Monoclonal Antibodies: Pipeline Analysis and Competitive Assessment
Author: Mark C. Via
In the nearly 35 years since the first process for creating mAbs was introduced, they have remained a centerpiece of the growing biotechnology industry. Thirty therapeutic mAbs have been approved around the world, including 23 in the United States. A number of these drugs have attained blockbuster status, with sales reaching the coveted billion-dollar mark and well beyond. Rituxan, Remicade, Avastin, Herceptin, and Humira alone generated sales of over $4 billion each in 2008, and global sales for this entire sector surpassed $30 billion last year.
Key challenges and implications presented in this new report include:
- Future products and their indications
- Merits of human versus chimeric structures
- Costs of mAb therapy and the US healthcare debate
- Clinical pipeline with over 250 candidates
- A focus on "engineered" antibodies
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, concentrating on those used for therapeutic applications. It surveys the latest technologies being applied to the development of these compounds and profiles the major companies, drugs, and projects. It then draws conclusions about the future market potential for mAbs and discusses the major challenges faced by the industry.
The biotech industry devoted years to reducing the immunogenicity of mAbs, developing the technologies—detailed in this report—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 currently in the middle of a major shift toward humanized and human products.
Much work has also been done on altering antibodies’ outward form to boost their efficacy, enabling them to more readily penetrate tumors, enhancing their ability to stimulate beneficial immune responses, or otherwise improving 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 presented.
Monoclonal Antibodies: Pipeline Analysis and Competitive Assessment presents an analysis for the current state of mAb drug development. It identifies more than 250 therapeutic products now in clinical trials, which are largely concentrated in the areas of cancer, immunological and inflammatory diseases, as well as infectious diseases. Beyond these, hundreds more candidates are at the preclinical stage of development. Reviewed here are 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.
About the Author: Mark C. Via, an editor at CTB International Publishing, has more than 15 years of experience writing and editing for pharmaceutical trade publications. Mr. Via has authored previous Cambridge Healthtech reports, including Neurodegenerative Diseases: Next-Generation Drugs for Four Major Disorders (www.InsightPharmaReports.com/reports/2009).