Increasing role of CDMOs as partners in supporting licensing deals and New Drug Product Approvals


Anil Kane
Executive Director, Global Head of Formulation Sciences, Pharmaceutical Development Services


In the current environment of decline in new molecular entities, increasing pricing pressures and changing regulatory requirements, global pharmaceutical and life science companies face increasing challenges to achieve and maintain profitable growth. Pressures in the industry to develop new products and therapies requires small, emerging, specialty and big pharma companies to develop strategies for taking successful candidates from discovery through clinical to commercial stage with speed and the right investment by the right partners. Over the past two decades, outsourcing of development and manufacturing has become increasingly prevalent and is now a major trend in the pharmaceutical industry.

Contract Development & Manufacturing Organizations (CDMOs) develop small molecules, biologics and finished products on behalf of small to emerging companies that are in many cases out-licensed to larger pharma companies. This shift in the marketplace to a collaborative and partnering model is driven by a number of factors: CMC expertise, investment or financing programs and the ability to take products to market quicker. Larger CDMOs are now providing integrate ...