세계의 줄기세포 제조 시장 : 점유율 분석, 산업 동향, 통계, 성장 예측(2025-2030년)

The Stem Cell Manufacturing Market size is estimated at USD 17.03 billion in 2025, and is expected to reach USD 31.32 billion by 2030, at a CAGR of 12.96% during the forecast period (2025-2030).

Rising adoption of automated, closed-system bioreactors, regulatory harmonization in major economies, and the need for large-batch production to serve regenerative therapies collectively underpin this growth trajectory. Consumables remain the single largest revenue contributor, reflecting their recurring use in every production run, while instruments are scaling fastest as manufacturers deploy robotics and advanced analytics to counter talent shortages. North America retains leadership through strong FDA frameworks and sustained public-private funding, whereas Asia Pacific posts the quickest expansion on the back of policy modernization in Japan and China. The transition from manual workflows toward single-use technologies is lowering contamination risk and enabling distributed manufacturing close to clinical sites. However, bottlenecks in fetal bovine serum supply and a global skills crunch in bioprocess engineering pose near-term operational challenges.

Global Stem Cell Manufacturing Market Trends and Insights

Automated, Closed-System Bioreactors Transform Manufacturing Paradigms

Industrial deployment of automated, closed-system bioreactors is redefining production economics across the stem cell manufacturing market. Lonza's Cocoon platform cuts human intervention by up to 70% while maintaining GMP compliance, directly alleviating the global shortage of skilled operators. Job postings for bioprocess engineers climbed 400% between 2019 and 2023, yet remain difficult to fill, underscoring the urgency of automation. Single-use assemblies reduce cross-contamination and lower facility footprints, enabling distributed production models that place manufacturing closer to point-of-care delivery. The University of Technology Sydney's 3D-printed microfluidic harvester integrates multiple steps into one device, shrinking cost per batch and improving cell viability. Collectively, these innovations anchor a long-term uplift in capacity that underpins the market's 12.96% CAGR outlook.

Growing Public-Private Funding Accelerates Commercial Translation

Escalating government initiatives and industry alliances continue to channel capital into advanced facilities and workforce programs. The National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) sponsors collaborative projects that de-risk scale-up challenges while offering experiential training to new technicians. Biofoundry models, often housed within academic settings, are shortening iteration cycles and enabling small firms to access state-of-the-art infrastructure without heavy capital outlay. These funding streams improve technology readiness levels and bring novel therapies closer to commercial launch, solidifying the long-term demand base across the stem cell manufacturing market.

High GMP Operational Costs Constrain Market Entry

Building and running GMP-compliant facilities requires USD 10-50 million in upfront investments, with operating expenses consuming 15-25% of annual revenue, challenging small firms and emerging nations. Larger incumbents leverage economies of scale and diversified product portfolios to absorb these costs, widening competitive gaps. Bio-Techne's transition to animal-free reagents illustrates how vendors must continuously invest in compliance-driven process upgrades while balancing cost containment. Contract manufacturing organizations (CMOs) specializing in cell therapies are beginning to democratize access, yet capacity remains limited relative to demand.

Other drivers and restraints analyzed in the detailed report include:

1. Rising Chronic-Disease Burden Creates Sustained Demand Pull
2. Public Awareness Drives Market Acceptance and Investment
3. Complex Regulatory Frameworks Slow Global Market Development

For complete list of drivers and restraints, kindly check the Table Of Contents.

Segment Analysis

In 2024, consumables accounted for 47.12% of the stem cell manufacturing market share, underscoring the indispensability of media, reagents, and single-use assemblies to every production run. Recurrent demand ensures stable cashflows, allowing suppliers to invest in serum-free and chemically defined formulations that mitigate contamination risk and combat the looming fetal bovine serum shortage. Instruments, although smaller in absolute revenue today, are projected to register a 13.85% CAGR through 2030 as facilities install closed-system bioreactors, automated cell sorters, and AI-enabled monitoring probes. The stem cell manufacturing industry is witnessing a surge in strategic alliances between equipment vendors and therapy developers, enabling real-time process optimization and reducing batch failures.

Emerging platform technologies exemplify the transformational nature of the instrument segment. Ori Biotech's IRO system delivers 70% labor reduction and 50% cost savings, highlighting how smart hardware can reset production cost baselines. Integration of machine learning models into bioreactors allows dynamic adjustment of feed rates and oxygenation, elevating reproducibility. Consumable suppliers are responding by bundling sensors and pre-sterilized bags, creating end-to-end kits that simplify validation. Collectively, these trends diversify revenue pools and enhance resilience across the stem cell manufacturing market.

The Stem Cell Manufacturing Market Report is Segmented by Product Type (Culture Media, Consumables, Instruments, Stem Cell Lines, and Services), Application (Stem Cell Therapy, Drug Discovery and Toxicology, Stem Cell Banking and More), End User (Pharmaceutical and Biotechnology Companies, Cell and Tissue Banks, and More), and Geography (North America, Europe, and More). The Market Forecasts are Provided in Terms of Value (USD).

Geography Analysis

North America retained 41.32% revenue share in 2024, driven by the world's largest cluster of cell therapy developers, abundant venture capital, and FDA pathways such as RMAT and accelerated approval that shorten commercialization lead times. The region also houses the highest concentration of CMOs, offering flexible capacity to smaller sponsors. Yet the acute shortfall of bioprocess engineers-vacancies outpace qualified candidates three-to-one-could restrain build-out plans unless workforce initiatives gain further traction. Partnerships among community colleges, NIIMBL, and industry accelerate technician training, but competition from mRNA and viral-vector facilities intensifies hiring pressures.

Asia Pacific is the fastest-growing territory, projected to log a 14.22% CAGR as Japan's conditional approval scheme and China's sizeable provincial subsidies encourage rapid scaling of local plants. South Korea's authorization of 16 cell-based products, including three stem cell therapies, underscores regulatory maturity and positions the peninsula as an exporter of manufacturing know-how. Furthermore, cost-competitive labor and land in China and India lure multinational firms to establish satellite facilities, diversifying supply chains. However, disparate approval procedures among ASEAN members still create time-to-market frictions that multinational sponsors must navigate carefully.

Europe commands a significant but more regulated market environment. The European Medicines Agency's ATMP framework sets stringent quality benchmarks, which extend development timelines yet elevate global confidence in product safety. Implementation of the European Pharmacopoeia chapter on cell-based products offers clearer analytical standards, easing some validation uncertainties. Funding from Horizon Europe and national programs continues to support infrastructure upgrades, while public skepticism toward animal-derived components accelerates adoption of chemically defined media. Smaller regions such as the Middle East and Africa and South America observe emergent local initiatives-Brazilian and South African centers now pilot stem cell transplant programs-yet limited capital and skills infrastructures temper near-term scale-up prospects.

1. Thermo Fisher Scientific
2. Merck
3. Sartorius
4. Lonza Group
5. FUJIFILM Cellular Dynamics
6. Stem Cell Technologies
7. Beckton Dickinson
8. Corning
9. Miltenyi Biotec
10. Takeda Pharmaceutical Co.
11. Daiichi-Sankyo Co.
12. Abbvie
13. Pluri (Pluristem Therapeutics)
14. Cytiva
15. Bio-Rad Laboratories
16. CellGenix
17. BICO ( CELLINK )

Additional Benefits:

• The market estimate (ME) sheet in Excel format
• 3 months of analyst support

TABLE OF CONTENTS

1 Introduction

• 1.1 Study Assumptions & Market Definition
• 1.2 Scope of the Study

2 Research Methodology

3 Executive Summary

4 Market Landscape

• 4.1 Market Overview
• 4.2 Market Drivers
  • 4.2.1 Automated, closed-system bioreactors & single-use tech
  • 4.2.2 Growing public-private funding for stem-cell R&D
  • 4.2.3 Rising chronic-disease burden fueling regenerative demand
  • 4.2.4 Growing public awareness about the therapeutic potency of stem cell products
  • 4.2.5 Favorable regulatory and policy support
  • 4.2.6 Strategic collaborations and market expansion
• 4.3 Market Restraints
  • 4.3.1 High GMP operational costs
  • 4.3.2 Complex regulatory and ethical hurdles
  • 4.3.3 Shortage of cell-manufacturing bioprocess engineers
  • 4.3.4 Supply-chain bottlenecks for GMP growth factors and vectors
• 4.4 Regulatory Landscape
• 4.5 Technological Outlook
• 4.6 Porter's Five Forces Analysis
  • 4.6.1 Threat of New Entrants
  • 4.6.2 Bargaining Power of Buyers
  • 4.6.3 Bargaining Power of Suppliers
  • 4.6.4 Threat of Substitutes
  • 4.6.5 Intensity of Rivalry

5 Market Size & Growth Forecasts (Value)

• 5.1 By Product Type
  • 5.1.1 Culture Media
  • 5.1.2 Consumables
  • 5.1.3 Instruments
  • 5.1.4 Stem Cell Lines
  • 5.1.5 Services
• 5.2 By Application
  • 5.2.1 Stem Cell Therapy
  • 5.2.2 Drug Discovery and Toxicology
  • 5.2.3 Stem Cell Banking
  • 5.2.4 Tissue Engineering and Regenerative Medicine
• 5.3 By End User
  • 5.3.1 Pharmaceutical and Biotechnology Companies
  • 5.3.2 Academic and Research Institutes
  • 5.3.3 Cell and Tissue Banks
  • 5.3.4 Other End Users
• 5.4 By 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 Market Concentration
• 6.2 Market Share Analysis
• 6.3 Company Profiles (includes Global level Overview, Market level overview, Core Segments, Financials as available, Strategic Information, Market Rank/Share for key companies, Products & Services, and Recent Developments)
  • 6.3.1 Thermo Fisher Scientific Inc.
  • 6.3.2 Merck KGaA
  • 6.3.3 Sartorius AG
  • 6.3.4 Lonza Group AG
  • 6.3.5 FUJIFILM Cellular Dynamics
  • 6.3.6 STEMCELL Technologies
  • 6.3.7 Becton, Dickinson and Company
  • 6.3.8 Corning Incorporated
  • 6.3.9 Miltenyi Biotec
  • 6.3.10 Takeda Pharmaceutical Co.
  • 6.3.11 Daiichi-Sankyo Co.
  • 6.3.12 AbbVie Inc.
  • 6.3.13 Pluri (Pluristem Therapeutics)
  • 6.3.14 Cytiva (Danaher)
  • 6.3.15 Bio-Rad Laboratories
  • 6.3.16 CellGenix GmbH
  • 6.3.17 BICO ( CELLINK )

7 Market Opportunities & Future Outlook

• 7.1 White-space & Unmet-Need Assessment