GBI Research has released its pharmaceuticals report: “Alzheimer’s Disease Therapeutics Market to 2019 – Early Stage Innovation Points to Disease Modifying Therapies and Market Transformation”. The Alzheimer’s Disease (AD) market is characterized by a lack of products with strong disease-modifying properties and a number of high-profile product failures in late stages of development over recent years. In addition, recent or impending patent expiries for all of the four currently marketed products and a late-stage pipeline with limited-to-moderate prospects are expected to impede growth over the next few years. In the medium-term future, the market is expected to be characterized by substantial generic competition and overall decline. However, the current development pipeline shows signs of meaningful innovation, although the vast majority of these products are currently in the early stages of development. Despite one of the highest drug attrition rates across the industry, a number of innovative and potentially disease-modifying therapeutics are likely to enter the market and translate recent insights into the etiology of AD combined with an earlier therapeutic intervention into better products, which will begin to transform the AD market towards the end of the decade.

Scope

• A brief introduction to AD etiology, pathogenesis, diagnosis, and treatment regimes
• Profiling of the marketed products in the AD market, including analysis of their safety, efficacy, treatment patterns, and strengths and weaknesses
• Comprehensive review of the pipeline for AD therapies, including individual analysis of a number of late-stage pipeline drugs that are likely to enter the market during the forecast period. The pipeline is analyzed on the basis of phase distribution, molecule type, and molecular target.
• Additional in-depth analysis of pipeline drug clinical trials, analyzed by phase, molecule type, trial size, trial duration and program failure rate, for each molecule type and mechanism of action
• Multi-scenario forecast data for the market to 2019, taking into account how it will be affected by the introduction of new drugs, the expiry of key patents on current drugs, and changes in disease epidemiology across the key developed markets of the US, Japan, Germany, the UK, France, Italy and Spain
• Discussion of the drivers of and barriers to market growth
• Analysis of the licensing and co-development deals landscape

Reasons to Buy

• Understand the different levels of AD therapies, from early-stage or mild AD to severe AD
• Understand the vast scope of the pipeline, including which molecule types and mechanisms of action are prominent
• Observe trends in terms of clinical trial duration and size among clinical phases and molecule types, and use the clinical trial failure rate analysis to assess the risk profiles of current and/or future developmental programs for AD therapeutics
• Assess the potential clinical and commercial impact of current late-stage pipeline molecules on the AD therapeutics market

Table of Contents

1 Table of Contents

1 Table of Contents 5

1.1 List of Tables 6

1.2 List of Figures 7

2 Introduction 8

2.1 Symptoms 8

2.2 Etiology 9

2.3 Pathophysiology 10

2.3.1 Amyloidosis 10

2.3.2 Tau Hyperphosphorylation 10

2.4 Comorbidities/Complications 11

2.5 Diagnosis 11

2.5.1 Physical Examination 12

2.5.2 Mini Mental State Exam 12

2.5.3 Alzheimer's Disease Assessment Scale-cognitive 14

2.5.4 Alzheimer's Disease Co-operative Study - Activities of Daily Living Inventory 15

2.5.5 Other Diagnostic Tests 15

2.5.6 Blood Tests 15

2.5.7 Imaging Tests 15

2.5.8 Lumbar Puncture 15

2.5.9 Disease Biomarkers 16

2.5.10 Biomarker Market 17

2.6 Prognosis 18

2.7 Treatment Options 18

2.7.1 Treatment Algorithm 19

2.7.2 Non-Pharmacological Treatments 19

3 Marketed Products 20

3.1 Namenda/Axura/Memary (memantine), Merz Pharma/Lundbeck/Forest Laboratories/Daiichi Sankyo 20

3.2 Aricept (donepezil), Eisai Inc. 21

3.3 Exelon (rivastigmine), Novartis AG 22

3.4 Razadyne (galantamine), Janssen Pharmaceuticals 22

3.5 Cognex (tacrine), Shiniogi Inc. 23

3.6 Unmet Need 24

4 Pipeline for Alzheimer's Disease Therapeutics 25

4.1 Overall Pipeline 25

4.2 Mechanisms of Action within the AD Pipeline 27

4.3 Clinical Trials 29

4.3.1 Clinical Trial Failure Rate 29

4.3.2 Clinical Trial Size 33

4.3.3 Clinical Trial Duration 35

4.4 Notable Pipeline Drugs 38

4.4.1 Solanezumab - Eli Lilly and Company 38

4.4.2 LMTX (Methylene Blue) - TauRX Therapeutics Ltd. 39

4.4.3 RG-1540 (gantenerumab) - Roche 39

4.4.4 AD-02 - AFFiRiS AG 40

4.4.5 MK-8931 - Merck & Co. 41

4.4.6 CAD-106 - Novartis AG 41

4.4.7 LuAE58054 - Lundbeck 42

4.4.8 Crenezumab (RG7412) - Genentech 42

4.5 Conclusion 42

5 Market Forecast to 2019 44

5.1 Geographical Markets 44

5.1.1 Key Developed Markets 44

5.1.2 US 47

5.1.3 Leading Five EU Countries (EU5) 49

5.1.4 Japan 53

5.2 Drivers and Barriers 55

5.2.1 Drivers 55

5.2.2 Barriers 56

6 Deals and Strategic Consolidations 58

6.1 Key Licensing Deals 58

6.1.1 Forest Laboratories Inc. Enters into Agreement with Adamas Pharmaceuticals Inc. 60

6.1.2 AC Immune SA Enters into an Agreement with Genentech Inc. 60

6.1.3 Cephalon Inc. Enters into Agreement with Mesoblast Limited 60

6.1.4 Acadia Pharmaceuticals Inc. Enters into Agreement with Biovail Laboratories International SRL 60

6.1.5 Astellas Pharma Inc. enters into Agreement with CoMentis Inc. 61

6.2 Key Co-development Deals 61

6.2.1 Evotec AG Enters into Agreement with F. Hoffman-La Roche Ltd. 63

6.2.2 Alectos Therapeutics Inc. Enters into Agreement with Merck & Co. Inc. 63

6.2.3 Targacept Inc. Expands Agreement with AstraZeneca PLC. 63

6.2.4 GlaxoSmithKline Enters into an Agreement with Epix Pharmaceuticals 64

7 Appendix 65

7.1 All Pipeline Drugs by Phase - Tables 65

7.2 Market forecast to 2019 - Tables 81

7.3 References 84

7.4 Abbreviations 87

7.5 Methodology 89

7.6 Secondary Research 89

7.7 Therapeutic Landscape 90

7.8 Contact Us 90

7.9 Disclaimer 90

List of Tables

Table 1: Alzheimer's Disease, Global, All Pipeline Products (Discovery) 65

Table 2: Alzheimer's Disease, Global, All Pipeline Products (Preclinical) 68

Table 3: Alzheimer's Disease, Global, All Pipeline Products (Phase I) 76

Table 4: Alzheimer's Disease, Global, All Pipeline Products (Phase II) 79

Table 5: Alzheimer's Disease, Global, All Pipeline Products (Phase III) 81

Table 6: Alzheimer's Disease, Global, Market Forecast, 2012-2019 81

Table 7: Alzheimer's Disease, US, Market Forecast, 2012-2019 81

Table 8: Alzheimer's Disease, UK, Market Forecast, 2012-2019 82

Table 9: Alzheimer's Disease, France, Market Forecast, 2012-2019 82

Table 10: Alzheimer's Disease, Germany, Market Forecast, 2012-2019 82

Table 11: Alzheimer's Disease, Italy, Market Forecast, 2012-2019 83

Table 12: Alzheimer's Disease, Spain, Market Forecast, 2012-2019 83

Table 13: Alzheimer's Disease, Japan, Market Forecast, 2012-2019 83

List of Figures

Figure 1: Mini-Mental State Exam 13

Figure 2: Alzheimer's Disease Assessment Scale Cognitive Subscale 14

Figure 3: Alzheimer's Disease, Overall Pipeline 26

Figure 4: Alzheimer's Disease, Mechanisms of Action in the Pipeline, 2006-2013 29

Figure 5: Alzheimer's Disease, Failure Rates of Clinical Trials, 2006-2013 30

Figure 6: Alzheimer's Disease, Failure Rates by Mechanism of Action, 2006-2013 31

Figure 7: Alzheimer's Disease, Reasons for Clinical Trial Failure, 2006-2013 32

Figure 8: Alzheimer's Disease, Clinical Trial Size by Phase, 2006-2013 33

Figure 9: Alzheimer's Disease, Clinical Trial Size by Molecule Type, 2006-2013 34

Figure 10: Alzheimer's Disease, Clinical Trial Duration by Phase, 2006-2013 35

Figure 11: Alzheimer's Disease, Clinical Trial Duration by Molecule Type, 2006-2013 36

Figure 12: Alzheimer's Disease, Global, 2012-2019 46

Figure 13: Alzheimer's Disease, US, 2012-2019 48

Figure 14: Alzheimer's Disease, EU5, Patient Number (‘000) 2012-2019 50

Figure 15: Alzheimer's Disease, EU5, Annual Cost of Treatment ($), 2012-2019 51

Figure 16: Alzheimer's Disease, EU5, Market Size ($m), 2012-2019 52

Figure 17: Alzheimer's Disease, Japan, 2012-2019 54

Figure 18: Alzheimer's Disease, Global, Licensing Deals by Region and Year, 2012-2019 58

Figure 19: Alzheimer's Disease, Global, Licensing Deals by Phase and Molecule Type, 2012-2019 59

Figure 20: Alzheimer's Disease, Global, Co-development Deals by Region and Year, 2012-2019 61

Figure 21: Alzheimer's Disease, Global, Co-development Deals by Phase and Molecule Type, 2006-2013 62