Biologics Pipelines: Who Has the Next Promising Recombinant Proteins?

Therapeutic recombinant protein development has added a broad range of new products to the pharmaceutical armamentarium and led to a burgeoning biotechnology industry that is growing much faster than the smallmolecule- based pharmaceutical industry. New market leaders may soon emerge that are able to reap the benefits afforded by the development of multiple types of recombinant proteins. Success in future therapeutic protein markets will require flexibility, insight, and, most important, the ability to develop affordable biologics for patients, physicians, and payers - all of whom are clamoring for value-for-money drugs.

• Biologics markets are evolving into a complex mix of brands, next-generation brands, biosimilars, and second-generation biosimilars. What opportunities are emerging in this rapidly growing market? What market trends will drive this growth? What new business strategies will companies need to stay competitive?
• Recombinant proteins enjoy significant market success, with sales expected to increase from 9% to 10% of the worldwide drug market over the next five years (i.e., from $54.5 billion in 2007 to $75.8 billion in 2012). What company' s top position in this market is in jeopardy, and what is this company doing to stay one step ahead of the competition? What lies ahead in the recombinant protein market, and who is the current trendsetter?
• Hundreds of recombinant proteins are in clinical development across diverse therapeutic areas. Which ones are in late-stage clinical development? Which ones show the most promise for future success?

• A review of the evolving therapeutic protein market: technology market segments, top-selling brands, market leaders, impact of safety concerns.
• There were 142 recombinant proteins in clinical development in March 2007: overview of seven therapeutic categories, including blood-related disorders, cardiovascular and central nervous system diseases, cancer, and type 1 and 2 diabetes; companies, indications, and current development.
• Decision Resources analysts give their opinion on the status of recombinant proteins in development for various disease indications: delivery improvements for insulin; a new pegylated interferon for the treatment of lupus nephritis; development of biosimilars for cancer treatments; a new drug to treat acute ischemic stroke.
• Companies cannot afford to rest on the laurels of their past success: gauging when and how to enter a therapeutic recombinant protein market will be the key to success. An example of a trendsetting company that is forging a new path to success in tomorrow' s competitive biologics landscape.