Abstract
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.
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