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Drug Therapeutics: Therapeutic Proteins
Greystone Associates, July 2009, Pages: 175
In recent years, the number of protein-based pharmaceuticals reaching the marketplace has increased exponentially. The clinical application of these drugs is limited by a lack of desirable attributes for adequate absorption or distribution. It therefore becomes critical to formulate these drugs into safe, stable and efficacious delivery systems. Because these drugs face formidable enzymatic and penetration barriers when administered orally, peptide and protein drugs continue to be developed almost exclusively for parenteral administration. These combination drug-device products, where the drug and device are clinically tested and approved as a single product entity, are becoming one of the fastest new drug categories. On a unit basis, in spite of their higher cost protein drugs are growing in excess of fifteen percent annually. The growth of protein drug products is having a significant effect on the way drugs and devices are developed. Cooperation between device designers and drug developers is occurring much earlier in the drug development cycle, allowing device designs in many cases to be tailored to the bioavailability targets and pharmacokinetic profiles of specific drug therapies.
Feature Summary
- Analyzes approved therapeutic protein products and pipeline candidates and assesses the impact of formulation and delivery strategies on the market potential for existing and probable future protein drugs
- Examines protein delivery design issues, packaging, distribution and technology factors
- Assesses the role of protein formulation decisions on therapeutic protein commercialization and market potential
- Examines historical protein drug data for nine major therapeutic segments and provides forecasts by disease segment to 2012
- Profiles therapeutic protein companies, their commercial products, product development activity, and business strategies
- Evaluates the impact of economic, technology, and regulatory factors on the successful commercialization of therapeutic proteins
Methodology
- Research methodology is based on primary research in the form of in-depth interviews with key market participants, technology developers, distributors, industry experts, and market influencers, a list that includes regulatory officials, industry trade groups, and materials standards organizations.
- Primary data is evaluated and normalized against secondary sources including trade journal articles, technical literature, industry publications, company data sheets and published information, and statistical data from government agencies and trade associations.
- Forecasts and projections of market demand and future market activity are derived using standard modeling and statistical techniques.
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