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

Publisher Name :
Date: 01-Nov-2017
No. of pages: 57

Antibodies, otherwise known as immunoglobulins (Ig), are large, Y-shaped glycoproteins produced by immune cells in response to pathogens such as bacteria and viruses. They consist of two large heavy polypeptide chains and two smaller light polypeptide chains (Janeway et al., 2001). The carboxyterminal domains of the heavy chains are responsible for determining the types of constant fragments (Fc) that comprise the antibody. These Fc regions are used to characterize antibodies into Ig families, including IgG, IgD and IgE.

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.

By 2013, global sales revenues for mAb products totaled almost $75 billion, accounting for approximately half of the total revenue accrued by all biopharmaceutical products. This value has continued to increase, with mAb sales in 2016 totaling over $90 billion (GlobalData, 2017). An estimated record number of mAb approvals is forecast for 2017, which will only increase this value further. This domination of the biopharmaceuticals market is a reflection of their potential impact on the entire pharmaceutical industry, with versatility across a wide range of indications contributing to this success.

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, currently, there are 85 mAb programs in Phase III development, and 22 at the Pre-registration stage, accounting for just under 4% of the total mAb pipeline.

The report “Monoclonal Antibodies Global Trends in the Competitive, Technological and R&D Landscape” 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.

Companies mentioned in this report: Novartis AG, Biosynergics Inc, Genentech Inc, Amgen Inc

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.

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

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 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

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

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

List of Figures

Figure 1: Types of Immunoglobulins 4
Figure 2: Antigen-Antibody Binding – Monoclonal versus Polyclonal 5
Figure 3: Detailed Structure of Immunoglobulin G (IgG) 5
Figure 4: Timeline of Notable Events in Therapeutic mAb Development 8
Figure 5: mAb Approvals, US and Europe, 1986–2017 9
Figure 6: Types of mAb 11
Figure 7: Advantages and Disadvantages of Monospecific mAbs 12
Figure 8: Advantages and Disadvantages of Bispecific mAbs 13
Figure 9: Hybridoma Technology Protocol 15
Figure 10: Pathways for Nucleotide Formation 16
Figure 11: mAb Production by Phage Display 18
Figure 12: mAbs Market, Global, Annual Revenue for Humira, 2006–2023 28
Figure 13: mAbs Market, Global, Annual Revenue for Remicade, 2006–2023 29
Figure 14: mAbs Market, Global, Annual Revenue for Rituxan, 2006–2023 30
Figure 15: mAbs Market, Global, Annual Revenue for Avastin, 2006–2023 31
Figure 16: mAbs Market, Global, Annual Revenue for Herceptin, 2006–2023 33
Figure 17: mAbs Market, Global, Annual Revenue for Opdivo, 2014–2023 34
Figure 18: mAbs Market, Global, Annual Revenue for Lucentis, 2006–2023 35
Figure 19: mAbs Market, Global, Annual Revenue for Stelara, 2010–2023 36
Figure 20: mAbs Market, Global, Annual Revenue for Soliris, 2007–2023 38
Figure 21: mAb Pipeline by Therapy Area and Stage of Development 39
Figure 22: mAb Pipeline by Therapy Area and Stage of Development 40
Figure 23: mAb Pipeline by Therapy Area and Stage of Development 41
Figure 24: Versatility of Pipeline Products across Therapy Areas, Indications and Targets 41
Figure 25: mAb Pipeline by mAb Type 42
Figure 26: mAb Pipeline by mAb Type within Key Therapy Areas 43
Figure 27: mAb Pipeline by Company and Stage of Development 44
Figure 28: mAb Pipeline by Company and Therapy Area 45
Figure 29: mAb Pipeline by Company and Stage of Development 46
Figure 30: mAb Pipeline by Company and Stage of Development 47

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