세계의 바이오프로세스 백 시장 평가 : 유형별, 제품 유형별, 워크플로우별, 최종사용자별, 지역별, 기회 및 예측(2018-2032년)

Global bioprocess bags market is projected to witness a CAGR of 9.21% during the forecast period 2025-2032, growing from USD 3.35 billion in 2024 to USD 6.78 billion in 2032. The global bioprocess bags market is expected to witness growth owing to increasing production of biologics such as monoclonal antibodies and vaccines, advancements in single-use technologies, increasing focus on cell and gene therapies and increasing demand for flexible and scalable bioprocess solutions such as bioprocess bags.

Bioprocess bags represent a fast-growing market sector within the biopharmaceutical and life sciences fields because single-use technologies (SUT) are receiving increasing adoption across biomanufacturing facilities. Bioprocess bags serve as essential tools for storing, mixing, and transporting critical biopharmaceutical fluids, such as cell cultures, media, and buffers, driving the global bioprocess bags market demand in the forecast period. Bioprocess bags outperform stainless-steel systems because they reduce contamination risks, operational expenditures, and accelerate production throughput times, pushing market growth.

The expanding market growth, increasing demand for biologics, including vaccines, monoclonal antibody demand, and cell and gene therapy requirements. Biomanufacturers select single-use bioprocess bags for their operations since these products eliminate the need for cleaning and sterilization steps in both small-scale and large-scale flexible manufacturing processes. Single-use bioprocess bags experienced increasing adoption because of the supportive guidelines issued by the FDA and EMA.

The market maintains its primary position in North America as it is an established biopharmaceutical industry, whereas the Asia-Pacific region demonstrates the fastest growth through its expanding biomanufacturing operations in China and India. Future market growth will be driven by ongoing advancements in sustainable materials and customized bag designs, despite current challenges such as leachables and extractables testing and constraints in the raw material supply chain.

Additionally, companies are collaborating to innovate advanced technology to support the bioprocess bags market. For instance, in June 2024, Qosina Crop announced a partnership with Polestar Technologies to acquire Polestar Technologies' iDOT Single-Use Sensor Bag Ports to its extensive portfolio. The bag allows for non-invasive monitoring of dissolved oxygen and pH in single-use bags, including bioreactors.

Growing Adoption of Single-Use Technologies (SUTs) Boosts Market Demand

The growing adoption of single-use technologies (SUTs) is significantly increasing the demand for bioprocess bags in the pharmaceutical and biopharmaceutical industries. The advantages of SUTs include lower contamination risk, mitigating capital costs, faster production timelines, and flexible manufacturing operations. Bioprocess bags are an essential component of SUTs' processes for storing and transporting cell cultures, media, and buffers in upstream and downstream stages. Single-use systems have established themselves as the key choice over stainless-steel equipment by providing economical, scalable, and productive bio-manufacturing solutions. The increasing interest in biologics, together with vaccines and personalized medicines, fuels rapid market growth. The market expands because of both emerging markets and technological advancements in bioprocessing. Bioprocess bags will maintain their market growth momentum due to regulatory support and facility modularization needs. Market expansion continues because key industry players develop innovative solutions while maintaining sustainability to address changing industry needs.

For instance, in April 2024, SaniSure launched Fill4Sure, a custom single-use filling assembly, to expedite drugs to market and build security, efficiency, and repeatability in drug product filling.

Biopharmaceutical Industry Support Market Expansion

The biopharmaceutical sector is rapidly growing due to its manufacturing production of monoclonal antibodies (mAbs), vaccines, cell & gene therapies, and biosimilars. These advanced therapies require 1sterile manufacturing solutions that are flexible and scalable, so the demand for disposable bioprocess containers (BPCs) continues to rise. Single-use BPCs offer advantages over stainless-steel systems by minimizing cross-contamination risks, reducing cleaning validation costs, and speeding up batch changeover processes. The modular design enables BPCs to be easily scaled up so contract manufacturing organizations (CMOs) and biotech firms can quickly adjust to shifting production requirements. BPCs decrease capital requirements during facility construction while shrinking facility dimensions to enable faster delivery of essential therapies. The modern bioprocessing industry benefits from disposable systems because they provide cost-effective, efficient, and compliant solutions that meet the demand for personalized high-value biologics.

For instance, in August 2023, Kriya Therapeutics, Inc., raised USD 150 million in Series C funding to advance its pipeline of gene therapies. This is expected to boost demand for high-performance bioprocess bags as the company expands its clinical production capabilities.

2D Bioprocess Bags Hold the Largest Global Bioprocess Bags Market Share

The 2D bioprocess bags lead the market as they provide flexible solutions at affordable prices while remaining simple to operate. Biopharmaceutical manufacturing, cell culture, and storage operations extensively use these bags because they offer space-efficient compact solutions. The flat structure of these bags makes them convenient for handling, transportation, and storage; thus, users choose them for single-use bioprocessing applications. The use of 2D bags reduces contamination risks and decreases cleaning requirements, which leads to better operational performance. Single-use technologies in biomanufacturing are experiencing growing adoption because they eliminate sterilization requirements and shorten downtime periods. The selection of 2D bioprocess bags by biopharmaceutical and pharmaceutical organizations depends on their different bioprocessing approach requirements and their need for simple scalability. The market will maintain its leadership position for 2D bioprocess bags due to ongoing material science developments and rising biopharmaceutical production investments. The growing use of these products in developing markets drives the continuous expansion of this market segment.

For instance, in July 2023, Qosina Crop announced the addition of Aramus 2D bag chambers from Entegris. They are high-performance fluid-storage and transfer bag chambers that are made of a high-grade, gamma-stable fluoropolymer, providing high purity and exceptional compatibility.

North America Dominates the Bioprocess Bags Market

North America held the largest share of the global bioprocess bags market due to its modern healthcare facilities combined with major pharmaceutical and biotech companies, and its extensive implementation of single-use technologies. The region obtains substantial research funding and enforces strict regulatory requirements that safeguard product quality and safety. The U.S. leads the largest market share since biologics, along with vaccines and cell therapies, experience continuous market growth. Market growth receives extra support through the increasing popularity of biopharmaceutical manufacturing and the expanding number of contract manufacturing organizations. The Canadian biotechnology sector, along with government programs for new treatments, helps North America maintain its regional power. The industry applications of disposable bioprocessing methods help North America keep its market leadership position by reducing operational costs and lowering contamination risks.

For instance, in December 2023, the Canadian Government invested USD 15 million over three years to expand Northern RNA's biomanufacturing capacity to produce mRNA vaccines and therapies. These investments increase the bioprocess bags market.

Impact of U.S. Tariffs on the Global Bioprocess Bags Market

The implementation of U.S. tariffs on imported bioprocess bags has significantly impacted the market by increasing production costs for both manufacturers and their customers. The tariffs on Chinese bioprocess bag products have disrupted supply chains, and companies find alternative suppliers or accept increased costs. The lower competition benefits domestic producers, yet the entire market experiences price increases, which decreases the affordability for biopharmaceutical organizations. Smaller companies face rising operational costs, which create barriers to innovation and production growth. Trade uncertainties discourage long-term investments in the sector. The process of reshoring manufacturing exists as an option, but it remains slow and expensive. The tariffs have generated immediate problems, which will evolve according to worldwide trade patterns and industry adjustment methods.

Key Players Landscape and Outlook

With a growing demand for flexible, scalable, and GMP-compliant biomanufacturing solutions, the bioprocess bags market is on a dynamic upward path. Emerging innovations in sensor-enabled bags, integrated mixing technologies, and customizable formats are reshaping the fluid management landscape for biologics production. As industry stakeholders accelerate the transition toward disposable systems, the bioprocess bags market is set to become a cornerstone of modern biopharma manufacturing.

In March 2023, Sartorius AG acquired France-based Polyplus for around USD 26.2 billion. This deal helps the company expand its product portfolio in the market.

In April 2023, Merck KGaA announced the launch of Ultimus Single-Use Process Container Film to provide extreme durability and leak resistance for single-use assemblies used for bioprocessing liquid applications.

Table of Contents

1. Project Scope and Definitions

2. Research Methodology

3. Impact of U.S. Tariffs

4. Executive Summary

5. Global Bioprocess Bags Market Outlook, 2018-2032F

• 5.1. Market Size Analysis & Forecast
  • 5.1.1. By Value
• 5.2. Market Share Analysis & Forecast
  • 5.2.1. By Type
    • 5.2.1.1. 2D Bioprocess Bags
    • 5.2.1.2. 3D Bioprocess Bags
    • 5.2.1.3. Others
  • 5.2.2. By Product Type
    • 5.2.2.1. Single-Use Bioprocessing Bags
    • 5.2.2.2. Multi-Use Bioprocessing Bags
  • 5.2.3. By Workflow
    • 5.2.3.1. Upstream Process
    • 5.2.3.2. Downstream Process
    • 5.2.3.3. Process Development
    • 5.2.3.4. Media preparation
  • 5.2.4. By End-user
    • 5.2.4.1. Pharmaceutical and Biopharmaceutical Companies
    • 5.2.4.2. CMOs and CROs
    • 5.2.4.3. Academic and Research Institutes
  • 5.2.5. By Region
    • 5.2.5.1. North America
    • 5.2.5.2. Europe
    • 5.2.5.3. Asia-Pacific
    • 5.2.5.4. South America
    • 5.2.5.5. Middle East and Africa
  • 5.2.6. By Company Market Share Analysis (Top 5 Companies and Others - By Value, 2024)
• 5.3. Market Map Analysis, 2024
  • 5.3.1. By Type
  • 5.3.2. By Product Type
  • 5.3.3. By Workflow
  • 5.3.4. By End-user
  • 5.3.5. By Region

6. North America Bioprocess Bags Market Outlook, 2018-2032F

• 6.1. Market Size Analysis & Forecast
  • 6.1.1. By Value
• 6.2. Market Share Analysis & Forecast
  • 6.2.1. By Type
    • 6.2.1.1. 2D Bioprocess Bags
    • 6.2.1.2. 3D Bioprocess Bags
    • 6.2.1.3. Others
  • 6.2.2. By Product Type
    • 6.2.2.1. Single-Use Bioprocessing Bags
    • 6.2.2.2. Multi-Use Bioprocessing Bags
  • 6.2.3. By Workflow
    • 6.2.3.1. Upstream Process
    • 6.2.3.2. Downstream Process
    • 6.2.3.3. Process Development
    • 6.2.3.4. Media preparation
  • 6.2.4. By End-user
    • 6.2.4.1. Pharmaceutical and Biopharmaceutical Companies
    • 6.2.4.2. CMOs and CROs
    • 6.2.4.3. Academic and Research Institutes
  • 6.2.5. By Country Share
    • 6.2.5.1. United States
    • 6.2.5.2. Canada
    • 6.2.5.3. Mexico
• 6.3. Country Market Assessment
  • 6.3.1. United States Bioprocess Bags Market Outlook, 2018-2032F*
    • 6.3.1.1. Market Size Analysis & Forecast
      • 6.3.1.1.1. By Value
    • 6.3.1.2. Market Share Analysis & Forecast
      • 6.3.1.2.1. By Type
        • 6.3.1.2.1.1. 2D Bioprocess Bags
        • 6.3.1.2.1.2. 3D Bioprocess Bags
        • 6.3.1.2.1.3. Others
      • 6.3.1.2.2. By Product Type
        • 6.3.1.2.2.1. Single-Use Bioprocessing Bags
        • 6.3.1.2.2.2. Multi-Use Bioprocessing Bags
      • 6.3.1.2.3. By Workflow
        • 6.3.1.2.3.1. Upstream Process
        • 6.3.1.2.3.2. Downstream Process
        • 6.3.1.2.3.3. Process Development
        • 6.3.1.2.3.4. Media preparation
      • 6.3.1.2.4. By End-user
        • 6.3.1.2.4.1. Pharmaceutical and Biopharmaceutical Companies
        • 6.3.1.2.4.2. CMOs and CROs
        • 6.3.1.2.4.3. Academic and Research Institutes
  • 6.3.2. Canada
  • 6.3.3. Mexico

All segments will be provided for all regions and countries covered

7. Europe Bioprocess Bags Market Outlook, 2018-2032F

• 7.1. Germany
• 7.2. France
• 7.3. Italy
• 7.4. United Kingdom
• 7.5. Russia
• 7.6. Netherlands
• 7.7. Spain
• 7.8. Turkey
• 7.9. Poland

8. Asia-Pacific Bioprocess Bags Market Outlook, 2018-2032F

• 8.1. India
• 8.2. China
• 8.3. Japan
• 8.4. Australia
• 8.5. Vietnam
• 8.6. South Korea
• 8.7. Indonesia
• 8.8. Philippines

9. South America Bioprocess Bags Market Outlook, 2018-2032F

• 9.1. Brazil
• 9.2. Argentina

10. Middle East and Africa Bioprocess Bags Market Outlook, 2018-2032F

• 10.1. Saudi Arabia
• 10.2. UAE
• 10.3. South Africa

11. Demand Supply Analysis

12. Porter's Five Forces Analysis

13. PESTLE Analysis

14. Pricing Analysis

15. Market Dynamics

• 15.1. Market Drivers
• 15.2. Market Challenges

16. Market Trends and Developments

17. Policy and Regulatory Landscape

18. Case Studies

19. Competitive Landscape

• 19.1. Competition Matrix of Top 5 Market Leaders
• 19.2. SWOT Analysis for Top 5 Players
• 19.3. Key Players Landscape for Top 10 Market Players
  • 19.3.1. Thermo Fisher Scientific Inc.
    • 19.3.1.1. Company Details
    • 19.3.1.2. Key Management Personnel
    • 19.3.1.3. Products and Services
    • 19.3.1.4. Financials (As Reported)
    • 19.3.1.5. Key Market Focus and Geographical Presence
    • 19.3.1.6. Recent Developments/Collaborations/Partnerships/Mergers and Acquisition
  • 19.3.2. Sartorius AG
  • 19.3.3. Merck KGaA
  • 19.3.4. Compagnie de Saint-Gobain S.A.
  • 19.3.5. Avantor, Inc.
  • 19.3.6. Corning Incorporated
  • 19.3.7. Lonza Group AG
  • 19.3.8. Entegris, Inc.
  • 19.3.9. Meissner Filtration Products, Inc.
  • 19.3.10. Solesis LLC

Companies mentioned above DO NOT hold any order as per market share and can be changed as per information available during research work.

20. Strategic Recommendations

21. About Us and Disclaimer