The biopharmaceutical contract manufacturing sector is set to expand substantially in the next few years as biotech companies increasingly rely on outsourcing to improve efficiency and reduce costs, new research suggests.
According to a report published by consulting firm HighTech Business Decisions, pharmaceutical and biotech firms are relying more and more on contractors to provide more production capacity and a wider range of services.
"Biopharmaceutical companies outsource for various reasons. First, there are early stage companies who have no or limited manufacturing capability, generally they have limited resources and are focusing their efforts on drug development," William Downey, president of HighTech Business Decisions, told Outsourcing-Pharma.com.
"Second, there are biotech companies whose business model is to not invest in manufacturing infrastructure, but to focus solely on drug development and marketing - essentially a virtual company."
In addition, said Downey, there are larger biopharmaceutical firms who look to outsource as a way to ensure that they have production capability available to adapt with demand.
Finally, he explained, some larger pharma companies are now seeing that contract manufacturing organisations (CMOs) have the production, technology and experience that they do not have and they would rather not spend the funds and time to develop their own processes or technologies.
This increasing trend has also been fuelled by the increased demand for biologics. Indeed, the pharma industry has seen a biotechnology revolution in the past few years and it is estimated that biologics now make up 13 per cent of the total prescription drug sales in the US.
With currently more than 400 biologic products in clinical trials and approximately 700 biologics products in pre-clinical or early stage development, there is growing thirst for contract production to support biomanufacturing processes.
As a result, the biopharma contract manufacturing market will see important changes over the next years as contract manufacturers add new capacity and expand their services offering to meet the demand from drugmakers, predicts the report.
"In our latest study, we see that many of the contract manufacturers are offering more services to their clients, as many of the biotech companies want a complete turn-key service from their contract manufacturer," said Downey.
"This includes items such as cell line development, process development, analytical and assay development services through fill and finish."
In addition, new technologies are being deployed that will positively impact yields and productivity, including use of disposables, new host cell systems and perfusion technologies.
Downey added that many biotech firms look to their CMOs to provide assistance with the regulatory process as well, in particular smaller companies who usually don't have the resources necessary.
According to the report the growth of the market, which is currently estimated at $2.1bn (€1.6bn) worldwide, is showing no signs of slowing down.
"In our study, biotechnology companies will be devoting a larger share of their manufacturing budget to outsourcing over the next five years," said Downey.
"In 2008, we expect the market to reach $2.8bn - this is driven by increased production and increase in the service offered."
The study, called "Biopharmaceutical Contract Manufacturing 2007: Quality, Capacities and Emerging Technologies", gathered data from 41 biotech companies and 27 biopharma contract manufacturers.