시장보고서

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1663327

일회용 바이오리액터 : 시장 인사이트, 경쟁 구도, 시장 예측(2032년)

Single-use Bioreactors - Market Insights, Competitive Landscape, and Market Forecast - 2032

발행일: On demand Report | 리서치사:

DelveInsight | 페이지 정보: 영문 150 Pages | 배송안내 : 2-10일 (영업일 기준)

■ 보고서에 따라 최신 정보로 업데이트하여 보내드립니다. 배송일정은 문의해 주시기 바랍니다.

샘플 요청 목록에 추가

세계의 일회용 바이오리액터 시장 규모는 2024년에 30억 9,217만 달러로, 2032년까지 103억 1,591만 달러에 달할 것으로 예측되며, 2025-2032년의 예측 기간에 CAGR로 16.33%의 성장이 전망됩니다.

일회용 바이오리액터 시장 역학

바이오 제약 산업에서 일회용 기술의 급속한 채택은 전 세계 일회용 바이오리액터 시장의 큰 성장을 가속하고 있습니다. 이러한 추세는 비용 효율성, 오염 위험 감소, 제조 유연성 향상과 같은 주요 이점에 의해 촉진되고 있습니다. 일회용 바이오리액터는 기존 스테인리스강 시스템에 비해 설비 투자가 적고, 대규모 세척 및 검증이 필요하지 않아 비용을 크게 절감할 수 있습니다. 이러한 장점은 대규모 인프라를 구축할 자원이 부족한 소규모 생명공학 기업이나 수탁제조기관(CMO)에 특히 유용합니다.

예를 들어 스페인의 CDMO인 mAbxience는 2023년 4월 레온의 시설에 ABEC의 4,000L 일회용 바이오리액터를 설치하여 생산 효율을 향상시키면서 운영 비용을 최소화했습니다. 마찬가지로 우시 바이오로직스(WuXi Biologics)는 우시(Wuxi) 시설에 4,000L의 일회용 바이오리액터를 여러개 설치하여 업계가 보다 안전하고 규정을 준수하며 확장 가능한 제조 솔루션으로 전환하고 있음을 보여줍니다.

일회용 바이오리액터는 일회용이기 때문에 배치 간 이차 오염의 위험이 현저히 감소합니다. 이는 백신이나 단클론 항체 등 사소한 오염도 안전성 우려와 경제적 손실로 이어질 수 있는 민감한 생물제제를 제조할 때 매우 중요한 이점입니다.

이러한 요인들은 2025-2032년의 예측 기간 중 세계 일회용 바이오리액터 시장을 촉진할 것으로 예상됩니다. 그러나 일회용 시스템에서 발생하는 플라스틱 폐기물 증가는 환경 문제를 야기하고 시장 성장에 대한 작은 도전이 될 수 있습니다.

북미가 전체 일회용 바이오리액터 시장을 독식할 것으로 예상됩니다.

북미는 2024년 세계 일회용 바이오리액터 시장에서 가장 큰 점유율을 차지합니다. 이 지역의 우위는 Pfizer, Moderna, Amgen 등 첨단 바이오프로세스 기술 채택을 선도하는 주요 기업이 있는 탄탄한 바이오 제약 부문 덕분입니다. 생물제제, 세포 및 유전자 치료, 맞춤형 의료에 대한 관심이 높아지면서 일회용 바이오리액터가 큰 이점을 제공하는 이 분야에서 유연한 제조 솔루션에 대한 수요가 더욱 증가하고 있습니다.

FDA와 같은 기관의 규제 지원은 기술 혁신을 촉진하고, 주요 제조업체와 연구 기관의 존재는 제품 개발을 가속화합니다. 또한 생명공학 인프라에 대한 투자 증가와 임상시험의 확대로 인해 확장 가능하고 비용 효율적인 생산 솔루션에 대한 요구가 증가하고 있습니다.

북미에서 일회용 기술의 채택이 급증하는 이유는 이러한 시스템이 제공하는 유연성, 확장성, 운영 효율성 때문입니다. 바이오 제약사들은 일회용 바이오리액터를 통해 신속한 생산 설정과 원활한 배치 전환, 그리고 엄격한 규제 환경에서 제품의 안전과 품질을 유지하는 데 필수적인 오염 위험을 최소화하는 데 활용하고 있습니다. 대규모 세척 및 멸균이 필요한 기존 스테인리스강 시스템과 달리 일회용 바이오리액터는 다운타임과 운영 비용을 줄여주기 때문에 수탁제조(CMO) 및 소규모 바이오테크 기업에게 특히 매력적입니다.

임상시험 및 생물제제 제조가 점점 더 작은 배치 크기와 연속 처리로 이동함에 따라 일회용 시스템의 다용도성은 기업이 진화하는 생산 수요에 신속하게 대응할 수 있도록 돕습니다. 미국 시장의 성장은 신제품 혁신에 의해 더욱 촉진될 것입니다. 예를 들어 미국의 Agilitech는 2021년 10월 Agilitech 바이오리액터 컨트롤러를 출시했습니다. 이 컨트롤러는 30L에서 2,000L 용량의 일회용 바이오리액터를 최대 2대까지 관리할 수 있습니다.

이러한 요인을 종합하면 북미 일회용 바이오리액터 시장은 예측 기간 중 건전한 성장을 보일 것으로 예상됩니다.

세계의 일회용 바이오리액터 시장에 대해 조사분석했으며, 시장 규모와 예측, 과거 3년의 제품/기술개발, 시장의 주요 기업, 이용 가능한 기회 등의 정보를 제공하고 있습니다.

Single-use Bioreactors Market by Capacity (<=10 L, 11-100 L, 101-500 L, 501-1,500 L, and Above 1,500 L), Product (System and Accessories), Type (Stirred Tank Bioreactors, Wave-Induced Bioreactors, Bubble-Column Bioreactors, and Others), and Geography (North America, Europe, Asia-Pacific, and Rest of the World) is expected to grow at a steady CAGR forecast till 2032 owing to the rapid adoption of single-use technologies by the industries, minimal risk of contamination between batches, and growing product development activities across the globe.

The single-use bioreactors market was valued at USD 3,092.17 million in 2024, growing at a CAGR of 16.33% during the forecast period from 2025 to 2032 to reach USD 10,315.91 million by 2032. The rapid adoption of single-use technologies, especially in biopharmaceutical manufacturing, is driven by their flexibility and efficiency, allowing quick setup for various processes to meet the growing demand for diverse bioproducts. The minimal risk of contamination between batches enhances product safety and quality, crucial in regulated environments, while also reducing cleaning and validation costs. Additionally, increased product development activities in biologics and personalized medicine require innovative manufacturing solutions for smaller batch sizes and rapid production adjustments. Collectively, these factors are expected to drive the market for single-use bioreactors, establishing them as a preferred choice in modern biomanufacturing during the forecast period from 2025 to 2032.

Single-use Bioreactors Market Dynamics:

The rapid adoption of single-use technologies in the biopharmaceutical industry is driving significant growth in the global single-use bioreactor market. This trend is fueled by key advantages such as cost efficiency, reduced contamination risk, and enhanced manufacturing flexibility. Compared to traditional stainless-steel systems, single-use bioreactors require lower capital investment and eliminate the need for extensive cleaning and validation, resulting in substantial cost savings. These benefits are particularly valuable for small biotech companies and contract manufacturing organizations (CMOs) with limited resources for large-scale infrastructure.

For example, in April 2023, Spanish CDMO mAbxience installed a 4,000 L single-use bioreactor from ABEC at its Leon facility to improve production efficiency while minimizing operational costs. Similarly, WuXi Biologics implemented multiple 4,000 L single-use bioreactors at its Wuxi facility, underscoring the industry's shift toward safer, more compliant, and scalable manufacturing solutions.

The disposable nature of single-use bioreactors significantly reduces the risk of cross-contamination between batches a critical advantage in producing sensitive biologics such as vaccines and monoclonal antibodies, where even minor contamination can lead to safety concerns and financial losses.

These factors are projected to propel the global single-use bioreactor market during the 2025-2032 forecast period. However, the increased plastic waste generated by disposable systems raises environmental concerns, which may pose a minor challenge to market growth.

Single-use Bioreactors Market Segment Analysis:

In the capacity segment of the single-use bioreactors market, bioreactors exceeding 1,500 liters are projected to capture a significant revenue share in 2024. The growing adoption of these large-capacity systems is significantly driving the market, enabling biopharmaceutical manufacturers to scale up production efficiently while benefiting from the core advantages of single-use technologies reduced contamination risk, minimized cleaning and validation requirements, and faster turnaround times.

Leading industry players like Lonza and Sartorius have made notable strides in developing large-volume single-use bioreactors to streamline the production of biologics, including monoclonal antibodies and vaccines. For example, in June 2024, WuXi Biologics, a global Contract Research, Development, and Manufacturing Organization (CRDMO), successfully installed three 5,000 L single-use bioreactors at its Hangzhou facility, enhancing large-scale drug substance manufacturing capabilities.

The integration of high-capacity single-use bioreactors into existing manufacturing workflows reduces the need for extensive infrastructure modifications typically associated with traditional stainless-steel systems. This operational flexibility is vital for companies aiming to optimize production without incurring significant capital expenditures. As biopharmaceutical manufacturers increasingly focus on process intensification and adopt continuous manufacturing practices, larger single-use bioreactors offer the scalability needed to achieve higher yields within shorter production cycles.

These factors of scalability, operational efficiency, and improved product quality are propelling the growth of the above 1,500 L capacity segment, thereby contributing to the overall expansion of the global single-use bioreactors market.

North America is expected to dominate the overall single-use bioreactors market:

North America is projected to hold the largest share of the global single-use bioreactors market in 2024. The region's dominance is driven by its well-established biopharmaceutical sector, with key players such as Pfizer, Moderna, and Amgen leading the adoption of advanced bioprocessing technologies. The growing focus on biologics, cell and gene therapies, and personalized medicine further fuels the demand for flexible manufacturing solutions in an area where single-use bioreactors offer significant advantages.

Regulatory support from agencies like the FDA encourages innovation, while the presence of leading manufacturers and research institutions accelerates product development. Additionally, increasing investments in biotechnology infrastructure and the expanding number of clinical trials heighten the need for scalable, cost-effective production solutions.

The surge in single-use technology adoption across North America stems from the flexibility, scalability, and operational efficiency these systems provide. Biopharmaceutical companies are leveraging single-use bioreactors for faster production setup, seamless batch transitions, and minimal contamination risk crucial for maintaining product safety and quality in highly regulated environments. Unlike traditional stainless-steel systems that require extensive cleaning and sterilization, single-use bioreactors reduce downtime and operational costs, making them particularly attractive to contract manufacturing organizations (CMOs) and smaller biotech firms.

As clinical trials and biologics manufacturing increasingly shift toward smaller batch sizes and continuous processing, the versatility of single-use systems enables companies to adapt swiftly to evolving production demands. The market's growth in the U.S. is further bolstered by new product innovations. For example, in October 2021, Agilitech a U.S.-based company launched the Agilitech bioreactor controller, capable of managing up to two single-use bioreactors with capacities ranging from 30 L to 2,000 L. Its flexible design ensures compatibility with various single-use bioreactor brands, reflecting industry-wide efforts to enhance manufacturing agility.

Collectively, these factors are expected to drive robust growth in the North American single-use bioreactors market over the forecast period.

Single-use Bioreactors Market Key Players:

Some of the key market players operating in the single-use bioreactors market include Getinge AB, Agilitech, WuXi Biologics, mAbxience, Eppendorf AG, Sartorius AG, Cytiva Life Sciences, Merck KGaA, Bionet, OmniBRx Biotechnologies, Thermo Fisher Scientific Inc., Pall Corporation, Distek, Inc., AGC Biologics, Celltainer, Applikon Biotechnology, Biolinx Labsystems, Sartorius Stedim Biotech, Solaris Biotech, Synthecon, and others.

Recent Developmental Activities in the Single-use Bioreactors Market:

In March 2024, Getinge AB extended the bioreactor portfolio with larger single-use systems.
In September 2023, Getinge AB launched a single-use bioreactor for clinical cell and gene therapies.

Key Takeaways from the Single-use Bioreactors Market Report Study

Market size analysis for current single-use bioreactors size (2024), and market forecast for 8 years (2025 to 2032)
Top key product/technology developments, mergers, acquisitions, partnerships, and joint ventures happened over the last 3 years.
Key companies dominating the single-use bioreactors market.
Various opportunities available for the other competitors in the single-use bioreactors market space.
What are the top-performing segments in 2024? How these segments will perform in 2032?
Which are the top-performing regions and countries in the current single-use bioreactors market scenario?
Which are the regions and countries where companies should have concentrated on opportunities for single-use bioreactors market growth in the coming future?

Target Audience Who Can be Benefited from this Single-use Bioreactors Market Report Study

Single-use bioreactor product providers
Research organizations and consulting companies
Single-use bioreactors -related organizations, associations, forums, and other alliances
Government and corporate offices
Start-up companies, venture capitalists, and private equity firms
Distributors and traders dealing in single-use bioreactors
Various end-users who want to know more about the single-use bioreactors market and the latest technological developments in the single-use bioreactors market.

Frequently Asked Questions for the Single-use Bioreactors Market:

1. What are single-use bioreactors?

Single-use bioreactors are disposable bioprocessing systems designed for cultivating cells or microorganisms, typically used in pharmaceutical and biopharmaceutical manufacturing. They feature pre-sterilized, plastic components, reducing contamination risks and eliminating the need for cleaning, making them ideal for flexible and cost-effective production.

2. What is the market for single-use bioreactors?

The single-use bioreactors market was valued at USD 3,092.17 million in 2024, growing at a CAGR of 16.33% during the forecast period from 2025 to 2032 to reach USD 10,315.91 million by 2032.

3. What are the drivers for the global single-use bioreactors market?

The rapid adoption of single-use technologies, especially in biopharmaceutical manufacturing, is driven by their flexibility and efficiency, allowing quick setup for various processes to meet the growing demand for diverse bioproducts. The minimal risk of contamination between batches enhances product safety and quality, crucial in regulated environments, while also reducing cleaning and validation costs. Additionally, increased product development activities in biologics and personalized medicine require innovative manufacturing solutions for smaller batch sizes and rapid production adjustments. Collectively, these factors are expected to drive the market for single-use bioreactors, establishing them as a preferred choice in modern biomanufacturing during the forecast period from 2025 to 2032.

4. Who are the key players operating in the global single-use bioreactors market?

Some of the key market players operating in the single-use bioreactors are Getinge AB, Agilitech, WuXi Biologics, mAbxience, Eppendorf AG, Sartorius AG, Cytiva Life Sciences, Merck KGaA, Bionet, OmniBRx Biotechnologies, Thermo Fisher Scientific Inc., Pall Corporation, Distek, Inc., AGC Biologics, Celltainer, Applikon Biotechnology, Biolinx Labsystems, Sartorius Stedim Biotech, Solaris Biotech, Synthecon, and others.

5. Which region has the highest share in the global Single-use Bioreactors market?

North America is expected to account for the highest proportion of the Single-use Bioreactors market in 2024, out of all regions. The region's well-established biopharmaceutical sector, with companies like Pfizer, Moderna, and Amgen, drives high adoption of advanced bioprocessing technologies, including single-use systems. Additionally, the growing focus on biologics, cell and gene therapies, and personalized medicine fuels the demand for flexible manufacturing solutions, which single-use bioreactors provide. Strong regulatory support from agencies like the FDA encourages innovation, while the presence of leading manufacturers and research institutions accelerates product development. Moreover, increasing investments in biotechnology infrastructure and the rising need for scalable production due to clinical trials further strengthen North America's leadership in the market.

1. Single-use Bioreactors Market Report Introduction

1.1. Scope of the Study
1.2. Market Segmentation
1.3. Market Assumption

2. Single-use Bioreactors Market Executive Summary

2.1. Market at Glance

3. Competitive Landscape

4. Regulatory Analysis

4.1. The United States
4.2. Europe
4.3. Japan
4.4. China

5. Single-use Bioreactors Market Key Factors Analysis

5.1. Single-use Bioreactors Market Drivers
- 5.1.1. The rapid adoption of single-use technologies by industries
- 5.1.2. Minimal risk of contamination between batches
- 5.1.3. Growing product development activities across the globe.
5.2. Single-use Bioreactors Market Restraints and Challenges
- 5.2.1. Raising environmental concerns due to the use of disposable single-use bioreactors
5.3. Single-use Bioreactors Market Opportunities
- 5.3.1. Ongoing advancements in automation and sensor technologies

6. Single-use Bioreactors Market Porter's Five Forces Analysis

6.1. Bargaining Power of Suppliers
6.2. Bargaining Power of Consumers
6.3. Threat of New Entrants
6.4. Threat of Substitutes
6.5. Competitive Rivalry

7. Single-use Bioreactors Market Assessment

7.1. By Capacity
- 7.1.1. =10 L
- 7.1.2. 11-100 L
- 7.1.3. 101-500 L
- 7.1.4. 501-1,500 L
- 7.1.5. Above 1,500 L
7.2. By Product
- 7.2.1. System
- 7.2.2. Accessories
7.3. By Usage
- 7.3.1. Stirred Tank Bioreactors
- 7.3.2. Wave-Induced Bioreactors
- 7.3.3. Bubble-Column Bioreactors
7.4. By Geography
- 7.4.1. North America
  - 7.4.1.1. United States Single-use Bioreactors Market Size in USD Million (2022-2032)
  - 7.4.1.2. Canada Single-use Bioreactors Market Size in USD Million (2022-2032)
  - 7.4.1.3. Mexico Single-use Bioreactors Market Size in USD Million (2022-2032)
- 7.4.2. Europe
  - 7.4.2.1. France Single-use Bioreactors Market Size in USD Million (2022-2032)
  - 7.4.2.2. Germany Single-use Bioreactors Market Size in USD Million (2022-2032)
  - 7.4.2.3. United Kingdom Single-use Bioreactors Market Size in USD Million (2022-2032)
  - 7.4.2.4. Italy Single-use Bioreactors Market Size in USD Million (2022-2032)
  - 7.4.2.5. Spain Single-use Bioreactors Market Size in USD Million (2022-2032)
  - 7.4.2.6. Rest of Europe Single-use Bioreactors Market Size in USD Million (2022-2032)
- 7.4.3. Asia-Pacific
  - 7.4.3.1. China Single-use Bioreactors Market Size in USD Million (2022-2032)
  - 7.4.3.2. Japan Single-use Bioreactors Market Size in USD Million (2022-2032)
  - 7.4.3.3. India Single-use Bioreactors Market Size in USD Million (2022-2032)
  - 7.4.3.4. Australia Single-use Bioreactors Market Size in USD Million (2022-2032)
  - 7.4.3.5. South Korea Single-use Bioreactors Market Size in USD Million (2022-2032)
  - 7.4.3.6. Rest of Asia-Pacific Single-use Bioreactors Market Size in USD Million (2022-2032)
- 7.4.4. Rest of the World (RoW)
  - 7.4.4.1. Middle East Single-use Bioreactors Market Size in USD Million (2022-2032)
  - 7.4.4.2. Africa Single-use Bioreactors Market Size in USD Million (2022-2032)
  - 7.4.4.3. South America Single-use Bioreactors Market Size in USD Million (2022-2032)

8. Single-use Bioreactors Market Company and Product Profiles

8.1. Getinge AB
- 8.1.1. Company Overview
- 8.1.2. Company Snapshot
- 8.1.3. Financial Overview
- 8.1.4. Product Listing
- 8.1.5. Entropy
8.2. Agilitech
- 8.2.1. Company Overview
- 8.2.2. Company Snapshot
- 8.2.3. Financial Overview
- 8.2.4. Product Listing
- 8.2.5. Entropy
8.3. WuXi Biologics
- 8.3.1. Company Overview
- 8.3.2. Company Snapshot
- 8.3.3. Financial Overview
- 8.3.4. Product Listing
- 8.3.5. Entropy
8.4. mAbxience
- 8.4.1. Company Overview
- 8.4.2. Company Snapshot
- 8.4.3. Financial Overview
- 8.4.4. Product Listing
- 8.4.5. Entropy
8.5. Eppendorf AG
- 8.5.1. Company Overview
- 8.5.2. Company Snapshot
- 8.5.3. Financial Overview
- 8.5.4. Product Listing
- 8.5.5. Entropy
8.6. Sartorius AG
- 8.6.1. Company Overview
- 8.6.2. Company Snapshot
- 8.6.3. Financial Overview
- 8.6.4. Product Listing
- 8.6.5. Entropy
8.7. Cytiva Life Sciences
- 8.7.1. Company Overview
- 8.7.2. Company Snapshot
- 8.7.3. Financial Overview
- 8.7.4. Product Listing
- 8.7.5. Entropy
8.8. Merck KGaA
- 8.8.1. Company Overview
- 8.8.2. Company Snapshot
- 8.8.3. Financial Overview
- 8.8.4. Product Listing
- 8.8.5. Entropy
8.9. Bionet
- 8.9.1. Company Overview
- 8.9.2. Company Snapshot
- 8.9.3. Financial Overview
- 8.9.4. Product Listing
- 8.9.5. Entropy
8.10. OmniBRx Biotechnologies
- 8.10.1. Company Overview
- 8.10.2. Company Snapshot
- 8.10.3. Financial Overview
- 8.10.4. Product Listing
- 8.10.5. Entropy
8.11. Thermo Fisher Scientific Inc.
- 8.11.1. Company Overview
- 8.11.2. Company Snapshot
- 8.11.3. Financial Overview
- 8.11.4. Product Listing
- 8.11.5. Entropy
8.12. Pall Corporation
- 8.12.1. Company Overview
- 8.12.2. Company Snapshot
- 8.12.3. Financial Overview
- 8.12.4. Product Listing
- 8.12.5. Entropy
8.13. Distek, Inc.
- 8.13.1. Company Overview
- 8.13.2. Company Snapshot
- 8.13.3. Financial Overview
- 8.13.4. Product Listing
- 8.13.5. Entropy
8.14. AGC Biologics
- 8.14.1. Company Overview
- 8.14.2. Company Snapshot
- 8.14.3. Financial Overview
- 8.14.4. Product Listing
- 8.14.5. Entropy
8.15. Celltainer
- 8.15.1. Company Overview
- 8.15.2. Company Snapshot
- 8.15.3. Financial Overview
- 8.15.4. Product Listing
- 8.15.5. Entropy
8.16. Applikon Biotechnology
- 8.16.1. Company Overview
- 8.16.2. Company Snapshot
- 8.16.3. Financial Overview
- 8.16.4. Product Listing
- 8.16.5. Entropy
8.17. Biolinx Labsystems
- 8.17.1. Company Overview
- 8.17.2. Company Snapshot
- 8.17.3. Financial Overview
- 8.17.4. Product Listing
- 8.17.5. Entropy
8.18. Sartorius Stedim Biotech
- 8.18.1. Company Overview
- 8.18.2. Company Snapshot
- 8.18.3. Financial Overview
- 8.18.4. Product Listing
- 8.18.5. Entropy
8.19. Solaris Biotech
- 8.19.1. Company Overview
- 8.19.2. Company Snapshot
- 8.19.3. Financial Overview
- 8.19.4. Product Listing
- 8.19.5. Entropy
8.20. Synthecon
- 8.20.1. Company Overview
- 8.20.2. Company Snapshot
- 8.20.3. Financial Overview
- 8.20.4. Product Listing
- 8.20.5. Entropy

일회용 바이오리액터 : 시장 인사이트, 경쟁 구도, 시장 예측(2032년)

Single-use Bioreactors - Market Insights, Competitive Landscape, and Market Forecast - 2032

목차

제1장 일회용 바이오리액터 시장 보고서 서론

제2장 일회용 바이오리액터 시장 개요

제3장 경쟁 구도

제4장 규제 분석

제5장 일회용 바이오리액터 시장의 주요 요인 분석

제6장 일회용 바이오리액터 시장의 Porter's Five Forces 분석

제7장 일회용 바이오리액터 시장 평가

제8장 일회용 바이오리액터 시장의 기업과 제품 개요

제9장 KOL의 견해

제10장 프로젝트 어프로치

제11장 DelveInsight 소개

제12장 면책사항, 문의