Single-use Bioreactors Market: Growth, Size, Share, and Trends

Market Growth Outlook Summary

The global single-use bioreactors market growth forecasted to transform from USD 4.4 billion in 2024 to USD 9.1 billion by 2029, driven by a CAGR of 15.4%. Growth in this market can be attributed to factors such as increasing adoption among CDMOs, CMOs, and SMEs, advantages over conventional bioreactors, reduced capital investment, lower water and energy consumption, and the expanding biologics and biosimilars markets. On the other hand, issues related to extractables and leachables, regulatory hurdles and compliance challenges, and the impact of PFAS restrictions on product development are expected to hinder market growth.

Single-use Bioreactors Market – Global Forecast and Growth Insights to 2029

To know about the assumptions considered for the study, Request for Free Sample Report

Single-use Bioreactors Market – Global Forecast and Key Opportunities to 2029

Single-use Bioreactors Market Dynamics to 2029

DRIVER: Growing adoption among CDMOs, CMOs, and SMEs

The single-use bioreactors market has experienced substantial growth as a result of the growing demand from contract development and manufacturing organizations (CDMOs) and contract manufacturing organizations (CMOs). By providing specialized services to companies seeking to outsource their pharmaceutical research and manufacturing processes, these companies are essential in the biopharmaceutical sector. Often handling several products and projects with different scales and needs, CDMOs and CMOs Single-use systems let them quickly transition between several processes without requiring the significant cleaning and validation processes associated with stainless-steel equipment. The initial investment for a single-use system, which includes capital, cleansing processes, labor, and waste, is nearly 42% lower than that of conventional stainless-steel systems. Small companies are thus also adopting single-use bioreactors increasingly to produce biopharmaceuticals since they are usually more affordable for small-scale operations.

RESTRAINT: Regulatory hurdles and compliance issues

Globally, regulatory authorities set strict criteria to guarantee the quality, efficacy, and safety of pharmaceuticals. Approval of the market, product commercialization, and continuous manufacturing activities depend on following these standards. One of the difficulties, however, is that single-use technologies and their application in biologic manufacturing are not specifically governed. In single-use bioreactors, end products are almost always made on a small scale. When these end products are scaled up to a larger scale, they must adhere to GMP safety, efficiency, and effectiveness standards. A major concern regarding the use of SUBs during the scale-up or scale-down process is that the molecules do not give the same results as they do in clinical trials. Additionally, concerns raised due to the mixing principle of single-use bioreactors have also increased the stringency of regulations and restricted their use.

OPPORTUNITY: Hybrid facilities

The hybrid facilities incorporating stainless steel and single-use systems represent a substantial opportunity within the single-use bioreactors market. Many companies use a hybrid approach, which includes some components of the process using single-use technologies, while others use traditional reusable, permanently plumbed systems. The pharmaceutical industry constantly experiences significant time and cost pressures. To respond to new developments in the sector as quickly as possible, the focus is increasingly centered on time-to-market and modular, highly flexible production models for novel biopharmaceutical products. The key benefits of 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 result in their increased use by CDMOs and their clients.

CHALLENGE: Potential breakage of SU bags

The SU bags are extensively employed in a variety of bioprocessing stages, including media preparation, cell culture, storage, and transport, and are constructed from multi-layered plastic films. Their vulnerability to physical injury presents substantial hazards, such as operational disruptions, contamination, and product loss. The average cost of a single bag breaking was estimated to be between USD 100 and USD 1 million. One of the top three constraints that impede the further implementation of single-use technologies in biopharmaceutical processes, as identified by BioProcess International, is leakage. It has resulted in annual product losses of millions of dollars for certain biopharmaceutical manufacturers. Leaks can disrupt production and planning, result in product shortages, and pose a risk to operators, particularly when managing hazardous products like viruses or antibody-drug conjugates (ADCs). The Bio-Process Systems Alliance (BPSA) established a work group to establish best practices for assuring the integrity of single-use systems (SUS). This was done in response to concerns regarding the integrity of SUS.

Single-use Bioreactors Market Map & Ecosystem Overview

The single-use bioreactors market operates within a complex ecosystem that includes a wide array of stakeholders, each playing a crucial role in developing, adopting, and implementing single-use technologies. This ecosystem encompasses single-use system & consumable manufacturers, biopharmaceutical companies, CMOs, CROs, and regulatory bodies.

The single-use bioreactor systems segment dominated single use bioreactors industry in 2023.

Based on products, the single use bioreactors market is segmented into single-use bioreactor systems, single-use media bags, single-use assemblies, and other products (including single-use vessels, sensors, tubing, connectors, software, control systems, and probes, among others). In 2023, the single-use bioreactor systems segment dominated the market. One of the biggest advantages of single-use bioreactor systems is their flexibility. The increasing focus of the biopharmaceutical industry on the production of multiple drugs simultaneously demands the production of different drugs using the same facility, with minimum time and cost and without compromising the quality of the drug. Players in the biopharmaceutical industry are increasingly adopting single-use systems due to their numerous advantages.

The stirred-tank single-use bioreactors segment dominated the single-use bioreactors industry in 2023.

Based on the type of single-use bioreactor systems, the single use bioreactors market is segmented into stirred-tank, wave-induced, bubble-column, and other single-use bioreactors (including hybrid bioreactors and single-use bioreactors with vertically perforated discs). The stirred-tank single-use bioreactors segment accounted for the largest share of the single-use bioreactors market in 2023. Stirred-tank bioreactors are the most common type of single-use bioreactors. Stirred-tank single-use bioreactors promote greater oxygen transfer than wave-induced single-use bioreactors. Hence, they are preferred to cultivate aerobic microbial cultures. The aeration and mixing in bioreactors are ensured by an aeration device, a static and rotating stirrer installed in the bag, resulting in high oxygen transfer rates and short mixing times.

Single-use Bioreactors Market by Region – Forecast to 2029

To know about the assumptions considered for the study, download the pdf brochure

North America was the largest regional market for the single use bioreactors industry in 2023.

The global single use bioreactors market is segmented into six major regions—North America, Europe, the Asia Pacific, Latin America, Middle East and Africa. North America was the largest segment in 2023 in the single-use bioreactors market, followed by Europe and the Asia Pacific. Factors such as the presence of key biopharmaceutical research and development facilities in the region, rising demand for key biopharmaceutical products including monoclonal antibodies, vaccines, gene therapies, and cell therapies, among others are responsible for the largest share of this segment.

Key players in the single use bioreactors market include Sartorius AG (Germany), Danaher Corporation (US), Thermo Fisher Scientific Inc. (US), Merck KGaA (Germany), Avantor, Inc. (US), Repligen Corporation (US), Getinge AB (Sweden), Eppendorf SE (Germany), Parker Hannifin Corporation (US), Entegris (US), Saint-Gobain (France), Corning Incorporated (US), Lonza (Switzerland), TECNIC Bioprocess Equipment Manufacturing (Spain), FUJIMORI KOGYO CO., LTD. (Japan), Kühner AG (Switzerland), OmniBRx Biotechnologies (India), New Horizon Biotechnology, Inc. (US), PBS Biotech, Inc. (US), bbi-biotech GmbH (Germany), ABEC, Inc. (US), Esco Lifesciences Group Ltd. (US), Distek, Inc. (US), SATAKE MultiMix Corporation (Japan), Cell Culture Company, LLC (US), Micro Digital Co., Ltd. (South Korea), Celltainer Biotech B.V. (Netherlands), Meissner Filtration Products, Inc. (US), Solida Biotech GmbH (Germany), G&G Technologies, Inc. (US), PharmNXT Biotech (India), and Tofflon Life Science Co., Ltd. (China).

Single-use Bioreactors Market Report Scope and Insights

Single-use Bioreactors Market Segmentation and Analysis

By Product

• Single-use Bioreactor Systems
  • ≤10 L
  • 11–100 L
  • 101–500 L
  • 501–1,500 L
  • >1,500 L
• Single-use Media Bags
  • 2D Single-use Media Bags
  • 3D Single-use Media Bags
  • Other Single-use Media bags
• Single-use Assemblies
• Other Products

By Type

• Stirred-Tank Single-use Bioreactors
• Wave-Induced Single-use Bioreactors
• Bubble-Column Single-use Bioreactors
• Other Single-use Bioreactors

By Molecule Type

• Monoclonal Antibodies
• Vaccines
• Therapeutic Proteins & Peptides
• Stem Cells
• Cell & Gene Therapy

By Cell Type

• Mammalian Cells
• Bacterial Cells
• Yeast Cells
• Other Cells

By Application

• Bioproduction
• Process Development
• Research & Development

By End User

• Pharmaceutical & Biotechnology Companies
• CMOs & CROs
• 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
  • Australia
  • Rest of Asia Pacific (RoAPAC)
• Latin America
  • Brazil
  • Mexico
  • RoLATAM
• Middle East
  • GCC
    • Saudi Arabia
    • UAE
    • Rest of GCC
  • Rest of Middle East
• Africa

Single-use Bioreactors Market Recent Developments and Insights

• In March 2024, Getinge AB launched the Single-Use Production Reactor (SUPR) system, available in 50-liter and 250-liter sizes.
• In April 2023, Merck KGaA launched the Ultimus single-use process container film designed to provide extreme durability and leak resistance for single-use assemblies used for bioprocessing liquid applications.

Frequently Asked Questions (FAQ):

To speak to our analyst for a discussion on the above findings, click Speak to Analyst