 | • レポートコード：MRC2106A042 • 出版社/出版日：Mordor Intelligence / 2021年5月20日 • レポート形態：英文、PDF、112ページ • 納品方法：Eメール（受注後2-3営業日） • 産業分類：医療 |
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レポート概要
| 本調査レポートでは、使い捨てバイオプロセスの世界市場について調査・分析を行い、イントロダクション、調査手法、エグゼクティブサマリー、市場動向、製品別（ろ過アセンブリ、媒体バッグ＆容器、使い捨て/使い捨てバイオリアクター、使い捨てミキサー、その他）分析、用途別（ろ過、細胞培養、精製、その他）分析、エンドユーザー別（バイオ医薬品メーカー、学術＆臨床研究機関、その他）分析、地域別分析、競争状況、市場機会・未来動向などを掲載しています。 ・イントロダクション ・調査手法 ・エグゼクティブサマリー ・市場動向 ・使い捨てバイオプロセスの世界市場規模：製品別（ろ過アセンブリ、媒体バッグ＆容器、使い捨て/使い捨てバイオリアクター、使い捨てミキサー、その他） ・使い捨てバイオプロセスの世界市場規模：用途別（ろ過、細胞培養、精製、その他） ・使い捨てバイオプロセスの世界市場規模：エンドユーザー別（バイオ医薬品メーカー、学術＆臨床研究機関、その他） ・使い捨てバイオプロセスの世界市場規模：地域別 ・競争状況 ・市場機会・未来動向 |
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 outbreak of COVID-19 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 COVID-19 virus. However, Single-use Technology (SUT) has become a leading technology in pre-commercial manufacturing, including preclinical and clinical scale. 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 of the factors which are 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 its 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 that are propelling the revenue growth of the market. Furthermore, automation in the single-use system led to incorporate big data-based machine learning which will help in boost product yield, in addition to this ability to achieve maximum productivity and efficiency in terms of process and a mainstream approach by many biopharmaceutical manufacturers is also 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. In addition Partnerships between industries and academic institutions have witnessed a significant rise, over the recent years. For example, in March 2019, Pall Corporation and ARTESYN entered a partnership to develop single-use automated bioprocessing components.
Other factors limiting the growth of this market are the Issues related to leachable and extractables 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. In addition 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 are some of the benefits associated with these technologies. Moreover, these single-use bioprocessing plants has 35% more favorable CO2 balance compared to 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 a span of two years. This investment followed Merck’s announcement of a EUR-80-million life science investment in China in the year 2016 will also accelerate Merck’s Mobius single-use manufacturing in China, for the development of biosimilars. Furthermore, growing popularity, awareness and highly adopted by several manufacturers like, CMOS, OEM and the inhouse manufacturers is also promoted the segment 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 as well as benefits of single-use bioprocessing technologies, the demand for the same will gradually increase. In addition, 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 and 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. In addition 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 the 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 also fueling the growth of the overall regional market to a large extent.
Competitive Landscape
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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1 INTRODUCTION
1.1 Study Assumptions and Market Definition
1.2 Scope of the Study
2 RESEARCH METHODOLOGY
3 EXECUTIVE SUMMARY
4 MARKET DYNAMICS
4.1 Market Overview
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 Porter’s Five Force Analysis
4.4.1 Threat of New Entrants
4.4.2 Bargaining Power of Buyers/Consumers
4.4.3 Bargaining Power of Suppliers
4.4.4 Threat of Substitute Products
4.4.5 Intensity of Competitive Rivalry
5 MARKET SEGMENTATION
5.1 By Product
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 Others
5.2 By Applications
5.2.1 Filtration
5.2.2 Cell Culture
5.2.3 Purification
5.2.4 Others
5.3 By End User
5.3.1 Biopharmaceutical Manufacturers
5.3.2 Academic & Clinical Research Institutes
5.3.3 Others
5.4 Geography
5.4.1 North America
5.4.1.1 United States
5.4.1.2 Canada
5.4.1.3 Mexico
5.4.2 Europe
5.4.2.1 Germany
5.4.2.2 United Kingdom
5.4.2.3 France
5.4.2.4 Italy
5.4.2.5 Spain
5.4.2.6 Rest of Europe
5.4.3 Asia-Pacific
5.4.3.1 China
5.4.3.2 Japan
5.4.3.3 India
5.4.3.4 Australia
5.4.3.5 South Korea
5.4.3.6 Rest of Asia-Pacific
5.4.4 Middle East and Africa
5.4.4.1 GCC
5.4.4.2 South Africa
5.4.4.3 Rest of Middle East and Africa
5.4.5 South America
5.4.5.1 Brazil
5.4.5.2 Argentina
5.4.5.3 Rest of South America
6 COMPETITIVE LANDSCAPE
6.1 Company Profiles
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
6.1.6 3M
6.1.7 Pall Corporation
6.1.8 CESCO BIOENGINEERING CO., LTD
6.1.9 PBS Biotech
6.1.10 ABEC Inc.
6.1.11 Celltainer
6.1.12 Distek Inc.
6.1.13 OmniBRx Biotechnologies
7 MARKET OPPORTUNITIES AND FUTURE TRENDS