シングルユースバイオリアクターの市場規模：地域別、範囲および予測

シングルユースバイオリアクターの市場規模と予測

シングルユースバイオリアクター市場規模は、2023年に43億7,000万米ドルと評価され、2024年から2031年にかけて19.26%のCAGRで成長し、2031年には179億米ドルに達すると予測されています。シングルユースバイオリアクター市場とは、バイオプロセス産業における、様々なバイオ医薬品・バイオテクノロジー用途のシングルユースバイオリアクターシステムの開発、製造、利用に焦点を当てたセグメントを指します。これらのシステムは、従来のステンレス製バイオリアクターの必要性を最小限に抑えながら、細胞増殖、発酵、タンパク質発現などの細胞培養プロセスに効率的でコスト効率の高いソリューションを提供するように設計されています。

シングルユースバイオリアクターの世界市場力学

主な市場促進要因

生物製剤需要の増加：

様々な慢性疾患の治療と管理に有効な生物製剤とバイオシミラーに対する世界の需要の急増は、シングルユースバイオリアクター市場の主要な促進要因です。これらのリアクターは、生物製剤製造のための費用対効果に優れ、汎用性が高く、より迅速なソリューションを提供し、医薬品に対するニーズの高まりに応えています。

コスト効率と汚染リスクの低減：

シングルユースバイオリアクターは、高度な滅菌技術の必要性や、医薬品製造において重要な交差汚染のリスクを低減します。使い捨てが可能なため、洗浄、メンテナンス、ダウンタイムにかかるコストが削減され、組織にとって経済的に実行可能な選択肢となります。

柔軟性と拡張性：

シングルユースバイオリアクターは、大規模な設備投資を必要とせず、パイロットから商業生産まで、さまざまな生産規模に対応できる汎用性が、その応用を後押ししています。この適応性は、バイオ医薬品の研究開発のダイナミックなニーズに対応し、迅速なオペレーションの拡張を可能にし、市場開拓を促進します。

技術の進歩と規制上のサポート：

バイオリアクターの設計、材料、センサー技術の絶え間ない開発により、バイオプロセスの効率と制御が向上しています。規制当局による臨床および商業製造用のシングルユースシステムの承認は、業界標準への準拠を保証することで市場成長に貢献しています。

主な課題：

廃棄物管理と環境問題：

シングルユースバイオリアクターの使い捨ては、プラスチックゴミの発生による深刻な環境問題を引き起こします。この廃棄物は、製薬業界やバイオテクノロジー業界が環境の持続可能性を重視するようになっていることと矛盾するため、責任を持って管理することが難しく、市場の需要を阻害しています。

規模の限界：

シングルユースバイオリアクターは、特定の生産規模では柔軟で費用対効果が高いが、大規模なバイオ製造に関しては限界があります。大容量が要求されるため、シングルユースシステムは実用的でなくなり、大量の生物学的プロセスでの使用が制限される可能性があります。

材料適合性と溶出物：

シングルユースバイオリアクターに使用される材料は、幅広いバイオプロセスに適合し、製品と好ましくない相互作用を起こさないものでなければならないです。生物製剤を汚染する可能性のある溶出物や抽出物は、製品の純度と安全性を維持する上で大きな障害となり、業界の拡大を制限しています。

主要動向：

細胞・遺伝子治療への拡大：

シングルユースバイオリアクターは、細胞治療や遺伝子治療が治療の主流になるにつれ、その製造にますます使用されるようになっています。適応性が高く、汚染リスクが低いため、これらの医薬品に求められる精密で繊細な製造工程に最適です。

持続可能性への取り組み：

環境問題への懸念から、より持続可能なシングルユースバイオリアクターシステムを作ろうという動きが高まっています。これには、使用済み材料のリサイクル、使い捨て品の二酸化炭素排出量の最小化、環境への影響を軽減することを目的とした生分解性または環境に優しい代替品の開発などの試みが含まれます。

カスタマイズとスケーラビリティ・ソリューション：

開発企業は、小規模な研究開発から大規模な商業生産に至るまで、独自の製造要件を満たすカスタマイズされたソリューションの提供に注力しています。カスタマイズ可能でスケーラブルなシングルユースバイオリアクターセットアップへのこの動向は、バイオ医薬品企業のさまざまなニーズを満たし、幅広いアプリケーションを可能にします。

目次

第1章 イントロダクション

• 市場の定義
• 市場セグメンテーション
• 調査手法

第2章 エグゼクティブサマリー

• 主な調査結果
• 市場概要
• 市場ハイライト

第3章 市場概要

• 市場規模と成長の可能性
• 市場動向
• 市場促進要因
• 市場抑制要因
• 市場機会
• ポーターのファイブフォース分析

第4章 シングルユースバイオリアクター市場：バイオリアクタータイプ別

• 攪拌タンク型バイオリアクター
• 波動混合型バイオリアクター
• バブルカラムバイオリアクター

第5章 シングルユースバイオリアクター市場：細胞タイプ別

• 哺乳類細胞
• 微生物細胞
• 酵母細胞

第6章 シングルユースバイオリアクター市場：用途別

• モノクローナル抗体製造
• ワクチン製造
• 遺伝子治療
• 幹細胞培養
• バイオプロセス

第7章 地域分析

• 北米
• 米国
• カナダ
• メキシコ
• 欧州
• 英国
• ドイツ
• フランス
• イタリア
• アジア太平洋
• 中国
• 日本
• インド
• オーストラリア
• ラテンアメリカ
• ブラジル
• アルゼンチン
• チリ
• 中東・アフリカ
• 南アフリカ
• サウジアラビア
• アラブ首長国連邦

第8章 市場力学

• 市場促進要因
• 市場抑制要因
• 市場機会
• COVID-19の市場への影響

第9章 競合情勢

• 主要企業
• 市場シェア分析

第10章 企業プロファイル

• 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

第11章 市場の展望と機会

• 新興技術
• 今後の市場動向
• 投資機会

第12章 付録

• 略語リスト
• 出典と参考文献

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