세포 및 유전자 치료제 제조 시장 규모, 점유율, 성장 분석 : 치료법별, 제조 공정별, 규모별, 최종사용자별, 지역별 - 업계 예측(2026-2033년)

Global Cell And Gene Therapy Manufacturing Market size was valued at USD 8.52 Billion in 2024 and is poised to grow from USD 9.76 Billion in 2025 to USD 28.85 Billion by 2033, growing at a CAGR of 14.52% during the forecast period (2026-2033).

The global cell and gene therapy manufacturing landscape has evolved significantly, driven by scientific innovation and unmet clinical needs. Currently, the market is characterized by Good Manufacturing Practice (GMP) biomanufacturing tailored for autologous and allogeneic therapies, alongside viral vector and genome-edited products aimed at providing lasting, single-administration treatments for cancer and rare genetic conditions. The shift from academic labs to GMP contract manufacturers has facilitated the broader production of CAR T-cell therapies. Additionally, adeno-associated virus vectors have transitioned from niche trials to studies targeting larger populations, necessitating substantial resource investments. To meet surging demand and the complexities of personalized treatments, sponsors increasingly rely on contract development and manufacturing organizations (CDMOs) and modular facilities, enhancing throughput while minimizing contamination risks.

Top-down and bottom-up approaches were used to estimate and validate the size of the Global Cell And Gene Therapy Manufacturing market and to estimate the size of various other dependent submarkets. The research methodology used to estimate the market size includes the following details: The key players in the market were identified through secondary research, and their market shares in the respective regions were determined through primary and secondary research. This entire procedure includes the study of the annual and financial reports of the top market players and extensive interviews for key insights from industry leaders such as CEOs, VPs, directors, and marketing executives. All percentage shares split, and breakdowns were determined using secondary sources and verified through Primary sources. All possible parameters that affect the markets covered in this research study have been accounted for, viewed in extensive detail, verified through primary research, and analyzed to get the final quantitative and qualitative data.

Global Cell And Gene Therapy Manufacturing Market Segments Analysis

Global cell and gene therapy manufacturing market is segmented by therapy type, process, scale, end-user and region. Based on therapy type, the market is segmented into Cell Therapy Manufacturing and Gene Therapy Manufacturing. Based on process, the market is segmented into Upstream Bioprocessing, Downstream Purification and Fill-Finish. Based on scale, the market is segmented into Clinical-Scale and Commercial-Scale. Based on end-user, the market is segmented into Pharma & Biotech Companies, CDMOs and Academic Medical Centers. Based on region, the market is segmented into North America, Europe, Asia Pacific, Latin America and Middle East & Africa.

Driver of the Global Cell And Gene Therapy Manufacturing Market

The global market for cell and gene therapy manufacturing is being propelled by significant advancements in bioprocess technologies, which enhance scalability, consistency, and throughput. These innovations facilitate the transition of products from laboratory settings to commercial production with greater efficiency. Enhanced bioreactor designs, automation in cell handling, and refined process controls lead to reduced variability and increased batch reliability. As a result, contract manufacturers and innovative developers are more likely to adopt these technologies. This progress diminishes operational complexity, aligns manufacturing capacity with clinical demand, and stimulates investment in capacity expansion, encouraging firms to pursue more ambitious therapeutic projects that require dependable and reproducible manufacturing processes.

Restraints in the Global Cell And Gene Therapy Manufacturing Market

The Global Cell and Gene Therapy Manufacturing market faces notable challenges due to the consistently high expenses linked to specialized facilities, advanced equipment, skilled personnel, and rigorous quality control systems. These financial hurdles significantly hinder many organizations from developing or enhancing their manufacturing capabilities. The substantial capital required for building compliant cleanrooms and obtaining specialized materials adds budgetary strain, often discouraging smaller innovators from advancing their product candidates. Moreover, these cost pressures can restrict production flexibility, compelling companies to prioritize certain programs, which ultimately slows market growth by limiting the number of therapies that can be produced at the necessary scale and quality.

Market Trends of the Global Cell And Gene Therapy Manufacturing Market

The Global Cell and Gene Therapy Manufacturing market is witnessing a significant trend towards modular facility expansion, characterized by the adoption of modular and prefabricated designs that enhance the speed and efficiency of production capability. This transformative approach not only enables rapid reconfiguration for varied therapies but also fosters greater collaboration between sponsors and specialized contract manufacturers. By promoting plug-and-play process integration, it addresses the challenges of technology obsolescence through simplified retrofitting. Furthermore, the modular strategy is gaining favor among investors and regulators alike, as it offers flexible validation pathways and scalable capacities that align with the continuously evolving landscape of therapeutic solutions.

Table of Contents

Introduction

• Objectives of the Study
• Market Definition & Scope

Research Methodology

• Research Process
• Secondary & Primary Data Methods
• Market Size Estimation Methods

Executive Summary

• Global Market Outlook
• Key Market Highlights
• Segmental Overview
• Competition Overview

Market Dynamics & Outlook

• Macro-Economic Indicators
• Drivers & Opportunities
• Restraints & Challenges
• Supply Side Trends
• Demand Side Trends
• Porters Analysis & Impact
  • Competitive Rivalry
  • Threat of Substitute
  • Bargaining Power of Buyers
  • Threat of New Entrants
  • Bargaining Power of Suppliers

Key Market Insights

• Key Success Factors
• Market Impacting Factors
• Top Investment Pockets
• Ecosystem Mapping
• Market Attractiveness Index 2025
• PESTEL Analysis
• Regulatory Landscape

Global Cell And Gene Therapy Manufacturing Market Size by Therapy Type & CAGR (2026-2033)

• Market Overview
• Cell Therapy Manufacturing
  • CAR-T
  • NK Cell
  • Stem Cell
• Gene Therapy Manufacturing

Global Cell And Gene Therapy Manufacturing Market Size by Process & CAGR (2026-2033)

• Market Overview
• Upstream Bioprocessing
• Downstream Purification
• Fill-Finish

Global Cell And Gene Therapy Manufacturing Market Size by Scale & CAGR (2026-2033)

• Market Overview
• Clinical-Scale
• Commercial-Scale

Global Cell And Gene Therapy Manufacturing Market Size by End-User & CAGR (2026-2033)

• Market Overview
• Pharma & Biotech Companies
• CDMOs
• Academic Medical Centers

Global Cell And Gene Therapy Manufacturing Market Size & CAGR (2026-2033)

• North America (Therapy Type, Process, Scale, End-User)
  • US
  • Canada
• Europe (Therapy Type, Process, Scale, End-User)
  • Germany
  • Spain
  • France
  • UK
  • Italy
  • Rest of Europe
• Asia Pacific (Therapy Type, Process, Scale, End-User)
  • China
  • India
  • Japan
  • South Korea
  • Rest of Asia-Pacific
• Latin America (Therapy Type, Process, Scale, End-User)
  • Mexico
  • Brazil
  • Rest of Latin America
• Middle East & Africa (Therapy Type, Process, Scale, End-User)
  • GCC Countries
  • South Africa
  • Rest of Middle East & Africa

Competitive Intelligence

• Top 5 Player Comparison
• Market Positioning of Key Players, 2025
• Strategies Adopted by Key Market Players
• Recent Developments in the Market
• Company Market Share Analysis, 2025
• Company Profiles of All Key Players
  • Company Details
  • Product Portfolio Analysis
  • Company's Segmental Share Analysis
  • Revenue Y-O-Y Comparison (2023-2025)

Key Company Profiles

• Lonza Group (Cocoon Platform)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Catalent Inc.
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Thermo Fisher Scientific
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• WuXi Advanced Therapies
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Fujifilm Diosynth Biotechnologies
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Sartorius AG
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Cytiva (Danaher)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Oxford Biomedica plc
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Andelyn Biosciences
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Cellipont Bioservices
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• PCT (Hitachi)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Novatek International
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• AGC Biologics
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Orion Pharma
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Kite Pharma (Gilead)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Novartis (AveXis)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Bristol Myers Squibb (Juno)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Samsung Biologics
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Rentschler Biopharma
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• KBI Biopharma
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments

Conclusion & Recommendations