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

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.

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.

Reasons to buy

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

Summary

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.

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.

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

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

List of Figures

1.2 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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