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Monoclonal Antibodies - Global Trends in the Competitive, Technological and R&D Landscape

October 2017 | 57 pages | ID: M7E84939F78EN
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SUMMARY

CBR Pharma Insights’s latest report, 'Monoclonal Antibodies - Global Trends in the Competitive, Technological and R&D Landscape' discusses both the pipeline and market shares of monoclonal antibodies (mAbs) across a number of therapy areas. mAbs are defined as a collection of antibodies produced from a single B-cell clone. These antibodies therefore share binding specificity towards a certain antigen, and can be used as a means of targeted therapy within a number of indications across the pharmaceutical market.

mAbs have been in development in humans since the mid-1970s, and a substantial number of mAb products have entered the market. However, the majority are still in early-stage development, indicating delays and setbacks in the progression of potential products. Despite this, mAbs are the largest and fastest-growing segment of the biopharmaceutical sector, and account for almost half of the global revenue accrued from this area annually.

The pipeline is highly active, with 2,836 mAbs currently in development. Most are at an early stage of development, with 76% at the Discovery or Preclinical stage. Additionally, there are currently 85 mAb programs in Phase III development, and 22 at the Pre-registration stage, accounting for just under 4% of the total mAb pipeline.

This CBR report provides a comprehensive view of the clinical, R&D, commercial and competitive landscape of mAbs, and assesses key developments in manufacturing and development, covering strategies to combat challenges associated with the use of mAbs in human patients.

SCOPE
  • While many mAbs that enter the market achieve commercial success, a large proportion are stuck at early-stage development:
  • What strategies can be put in place to advance the production of mAbs?
  • What strategies can be used to improve both the affinity and therapeutic efficacy of mAbs?
  • What are the relative advantages and disadvantages of each mAb type, and which hold the most promise?
  • What proportion of the overall mAb R&D pipeline is occupied by each mAb type?
  • In which therapy areas is there the highest level of R&D activity for mAbs?
  • Which stage of development accounts for the majority of the pipeline?
  • How do mAbs fit into the overall portfolios of companies developing them?
  • What is the level of involvement in mAbs research for the top 15 Big Pharma companies?
KEY REASONS TO PURCHASE
  • Understand the current status of the field of therapeutic mAbs, and the relative clinical and commercial success of currently marketed products, comprising Humira, Remicade, Rituxan, Avastin, Herceptin, Opdivo, Lucentis, Stelara and Soliris
  • Assess the pipeline for mAbs split by therapy area, mAb type, and stage of development. Additionally, a granular assessment of the pipeline is provided across the four most active therapy areas for mAbs: oncology, infectious diseases, immunology and central nervous system disorders
  • Gain a picture of the current competitive landscape, with a detailed breakdown of the companies actively involved in the mAb pipeline. Understand the level of involvement of Big Pharma companies, and the extent to which mAbs fit into the portfolios of companies in this field. Additionally, a highly granular breakdown of companies developing mAbs is provided.
1 TABLE OF CONTENTS

1.1 List of Tables
1.2 List of Figures

2 OVERVIEW OF MABS

2.1 Initial mAb Development
2.2 Transition to Therapeutics
2.3 Present-Day Clinical and Research Applications
2.4 Commercial Progress within the mAb Market

3 MANUFACTURE AND MECHANISM OF MABS

3.1 Classification of mAbs
  3.1.1 By Type
  3.1.2 By Target Specificity
  3.1.3 By Mechanism of Action
3.2 Production of mAbs
  3.2.1 Hybridomas
  3.2.2 Phage Libraries/Phage Display
  3.2.3 Transgenic Animals
3.3 Challenges in the mAb Market
  3.3.1 Strategies for Improving mAb Efficacy
  3.3.2 Biosimilars and Biobetters

4 MAJOR MAB-TARGETING THERAPY AREAS

4.1 Anti-Cancer
4.2 Anti-Inflammatory/Autoimmune

5 KEY MARKETED MAB PRODUCTS

5.1 Humira (adalimumab) and Remicade (infliximab)
5.2 Rituxan (rituximab)
5.3 Avastin (bevacizumab)
5.4 Herceptin (trastuzumab)
5.5 Opdivo (nivolumab)
5.6 Lucentis (ranibizumab)
5.7 Stelara (ustekinumab)
5.8 Soliris (eculizumab)

6 MAB PIPELINE

6.1 mAb Pipeline by Therapy Area and Stage of Development
6.2 mAb Pipeline by mAb Type
6.3 Company Positioning
  6.3.1 Companies by Therapy Area
  6.3.2 Companies by Stage of Development
  6.3.3 Companies by mAb Type

7 CONCLUSION

8 APPENDIX

8.1 Abbreviations
8.2 References
8.3 Report Methodology
8.4 About GBI Research
8.5 Disclaimer

LIST OF TABLES

Table 1: Causes of Immunogenicity and Strategies to Overcome Them
Table 2: mAb Products within Oncology Market with 2016 Revenue Exceeding $1 Billion
Table 3: mAb Products within Immunology Market with 2016 Revenue Exceeding $1 Billion
Table 4: Marketed mAb Products, Humira
Table 5: Marketed mAb Products, Remicade
Table 6: Marketed mAb Products, Rituxan
Table 7: Marketed mAb Products, Avastin
Table 8: Marketed mAb Products, Herceptin
Table 9: Marketed mAb Products, Opdivo
Table 10: Marketed mAb Products, Lucentis
Table 11: Marketed mAb Products, Stelara
Table 12: Marketed mAb Products, Soliris

Monoclonal Antibodies (mAbs) have been in development in humans since the mid-1970s, and a substantial number of mAb products have entered the market. However, the majority are still in early-stage development, indicating delays and setbacks in the progression of potential products. Despite this, mAbs are the largest and fastest-growing segment of the biopharmaceutical sector and account for almost half of the global revenue accrued from this area annually.

Fiona Chisholm, Healthcare Analyst at GBI Research, commented:

“A range of companies are developing products in the mAb pipeline. This includes diversified companies developing mAbs as part of a broad product portfolio, to highly specialized companies focusing exclusively or near-exclusively on mAb development. The involvement of the top 15 pharmaceutical companies is major, with 12 out of 15 involving themselves heavily in mAb development.”

Monoclonal Antibodies: Global Trends in the Competitive, Technological and R&D Landscape discusses both the pipeline and market shares of monoclonal antibodies across a number of therapy areas. MAbs are defined as a collection of antibodies produced from a single B-cell clone. These antibodies therefore share binding specificity towards a certain antigen and can be used as a means of targeted therapy within a number of indications across the pharmaceutical market.



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