The survey says...

Things are looking up in the cleanroom and contamination control sectors, with an increasing demand for their capabilities and products across a wide array of industries and around three quarters of professionals in an "optimistic" mood over their current positions and prospects.

These are just some of the findings following a recent market study conducted by Contamination Control & Cleanroom Products 2006 (3C 2006) and Cleanroom Technology magazine. The indicative survey quizzed professionals across all industry sectors and job functions, around 60% of whom were based in the UK. The need for cleanroom and contamination services is mainly deemed to be rising in the biotechnology and pharmaceutical sectors, with hospitals, medical device and in vitro manufacturing, and food and beverages not far behind. Indeed, Dr Hans Schicht, an independent consultant specialising in cleanroom technology and contamination control, believes that "global cleanroom demand for the manufacture of miniaturised sensors and microsurgical instruments [could] grow by 45% per year". According to a report entitled "Pharmaceutical cleanroom trends" by Robert McIlvaine of the McIlvaine Company,¹ the value of the global pharmaceutical cleanroom industry is estimated at around $11bn, with advances in micro- and nanotechnologies providing growth and promise for the future. The report points out that the batch-testing method used by the pharmaceutical and biotechnology industries, due to the heat sensitivity of their products, means that they are "increasingly challenged" in their production of sterile components and can only "approximate sterility as closely as possible". This will obviously drive their need and search for "clean" space. The report also states that the industries' standard practice is to opt for Class 100 (ISO Class 5) conditions in "critical areas".

Industry fears The survey found that the main fears for the cleanroom industry were regulations, staff training, costs and competition from the Far East. Almost a fifth (19.2%) of respondents cited regulation as the most significant challenge facing their business; and a further 10.3% cited lack of trained staff. Nearly half of respondents (47.5%) said their greatest fears were over areas covering cost: R&D; staff and labour; and materials/consumables, while 24.4% were most concerned about "staying ahead of industry advances and technological developments". "Competitor behaviour" was worrying 10.3% of respondents with many making such remarks as: "Competition from the Far East (China) means we cannot compete on product cost due to labour costs." These are not irrational fears according to the McIlvane Company: "China has an average growth rate of 10-12% and is the eighth largest pharmaceutical market in the world with more than US$8bn total sales in 2004. With manufacturing steadily increasing at 8.4% annually, China has the potential to become the largest R&D base in the world. GlaxoSmithKline and Roche have already set up R&D centres there." India is also experiencing growth: its pharmaceutical industry is estimated at $8.7bn and its domestic output has increased at a compound growth rate of 13.7% per annum, according to the report. It is now ranked fourth globally in terms of volume and thirteenth in terms of value. The lower costs in these areas in turn trigger an upsurge in outsourcing. With drug development costs often ranging between US$500-800m^1,2 and cleanroom costs continuing to increase to meet ever stricter regulation, companies are always going to look for areas in which they can save, leaving many professionals based in the West feeling that they have no way to compete. Some 14.1% of respondents blame regulations for this, dubbing the industry "over-regulated" and citing this as a cause of cost constraints; however, unsurprisingly for an industry founded upon regulation, 57.7% of those surveyed feel that the industry is well-regulated and 19.2% feel that it is under-regulated. Overall the future looks promising, with the need for "clean" space unlikely to diminish. Some may fear competition and cost issues, but as the very essence of business these are the issues that primarily drive innovation and progress. Many of those who felt optimistic about the state of the industry cited growth as a factor behind this optimism – and growth, as a sign of a healthy market, cannot occur without competition.