Enhancing the Value Proposition of Biologics

Biology is amazing. The modern biotechnology industry has produced numerous cures for humanity’s persistent diseases. However, biologics are expensive. In 2017, only 2% of US prescriptions comprised biologics, yet this small percentage accounted for 37% of net drug spending. Also, since 2014, 93% of net drug spending at a global level emanated from biologics. It is estimated that, on average, the daily dose of a biologic costs 22 times more than that of a small molecule. Given the complexity of manufacturing, the high costs of biologics are hardly a surprise. There are, however, some favorable developments. Researchers are integrating continuous manufacturing in their plants to improve scalability and facilitate time to market while lowering capital and operating costs and enhancing quality. Similarly, the advent of new process analytical tools to improve process robustness, accelerate scale-up to commercial production, and drive more efficient use of resources is on the rise. Manufacturers are also using single-use systems to increase flexibility and reduce production lead times while lowering capital investment and energy requirements. While all this is ongoing, the development of biosimilars is on the rise, which has the potential to further lower the costs of medicines.