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肥満 - ファーストインクラスの技術革新の特定と商品化

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

発行 GBI Research 商品コード 345477
出版日 ページ情報 英文 87 Pages
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肥満 - ファーストインクラスの技術革新の特定と商品化 Frontier Pharma: Obesity - Identifying and Commercializing First-in-Class Innovation
出版日: 2015年10月01日 ページ情報: 英文 87 Pages
概要

肥満は世界的な健康問題です。肥満患者の健康リスクを大幅に低減するために、減量のための生活習慣の改善に加え薬物療法が用いられています。しかし現在入手可能な肥満治療薬は長期的な安全性の低さと緩やかな減量効果によって大きく制限されています。

当レポートでは、世界の肥満治療薬市場について調査し、現在のアンメットニーズとパイプライン動向、革新的製品の概要、今後の見通しなどをまとめています。

第1章 目次

第2章 エグゼクティブサマリー

  • 肥満市場における高いアンメットニーズ
  • 非常に革新的かつ多様なパイプライン
  • 取引環境が持続的投資の機会に

第3章 技術革新事例

  • 生物製剤の機会拡大
  • 分子標的の多用か
  • 革新的ファーストインクラス製品開発の魅力
  • 法規制、償還政策がファーストインクラス製品の技術革新に
  • 持続的技術革新
  • GBIリサーチレポートガイダンス

第4章 臨床的および商業的環境

  • 疾患の概要
  • 病因
  • 病態生理学
  • 疫学
  • 分類と診断
  • 併存疾患
  • 予後
  • 治療アルゴリズムおよび治療法
  • 上市済み製品の概要
  • 現在のアンメットニーズ

第5章 パイプライン製品の技術革新評価

  • 分子別、相別、治療標的別パイプライン
  • 肥満市場と治療標的ファミリー別パイプラインとの間のプログラム比較分布
  • 新規分子標的を標的としたファーストインクラスパイプラインプログラム

第6章 シグナリング経路、遺伝学、技術革新

  • 肥満のシグナリングネットワークの複雑さ
  • シグナリング経路、遺伝的リスクファクター、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評価

第7章 ファーストインクラス標的評価

第8章 取引と戦略的連携

  • 業界におけるファーストインクラス取引
  • ライセンシング
  • 共同開発
  • ライセンシングまたは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

目次
Product Code: GBIHC371MR

Executive Summary

Obesity is a major growing health concern around the world. In most markets, a person is considered obese if their Body Mass Index (BMI) exceeds 30 kilograms per square meter (kg/m2), calculated by dividing body mass in kilograms by height in meters squared. With the global prevalence continuing to rise, the disease has placed significant burden on healthcare expenditure, as it is also a major risk factor for cardiovascular diseases, diabetes and cancer.

Anti-obesity pharmacotherapy can be used as an adjunct lifestyle modification to improve weight loss in order to significantly reduce obesity-associated health risks in obese patients. However, the use of currently available anti-obesity drugs is largely limited by poor long-term safety and a modest weight loss effect. Despite substantial clinical and regulatory challenges, the early-stage obesity pipeline remains robust, containing a high level of first-in-class innovation that has the potential to be translated into effective and safe weight loss treatments.

Scope

Historically, the obesity market has suffered from long-term safety concerns and modest efficacy with current treatments, both of which contribute to the low prescription rate and limited widespread use.

  • What are the main safety concerns that lead to significant challenges in gaining drug approval in obesity?
  • Why is sustainable weight loss difficult to achieve, and what is the implication for future drug development?

Analysis reveals a high level of innovation and diversity in the pipeline, with 75 first-in-class programs identified to act on 60 unique molecular targets.

  • What is the dominant target family across these first-in-class pipeline products?
  • How well do they align with the underlying signaling pathways governing the central and peripheral regulation of food intake, and energy expenditure?

Some first-in-class targets are deemed more likely to be developed into marketable treatments than others, having demonstrated substantial body weight reduction in Preclinical studies and addressing multiple mechanisms underpinning the development of obesity.

  • What is the scientific rationale behind these targets? How are they likely to surpass existing treatment?
  • Apart from body weight change, what other parameters are commonly used to measure the effect of investigational therapies?

Deals involving first-in-class obesity products are more likely to be made in earlier stages of development than non-first-in-class deals, supported by industry-wide analysis.

  • What is the dominant molecular target in the obesity 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 disease pathogenesis, diagnosis, prognosis, and the available treatment options and their limitations in terms of safety and efficacy.
  • Visualize the composition of the obesity market to highlight the current unmet needs in order to gain a competitive understanding of the key opportunities.
  • Analyze the obesity pipeline and stratify by stage of development, molecule type, and molecular target; the diversity of molecular targets in the pipeline is extremely encouraging as obesity is characterized by the complex interplay between central and peripheral mechanisms.
  • 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 obesity 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 Need Remains in the Obesity Market
  • 2.2. Highly Innovative and Diverse Pipeline
  • 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. Disease Etiology
    • 4.2.1. Genetics
  • 4.3. Disease Pathophysiology
    • 4.3.1. Central Regulation of Energy Homeostasis
    • 4.3.2. Endocrine Regulation in Energy Balance
    • 4.3.3. Adipose Tissue and Regulation of Energy Expenditure
    • 4.3.4. Dysregulation of Adipokines and Contribution to Obesity and Related Metabolic Disorders
  • 4.4. Epidemiology
  • 4.5. Classification and Diagnosis
  • 4.6. Co-morbidities
    • 4.6.1. Type 2 Diabetes
    • 4.6.2. Hypertension
    • 4.6.3. Dyslipidemia and Cardiovascular Diseases
    • 4.6.4. Respiratory Complications
    • 4.6.5. Osteoarthritis
    • 4.6.6. Cancer Risk
  • 4.7. Prognosis
  • 4.8. Treatment Algorithm and Options
    • 4.8.1. Lifestyle and Behavioral Modification
    • 4.8.2. Bariatric Surgery
    • 4.8.3. Pharmacotherapy
  • 4.9. Overview of Marketed Products
    • 4.9.1. Molecule Type and Target Analysis
    • 4.9.2. Major Drug Withdrawals in the Obesity Market
    • 4.9.3. Significant Challenges with Reimbursement in the Obesity Market
  • 4.10. Current Unmet Needs

5. Assessment of Pipeline Product Innovation

  • 5.1. Obesity Pipeline by Molecule Type, Phase and Therapeutic Target
  • 5.2. Comparative Distribution of Programs between Obesity 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 Obesity
  • 6.2. Signaling Pathways, Genetic Risk Factors 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 Growth Hormone Secretagogue Receptor 1a and Ghrelin
  • 7.2. Pipeline Programs Targeting Neuropeptide Y Receptor 2
  • 7.3. Pipeline Programs Targeting Neuropeptide Y Receptor 1
  • 7.4. Pipeline Programs Targeting Adipocyte Fatty Acid Binding Protein 4
  • 7.5. Pipeline Programs Targeting Sterol Regulatory Element-Binding Protein 1 and 2
  • 7.6. Pipeline Programs Targeting Glycoprotein 130 Receptor
  • 7.7. Pipeline Programs Targeting Bombesin Receptor Subtype 3
  • 7.8. Pipeline Programs Targeting Acetyl-CoA Carboxylase 1 and 2
  • 7.9. Pipeline Programs Targeting Stearoyl-CoA Desaturase 1
  • 7.10. Pipeline Programs Targeting Bone Morphogenetic Protein-7
  • 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. References
  • 9.3. Methodology
  • 9.4. Secondary Research
  • 9.5. Contact Us
  • 9.6. Disclaimer

List of Tables

  • Table 1: The International Classification of Underweight, Overweight and Obesity in Adults
  • Table 2: Treatment Options Dependent on Body Mass Index

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: Molecular Targets of Marketed Products, 2015
  • Figure 4: Developmental Pipeline Overview
  • Figure 5: Players in the Obesity Pipeline
  • Figure 6: Developmental Pipeline Overview
  • Figure 7: Molecular Target Category Comparison, Pipeline and Marketed Products
  • Figure 8: Molecular Target Category Comparison, Pipeline First-in-Class and Established Molecular Targets
  • Figure 9: Obesity, Global, First-in-Class Pipeline Products
  • Figure 10: Signaling Networks of Functional Families in Obesity
  • Figure 11: Location of Key First-in-Class Targets within the Signaling Matrix
  • Figure 12: First-in-Class Molecular Target Analysis Matrix
  • Figure 13: Data and Evidence for Growth Hormone Secretagogue Receptor 1a as a Therapeutic Target
  • Figure 14: Pipeline Programs Targeting Growth Hormone Secretagogue Receptor 1a and Ghrelin
  • Figure 15: Data and Evidence for Neuropeptide Y Receptor 2 as a Therapeutic Target
  • Figure 16: Pipeline Programs Targeting Neuropeptide Y Receptor 2
  • Figure 17: Data and Evidence for Neuropeptide Y Receptor 1 as a Therapeutic Target
  • Figure 18: Pipeline Programs Targeting Neuropeptide Y Receptor 1
  • Figure 19: Data and Evidence for Adipocyte Fatty Acid Binding Protein 4as a Therapeutic Target
  • Figure 20: Pipeline Programs Targeting Adipocyte Fatty Acid Binding Protein 4
  • Figure 21: Data and Evidence for Sterol Regulatory Element-Binding Protein 1 and 2 as a Therapeutic Target
  • Figure 22: Pipeline Programs Targeting Sterol Regulatory Element-Binding Protein 1 and 2
  • Figure 23: Data and Evidence for Glycoprotein 130 Receptor as a Therapeutic Target
  • Figure 24: Pipeline Programs Targeting Glycoprotein 130 Receptor
  • Figure 25: Data and Evidence for Bombesin Receptor Subtype 3 as a Therapeutic Target
  • Figure 26: Pipeline Programs Targeting Bombesin Receptor Subtype 3
  • Figure 27: Data and Evidence for Acetyl-CoA Carboxylase 1 and 2 as a Therapeutic Target
  • Figure 28: Pipeline Programs Targeting Acetyl-CoA Carboxylase 1 and 2
  • Figure 29: Data and Evidence for Stearoyl-CoA Desaturase 1 as a Therapeutic Target
  • Figure 30: Pipeline Programs Targeting Stearoyl-CoA Desaturase 1
  • Figure 31: Data and Evidence for Bone Morphogenetic Protein-7 as a Therapeutic Target
  • Figure 32: Pipeline Programs Targeting Bone Morphogenetic Protein-7
  • Figure 33: Industry-Wide Deals by Stage of Development, 2006-2014
  • Figure 34: Industry-Wide Deals by Stage of Development, 2006-2014
  • Figure 35: Licensing Deals in Obesity, 2006-2015
  • Figure 36: Licensing Deals, Global Distribution, 2006-2015
  • Figure 37: Licensing Deals by Molecule Type and Value, 2006-2015
  • Figure 38: Licensing Deals by Molecular Target, 2006-2015
  • Figure 39: Summary of Licensing Deals in Obesity, 2006-2015
  • Figure 40: Co-development Deals in Obesity, 2006-2015
  • Figure 41: Co-development Deals Global Distribution, 2006-2015
  • Figure 42: Co-development Deals by Molecule Type, 2006-2015
  • Figure 43: Co-development Deals by Molecular Target, 2006-2015
  • Figure 44: Summary of Co-Development Deals in Obesity, 2006-2015
  • Figure 45: First-in-Class Programs with No Recorded Prior Deal Involvement, 2006-2015
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