New Manufacturing Strategies For The Precision Medicine Future

Blockbuster drugs and one-size-fits-all treatments now share portfolio space with highly targeted therapies for smaller patient populations. This new era is an opportunity for savvy companies to create greater value, both for patients and themselves. Yet, while precision medicine offers many financial advantages to pharmaceutical manufacturers, the increased cost of targeted active pharmaceutical ingredients (APIs) creates new challenges. Learn how precision medicine will change pharmaceutical manufacturing, and how you can prepare.

Precision medicine is a departure from the classical pharma economic model. While wide-application drugs require large outcome studies, trials for targeted therapies are smaller and faster, making them less expensive to run. Patient advocacy groups even assist with recruiting in some cases. Though the number of potential patients for a precision therapy is much smaller than for a blockbuster drug, companies are now profiting on expensive therapies instead of on sheer volume. Additionally, the opportunity for successful approval is greater. Clinical success rates for rare disease therapies are at 26%, compared with just 11% for all categories. Many rare diseases currently have no alternate treatment available, increasing the likelihood that a drug will be approved and speeding its time to market. Reduced R&D costs without a decrease in revenue is a net positive for biopharma.

Despite these advantages, precision medicine faces several hurdles. Regulation is still evolving for both the therapies and the diagnostics that guide them, as is the insurance reimbursement framework. In order to truly scale, clinical adoption is key. Many diagnostics are based on cutting-edge technology, and education of physicians will be critical to their acceptance.