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Innovation Tracking Factbook 2018: An Assessment of the Pharmaceutical Pipeline

  • ID: 4745316
  • Report
  • Region: Global
  • 57 Pages
  • CBR Pharma Insights
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Innovation Tracking Factbook 2018: An Assessment of the Pharmaceutical Pipeline

Summary

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. One of the methods companies use to gain more revenue is developing first-in-class products.

Though developing first-in-class products requires high investment in terms of time and money, it has proven to result in blockbuster drugs, when compared with me-too products. The perks of successful innovation are high, and without successful innovation companies would see a long decline in their growth.

All the therapy areas have shown growth in their pipeline size, of which the genetic disorders pipeline observed the highest change of nearly 130%. 80% of the rare diseases are genetic in origin, and progress in terms of understanding these diseases at the molecular and genome level is helping to create new medicines. Increasing patient population and high level of unmet needs in most of the diseased conditions are constantly driving the industry towards 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.

Small molecule products are leading the pipeline owing to their inherent nature of action and the cost of developing them. Small molecules have also proven their worth in generating revenue and are ranked top in terms of sales. Combination and multiple therapies are also a strategy to bring new drugs into market and maximize the return on investment. Currently oncology holds the highest number of multiple therapy drugs.

The 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. A particular focus of this report is placed on analysis of the development of innovative drugs, specifically first-in-class innovation.

The Drug 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.

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
Note: Product cover images may vary from those shown
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1 Table of Contents
1.1 List of Tables
1.2 List of Figures

2 Introduction
2.1 Increasing Cost of Drug Development
2.2 Most Drugs Fail to Recuperate R&D Costs
2.3 Contracting Life Cycles for Approved Products
2.4 The Case for First-in-Class Pharmaceutical Innovation
2.5 Status of Innovation in Rare Diseases
2.6 Conclusion

3 Assessment of Pharmaceutical Industry Pipeline
3.1 Pipeline and Clinical Trials Landscape by Therapy Area
3.2 Pipeline by Stage of Development
3.3 Pipeline by Molecule Type
3.4 Key Therapy Areas by Indication
3.4.1 Oncology
3.4.2 Infectious Diseases
3.4.3 Central Nervous System
3.4.4 Immunology
3.5 Conclusion

4 Assessment of Innovation in the Pharmaceutical Industry Pipeline
4.1 First-in-Class Innovation by Stage of Development
4.2 Key Therapy Areas by Indication
4.2.1 Oncology
4.2.2 Infectious Diseases
4.2.3 Central Nervous System
4.2.4 Immunology
4.3 Conclusion

5 Appendix
5.1 References
5.2 Abbreviations
5.3 Contact Us
5.4 Disclaimer

1.1 List of Tables
Table 1: Trends in Clinical Trial Protocol Complexity, 2001-2015
Table 2: Pipeline Products by Therapy Area, 2015-Q3 2018
Table 3: Number of Clinical Trials Initiated by Therapy Area, 2007-2017
Table 4: Pipeline Products by Therapy Area and Stage of Development, Q3 2018
Table 5: Pipeline Products by Therapy Area and Molecule Type, Q3 2018
Table 6: First-in-Class Pipeline Products by Therapy Area, Q1 2015-Q3 2018
Table 7: First-in-Class Oncology Pipeline Products by Indication, Q1 2015-Q3 2018
Table 8: First-in-Class Infectious Diseases Pipeline Products by Indication, Q1 2015-Q3 2018
Table 9: First-in-Class Central Nervous System Disorder Pipeline Products by Indication, Q1 2015-Q3 2018
Table 10: First-in-Class Immunology Pipeline Products by Indication, Q1 2015-Q3 2018

1.2 List of Figures
Figure 1: US Life Expectancy by Sex, 1950-2017
Figure 2: FDA Approvals, 1993-2018
Figure 3: Average Cost of Developing a Novel Drug ($m), 1970-2016
Figure 4: Projected R&D Returns (%), 2010-2017
Figure 5: Drivers of Shortened Pharmaceutical Product Life Cycles, 1970-2011
Figure 6: Patent Challenges by Generic Companies
Figure 7: FDA Approvals by Innovation Status, 1987-2017
Figure 8: Average Sales of First-in-Class and Non-First-in-Class Products After Launch ($m), 2006-2014
Figure 9: Average Projected Sales of First-in-Class and Non-First-in-Class Products Launched in 2015 ($m), 2016-2022
Figure 10: FDA Orphan Drug Approvals, 1983-2017
Figure 11: Pipeline Products by Stage and Molecule Type, Q3 2018
Figure 12: Pipeline Products by Therapy Area, Q3 2018
Figure 13: Overall Pipeline, Number of Products and Pipeline Growth by Therapy Area, Q1 2015-Q3 2018
Figure 14: Number of Clinical Trials Initiated, 2007-2017
Figure 15: Number of Clinical Trials Initiated by Therapy Area, 2007-2017
Figure 16: Pipeline Products by Therapy Area and Stage of Development (%), Q3 2018
Figure 17: Pipeline Products by Therapy Area and Stage of Development, Q3 2018
Figure 18: Pipeline Products by Therapy Area and Molecule Type, Q3 2018
Figure 19: Pipeline Products by Therapy Area and Molecule Type, Q3 2018
Figure 20: Oncology Pipeline Products by Indication, Q3 2018
Figure 21: Oncology Pipeline, Number of Products by Indication, Q1 2015-Q3 2018
Figure 22: Infectious Disease Pipeline, Number of Products by Indication, Q3 2018
Figure 23: Infectious Disease Pipeline, Number of Products and Pipeline Growth by Indication, Q1 2015-Q3 2018
Figure 24: Central Nervous System Pipeline, Number of Products by Indication, Q3 2018
Figure 25: Central Nervous System Pipeline, Number of Products and Pipeline Growth by Indication, Q1 2015-Q3 2018
Figure 26: Immunology Pipeline, Number of Products by Indication, Q3 2018
Figure 27: Immunology Pipeline, Number of Products and Pipeline Growth by Indication, Q1 2015-Q3 2018
Figure 28: Pipeline Products by Therapy Area and Proportion of Established and First-in-Class Products, Q3 2018
Figure 29: First-in-Class Pipeline, Number of Products and Pipeline Growth by Therapy Area, Q1 2015-Q3 2018
Figure 30: First-in-class Pipeline Products by Therapy Area and Stage of Development, Q3 2018
Figure 31: First-in-Class Oncology Pipeline Products by Indication, Q3 2018
Figure 32: First-in-Class Oncology Pipeline, Number of Products and Pipeline Growth by Indication, Q1 2015-Q3 2018
Figure 33: First-in-Class Infectious-Diseases Pipeline Products by Indication, Q3 2018
Figure 34: First-in-Class Infectious Disease Pipeline, Number of Products and Pipeline Growth by Indication, Q1 2015-Q3 2018
Figure 35: First-in-Class Central Nervous System Disorder Pipeline Products by Indication, Q3 2018
Figure 36: First-in-Class Central Nervous System Disorder Pipeline, Number of Products and Pipeline Growth by Indication, Q1 2015-Q3 2018
Figure 37: First-in-Class Immunology Disorder Pipeline, Number of Products by Indication, Q3 2018
Figure 38: First-in-Class Immunology Pipeline, Number of Products and Pipeline Growth by Indication, Q1 2015-Q3 2018

Note: Product cover images may vary from those shown
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Cost of developing new drug molecules continues to increase

The cost of developing a new drug molecule has reached a record level and shows no sign of decreasing in the near future. Adding to this burden, most of the drugs fail to recuperate the R&D cost after entering the market, building huge pressure on the pharmaceutical industry to reduce the cost. Competition from generics and me-too products are also showing their presence, and the effect of generic substitution has increased in recent years.

One of the methods companies use to gain more revenue is developing first-in-class products. Though developing first-in-class products requires high investment in terms of time and money, it has proven to result in blockbuster drugs,
when compared with me-too products. 

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 2002 and is helping to meet the unmet needs.

Advancements in the fields of genetics, genomics, metabolomics and cell biology at the molecular level over the past two decades have deepened the available knowledge about different diseases and their underlying mechanisms paving the way to find more targets and bring target-oriented drug deliveries into the market.

A greater diversity in terms of the molecular targets in successfully approved products and pipeline development programs has been achieved in many of the most prevalent indications in these areas, thereby increasing the chances of the emergence of therapeutics that could transform the clinical and commercial landscape.

Although innovation is moving towards biologics, small molecules are still favored by the pharmaceutical industry

Small molecule products are leading the pipeline owing to their inherent nature of action and the cost of developing them. Small molecules have also proven their worth in generating revenue and are ranked top in terms of sales. Combination and multiple therapies are also a strategy to bring new drugs into market and maximize the return on investment. Currently oncology holds the highest number of multiple therapy drugs.

Note: Product cover images may vary from those shown
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