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イノベーションと臨床試験のトラッキングファクトブック 2017年:医薬品パイプラインの査定

Innovation and Clinical Trial Tracking Factbook 2017: An Assessment of the Pharmaceutical Pipeline

 

出版社 出版年月電子媒体価格ページ数図表数
CBR Pharma Insights
CBRファーマインサイツ
2017年5月US$2,995
シングルユーザライセンス(PDF)
69 75

サマリー

Description

 

GBI Research’s latest report: “Innovation and Clinical Trial Tracking Factbook 2017: An Assessment of the Pharmaceutical Pipeline” is a comprehensive, granular analysis of the 25,522 products currently in the pharmaceutical industry pipeline, from the Discovery stage through to Pre-registration and split into therapy areas and key indications. This pipeline is also benchmarked against its size across each segment compared to 2015 and 2016, and an assessment of the level of first-in-class innovation is provided. In addition, a detailed contextual analysis of the key drivers of this pipeline is provided, in addition to an assessment of companies present in the pipeline and historical deal value and volume.

Innovation, particularly the development of new products, is a crucial element of the pharmaceutical industry. The market is highly research-intensive, being deeply reliant on a high level of R&D investment and a strong product pipeline to maintain growth and ensure long-term revenue generation. Without successful innovation, which can be broadly defined as the market launch of novel therapeutic molecules that cost-effectively treat or cure diseases, the industry would face a substantial long-term decline in revenue.

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 each year since 1994, with the exception of the years 2005–2008, when the proportion was relatively high.

Scope

  • What is the current size and composition of the pharmaceutical industry pipeline and how has it changed in the last two 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 the 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?

  • Historically, what has the risk of clinical trial attrition been across each therapy area and molecule type in the pharmaceutical industry? How long have their associated clinical trials been and how many patients, on average, were recruited?

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

  • Understand and benchmark the risk of attrition, clinical trial duration and size across the pharmaceutical industry



目次

1 Table of Contents 2

1.1 List of Tables 3

1.2 List of Figures 3

2 Introduction 5

2.1 Increasing Cost of Drug Development 7

2.2 Most Drugs Fail to Recuperate R&D Costs 8

2.3 Contracting Life Cycles for Approved Products 9

2.4 The Case for First-in-Class Pharmaceutical Innovation 10

2.5 Conclusion 13

3 Assessment of the Pharmaceutical Industry Pipeline 14

3.1 Pipeline and Clinical Trials Landscape by Therapy Area 14

3.2 Pipeline by Stage of Development 19

3.3 Pipeline by Molecule Type 22

3.4 Key Therapy Areas by Indication 26

3.4.1 Oncology 26

3.4.2 Infectious Diseases 27

3.4.3 Central Nervous System 29

3.4.4 Immunology 32

3.5 Conclusion 33

4 Assessment of Innovation in the Pharmaceutical Industry Pipeline 34

4.1 First-in-Class Innovation by Stage of Development 36

4.2 Key Therapy Areas by Indication 37

4.2.1 Oncology 37

4.2.2 Infectious Diseases 40

4.2.3 Central Nervous System 43

4.2.4 Immunology 46

4.3 Conclusion 48

5 Assessment of the Pharmaceutical Industry Clinical Trial Landscape 49

5.1 Clinical Trial Attrition Rates 49

5.1.1 Therapy area 50

5.1.2 Molecule Type 54

5.2 Clinical Trial Duration 57

5.2.1 Therapy Area 58

5.2.2 Molecule Type 61

5.3 Clinical Trial Size 62

5.3.1 Therapy Area 63

5.3.2 Molecule Type 65

5.4 Conclusion 67

6 Appendix 68

6.1 References 68

6.2 Abbreviations 69

6.3 Contact Us 69

6.4 Disclaimer 69

 

List of Figures

Figure 1: US Life Expectancy by Sex, 1950–2015 5

Figure 2: FDA Approvals, 1987–2015 7

Figure 3: Average Cost of Developing a Novel Drug ($m), 1970–2015 8

Figure 4: Average Lifetime Sales after Tax by Decile ($m), 1990–1994 9

Figure 5: Drivers of Shortened Pharmaceutical Product Life Cycles, 1970–2003 10

Figure 6: FDA Approvals by Innovation Status, 1987–2015 11

Figure 7: Average Sales of First-in-Class and Non-First-in-Class Products After Launch ($m), 2006–2014 12

Figure 8: Average Projected Sales of First-in-Class and Non-First-in-Class Products Launched in 2015 ($m), 2016–2022 13

Figure 9: Pipeline Products by Stage and Molecule Type, Q1 2017 14

Figure 10: Pipeline Products by Therapy Area, Q1 2017 15

Figure 11: Overall Pipeline, Number of Products and Pipeline Growth by Therapy Area, Q1 2015–Q1 2017 16

Figure 12: Number of Clinical Trials Initiated, 2006–2016 17

Figure 13: Number of Clinical Trials Initiated by Therapy Area, 2006–2016 18

Figure 14: Pipeline Products by Therapy Area and Stage of Development (%), Q1 2017 20

Figure 15: Pipeline Products by Therapy Area and Stage of Development, Q1 2017 21

Figure 16: Pipeline Products by Therapy Area and Molecule Type, Q1 2017 23

Figure 17: Pipeline Products by Therapy Area and Molecule Type, Q1 2017 24

Figure 18: Oncology Pipeline Products by Indication, Q1 2017 26

Figure 19: Oncology Pipeline, Number of Products by Indication, Q1 2015–Q1 2016 27

Figure 20: Infectious Disease Pipeline, Number of Products by Indication, Q1 2017 28

Figure 21: Infectious Disease Pipeline, Number of Products and Pipeline Growth by Indication, Q1 2015–Q1 2016 29

Figure 22: Central Nervous System Pipeline, Number of Products by Indication, Q1 2017 30

Figure 23: Central Nervous System Pipeline, Number of Products and Pipeline Growth by Indication, Q1 2015–Q1 2017 31

Figure 24: Immunology Pipeline, Number of Products by Indication, Q1 2017 32

Figure 25: Immunology Pipeline, Number of Products and Pipeline Growth by Indication, Q1 2015–Q1 2017 33

Figure 26: Pipeline Products by Therapy Area and Proportion of Established and First-in-Class Products, Q1 2017 34

Figure 27: First-in-Class Pipeline, Number of Products and Pipeline Growth by Therapy Area, Q1 2015–Q1 2017 35

Figure 28: First-in-class Pipeline Products by Therapy Area and Stage of Development, Q1 2017 37

Figure 29: First-in-Class Oncology Pipeline Products by Indication, Q1 2017 37

Figure 30: First-in-Class Oncology Pipeline, Number of Products and Pipeline Growth by Indication, Q1 2015–Q1 2017 38

Figure 31: First-in-Class Infectious-Diseases Pipeline Products by Indication, Q1 2016 40

Figure 32: First-in-Class Infectious Disease Pipeline, Number of Products and Pipeline Growth by Indication, Q1 2015–Q1 2016 41

Figure 33: First-in-Class Central Nervous System Disorder Pipeline Products by Indication, Q1 2016 43

Figure 34: First-in-Class Central Nervous System Disorder Pipeline, Number of Products and Pipeline Growth by Indication, Q1 2015–Q1 2016 44

Figure 35: First-in-Class Immunology Disorder Pipeline, Number of Products by Indication, Q1 2016 46

Figure 36: First-in-Class Immunology Pipeline, Number of Products and Pipeline Growth by Indication, Q1 2015–Q1 2016 47

Figure 37: Pharmaceutical Industry, Clinical Trial Failure and Attrition Rates, 2006–Q1 2017 50

Figure 38: Pharmaceutical Industry, Clinical Trial Failure Rates in Phase I by Therapy Area, 2006–Q1 2017 50

Figure 39: Pharmaceutical Industry, Clinical Trial Failure Rates in Phase II by Therapy Area, 2006–Q1 2017 51

Figure 40: Pharmaceutical Industry, Clinical Trial Failure Rates in Phase III by Therapy Area, 2006–Q1 2017 51

Figure 41: Pharmaceutical Industry, Clinical Trial Attrition Rates Therapy Area, 2006–Q1 2017 52

Figure 42: Pharmaceutical Industry, Clinical Trial Failure Rates in Phase I by Molecule Type, 2006–Q1 2017 54

Figure 43: Pharmaceutical Industry, Clinical Trial Failure Rates in Phase II by Molecule Type, 2006–Q1 2017 54

Figure 44: Pharmaceutical Industry, Clinical Trial Failure Rates in Phase III by Molecule Type, 2006–Q1 2017 55

Figure 45: Pharmaceutical Industry, Clinical Trial Attrition Rates by Molecule Type, 2006–Q1 2017 56

Figure 46: Pharmaceutical Industry, Clinical Trial Duration by Stage of Development, 2006–Q1 2017 57

Figure 47: Pharmaceutical Industry, Clinical Trial Duration in Phase I by Therapy Area, 2006–Q1 2017 58

Figure 48: Pharmaceutical Industry, Clinical Trial Duration in Phase II by Therapy Area, 2006–Q1 2017 59

Figure 49: Pharmaceutical Industry, Clinical Trial Duration in Phase III by Therapy Area, 2006–Q1 2017 60

Figure 50: Pharmaceutical Industry, Clinical Trial Duration in Phase I by Molecule Type, 2006–Q1 2017 61

Figure 51: Pharmaceutical Industry, Clinical Trial Duration in Phase II by Molecule Type, 2006–Q1 2017 61

Figure 52: Pharmaceutical Industry, Clinical Trial Duration in Phase III by Molecule Type, 2006–Q1 2017 62

Figure 53: Pharmaceutical Industry, Clinical Trial Size by Stage of Development, 2006–Q1 2017 63

Figure 54: Pharmaceutical Industry, Clinical Trial Size in Phase I by Therapy Area, 2006–Q1 2017 63

Figure 55: Pharmaceutical Industry, Clinical Trial Size in Phase II by Therapy Area, 2006–Q1 2017 64

Figure 56: Pharmaceutical Industry, Clinical Trial Size in Phase III by Therapy Area, 2006–Q1 2017 64

Figure 57: Pharmaceutical Industry, Clinical Trial Size in Phase I by Molecule Type, 2006–Q1 2017 65

Figure 58: Pharmaceutical Industry, Clinical Trial Size in Phase II by Molecule Type, 2006–Q1 2017 66

Figure 59: Pharmaceutical Industry, Clinical Trial Size in Phase III by Molecule Type, 2006–Q1 2017 66

 

List of Tables

Table 1: Trends in Clinical Trial Protocol Complexity, 2000–2011 8

Table 2: Pipeline Products by Therapy Area, 2015–Q1 2017 17

Table 3: Number of Clinical Trials Initiated by Therapy Area, 2006–2016 19

Table 4: Pipeline Products by Therapy Area and Stage of Development, Q1 2017 22

Table 5: Pipeline Products by Therapy Area and Molecule Type, Q1 2017 25

Table 6: First-in-Class Pipeline Products by Therapy Area, Q1 2015–Q1 2017 36

Table 7: First-in-Class Oncology Pipeline Products by Indication, Q1 2015–Q1 2017 39

Table 8: First-in-Class Infectious Diseases Pipeline Products by Indication, Q1 2015–Q1 2016 42

Table 9: First-in-Class Central Nervous System Disorder Pipeline Products by Indication, Q1 2015–Q1 2016 45

Table 10: First-in-Class Immunology Pipeline Products by Indication, Q1 2015–Q1 2016 48

Table 11: Pharmaceutical Industry, Clinical Trial Failure and Attrition Rates by Therapy Area, 2006–Q1 2017 53

Table 12: Pharmaceutical Industry, Clinical Trial Failure and Attrition Rates by Molecule Type, 2006–Q1 2017 56

Table 13: Pharmaceutical Industry, Median Clinical Trial Duration by Therapy Area (Months), 2006–Q1 2017 60

Table 14: Pharmaceutical Industry, Clinical Trial Duration by Molecule Type, 2006–Q1 2017 62

Table 15: Pharmaceutical Industry, Median Clinical Trial Size by Therapy Area (Participants), 2006–Q1 2017 65

Table 16: Pharmaceutical Industry, Clinical Trial Size by Molecule Type, 2006–Q1 2017 67

 

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