일회용 바이오리액터 시장 규모 : 지역별, 범위 및 예측

Single-Use Bioreactors Market Size And Forecast

Single-use Bioreactors Market size was valued at USD 4.37 Billion in 2023 and is projected to reach USD 17.9 Billion by 2031, growing at a CAGR of 19.26% from 2024 to 2031. The Single-use Bioreactors Market refers to the segment within the bioprocessing industry that focuses on the development, manufacturing, and utilization of single-use bioreactor systems for various biopharmaceutical and biotechnology applications. These systems are designed to provide efficient and cost-effective solutions for cell culture processes, including cell growth, fermentation, and protein expression, while minimizing the need for traditional stainless steel bioreactors.

Global Single-Use Bioreactors Market Dynamics

The key market dynamics that are shaping the single-use bioreactors market include:

Key Market Drivers

Increasing Demand for Biologics:

The global spike in demand for biologics and biosimilars, which are effective in treating and managing a variety of chronic diseases, is a major driver of the single-use bioreactors market. These reactors provide a cost-effective, versatile, and speedier solution for biologics manufacturing, meeting the growing need for medicinal pharmaceuticals.

Cost Efficiency and Lower Contamination Risks:

Single-use bioreactors decrease the need for sophisticated sterilization techniques and the risk of cross-contamination, which is critical in pharmaceutical manufacturing. Their disposability results in cost savings on cleaning, maintenance, and downtime, making them an economically viable option for organizations.

Flexibility and Scalability:

The versatility of single-use bioreactors to various production sizes, from pilot to commercial, without requiring major capital investment, drives their application. This adaptability meets the dynamic needs of biopharmaceutical research and development, enabling quick scaling of operations and propelling market growth.

Technological Advancements and Regulatory Support:

Continuous developments in bioreactor design, materials, and sensor technology improve bioprocess efficiency and control. The approval of single-use systems for clinical and commercial manufacturing by regulatory organizations contributing to market growth by assuring compliance with industry standards.

Key Challenges:

Waste Management and Environmental Concerns:

The disposability of single-use bioreactors presents serious environmental problems due to the production of plastic trash. This waste is difficult to manage responsibly because it contradicts the pharmaceutical and biotech industries' growing emphasis on environmental sustainability, inhibiting the market demand.

Limitations in Scale:

While single-use bioreactors are flexible and cost-effective for particular scales of production, they have limitations when it comes to large-scale biomanufacturing. The requirement for bigger volumes makes single-use systems less practicable, potentially limiting their use in high-volume biologic processes.

Material Compatibility and Leachables:

The materials used in single-use bioreactors must be suitable with a wide range of bioprocesses and have no unfavorable interactions with the product. The concerning leachables and extractables that could contaminate biologic goods present significant hurdles to maintaining product purity and safety, limiting industry expansion.

Key Trends:

Expansion into Cell and Gene Therapies:

Single-use bioreactors are being used more and more in the manufacturing of cell and gene therapies as they become mainstream medical treatments. Their adaptability and low contamination risk make them perfect for the precise and sensitive manufacturing processes required by these medicines.

Sustainability Initiatives:

In response to environmental concerns, there is a rising movement to create more sustainable single-use bioreactor systems. This involves attempts to recycle used materials, minimize the carbon footprint of disposables, and develop biodegradable or eco-friendly alternatives that aim to lessen environmental effects.

Customization and Scalability Solutions:

Manufacturers are focusing on delivering customized solutions that meet unique manufacturing requirements, ranging from small-scale research and development to large-scale commercial production. This trend towards customizable and scalable single-use bioreactor setups meets the different needs of biopharmaceutical firms, enabling a wide range of applications.

Global Single-use Bioreactors Market Regional Analysis

Here is a more detailed regional analysis of the single-use bioreactors Market:

North America:

According to Verified Market Research, North America is estimated to dominate in single-use bioreactors market over the forecast period. North America, particularly the United States, has a thriving and advanced biopharmaceutical industry that leads in biologics and vaccine production. This industry's strength provides a sizable client base for single-use bioreactors, promoting their usage in flexible, cost-effective, and efficient biomanufacturing processes.

The region's strong investment in R&D, which is supported by both the commercial and public sectors, drives innovation in bioprocessing technology. This investment promotes the use of single-use bioreactors, which are essential for the development and production of next-generation biopharmaceuticals.

The strict regulatory framework in North America, which focuses on product safety and manufacturing efficiency, promotes the usage of single-use bioreactors. These systems provide advantages in terms of compliance, reduced contamination risk, and scalability, while also meeting regulatory agencies' quality assurance standards for pharmaceutical manufacturing.

Furthermore, North America has been at the forefront of introducing new technology into biomanufacturing, such as single-use bioreactors. The region's openness to embrace innovation promotes operational efficiencies, shorter production timelines, and cheaper prices, cementing its dominance in the global market for single-use bioreactors.

Asia Pacific:

The biopharmaceutical industry in the Asia Pacific is growing quickly, fueled by a rise in investments in biotech startups and the regional growth of multinational pharmaceutical corporations. This expansion increases demand for single-use bioreactors, which provide flexibility and efficiency in biologics production.

Many nations in the Asia Pacific are enacting supporting laws and providing funds to grow their biotech industry. Government attempts to improve healthcare infrastructure, promote R&D, and attract foreign investment all contribute to the growing need for single-use bioreactors.

Furthermore, the region's huge and ageing population, combined with expanding healthcare awareness and expenditure, is driving up demand for biopharmaceuticals. Single-use bioreactors, which are essential for the quick manufacture of vaccines and biologics, are increasingly being used to address these healthcare demands efficiently.

Europe:

Europe is experiencing tremendous investment in biopharmaceutical research and development from both the public and private sectors. This funding promotes innovation in bioprocessing technologies, such as single-use bioreactors, thereby facilitating their application in the development and manufacturing of improved medicinal solutions.

European regulatory organizations have backed innovative manufacturing technologies that promise to improve product quality and safety. This regulatory environment pushes pharmaceutical companies to deploy single-use bioreactor systems, which increase sterility and reduce contamination risk while adhering to regulatory requirements.

Furthermore, the increased emphasis on sustainability and decreasing environmental footprints in European manufacturing promotes the usage of single-use bioreactors. Despite waste concerns, the overall environmental impact is offset through lower energy and water consumption, which is consistent with the region's sustainability goals.

Global Single-Use Bioreactors Market Segmentation Analysis

The Single-use Bioreactors Market is segmented based on Product, Cell, Molecule, End-User, And Geography.

Single-use Bioreactors Market, By Product

• Bioreactor Systems
• Media Bags
• Filtration Assemblies
• Others

Based on Product, the market is segmented into Bioreactor Systems, Media Bags, Filtration Assemblies and Others. The bioreactor systems segment is estimated to dominate the single-use bioreactors market due to the critical role that these systems play in cell culture and biopharmaceutical synthesis. Single-use bioreactor systems provide substantial benefits, such as reduced contamination risk, lower initial investment, and shorter batch turnaround times, which are especially useful in the fast-paced pharmaceutical and biotech sectors. Their scalability and flexibility make them appropriate for a wide range of applications, from small-scale R&D to large-scale commercial manufacturing.

Single-use Bioreactors Market, By Cell

• Mammalian Cell
• Bacteria
• Yeast
• Others

Based on Cell, the market is segmented into Mammalian Cells, Bacteria, Yeast and Others. The mammalian cell segment is estimated to dominate the single-use bioreactors market due to the important role mammalian cells play in the synthesis of complex biologics such as monoclonal antibodies, vaccines, and recombinant proteins. These cells are critical for expressing proteins with appropriate folding, assembly, and post-translational modifications, which are required for therapeutic efficacy and safety.

Single-use Bioreactors Market, By Molecule

• Vaccines
• Monoclonal Antibodies
• Stem Cells
• Recombinant Proteins
• Others

Based on Molecule, the market is segmented into Vaccines, Monoclonal Antibodies, Stem Cells, Recombinant Proteins and Others. The vaccines segment is estimated to dominate the single-use bioreactors market owing to the global emphasis on immunization programmes and the rapid development of vaccines, as evidenced by the urgent manufacture of the COVID-19 vaccine. Single-use bioreactors provide significant benefits for vaccine production, including increased flexibility in scaling operations, a lower risk of cross-contamination, and faster turnaround times for vaccine development and manufacturing.

Single-use Bioreactors Market, By End-User

• Pharmaceutical & Biopharmaceutical Industries
• Contract Research Organizations (CRO)
• Others

Based on End-User, the market is divided into Pharmaceutical & Biopharmaceutical Industries, Contract Research Organizations (CROs) and Others. The pharmaceutical & biopharmaceutical industries segment is estimated to dominate the market over the forecast period. This dominance is due to the substantial role these industries play in biopharmaceutical research, development, and manufacture, which includes vaccines, monoclonal antibodies, and other biologics. The rising frequency of chronic diseases and the desire for personalized medicine have contributed to an increase in the use of single-use bioreactors.

Single-use Bioreactors Market, By Geography

• North America
• Europe
• Asia Pacific
• Rest of the world

Based on Geography, the single-use bioreactors market is classified into North America, Europe, Asia Pacific, and the Rest of the world. North America is expected to dominate the single-use bioreactors market during the forecast period. North America, particularly the United States, has a highly developed biopharmaceutical sector that is at the forefront of biologics and vaccine invention and production worldwide. This thriving industry generates enormous demand for single-use bioreactors, which are critical for the efficient and adaptable manufacturing procedures required by modern biopharmaceutical production.

Key Players

• The "Single-use Bioreactors Market" study report will provide valuable insight with an emphasis on the global market. The major players in the market are
• Thermo Fisher Scientific, Merck KGaA, Danaher Corporation, Sartorius Stedim Biotech, GE Healthcare, Eppendorf AG, Inovenio, MilliporeSigma, XCell Biotek, PBS Biotech, HYCON Bruggemann GmbH, Dolomite Bio, Applikon Biotechnology, Boehringer Ingelheim, Lonza Group Ltd and Samsung Biologics.

Our market analysis also entails a section solely dedicated to such major players wherein our analysts provide an insight into the financial statements of all the major players, along with product benchmarking and SWOT analysis. The competitive landscape section also includes key development strategies, market share, and market ranking analysis of the above-mentioned players globally.

• Single-use Bioreactors Market Recent Developments
• In November 2022, Sartorius AG, a major participant in the region from Germany, announced plans to broaden its operations. To better meet the needs of the biopharmaceutical industry, this expansion comprises the establishment of new R&D laboratories as well as the implementation of equipment automation and digitization.
• In November 2022, Danaher Corporation's subsidiary Cytiva invested roughly USD 8 million to expand its Fast Trak centre in Shanghai, China. The expansion seeks to promote the adoption of single-use technologies (SUT) in the region and facilitate the industry's transition to single-use bioprocessing solutions.

TABLE OF CONTENTS

1. Introduction

• Market Definition
• Market Segmentation
• Research Methodology

2. Executive Summary

• Key Findings
• Market Overview
• Market Highlights

3. Market Overview

• Market Size and Growth Potential
• Market Trends
• Market Drivers
• Market Restraints
• Market Opportunities
• Porter's Five Forces Analysis

4. Single-Use Bioreactors Market, By Type of Bioreactor

• Stirred-Tank Bioreactors
• Wave-Mixed Bioreactors
• Bubble Column Bioreactors

5. Single-Use Bioreactors Market, By Cell Type

• Mammalian Cells
• Microbial Cells
• Yeast Cells

6. Single-Use Bioreactors Market, By Application

• Monoclonal Antibody Production
• Vaccine Manufacturing
• Gene Therapy
• Stem Cell Culture
• Bioprocessing

7. Regional Analysis

• North America
• United States
• Canada
• Mexico
• Europe
• United Kingdom
• Germany
• France
• Italy
• Asia-Pacific
• China
• Japan
• India
• Australia
• Latin America
• Brazil
• Argentina
• Chile
• Middle East and Africa
• South Africa
• Saudi Arabia
• UAE

8. Market Dynamics

• Market Drivers
• Market Restraints
• Market Opportunities
• Impact of COVID-19 on the Market

9. Competitive Landscape

• Key Players
• Market Share Analysis

10. Company Profiles

• Sartorius AG
• Danaher Corporation
• Thermo Fisher Scientific Inc
• Merck KGaA
• Eppendorf AG
• Getinge AB
• CESCO BIOENGINEERING CO LTD
• Applikon Biotechnology
• PBS Biotech Inc
• Distek Inc
• Celltainer

11. Market Outlook and Opportunities

• Emerging Technologies
• Future Market Trends
• Investment Opportunities

12. Appendix

• List of Abbreviations
• Sources and References