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Frontier Pharma:非小細胞肺癌(NSCLC)- First-in-Class的革新認識和商業化

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

出版商 GBI Research 商品編碼 318230
出版日期 內容資訊 英文 93 Pages
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Frontier Pharma:非小細胞肺癌(NSCLC)- First-in-Class的革新認識和商業化 Frontier Pharma: Non-Small Cell Lung Cancer - Identifying and Commercializing First-in-Class Innovation
出版日期: 2014年10月31日 內容資訊: 英文 93 Pages





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
  • 分子標的多樣化
  • 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、給付政策,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

  • 疾病的症狀
  • 疾病的病因與病情生理
  • NSCLC治療概要
  • 手術和放射線治療
  • 治療流程
  • NSCLC上市產品概要
    • 分子類型分析
    • 分子標的分析
    • NSCLC市場創新的產品
    • 上市產品的功效和安全性
    • 目前未滿足需求

第5章 開發中產品革新的評估

  • NSCLC開發平台:各分子類型、階段、治療標的
  • NSCLC市場與開發平台計劃比較分佈:各治療標的系列
  • 新分子標的First-in-Class開發平台計劃

第6章 信號(信號傳達)網路、疾病的因果關係、革新的調整

  • 腫瘤學的信號傳達網路的複雜
  • 信號傳達途徑,成為疾病原因的變異,First-in-Class分子標的整合
  • First-in-Class標的矩陣的評估

第7章 First-in-Class標的評估

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

第8章 與交易策略性整合

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

第9章 附錄


Product Code: GBIHC341MR


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.


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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