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.
- 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.
1.1 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
3.2.2 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
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
8.3 Report Methodology
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
List of Figures
Figure 1: Types of Immunoglobulins
Figure 2: Antigen-Antibody Binding – Monoclonal versus Polyclonal
Figure 3: Detailed Structure of Immunoglobulin G (IgG)
Figure 4: Timeline of Notable Events in Therapeutic mAb Development
Figure 5: mAb Approvals, US and Europe, 1986–2017
Figure 6: Types of mAb
Figure 7: Advantages and Disadvantages of Monospecific mAbs
Figure 8: Advantages and Disadvantages of Bispecific mAbs
Figure 9: Hybridoma Technology Protocol
Figure 10: Pathways for Nucleotide Formation
Figure 11: mAb Production by Phage Display
Figure 12: mAbs Market, Global, Annual Revenue for Humira, 2006–2023
Figure 13: mAbs Market, Global, Annual Revenue for Remicade, 2006–2023
Figure 14: mAbs Market, Global, Annual Revenue for Rituxan, 2006–2023
Figure 15: mAbs Market, Global, Annual Revenue for Avastin, 2006–2023
Figure 16: mAbs Market, Global, Annual Revenue for Herceptin, 2006–2023
Figure 17: mAbs Market, Global, Annual Revenue for Opdivo, 2014–2023
Figure 18: mAbs Market, Global, Annual Revenue for Lucentis, 2006–2023
Figure 19: mAbs Market, Global, Annual Revenue for Stelara, 2010–2023
Figure 20: mAbs Market, Global, Annual Revenue for Soliris, 2007–2023
Figure 21: mAb Pipeline by Therapy Area and Stage of Development
Figure 22: mAb Pipeline by Therapy Area and Stage of Development
Figure 23: mAb Pipeline by Therapy Area and Stage of Development
Figure 24: Versatility of Pipeline Products across Therapy Areas, Indications and Targets
Figure 25: mAb Pipeline by mAb Type
Figure 26: mAb Pipeline by mAb Type within Key Therapy Areas
Figure 27: mAb Pipeline by Company and Stage of Development
Figure 28: mAb Pipeline by Company and Therapy Area
Figure 29: mAb Pipeline by Company and Stage of Development
Figure 30: mAb Pipeline by Company and Stage of Development