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市場調查報告書

Frontier Pharma:疼痛 - First-in-Class的革新認識和商業化

Frontier Pharma: Pain - Identifying and Commercializing First-in-Class Innovation

出版商 GBI Research 商品編碼 326291
出版日期 內容資訊 英文 106 Pages
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Frontier Pharma:疼痛 - First-in-Class的革新認識和商業化 Frontier Pharma: Pain - Identifying and Commercializing First-in-Class Innovation
出版日期: 2015年01月31日 內容資訊: 英文 106 Pages
簡介

疼痛治療藥的開發平台,在全階段中796個產品正在開發,在分子標靶中非常富有多樣性。

本報告提供疼痛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
  • 上市產品概要

第5章 開發中產品革新的評估

  • 疼痛治療藥開發平台:各分子類型、階段、治療標靶
  • 疼痛治療藥市場與開發平台計劃比較分佈:各治療標靶系列
  • First-in-Class開發平台計劃
  • First-in-Class標靶:各疼痛子類型

第6章 疼痛治療藥的專利分析

第7章 First-in-Class標靶、開發平台計劃的評估

第8章 交易與策略性整合

  • 產業整體First-in-Class交易
  • 交易形勢
  • 許可證交易
  • 共同開發交易
  • 不參與許可/共同開發交易的First-in-Class計劃

第9章 附錄

圖表

目錄
Product Code: GBIHC356MR

Executive Summary

Large and Innovative Pipeline

The active pain pipeline is populated by 796 products across all stages of development, which exhibit a highly diverse range of molecular targets. GBI Research's analyses identified 122 first-in-class programs in active development, constituting 13.6% of the pipeline and acting on 65 first-in-class molecular targets, indicating a high degree of innovation. This is in stark contrast to the pain therapeutics market, which has been largely characterized by only incremental product innovation over the last decade, as most market segments continue to be dominated by long-established active pharmaceutical ingredients and the concomitant mechanisms of action. Moderate-to-severe pain continues to be dominated by opioids that are increasingly being reformulated to offer abuse-resistance, while mild pain is effectively treated with Non-Steroidal Anti-Inflammatory Drugs (NSAID). However, significant unmet needs remain, as chronic pain and some neuropathic pain subtypes do not respond well to existing therapies, which are not adequate to treat associated hypersensitization and do not align to the underlying molecular pathophysiological profile.

Despite being mostly distributed in the early stages of development, first-in-class innovation is particularly concentrated on novel molecular targets that are aligned to the central sensitization associated with neuropathic pain, which is arguably the most debilitating and difficult-to-treat type of chronic pain. This gives them the potential to transform the future market by expanding the range of drug classes.

Highly Diversified Range of Innovative Programs in Early Pipeline and in Granted Patents

Pain is a complex and multifaceted disorder with a complex interplay between different pathological processes, and different pain subtypes exhibit distinct underlying etiologies and pathophysiologies. While technological advances and extensive research efforts have furthered the understanding of these complex underpinnings, gaps remain. However, these insights have translated into the expanding pool of novel therapeutic targets, as reflected by the highly innovative pipeline. GBI Research's proprietary analysis shows that early-stage, first-in-class programs exhibit a higher level of diversity with respect to novel therapeutic targets. The significant diversity in terms of targets is a reflection of the complex underpinnings of distinct pain subtypes. Although the pipeline continues to feature established therapies, the range of mechanisms of action employed by novel compounds is extremely diverse, with the vast majority residing in the Preclinical stage. This innovation and diversity is maintained throughout the pipeline from early- to late-stage development, although the degree of innovation diminishes from Phase II. Additionally, although NSAIDs and opioids remain the cornerstone of pain treatment, GBI Research analysis indicates a shift towards pain subtypes that are more difficult to treat. Encouragingly, these first-in-class compounds often target molecules which are strongly implicated in pain and its associated signaling pathways. Although there are significant differentiations in the scientific rationale and clinical prospects across these first-in-class products, the majority demonstrate significant Preclinical evidence and alignment to molecular pathophysiological changes.

In addition, GBI Research's comprehensive and complementary analysis of granted patents highlighted a significant number of first-in-class product technologies, many of which have not been identified in the pain product pipelines or even in pipelines across the industry. The distribution of these products across the molecular target superfamilies and families highlighted that they predominantly align with the proportional distribution observed across the pain pipeline, with G-protein-coupled receptors and enzymes inhibitors constituting the two major categories. However, an array of novel molecular targets within those groups has been identified, which do not present in any pipeline or marketed products across the industry. A significant degree of innovation has also been identified in other molecular target categories.

Active Deals Landscape with Numerous Investment Opportunities

The pain deals landscape has been highly active over the past eight years, with 261 licensing deals and 112 co-development deals. However, despite high levels of investment activity, deals for first-in-class products have been relatively rare.

Overall, more than 50% of deals involving first-in-class targets were settled in the early stages of development, which is a striking contrast with non-first-in-class products, which are more frequently entered into deals in the later stages of development. This reflects companies' willingness to invest despite the high-risk profile of first-in-class products.

With 107 first-in-class products available for strategic consolidations, a wide variety of investment opportunities are available for licensing deals or co-development deals in pain. This will be encouraged by the growing unmet need for chronic pain therapies, and an increased understanding of the distinct underlying pathophysiologies of distinct pain sub-types, allowed by technological advances. Among these, some first-in-class products have demonstrated promising Preclinical evidence and have significant potential to become game-changing products, representing high-reward investments.

Scope

The report covers and includes -

  • A brief introduction to pain, including the different subtypes of pain, 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 of which clinical utility has yet to be evaluated, as well as literature reviews on novel molecular targets
  • Assessment of the licensing and co-development deal landscape for pain 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 pain therapeutics 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 pain, 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 Figures

2. Executive Summary

  • 2.1. Large and Innovative Pipeline
  • 2.2. Highly Diversified Range of Innovative Programs in Early Pipeline and in Granted Patents
  • 2.3. Active Deals landscape with Numerous Investment Oppertunities

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 Development Remains 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
    • 4.1.1. Chronic and Neuropathic Pain
    • 4.1.2. Disease Pathophysiology
    • 4.1.3. Diagnosis
    • 4.1.4. Treatment Option
    • 4.1.5. Treatment Algorithm
  • 4.2. Overview of Marketed Products for Pain
    • 4.2.1. Analgesic Product Categories
    • 4.2.2. Molecular Type Analysis
    • 4.2.3. Molecular Target Analysis
    • 4.2.4. Current Unmet Needs

5. Assessment of Pipeline Product Innovation

  • 5.1. Pain Pipeline by Molecule Type, Phase and Therapeutic Targets
  • 5.2. Comparative Distribution of Programs between the Pain Market and Pipeline by Therapeutic Target Family
  • 5.3. First-in-Class Pipeline Programs
  • 5.4. First-in-Class Targets by Pain Subtype

6. Pain Patent Analysis

7. First-in-Class Target and Pipeline Program Evaluation

  • 7.1. Pipeline Programs Targeting Fatty Acid Amide Hydrolase
  • 7.2. Pipeline Programs Targeting Purinoceptor 3
  • 7.3. Pipeline Programs Targeting Purinoceptor 7
  • 7.4. Pipeline Programs Targeting Purinoceptor 4
  • 7.5. Pipeline Programs Targeting Orexin Receptor Type 1
  • 7.6. Pipeline Programs Targeting Neuronal Nitric Oxide Synthase
  • 7.7. Pipeline Programs that Target Tropomyosin-Related Kinase A
  • 7.8. Pipeline Programs that Target C-C Chemokine Receptor 2
  • 7.9. Pipeline Programs that Target Endomorphin 2
  • 7.10. Pipeline Programs that Target Protein Kinase Cγ
  • 7.11. Pipeline Programs that Target Opioid Receptor-Like-1 Receptor
  • 7.12. Pipeline Programs that Target Bradykinin B1 Receptor
  • 7.13. Pipeline Programs Targeting Galanin Receptor 2
  • 7.14. Pipeline Programs Targeting Nerve Growth Factor

8. Deals and Strategic Consolidations

  • 8.1. Industry Industry-wide First-in-Class Deals
  • 8.2. Pain Deals Landscape
  • 8.3. Licensing Deals
    • 8.3.1. Molecule Type
    • 8.3.2. Mechanism of Action
  • 8.4. Co-development Deals
    • 8.4.1. Molecule Type
    • 8.4.2. Mechanism of Action
  • 8.5. First-in-Class Programs Not Involved in Licensing or Co-Development Deals

9. Appendix

  • 9.1. Abbreviations
  • 9.2. References
  • 9.3. Contact Us
  • 9.4. Disclaimer

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 Products 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: Treatment Algorithm
  • Figure 5: WHO Analgesic Ladder
  • Figure 6: Molecule Types in Marketed Products
  • Figure 7: Marketed Products, Part 2
  • Figure 8: Developmental Pipeline Overview
  • Figure 9: Developmental Pipeline Molecular Target Categories
  • Figure 10: Molecular Target Category Comparison, Pipeline and Marketed Products
  • Figure 11: Molecular Target Category Comparison, Pipeline First-in-Class and Established Molecular Targets
  • Figure 12: Total Pipeline Targets by Pain Subtype
  • Figure 13: First-in-Class Pipeline Targets by Pain Subtypes
  • Figure 14: First-in-Class Products in the Pipeline
  • Figure 15: Patent Families Filed and Granted by Year
  • Figure 16: Organizations Frequently Applying for Pain-Related Patent Families, (2008-2012)
  • Figure 17: Granted Patents by Mechanism of Action
  • Figure 18: Granted Patent Families by Molecular Target Family, 2009-2012
  • Figure 19: Molecular Targets Identified in Patents(Part 1), 2008-2012
  • Figure 20: Molecular Targets Identified in Patents(Part 2), 2008-2012
  • Figure 21: Molecular Targets Identified in Patents(Part 3), 2008-2012
  • Figure 22: Molecular Targets Identified in Patents(Part 4), 2008-2012
  • Figure 23: Data and Evidence for Fatty Acid Amide Hydrolase as a Therapeutic Target
  • Figure 24: Pipeline Programs Targeting FAAH
  • Figure 25: Data and Evidence for P2X3 as a Therapeutic Target
  • Figure 26: Pipeline Programs Targeting P2X3
  • Figure 27: Data and Evidence for P2X7 as a Therapeutic Target
  • Figure 28: Pipeline Programs Targeting P2X7
  • Figure 29: Pipeline Programs Targeting P2X4
  • Figure 30: Pipeline Programs Targeting Orexin Receptor Type 1
  • Figure 31: Pipeline Programs Targeting Orexin Receptor Type 1
  • Figure 32: Data and Evidence for Neuronal Nitric Oxide Synthase as a Therapeutic Target
  • Figure 33: Pipeline Programs Targeting Neuronal Nitric Oxide Synthase
  • Figure 34: Data and Evidence for Tropomyosin-Related Kinase A as a Therapeutic Target
  • Figure 35: Pipeline Programs Targeting Tropomyosin-Related Kinase A
  • Figure 36: Data and Evidence for C-C Chemokine Receptor 2 as a Therapeutic Target
  • Figure 37: Pipeline Programs Targeting C-C Chemokine Receptor 2
  • Figure 38: Data and Evidence for Endomorphin 2 as a Therapeutic Target
  • Figure 39: Pipeline Programs Targeting Endomorphin 2
  • Figure 40: Data and Evidence for Protein Kinase C γ as a Therapeutic Target
  • Figure 41: Pipeline Programs Targeting Protein Kinase C γ
  • Figure 42: Data and Evidence for Opioid Receptor-Like-1 Receptor as a Therapeutic Target (Part 1)
  • Figure 43: Data and Evidence for Opioid Receptor-Like-1 Receptor as a Therapeutic Target (Part 2)
  • Figure 44: Pipeline Programs Targeting Opioid Receptor-Like-1 Receptor
  • Figure 45: Data and Evidence for Bradykinin B1 Receptor as a Therapeutic Target (Part 1)
  • Figure 46: Data and Evidence for Bradykinin B1 Receptor as a Therapeutic Target (Part 2)
  • Figure 47: Data and Evidence for Bradykinin B1 Receptor as a Therapeutic Target (Part 3)
  • Figure 48: Pipeline Programs Targeting Bradykinin B1 Receptor
  • Figure 49: Data and Evidence for Galanin Receptor 2 as a Therapeutic Target
  • Figure 50: Pipeline Programs Targeting Galanin Receptor 2
  • Figure 51: Data and Evidence for Nerve Growth Factor as a Therapeutic Target
  • Figure 52: Pipeline Programs Targeting Nerve Growth Factor
  • Figure 53: Industry-wide Deals by Stage of Development, 2006-2014
  • Figure 54: Industry Licensing Deal Values by Stage of Development, 2006-2014
  • Figure 55: Licensing Deals, 2006-2015
  • Figure 56: Regional Network of Licensing Deals, 2006-2015
  • Figure 57: Licensing Deals by Molecule Type and Phase, 2006-2015
  • Figure 58: Licensing Deals by Target, 2006-2015
  • Figure 59: Summary of Licensing Deals, 2006-2015 (Part1)
  • Figure 60: Summary of Licensing Deals, 2006-2015 (Part 2)
  • Figure 61: Summary of Licensing Deals, 2006-2015 (Part 3)
  • Figure 62: Co-development Deals, 2006-2015
  • Figure 63: Regional Network of Co-development Deals, 2006-2015
  • Figure 64: Co-Development Deals by Molecule Type and Phase, 2006-2015
  • Figure 65: Co-Development Deals by Target, 2006-2015
  • Figure 66: Summary of Co-development Deals, 2006-2015 (Part 1)
  • Figure 67: Summary of Co-development Deals, 2006-2015 (Part 2)
  • Figure 68: First-in-Class Products not Involved in Prior Deals
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