide an easily digestible summary of these clinical characteristics, provides detailed information on all late-stage clinical trial results for products in the AD market and Phase III pipeline. These are split along therapy lines, and are therefore reflective of the treatment algorithm.

All safety and efficacy endpoints reported in these trials are displayed, for both the drug and placebo groups. In addition, key study characteristics such as the size, composition and patient segment of the study population are provided. These results are presented in a visually accessible, color-coded manner in order to maximize ease of use.

The accompanying text provides a detailed analysis of the clinical benchmarks set by the current market landscape, and the anticipated changes to these benchmarks, and to the treatment algorithm, as a result of the late-stage pipeline.

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Scope

• What preventative early-stage drugs are generating interest within the AD pipeline? 
• Will the current AD market landscape ensure that the first drug with a disease-modifying mechanism of action will become the market leader?
• What are the clinical characteristics of currently approved therapies for AD, in terms of specific safety and efficacy parameters?
• What are the key unmet needs in this indication, and which clinical safety and efficacy parameters are the most closely linked to them?
• How will current late-stage molecules affect the market for AChEIs, and are they able to yield comparable clinical efficacy results?
• With three amyloid inhibitors present in the late-stage pipeline, do they have sufficient differentiating characteristics from previous clinical failures from this class to have an impact on the market?

Reasons to buy

• Understand the current clinical landscape by considering the treatment options available by drug class.
• Visually compare the currently approved treatments available by drug class, based on the most important efficacy and safety parameters tested in clinical trials.
• Assess the current late-stage pipeline, in terms of the likely positioning of each product and the implications for the clinical landscape at each line of therapy
• Understand the relative strengths and weaknesses of the studies used to gather these data.
• Build up a nuanced understanding of the clinical benchmarks set by these products, and consider how the current late-stage pipeline will affect these benchmarks.
• Assess your own pipeline programs in light of these benchmarks in order to optimally position them and maximize uptake by clinicians.

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