The continuous bioprocessing market is estimated to be valued at USD 395 Mn in 2024 and is expected to reach USD 695 Mn by 2031, growing at a compound annual growth rate (CAGR) of 8.4% from 2024 to 2031.

Continuous bioprocessing offers various advantages over traditional batch manufacturing which includes higher productivity, reduced operational costs and lesser process development time. This has accelerated the adoption of continuous bioprocessing manufacturing among pharma companies and contract manufacturers. Advancements in sensors and process analytical technology have enabled real-time monitoring of bioprocesses which has further optimized processes and improved yields. Government support and heavy investments by major players to develop novel continuous bioprocessing platforms are also fueling growth of this market.

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.

Most leading players have shifted their focus towards single-use technologies to enable continuous manufacturing. In 2017, Merck invested $75 million to build a continuous bioprocessing plant in Kenilworth, New Jersey that relies entirely on single-use technologies. This allows for greater flexibility and speed compared to traditional stainless-steel plants.

Similarly, GE Healthcare built a flexible biomanufacturing facility in Canton, Massachusetts in 2018 focused on single-use.

These early investments have paid off - Merck and GE now have a strong foothold in the growing market for continuous processing. Single-use technologies reduce facility footprints, changeover times and product contamination risks, helping companies manufacture batches continually with quick turnarounds.

To gain expertise in continuous bioprocessing, companies have acquired innovative startups working in this area. For example, in 2019, Novartis acquired cell therapy manufacturer CellforCure to boost its leadership in this field. Similarly, Thermo Fisher acquired continuous bioprocessing pioneer ABEC in 2018.

Given the significant investment required, partnerships have emerged as a popular strategy. For instance, Merck collaborated with Batavia Biosciences in 2017 to develop automated continuous manufacturing solutions using Batavia’s ChemoFast technologies. Similarly, Boehringer Ingelheim partnered with ABEC in 2019 to speed development of viral vectors through continuous manufacturing processes. Such partnerships help lower risks for large

Insights, By Type of Manufacturer: Reliance on continuous innovation

 In terms of type of manufacturer, innovator / drug developer sub-segment contributes the highest share of 60.7% in the continuous bioprocessing market owning to their ongoing need for innovation. Drug developers are constantly working to develop new treatments and bring them to patients as quickly as possible. Continuous bioprocessing allows them to accelerate drug development timelines significantly compared to traditional batch manufacturing approaches. By keeping production going continuously with no stop-and-go batches, drug developers save valuable time in getting products from concept to commercialization.

This need for speed is crucial as drug developers strive to be first-to-market with new therapies. Time saved through continuous processes translates directly to greater revenue potential before generics enter. Remaining at the forefront of innovation also helps drug developers protect and expand their existing product portfolios. Continuous bioprocessing gives them a competitive edge over rivals by supporting increasingly complex product pipelines. Its flexibility also lowers risk by allowing smaller volume production of experimental drugs in clinical trials.

As regulatory expectations rise for demonstrating process understanding, drug developers also turn to continuous bioprocessing for more robust manufacturing. Its ability to continuously monitor and control critical process parameters improves production consistency and quality. This helps drug developers more reliably scale up processes from lab to commercial scale. By choosing flexible continuous platforms, they can more readily meet new regulatory requirements for post-approval changes or additional indications.

Insights, By Company Size: Economies of scale for large companies

 In terms of company size, the large sub-segment contributes the highest share of 45.1% in the continuous bioprocessing market due to economies of scale. Large pharmaceutical manufacturers have vastly greater production needs than mid-sized or small companies. To meet commercial demand for multiple drug products, they require high-capacity manufacturing suitable for mass production.

Compared to batch technologies, continuous bioprocessing delivers significant economies of scale. Its ability to run processes nearly continuously with fewer stop-and-start changeovers means large companies gain efficiency from maximizing equipment use. Integrated modular designs of continuous platforms also allow linear expansion just by adding more identical production modules. This modular scaling avoids high costs for custom building separate large-scale facilities.

As continuous bioprocessing entails high upfront capital investment in equipment and facilities, its economies of scale are especially important for large companies to realize full return on investment. Only by taking full advantage of large production capacities do they achieve optimal low unit costs. Furthermore, automation and digital enhancements and increasingly characterized continuous bioprocessing as more "plug and play." This means large companies can readily benefit from standardized equipment designs across their extensive global manufacturing footprints.

• The market is moving towards continuous bioprocessing due to its cost and efficiency benefits. Continuous bioprocessing technologies reduce manufacturing costs, minimize facility footprints, and improve product consistency. The technology's adoption is accelerated by the COVID-19 pandemic. Challenges remain in defining continuous processes and aligning with GMP requirements. However, the opportunity for growth in this domain is significant, with an increasing number of companies exploring continuous bioprocessing lines and upgrading their operations.

The major players operating in the continuous bioprocessing market include AGC Biologics, Biogen, Bristol-Myers Squibb, Sanofi Genzyme, FUJIFILM Diosynth Biotechnologies, Merck KGaA, Novasep, UCB Pharma, Enzene Biosciences, and WuXi Biologics.