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Preclinical Development of Monoclonal Antibodies and Related Biologicals: Emerging Technologies and New Therapeutic Candidates
Business Insights, March 2010, Pages: 392
Monoclonal antibodies form the fastest growing segment of the pharmaceutical industry, with total annual sales expected to top $50 billion in the next four years. 23 full-size monoclonal antibodies and three monoclonal antibody fragments have been launched so far, several having quickly reached ‘blockbuster status’ (annual sales of over $1 billion). Between 1995 and 2007, the number of monoclonal antibody-based drug candidates entering clinical trials more than tripled, and this expansion is continuing.
This report explains what monoclonal antibodies are, and why large pharmaceutical companies are investing so heavily both in developing such drugs internally and acquiring monoclonal antibody candidates from others. More than 80 popular and emerging technologies are named, explained and illustrated with original full-colour diagrams.
The newest wave of drug candidates based on these technologies can be seen in more than 200 case studies, which identify every commercial company known to have carried out preclinical studies of therapeutic monoclonal antibodies in the last year. Finally, prospects and challenges for the future of this field are discussed, with opinions from scientific pioneers and industry leaders.
Key features of this report
- Illustrated ‘beginners guide’ to monoclonal antibodies: What they are, how they are made and why they hold such great promise for the treatment of disease.
- More than 80 descriptions of proprietary technologies currently in use around the world to select, produce and re-engineer monoclonal antibodies.
- More than 30 original, full-colour diagrams illustrating the science and technology of monoclonal antibodies, both as they appear in nature and in the myriad new forms now being assessed in preclinical trials.
Scope of this report
- Understand the basic qualities of monoclonal antibodies and how these qualities translate into unique medical and commercial features for drug candidates.
- Appreciate the challenges and risks of monoclonal antibodies, as well as their promise.
- Assess promising new technologies for investment or in-licensing.
- Identify which companies are involved in this field, and what they are doing.
- Predict the kinds of drug that will enter clinical trials in the next 1-4 years and may reach the market in the next 5-10 years.
Key Market Issues
- New monoclonal antibodies can be used to target new disease processes that are not currently addressed by any other therapies, thereby accessing market areas with high unmet demand.
- The inherent specificity and predictability of monoclonal antibodies have been shown to shorten drug development times and increase rates of success in preclinical and clinical trials, relative to non-biological ‘small molecule’ drugs.
- High barriers to entry currently prevent many new companies from entering this field. The techniques now used to create, select and modify monoclonal antibodies for human therapeutic use are protected by intellectual property, which the originators defend vigorously. However, several early patents on fundamental techniques will expire very soon.
Key findings from this report
- Early challenges relating to immunogenicity, tissue penetration, administration and production of monoclonal antibodies are being addressed by myriad new technologies.
- The competitive benefits of identifying and addressing new therapeutic targets continue to provide incentives for new target selection and monoclonal antibody identification programs.
- Established techniques for ‘humanization’ of non-human monoclonal antibodies remain popular, despite the rise of newer ‘fully human’ monoclonal antibody technologies. This may be due to the robust nature of the earlier technologies and/or the imminent expiries of key patents.
- Genetic engineering methods and novel ‘host cell’ production systems are being used to optimize and modify functions of monoclonal antibodies. Proprietary platforms using these methods have been widely licensed to many of the major players in the biopharmaceutical industry.
Key questions answered
- What are monoclonal antibodies, and what can they do?
- Why are so many companies developing them as therapeutic agents?
- Which companies are currently working to validate and develop the latest generation of drug candidates based on monoclonal antibodies?
- What technological and regulatory challenges face these companies in developing such candidates and bringing drugs to market?
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