CPHI Milan opens next week with manufacturing under growing scrutiny across the pharmaceutical industry.

Drugmakers are reassessing supply chains while demand grows for specialist capacity to manufacture more complex medicines. AI and automation are also moving closer to production, but the industry still has to work out where these technologies can deliver meaningful gains. All of this is happening under continued pressure to control costs and bring products to market faster.

On 28 September, the Council of the EU adopted the bloc’s new pharmaceutical package, including measures intended to strengthen security of supply, reduce regulatory burdens and improve the industry’s competitiveness.

CPHI Milan’s 2026 programme reflects many of these pressures, with manufacturing, supply chains, bioproduction, investment, AI and sustainability all on the agenda. Three questions in particular are worth watching when the event opens on 6 October..

On the Radar

• Resilience comes at a cost. Geographic diversification can reduce supply risk, but additional suppliers, inventory and manufacturing options require investment.
• Not all manufacturing capacity is equally valuable. Growth in biologics, complex injectables and advanced therapies is increasing the importance of specialist facilities and expertise.
• AI faces an operational test. Manufacturers will be looking for evidence that new systems can work reliably within regulated production and deliver returns.

Is Supply Resilience Changing Where Pharma Manufactures?

Shortages, geopolitical risk and dependence on concentrated sources of production are changing how drugmakers think about sourcing. Cost still matters, but so do security of supply, regulatory exposure and the ability to keep production running when disruption hits.

That does not point to a wholesale retreat from global supply chains. Drugmakers are instead looking for more options, from additional suppliers and inventory buffers to manufacturing capacity spread across different regions.

Building that resilience is neither quick nor cheap. Adding a new supplier or moving production can require site qualification, validation and regulatory approval, while alternative capacity may not exist at the required scale. Europe’s push to strengthen medicine supply and pharmaceutical competitiveness adds further pressure.

Sustainability is moving further into the same discussion, with CPHI launching its first dedicated Sustainability Summit this year as manufacturers weigh energy use and resource efficiency alongside cost and supply security.

The commercial trade-off is becoming clearer: greater resilience requires companies to decide how much redundancy they are prepared to pay for and where additional capacity can realistically be secured.

Which Manufacturing Capabilities Are Becoming Most Valuable?

Pharma’s outsourcing needs are becoming more specialised. Biologics, complex injectables and advanced therapies can require dedicated facilities, analytical expertise and regulatory experience that cannot easily be replicated between sites.

That creates an important distinction between available capacity and usable capacity. A facility may have space, but that does not mean it can manufacture a particular product economically, at the required scale or within the necessary regulatory framework.

Visiongain forecasts the Pharmaceutical Contract Manufacturing market to grow from US$171.0bn in 2026 to US$367.06bn by 2036, as outsourcing expands and manufacturing requirements become more specialised.

This is particularly important in advanced therapies. Cell and gene therapies can involve highly specific processes, variable starting materials and complex quality requirements, making manufacturing difficult to standardise and scale. Those challenges are reflected in CPHI’s bioproduction programme, where scaling advanced therapies, automation and new manufacturing technologies are among the issues in focus.

Location, technical expertise and regulatory readiness can therefore matter as much as the amount of capacity available. Drugmakers need manufacturing partners that can bring the right capabilities into a programme, not simply offer additional production volume.

Where Can AI Deliver in Pharma Manufacturing?

AI will be difficult to miss in Milan. CPHI has introduced a dedicated AI & Tech area covering manufacturing optimisation, digital twins, predictive maintenance and quality systems.

The real test comes when these technologies move into regulated manufacturing.

A successful pilot only goes so far. New systems also have to work with existing manufacturing infrastructure, meet data integrity and validation requirements and produce gains that justify the investment.

Technology suppliers will need to show what their systems can actually improve, whether that means reducing downtime, increasing yields or strengthening quality control.

Adoption will ultimately depend less on what the technology promises than on what manufacturers can validate, integrate and use reliably.

Visiongain Insight

The three themes point to a broader question for pharma manufacturing: where should the next round of investment go?

Resilience is pushing companies to reconsider where and how they source. More complex medicines are increasing demand for specialist manufacturing capabilities, while AI and automation could change the economics of existing facilities.

CPHI Milan should offer an early indication of how the industry is responding: where companies are investing, which technologies are moving closer to deployment and how manufacturers are balancing resilience, capability and cost.

Meet Visiongain at CPHI Milan

Attending CPHI Milan? Get in touch to arrange a conversation with Visiongain about the manufacturing trends shaping your market, from outsourcing and specialist capacity to supply-chain strategy and emerging technologies.

Contact us: contactus@visiongain.com

From Visiongain: Contract Manufacturing & CDMOs Hub

Visiongain’s Contract Manufacturing & CDMOs Hub brings together market analysis and forecasts covering pharmaceutical outsourcing, manufacturing investment, biologics, advanced therapies and supply-chain strategy.

Related research:

• Pharmaceutical Contract Manufacturing Market Report 2026–2036
• Cell & Gene Therapy Manufacturing Market Report 2026–2036
• Vaccine Contract Manufacturing Market Report 2026-2036
• Pharmaceutical Packaging Market Report 2026-2036

Press & Media Enquiries

For commentary, data requests or interview enquiries, please contact: press@visiongain.com