The single-use bioprocessing market is projected to register a CAGR of 11.5% during the forecast period.
The COVID-19 pandemic has been continuing to transform the growth of various markets, the immediate impact of the outbreak is varied. While a few industries registered a drop in demand, numerous other markets may continue to remain unscathed and show promising growth opportunities. Initially, the COVID-19 outbreak, worldwide, and the lockdown situation across some countries have shown some challenges on the market studied, due to hold on bioprocessing-related supplies manufacturing and services, in order to prevent the spread of SARS-CoV-2. However, single-use technology (SUT) has become a leading technology in pre-commercial manufacturing, including preclinical and clinical scales. Thus, drug discovery using SUT has become a major focus for the management of the pandemic. For instance, many COVID-19 vaccine research is based on single-use technologies. These efforts involve the use of novel approaches, such as mRNA and DNA technologies.
Moreover, some factors driving the single-use bioprocessing market are increasing demand for biopharmaceuticals, faster implementation, and lower risk of product cross-contamination and lower costs, and lesser environmental impact of single-use bioprocessing technologies. Single-use technology is one of the prominent technologies in the area of manufacturing scale and is widely used in upstream precommercial biopharmaceutical manufacturing. The high adoption of these devices is mainly due to their speed and flexibility while maintaining total operating expenditure.
Moreover, high energy efficiency, less space required, low water usage, and less risk of contamination associated with the product are some more factors propelling the revenue growth of the market. Furthermore, automation in the single-use system led to the incorporation of big data-based machine learning, which may help boost product yield and achieve maximum productivity and efficiency in terms of process, and a mainstream approach by many biopharmaceutical manufacturers are fueling the single-use bioprocessing market.
Furthermore, according to the Food and Drug Administration (FDA), 17 biologics were approved in 2018, of which 12 were monoclonal antibodies (mAb), three pegylated enzymes, one protein, and one fusion protein. Therefore, the growing number of biological approvals and patent expiry is expected to increase the biopharmaceuticals manufacturing process, ultimately helping to increase the use of single-use bioprocessing over the forecast period. Additionally, partnerships between industries and academic institutions have witnessed a significant rise over the recent years. For example, in March 2019, Pall Corporation and ARTESYN partnered to develop single-use automated bioprocessing components.
Other factors limiting the growth of this market are the issues related to leachable and extractable and high regular recurring expenses.
Key Market Trends
Single use Bioprocessing in Biopharmaceutical Manufacturer is Estimated to Witness a Healthy Growth in Future.
The COVID-19 pandemic has affected the supply chain of pharmaceutical products. The restrictions on pharmaceutical manufacturing and export had affected many products sold in countries, such as the United States, Europe, and other countries. Amid the COVID-19 pandemic, the health systems of countries are rapidly investing in research and development to combat the virus. In order to screen SARS-CoV-2 against a library of 50,000 compounds, it is necessary to use a single-use bioreactor for flexibility and speed, while keeping the total operating expenditure to a minimum. For instance, in India, the Vaccine Task Force (VTF) set up by Prime Minister’s Office (PMO) for focused research on coronavirus vaccines has allowed research institutions and laboratories to use patient samples for research and development (R&D) purposes. The government has framed detailed guidelines for sharing bio-specimen and data for such researches among institutions. Additionally, in September 2019, ABEC Inc. launched a single-use bioreactor system with a working volume of 6,000 L, three times that of the industry’s standard upper limit. Single-use bioprocessing is crucial during the COVID-19, and thus, creating several growth opportunities.
Moreover, single-use bioprocessing in biopharmaceutical manufacturers is estimated to witness healthy growth in the future owing to its several advantages over conventional bioprocessing methods. Reducing the initial investment and R&D cost, low cost of labor and material, easily disposed of are some of the benefits associated with these technologies. Moreover, these single-use bioprocessing plants have a 35% more favorable CO2 balance than stainless steel reactors, which are used in conventional bioprocessing, due to which these are high adopted by the manufacturer. In 2018, Merck KGaA announced an additional investment of EUR 40 million, to build a robust manufacturing and distribution platform in Asia, for over two years. This investment followed Merck’s announcement of a EUR-80-million life science investment in China in 2016 may also accelerate Merck’s Mobius single-use manufacturing in China, for the development of biosimilars. Furthermore, growing popularity, awareness, and highly adoption by several manufacturers, like CMOS, OEM, and the inhouse manufacturers, promoted the segment's growth.
North America is Expected to Hold a Significant Share in the Market and Expected to do Same in the Forecast Period
The United States is the most COVID-affected country across the world. The supply chain of products was highly impacted in this country. Initially, there is a decline in demand for single-use bioprocessing products, which has negatively impacted the overall market growth. However, with the growing awareness regarding the importance and benefits of single-use bioprocessing technologies, the demand for the same may gradually increase. Additionally, the North American government is investing enormously in the development of vaccines, drugs, and diagnostic tests for the treatment of COVID-19, which is likely to drive the market for single-use bioreactors, thus, ultimately drive the overall market growth. In March 2020, the government of Canada announced CAD 275 million (EUR 179 million) for the R&D activities related to antivirals, diagnostics, vaccines, and clinical trials for COVID-19. Additionally, in April 2020, Moderna Inc. received USD 483 million from the government of the United States for the development of the vaccine against COVID-19.
North America is expected to hold a significant market share in the global single-use bioprocessing market due to high R&D expenditure, the presence of largescale manufacturing units, the growing popularity of disposables, increasing healthcare expenditure, and the presence of well-established healthcare infrastructure. Adoption of disposables has become a trend among contract manufacturing organizations (CMO), and this region is recognized as a significant market for contract service providers. This factor serves as a catalyst for continued investments by local and global companies for the implementation of disposables in the contract development and manufacturing organizations and biomanufacturing plants in the region. In 2019, Applikon Biotechnology (Getinge) launched a single-use 'AppliFlex ST lab-scale bioreactor' as a significant extension to its range of innovative bioreactor systems. It is a fully customizable and scalable stirred-tank single-use bioreactor that uses 3D printing technology to provide a head plate that is uniquely configured to each individual process, including custom impeller design and different sample port connections. Furthermore, increasing demand for biopharmaceutical drugs from the geriatric population and patient expiries of biologics are some more factors that are fueling the growth of the overall regional market to a large extent.
The single-use bioprocessing market is moderately competitive and consists of several major players. Some of the companies, which are currently dominating the market are Sartorius AG, Thermo Fisher Scientific, Cytiva, Eppendorf AG, Merck KGaA, 3M, Infors AG, Boehringer Ingelheim International GmbH, and PBS Biotech.
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Table of Contents
1.2 Scope of the Study
4.2 Market Drivers
4.2.1 Faster Implementation and Lower Risk of Product Cross-contamination
4.2.2 Increasing Demand for Biopharmaceuticals
4.2.3 Lower Costs and Lesser Environmental Impact of Single-use Bioprocessing Technologies
4.3 Market Restraints
4.3.1 Issues Related to Leachables and Extractables
4.4 Industry Attractiveness - Porter's Five Forces Analysis
4.4.1 Bargaining Power of Buyers/Consumers
4.4.2 Bargaining Power of Suppliers
4.4.3 Threat of New Entrants
4.4.4 Threat of Substitute Products
4.4.5 Intensity of Competitive Rivalry
5.1.1 Filtration Assemblies
5.1.2 Media Bags and Containers
5.1.3 Disposable/Single-use Bioreactors
5.1.4 Disposable Mixers
5.1.5 Other Products
5.2 By Application
5.2.2 Cell Culture
5.2.4 Other Applications
5.3 By End User
5.3.1 Biopharmaceutical Manufacturers
5.3.2 Academic and Clinical Research Institutes
5.3.3 Other End Users
5.4 By Geography
5.4.1 North America
184.108.40.206 United States
220.127.116.11 United Kingdom
18.104.22.168 Rest of Europe
5.4.3 Asia Pacific
22.214.171.124 South Korea
126.96.36.199 Rest of Asia Pacific
5.4.4 Middle-East and Africa
188.8.131.52 South Africa
184.108.40.206 Rest of Middle-East and Africa
5.4.5 South America
220.127.116.11 Rest of South America
6.1.1 Sartorius AG
6.1.2 Thermo Fisher Scientific
6.1.3 Cytiva (GE Healthcare)
6.1.4 Eppendorf AG
6.1.5 Merck KGaA
6.1.7 Pall Corporation
6.1.8 CESCO BIOENGINEERING CO. LTD
6.1.9 PBS Biotech
6.1.10 ABEC Inc.
6.1.12 Distek Inc.
6.1.13 OmniBRx Biotechnologies
A selection of companies mentioned in this report includes:
- Sartorius AG
- Thermo Fisher Scientific
- Cytiva (GE Healthcare)
- Eppendorf AG
- Merck KGaA
- Pall Corporation
- CESCO BIOENGINEERING CO. LTD
- PBS Biotech
- ABEC Inc.
- Distek Inc.
- OmniBRx Biotechnologies