As an industry, biopharmaceutical manufacturing is in transition and is facing challenges borne out of success. It was in the early 1980s that the first products were commercialized, namely the replacement hormones insulin and human growth hormone. The industry initially grew rapidly in the early ‘80s against a background of an immature supply industry: there were no large-scale columns (>10 cm diameter), column controllers, limited resin supplies and no established ultrafiltration technology. The position today is that the industry has achieved sales of around $85 billion in 2007 (1). This has been accompanied by a huge investment in capacity; for example, cell culture capacity has grown from less than 300,000 L pre-2000 to around 3 million litres today, driven by the requirements for Monoclonal Antibodies (MAbs). Although we often talk about the biopharm industry as a homogeneous entity, it is in fact highly heterogeneous, with mature segments such as the replacement hormones and traditional vaccines, maturing segments such as MAbs and modern vaccines, and next-generation products such as gene therapy, tissue replacement and stem cell technologies. Each area has its own manufacturing challenges.
The industry is facing challenges borne out of success, at a time when the rate of innovation is slowing and competition from biosimilars is increasing.
This supplement is a timely assessment of the challenges we face as an industry and of the industry’s response in terms of technical innovation and business practices. It is worth reflecting on the fact that these challenges arise as a result of delivering successful novel therapeutics, a theme developed in Vince Anicetti’s article (see pp 6–13). These successful new biological treatments are under close scrutiny in terms of the cost benefit to the patient. The cost benefit is becoming an ever-more critical issue in healthcare spending policy on both sides of the Atlantic (2): in the US, they are looking at adopting the methodology developed by the UK’s National Institute for Clinical Excellence (NICE). Pressure to reduce prices come at a time when the rate of innovation is slowing and competition from biosimilars is increasing: these factors affect all the maturing sectors of vaccines and therapeutic proteins. It is, therefore useful to get the perspective of the industry leaders in the roundtable discussion, where they recognize that cost is an issue and that the industry will have to deliver significant reductions in cost of goods during the next 5 years. To maintain the cost-effectiveness of facilities, it is important that they are operated at close to design capacity, ensuring utilization levels in excess of 80%; levels much below this will significantly reduce the returns on these high capital investments. To ensure this, there should be a continuation of the trend towards sharing capacity between companies to balance the industry’s capacity. History shows that if we can innovate and operate facilities effectively, we can stave off the threat from Asia. This should spur us in the West to innovate more. The crucial point is that companies need to understand their cost base in terms of CoGs and how this is calculated, so that they can understand better key cost drivers. This will facilitate better assessment of the impact of new processes, manufacturing technologies and business processes.