Monoclonal Antibodies: Pipeline Analysis and Competitive Assessment
By Mark C. Via
In the more than 30 years since the first process for creating monoclonal antibodies, or mAbs, was introduced, they have remained a centerpiece of the growing biotechnology industry. Twenty-four therapeutic mAbs have been approved, several of which have attained blockbuster status, with sales reaching the coveted billion-dollar mark and well beyond. Two drugs, Remicade and Rituxan, generated sales of about $4 billion each in 2006, and global sales for this entire portfolio approached $20 billion in that year. Monoclonal Antibodies: Pipeline Analysis and Competitive Assessment reviews the broad drug development effort that is focused on bringing improved mAb-based products to the market, focusing on those used for therapeutic applications.
Specifically, the report covers:
- Discussion of the latest technologies being applied to the development of mAbs
- Profiles the major companies, drugs, and projects
- Conclusions about the future market potential for mAbs
- Discussion of some of the major challenges faced by the industry
- Analysis of the results from an online survey of industry professionals
In that survey, 81% of respondents indicated that their organization’s pipeline of mAb products has increased over the past 5 years.
Monoclonal antibodies are highly specific antibodies produced in the laboratory by a variety of methods. The first generation of mAbs were murine (derived from mice), but these were soon discovered to have several weaknesses. They were targeted for neutralization by the human immune system and also induced the formation of damaging immune complexes. The biotech industry devoted years to reducing the immunogenicity of mAbs, developing the technologies to progress from chimeric to humanized to fully human antibodies. These succeeding generations of mAbs have demonstrated incremental improvements in safety and activity, and the industry is in the middle of a major shift from murine toward humanized and human products. Much work has also been done on altering antibodies’ outward form to:
- Boost their efficacy
- Enable them to more readily penetrate tumors
- Enhance their ability to stimulate beneficial immune responses
- Otherwise improve their characteristics
Into this realm fall such constructions as antibody fragments, diabodies, synthetic antibodies, bispecific antibodies, and antibody conjugates. This report looks at some of the engineered forms of antibodies and the companies that are leading the way in this research. Other complementary technologies such as PEGylation and glycosylation are also discussed.
Monoclonal Antibodies: Pipeline Analysis and Competitive Assessment goes on to evaluate the current state of mAb drug development. It identifies about 175 therapeutic products now in clinical trials, which are largely concentrated in the areas of cancer, immunologic and inflammatory diseases, and infectious diseases. Beyond these, hundreds more candidates are at the preclinical stage of development. This report reviews the products that are already available, those in clinical development, and those still at the preclinical stage that are likely to play an important role in the advancement of the field.
Monoclonal Antibodies: Pipeline Analysis and Competitive Assessment is an indespensible report for research directors, product managers, and others directly involved in the research and development of mAb-based therapies, or further development of exisiting therapies.
About the Author
Mark C. Via, an editor at CTB International Publishing, has more than 13 years of experience writing and editing for pharmaceutical trade publications. He holds a BA in history from Williams College. Mr. Via has authored previous Cambridge Healthtech reports, including Cytokine Therapies and Inhibitors: A Vibrant Pipeline and Active Approved Market (www.insightpharmareports.com/reports/2007/76_Cytokines/overview.asp).