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市場調査レポート

Frontier Pharma:非小細胞肺がん(NSCLC)- ファーストインクラスのイノベーション認識と商業化

Frontier Pharma: Non-Small Cell Lung Cancer - Identifying and Commercializing First-in-Class Innovation

発行 GBI Research 商品コード 318230
出版日 ページ情報 英文 93 Pages
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Frontier Pharma:非小細胞肺がん(NSCLC)- ファーストインクラスのイノベーション認識と商業化 Frontier Pharma: Non-Small Cell Lung Cancer - Identifying and Commercializing First-in-Class Innovation
出版日: 2014年10月31日 ページ情報: 英文 93 Pages
概要

非小細胞肺がん(NSCLC)パイプラインは、現在、全ステージにおいて389製品が開発中ですが、市場における作用機序とパイプラインとの間には、明らかな対比があります。

当レポートでは、非小細胞肺がん(NSCLC)治療薬市場について調査分析し、イノベーション事例、臨床・商業的状況、パイプライン製品の評価、プログラム評価、最近の取引などについて、体系的な情報を提供しています。

第1章 目次

第2章 エグゼクティブサマリー

第3章 イノベーション(技術革新)事例

  • 生物製剤の機会が拡大
  • 分子標的の多様化
  • 革新的なファーストインクラス製品(画期的医薬品)の開発が今も魅力的
  • 規制・償還政策が、ファーストインクラス製品のイノベーションに有利に
  • 持続的なイノベーション
  • レポートガイダンス

第4章 臨床・商業的状況

  • 疾患の症状
  • 疾患の病因と病態生理
  • NSCLC治療の概要
  • 手術と放射線療法
  • 治療アルゴリズム
  • NSCLC上市製品の概要
    • 分子タイプ分析
    • 分子標的分析
    • NSCLC市場の革新的製品
    • 上市製品の効能と安全性
    • 現在のアンメットニーズ

第5章 パイプライン製品イノベーションの評価

  • NSCLCパイプライン:分子タイプ、フェーズ、治療標的別
  • NSCLC市場とパイプラインプログラムの比較分布:治療標的ファミリー別
  • 新分子標的のファーストインクラスパイプラインプログラム

第6章 シグナリング(シグナル伝達)ネットワーク、疾患の因果関係、イノベーションの調整

  • 腫瘍学におけるシグナル伝達ネットワークの複雑さ
  • シグナル伝達経路、疾患の原因となる変異、ファーストインクラス分子標的の統合
  • ファーストインクラス標的マトリクスの評価

第7章 ファーストインクラス標的の評価

  • PTK2
  • Erbb3
  • TP53
  • CD274
  • Akt2
  • STAT3
  • FGF1
  • CDK4
  • AURKB
  • FNTA
  • CHEK1
  • HIF1A
  • DKK1

第8章 取引と戦略的統合

  • 産業全体のファーストインクラス取引
  • NSCLC取引情勢
  • ライセンス取引
  • 共同開発取引
  • ライセンス/共同開発に関与しないファーストインクラスプログラム

第9章 付録

図表

目次
Product Code: GBIHC341MR

Summary

Large Degree of Innovation in NSCLC Pipeline

The NSCLC pipeline currently has 389 products in active development across all stages, but a stark contrast between the mechanisms of action employed in the current market and the pipeline is evident. Where the market comprises primarily ineffective chemotherapies that target tubulin or DNA replication, the pipeline shows an incredibly diverse range of therapies targeting multiple signaling pathways and molecules integral to cancer development. This diversity is partially due to the presence of 122 first-in-class products, which accounts for 38% of the overall pipeline therapies that disclosed their target. In an industry, market and development landscape that favors first-in-class over non-first-in-class development in many ways, such as through faster approval or greater revenue, this finding has strategic implications for a wide array of market participants, both large and small. Despite a high attrition rate in NSCLC, first-in-class therapies that reach the market have the potential to transform and improve the NSCLC treatment landscape.

Alignment of First-in-Class Molecular Target with Disease Causation

The method of characterizing NSCLC tumors is currently shifting from the traditional histology-based characterization to a more specific molecule-based method of characterization. This has resulted in the identification of key oncogenic mutations in NSCLC and has coincided with the rise of targeted pipeline therapies, which are designed to target proteins in signaling pathways that are frequently mutated, amplified or overexpressed in NSCLC. Aligning the molecular target with disease-causing signaling pathways and frequently mutated pathways therapies can benefit from reduced systemic cytotoxic effects while still inhibiting tumor-promoting signaling. Therefore, targeted therapies often display superior safety and efficacy to chemotherapies.

GBI Research's proprietary analysis showed substantial variation in how well NSCLC first-in-class targets align to frequent gene mutations. Further in-depth analysis identified the most promising first-in-class targets based on various scientific and clinical parameters. Examining scientific and clinical data of promising first-in-class targets showed that first-in-class status is not, in its own right, enough for a successful product; however, the first-in-class products substantiated by scientific and clinical evidence will be exciting future prospects with the potential to transform the NSCLC market.

First-in-Class Products in Licensing and Co-development Deals

The NSCLC deals landscape appears relatively quiet for such a large indication. However, analysis showed that of the therapies with disclosed deal values there is significant range in the value of NSCLC deals. Concerning first-in-class specifically, only five licensing or co-development deals have been made since 2006. Despite the low sample size, it is clear that the first-in-class NSCLC products offer an attractive investment prospect as they command much higher deal values and, on average, deals occur earlier in development compared to non-first-in-class counterparts. Both trends were substantiated by industry-wide data that showed that, particularly in Phase I, first-in-class products would attract larger mean and median total deal values. The data highlight that the first-in-class deals landscape is different and indicates a greater chance of becoming much more lucrative than the deals landscape for addition-to-class or advance-in-class therapies.

A total of 117 first-in-class products that are currently in development have not yet been entered into a licensing or co-development deal. In a transforming market that will favor innovative, targeted therapies with a strong clinical record, there are numerous opportunities for strategic alliances to bolster a first-in-class portfolio or fund clinical development. Although not all are aligned to disease-causing signaling pathways, many are supported by robust scientific and clinical data, making them attractive prospects as both therapeutics and investment opportunities.

Scope

The report analyzes innovation in NSCLC in the context of the overall pipeline and current market landscape. It also analyzes the deals landscape surrounding first-in-class products and pinpoints in-licensing opportunities.The report includes -

  • A brief introduction to NSCLC, including symptoms, pathophysiology, and an overview of pharmacotherapy and treatment algorithms
  • Extensive categorization of histological and molecular features of NSCLC tumors
  • Coverage of the changing molecular target landscape and particular points of innovation in the pipeline
  • A comprehensive review of the pipeline for first-in-class therapies, analyzed by 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 of novel molecular targets
  • Industry-wide analysis of first-in-class deals compared to non-first-in-class deals
  • An assessment of the licensing and co-development deal landscape for NSCLC therapies and benchmarking of deals comparing first-in-class and non-first-in-class-products

Reasons to buy

The report will enable business development and enable marketing executives to strategize their product launches by allowing them to -

  • Understand the focal shifts in molecular targets in the NSCLC 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 NSCLC, benchmarked against non-first-in-class targets
  • Assess the valuations of licensed and co-developed NSCLC treatments
  • 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. A High Degree of First-In-Class Innovation in an Active Pipeline
  • 2.2. Increasing Molecular Characterization of Tumors with Concomitant First-in-Class Innovation Alignment
  • 2.3. Stagnant Deals Landscape Higlights 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 Symptoms
  • 4.2. Disease Etiology and Pathophysiology
    • 4.2.1. Adenocarcinoma
    • 4.2.2. Squamous Cell Carcinoma
    • 4.2.3. Large Cell Carcinoma
    • 4.2.4. Diagnosis
    • 4.2.5. Prognosis
  • 4.3. Introduction to NSCLC Treatment
  • 4.4. Surgery and Radiation Therapy
  • 4.5. Treatment Algorithm
    • 4.5.1. First-Line Treatment
    • 4.5.2. Maintenance Therapy
    • 4.5.3. Second-Line Therapy
    • 4.5.4. Third-Line Therapy
    • 4.5.5. Adjuvant Therapy
  • 4.6. Overview of Marketed Products for NSCLC
    • 4.6.1. Molecular Type Analysis
    • 4.6.2. Molecular Target Analysis
    • 4.6.3. Innovative Products in the NSCLC Market
    • 4.6.4. Efficacy and Safety of Marketed Products
    • 4.6.5. Current Unmet Needs

5. Assessment of Pipeline Product Innovation

  • 5.1. NSCLC Pipeline by Molecule Type, Phase and Therapeutic Target
  • 5.2. Comparative Distribution of Programs between the NSCLC Market and Pipeline by Therapeutic Target Family
  • 5.3. First-in-class Pipeline Programs Targeting Novel Molecule Targets

6. Signaling Network, Disease Causation and Innovation Alignment

  • 6.1. The Complexity of Signaling Networks in Oncology
  • 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 PTK2
  • 7.2. Pipeline Programs Targeting Erbb3
  • 7.3. Pipeline Programs Targeting TP53
  • 7.4. Pipeline Programs Targeting CD274
  • 7.5. Pipeline Programs Targeting Akt2
  • 7.6. Pipeline Programs Targeting STAT3
  • 7.7. Pipeline Programs Targeting FGF1
  • 7.8. Pipeline Programs Targeting CDK4
  • 7.9. Pipeline Programs Targeting AURKB
  • 7.10. Pipeline Programs Targeting FNTA
  • 7.11. Pipeline Programs Targeting CHEK1
  • 7.12. Pipeline Programs Targeting HIF1A
  • 7.13. Pipeline Programs Targeting DKK1
  • 7.14. Conclusion

8. Deals and Strategic Consolidations

  • 8.1. Industry-wide First-in-Class Deals
  • 8.2. NSCLC Deals Landscape
  • 8.3. Licensing Deals
  • 8.4. Co-development Deals
  • 8.5. First-in-Class Programs Not Involved in Licensing or Co-Development Deals

9. Appendix

  • 9.1. References
  • 9.2. Abbreviations
  • 9.3. References for Heat Map
  • 9.4. Contact Us
  • 9.5. Disclaimer

List of Tables

  • Table 1: Tumor Node Metastasis Classification
  • Table 2: Stage I-IV Treatment Options - All Histologies
  • Table 3: Stage IIIB-IV Treatment Options - All Histologies
  • Table 4: Chemotherapy Treatment in Late-stage NSCLC Patients with Varied Histologies
  • Table 5: Chemotherapy Treatment in Stage IIIB/IV NSCLC Patients by Regimen
  • Table 6: References for Heat Map

List of Figures

  • Figure 1: Innovation Trends in Product Approvals
  • Figure 2: Sales Performance of First-in-Class and Non-First-in-Class Product post Marketing Approval
  • Figure 3: Molecular Characteristic Frequency (%)
  • Figure 4: Non-Squamous Stage IIIB/IV Treatment Algorithm
  • Figure 5: Squamous Stage IIIB/IV Treatment Algorithm
  • Figure 6: Molecule Types in Marketed Products
  • Figure 7: Targets in Marketed Products
  • Figure 8: DNA Synthesis/Repair Targets
  • Figure 9: Efficacy and Safety Heatmap of Marketed Products
  • Figure 10: Developmental Pipeline Overview
  • Figure 11: Receptor Tyrosine Kinase Molecular Targets
  • 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: First-in-Class Products in the Pipeline, Part 1
  • Figure 15: First-in-Class Products in the Pipeline, Part 2
  • Figure 16: Signaling networks of functional families in NSCLC
  • Figure 17: Signaling network of multi-process functional proteins in NSCLC
  • Figure 18: First-in-Class Molecular Target Analysis Matrix (Part 1)
  • Figure 19: First-in-Class Molecular Target Analysis Matrix (Part 2)
  • Figure 20: Data and Evidence for PTK2 as a Therapeutic Target
  • Figure 21: Pipeline Programs Targeting PTK2
  • Figure 22: Data and Evidence for Erbb3 as a Therapeutic Target
  • Figure 23: Pipeline Programs Targeting ErbB3
  • Figure 24: Data and Evidence for TP53 as a Therapeutic Target
  • Figure 25: Pipeline Programs Targeting P53
  • Figure 26: Data and Evidence for CD274 as a Therapeutic Target
  • Figure 27: Pipeline Programs Targeting CD274
  • Figure 28: Data and Evidence for Akt2 as a Therapeutic Target,
  • Figure 29: e Programs Targeting Akt2
  • Figure 30: Data and Evidence for STAT3 as a Therapeutic Target
  • Figure 31: Pipeline Programs Targeting STAT3
  • Figure 32: Data and Evidence for FGF1 as a Therapeutic Target
  • Figure 33: Pipeline Programs Targeting FGF1
  • Figure 34: Data and Evidence for CDK4 as a Therapeutic Target
  • Figure 35: Pipeline Programs Targeting CDK4
  • Figure 36: Data and Evidence for AURKB as a Therapeutic Target
  • Figure 37: Pipeline Programs Targeting AURKB
  • Figure 38: Data and Evidence for FNTA as a Therapeutic Target
  • Figure 39: Pipeline Programs Targeting FNTA
  • Figure 40: Data and Evidence for CHEK1 as a Therapeutic Target
  • Figure 41: Pipeline Programs Targeting CHEK1
  • Figure 42: Data and Evidence for HIF1A as a Therapeutic Target
  • Figure 43: Pipeline Programs Targeting HIF1A
  • Figure 44: Data and Evidence for DKK1 as a Therapeutic Target
  • Figure 45: Pipeline Programs Targeting DKK1
  • Figure 46: Industry Wide Deals by Stage of Development, 2006-2014
  • Figure 47: Industry Licensing Deal Values by Stage of Development, 2006-2014
  • Figure 48: Licensing Agreements, 2006-2014
  • Figure 49: First-in-Class and Non-First-in-Class Deals Comparison, 2006-2014
  • Figure 50: Regional Network of Licensing Agreements, 2006-2014
  • Figure 51: Licensing Agreements by Molecule Type, 2006-2014
  • Figure 52: Licensing Agreements by Mechanism of Action, 2006-2014
  • Figure 53: Summary of Licensing Deals, 2006-2014
  • Figure 54: Co-development Deals by Year and Phase, 2006-2014
  • Figure 55: Regional Network of Co-development Deals, 2006-2014
  • Figure 56: Co-development Deals by Molecule Type, 2006-2014
  • Figure 57: Co-development Deals by Mechanism of Action, 2006-2014
  • Figure 58: Summary of Co-development Deals, 2006-2014
  • Figure 59: First-in-class Programs with no Recorded Prior Deal Involvement, 2006-2014 (Part 1)
  • Figure 60: First-in-class Programs with no Recorded Prior Deal Involvement, 2006-2014 (Part 2)
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