12 March 2020
With the global healthcare spend continuing to increase dramatically and projected to reach in excess of US$10 trillion by 2022, pharmaceutical companies are making significant investments in the research, development, and manufacturing of biologics, which are drugs that are derived in living organisms. Biologics projects consist of many elements, including the overall design, construction, and start-up of the entire facility, but one of the most important pieces of equipment involved in the manufacturing process is the bioreactor. Because of their long lead times, these reactors can greatly influence a biotech project’s critical path and affect the overall project timeline. By focusing early on a bioreactor’s design and development, clients can control one key aspect in ensuring the successful and timely delivery of biologics projects.
Investments in biologics are driven in large part by the global increase in life expectancy, improved access to medicines and the growth of non-communicable diseases, most prominently cancer, heart disease and diabetes. Spending on new cancer drugs alone is expected to grow by more than 50% over the next few years, with particular focus on the production of biologics. These biologics have revolutionised the treatment of many cancers and chronic conditions, such as multiple sclerosis, arthritis and rheumatoidarthritis, Crohn’s disease and other autoimmune diseases.
Additionally, established life science companies are upgrading their existing facilities to keep track with the latest regulations and technology. Start-ups are also joining the fray, as funding has become available based on the anticipated high return-on-investments. Thus, biologics manufacturing is expected to skyrocket over the coming years. The manufacturing of biologics relies heavily on the use of bioreactors. A bioreactor is simply a vessel in which a chemical process, usually involving organisms or biochemically active substances derived from such organisms, is carried out. There are two types of reactors: multi-use and single-use.
A single-use bioreactor, or disposable bioreactor, is a bioreactor that is lined with a disposable bag. A multi-use reactor is a vessel made typically of stainless steel or glass. With the full-on press of the pharma industry into biotech, the bioreactor market is red hot.
As such, with any significant investment, understanding the critical equipment and the lead times help our clients to better plan and prepare their projects for success. Our clients depend on us, as the market intelligence leader, to bring this insight to their projects. To this end, Linesight created a diagnostic that was based on real-time data that was gathered through a survey administered to a cross-section of bioreactor manufacturers located across the globe. The respondents were business owners, operations managers, and sales managers with current project experience. The objective of the survey was to understand the current conditions, drivers, and future trends of the bioreactor industry.
Historically, the US and Europe have been the major consumers of bioreactors and continue to be in a strong position with robust demand. The US biologics market could, however, face possible threats to its vitality, depending on the US Presidential election and any incoming changes to policies regarding healthcare and drug pricing. The market in Asia, on the other hand, is having a major effect on the purchasing of bioreactors and is expected to see growth, with many of the bioreactor suppliers moving to the region to meet the demand. 80% of the reactor suppliers see the market increasing in activity, thus adding more pressure to lead times. The factors that are driving biologics are not expected to change if a global recession were to occur.
With their long lead times, bioreactors are driving the critical path of biotech projects. Though lead times are primarily influenced by reactor size and the manufacturers’ supply chain, there are specific actions that clients can take to help minimise delays by locking in their process design early, providing focused show drawing reviews and streamlining approvals. Linesight has seen success with clients that have a strategic focus on sourcing. These sophisticated clients have engaged Linesight to bring industry and marketplace expertise to help implement and execute sourcing strategies that are aimed to deliver value across their programme of work. These clients have successfully leveraged their buying power and have strategically aligned with some of these reactor manufacturers to improve costs and lead times. The work does not stop at the sourcing stage; order management is equally important, where focus must be on maintaining regular contact with the manufacturer and visiting the fabrication facilities to ensure processes are on track. Understanding bioreactor lead times and working with construction consultancies that have experience in reducing delays on this critical equipment are proactive steps to ensuring overall success on biotech projects.