Manufacturing as a strategic lever
As the industry adapts to these changes, manufacturing is emerging as a strategic lever in the new architecture of biopharma. Traditional batch-based, product-specific manufacturing plants are increasingly inadequate for the next generation of therapies. The industry is shifting toward modular, platform-style factories that utilize single-use systems, continuous processing, and advanced digital controls. These innovations enable faster scale-up, multi-product flexibility, and consistent quality—key factors as pipelines diversify and timelines shorten. The integration of manufacturing early in drug development is critical, as organizations that view their infrastructure as a strategic asset will gain a competitive edge in the evolving landscape.
The new paradigm
The orchestration of various stakeholders in the biopharma ecosystem is becoming more complex. A single therapy often involves numerous partners, including biotechs, contract research organizations (CROs), and regulatory bodies. Collaboration is now foundational, but effective orchestration—encompassing governance, interoperable systems, shared data, and aligned incentives—is essential for success. Many organizations struggle with fragmented data and legacy systems, which hinder decision-making and increase execution risks. As AI ambitions collide with compliance and data integrity requirements, digital transformation must prioritize resilience, trust, and speed.