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イノベーショントラッキングファクトブック 2018年:医薬品パイプラインの査定

Innovation Tracking Factbook 2018: An Assessment of the Pharmaceutical Pipeline

 

出版社 出版年月電子版価格
CBR Pharma Insights
CBRファーマインサイツ
2018年12月US$2,995
シングルユーザライセンス(PDF)

サマリー

米国調査会社CBRファーマインサイツ(CBR Pharma Insights、GBIリサーチ社の傘下)の調査レポート「イノベーショントラッキングファクトブック 2018年:医薬品パイプラインの査定」は、新薬発見から予備登録の段階まで、現在医薬品産業のパイプラインにある25,284の製品の詳細な分析を治療分野や効能毎に区分して分析している。2015年第一四半期から2018年第三四半期までのそれぞれのセグメントの規模も評価している。主要な治療分野の促進要因の詳細な文脈解析や、画期的医薬品(ファースト・イン・クラス)のレベルについても査定している。

Description


GBI Research’s latest report “Innovation Tracking Factbook 2018: An Assessment of the Pharmaceutical Pipeline” is a comprehensive, granular analysis of the 25,284 products currently in the pharmaceutical industry pipeline, from the Discovery stage through to Pre-registration and split into key therapy areas and indications. This pipeline is also benchmarked against its size across each segment compared from Q1 2015 to Q3 2018. In addition, a detailed contextual analysis of the drivers of this pipeline in key therapy areas and an assessment of the level of first-in-class innovation is also provided.

Innovation in developing new products is the key element in growth in the pharmaceutical industry. The market is highly research-intensive, powered by high R&D investment, and it possesses a strong product pipeline to maintain growth and ensure long-term revenue generation. The perks of successful innovation are high, and without successful innovation companies would see a long decline in their growth. A particular focus of this report is placed on analysis of the development of innovative drugs, specifically first-in-class innovation. Over recent decades, in addition to an increase in the yearly number of new chemical entity approvals by the FDA, the number and proportion of these approvals that were first-in-class at the time of approval have also increased. The proportion of first-in-class approvals has increased steadily most years since 2002.

Scope

  • What is the current size and composition of the pharmaceutical industry pipeline and how has it changed in the last four years? What can we learn from this?

  • The largest therapy area, by a substantial margin, is oncology, and, with growth in the pipeline sizes for all major oncology indications since Q1 2015, this trend appears set to continue. Why is this case?

  • What is the overall advantage for companies including first-in-class product developments in their pipeline portfolio, rather than opting for better-characterized established molecular targets?

  • What factors have been driving the increasing number of first-in-class product approvals over recent decades?

  • What key discernible trends have appeared in the strategic consolidations landscape in the past decade and which disease areas have been most active?

Reasons To Buy

  • Achieve an up-to-date understanding of the landscape of the overall pharmaceutical pipeline, on both a broad and granular level; this also provides a highly accessible reference which is useful in any pharmaceutical strategic decision making process

  • Benchmark key therapy areas and indications in terms of the number of pipeline products and level of innovation, and assess one’s own strategic positioning against this backdrop

  • Understand the contemporary role and importance of radical and incremental innovation within the various disease areas and indications

  • Make key decisions about the role of innovation within one’s own pipeline portfolio



目次

1 Table of Contents 3

1.1 List of Tables 4

1.2 List of Figures 4

2 Introduction 6

2.1 Increasing Cost of Drug Development 9

2.2 Most Drugs Fail to Recuperate R&D Costs 10

2.3 Contracting Life Cycles for Approved Products 11

2.4 The Case for First-in-Class Pharmaceutical Innovation 13

2.5 Status of Innovation in Rare Diseases 14

2.6 Conclusion 16

3 Assessment of Pharmaceutical Industry Pipeline 17

3.1 Pipeline and Clinical Trials Landscape by Therapy Area 18

3.2 Pipeline by Stage of Development 24

3.3 Pipeline by Molecule Type 26

3.4 Key Therapy Areas by Indication 30

3.4.1 Oncology 30

3.4.2 Infectious Diseases 32

3.4.3 Central Nervous System 34

3.4.4 Immunology 36

3.5 Conclusion 38

4 Assessment of Innovation in the Pharmaceutical Industry Pipeline 39

4.1 First-in-Class Innovation by Stage of Development 42

4.2 Key Therapy Areas by Indication 43

4.2.1 Oncology 43

4.2.2 Infectious Diseases 46

4.2.3 Central Nervous System 49

4.2.4 Immunology 52

4.3 Conclusion 54

5 Appendix 55

5.1 References 55

5.2 Abbreviations 56

5.3 Contact Us 56

5.4 Disclaimer 57

 

List of Figures

 

Figure 1: US Life Expectancy by Sex, 1950–2017 6

Figure 2: FDA Approvals, 1993–2018 8

Figure 3: Average Cost of Developing a Novel Drug ($m), 1970–2016 9

Figure 4: Projected R&D Returns (%), 2010-2017 10

Figure 5: Drivers of Shortened Pharmaceutical Product Life Cycles, 1970–2011 11

Figure 6: Patent Challenges by Generic Companies 12

Figure 7: FDA Approvals by Innovation Status, 1987–2017 13

Figure 8: Average Sales of First-in-Class and Non-First-in-Class Products After Launch ($m), 2006–2014 14

Figure 9: Average Projected Sales of First-in-Class and Non-First-in-Class Products Launched in 2015 ($m), 2016–2022 14

Figure 10: FDA Orphan Drug Approvals, 1983–2017 15

Figure 11: Pipeline Products by Stage and Molecule Type, Q3 2018 17

Figure 12: Pipeline Products by Therapy Area, Q3 2018 18

Figure 13: Overall Pipeline, Number of Products and Pipeline Growth by Therapy Area, Q1 2015–Q3 2018 19

Figure 14: Number of Clinical Trials Initiated, 2007–2017 21

Figure 15: Number of Clinical Trials Initiated by Therapy Area, 2007–2017 22

Figure 16: Pipeline Products by Therapy Area and Stage of Development (%), Q3 2018 24

Figure 17: Pipeline Products by Therapy Area and Stage of Development, Q3 2018 25

Figure 18: Pipeline Products by Therapy Area and Molecule Type, Q3 2018 27

Figure 19: Pipeline Products by Therapy Area and Molecule Type, Q3 2018 28

Figure 20: Oncology Pipeline Products by Indication, Q3 2018 30

Figure 21: Oncology Pipeline, Number of Products by Indication, Q1 2015–Q3 2018 31

Figure 22: Infectious Disease Pipeline, Number of Products by Indication, Q3 2018 32

Figure 23: Infectious Disease Pipeline, Number of Products and Pipeline Growth by Indication, Q1 2015–Q3 2018 33

Figure 24: Central Nervous System Pipeline, Number of Products by Indication, Q3 2018 34

Figure 25: Central Nervous System Pipeline, Number of Products and Pipeline Growth by Indication, Q1 2015–Q3 2018 35

Figure 26: Immunology Pipeline, Number of Products by Indication, Q3 2018 36

Figure 27: Immunology Pipeline, Number of Products and Pipeline Growth by Indication, Q1 2015–Q3 2018 37

Figure 28: Pipeline Products by Therapy Area and Proportion of Established and First-in-Class Products, Q3 2018 39

Figure 29: First-in-Class Pipeline, Number of Products and Pipeline Growth by Therapy Area, Q1 2015–Q3 2018 40

Figure 30: First-in-class Pipeline Products by Therapy Area and Stage of Development, Q3 2018 42

Figure 31: First-in-Class Oncology Pipeline Products by Indication, Q3 2018 43

Figure 32: First-in-Class Oncology Pipeline, Number of Products and Pipeline Growth by Indication, Q1 2015–Q3 2018 44

Figure 33: First-in-Class Infectious-Diseases Pipeline Products by Indication, Q3 2018 46

Figure 34: First-in-Class Infectious Disease Pipeline, Number of Products and Pipeline Growth by Indication, Q1 2015–Q3 2018 47

Figure 35: First-in-Class Central Nervous System Disorder Pipeline Products by Indication, Q3 2018 49

Figure 36: First-in-Class Central Nervous System Disorder Pipeline, Number of Products and Pipeline Growth by Indication, Q1 2015–Q3 2018 50

Figure 37: First-in-Class Immunology Disorder Pipeline, Number of Products by Indication, Q3 2018 52

Figure 38: First-in-Class Immunology Pipeline, Number of Products and Pipeline Growth by Indication, Q1 2015–Q3 2018 53

 

List of Tables

 

Table 1: Trends in Clinical Trial Protocol Complexity, 2001–2015 9

Table 2: Pipeline Products by Therapy Area, 2015–Q3 2018 20

Table 3: Number of Clinical Trials Initiated by Therapy Area, 2007–2017 23

Table 4: Pipeline Products by Therapy Area and Stage of Development, Q3 2018 26

Table 5: Pipeline Products by Therapy Area and Molecule Type, Q3 2018 29

Table 6: First-in-Class Pipeline Products by Therapy Area, Q1 2015–Q3 2018 41

Table 7: First-in-Class Oncology Pipeline Products by Indication, Q1 2015–Q3 2018 45

Table 8: First-in-Class Infectious Diseases Pipeline Products by Indication, Q1 2015–Q3 2018 48

Table 9: First-in-Class Central Nervous System Disorder Pipeline Products by Indication, Q1 2015–Q3 2018 51

Table 10: First-in-Class Immunology Pipeline Products by Indication, Q1 2015–Q3 2018 54

 

 

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