Single-use Bioreactors Market by Product [Systems, Media Bags (2D, 3D), Filtration Assemblies], Type [Stirred-tank, Wave-induced], Cell [Mammalian, Bacterial, Yeast], Application [Commercial (Mab, Vaccine), Research], End User - Global Forecast to 2030

The Single-use Bioreactors Market is projected to reach $10.3 billion by 2030, at a CAGR of 15.8% from 2023 to 2030. Single-use bioreactors, also called disposable bioreactors, are made of disposable bags instead of a culture vessel. These bioreactors eliminate the need for expensive and bulky clean-in-place (CIP) or steam-in-place (SIP) systems and offer flexibility and a low risk of contamination, contributing to their adoption by pharma & biotech companies. These companies are focusing on organic & inorganic strategies like expanding manufacturing capacity or acquisitions to increase their bioproduction, increasing the adoption of biopharma equipment, including bioreactors.

For instance, in December 2022, Thermo Fisher Scientific Inc. (U.S.) expanded its presence in Hangzhou, China, to support customers' manufacturing needs, enabling them to serve more patients worldwide. This site offers integrated clinical and commercial drug substance and drug product capabilities, including process development, cell line development, biologics drug substance manufacturing and sterile fill-finish. This includes the use of packaging and labeling capabilities. Advanced technologies in the facility include Thermo Fisher 2,000-liter HyPerforma Single-Use Bioreactors and associated Single-Use equipment and, in the future, bioreactor capacity up to 5,000 liters through Thermo Scientific DynaDrive technology.

In March 2021, Pall Corporation (U.S.), a subsidiary of Danaher Corporation (U.S.), acquired Pall-Austar Lifesciences Limited (Hong Kong) (a joint Venture between Pall and Austar Group). This acquisition is intended to expand the single-use technology manufacturing capabilities of the company in China for products supporting the scale-up of COVID-19 vaccines.

The rapid adoption of disposable technology in the pharmaceutical and biotechnology industry, growing demand for biopharmaceuticals, and capacity expansion of biopharmaceutical plants are some of the major factors driving the growth of the single-use bioreactors market.

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Capacity Expansion of Biopharmaceutical Plants is Driving the Growth of this Market

Recently, the manufacturing of various biopharma products, such as vaccines and biosimilars, has increased due to the price advantage compared to biologics, the COVID-19 pandemic, and biosimilar substitution laws. Biopharmaceutical manufacturers and CDMOs are increasing their capacity through expansions, which will generate additional demand for biopharmaceutical manufacturing equipment and consumables, propelling the growth of this market.

For instance, in June 2022, Merck KGaA (Germany) expanded its Life Science business sector by establishing a facility in Wisconsin, U.S. This USD 62 million (EUR 59 million) site is expected to increase high-potent active pharmaceutical ingredients (HPAPI) production capacity. Furthermore, in May 2022, Sartorius AG (Germany) established a new manufacturing site in Tunisia to increase its fluid management technology production, thereby meeting the high demand from the biopharmaceutical industry.

The Rising Adoption of Personalized Medicines is an Opportunity for the Players in this Market

Personalized medicine is an emerging practice that uses an individual's genetic profile to guide disease prevention, diagnosis, and treatment decisions. These medicines are now considered the mainstream clinical approach, thereby changing disease identification, classification, and treatment method.

According to a report published by the Personalized Medicine Coalition, personalized medicines are increasing rapidly. The share of personalized medicine increased steadily in the total drugs approved in the U.S. by FDA from 28% in 2015 to 35% in 2021. In 2021, the FDA’s Center for Drug Evaluation and Research (CDER) approved 48 new molecular entities (NMEs) (drugs, agents, or therapeutic biologics). Out of these 48 drugs, 17 were classified as personalized medicines. Globally, the number of personalized medicines was 132 in 2016, which increased to 286 in 2020. The increasing number of FDA approvals and the availability of new personalized medicines are expected to create demand for their upstream processing equipment, such as bioreactors.

Key Findings in the Single-use Bioreactors Market Study:

Based on Product, the Media Bags Segment is Projected to Register the Highest CAGR

The growth of this segment is driven by its benefits, such as high flexibility, low levels of extractable and leachable, and product stability during storage compared to culture vessels.

Based on type, the Wave-induced Bioreactors Segment is Projected to Register the Highest CAGR

In contrast to conventional stirred tank bioreactors, wave-induced bioreactor systems do not rely on oxygen bubbles for culture aeration or agitators for mixing. Instead, these bioreactors' large surface-to-volume ratio and rocking motion generate surface aeration to meet the oxygen demands of mammalian cell cultures, often exceeding those delivered by stirred tanks. Rocking-motion bioreactor systems have also been shown to improve fluid turnover and minimize shear forces compared to stirred tanks. Such flow conditions reportedly produce better cell suspension and reduce the risk of cell damage, enabling rocking-motion bioreactors to reach higher maximum cell densities than traditional spinner flasks. All these advantages of wave-induced bioreactors contribute to the growth of this segment.

In 2023, the Mammalian Cells Segment is Expected to Account for the Largest Share

Based on cell type, in 2023, the mammalian cells segment is expected to account for the largest share of the market. Mammalian cells are mostly used for mAbs production and can produce large amounts of mAbs with a consistent quality and adapt well to culture in large-scale suspension bioreactors. These cells can perform the required protein folding, assembly and post-translational modifications such as glycosylation and provide greater commercial success for protein & genomic research, thus driving the adoption of single-use bioreactors.

In 2023, the Commercial Bio-Production Segment is Expected to Account for the Largest Share

Based on application, in 2023, the commercial bio-production segment is expected to account for the largest share of the market. The large market share of this segment is attributed to the growing support from regulatory agencies & initiatives by biopharma companies. For instance, in October 2021, the U.S. Food and Drug Administration, the National Institutes of Health (NIH), 10 pharmaceutical companies, and five non-profit organizations partnered to accelerate the development of gene therapies for the 30 million Americans suffering from rare diseases. In January 2021, Cognate BioServices, Inc. (U.S.), a cell and gene therapy CDMO, announced plans to expand its cell and gene therapy manufacturing facility, warehouse capabilities, and laboratory space at its U.S. and European sites.

In 2023, the Pharmaceutical & Biopharmaceutical Companies Segment is Expected to Account for the Largest Share of the Market

The large market share of this segment is attributed to the rise in R&D activities, high adoption of bioreactors in pharmaceutical laboratories, and concerns over flexibility, sterility, cost efficiency, and enhanced productivity.

Europe: Largest Regional Market

The growth of this market is driven by the increasing sales of drugs, support from government and regulatory authorities to promote the use of biopharmaceuticals for various health indications, and various companies expanding their manufacturing capacities as well as their operations.

Key Players

The report includes a competitive landscape based on an extensive assessment of the key growth strategies adopted by leading market participants in the last 3 to 4 years. The key players profiled in the single-use bioreactors market report are Merck KGaA (Germany), Danaher Corporation (U.S.), Sartorius AG (Germany), Thermo Fisher Scientific Inc. (U.S.), Eppendorf AG (Germany), Solaris Biotechnology srl (Italy), Cellexus International Ltd. (U.K.) CESCO Bioengineering Co., Ltd. (Taiwan), PBS Biotech, Inc. (U.S.), Distek, Inc. (U.S.), and Infors AG (Switzerland).

Scope of the Report:

Single-use Bioreactors Market, by Product

• Single-use Bioreactor Systems
  • Upto 10L
  • 11L-500L
  • 501-1000L
  • Above 1001L
• Media Bags
  • 2D
  • 3D
  • Linear
• Filtration Assemblies
• Other Products
  (Note: Other products include pumps, single-use vessels, tubing & connectors, gas components, rockers, cables, sensors/probes, and films.)

Single-use Bioreactors Market, by Type

• Stirred-tank Bioreactors
• Wave-induced Bioreactors
• Other Types
  (Note: Other types of bioreactors include hybrid bioreactors, bubble-column, and bioreactors with vertically perforated discs.)

Single-use Bioreactors Market, by Cell Type

• Mammalian cells
• Bacterial Cells
• Yeast Cells
• Other Cell Types
  (Note: Other cell types include plant cells and insect cells.)

Single-use Bioreactors Market, by Application

• Commercial Bioproduction
  • Monoclonal Antibody Production
  • Vaccine Production
  • Therapeutic Protein Production
  • Cell & Gene Therapy
• Research Bioproduction

Single-use Bioreactors Market, by End User

• Pharmaceutical and Biopharmaceutical Companies
• Contract Development and Manufacturing Organizations (CDMO) and Contract Research Organizations (CROs)
• Academic & Research Institutes

Single-use Bioreactors Market, by Geography

• North America
  • U.S.
  • Canada
• Europe
  • Germany
  • U.K.
  • France
  • Italy
  • Switzerland
  • Ireland
  • Denmark
  • Belgium
  • Spain
  • Rest of Europe (RoE)
• Asia-Pacific (APAC)
  • China
  • Japan
  • India
  • South Korea
  • Rest of APAC (RoAPAC)
• Latin America
• Middle East & Africa

Key questions answered in the report: