1 Table of Contents

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

Innovation Tracking Factbook 2018: An Assessment of the Pharmaceutical Pipeline

Summary

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