[227 Pages Report] The global single-use bioreactors (SUBs) market is projected to reach USD 3.9 billion by 2025 from USD 1.7 billion in 2020, at a CAGR of 18.0% during the forecast period. Increasing adoption of SUBs among small companies and startups, reduced automation complexity, ease in the cultivation of marine organisms, reduced energy and water consumption, the growing biologics market, technological advancements in SUBs, and increasing Biopharmaceutical R&D are factors driving the growth of this market.

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covid-19 impact on the global single-use bioreactors market

COVID-19 is an infectious disease caused by the most recently discovered novel coronavirus. Largely unknown before the outbreak began in Wuhan (China) in December 2019, COVID-19 has moved from a regional crisis to a global pandemic in just a matter of a few weeks. The World Health Organization (WHO) declared COVID-19 as a pandemic on March 11, 2020. Many biopharmaceutical companies are rapidly developing vaccines in response to the novel coronavirus pandemic. For example, Moderna Therapeutics has a messenger RNA in Phase I trials, Inovio Pharmaceuticals� has a DNA vaccine which has entered human trials, and Novavax is developing a vaccine based on its recombinant protein nanoparticle platform. If these programs pass the trial phases, the clinical and commercial manufacturing platforms will be largely supported by single-use equipment and systems.

In the race to develop a vaccine against the coronavirus, many leading manufacturers of single-use bioreactors are currently working with companies that have a vaccine in development or already in the clinical test phases. For instance, Sartorius has supported CanSino Biologics Inc. and Maj. Gen. Chen Wei�s team at the Institute of Bioengineering at the Academy of Military Medical Sciences in China in their development of the first vaccine candidate against the novel coronavirus SARS-CoV-2 to enter clinical trials. This, in a way, has led to a positive impact on the SUB market.

According to one of the leading bioprocess manufacturers, the impact of the coronavirus crisis on supply chains, production, and shipments to customers has been manageable until now in the bioprocessing solutions market. Short and medium-term predictability is extremely limited and has a negligible impact. However, a decrease in the global pharmaceutical R&D spending and a drop in biologics sales in 2020 due to the COVID-19 outbreak will have a significant impact on the growth of the SUBs market during the forecast period.

single-use bioreactors Market Dynamics

Driver: Increasing biopharmaceutical R&D

The demand for biopharmaceuticals is increasing globally due to the growing geriatric population, as this population group is more susceptible to a wide range of diseases. In anticipation of this demand, global companies are focusing on biopharmaceutical R&D and manufacturing for product development and increased production. The biopharmaceutical industry invests an average of six times more in R&D as a percentage of sales compared to other manufacturing industries. In 2018, the biopharmaceutical company invested USD 102 Billion (estimated) in research and development (Source: PhRMA). Single-use technologies are an integral part of biopharmaceutical manufacturing workflows. They make up a large percentage of small- and mid-scale biopharmaceutical manufacturing, particularly in clinical testing and research and development. Due to the advantages of single-use systems over conventional biomanufacturing techniques, their adoption has increased in biopharmaceutical R&D. Thus, the rising R&D expenditure is considered a positive indicator of the growth of the single-use bioreactors market.

Opportunity: Emerging markets

The significant growth opportunities offered by emerging countries such as China, India, and Indonesia can be attributed to high growth in their respective pharmaceutical & biopharmaceutical sectors due to the presence of less-stringent regulatory policies as well as low-cost and skilled labor. Owing to cost advantages and skilled labor, these countries are a hub for bioprocess outsourcing. Developing countries are showing faster growth rates in single-use systems. For example, many of the new bioprocessing facilities are expected to be constructed in China to meet both domestic demand and its desire to become an exporter of biopharmaceuticals. China�s biopharma companies also have found CMOs in China to be more open-minded in adopting single-use technology, as compared to domestic biologics developers/manufacturers. In 2018, Wuxi Biologics partnered with ABEC and installed its 4,000-liter Custom Single Run disposable bioreactors for its new commercial manufacturing facility in Wuxi city, China.

Challenges: Need for improved single-use sensors

The availability of dependable, accurate, and low-cost sensors that meet the needs of SUBs is one of the key challenges in the market. The sensors used in SUBs need to be compatible with the existing SUB platforms and are required to manage the system without affecting the sterility of materials. Traditionally, sensors were installed in SUB systems, but this practice lowered the quality of the final product.

Ideally, sensors and SUBs should be delivered as a single unit where the sensor is pre-installed in the SUB, which ensures sterilization of both containers and sensors. However, till date, the quality of sensors available is not as per the GMP standards because of leachability and extractability issues. This creates challenges while using SUBs, though there is a scope for improvement in this segment of the market, such as the development of more accurate and individual process sensors for various parameters (pH, temperature, flow measurement, and quality of the product), which can then be embedded in the bioprocess workflow.

By product, the single-use bioreactor systems segment accounted for the largest share of the single-use bioreactors market in 2019.

Based on product, the single-use bioreactors market is categorized into single-use bioreactor systems, single-use media bags, single-use filtration assemblies, and other products such as single-use vessels, tubing, connectors, control systems, and probes/sensors, among others. The single-use bioreactor systems segment dominated the single-use bioreactors market in 2019. SUB systems offer benefits such as lower capital investment, lower operating expenses, and lower environmental footprint, thus driving the growing adoption of these systems in biopharma applications.

By type, the stirred-tank SUBs segment accounted for the largest share of the single-use bioreactors market in 2019.

Based on type, the single-use bioreactors market is categorized into wave-induced SUBs, stirred-tank SUBs, bubble-column SUBs, and other bioreactors such as hybrid bioreactors and SUBs with vertically perforated discs. The stirred-tank SUBs segment dominated the single-use bioreactors market in 2019. The large share of this segment can be attributed to factors such as the high preference for stirred-tank SUBs in the cultivation of aerobic microbial cultures. Stirred-tank SUBs promote greater oxygen transfer and reduced engineering challenges such as heat removal, mass transfer, and higher agitation rates.

By type of cells, the mammalian cells segment accounted for the largest share of the single-use bioreactors market in 2019.

Based on the type of cell, the global single-use bioreactors market is categorized into mammalian cells, bacterial cells, yeast cells, and other cells (insect and plant cells). In 2019, the mammalian cells segment accounted for the largest market share owing ot increased adoption of mammalian cells due to their highly mechanized metabolic machinery.

By molecule type, the monoclonal antibodies segment accounted for the largest share of the single-use bioreactors market in 2019.

Based on molecule type, the global single-use bioreactors market is categorized into monoclonal antibodies (mAbs), vaccines, gene-modified cells, stem cells, and other molecules (recombinant proteins including growth factors & interferons, antisense, and RNA interference). In 2019, the monoclonal antibodies segment accounted for the largest share of the global single-use bioreactors market. The large share of this segment can be attributed to the increasing demand for SUBs in the manufacturing of mAbs, owing to low investment costs, the low requirement of the workforce, and reduction in time-consuming changeover procedures.

By application, the pharmaceutical manufacturing applications segment accounted for the largest share of the single-use bioreactors market in 2019.

Based on application, the single-use bioreactors market is segmented into research & development, process development, and bioproduction. The bioproduction segment accounted for the largest share of the market in 2019. The large share of the bioproduction segment can be attributed to the increasing use of single-use bioreactors in biomanufacturing and the increasing demand for SUBs in CMOs owing to its advantages such as flexibility and easy scale-up.

By end user, the pharmaceutical and biopharmaceutical companies segment accounted for the largest share of the single-use bioreactors market in 2019.

Based on end users, the single-use bioreactors market is segmented into pharmaceutical and biopharmaceutical companies, CROs & CMOs, and academic and research institutes. The bioproduction segment accounted for the largest share of the market in 2019. The large share of pharmaceutical and biopharmaceutical companies in this market is attributed to increasing R&D in these companies and the increasing production of biologics.

North America accounted for the largest share of the single-use bioreactors market in 2019.

In 2019, North America accounted for the largest share of the single-use bioreactors market, followed by Europe. The large share of the North American regional segment can be attributed to the presence of an established biopharmaceutical industry and the presence of major players operating in the single-use bioreactors market in North America.

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Sartorius Stedim Biotech (France), Thermo Fisher Scientific (US), Danaher Corporation (US), and Merck Millipore (Germany) are the prominent players operating in the single-use bioreactors market.



Scope of the report

Report Metric Details Market Size Available for Years 2018�2025 Base Year Considered 2019 Forecast Period 2020�2025 Forecast Units Value (USD) Segments Covered Product, Type, Type of Cell, Molecule Type, Application, End User and Region Geographies Covered North America, Europe, APAC, Latin America and Middle East & Africa Companies Covered The major market players include as Sartorius Stedim Biotech (France), Thermo Fisher Scientific (US), Danaher Corporation (US), Merck Millipore (Germany), Getinge (Sweden), Eppendorf AG (Germany), Parker Hannifin Corporation (US).

(Total 25 companies)

The study categorizes the single-use bioreactors market into the following segments and subsegments:

PRODUCT

Single-use Bioreactor Systems Up to 10L 11�100L 101�500L 501�1500L Above 1500L

Single-use Media Bags 2D Bags 3D Bags Other Bags

Single-use Filtration Assemblies

Other Products (Single-use vessels, tubing and connectors, samplers, and probes/sensor, among others)

TYPE

Stirred-tank SUBs

Wave-induced SUBs

Bubble-column SUBs

Other SUBs (Hybrid bioreactors and SUBs with vertically perforated discs)

TYPE OF CELL

Mammalian Cells

Bacterial Cells

Yeast Cells

Other Cells (Insect and plant cells)

MOLECULE TYPE

Monoclonal Antibodies

Vaccines

Gene-modified cells

Stem Cells

Other Molecules (Recombinant proteins including growth factors & interferons, antisense, and RNA interference)

BY APPLICATION

Research and Development (R&D)

Process Development

Bioproduction

BY END USER

Pharmaceutical & Biopharmaceutical Companies

CROs & CMOs

Academic & Research Institutes

By Region

North America US Canada

Europe Germany UK France Rest of Europe

Asia Pacific China Japan India South Korea Rest of Asia Pacific

Latin America

The Middle East and Africa

Recent Developments

In 2020, Sartorius Stedim Biotech (France) launched BIOSTAT STR Generation 3 Single-Use Bioreactor

In 2019, Pall Corporation (US) entered into a partnership with Freeline (UK) to implement its iCELLis bioreactor system in the Freeline�s adeno-associated virus (AAV) manufacturing platform. This partnership aims to achieve commercial scale and quality production of AAV gene therapy vectors.

In 2018, Getinge (Sweden) acquired Applikon Biotechnology (Netherlands), a leading provider of bioreactor systems. This acquisition will strengthen Getinge�s Life Science business segment in the single-use bioreactors market.

In 2017, Merck Millipore (Germany) allied with Samsung BioLogics (South Korea) to provide biopharmaceutical manufacturing and single-use solutions.

In 2017, Merck Millipore (Germany) opened a Mobius single-use manufacturing facility in Wuxi, China, to support the biopharma industry development in China.

Frequently Asked Questions (FAQ):

What is the current size of the global single-use bioreactors market? The global single-use bioreactors market size is estimated to be USD 1.7 billion in 2020 and projected to reach USD 3.9 billion by 2025, at a CAGR of 18.0%. Who are the leading players in the single-use bioreactors market? Some of the leading players in the single-use bioreactors market include Sartorius Stedim Biotech (France), Thermo Fisher Scientific (US), Danaher Corporation (US), Merck Millipore (Germany). What are the major applications of the single-use bioreactors market? The application of the single-use bioreactors market is segmented into research & development, process development, and bioproduction. The bioproduction segment accounted for the largest share of the market in 2019. What are the major drivers of the single-use bioreactors market? Some of the major drivers of the single-use bioreactors market includes, increasing adoption of SUBs among small companies and startups, reduced automation complexity, ease in the cultivation of marine organisms, reduced energy and water consumption, the growing biologics market, technological advancements in SUBs, and increasing Biopharmaceutical R&D. .

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