The need to increase speed and flexibility in drug development and manufacturing has led to new strategies to improve the development and clinical trial process. It has also led to technological innovations, such as those driving the implementation of continuous manufacturing and/or process intensification. Even the regulatory landscape of the pharmaceutical industry has changed, as alternative pathways for accelerated drug approval have paved the way for quicker access to promising novel medicines.
Nevertheless, as the industry identifies more efficient ways to deliver drugs to patients, these advancements also increase pressure to acquire significant capacity that can quickly deliver therapies to the patients who need them most, especially for diseases affecting large patient populations (e.g., vaccines, oncology, and central nervous system diseases).
Drug manufacturers are now facing shorter timelines for decision making due to accelerated regulatory pathways. Deciding on the size, number, and type of facilities to build without adequate data about demand creates substantial risks with costly consequences.
The uncertainty is further compounded by ...