According to Inkwood Research, the global single-use bioprocessing market is projected to exhibit substantial growth prospects, with a CAGR of 15.66%, between 2024 to 2032. The single-use bioprocessing market encompasses the supply of essential components like bioreactor bags, tubing, connectors, and filters designed for one-time use in biopharmaceutical manufacturing. This innovative approach eliminates the need for cleaning, sterilization, or validation between batches, offering enhanced flexibility, efficiency, and reduced risk compared to traditional stainless steel equipment.
Single-use components significantly streamline transitional processes between batches, leading to faster turnarounds, reduced downtime, and heightened responsiveness to clinical material demands. Furthermore, their use requires smaller manufacturing footprints, resulting in considerable capital expenditure savings.
Single-Use Bioprocessing Market: Diverse Applications & Key Benefits
The global single-use bioprocessing market is rapidly expanding due to the versatility and advantages these technologies provide. From biopharmaceutical manufacturing to cell and gene therapies, single-use systems enable greater flexibility, efficiency, and cost savings compared to traditional stainless steel equipment.
On that note, let’s take a look at some of the key advantages of single-use solutions –
- For small to mid-size drug developers lacking permanent stainless steel biopharmaceutical infrastructure, single-use technologies offer an avenue to expand production capabilities in a cost-efficient manner. Concurrently, major bio-manufacturers are incorporating single-use technologies to supplement existing infrastructure and mitigate contamination risks associated with fixed equipment.
- Furthermore, continual technological advancements have played a pivotal role in driving the increased adoption of single-use bioprocessing. These developments include high-performance single-use bioreactors, fully automated manifolds, and improved connectivity, ensuring superior process monitoring and control.
- Single-use bioreactors (SUBs) are disposable and made of plastic, eliminating the need for cleaning stainless steel units. They offer adaptability in sizes and configurations, suitable for various batches without major process changes. SUBs require lower initial investment as they don’t need permanent infrastructure. They are easy to set up, pre-sterilized, and feature advanced monitoring for optimal conditions. SUBs also reduce environmental impact by cutting water, energy, and chemical usage compared to traditional bioreactors.
Regional Dynamics & Strategic Integration of Single-Use Technologies –
The Asia-Pacific represents a high-growth market for single-use bioprocessing technologies. This is mainly attributed to:
- The rapid development of biopharmaceutical sectors in China and India owing to favorable government policies, large talent pools and low operating costs.
- Significant investments by both domestic and multinational drug makers into expanding manufacturing capacities and R&D infrastructure across the Asia-Pacific.
- Increasing focus on biosimilars and biologics development in cost-sensitive Asian markets, creating demand for flexible and affordable single-use technologies.
- Strategic partnerships between global single-use suppliers and local players to provide training, distribution channels and system integration support across Asia Pacific.
- Advancements in R&D programs and clinical trial activities in countries like China, South Korea, Singapore, Taiwan and Australia requiring quick turnaround times that single-use technologies enable.
- Significant cost advantages, reduction in facility footprint and decreased contamination risks that disposable technologies offer Asian biomanufacturers.
The strategic integration of single-use technologies has become pivotal in response to the increasing intensity of drug development processes and persistent cost pressures. While initially favored for pre-clinical phases, the adoption of single-use technology continues to rise steadily across late-phase and commercial manufacturing.
Single-Use Bioprocessing Market | An Overview of Key Trends
The single-use bioprocessing market is experiencing robust growth driven by increased adoption across biopharmaceutical manufacturing and rising demand for flexible, cost-efficient bioproduction. These trends are expected to further expand applications and drive continued market expansion over the coming years.
- Increasing adoption in pre-clinical and clinical phases of biologics development to facilitate quicker and more efficient trials.
- Rising utilization for late-phase and commercial manufacturing in response to intensified processes and persistent cost pressures.
- Growing demand from small to mid-size drug developers without permanent stainless steel infrastructure.
- Large bio-manufacturers’ implementation of single-use technologies to complement existing infrastructure.
- Ongoing technological advancements in single-use bioreactors, automated manifolds, and connectors to enhance process monitoring and control.
By Kiran Raut
Regulatory agencies worldwide, such as the FDA (Food and Drug Administration), EMA (European Medicines Agency), and others, have established guidelines and standards to ensure the safety, quality, and efficacy of biopharmaceutical products manufactured using single-use bioprocessing systems. Compliance with these regulations is crucial for market players, as it involves validation, documentation, and adherence to good manufacturing practices (GMP).
Single-use bioprocessing technologies find applications across various stages of biopharmaceutical production, including cell culture, filtration, purification, mixing, storage, and transport. These technologies are extensively utilized in the production of vaccines, monoclonal antibodies, gene therapies, recombinant proteins, and other biologics.