Continuous Bioprocessing Market Trends

Market Driver - Cost reduction and efficiency improvement in bioprocessing

One of the major drivers for the adoption of continuous bioprocessing technologies is the potential for significant cost reductions and improvements in efficiency that it offers over traditional batch manufacturing methods. Continuous processing allows for running biological production without interruption 24 hours a day for 7 days a week and eliminates the time-consuming cleaning and start-up cycles between batches. This translates to higher asset utilization and a much more efficient use of production capacity. Manufacturers can continuously harvest and refine their products within a closed system without any batch changes or interruptions. This uninterrupted workflow allows for higher quality consistency and minimizes deviations between batches.

Continuous manufacturing also results in a smaller physical plant size compared to batch processes for the same production output. It requires significantly lesser floorspace which translates to lower capital costs. Less manufacturing equipment is required which reduces capital expenditure. There is also a substantial reduction in auxiliary equipment needs like storage tanks and pipe works since continuous processes utilize in-line refining and purification. Operating costs are lower as it needs less direct labor and plant maintenance is also minimized due to reduced cleaning cycles. Energy requirements are reduced due to improved thermal efficiency when operating continuously at a steady state instead of frequent stop-start cycles typical of batch operations. Utilities and consumables costs are lower as continuous processes are inherently more productive and result in less wastage.

Market Driver - Accelerated adoption due to the COVID-19 pandemic

The ongoing COVID-19 pandemic has significantly impacted the biopharmaceutical industry in multiple ways. One notable effect has been an accelerated focus on and adoption of continuous bioprocessing technologies by both biotech firms as well as large biopharma players. The pandemic exposed vulnerabilities in the existing global drug supply chains and dependence on traditional batch manufacturing methods. It highlighted the critical need to improve production flexibility, speed, resilience and capacity surges to address future public health emergencies.

Continuous manufacturing approaches allow for rapid adjustments to production volumes according to demand fluctuations without lengthy changeovers. This proved invaluable during the pandemic when there was an urgent requirement to massively scale up manufacturing capabilities to meet the soaring needs for vaccines and therapeutics. Continuous processes gave companies the ability to quickly activate manufacturing lines and bring additional capacity online in a matter of weeks compared to months for new batch facilities. They also offer production redundancy through synchronized manufacturing across multiple modular facilities. This distributed manufacturing model with rapid scale-up ability is ideal to mitigate supply bottlenecks and disruptions due to factors like regional lockdowns.

The demand surge during the pandemic also compelled regulatory agencies to adapt new avenues for expediting manufacturing approvals and technology transfers. This created a more facilitative regulatory environment conducive for continuous platforms. Companies now have greater motivation to fast-track their continuous bioprocessing programs in order to build resilient, scalable and flexible infrastructure to effectively address future public health crises. With its agility and surge capabilities, continuous biomanufacturing has moved to the forefront as a strategic priority for both industry and governments in light of the lessons from the COVID-19 experience. This is a major driver propelling greater adoption of these advanced technologies.

Market Challenge - Complexity in defining continuous processes

One of the key challenges in the continuous bioprocessing market is the complexity in defining continuous processes. Continuous biomanufacturing requires redesigning established batch processes into integrated, continuous train models which involves substantial process development efforts. Compared to batch processes which have clear start and stop points, continuous processes operate in a more complex manner where the different unit operations are interconnected. This makes defining the process parameters, operating conditions and validating the system performance more complicated. Ensuring smooth transition of material between various unit operations while maintaining product quality also poses technical challenges. Additionally, continuous processes deal with significantly larger volumes of material flowing through the system compared to batch. This escalates issues related to process control and streamlining. The non-steady state behavior of such complex, continuously operated trains also makes mathematical modeling and rigorous validation difficult. Overcoming these complexities in designing and developing robust continuous processes requires extensive research and engineering innovations.

Market Opportunity - Development of end-to-end continuous bioproduction lines

One of the major opportunities in the continuous bioprocessing market is the development of fully integrated, end-to-end continuous biomanufacturing lines. Currently most biopharmaceutical manufacturing involves separate independent unit operations performed in a batch mode. This leads to downstream bottlenecks and high production costs. Developing fully automated, continuous production trains that integrate upstream and downstream processing without any intermediary storage or batch transitions has potential to significantly enhance productivity, reduce costs and improve supply chain efficiencies.

Establishing standardized modular platform technologies that can realize scalable, single-use end-to-end solutions will drive the next generation of biomanufacturing. This can open up opportunities for novel business models in contract manufacturing. Continuous bioprocessing allows for on-demand production capabilities matching demand fluctuations. End-to-end integrated platforms thus promise to optimize capacity utilization, make production more demand-driven and accelerate product availability. Their successful realization relies on collaborative efforts across bioprocess engineering, automation, equipment design and supply chain domains.