Global Monoclonal Antibodies Pipeline Insight 2015

Publish Date:- Mar-2015      No Of Pages (1600)

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Ever since the Nobel Prize was bestowed on the person who invented the technology which enabled the preparation of monoclonal antibodies in 1984, their use has considerably expanded far beyond the scientific realm. Paul Ehrlich framed a hypothesis that a “magic bullet” could be developed with an objective of targeting selective diseases. With the introduction and development of hybridoma technology by Kohler and Milstein, this hypothesis has become a reality. These monoclonal antibodies have come to be known as highly valuable therapeutic agents. This technology rendered mAbs to be highly potential of specific associations with their targeted antigens.Muromonab-CD3 (Orthoclone OKT3; Ortho Biotech) was the first of these antibodies which was approved in 1986, in the prevention of acute transplant rejection. This has been followed by an increasing number of other monoclonal antibodies, of which many were among the best-selling drugs across the globe.

Utility of mAbs in therapeutic treatment have been widely accepted among physicians and patients across the globe. This could be attributed to their high specificity due to which only diseased cells are eliminated while normal cells are spared. Their ability to bind target is high because they are made by using single antigen giving them high specificity. As a result, side effects are minimized as compared to other therapeutics available in global market. They are bit larger than other therapeutic molecules but they are highly customizable due to which they could be designed for particular disease. Clinical data has also shown that they have high safety and efficacy profiles due to which more patients are willing to include them in their regular therapeutic regime. They could be used to treat various ailments like cancer, auto-immune, anti-inflammatory and other disease indications. Out of these ailments, cancer mAb segment occupies major market shares and generates huge revenues across the globe.  Pharmaceutical companies are trying to develop them for more ailments in other to generate diversify and strengthen their portfolio.

Different mAbs have different action mechanism due to which they can be used against multiple malignancies. Depending upon malignancy in question, mAb could be customized due to which their dominance in global cancer market could be observed. For instance, rituximab is used for lymphoma treatment; it binds to the cancerous cells and makes it more susceptible to attack by immune system. On the other hand, Ibritumomab for Non-Hodgkin Lymphoma (NHL) treatment consists of radioactive pay load to eliminate cancerous cells. Chemotherapeutics are one of the major contenders having largest market shares in cancer category but their severe side effects noticeable during treatment. To alleviate patients’ medical condition pharmaceutical companies have also launched the mAb version of chemotherapeutics. For instance, ado-trastuzumab emtansine has been launched in market for Her 2 positive breast cancer treatment.

With existing product pipelines on the verge of being exhausted, it is most likely that the future years would witness an increased level of investments from the pharma companies so as to fill up their R&D pipelines. Additionally, a significant amount of research is being currently conducted to improve the level of potency of monoclonal antibodies. Cancer is becoming a major area where the use of monoclonal antibodies is increasing substantially in the recent years. In the future also, this field is expected to have the maximum application of mAbs.

 

“Global Monoclonal Antibodies Pipeline Insight 2015” Report Highlight: 

  • Monoclonal Antibodies Classification
  • Mechanism of Monoclonal Antibodies
  • Global Monoclonal Antibodies Market Overview
  • Global Monoclonal Antibodies Clinical Pipeline by Company, Indication & Phase
  • Global Monoclonal Antibodies Clinical Pipeline: 1096 mAb
  • Marketed Monoclonal Antibodies: 66 mAb
  • Global Cancer Monoclonal Antibodies Clinical Pipeline: 602 mAb
  • Marketed Cancer Monoclonal Antibodies: 34 mAb


Ever since the Nobel Prize was bestowed on the person who invented the technology which enabled the preparation of monoclonal antibodies in 1984, their use has considerably expanded far beyond the scientific realm. Paul Ehrlich framed a hypothesis that a “magic bullet” could be developed with an objective of targeting selective diseases. With the introduction and development of hybridoma technology by Kohler and Milstein, this hypothesis has become a reality. These monoclonal antibodies have come to be known as highly valuable therapeutic agents. This technology rendered mAbs to be highly potential of specific associations with their targeted antigens.Muromonab-CD3 (Orthoclone OKT3; Ortho Biotech) was the first of these antibodies which was approved in 1986, in the prevention of acute transplant rejection. This has been followed by an increasing number of other monoclonal antibodies, of which many were among the best-selling drugs across the globe.

Utility of mAbs in therapeutic treatment have been widely accepted among physicians and patients across the globe. This could be attributed to their high specificity due to which only diseased cells are eliminated while normal cells are spared. Their ability to bind target is high because they are made by using single antigen giving them high specificity. As a result, side effects are minimized as compared to other therapeutics available in global market. They are bit larger than other therapeutic molecules but they are highly customizable due to which they could be designed for particular disease. Clinical data has also shown that they have high safety and efficacy profiles due to which more patients are willing to include them in their regular therapeutic regime. They could be used to treat various ailments like cancer, auto-immune, anti-inflammatory and other disease indications. Out of these ailments, cancer mAb segment occupies major market shares and generates huge revenues across the globe.  Pharmaceutical companies are trying to develop them for more ailments in other to generate diversify and strengthen their portfolio.

Different mAbs have different action mechanism due to which they can be used against multiple malignancies. Depending upon malignancy in question, mAb could be customized due to which their dominance in global cancer market could be observed. For instance, rituximab is used for lymphoma treatment; it binds to the cancerous cells and makes it more susceptible to attack by immune system. On the other hand, Ibritumomab for Non-Hodgkin Lymphoma (NHL) treatment consists of radioactive pay load to eliminate cancerous cells. Chemotherapeutics are one of the major contenders having largest market shares in cancer category but their severe side effects noticeable during treatment. To alleviate patients’ medical condition pharmaceutical companies have also launched the mAb version of chemotherapeutics. For instance, ado-trastuzumab emtansine has been launched in market for Her 2 positive breast cancer treatment.

With existing product pipelines on the verge of being exhausted, it is most likely that the future years would witness an increased level of investments from the pharma companies so as to fill up their R&D pipelines. Additionally, a significant amount of research is being currently conducted to improve the level of potency of monoclonal antibodies. Cancer is becoming a major area where the use of monoclonal antibodies is increasing substantially in the recent years. In the future also, this field is expected to have the maximum application of mAbs.

 

“Global Monoclonal Antibodies Pipeline Insight 2015” Report Highlight: 

  • Monoclonal Antibodies Classification
  • Mechanism of Monoclonal Antibodies
  • Global Monoclonal Antibodies Market Overview
  • Global Monoclonal Antibodies Clinical Pipeline by Company, Indication & Phase
  • Global Monoclonal Antibodies Clinical Pipeline: 1096 mAb
  • Marketed Monoclonal Antibodies: 66 mAb
  • Global Cancer Monoclonal Antibodies Clinical Pipeline: 602 mAb
  • Marketed Cancer Monoclonal Antibodies: 34 mAb

1. Introduction to Monoclonal Antibodies

 

2. Monoclonal Antibodies Classification

  2.1 Naked Monoclonal Antibodies

  2.2 Conjugated Monoclonal Antibodies

    2.2.1 Radiolabeled Antibodies

    2.2.2 Chemolabeled Antibodies

    2.2.3 Immunotoxins

 

3. Mechanism of Monoclonal Antibodies

  3.1 Generation of Hybridomas

    3.1.1 In Vitro Production of Monoclonal Antibodies

    3.1.2 Batch Tissue Culture Methods

    3.1.3 Semipermeable Membrane Based Systems

    3.1.4 Advantages & Disadvantages of In Vitro and In Vivo Methods

  3.2 Working of Monoclonal Antibodies

 

4. Need for Monoclonal Antibodies

 

5. Emerging Area: Cancer Monoclonal Antibodies Therapy

 

6. Global Monoclonal Antibodies Market Overview

  6.1 Current Market Scenario

  6.2 Monoclonal Antibodies Pipeline Insight

  6.3 Cancer Monoclonal Antibodies Clinical Pipeline Insight

 

7. Monoclonal Antibodies Market Dynamics

  7.1 Favorable Market Parameters

  7.2 Development & Commercialization Challenges

 

8. Global Monoclonal Antibodies Market Future Outlook

 

9. Monoclonal Antibodies Clinical Pipeline by Company, Indication & Phase

  9.1 Unknown

  9.2 Research

  9.3 Preclinical

  9.4 Clinical

  9.5 Phase-0

  9.6 Phase-I

  9.7 Phase-I/II

  9.8 Phase-II

  9.9 Phase-II/III

  9.10 Phase-III

  9.11 Preregistration

  9.12 Registered

 

10. Marketed Monoclonal Antibodies by Company & Indication

 

11. Competitive Landscape

  11.1 Abbvie

  11.2 Amgen

  11.3 Bayer HealthCare

  11.4 Biogen Idec

  11.5 Eli Lilly

  11.6 Genmab

  11.7 Gilead Sciences

  11.8 GlaxoSmithKline

  11.9 Novartis

  11.10 Pfizer

  11.11 Roche

  11.12 Seattle Genetics


Figure 1-1: Evolution of Monoclonal Antibody    

Figure 1-2: History of Development of Monoclonal Antibodies   

Figure 2-1: Types of Monoclonal Antibodies       

Figure 5-1: Working of Monoclonal Antibodies  

Figure 6-1: Global Biologics Market Segmentation            

Figure 6-2: Share of Monoclonal Antibodies in Global Biologics Market   

Figure 6-3: Global Market for Monoclonal Antibodies, (US$ Billion)          

Figure 6-5: Monoclonal Antibodies Pipeline Overview by Phase, (%)       

Figure 6-6: Monoclonal Antibodies Pipeline Overview by Phase, (Numbers)        

Figure 6-7: Cancer Monoclonal Antibodies Therapy Pipeline by Phase (%), 2014 

Figure 6-8: Cancer Monoclonal Antibodies Therapy Pipeline by Phase (Number), 2014   

Figure 7-1: Monoclonal Antibodies Market Challenges