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Pipeline and Commercial Insight: Alzheimer's Disease - Market cautiously awaits the first generation of disease-modifying therapies
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| Inhalt der Studie: |
Introduction
Current management of Alzheimer’s disease is wholly inadequate, providing only symptomatic benefit to patients in whom the underlying neurodegeneration continues unabated. However, with .....
Introduction Current management of Alzheimer’s disease is wholly inadequate, providing only symptomatic benefit to patients in whom the underlying neurodegeneration continues unabated. However, with the launch of the first disease-modifying drugs, combined with the availability of predictive biomarker tests that enable earlier diagnosis, the Alzheimer’s disease treatment paradigm is set to change radically. Features and benefits * Forecasts of Alzheimer's disease patient population numbers based on a comprehensive epidemiology review. * Breakdown of historic (2005-09) and future (2010-19) prescription sales across the seven major markets consisting of the US, Japan, and 5EU. * Review of the Alzheimer's disease drug pipeline dynamics, including detailed profiles of key late-stage products. * Commercial and clinical assessment of key late-stage pipeline drugs, with key opinion leader comment and region-specific sales forecasts to 2019. * Analysis of current treatment approaches, patient acquisition and clinical unmet needs. Highlights The value of the Alzheimer’s disease market across the seven major markets was $4.7bn in 2009 and is forecast to reach $11.9bn by 2019. Future market growth is set to be driven by the first disease-modifying drugs, given their significant price premium, likely therapeutic role as an adjunctive and potential utility in prodromal Alzheimer's disease. Datamonitor forecasts that the current late-stage pipeline will yield three blockbusters, but this is by no means guaranteed considering the high risk of failure in Phase III Alzheimer’s disease trials. Of the pipeline drugs, Datamonitor believes that bapineuzumab and solanezumab have the most commercial and clinical potential. Datamonitor expects the symptomatic market will remain active in this disease. New symptomatic entrants to the market will include Aricept patch and the first-in-class 5-HT6 receptor antagonist SB-742457. Your key questions answered * Who will be the winners and losers in the future Alzheimer's disease market? * What are the commercial prospects of potentially disease-modifying therapies in Alzheimer's disease patients over the next 10 years? * Is the market still receptive to drugs with a purely symptomatic mode of action, in light of the impending availability of generic donepezil? * How will biomarker tests and novel therapeutics affect the way Alzheimer's disease is treated? How can this be exploited by drug developers? [Studien Infos ausblenden] |
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Executive Summary Strategic scoping and focus Datamonitor insight into the Alzheimer’s disease market Related reports Upcoming related reports OVERVIEW Catalyst Summary 1. PATIENT POTENTIAL Key findings Current treatment options Unmet need in Alzheimer’s disease Disease-modifying or slowing treatments Improved symptomatic treatment Better diagnostic tools Better understanding of Alzheimer’s disease etiology Diagnosis rate of Alzheimer’s disease North America and Europe Japan Future trends in diagnosis rates Prodromal Alzheimer’s disease 2. EPIDEMIOLOGY Introduction Key findings Disease definition, classification and diagnosis criteria Risk factors Age Congestive heart failure Diet Depression Education Gender Genetics Metabolic syndrome Mild cognitive impairment Race Co-morbidities Global variation and temporal trends Epidemiological forecasting of Alzheimer’s disease Sources of epidemiological data Description of methods Results Current prevalent cases and future trends Annual growth rate of disease population Discussion Strengths of Datamonitor’s epidemiological projections Conclusions 3. MARKET OVERVIEW Key findings Market definition for this report Seven major markets Current and future market assessment Rest of the world snapshot Current market assessment Patient acquisition process Trigger point one: presymptomatic diagnosis of Alzheimer’s disease Trigger point two: increasing presentation rate Key developers Eisai dominates the current Alzheimer’s disease market Big Pharma has considerable a considerable stake in the Alzheimer’s disease pipeline 4. BRAND DYNAMICS Key findings Overview of competitive landscape Original brands grow unhindered by lack of new drug launches over the past decade Comparative forecasts Reimbursement: tiering of key brands Aricept, Exelon and Namenda possess favorable formulary listings Change in stance for the UK’s National Health Service Aricept (donepezil; Eisai/Pfizer) Drug overview Drug profile Product positioning SWOT analysis Brand forecast to 2019 Exelon (rivastigmine; Novartis) Drug overview Drug profile Product positioning SWOT analysis Brand forecast to 2019 Razadyne (galantamine; Johnson & Johnson/Shire) Drug overview Drug profile Product positioning SWOT analysis Brand forecast to 2019 Namenda (memantine; Forest/Merz/Lundbeck) Drug overview Drug profile Product positioning SWOT analysis Brand forecast to 2019 5. PIPELINE OVERVIEW AND R&D DYNAMICS Key findings Pipeline overview Trends in the current pipeline Comparative forecasts Datamonitor’s pipeline assessment summary Clinical trial design in Alzheimer’s disease What constitutes disease modification? Determination of disease modification Clinical trial endpoints 6. PIPELINE DRUG ANALYSIS & FORECASTS: DRUGS TARGETING BETA-AMYLOID Key findings Overview of drugs targeting beta-amyloid Pipeline summary Comparative forecasts Datamonitor’s pipeline assessment summary Definition of current comparator therapy Aricept is Datamonitor’s gold-standard therapy for Alzheimer’s disease Bapineuzumab (AAB-001; Elan/Johnson & Johnson/Pfizer) Drug overview Drug profile Clinical trial data SWOT analysis Clinical and commercial attractiveness Satisfaction of unmet needs Forecasts to 2019 Gammagard (immune globulin intravenous [human]; Baxter) Drug overview Drug profile Clinical trial data SWOT analysis Clinical and commercial attractiveness Satisfaction of unmet needs Forecasts to 2019 LY2062430 (solanezumab; Eli Lilly) Drug overview Drug profile Clinical trial data SWOT analysis Clinical and commercial attractiveness Satisfaction of unmet needs Forecasts to 2019 ELND005 (scyllo-inositol; Elan/Transition Therapeutics) Drug overview Drug profile Clinical trial data SWOT analysis Clinical and commercial attractiveness Satisfaction of unmet needs Forecasts to 2019 Other drugs targeting beta-amyloid ACI-24 (AC Immune) ACI-91 (AC Immune) AD02 (amyloid beta peptide epitope vaccine; GlaxoSmithKline/Affiris) ARC-029 (nilvadipine; Archer Pharmaceuticals) BMS-708163 (Bristol-Myers Squibb) CAD106 (amyloid beta peptide vaccine; Novartis/Cytos Biotechnology) ACC-001 (conjugate amyloid beta vaccine; Elan/Johnson & Johnson/Pfizer) EHT 0202 (etazolate; ExonHit Therapeutics) NIC5-15 (Humanetics) Octagam (intravenous immunoglobulin [human]; Octapharma) PF-4360365 (ponezumab; Pfizer) PF-4494700 (Pfizer/TransTech Pharma) PBT2 (Prana Biotechnology) Late-stage development compounds recently discontinued LY450139 (semagacestat; Eli Lilly) Flurizan (tarenflurbil; Myriad Genetics) Alzhemed (tramiprosate; Neurochem) 7. PIPELINE DRUG ANALYSIS & FORECASTS: DRUGS TARGETING TAU Key findings Overview for drugs targeting tau Pipeline summary Definition of current comparator therapy Aricept is Datamonitor’s gold-standard therapy for Alzheimer’s disease Rember (methylthioninium chloride; TauRx Pharmaceuticals) Drug overview Drug profile Clinical trial data SWOT analysis Clinical and commercial attractiveness Satisfaction of unmet needs Forecasts to 2019 Other drugs targeting tau hyperphosphorylation AL-108 (davunetide; Allon Therapeutics) Nypta (tideglusib; Noscira) 8. PIPELINE DRUG ANALYSIS & FORECASTS: GENERAL NEUROPROTECTION Key findings Overview for general neuroprotective drugs Pipeline summary Definition of current comparator therapy Aricept is Datamonitor’s gold-standard therapy for Alzheimer’s disease Dimebon (latrepirdine; Pfizer/Medivation) Drug overview Drug profile Clinical trial data SWOT analysis Clinical and commercial attractiveness Satisfaction of unmet needs Forecasts to 2019 Other general neuroprotective drugs AB1010 (masitinib; AB Science) ABT-126 (Abbott) CERE-110 (AAV2-NGF; Ceregene) PF-04447943 (Pfizer) Cogane (PYM50028; Phytopharm) T-817MA (Toyama Chemical) 9. PIPELINE DRUG ANALYSIS & FORECASTS: SYMPTOMATIC RELIEF Key findings Overview for drugs targeting symptomatic relief Pipeline summary Comparative forecasts Datamonitor’s pipeline assessment summary Definition of current comparator therapy Aricept is Datamonitor’s gold-standard therapy for Alzheimer’s disease Aricept patch (transdermal donepezil patch; Eisai/Teikoku USA) Drug overview Drug profile Clinical trial data SWOT analysis Clinical and commercial attractiveness Satisfaction of unmet needs Forecasts to 2019 SB-742457 (GlaxoSmithKline) Drug overview Drug profile Clinical trial data SWOT analysis Clinical and commercial attractiveness Satisfaction of unmet needs Forecasts to 2019 Other symptomatic drugs ABT-288 (Abbott Laboratories) AZD1446 and AZD3480 (ispronicline; AstraZeneca/Targacept) AVN-101 (Avineuro Pharmaceuticals) EVP-6124 (EnVivo Pharmaceuticals) R3487 (Roche) GSK239512 (GlaxoSmithKline) Lu AE58054 (Lundbeck) PRX-3140 (Nanotherapeutics) Chantix (varenicline; Pfizer) PF-5212365 (Pfizer) SYN-114 (Roche/Synosia Therapeutics) 10. INNOVATIVE EARLY-STAGE APPROACHES Key findings Drug delivery across the blood-brain barrier Craniotomy-based drug delivery Molecular Trojan horse Tau immunotherapy Focus on beta-amyloid leaves therapies targeting tau lagging behind Tau vaccines show promise in rodent models Neuroregeneration Human umbilical cord blood cells The future of treatment in Alzheimer’s disease Targeting patients in the presymptomatic stage of disease is the future Prophylactic treatment Biomarker tests BIBLIOGRAPHY Patient potential Publications and online articles Datamonitor reports and products Epidemiology Publications and online articles Market overview Publications and online articles Brand dynamics Publications and online articles Datamonitor reports and products Pipeline overview and R&D dynamics Publications and online articles Pipeline drug analysis & forecasts: drugs targeting beta-amyloid Publications and online articles Datamonitor reports and products Pipeline drug analysis & forecasts: drugs targeting tau Publications and online articles Pipeline drug analysis & forecasts: general neuroprotection Publications and online articles Pipeline drug analysis & forecasts: symptomatic relief Publications and online articles Innovative early-stage approaches Publications and online articles Datamonitor reports and products Appendix Publications and online articles Datamonitor reports and products APPENDIX Forecasting assumptions New product launches Generic launches Methodology Datamonitor’s forecast methodology Product forecasts Sales calculations Definition of a standard unit Exchange rates Datamonitor’s disease-modifying drugs’ patient-based forecast methodology Epidemiology forecasting of prodromal Alzheimer’s disease Country group definitions Datamonitor drug assessment scorecard Contributing experts [Inhaltsverzeichnis ausblenden] |
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