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Pursuing Next-Generation Therapeutic Antibodies as the Next Source of Blockbuster Drugs
Decision Resources, Inc, June 2011
Next-generation antibodies promise to create not just me-too products of existing protein therapeutics but me-better products through protein engineering. The success of monoclonal antibody (MAb) and antibody-derived therapeutics is encouraging pharmaceutical companies to explore exciting, next-generation antibody formats with superior properties as sources of blockbuster drugs. Formats of interest include antibody fragments, Fc fusion proteins, bispecific antibodies, multimodular antibodies, antibody mimetics, and T-cell receptors. These formats could yield drugs against difficult targets and enable companies to bypass existing patents. The first wave of next-generation antibodies has reached the market, and many more novel drugs are in development.
Questions answered in this report:
- The number of therapeutic antibodies and antibody derivatives approved by regulatory agencies has risen dramatically in recent years. Which antibody-based therapies are among the top-selling drugs worldwide? How much revenue do these drugs generate?
- The commercial success of therapeutic antibodies and antibody derivatives is encouraging pharmaceutical companies to explore novel antibody formats as the next source of blockbuster drugs. Which formats are most interesting to pharmaceutical companies? Which technologies hold the most promise of generating innovative drug classes? What drugs based on novel formats have already reached the market?
- The current market landscape offers innovative biotech companies with novel development programs significant commercial opportunities for generating next-generation antibodies. What companies are developing novel formats for creating innovative, antibody-based therapeutics? What technologies are these companies developing? How far have these programs advanced?
- Pharmaceutical companies can gain access to new technologies and antibody candidates through partnerships and M&As. Which pharmaceutical companies have formed major alliances with or acquired biotech companies? Which novel strategies are attracting the interest of Big Pharma?
- Lead optimization and manufacture of next-generation antibody formats present significant challenges. What obstacles hinder the optimization and manufacture of next-generation antibody therapeutics? Which companies have developed technologies to overcome these difficulties?
Scope:
Landscape: Rise of therapeutic antibodies, revenue generated, advantages of traditional monoclonal antibodies (MAbs), novel approaches and formats, main challenges
Antibody fragments and variants: Fab fragments, single-chain variable region fragments (scFv), single-domain antibodies (dAb), Fc fusion proteins, development candidates
Bispecific, multivalent, and multimodular antibodies: Advantages, myriad formats, manufacturing challenges, development candidates
Antibody mimetics: Technological approaches, structures, development candidates
T-cell receptor therapeutics: T-cell receptors, major histocompatibility complex, cell-mediated immunity, development candidates
Lead optimization: Challenges, manufacturing issues, promising technologies and approaches
Therapeutic areas: Broadly applicable platform useful for targeting multiple therapeutic areas; current therapies approved for a wide range of diseases, including cancers, autoimmune diseases, inflammatory disorders, infectious diseases, and ocular disorders
Detailed figures: Detailed schematics of various antibody and antibody derivative structures
Outlook for next-generation antibodies: Promising classes and mechanisms, applications of small antibody fragments, lead optimization, strategic advantages of biotech companies.
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