Northbrook, IL 60062 -- (SBWIRE) -- 07/21/2023 -- According to Research Report Single-Use Bioreactors Market in terms of revenue was estimated to be worth $4.2 billion in 2023 and is poised to reach $10.0 billion by 2028, growing at a CAGR of 19.0% from 2023 to 2028 according to a new report by MarketsandMarkets™. Factors such as the increasing adoption of single-use bioreactors among startups and SMEs, lower operational complexity of single-use bioreactors compared to conventional stainless-steel bioreactors, reduced energy and water consumption, growing size of the biologics and biosimilars market, and technological advancements in single-use bioreactors.

The single-use bioreactor market is expected to be one of the fastest-growing segments in the bioprocessing industry over the next few years. This is due to the increasing demand for biopharmaceuticals and biologic products, as well as the cost and time savings associated with single-use systems. Additionally, the increasing adoption of single-use technologies, such as single-use bioreactors, is expected to drive the growth of the market. Companies are focusing on the development of next-generation bioreactors that can improve process efficiency, reduce costs, and increase production capacity. In addition, key players are focusing on increasing the automation of bioreactors to reduce labor costs and increase process control.

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Key Market Players:

Key players in the single-use bioreactors Market are Sartorius AG (Germany), Thermo Fisher Scientific (US), Danaher Corporation (US), and Merck Millipore (Germany).

Driver: Increasing adoption of single use bioreactors among startups and SMEs

Biomanufacturing facility set up demands huge capital investments. For emerging pharmaceutical, biopharmaceutical, biotechnology companies, biomanufacturing involves less than five batches or campaigns per year. For this scale, setting up of stainless-steel facility can be capital intensive. However, on the other side, manufacturing facilities with single use systems are less capital intensive as cleaning processes, sterilization, changeover and validation procedures steps are not required in such facilities. Therefore, startups and SMEs save on costs by adopting single use systems and associated products. Moreover, the flexibility in scaling up offered by single use bioreactors is also attracting these companies as top global players offer a broad range of bioreactor volumes with accessories.

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Restraint: Issues related to leachables and extractables

Extractables and leachables have been an issue in single use bioprocessing in the past for more than a decade now. As single use bioreactorsare primarily made of polymer layers welded together in which each of the layers adds to the physical or chemical properties required for the single use bioreactor to function as a bioreactor properly. These polymer layers may have their particular set of additives like antioxidants, fillers, plasticizers, and stabilizers, among others, to obtain the necessary characteristics. These leach out of the layers into the drug substance bioprocessed in the single use bioreactor bags. Moreover, there are no well-established regulations in use of these polymers. Thus, this factor is likely to restrain the market growth to certain extent.

Opportunity: Hybrid facilities for sustainable manufacturing

Hybrid approach includes manufacturing some components of the process using single use technologies, while others using traditional reusable, permanently plumbed systems. Cost and time pressures on the pharmaceutical industry are ever-growing. Currently, in order to react to new developments in the sector as quickly as possible, the focus is increasingly centered on time-to-market as well as modular, highly flexible production concepts for new biopharmaceutical products. The key advantages offered by hybrid facilities include lower costs, smaller footprints, and less support infrastructure, with some reusable equipment. Thus, an overall decrease in capital investment and increased flexibility associated with single use systems are resulting in their increased use by CDMOs as well as their clients.

Challenge: Disposal of waste

single use bioreactors are stainless-steel bodies lined with bioreactor bags, assemblies, and other accessories for applications such as bioproduction, process development, and research & development. These bags and assemblies are disposed-off after a single use. This creates large amounts of plastic waste after every cycle of production. Biopharmaceutical companies are increasingly adopting single use bioprocessing systems considering the several benefits offered by them, such as cost reduction, faster process development time, and lower capital investments, but there are serious concerns related to the waste disposal from this alternative technology. Many single use suppliers are actively pursuing the development or implementation of more sustainable options for manufacturers. Currently, most used materials from single use manufacturing are decontaminated and commercially landfilled or incinerated. But there is an opportunity to further reduce the unfavorable impact of single use systems through incineration with energy recovery or other more sustainable waste streams. These include landfill (untreated, treated, or with grinding), recycling, incineration (with and without energy recovery), and pyrolysis.

The monoclonal antibodies segment accounted for the largest share of the type of molecule segment in the single-use bioreactors market in 2022.

Based on the type of molecule, the global single-use bioreactors market is segmented into monoclonal antibodies (mAbs), vaccines, gene-modified cells, stem cells, and other molecules. The monoclonal antibodies segment accounted for the largest share of the global single-use bioreactors market in 2022 owing to increasing demand for single-use bioreactors in the manufacturing of mAbs, and factors such as low investment costs and a reduction in time-intensive changeover procedures.

The mammalian cells segment accounted for the fastest growing share of the type of cell segment in the single-use bioreactors market in 2022.

Based on the type of cell, the global single-use bioreactors market is segmented into mammalian cells, bacterial cells, yeast cells, and other cells. In 2022, the mammalian cells segment accounted for the largest share of the market owing to increasing adoption of mammalian cells due to their post-translational modification capacity and human protein-like molecular structure assembly are expected to propel market growth.
The Asia Pacific region is the fastest-growing region of the single-use bioreactors market in 2022.
Based on the region, the single-use bioreactors market is segmented into five major regions: North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa. The Asia Pacific market is expected to register the highest CAGR during the forecast period. Factors such as the growing biopharmaceutical industry, rising investments by pharmaceutical & biotechnology companies, and the growing number of CROs & CMOs in several Asia Pacific countries are supporting the growth of the market in the region.

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Recent Developments:

- In November 2022, Sartorius GA (Germany) planned to invest in growing its operations by establishing new R&D laboratories and digitalizing & automating equipment, among other approaches. This development was aimed at meeting the high demand from the biopharmaceutical industry.

- In November 2022, Danaher Corporation (US) subsidiary, Cytiva invested around USD 8 million to expand its Fast Trak center in Shanghai, China. The Single-use Technologies (SUT) center of excellence in Asia offers new product R&D tests and validation with an aim to facilitate the industry's application of SUT throughout the region.

- In August 2022, Thermo Fisher Scientific (US) opened its largest single-use technology manufacturing site in Greater Nashville with an investment of USD 105 million to meet the growing demand for the bioprocessing materials needed to produce vaccines and breakthrough therapies for cancer and other diseases.

Single-Use Bioreactors Market Advantages:

- Cost Efficiency: Single-use bioreactors are cost-efficient, as they require fewer amounts of investments in terms of purchase, operation and maintenance. This, in turn, reduces the overall cost of production.

- Easy to Install and Operate: Single-use bioreactors are easy to install and operate, as they require minimal training and do not require complex infrastructure. This makes them an ideal choice for small-scale production.

- Increased Productivity: The use of single-use bioreactors can increase productivity, as they can be used to perform multiple processes in a single batch. This reduces the time required to complete the process.

- Reduced Risk of Contamination: Single-use bioreactors reduce the risk of contamination, as they do not require cleaning between batches. This enables manufacturers to produce high-quality products with minimal risk of contamination.

- Flexibility: Single-use bioreactors provide manufacturers with flexibility, as they can be used for a variety of processes and products. This reduces the cost of production, as manufacturers do not need to purchase multiple bioreactors for different processes.