To grow, pharma manufacturers need operations that scale - not just acquisitions

The pharma industry is in the middle of a great reshuffling.

Between $200 billion and $300 billion in annual drug sales will lose patent protection by 2030. That number, repeated in every sector briefing and investor call, has become something of a mantra for pharmaceutical executives. It reflects a shared acknowledgement that the ground is shifting and that standing still is not an option.

One of the direct consequences has been a wave of major acquisitions: facing the loss of exclusivity on its HIV franchise, GSK moved in June 2026 to buy cancer-drug developer Nuvalent for around $11 billion, its largest acquisition in eight years and its third deal of 2026, taking its dealmaking to roughly $14 billion for the year. Meanwhile, Merck has split its oncology business ahead of the 2028 US patent expiry of Keytruda, while buying flu-prevention biotech Cidara for $9.2 billion and plans to launch no fewer than 20 blockbuster candidates of its own.

The logic behind this activity is straightforward: buy the pipeline you cannot build fast enough. However, acquisitions can solve one problem and create another. A company that doubles its portfolio through deals does not automatically double its manufacturing capacity or its ability to run those facilities to the standard regulators expect.

The manufacturing standardisation gap

The need to create the next generation of blockbuster drugs goes hand in hand with the need to build the next generation of manufacturing sites. It also requires something less visible and arguably more complex: modernising and converting the plants that already exist.

The need to create the next generation of blockbuster drugs goes hand in hand with the need to build the next generation of manufacturing sites.”

A major challenge is that manufacturing environments in large pharmaceutical companies tend to evolve organically. Plants are acquired, inherited or built decades apart. Each site develops its own technology stack, procedures and operational habits. Over time, this produces a patchwork of systems that make standardisation difficult.

Research we conducted with Forrester last year found that “scaling processes from one manufacturing plant to others” was the single most pressing operational challenge identified by European pharmaceutical manufacturers (57%). Maintaining operational efficiency amid audits and growing capacity ranked a close second (55%). UK manufacturers sit squarely within that European sample and the challenge is especially acute here: much of the country’s capacity is spread across sites with decades of separate history, from AstraZeneca’s Macclesfield to GSK’s Barnard Castle and Montrose and the wider cluster spanning Wrexham and Craigavon.

With this first challenge comes its corollary: reliability. When maintenance practices, asset management systems and reliability data vary from site to site, it becomes difficult to scale production without introducing operational risk. Equipment failures, inconsistent maintenance procedures or fragmented data can quickly cascade into production delays or compliance issues.

Getting the infrastructure right

Manufacturers that are best positioned for growth share several operational characteristics.

First, they have a unified approach to enterprise asset management. Maintenance data, asset health and equipment performance can therefore be compared and acted upon across the network rather than remaining siloed within individual sites.

Second, they use asset performance management tools to move from reactive fixes to predictive maintenance. This reduces unplanned downtime at the worst possible moment, which in pharma tends to be during a product launch or a regulatory inspection. They also treat quality management as a system-wide function rather than a site-by-site compliance exercise.

A common operational framework allows best practice to transfer and performance to be benchmarked consistently.”

Pfizer has approached this directly. The company uses Octave Attune (formerly HxGN EAM) as part of a defined set of “core capabilities” that can be replicated across facilities. It is a sensible model. A common operational framework allows best practice to transfer and performance to be benchmarked consistently.

A clear business case for integrated quality management

This becomes especially important given a regulatory climate that is unusually layered for a UK manufacturer. Since Brexit, domestic sites answer to the Medicines and Healthcare products Regulatory Agency (MHRA), which now issues its own UK marketing authorisations and conducts its own GMP inspections independently of the European system.

A plant supplying the UK, EU and US must therefore satisfy the MHRA, EU GMP and FDA as three distinct regulatory relationships, only partly eased by mutual-recognition agreements.

That burden is also rising. In May 2025, the FDA announced it would expand unannounced inspections to foreign manufacturing facilities across all countries, ending the long-standing practice of giving non-US plants advance notice. A material change for the many UK sites that treat the US as a core export market. The consequences of being caught underprepared, whether a warning letter, an import alert or a production shutdown, are significant at any time. During a period of active growth they can be ruinous.

On that front, Octave Reliance (formerly ETQ) provides an integrated quality management system designed to maintain document control, deviation tracking and audit readiness continuously rather than only in the weeks before an inspector arrives.

There is a distinctly British reason to treat this as a question of margin and not merely compliance. UK manufacturers already operate under some of the tightest pricing terms in Europe: under the Voluntary Scheme for Branded Medicines Pricing, Access and Growth (VPAG), the clawback on NHS sales of newer medicines reached a record 22.9% in 2025. A level industry leaders publicly described as making the country “un-investable”, before the 2025 UK-US arrangement capped it at 15% for three years.

This economic pressure creates a compelling case for technological standardisation, strong asset management and integrated quality management.”

This economic pressure creates a compelling case for technological standardisation, strong asset management and integrated quality management. Growth in pharmaceuticals is ultimately a manufacturing story and companies that capitalise on the reshuffling underway will not only be those making the largest acquisitions or building the most innovative new plants. In the UK in particular, they will be the ones that have made their existing operations scalable, inspection-ready and fit to absorb the growth the sector is chasing.