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市場調查報告書

Frontier Pharma:老年癡呆症 - First-in-Class的革新認識和商業化

Frontier Pharma: Alzheimer's Disease - Identifying and Commercializing First-in-Class Innovation

出版商 GBI Research 商品編碼 326286
出版日期 內容資訊 英文 101 Pages
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Frontier Pharma:老年癡呆症 - First-in-Class的革新認識和商業化 Frontier Pharma: Alzheimer's Disease - Identifying and Commercializing First-in-Class Innovation
出版日期: 2014年11月30日 內容資訊: 英文 101 Pages
簡介

老年癡呆症的開發平台,有非常多種分子標靶,583產品正在開發。開發平台的46%,是First-in-Class產品 (劃時代的醫藥品) 。

本報告提供老年癡呆症治療藥市場相關調查分析、革新案例、臨床與商業性情形、開發中產品的評估、計劃評估、最近的交易等相關的系統性資訊。

第1章 目錄

第2章 摘要整理

第3章 革新 (技術創新) 案例

  • 生技藥品的機會擴大
  • 分子標靶多樣化
  • 創新的First-in-Class產品 (劃時代的醫藥品) 的開發現在也富有魅力
  • 法規、償付政策,對First-in-Class產品的革新有利
  • 持續性的革新
  • 報告指南

第4章 臨床、商業性情形

  • 疾病概要
  • 疾病的症狀
  • 疾病的病因
  • 病理生理學
  • 共生病症/併發症
  • 診斷
  • 預後
  • 治療的選項
  • 目前未滿足需求

第5章 開發中產品革新的評估

  • 老年癡呆症開發平台:各分子類型、階段、治療標靶
  • 老年癡呆症開發平台的作用機制
  • First-in-Class開發平台和現有的分子標靶計劃比較分佈
  • 現有分子標靶的開發平台計劃
  • 新分子標靶的First-in-Class開發平台計劃

第6章 信號 (信號傳達) 網路、遺傳學、革新的調整

  • 遺傳風險因子的複雜度
  • 信號傳達途徑、成為疾病原因的變異、First-in-Class分子標靶整合
  • First-in-Class標靶矩陣的評估

第7章 First-in-Class標靶評估

第8章 交易與策略性整合

  • 產業整體許可證交易
  • 交易與策略性整合
  • 共同開發交易

第9章 不參與許可/共同開發的First-in-Class分子

第10章 附錄

圖表

目錄
Product Code: GBIHC349MR

Executive Summary

Large and Innovative Pipeline

The active Alzheimer's Disease (AD) pipeline is populated with 583 products, with a highly diverse range of molecular targets. GBI Research analysis revealed a high degree of innovation in this indication, with 46% of the pipeline being first-in-class products, acting on over 40 first-in-class molecular targets. In addition, the pipeline is characterized by the strong presence of therapies that target multiple components implicated in the amyloid cascade, several molecular targets of which are known to trigger familial AD. Given that the currently approved therapies for AD are limited to acetylcholinesterase inhibitors and glutamate receptor antagonists, the pipeline offers a broad range of treatment options that may possess disease-modifying properties. However, evaluation of the Preclinical and clinical evidence for their therapeutic potential reveals that the novelty of the molecular target is not sufficient to effectively reduce the rate of AD progression in human patients.

Disease-Modifying Therapies Show Promise in Early-Stage Development

Programs undergoing Preclinical development exhibit diverse disease-modifying mechanisms of action, and many represent strong alternatives to targets with a direct role in the amyloid and tau processes due to their roles in promoting neuronal survival and plasticity, a process critical to memory and cognition. Brain-Derived Neurotrophic Factor (BDNF) and Nerve Growth Factor (NGF) are considered promising targets in AD, primarily due to their potency in exhibiting significant neuroprotective effects in Preclinical studies. Members of the caspase-mediated apoptotic cascade also show therapeutic potential, as early investigations have revealed an ability to modulate molecular mechanisms underlying synaptic plasticity in animal models, which translates into amelioration of behavioral deficits. Thus, growing insights into disease-causing processes in AD are being translated into a growing population of innovative therapeutic targets, as reflected in the highly innovative pipeline.

The merits of novel molecular targets depend largely on the body of Preclinical evidence underpinning their relevance to AD pathology. Many endpoints in Preclinical investigations focus on amelioration of amyloid burden and tau pathology, as well as cognitive performance in animal model systems. Based on these assessment criteria, it appears that programs targeting the amyloid cascade, tau pathology, and the promotion of neuronal survival and plasticity all demonstrate promising efficacy profiles. Other first-in-class targets that are less directly aligned to these three processes may not be able to confer disease-modifying properties and therefore lack clinical and commercial potential.

Active Deals Landscape with Numerous Investment Opportunities

The AD deals landscape has been highly active over the past eight years, with 83 licensing agreements and 103 co-development deals. Overall, non-first-in-class programs tend to have lower valuations than first-in-class programs across all stages of drug development, which highlights their commercial attractiveness, even in early-stage development. Although first-in-class programs are associated with greater risk, they have more potential to revolutionize or improve therapeutic options, meaning that identifying promising first-in-class compounds early in development offers the greatest potential commercial benefit to pharmaceutical companies.

With 153 first-in-class products that are currently in development having not yet been involved in a licensing or co-development deal, there are numerous opportunities for in-licensing or co-development in this indication.

Scope

The report covers and includes -

  • A brief introduction to AD, including symptoms, pathophysiology, and overview of pharmacotherapy and treatment algorithms
  • The changing molecular target landscape between market and pipeline and particular focal points of innovation in the pipeline
  • A comprehensive review of the pipeline for first-in-class therapies, analyzed on the basis of stage of development, molecule type and molecular target
  • Identification and assessment of first-in-class molecular targets with a particular focus on early-stage programs for which clinical utility has yet to be evaluated, as well as literature reviews of novel molecular targets
  • Assessment of the licensing and co-development deal landscape for AD therapies and benchmarking of deals involving first-in-class versus non-first-in-class-products

Reasons to buy

  • The report will assist business development and enable marketing executives to strategize their product launches, by allowing them to -
  • Understand the focal shifts in molecular targets in the AD pipeline
  • Understand the distribution of pipeline programs by phase of development, molecule type and molecular target
  • Access a scientific and clinical analysis of first-in-class developmental programs for AD, benchmarked against non-first-in-class targets
  • Access a list of the first-in-class therapies potentially open to deal-making opportunities

Table of Contents

1. Table of Contents

  • 1.1. List of Tables
  • 1.2. List of Figures

2. Executive Summary

  • 2.1. Large and Innovative Pipeline
  • 2.2. Therapies Promoting Neuronal Survival and Plasticity Show Promise in Early-Stage Development
  • 2.3. Extensive Investment in Amyloid-Beta-Targeting Programs despite Historically High Attrition Rates in Clinical Evaluation
  • 2.4. Active Deals Landscape with Numerous Investment Opportunities

3. The Case for Innovation

  • 3.1. Growing Opportunities for Biologic Products
  • 3.2. Diversification of Molecular Targets
  • 3.3. Innovative First-in-Class Product Developments Remain Attractive
  • 3.4. Regulatory and Reimbursement Policy Shifts Favor First-in-Class Product Innovation
  • 3.5. Sustained Innovation
  • 3.6. GBI Research Report Guidance

4. Clinical and Commercial Landscape

  • 4.1. Disease Overview
  • 4.2. Disease Symptoms
  • 4.3. Disease Etiology
    • 4.3.1. Genetics
    • 4.3.2. Predisposing Medical Conditions and Risk Factors
  • 4.4. Pathophysiology
    • 4.4.1. Amyloidosis
    • 4.4.2. Tau Hyperphosphorylation
    • 4.4.3. Receptor for Advanced Glycation Endproducts Signaling
    • 4.4.4. Oxidative Stress
    • 4.4.5. Neuroinflammation
  • 4.5. Comorbidities/Complications
  • 4.6. Diagnosis
    • 4.6.1. Tools for Screening Cognitive Function
    • 4.6.2. Imaging Tests
    • 4.6.3. Cerebral Spinal Fluid Testing
    • 4.6.4. Blood Tests
  • 4.7. Prognosis
  • 4.8. Treatment Options
    • 4.8.1. Treatment Algorithm
    • 4.8.2. Non-Pharmacological Treatments
  • 4.9. Current Unmet Needs

5. Assessment of Product Pipeline Innovation

  • 5.1. Alzheimer's Disease Pipeline by Molecule Type, Phase and Therapeutic Target
  • 5.2. Mechanisms of Action within the Alzheimer's Disease Pipeline
  • 5.3. Comparative Distribution of Programs with First-in-Class and Established Molecular Targets
  • 5.4. Pipeline Programs Targeting Established Molecular Targets
  • 5.5. First-in-Class Pipeline Programs with Novel Molecular Targets

6. Signaling Network, Genetics and Innovation Alignment

  • 6.1. The Complexity of Genetic Risk Factors in AD
  • 6.2. Signaling Pathways, Disease-Causing Mutations and First-in-Class Molecular Target Integration
  • 6.3. First-in-Class Target Matrix Assessment

7. First-in-Class Target Evaluation

  • 7.1. Pipeline Programs Targeting Calpain
  • 7.2. Pipeline Programs Targeting γ -Secretase
  • 7.3. Pipeline Programs Targeting Brain-Derived Neurotrophic Factor
  • 7.4. Pipeline Programs Targeting Apolipoprotein E
  • 7.5. Pipeline Programs Targeting β-Site Amyloid Precursor Protein Cleaving Enzyme 1
  • 7.6. Pipeline Programs Targeting Amyloid Precursor Protein and Amyloid-Beta
  • 7.7. Pipeline Programs Targeting Casein Kinase
  • 7.8. Pipeline Programs Targeting Nerve Growth Factor
  • 7.9. Pipeline Programs Targeting Kynurenine 3-Monooxygenase
  • 7.10. Pipeline Programs Targeting Leucine -Rich Repeat Kinase -2
  • 7.11. Pipeline Programs Targeting Insulin- Regulated Aminopeptidase
  • 7.12. Pipeline Programs Targeting Tau
  • 7.13. Pipeline Programs Targeting Cathepsin B
  • 7.14. Pipeline Programs Targeting Receptor for Advanced Glycation End-products
  • 7.15. Pipeline Programs Targeting Protein Phosphatase 2a
  • 7.16. Pipeline Programs Targeting Caspase
  • 7.17. Pipeline Programs Targeting Cyclin Dependent Kinase 5
  • 7.18. Conclusion

8. Deals and Strategic Consolidations

  • 8.1. Trends in Licensing Deals Across the Entire Pharmaceutical Industry
  • 8.2. Deals and Strategic Consolidations in Alzheimer's Disease
    • 8.2.1. Licensing Deals
    • 8.2.2. Molecule type
    • 8.2.3. Mechanism of Action
  • 8.3. Co-development Deals
    • 8.3.1. Molecule Type and Mechanism of Action

9. First-In-Class Molecules not Involved in Licensing or Co-development Deals

10. Appendix

  • 10.1. References
  • 10.2. Contact Us
  • 10.3. Disclaimer

List of Tables

  • Table 1: Mini-Mental State Exam, 2005
  • Table 2: Alzheimer's Disease Assessment Scale, Cognitive Subscale, 1984

List of Figures

  • Figure 1: Innovation Trends in Product Approvals, 1987-2012
  • Figure 2: Sales Performance of First-in-Class and Non-First-in-Class Product post Marketing Approval, 2006-2013
  • Figure 3: Sales Performance of Central Nervous System First-in-Class and Non-First-in-Class Products post Marketing Approval, 2006-2013
  • Figure 4: Alzheimer's Disease, Global, Developmental Pipeline
  • Figure 5: Alzheimer's Disease, Global, Established and First-in-Class Pipeline
  • Figure 6: Alzheimer's Disease, Global, Established Developmental Pipeline Part 1, 2014
  • Figure 7: Alzheimer's Disease, Global, Established Developmental Pipeline Part 2, 2014
  • Figure 8: Alzheimer's Disease, Global, Established Developmental Pipeline Part 3, 2014
  • Figure 9: Alzheimer's Disease, Global, Established Developmental Pipeline Part 4, 2014
  • Figure 10: Alzheimer's Disease, Global, First-in-Class Developmental Pipeline Part 1, 2014
  • Figure 11: Alzheimer's Disease, Global, First-in-Class Developmental Pipeline Part 2, 2014
  • Figure 12: Alzheimer's Disease, Global, First-in-Class Developmental Pipeline Part 3, 2014
  • Figure 13:Signaling Networks of Functional Families in Alzheimer's Disease, 2014
  • Figure 14: First-in-Class Molecular Target Analysis Matrix
  • Figure 15: Data and Evidence for Calpain as a Therapeutic Target
  • Figure 16: Pipeline Programs Targeting Calpain
  • Figure 17: Data and Evidence for γ Secretase as a Therapeutic Target
  • Figure 18: Pipeline Programs Targeting γ Secretase
  • Figure 19: Data and Evidence for Brain-Derived Neurotrophic Factor as a Therapeutic Target
  • Figure 20: Pipeline Programs Targeting Brain-Derived Neurotrophic Factor
  • Figure 21: Data and Evidence for Apolipoprotein E as a Therapeutic Target
  • Figure 22: Pipeline Programs Targeting Apolipoprotein E
  • Figure 23: Data and Evidence for β-secretase as a Therapeutic Target
  • Figure 24: Pipeline Programs Targeting β Secretase
  • Figure 25: Data and Evidence for Amyloid Precursor Protein as a Therapeutic Target
  • Figure 26: Pipeline Programs Targeting Amyloid-Beta and Amyloid Precursor protein
  • Figure 27: Pipeline Programs Targeting Casein Kinases
  • Figure 28: Pipeline Programs Targeting Casein Kinases
  • Figure 29: Pipeline Programs Targeting Nerve Growth Factor
  • Figure 30: Pipeline Programs Targeting Nerve Growth Factor
  • Figure 31: Pipeline Programs Targeting Kynurenine 3-Monooxygenase
  • Figure 32: Pipeline Programs Targeting Kynurenine 3-Monooxygenase,
  • Figure 33: Pipeline Programs Targeting Leucine-Rich Repeat Kinase 2
  • Figure 34: Pipeline Programs Targeting Insulin-Regulated Aminopeptidase
  • Figure 35: Data and Evidence for Tau as a Therapeutic Target
  • Figure 36: Pipeline Programs Targeting Tau
  • Figure 37: Data and Evidence for Cathepsin B as a Therapeutic Target, xxxx
  • Figure 38: Pipeline Programs Targeting Cathepsin B
  • Figure 39: Data and Evidence for Receptor for Advanced Glycation End-products as a Therapeutic Target
  • Figure 40: Pipeline Programs Targeting Receptor for Advanced Glycation End-products
  • Figure 41: Data and Evidence for Receptor for Protein Phosphatase 2A as a Therapeutic Target
  • Figure 42: Pipeline Programs Targeting Protein Phosphatase 2A
  • Figure 43: Data and Evidence for Receptor for Caspase as a Therapeutic Target
  • Figure 44: Pipeline Programs Targeting Caspase
  • Figure 45: Data and Evidence for Cyclin-Dependent Kinase 5 as a Therapeutic Target
  • Figure 46: Pipeline Programs Targeting Cyclin-dependent kinase 5
  • Figure 47: Stage of Development of First-in-Class and Non-First-in-Class Programs at Deal Completion, 2006-2014
  • Figure 48: First-in-class and Non-First-in-Class Programs, Deal Valuations by Stage of Development, 2006-2014
  • Figure 49: Licensing Deal Trends, 2006-2014
  • Figure 50: Network of Licensing Deals, 2006-2014
  • Figure 51: Licensing Deals by Molecule Type, 2006-2014
  • Figure 52: Licensing Deals by Mechanism of Action, 2006-2014
  • Figure 53: Licensing Deals (Part 1), 2006-2014
  • Figure 54: Licensing Deals (Part 2), 2006-2014
  • Figure 55: Co-development Deal Trends, 2006-2014
  • Figure 56: Network of Co-development Deals, 2006-2014
  • Figure 57: Co-development Deals by Molecule Type, 2006-2014
  • Figure 58: Co-development Deals by Mechanism of Action, 2006-2014
  • Figure 59: Co-development Deals, Global, 2006-2014
  • Figure 60: First-in-Class Programs not Previously Involved in Licensing or Co-development Deals (Part 1)
  • Figure 61: First-in-Class Programs not Previously Involved in Licensing or Co-development Deals (Part 2)
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