Abstract
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.
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