GBI Research’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.
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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.
Table of Contents
1 Table of Contents 2
1.1 List of Tables 3
1.2 List of Figures 3
2 Overview of mAbs 4
2.1 Initial mAb Development 6
2.2 Transition to Therapeutics 6
2.3 Present-Day Clinical and Research Applications 7
2.4 Commercial Progress within the mAb Market 8
3 Manufacture and Mechanism of mAbs 10
3.1 Classification of mAbs 10
3.1.1 By Type 10
3.1.2 By Target Specificity 11
3.1.3 By Mechanism of Action 13
3.2 Production of mAbs 15
3.2.1 Hybridomas 15
3.2.2 Phage Libraries/Phage Display 17
3.2.3 Transgenic Animals 18
3.3 Challenges in the mAb Market 18
3.3.1 Strategies for Improving mAb Efficacy 18
3.3.2 Biosimilars and Biobetters 21
4 Major mAb-Targeting Therapy Areas 23
4.1 Anti-Cancer 23
4.2 Anti-Inflammatory/Autoimmune 25
5 Key Marketed mAb Products 27
5.1 Humira (adalimumab) and Remicade (infliximab) 27
5.2 Rituxan (rituximab) 29
5.3 Avastin (bevacizumab) 30
5.4 Herceptin (trastuzumab) 32
5.5 Opdivo (nivolumab) 33
5.6 Lucentis (ranibizumab) 34
5.7 Stelara (ustekinumab) 36
5.8 Soliris (eculizumab) 37
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6 mAb Pipeline 39
6.1 mAb Pipeline by Therapy Area and Stage of Development 39
6.2 mAb Pipeline by mAb Type 42
6.3 Company Positioning 44
6.3.1 Companies by Therapy Area 45
6.3.2 Companies by Stage of Development 46
6.3.3 Companies by mAb Type 47
7 Conclusion 48
8 Appendix 49
8.1 Abbreviations 49
8.2 References 50
8.3 Report Methodology 57
8.4 About GBI Research 57
8.5 Disclaimer 57
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1.1 List of Tables
Table 1: Causes of Immunogenicity and Strategies to Overcome Them 19
Table 2: mAb Products within Oncology Market with 2016 Revenue Exceeding $1 Billion 24
Table 3: mAb Products within Immunology Market with 2016 Revenue Exceeding $1 Billion 26
Table 4: Marketed mAb Products, Humira 27
Table 5: Marketed mAb Products, Remicade 28
Table 6: Marketed mAb Products, Rituxan 30
Table 7: Marketed mAb Products, Avastin 31
Table 8: Marketed mAb Products, Herceptin 32
Table 9: Marketed mAb Products, Opdivo 34
Table 10: Marketed mAb Products, Lucentis 35
Table 11: Marketed mAb Products, Stelara 36
Table 12: Marketed mAb Products, Soliris 37
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