Alzheimer’s Disease (AD) is an irreversible, progressive neurodegenerative disease, characterized by cognitive impairment, memory loss and functional decline. Symptoms typically begin to first appear in patients in their mid-sixties, with symptoms appearing in varying stages. The pathological features of AD comprise histopathological changes within the brain. Mild Cognitive Impairment (MCI) is a heterogeneous condition between normal cognition and dementia, whereby cognitive changes in mental abilities, such as memory or thinking, are affected. Almost all cases of AD begin with MCI, but it should be noted that not all patients with MCI go on to develop AD.
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Although there is a high degree of failure and uncertainty within the R&D of AD drugs, the number of drugs in the pipeline is considerably high at 559. The majority of the pipeline products are novel drugs, with a total of seven repositioned and five generic drugs. This shows advancement in the progression of the different molecules being developed as therapeutic agents within the AD pipeline.
The AD market has a lack of therapeutic options.
– Which classes of drug dominate the market?
– What newly approved therapies have entered the market?
– How do the leading marketed therapies compare clinically?
– How will the new therapies be positioned in the treatment of AD?
– How have selected late-stage pipeline therapies performed in clinical trials?
The pipeline contains a range of molecule types and molecular targets, including those that are well established in AD, and novel, first-in-class therapies.
– Which molecular targets appear most frequently in the pipeline?
AD clinical trials have an overall attrition rate of 94%.
– What are the failure rates for individual Phases of clinical development?
– How do AD clinical trial characteristics, including failure rate, duration, and size compare against respiratory and industry averages?
The AD market is forecast to rise from a value of $5.2 billion in 2014 to $11.3 billion in 2021, at a CAGR of 11.8% across the eight major markets assessed.
– How much of a role will disease prevalence and new product approvals play in market growth?
– Will generic competition have a significant impact on the market over the forecast period?
There have been 170 licensing deals and 104 co-development deals pertaining to AD products since 2006.
– Which territories show the most deal activity?
– What were the trends in deal completion by product stage of development?
– What were the conditions of the key licensing or co-development deals to take place in AD?
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Reasons to buy
This report will allow you to –
– Understand the current clinical and commercial landscape through a comprehensive study of disease pathogenesis, diagnosis, prognosis, and the current treatment algorithm used in AD.
– Assess the safety and efficacy of current treatment options, with extensive product profiles on prominent marketed therapies, and a heatmap directly comparing safety and efficacy data.
– Analyze the AD pipeline and stratify by stage of development, molecule type, and molecular target. The most promising late-stage therapies are profiled and assessed in terms of clinical performance and competitiveness, alongside a single-product forecast.
– Predict growth in market size in eight major markets, with in-depth market forecasting from 2014 to 2021. The forecasts will provide an understanding of how epidemiology trends, new drug entries, and patent expirations will influence market value.
– Identify commercial opportunities in the AD deals landscape by analyzing trends in licensing and co-development deals, and by profiling the most significant deals that have occurred in this indication in recent years.
1 Table of Contents
1 Table of Contents 4
1.1 List of Tables 6
1.2 List of Figures 7
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2 Introduction 9
2.1 Disease Introduction 9
2.2 Epidemiology 9
2.3 Symptoms 10
2.4 Etiology 12
2.5 Pathophysiology 12
2.6 Disease Stages 13
2.7 Diagnosis 14
2.8 Prognosis 17
2.9 Treatment 18
2.9.1 Treatment Algorithm 18
2.9.2 Mild-to-Moderate AD 20
2.9.3 Moderate-to-Severe AD 21
3 Marketed Products 22
3.1 Aricept (donepezil) – Eisai 22
3.2 Exelon (rivastigimine) – Novartis 22
3.3 Razadyne (galanatamine) – Janssen 23
3.4 Namenda/Ebixa/Axura/Abixa (memantine), Merz Pharma/Lundbeck/Forest/Daiichi Sankyo 23
3.5 Cognex (tacrine) – Shiniogi 24
3.6 Namzaric (memantine ER + donepezil), Actavis-Adamas 24
4 Heat Map – Marketed Products Overview 25
5 Pipeline Product Developments 26
5.1 The Pipeline Development Landscape 26
5.2 Mechanisms of Action in the Pipeline 27
5.3 Clinical Trials 31
5.3.1 Failure Rate 31
5.3.2 Clinical Trial Duration 32
5.3.3 Clinical Trial Size 34
5.3.4 Competitive Clinical Trials Metric Analysis 38
5.4 Promising Pipeline Molecules 39
5.4.1 MK-8931 – Merck & Co. 39
5.4.2 LMTX (methylthioninium chloride) – TauRX Therapeutics 40
5.4.3 AZD3293 – AstraZeneca 41
5.4.4 AB1010 – AB Science 42
5.4.5 BIIB037 – Biogen 43
5.4.6 TP488 – vTv Therapeutics 44
5.4.7 EVP-6124 – FORUM Pharmaceuticals 45
5.4.8 LuAE58054 – Lundbeck 46
5.4.9 Gantenerumab (R-1540/RG-1450) – Roche 47
6 Heat Map – Pipeline Products Overview 50
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