Single Use Downstream Bioprocessing Market Trends

Market Driver - Increasing adoption of single-use technology in biopharmaceutical manufacturing

The biopharmaceutical industry has seen considerable growth in the last decade with the development and commercialization of many novel biologics and biotherapeutics. This has put tremendous pressure on manufacturers to ramp up production capacities to meet rising demands. At the same time, regulatory expectations around process validation and safety have also increased substantially. Traditional stainless steel-based manufacturing infrastructure is complex and capital intensive to expand. It also requires considerable lead time for designing, installing and validating new production lines.

On the other hand, single-use technologies provide a flexible and scalable approach to biomanufacturing. Systems incorporating disposable bags, tubing, mixers, filters and other components allow for modular production capacity that can be expanded faster by adding more production trains. Since the components are pre-sterilized and disposable, there are minimal cleaning and sterilization validations required, unlike stainless steel systems. This helps speed up implementation of capacity changes. For biopharma companies developing new molecules, single-use systems offer an attractive option to rapidly produce clinical trial materials with flexible production volumes.

Adoption is also driven by the fact that single-use systems reduce the risk of product cross-contamination. Since each production campaign utilizes a new sterile consumable set, there is no risk of carry-over from previous product runs. This makes single-use more suitable for facilities producing multiple drug substances in a given manufacturing suite. Overall equipment and facility footprints are compact compared to traditional processes. Single-use systems are also gaining preference for continuous manufacturing due to the ease of assembling fluid transfer connections.

Market Driver - Reduction in CO2 emissions and project lead time with single-use systems

Sustainability and environmental protection are becoming major considerations for both biopharma companies and their consumers. The industry recognizes the importance of minimizing manufacturing footprints and reducing carbon emissions to lessen environmental impact. Single-use bioprocessing technologies provide a clear edge over traditional stainless steel-based systems from this standpoint. Since disposable systems eliminate the need for large cylindrical steel tanks, mix-use skids and complex pipe work arrangements, overall equipment footprints are significantly smaller. Compact facilities translate to reduced energy consumption for plant operations and lower greenhouse gas emissions over the life cycle of the manufacturing plant.

In addition, project lead times for capacity additions using single-use are considerably shorter. With pre-assembled and pre-qualified disposable components, production lines can be rapidly configured on demand. There is no extensive plant equipment fabrication or lengthy on-site qualification phases. Installation and commissioning times are optimized through modular approaches. Also, since single-use systems avoid cross-contamination issues, changeover times between product batches and campaign configurations are minimal. This efficient implementation and flexibility allow manufacturers to quickly respond to changing market demands or re-purpose facilities. The reduced project cycle times in turn reduce CO2 emissions from construction activities at the site.

Market Challenge - High cost of single-use systems

One of the major challenges for the single use downstream bioprocessing market is the high costs associated with single-use systems. While single-use technologies offer advantages such as decreased risk of cross-contamination, faster setup times and reduced validation requirements, the per-run costs of single-use systems are still significantly higher than the costs of conventional stainless steel-based systems. This is majorly due to the high material costs involved in producing single-use components which are intended for a single-use. Despite efforts of major players to develop more economically viable single-use solutions through innovations in material choices, joint ventures and economies of scale of production, the costs associated with single-use manufacturing infrastructure like bags, tubing, connectors, single-use sensors etc. continue to remain higher than conventional systems. This high-cost challenge acts as a deterrent for biopharmaceutical manufacturers, especially those producing biosimilars and generic drugs, to switch to single-use technologies from conventional systems. Overcoming this cost challenge through further technological advancements and economies of scale is critical for the wider adoption of single-use systems and future growth of this market.

Market Opportunity - Technological advancements in single-use systems

One of the major opportunities for the single use downstream bioprocessing market lies in ongoing technological advancements in the field of single-use systems. Continuous efforts from major players are bringing about innovations that enhance the efficiency, versatility and functionality of single-use technologies. Advancements like multi-product single-use platforms, modular and customizable systems, integrated sensor technologies and connectivity solutions have increased the capabilities of single-use systems. Meanwhile, adoption of improvements like membrane adsorbers, affinity chromatography materials and continuous bioprocessing technologies in single-use formats improves process economics.

Such technological upgrades enable single-use systems to take on more complex manufacturing tasks like purification of multiple products. This expanding scope of application increases the appeal of single-use systems even for large-scale manufacturing facilities. Further innovations can be expected in areas like integrated automation, data analytics solutions and smart single-use technologies in coming years. These advancements will help boost the adoption of versatile and competitive single-use technologies for various bioprocessing needs.