Single Use Bioreactors Market

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Single Use Bioreactors Market Size, Share & Trends

The size of global 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. The research study consists of industry trends, pricing analysis, patent analysis, conference and webinar materials, key stakeholders, and buying behaviour in the market.

Startups and SMEs have been increasingly adopting Single use bioreactors due to the advantages they offer over conventional single use bioreactor systems, the reduced operational complexity offered by single use bioreactors, the growing market for biologic and biosimilar drugs and availability of technologically advanced single use bioreactors are factors attracting larger customer base for the players operating in this market. However, the extractable and leachable have been an issue of concern which is likely to restrict the market growth to certain extent.

Single Use Bioreactors Market Trends

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Single Use Bioreactors Market Dynamics

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.

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 bioreactors are 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 market ecosystem comprises raw material suppliers, manufacturers, and end users such as pharmaceutical & biotech companies, academic and research institutes, and CROS & CMOs.

The prominent single use bioreactor product providers are Sartorius AG (Germany), Danaher Corporation (US), Thermo Fisher Scientific Inc. (US), Merck KGaA (Germany), Getinge AB (Sweden), Eppendorf AG (Germany), Entegris, Inc. (US) and Avantor, Inc. (US).

Single Use Bioreactors Market Ecosystem Analysis

Source: Annual Reports, SEC Filings, Investor Presentations, Expert Interviews, and MarketsandMarkets Analysis

Based on product, single use bioreactor systems segment accounted for the largest market share of the single use bioreactors industry

Based on product, the single use bioreactors market is segmented into single use bioreactor systems, single use media bags, single use filtration assemblies, and other products. The single use bioreactor systems segment held the largest share in 2022 owing to the advantages that it offers such as lower capital investment, lower operating expenses, and lower environmental footprint.

Based on drug type, stirred-tank single use bioreactors segment accounted for the largest market share of the single use bioreactors industry

Based on drug type, the single use bioreactors market is segmented into stirred-tank single use bioreactors, wave-induced single use bioreactors, bubble-column single use bioreactors, and other single use bioreactors (hybrid bioreactors, single use bioreactors with vertically perforated discs). The stirred-tank single use bioreactors segment held the largest share in 2022, owing to the high preference for stirred-tank single use bioreactors in the bioproduction of aerobic microbial cell cultures.

Based on the type of molecule, monoclonal antibodies (mAbs) segment accounted for the largest market share of the single use bioreactors industry

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

The North American market is projected to contribute the largest share for the single use bioreactors industry.

The global market is segmented into five major regions—North America, Europe, the Asia Pacific, Latin America, and the Middle East & Africa. North America is the largest regional market for single use bioreactors, while Europe is the second-largest market. A well-established pharmaceutical, biotechnology industries and the presence of major players operating in the single use bioreactors in the region are driving the market growth. North America is the largest pharmaceutical market in the world, with many global pharmaceutical and biopharmaceutical giants headquartered in the region, such as Danaher Corporation (US) and Thermo Fisher Scientific (US).

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The single use bioreactors market is dominated by a few globally established players such as Sartorius AG (Germany), Danaher Corporation (US), Thermo Fisher Scientific Inc. (US), and Merck KGaA (Germany), among others, are the key product providers that provided market products in last few years. Major focus was given to the product launches, collaborations, agreements, acquisitions, and partnerships due to the changing requirements of pharmaceutical and biopharmaceutical companies, academic and research institutes, and CROs & CMOs across the world.

Scope of the Single Use Bioreactors Industry

This report categorizes the single use bioreactors market to forecast revenue and analyze trends in each of the following submarkets:

By Product

• single use bioreactor systems
• Up to 10 L
• 11–100 L
• 101–500 L
• 501–1500 L
• Above 1500 L
• single use media bags
• 2D Bags
• 3D Bags
• Other bags
• single use filtration assemblies
• Other products

By Type of Molecule

• Stirred-tank single use bioreactors
• Wave-induced single use bioreactors
• Bubble-column single use bioreactors
• Other single use bioreactors

By Type of Cell

• Mammalian cells
• Bacterial cells
• Yeast cells
• Other cells

By Application

• Bioproduction
• Process development
• Research & development

By End User

• Pharmaceutical & biotechnology companies
• CROs & CMOs
• Academic & research institutes

By Region

• North America
  • US
  • Canada
• Europe
  • Germany
  • UK
  • France
  • Italy
  • Spain
  • Rest of Europe (RoE)
• Asia Pacific (APAC)
  • China
  • South Korea
  • Japan
  • India
  • Rest of Asia Pacific (RoAPAC)
• Latin America (LATAM)
  • Brazil
  • RoLATAM
• Middle East and Africa (MEA)

Recent Developments of Single Use Bioreactors Industry

• 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.   

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