Tufts CSDD Outlook, published each January, highlights near-term pharmaceutical and biopharmaceutical drug development trends. Data and analyses contained in Tufts CSDD Outlook 2009 are based on proprietary research conducted by the Tufts CSDD research staff.

Outlook 2009

Here are the highlights of the 2009 Report….

R&D Efficiency: Continued high costs and lengthy development times, combined with growing regulatory and economic pressures, will drive drug developers to partner, outsource, and in-source to improve R&D productivity.

Regulatory Environment: Insufficient personnel and staff turnover will impede the FDA’s ability to confront and resolve pressing challenges. Europe’s EMEA and Japan’s MHLW will continue to harmonize with U.S. policies on a broad range of regulatory issues.

Biotechnology Trends: Market introduction of monoclonal antibodies will continue to increase as drug sponsors become more adept at development and drug regulators become more familiar with evaluating this product class.

Prescription Drug Policy: U.S. payers will increase their use of formulary management tools to contain costs, particularly with regard to specialty pharmaceuticals. Though the latter account for less than 15% of total drug expenditures, annual growth in specialty pharmaceutical spending is approaching 25%.

Drug Development Management Trends: Under growing pressure to achieve faster timelines, reduce costs, and deliver quality submissions, sponsor companies will look to improve protocol design and leverage relationships with CROs and sites.

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