Growing demand for real-time process monitoring and more consistent biopharmaceutical manufacturing is expected to drive investment in process analytical technology.
The global biopharmaceutical process analytical technology (PAT) market is forecast to reach $4.32 billion by 2031, according to a market report published by MarketsandMarkets on 28 July.
The commercial market forecast points to increasing adoption of analytical systems that allow manufacturers to measure and control production processes as they take place.
PAT systems support earlier detection of process deviations and tighter control of critical process parameters and quality attributes, an increasingly important capability as biologics production expands. IQVIA’s Global Medicine Use Trends 2026 report, published in February, forecasts oncology, a biologics-intensive therapy area, to grow by approximately nine percent annually between 2026 and 2030, with spending reaching around $250 billion by the end of the decade. Against this backdrop, controlling variability across raw materials, cell culture and downstream processing will be critical to maintaining product quality and batch consistency.
The PAT forecast comes as manufacturers increasingly pursue quality-by-design approaches, automation and continuous manufacturing. Integrating analytical measurements directly into production can reduce reliance on retrospective end-product testing, although implementation requires validated methods, suitable data-management systems and an appropriate control strategy.
In Europe, PAT also has relevance to the implementation of the International Council for Harmonisation’s guideline on continuous manufacturing. The European Medicines Agency’s ICH Q13 guideline addresses the development, operation and lifecycle management of continuous manufacturing processes.
When supported by sufficient process understanding and a scientifically justified control strategy, [PAT] may also contribute to real-time release testing approaches”
Effective PAT systems can provide the timely process data needed to demonstrate that manufacturing remains in a state of control. When supported by sufficient process understanding and a scientifically justified control strategy, the technology may also contribute to real-time release testing approaches.
While the $4.32 billion figure represents a commercial market estimate, the forecast indicates that process monitoring is becoming an increasingly important component of biopharmaceutical manufacturing strategies. Investment will need to be accompanied by robust method validation, data integrity controls and regulatory alignment if manufacturers are to realise the anticipated quality and efficiency benefits.
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