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市場調查報告書

Frontier Pharma:帕金森氏症 - First-in-Class創新的識別與商品化

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

出版商 GBI Research 商品編碼 322141
出版日期 內容資訊 英文 95 Pages
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Frontier Pharma:帕金森氏症 - First-in-Class創新的識別與商品化 Frontier Pharma: Parkinson's Disease - Identifying and Commercializing First-in-Class Innovation
出版日期: 2016年01月01日 內容資訊: 英文 95 Pages
簡介

本報告提供整體開發平台及目前的市場情勢為背景的帕金森氏症治療藥的創新相關分析,以一流產品為中心的契約形勢及引入授權的機會等分析彙整。

第1章 目錄

第2章 摘要整理

第3章 創新案例

  • 生物製藥的成長機會
  • 分子標的之多樣化
  • 創新的First-in-Class產品開發現在也仍富有魅力
  • 法規、醫療費償付政策轉移至方便的First-in-Class產品創新
  • 創新的持續
  • GBI Research 報告指南

第4章 臨床、商業形勢

  • 流行病學
  • 病的原因論
  • 病的病理學
  • 病徵
  • 共生病症、併發症
  • 診斷
  • 預後、分期
  • 治療選擇
  • 上市產品概要
  • 帕金森氏症用上市產品概要
  • 上市產品的功效、安全性
  • 治療流程
  • 目前未滿足需求

第5章 開發中產品創新的評估

  • 帕金森氏症的開發平台:分子類型、階段、治療標的
  • 帕金森氏症市場、開發平台間計劃比較分佈:各治療目標系列

第6章 信號傳達網路,帕金森氏症的非專利及創新的調整

  • 中樞神經系統的信號傳達網路的複雜
  • 信號傳達途徑,引起疾病的變異股及First-in-Class分子標的整合
  • First-in-Class標的矩陣評估

第7章 First-in-Class標的及開發平台計劃評估

  • 以下為目標的開發平台計劃概要
    • α-shinukurein
    • LRRK2
    • 膠質細胞源性神經營養因子(GDNF)
    • Progranulin
    • 腦內多巴胺神經營養因子
    • 中腦星狀細胞來源神經營養因子
    • 酪胺酸受體激酶B
    • 代謝型麩胺酸受體4
    • 代謝型麩胺酸受體8
    • c-Jun N末端激酶
    • DJ-1
    • 活性氧(ROS)
    • 熱休克轉錄因子(HSF)
    • 熱休克蛋白質90
    • 生長激素分泌促進物質受體
    • 蛋白質磷酸酶
    • 細胞色素P450 2D6
  • 結論

第8章 契約、策略性整合

  • 跨產業整體的First-in-Class契約
  • 帕金森氏症的契約形勢
  • 授權契約
  • 共同開發契約
  • 不包含授權或共同開發契約的First-in-Class計劃

第9章 附錄

圖表

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目錄
Product Code: GBIHC398MR

Executive Summary

Parkinson's Disease (PD) is the second most common neurodegenerative disease after Alzheimer's disease, affecting around 7.4 million people worldwide. It is caused by the progressive loss of dopamine-producing neurons in the substantia nigra within the basal ganglia. The main motor symptoms are tremors, bradykinesia and rigidity, although symptoms vary between individuals. As the disease progresses to more advanced stages, increasing symptoms and complications develop, which can cause severe disability in patients.

The current market offers a number of anti-PD treatment options which provide symptomatic relief. Levodopa is currently the gold standard therapy, with other drug classes including dopamine agonists and Monoamine Oxidase B (MAO-B) inhibitors also used to treat early and advanced cases. With no current treatment showing effectiveness in delaying the course of the disease, PD remains incurable. The high unmet need for a disease-modifying therapy is reflected in the pipeline, where a high proportion of early-stage first-in-class programs target the potential pathogenic mechanisms underlying neurodegeneration.

Scope

PD is a crowded market with many neuromodulatory drug classes available. However, a disease-modifying therapy with neuroprotective effects is yet to be developed.

What are the primary mechanisms that are thought to contribute to neuronal death?

What are the major barriers facing the development of investigational neuroprotective candidates?

Analysis reveals a high level of innovation and diversity in the pipeline, with 121 first-in-class programs acting on 57 unique molecular targets.

Neuromodulatory targets remain the dominant target family, particularly in the late-stage pipeline.

What are the first-in-class families with a significant presence?

How well do they align with the underlying pathways governing neuronal death in PD?

Some of the first-in-class targets have a potentially stronger chance of being translated into novel treatments for PD.

What is the scientific rationale behind these targets? How do they perform in Preclinical studies?

What are the commonly used disease models and the parameters measuring neuroprotective effects in PD animal studies?

Deals involving first-in-class PD products are more likely to be made in earlier stages of development than non-first-in-class deals.

What is the dominant molecular target in the PD deals landscape?

What are the promising first-in-class products still available for future licensing?

Reasons to buy

  • This report will allow you to -
  • Understand the current clinical and commercial landscape by considering the proposed pathogenic processes underlying PD neurodegeneration, diagnosis, prognosis, and the available treatment options and their usage in early and advanced PD.
  • Visualize the composition of the PD market to highlight the current unmet needs in order to gain a competitive understanding of the key opportunities.
  • Analyze the PD pipeline and stratify by stage of development, molecule type, and molecular target - the diversity of molecular targets in the pipeline is extremely encouraging due to the multifaceted nature of PD.
  • Assess the therapeutic potential of first-in-class targets using a proprietary matrix that assesses and ranks first-in-class products according to clinical potential.
  • Target the most promising and innovative PD products for early-stage investment by analyzing trends in licensing and co-development deals and accessing a curated list of 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. High Unmet Needs Remain in Parkinson's Disease Market
  • 2.2. Diverse and Innovative Pipeline to Shift Focus to Disease Modification
  • 2.3. Deals Landscape Presents Substantial 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. Epidemiology
  • 4.3. Disease Etiology
    • 4.3.1. Exposure to Environmental Toxins
    • 4.3.2. Genetic Causes of Familial Parkinson's Disease
    • 4.3.3. Susceptibility Genes for Parkinson's Disease
  • 4.4. Disease Pathophysiology
    • 4.4.1. Basal Ganglia Anatomy and Physiology
    • 4.4.2. Process Underlying Neurodegeneration
  • 4.5. Disease Symptoms
  • 4.6. Co-morbidities and Complications
  • 4.7. Diagnosis
  • 4.8. Classification of Disease Stages
    • 4.8.1. Hoehn and Yahr Scale
    • 4.8.2. Unified Parkinson's Disease Rating Scale
    • 4.8.3. Scale for the Assessment of Positive Symptoms
    • 4.8.4. Mini Mental State Examination
  • 4.9. Prognosis and Disease Staging
  • 4.10. Treatment Options
    • 4.10.1. Pharmacotherapy
    • 4.10.2. Non-pharmacological Treatment
  • 4.11. Overview of Marketed Products
    • 4.11.1. Molecule Type and Target Analysis
    • 4.11.2. Treatment Algorithm
  • 4.12. Current Unmet Needs

5. Assessment of Pipeline Product Innovation

  • 5.1. Parkinson's Disease Pipeline by Molecule Type, Phase and Therapeutic Target
  • 5.2. Comparative Distribution of Programs between Parkinson's Disease Market and Pipeline by Therapeutic Target Family
  • 5.3. First-in-Class Pipeline Programs Targeting Novel Molecular Targets

6. Signaling Pathways, Genetics and Innovation Alignment

  • 6.1. The Complexity of Signaling Networks in the Central Nervous System
  • 6.2. Signaling Pathways 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 α-synuclein
  • 7.2. Pipeline Programs Targeting DJ-1
  • 7.3. Pipeline Programs Targeting Parkin
  • 7.4. Pipeline Programs Targeting High Affinity Nerve Growth Factor Receptor
  • 7.5. Pipeline Programs Targeting C-jun N-Terminal Kinase
  • 7.6. Pipeline Programs Targeting Leucine-Rich Repeat Kinase 2
  • 7.7. Pipeline Programs Targeting Growth Hormone Secretagogue Receptor Type 1
  • 7.8. Pipeline Programs Targeting Metabotropic Glutamate Receptor 4
  • 7.9. Pipeline Programs Targeting NAD-dependent Protein Deacetylase Sirtuin-2
  • 7.10. Overview of Pipeline Programs Targeting Progranulin
  • 7.11. Conclusion

8. Deals and Strategic Consolidations

  • 8.1. Industry-Wide First-in-Class Deals
  • 8.2. Licensing Deals
  • 8.3. Co-development Deals
  • 8.4. First-in-Class Programs not Involved in Licensing or Co-development Deals

9. Appendix

  • 9.1. Abbreviations
  • 9.2. Bibliography
  • 9.3. Research Methodology
  • 9.4. Secondary Research
    • 9.4.1. Marketed Product Heatmaps and Treatment Algorithm
    • 9.4.2. Pipeline Analysis
    • 9.4.3. First-in-Class Matrix Assessment
    • 9.4.4. First-in-Class Target Profiles
    • 9.4.5. Licensing and Co-development Deals
  • 9.5. Contact Us
  • 9.6. Disclaimer

List of Tables

  • Table 1: Definition of the Stages of Disability in Hoehn and Yahr Scale, 1967
  • Table 2: Evaluation of Disability by Unified Parkinson Disease Rating Scale, 2013

List of Figures

  • Figure 1: Innovation Trends in Product Approvals, 1987-2013
  • Figure 2: Sales Performance of First-in-Class and Non-First-in-Class Products Post Marketing Approval, 2006-2013
  • Figure 3: Indirect and Direct Pathways in Basal Ganglia
  • Figure 4: Molecular Targets of Marketed Products
  • Figure 5: Treatment Algorithm of Parkinson's Disease
  • Figure 6: Efficacy and Safety of Treatments for Early Parkinson's Disease
  • Figure 7: Efficacy and Safety of Treatments for Advanced Parkinson's Disease
  • Figure 8: Efficacy and Safety of Treatment for Non-Motor Symptoms in Parkinson's Disease
  • Figure 9: Developmental Pipeline Overview
  • Figure 10: Parkinson's Disease Pipeline by Molecular Target
  • Figure 11: Parkinson's Disease Pipeline by Molecular Target
  • Figure 12: Molecular Target Category Comparison, Pipeline and Marketed Products
  • Figure 13: Molecular Target Category Comparison, Pipeline First-in-Class and Established Molecular Targets
  • Figure 14: Parkinson's Disease, Global, First-in-Class Pipeline Products
  • Figure 15: First-in-Class Molecular Target Analysis Matrix
  • Figure 16: Data and Evidence for α-synuclein as a Therapeutic Target
  • Figure 17: Pipeline Programs Targeting α-synuclein
  • Figure 18: Data and Evidence for DJ-1 as a Therapeutic Target
  • Figure 19: Pipeline Programs Targeting DJ-1
  • Figure 20: Data and Evidence for Parkin as a Therapeutic Target
  • Figure 21: Pipeline Programs Targeting Parkin
  • Figure 22: Data and Evidence for High Affinity Nerve Growth Factor Receptor as a Therapeutic Target
  • Figure 23: Pipeline Programs Targeting High Affinity Nerve Growth Factor Receptor
  • Figure 24: Data and Evidence for C-Jun N-Terminal Kinases as a Therapeutic Target
  • Figure 25: Pipeline Programs Targeting C-Jun N-Terminal Kinase
  • Figure 26: Data and Evidence for Leucine-Rich Repeat Kinase 2 as a Therapeutic Target
  • Figure 27: Pipeline Programs Targeting Leucine-Rich Repeat Kinase 2
  • Figure 28: Data and Evidence for Growth Hormone Secretagogue Receptor as a Therapeutic Target
  • Figure 29: Pipeline Programs Targeting Growth Hormone Secretagogue Receptor Type 1
  • Figure 30: Data and Evidence for Metabotropic Glutamate Receptor 4 as a Therapeutic Target
  • Figure 31: Pipeline Programs Targeting Metabotropic Glutamate Receptor 4
  • Figure 32: Data and Evidence for NAD-dependent Protein Deacetylase Sirtuin-2 as a Therapeutic Target
  • Figure 33: Pipeline Programs Targeting NAD-Dependent Protein Deacetylase Sirtuin-2
  • Figure 34: Data and Evidence for Progranulin as a Therapeutic Target
  • Figure 35: Pipeline Programs Targeting Progranulin
  • Figure 36: Industry-Wide Deals by Stage of Development, 2006-2014
  • Figure 37: Industry-Wide Deals by Stage of Development, 2006-2014
  • Figure 38: Licensing Deals, 2006-2015
  • Figure 39: Licensing Deals by Molecule Type, 2006-2015
  • Figure 40: Licensing Deals by Molecular Target, 2006-2015
  • Figure 41: Summary of Licensing Deals, 2006-2015
  • Figure 42: Co-development Deals, 2006-2015
  • Figure 43: Co-development Deals by Phase and Molecule Type, 2006-2015
  • Figure 44: Co-development Deals by Molecular Target, 2006-2015
  • Figure 45: Summary of Co-development Deals, 2006-2015
  • Figure 46: First-in-Class Programs with no Recorded Prior Deal Involvement, 2006-2015
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