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Innovation Tracking Factbook 2016 - An Assessment of the Pharmaceutical Pipeline

Published: Jun 16, 2016 | Pages: 70 | Publisher: CBR Pharma Insights | Industry: Pharmaceutical | Report Format: Electronic (PDF)

GBI Research’s latest report: “Innovation Tracking Factbook 2016: An Assessment of the Pharmaceutical Pipeline” is a comprehensive, granular analysis of the 20,756 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 in 2015, 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 since Q1 2015? 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?
-What strategies have companies typically been pursuing with their pipeline portfolio, in terms of how diverse, specialized or innovative they have been? Specifically, what strategies have the top 25 pharmaceutical companies been following?
-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

This report will allow you to:

-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
 Table of Contents

1 Table of Contents
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 28
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 38
4.2.1 Oncology 38
4.2.2 Infectious Diseases 41
4.2.3 Central Nervous System 43
4.2.4 Immunology 47
4.3 Conclusion 49

5 Company Analysis 50
5.1 Conclusion 54

6 Deals Analysis 55
6.1 Licensing Deals 55
6.2 Co-development Deals 60
6.3 Mergers and Acquisitions 65
6.4 Capital Raising 67

7 Appendix 69
7.1 References 69
7.2 Contact Us 70
7.3 Disclaimer 70
List of Table

Table 1: Trends in Clinical Trial Protocol Complexity, 2000-2011 8
Table 2: Pipeline Products by Therapy Area, 2015-Q1 2016 17
Table 3: Number of Clinical Trials Initiated by Therapy Area, 2006-2015 19
Table 4: Pipeline Products by Therapy Area and Stage of Development 22
Table 5: Pipeline Products by Therapy Area and Molecule Type, Q1 2016 25
Table 6: First-in-Class Pipeline Products by Therapy Area, Q1 2015-Q1 2016 36
Table 7: First-in-Class Oncology Pipeline Products by Indication, Q1 2015-Q1 2016 40
Table 8: First-in-Class Infectious Diseases Pipeline Products by Indication, Q1 2015-Q1 2016 43
Table 9: First-in-Class Central Nervous System Disorder Pipeline Products by Indication, Q1 2015-Q1 2016 46
Table 10: First-in-Class Immunology Pipeline Products by Indication, Q1 2015-Q1 2016 49
Table 11: Licensing Deal Value and Volume, 2006-Q1 2016 56
Table 12: Number of Licensing Deals by Therapy Area, 2006-Q1 2016 58
Table 13: Aggregate Licensing Deal Value by Therapy Area ($m), 2006-Q1 2016 59
Table 14: Co-development Deal Value and Volume, 2006-Q1 2016 61
Table 15: Co-development Deal Volume by Therapy Area, 2006-Q1 2016 63
Table 16: Co-development Deal Value by Therapy Area ($m), 2006-Q1 2016 64
Table 17: Merger and Acquisition Deal Value and Volume, 2006-Q1 2016 66
Table 18: Capital Raising Value and Volume, 2006-Q1 2016 68

List of Chart

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 12
Figure 9: Pipeline Products by Stage and Molecule Type, Q1 2016 14
Figure 10: Pipeline Products by Therapy Area, Q1 2016 15
Figure 11: Overall Pipeline, Number of Products and Pipeline Growth by Therapy Area, Q1 2015-Q1 2016 16
Figure 12: Number of Clinical Trials Initiated, 2006-2015 17
Figure 13: Number of Clinical Trials Initiated by Therapy Area, 2006-2015 18
Figure 14: Pipeline Products by Therapy Area and Stage of Development (%), Q1 2016 20
Figure 15: Pipeline Products by Therapy Area and Stage of Development Q1 2016 21
Figure 16: Pipeline Products by Therapy Area and Molecule Type, Q1 2016 23
Figure 17: Pipeline Products by Therapy Area and Molecule Type, Q1 2016 24
Figure 18: Oncology Pipeline Products by Indication, Q1 2016 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 2016 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 2016 30
Figure 23: Central Nervous System Pipeline, Number of Products and Pipeline Growth by Indication, Q1 2015-Q1 2016 31
Figure 24: Immunology Pipeline, Number of Products by Indication, Q1 2016 32
Figure 25: Immunology Pipeline, Number of Products and Pipeline Growth by Indication, Q1 2015-Q1 2016 33
Figure 26: Pipeline Products by Therapy Area and Proportion of Established and First-in-Class Products, Q1 2016 34
Figure 27: First-in-Class Pipeline, Number of Products and Pipeline Growth by Therapy Area, Q1 2015-Q1 2016 35
Figure 28: First-in-class Pipeline Products by Therapy Area and Stage of Development, Q1 2016 37
Figure 29: First-in-Class Oncology Pipeline Products by Indication, Q1 2016 38
Figure 30: First-in-Class Oncology Pipeline, Number of Products and Pipeline Growth by Indication, Q1 2015-Q1 2016 39
Figure 31: First-in-Class Infectious-Diseases Pipeline Products by Indication, Q1 2016 41
Figure 32: First-in-Class Infectious Disease Pipeline, Number of Products and Pipeline Growth by Indication, Q1 2015-Q1 2016 42
Figure 33: First-in-Class Central Nervous System Disorder Pipeline Products by Indication, Q1 2016 44
Figure 34: First-in-Class Central Nervous System Disorder Pipeline, Number of Products and Pipeline Growth by Indication, Q1 2015-Q1 2016 45
Figure 35: First-in-Class Immunology Disorder Pipeline, Number of Products by Indication, Q1 2016 47
Figure 36: First-in-Class Immunology Pipeline, Number of Products and Pipeline Growth by Indication, Q1 2015-Q1 2016 48
Figure 37: Companies by Number of Pipeline Products, Q1 2016 50
Figure 38: Number of Therapy Areas Covered by Company Pipelines, Q1 2016 51
Figure 39: Companies by Number of First-in-Class Products, Q1 2016 51
Figure 40: Top 25 Pharmaceutical Pipeline Portfolios by Stage of Development, Q1 2016 52
Figure 41: Top 25 Pharmaceutical Pipeline Portfolios by Therapy Area, Q1 2016 53
Figure 42: Top 25 Pharmaceutical Pipeline Portfolios, First-in-Class Products by Therapy Area, Q1 2016 54
Figure 43: Licensing Deal Value and Volume, 2006-Q1 2016 55
Figure 44: Number and Value of Licensing Deals by Therapy Area, 2006-2015 57
Figure 45: Co-development Deal Value and Volume, 2006-Q1 2016 60
Figure 46: Co-development Deal Value and Volume by Therapy Area, 2006-2015 62
Figure 47: Merger and Acquisition Deal Value and Volume, 2006-Q1 2016 65
Figure 48: Capital Raising Value and Volume, 2006-Q1 2016 67 



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