Innovation and Clinical Trial Tracking Factbook 2017

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.

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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.

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

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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

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

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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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