Market Overview:

The Global Single-Use Bioprocessing Systems Market Is Estimated At USD 3.44 Billion In 2022 And Is Projected To Grow At A CAGR Of 13.0% To USD 9.14 Billion By 2030.

Single-use bioprocessing systems are made up of bioprocessing tools that are only used once and then thrown away. Bioprocessing systems that only need to be used once are made of plastic parts that can be sterilized and sealed with gamma irradiation. Biopharmaceutical products are mixed, filtered, purified, upstream expressed, stored, and separated using systems that are only used once.

In different bioprocessing steps, single-use bioprocessing media bags and containers are used. In the bio manufacturing and biopharmaceutical industries, single-use containers are often used for important liquid handling tasks. Also, monoclonal antibodies (mAb) are made with single-use bioprocessing technologies. Because of this, this segment has the largest share of the global single-use bioprocessing market.

Most of the steps in the biomanufacturing process in biopharmaceutical companies' facilities are likely to change because of single-use equipment. There is a lot of potential to make processes more cost-effective by simplifying and customizing different parts of bioprocessing technology and lowering the cost of goods. In the last ten years, a number of single-use bioprocessing products have been introduced to the market. Over the past few years, they have been used more and more in the development and production of biopharmaceuticals. End users can now choose from a wide variety of SUB products from both global and local suppliers. Most SUB products are used in places where a wide range of biologics are made, such as research, clinical production, and manufacturing facilities. With the availability of single-use bioreactors, connectors, mixers, bioprocessing containers, sampling and transfer systems, sensors, single-use pumps, and other SUB products, end-users can fully adopt SUB, especially for upstream bioprocessing applications.

Market Dynamics:

Market Trends:

• The Rising Focus of Market Vendors on Strategic Partnerships

Strategic partnerships with suppliers, other private vendors, and end users will help vendors learn more about what the market wants and improve their product lines. For example, in September 2020, Humanigen, Inc. announced a strategic collaboration with Thermo Fisher Scientific to expand its manufacturing capacity for Lenzilumab, which is in the Phase 3 registration study for patients infected by COVID-19, to support a possible Emergency Use Authorization (EUA). In the coming years, these kinds of partnership agreements will allow vendors to improve their products and make them easier to get.

Driving Factors:

• The Growing Demand for Biopharmaceuticals

According to the UN's Ageing Population Highlights, about 727 million people around the world will be 65 or older in 2020. By 2050, this number is expected to double to 1.5 billion people. As the number of older people in major markets grows, the demand for biopharmaceuticals is likely to rise, since older people are more likely to have chronic conditions and diseases. To keep up with the growing demand for biopharmaceuticals, companies are turning more and more to single-use bioprocessing systems. These systems make the process run more smoothly and cost less than steel-based bioreactor systems that need to be cleaned, sterilized, and maintained. Biopharmaceutical applications for single-use bioprocessing technology include filtration, mixing, purification, upstream expression, storage, and separation. So, the growth of the single use bioprocessing industry is mostly due to the growing need for biopharmaceuticals.

• Increasing Use of Single-Use Technologies to Minimize the Risk of Contamination

When there is contamination between batches, the production yield goes down, the cost goes up, and it takes longer to get the product to market. Also, if regulatory bodies find impurities after the product has been sold, end users may be responsible for product recalls and legal actions. For example, in July 2018, the US Food and Drug Administration (FDA) announced a series of voluntary recalls for products that contained valsartan because they may have been contaminated with N-nitroso dimethylamine, which may cause cancer (NDMA). So, things like these and the strict rules of the US FDA, EMA, and China Food and Drug Administration (CFDA) will increase the demand for advanced technologies like SUB systems in the forecast period.

• Growing Global Aging Population

During the forecast period, the global single use bioprocessing market is likely to be driven by the growing number of older people around the world. In 2020, about 727 million people in the world were 65 or older, according to a UN report called "Aging Population Highlights." By 2050, that number is expected to reach nearly 1.5 billion. With a big rise in the number of older people, the demand for biopharmaceuticals is likely to go up a lot. At the same time, big companies are focusing more and more on improving the efficiency and lowering the cost of single-use systems.

• Increasing Strategic Acquisitions and Collaborations

Strategically buying single-use technology can make it easier for biopharmaceuticals to use it. Single-use technology is an efficient and cost-effective way to improve quality control, streamline operations, and cut down on waste. By buying high-quality, one-time-use technology in a strategic way, businesses can boost their competitive edge, cut costs, and improve efficiency. The strategic purchase of one-time-use technology can make processes easier to see and control, leading to more openness and compliance with industry rules. Strategically buying one-time-use technology can be a powerful way for businesses to cut costs, improve efficiency, and give themselves a competitive edge. Also, people in the industry are forming partnerships to make it easier for them to get into local markets for single-use bioprocessing.

Restraints/Challenges:

• Issues Related to Leachables and Extractables

Specific rules or guidelines have not yet been set up about how extractables and leachables can contaminate single-use bioprocessing systems. But the Bio-Process Systems Alliance has put together a full list of tests that can be done on single-use systems (BPSA). Source materials can be used to get extractables by using the right solvents in a strong laboratory setting. At the same time, leachables are substances that get into drug products from containers, caps, and processing parts. This means that leachables are a subset of extractables. These leachables and extractables are things that you don't want. Single-use bioprocessing products are often contaminated by leachables from the container because they are made of plastic that has been processed. So, major worries about extractables and leachables from the parts of single-use bioprocessing systems could slow market growth because they could affect the quality of the product and the health of the patient.

• The Problem Associated with Waste Disposal 

Biopharmaceutical companies are using single-use bioprocessing products more and more because they have many benefits, such as saving money, speeding up process development, and requiring less capital. But there are still big worries about how to get rid of the solid waste that this alternative technology creates. Recycling is not an option for these kinds of products because it takes a lot of work to separate the parts into ones that are all the same. Because of this, most one-time-use systems and their parts can't be recycled. These things are slowing down the growth of the market over the next few years.

Opportunities:

• Emerging Markets

China is a high-potential market for single-use bioprocessing systems in Asia, and India is a close second. This is because the government is helping, private investments are going up, the number of older people is growing, outsourcing is becoming more popular in emerging Asian markets, and these countries have skilled workers. Market players expect India, Japan, Brazil, and RoAPAC to be their new sources of income. The high growth potential of these markets is also due in part to how much money is put into biomanufacturing infrastructure. For example, Thermo Fisher Scientific said in March 2021 that it would spend $600 million to expand its bioprocessing capabilities. This investment was made to keep up with the growing need for vaccines and other biologics.

• Biopharmaceutical Industry Expansion

With more money being put into research and development of biologics and biosimilars, the biopharmaceutical industry was growing steadily. Biopharmaceutical companies are interested in single-use bioprocessing systems because they are cheaper, more flexible, and less likely to cause cross-contamination.

• Cost-Effectiveness and Sustainability

Single-use bioprocessing systems can save money because they don't need to go through the cleaning and validation steps that traditional systems do. They were also thought to be better for the environment because they used less water and chemicals.

• Biologics Pipeline Expansion

As the number of biologics and biosimilars in the pipeline grew, there was a greater need for bioprocessing solutions, such as single-use systems. The market for single-use bioprocessing was expected to grow as more biologics went through clinical trials and were approved by regulators.

Strategic Development:

• In March 2020 - Danaher bought the biopharmaceutical business from the Life Sciences segment of General Electric Company. Cytiva is a separate operating company that is part of Danaher's Life Sciences segment.
• In September 2020 - Thermo Fisher Scientific put more than $475 million into its St. Louis facility to add new capabilities for developing and making biologics, for cell and gene therapy, and for developing new drugs.
• In April 2023 - Boehringer Ingelheim opened the Biologics Development Center in Germany, which was worth $386 million. This plant was supposed to make therapeutic proteins and antibodies, and it was also supposed to create substances for clinical trials. More than half of the company's research pipeline is done at the plant.
• In March 2023 - One of the best biopharmaceutical companies in the world, Sartorius Stedim Biotech, signed a deal to buy Polyplus for more than €2.4 billion euros. Polyplus comes up with and makes high-quality GMP-grade transfection and other DNA/RNA delivery reagents and plasmid DNA. These are important parts for making viral vectors, which are used in gene and cell therapies and other new ways to treat diseases.
• In March 2023 - Thermo Fisher Scientific and Arsenal Biosciences gave an update on their strategic partnership to create manufacturing processes for advanced cancer treatments. This research-based partnership has helped ArsenalBio come up with an efficient way to make the next-generation programmable T cells that will be used to treat cancer.
• In January 2023 - Thermo Fisher Scientific Inc. announced that the Thermo Scientific Orbitrap Astral mass spectrometer would be coming out. This is one of the most important things to happen in mass spectrometry in the last 15 years. Researchers all over the world can now find proteins that were previously hard to find because the analyzer has high sensitivity, fast throughput, and deep proteome coverage. Researchers can use this information to find new clinical biomarkers, find ways to catch diseases early, and come up with new treatments for serious health problems.
• On April 20, 2022 - Thermo Fisher Scientific opened a new place to make single-use technologies in Ogden, Utah. This state-of-the-art facility will make it easier for the company to make high-quality technology and materials that can be used to make new vaccines and breakthrough treatments.
• On February 25, 2020 - MabPlex International, one of the top contract development and manufacturing companies with locations in China and the U.S., started up two new cell culture production lines, using 2,000-liter single-use bioreactors made by GE.

Key Vendors:

Top market players are

• Danaher Corporation

Danaher is a global leader in science and technology. They want to help the customers solve difficult problems and improve the quality of life for people all over the world.

• Eppendorf AG

Eppendorf is a leading company in the life sciences industry. It makes and sells instruments, consumables, and services for handling liquids, samples, and cells in labs all over the world. Pipettes are one of its products.

• Finesse Solutions

Finesse Solutions, Inc. in Silicon Valley, California, makes smart solutions for managing bioprocesses. The goal is to give the clients the tools they need to do their jobs better by giving them innovative sensors, bioreactors, controllers, and software for both upstream and downstream processes.

• GE Healthcare

GE HealthCare Technologies Inc. (GE HealthCare) is a global medical device company that designs, develops, makes, and sells diagnostic imaging and clinical systems, products and services for drug discovery, biopharmaceutical manufacturing, and cellular technologies, imaging agents used in medical scanning procedures, and a variety of healthcare IT solutions.

• Thermo Fisher Scientific

Thermo Fisher Scientific Inc. (Thermo Fisher) is a company that makes and sells medical equipment, analytical instruments, reagents and consumables, software, and services to help research, diagnostic, and clinical laboratories solve complex analytical problems. It has answers for cell biology and analysis, flow cytometry, and synthetic biology.

• Broadley-James Corporation

Broadley-James Corporation is the top company in its field for making pH and dissolved oxygen sensors for use in life science. There are single-use pH and DO sensors that just plug in and work for both upstream and downstream applications.

• Meissner Filtration Products

Meissner filters and housings, integrity test instruments, single-use biocontainers, and fluid path assemblies offer the highest levels of product performance, quality, consistency, and cost-effectiveness. We work with the pharmaceutical, biotechnology, microelectronics, ultrapure chemicals, food and beverage, and related industries.

• Merck Millipore

Merck KGaA, which is owned by E. Merck KG and goes by the name "Merck," is a science and technology company. It finds, develops, and makes prescription drugs to treat cancer, multiple sclerosis, and infertility. It also makes liquid crystal mixtures, organic light-emitting diode (OLED) materials, cosmetic active ingredients, coating pigments, and high-tech materials.

• Parker Hannifin Corporation

Parker Hannifin Corp., or "Parker," makes technologies and systems for moving and controlling things. The company provides important solutions for motion and control, such as fluid power systems, electromechanical controls, and other parts.

Segmentation Analysis:

The market is segmented on the basis of product type, application, workflow, method, end-user and region.

By Product Type:

The biopharmaceutical industry has changed a lot because of single-use bioprocessing equipment. With this technology, bioprocessing is more efficient, flexible, safe, and saves money. Single-use bioprocessing equipment is a set of technologies that are meant to replace stainless steel and other materials that have been used in bioprocessing in the past and can be used again and again. This equipment has parts like bags, bioreactors, tubing, syringes, connectors, and filters that are used only once and then thrown away. In 2022, the product type of single-use bioprocessing equipment had a larger share of the global market for single-use bioprocessing.

• Single-use media bags and containers
• Single-use assemblies
• Single-use bioreactors
• Disposable mixers
• Other products

By Application Outlook:

By application, the global market for single-use bioprocessing is split into monoclonal antibodies (mABs), vaccines, cell therapies, and other products. By application, monoclonal antibodies (mABs) have the largest market share. Single-use bioprocessing is a new technology that has changed how monoclonal antibodies (mAbs) are made. It is used in the biopharmaceutical industry. When making proteins like mAbs, single-use bioprocessing uses disposable bioreactors and other parts. Unlike traditional bioreactors made of stainless steel, single-use bioreactors can be set up quickly, need less cleaning, and reduce the risk of cross-contamination. Because of how complicated and expensive they are, these benefits make single-use bioprocessing a good choice for making mAbs.

• Monoclonal antibodies (mAbs)
• Vaccines
• Cell therapies
• Other products

By Workflow:

In 2022, 57.9% of the market was made up of the upstream bioprocessing segment. This is because technologies for upstream bioprocessing are always getting better and more advanced. For example, advanced products like Sartorius AG's Ambr 15 micro-bioreactor system offer high-throughput upstream process development, efficient cell culture processing, and media and feed optimization with automated experimental setup and sampling. The time it takes to do upstream bioprocessing tasks can be cut down with these solutions, which is expected to boost segment growth. During the forecast period, the fermentation segment is likely to have the second-fastest CAGR.

The growth is due to the release of a number of new fermentation products that make the best conditions for bioprocessing reactions. For example, the HyPerforma Enhanced S.U.F by Thermo Fisher Scientific, Inc. gives the culture the best oxygen mass transfer and temperature control by making the turbine impellers and cooling jackets bigger. Also, companies like Cytiva are working on single-use fermentation solutions for their customers. One example is the Xcellerex XDR MO, which is a stirred tank system for microbial cell culture with strong mixing, good temperature control, and high oxygen transfer capacities. This segment is likely to make more money with the help of important new ideas like these.

• Upstream Bioprocessing
• Fermentation
• Downstream Bioprocessing

By Method:

By method, the global market for single-use bioprocessing is split into filtration, storage and transport, cell culture, mixing, and purification. Most of the market is made up of filtration. In the biotechnology industry, single-use bioprocessing is a way to filter that is becoming more and more popular. It involves making, filtering, and processing bioproducts with systems that are single-use and self-contained. This type of filtration has many benefits, especially when it comes to making pharmaceutical and biological products. The biotechnology industry has changed a lot because of single-use bioprocessing. This means that traditional equipment and infrastructure aren't needed as much, which saves money and makes production more efficient.

• Filtration
• Storage
• Cell culture
• Mixing
• Purification

By End-User:

Over 39% of the global single-use bioprocessing market was made up of biopharmaceutical manufacturers. This part of the market is the most important and is likely to stay that way for the next few years because it is used so often in research and commercial manufacturing. Several companies that make biopharmaceuticals have already looked into how SUB solutions could be used in commercial production. But they could have a lot of benefits, especially for small-volume production in modular facilities. Most companies that make biopharmaceuticals, especially big and medium-sized ones, spend more than $50 million a year on equipment. Manufacturers of biopharmaceuticals have been seen to spend a lot of money on bioprocessing for a single use.

• Biopharmaceutical Manufacturers
• CMOs & CROs
• In-house Manufacturers
• Academic & Clinical Research Institutes

Regional Insights:

North America will have the largest share of revenue in 2021, with more than 32.9%. This is because the pharmaceutical and biomanufacturing industries there are well-established and the region does a lot of research and development. In the same way, the increasing focus on making vaccines is driving the need for one-time use bioprocessing equipment to help stop diseases in the region. Also, the fact that the Bioprocess Systems Alliance (BPSA) is in North America to promote the use of single-use technology is likely to increase sales of single-use systems in the area.

During the forecast period, Asia Pacific is expected to grow at the fastest rate. Several companies from around the world have put money into the growing bioprocessing market in the region. These investments help big companies build their presence in the area and take advantage of untapped opportunities. Also, the trend of CMOs using disposables and the growing interest of contract service providers to set up bases in APAC are both things that encourage local and international companies to keep investing. For example, in September 2021, Lonza's drug development facility in Singapore was made bigger. The CDMO now has more tools to help meet the growing needs of manufacturers in the area.

Geographically, the global Single-use Bioprocessing Systems market has been looked at in places like North America, Europe, Asia-Pacific, Latin America, the Middle East, and India. In the near future, this market will be dominated by the global region.

• North America
• US
• Canada
• Mexico
• Rest of North America
• Europe
• Germany
• France
• Italy
• Spain
• UK
• Nordic Countries
• Denmark
• Finland
• Iceland
• Sweden
• Norway
• Benelux Union
• Belgium
• The Netherlands
• Luxembourg
• Rest of Europe
• Asia-Pacific
• Japan
• China
• India
• Australia
• South Korea
• Southeast Asia
• Indonesia
• Thailand
• Malaysia
• Singapore
• Rest of Southeast Asia
• Rest of Asia-Pacific
• The Middle East & Africa
• Saudi Arabia
• UAE
• Egypt
• South Africa
• Rest of the Middle East & Africa
• Latin America
• Brazil
• Argentina
• Rest of Latin America

Scope of Report:

Conclusion:

• This study gives an in-depth look at the global single-use bioprocessing systems market, including current trends and predictions for the future.
• The report gives information about the market's key drivers, barriers, and opportunities, as well as a detailed analysis of the market's share around the world.
• The current market is looked at quantitatively to show the growth scenario of the global single-use bioprocessing systems market.
• The report gives a detailed analysis of the global Single-use Bioprocessing Systems Market based on how competitive it is and how it will change in the coming years