Enabling New Therapeutics
The importance of excipients and of formulations is growing as pressure continues on building product pipelines as efficiently and expediently as possible.

• The growing number of biological therapeutics is creating demand for new formulations.
• Formulations for insoluble or poorly soluble molecules can both improve efficiency when used in discovery as well as improve the hit-to-drug ratio.
• New high-throughput formulation systems will speed the development phase.
• Pressure is increasing to remove all animal-derived products from formulations.
• Scrutiny of excipients is intensifying and the regulatory environment will become more rigorous as new standards for excipients are spotlighted.

One of the commonly used components in pharmaceutical products is gelatin. An estimated $1.3 billion is spent annually by the pharmaceutical market for the purchase of gelatin alone. Widely used in the pharmaceutical market as a stabilized and bonding agent, gelatin can be found in vaccines, capsules, infusion solutions, and implants. As gelatin is used in about 85% of all pharmaceutical products, finding a replacement for it could have a significant impact on the industry. The excipient market overall is approximately $2-3 billion annually and the market for specialized formulations, in particular biologicals, exceeds $20 billion annually. Approximately 600,000 tons of pharmaceutical excipients are produced annually.

More than 200 companies participate in the production of excipients, and no company offers a complete portfolio of excipients. The industry is competitive and no single company controls more than 5% of the market, despite the participation of major multinational chemical and pharmaceutical companies. New market forces are driving change among companies within the formulation segment. Consolidation has begun among smaller companies within this very fragmented market. Companies providing innovative technologies to formulation solutions have also become acquisition targets.

Biologicals Demand New Formulations
The growing number of biological therapeutics is creating demand for new formulations. Sales of biologicals are growing at a compounded annual growth rate of 15%, and by 2005, sales of biologicals will be about $25 billion in the US. Globally, sales of biologicals will represent approximately 40% of the pharmaceutical market sales.

With the growing importance of formulations in the overall success of a candidate drug, particularly biologicals, new methods of rapidly providing the necessary improvements possible with formulation technologies is increasingly critical in the overall success of the drug development process.

New Drug Targets Increase Formulation Complexity—Excipients Become Multifunctional
Despite the primary reliance on already-approved excipients, innovation is taking place in the formulation segment. Excipient manufacturers are using modifications of existing products to improve specific characteristics without necessitating the development of completely new excipients. A major innovation trend is the creation of multifunctional excipients that can provide a time-savings and cost-savings component to the formulation process, particularly in today's environment of increasingly complex formulations. New methods to produce soluble drugs and to protect biologicals are being created. Many of these processes involve the use of excipients used in new ways or under new sets of circumstances. Today's innovation in formulations is being forced to occur with a minimum investment in completely new ingredients. Rational approaches are increasingly important as a means of quickly identifying the critical formulations issues that must be addressed and finding alternative solutions that can be tested. The position of formulations in grooming the next wave of blockbuster drugs has never been more critical than it is today.

Formulations for insoluble or poorly soluble molecules can both improve efficiency when used in discovery as well as improve the hit-to-drug ratio. More than 40% of molecules emerging from drug discovery are either insoluble or poorly soluble. Technologies that will improve solubility can provide a substantial improvement in the efficiency of both drug discovery and drug development. Solubility technologies are being applied to both newly discovered drugs as well as established and marketed drugs.