Pharmaceutical manufacturing can be traced back to the industrial revolution when pharmacists began to isolate, purify and manufacture alkaloids on a commercial scale. The discovery of dyestuffs and the tremendous boost it gave to organic chemical synthesis produced between 1880 and 1910 analgesics and barbiturates – drugs that treat symptoms but do not cure – the best of which are still being prescribed today.
Pharmaceutical manufacture as we know it can more appropriately be dated from the commercialisation of the sulphonamides between 1935 and 1940. Many of the features, good and bad, that are regarded as characteristic of the industry began to take shape with chemical synthesis on a lavish scale in research laboratories across Europe and North America, followed by the rapid development of commercial process technology.
The golden age of manufacturing was certainly between 1935 and 1960, when technology dominated and the industry could not produce enough to meet demand. Since 1970, however, market factors have started to shape manufacturing, which has been influenced by cost constraints.
The rate of discovery of new chemical entities was at its greatest between the wars, but this started to decline during the 1939-45 war. It was not until the 1950s that new introductions soared, and continued to soar until thalidomide brought about a halt in 1962. The flood of new discoveries during the 1940s and ’50s had a strong influence on the shape of this emerging market, since many years later some of the leading ethical drugs developed were successfully being marketed in the United States in 1965. The rapid rise to prominence of new products was then achieved at moderate cost during the 1940s and ’50s and the interval between discovery and introduction into the US and other leading countries was typically two to three years for quite revolutionary drugs, including the main antibiotics.
The top five companies in 1970 held a significant position in antibiotics, then the largest therapeutic group, one in which the main discoveries of the 1940s had either been unpatented, or out of patent by 1970, or had been superseded clinically. However, by the 1960s many of the drugs developed earlier ran into problems with the requirement for ever increasing toxicological data (eg, chloromycetin) and, as prescriptions declined, so did the fortunes of the companies such as Parke-Davies, at that time lacking further important research discoveries.
Today 50 companies control two thirds of the total world pharmaceutical market achieving sales of more than $1bn. The five largest companies together control one fifth of the world market, one third is controlled by the top 10, and almost 50 per cent by the top 20. The degree of polarisation is becoming even greater as a result of a great number of mergers and acquisitions. Within the next 10 years the industry is expected to be dominated by five to 10 huge multinational companies.
Since the early 1980s biotechnology companies have flourished. These companies are now estimated to account for over 4 per cent of the world market, the US market being the largest. Growth to four to six times the current volume is forecast in the next five years.
With technology involved in such companies, this places a demand on skill levels and provided new opportunities for new pharmacists. The pharmaceutical industry, once dominated by R&D-driven growth and by aggressive marketing to deliver high margins, is now under pressure and subject to considerable change.
One important consequence is the demise of the strategy that required production to be carried out locally to its market. Indeed, it is becoming all too clear to many companies that the gratitude from governments for local manufacturing investments in the form of rapid product approval, or the award of a favourable price, no longer offsets the penalties of an inefficient manufacturing operation.
These changes represent more than just a simple rationalisation of facilities: they underline a fundamental shift in the management of the business away from national market dominated structures towards an integrated global network cutting across all business functions.
Multiskilled generalists who are capable of delivering significantly increased output are quickly replacing the position of the specialist within a functional area. The concept of a virtual organisation with shared specialised resources providing world class performance at highly competitive costs is the future for pharmaceutical manufacturing.
In recent years, the United Kingdom pharmaceutical industry has suffered as a result of such strategies since there has been little incentive to encourage inward investment in manufacturing. Our export business was second only to the petroleum business, but if current trends continue the UK will become a net importer of pharmaceuticals in the new millennium.
Pharmacists have always had a key role within the industry and, in particular, in product development, quality control and manufacturing.
The qualified person (ie, the person authorised to release products for sale) is usually a pharmacist in most of Europe, but this is not the case in the UK and numbers of pharmacists in this position are declining. In recent years the numbers of pharmacists recruited to the industry has reduced owing to a shortage of pharmacists and the artificially high salaries created within community pharmacy.
The industry currently employs 75,000 people, of whom less than a quarter work in manufacturing. Employee numbers are, however, declining at 14 per cent per year, as the effects of manufacturing rationalisation begin to take effect. As technical sophistication increases, so the demand for new skills is developing and many of the traditional positions are being replaced. Pharmacists can provide many of the new skills required, but often they are in competition with graduates from other biosciences.
The future for the pharmaceutical industry in the United Kingdom is that it will require a greater number of specialists. The traditional manufacturing roles will decline as the basic manufacturing activities are transferred to those countries offering bigger investment incentives and low operating costs.
The future for pharmacy in industry will depend on how adaptable the profession can be to meet the changing role. To ignore this sector of pharmacy, as is the current practice within our society, will only result in pharmacy continuing to decline in numbers and influence.
John Jolley is currently managing director of Orthomol Ltd, a company specialising in nutritional medicine. He has for the past three years been chairman of the Royal Pharmaceutical Society’s Industrial Pharmacists Group and was a member of the Association of the British Pharmaceutical Industry’s technical committee for a number of years