Drug Development for Government, Nonprofit, and Developing-World Markets

These markets are distinct in some ways, but they are similar in that they all challenge the profit margin that supported the development programs of major pharmaceutical companies in the past. The pervasive challenge of lower profitability potential is due to low sales prices or small volumes. Other challenges include complex payer arrangements and attendant “lumpy” revenue streams as well as poor long-term sales visibility with substantial political or policy risks.

The unique circumstances faced by customers and end users often impose additional constraints, such as the need for a long shelf life, tolerance to poor refrigeration, or the ability to administer the product safely with a low level of medical oversight. In addition, technology transfer and intellectual property (IP) issues can be unusually challenging. These challenges are outlined in Table I.