SINGLE-USE BIOPROCESSING SYSTEMS MARKET ANALYSIS

Market Challenges And Opportunities

Global Single-use Bioprocessing Systems Market- Drivers

• Increased Use of Single-Use Systems for Vaccine and Therapeutics Manufacturing: The COVID-19 pandemic has highlighted the importance of rapid and scalable vaccine and therapeutic drug production capabilities. Single-use bioprocessing systems offer significant advantages in responding quickly to public health crises by enabling faster production timelines and flexible manufacturing capacities compared to traditional stainless-steel facilities. The pandemic response involved unprecedented investments and collaborations to develop and distribute vaccines in record time using single-use technologies. Many drug makers who previously used conventional facilities have now adopted single-use options to produce COVID vaccines and treatments on a massive scale. They recognize that single-use systems allow for faster scale-up of operations without lengthy and expensive construction of new cleanrooms. Regulatory approvals are also faster since these systems present lower risks of cross-contamination. Going forward, regulatory agencies and governments are likely to emphasize the development of rapid vaccine production capabilities to prepare for future pandemics. This will further drive investments in single-use technologies that facilitate quicker responses versus traditional stainless steel equipment with rigid capacities. The pandemic has showcased the advantages of single-use systems to the broader healthcare industry as well, raising awareness of their benefits for manufacturing other drugs and biologics outside of pandemic settings. Overall adoption is expected to continue increasing as biopharma firms recognize the flexibility, speed, and regulatory advantages that these systems provide for vaccine and therapeutics production.
• Increased Bioproduction of Complex and Novel Biologic Therapies: The biopharmaceutical industry is witnessing rapid development and approval of complex novel biologic therapies such as monoclonal antibodies, gene therapies, and cell therapies to treat cancer, autoimmune diseases, and other serious medical conditions. Production of these complex biologics requires advanced manufacturing capabilities and highly controlled environments compared to traditional small molecule drugs. Single-use bioprocessing systems are particularly well-suited for manufacturing such sensitive therapies since they eliminate issues like leachables, particles and bioburden associated with the reuse and cleaning of stainless-steel equipment. Their disposable and pre-sterilized nature also makes the transfer and injection of high-value biologics safer while reducing contamination risks. As the pipeline of novel biologic drugs grows, especially those involving regenerative medicine and gene/cell therapy approaches, demand is increasing for specialized single-use technologies fitted with sensors and controllers that can carefully regulate critical manufacturing parameters.

Global Single-use Bioprocessing Systems Market- Opportunities

• Growing Bio Pharmaceutical Industry: Biologics have become the fastest-growing segment of the pharmaceutical market. This rapid growth of biologics drives the demand for single-use technologies that provide the benefits of flexible operations, easy scale-up, and lower initial capital investments. Emerging markets also present major opportunities owing to increasing R&D investments from governments and rising biotech

Global Single-use Bioprocessing Systems Market - Restraints

• High costs associated with single-use components: The high costs associated with single-use components are one of the major factors restraining the growth of the global single-use bioprocessing systems market. Single-use technologies require single-use bags, tubing, connectors, sample bags, and other components that need to be replaced for every new process run. This makes the overall production process quite expensive as compared to traditional stainless steel based systems, which can be reused for multiple batches. The per-use nature of these single-use components means that pharmaceutical companies have to regularly procure fresh components and dispose-off the used ones after each manufacturing cycle. This drives up their recurring expenditure on consumables. Additionally, single-use systems also require capital investment in terms of their installation and validation, which adds to their overall cost. The high costs associated with procuring single-use bags, assemblies, sensors, etc. on a periodic basis negatively impacts the profit margins of pharmaceutical manufacturers, especially for large volume production. Manufacturers also have to factor in the costs of proper waste disposal of the used single-use components as per environmental guidelines, which further adds to their expenses. The bioprocessing waste generated from single-use systems contains microbiological contaminants and other hazardous materials that require incineration at high temperatures or autoclaving before safe disposal. This regulated waste management is costly for companies. The high costs of components and operations have discouraged certain pharmaceutical manufacturers, especially those involved in large volume drug production, from fully adopting single-use bioprocessing technologies. According to the data from the World Bank, the global average annual healthcare expenditure per capita increased from US$957 in 2015 to US $1,23 in 2020. This shows the rising healthcare costs worldwide, which impact the profitability of pharmaceutical manufacturers. The high costs of single-use technologies thus act as a deterrent for the greater adoption of these systems by all drug manufacturers.