The UK pharmaceutical and life science sector is facing many challenges that will influence the prospects for all companies, be they big pharmaceutical, generics or contract manufacturing operations. Pharmaceutical preparation manufacture including biopharmaceutical expects to see growth of 2.9% over the next five years.
Market pressures - ranging from regulatory controls, global manufacturing competition, product diversification, demographic changes and economic issues - are forcing a re-assessment about how manufacturing and production solutions can help meet demanding market drivers. One only has to acknowledge the upsurge in merger and acquisition activity in the sector to realise that many are, for example, addressing the shortage of new therapies by bolstering their existing product portfolios from elsewhere. This creates additional technology challenges as operations directors and heads of engineering suddenly find they are overseeing multiple technology standards across the enterprise of the business. They are also having to deal with a new and complex technology platform with wide-ranging legacy technology standards currently running their operations.
A good example is the difficulty in correlating disparate data management systems across operational sites as organisations come together.
Reducing losses
Such pressures apply equally to major pharmaceutical manufacturers as to the rapidly growing businesses reliant upon providing generic products at extremely competitive prices. Here any undue costs because of product waste issues, energy consumption or production downtime can severely influence the bottom line. Indeed, in this arena lost production through downtime has been known to culminate in entire order cancellation as market competition hots up and delivery guarantees can be made elsewhere.
The major pharmaceutical business model is being re-assessed within a new commercial and operational reality. One that is increasingly putting manufacturing operating efficiencies at the core of future strategies. This is driven in part by the looming void created by a lack of new blockbuster drugs in the development pipeline, as well as the influence of generic production which has rapidly entered the market as star drugs come off patent restrictions.
The slowdown in output has coincided with top-selling drugs losing patent protection and falling prey to competition from cheaper versions. Together with many governments around the globe, UK political leaders, via the NHS, are demanding price cuts for the vast amount of drugs they purchase. The pharmaceutical sector and all its constituents are increasingly having to seek answers to offset a future where tight margins are the new norm and intense competition is rife.
Challenges
In my opinion, three primary operational drivers are influencing the sector. They are the need to reduce manufacturing costs; the on-going responsibility to maintain product quality and the regulatory requirement to ensure patient safety at all times.
These are significant challenges, but key areas of operation which, following the examples of the automotive and electronics sectors, can readily utilise the benefits of advanced automation technology to deliver real value to a business. The sectors cited have, through their respective adoption of lean manufacturing techniques and advanced technologies, witnessed massive advancements in, for example, the operational efficiencies of their processes over recent years and are exemplar examples of best practice. Pharmaceutical and life science organisations need to follow suit. The time for talking is over.
While there is a growing interest across the pharmaceutical and life science industry in tackling the ‘inefficiency’ of manufacturing operations, it is still largely behind the technology curve - particularly in the automation technology arena. It is restricted in many cases by an adverse to change culture, incumbent and often obsolete legacy production systems, and a situation exasperated by the heavily regulated nature of the business and its procedures to protect patient safety.
Technologies can help
What is the answer? Collaboration with trusted, experienced and knowledgeable technology partners can lay a solid foundation and, indeed, innovative life science companies are turning to Siemens. For example, the ability to continually develop technology products and solutions to address changing manufacturing demands, support sustainable operations and ensure patient safety, offers the market a technology pathway to drive asset value and reduce time to manufacture. The delivery of real-time, accurate date measurement tools also ensures product quality within a validated manufacturing process. As such, commercial pressures to optimise and safeguard production can be satisfied, while access to intelligent and quick data generation not only provides compliance peace-of-mind, it can also inform and drive management and production strategies and future direction.
Key technologies under-score the objectives around reducing costs, driving quality and keeping patients safe. The integration of real-time data management, process analytical techniques (PAT-QbD), unique product identification concepts such as serialisation and ePedigree tools to combat the growth of the counterfeit market, electronic batch recording and weighing and dispensing solutions, can only enhance and optimise manufacturing performance - as well as protect the corporate brand.
The integration of such technologies only tells part of the story. The true benefit comes from a holistic approach that understands how technologies and data management can support a better understanding of the process and operation from starting materials through to the pharmacy and aid on-going manufacturing process efficiency. Central to this is the life cycle support model that has been adopted by many other industrial sectors and which has protected and maximised their investments and helped drive continuous assessment of the changing demands companies can face. As an example, with technology at its centre, life cycle support ensures a sustainable future by managing obsolescence as technology solutions improve and a transparent life cost model is established.
The pharmaceutical and life science sector in the UK makes an important contribution to the economic health of the nation and its scientific expertise is renowned around the world. The commercial environment continues to evolve and change, and unfortunately it will be the inert manufacturing operations that are left behind.
Applicable and proven technologies to help drive reductions in cost of manufacture, optimise operational efficiencies, deliver the right product on time, every time and maintain the trust of purchasing governments, health authorities and patients, are currently available to the pharmaceutical and life science community. A reluctance to invest in such technologies, as competitors take such steps, means you are effectively standing still.
That is not a viable option for a healthy commercial future
