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세계의 GMP 세포은행 서비스 시장

GMP Cell Banking Services

발행일: | 리서치사: Market Glass, Inc. (Formerly Global Industry Analysts, Inc.) | 페이지 정보: 영문 194 Pages | 배송안내 : 1-2일 (영업일 기준)

    
    
    



※ 본 상품은 영문 자료로 한글과 영문 목차에 불일치하는 내용이 있을 경우 영문을 우선합니다. 정확한 검토를 위해 영문 목차를 참고해주시기 바랍니다.

세계의 GMP 세포은행 서비스 시장은 2030년까지 22억 달러에 달할 전망

2024년에 9억 3,940만 달러로 추정되는 세계의 GMP 세포은행 서비스 시장은 2024-2030년의 분석 기간에 CAGR 15.0%로 성장하며, 2030년까지 22억 달러에 달할 것으로 예측됩니다. 이 리포트에서 분석 대상으로 한 부문의 하나인 바이오의약품 기업용은 14.6%의 CAGR을 기록하며, 분석 기간 종료시까지 15억 달러에 달할 것으로 예측됩니다. 또 수탁제조 기관용 부문의 성장률은 분석 기간에 16.0%의 CAGR로 추정되고 있습니다.

미국 시장은 2억 6,060만 달러로 추정되는 한편, 중국은 14.0%의 CAGR로 성장할 것으로 예측됩니다.

미국의 GMP 세포은행 서비스 시장은 2024년에 2억 6,060만 달러로 추정되고 있습니다. 세계 2위의 경제 규모를 자랑하는 중국은 2024-2030년의 분석 기간에 CAGR 14.0%로 추이하며, 2030년까지 3억 2,820만 달러의 시장 규모에 달할 것으로 예측됩니다. 기타 주목할 만한 지역별 시장 분석으로는 일본과 캐나다를 들 수 있으며, 각각 분석 기간 중 13.0%, 12.8%의 CAGR로 성장할 것으로 예측됩니다. 유럽에서는 독일이 약 10.7%의 CAGR로 성장할 것으로 예측됩니다.

세계의 GMP 세포은행 서비스 시장 - 주요 동향과 촉진요인의 개요

GMP 세포은행 서비스가 바이오의약품 개발 및 치료에 중요한 이유는 무엇인가?

GMP 세포은행 서비스는 치료제 개발을 위한 안전하고 신뢰할 수 있는 고품질 세포주에 대한 수요가 증가함에 따라 바이오 제약 산업에서 필수적인 요소로 자리 잡고 있습니다. 그렇다면 오늘날 GMP(Good Manufacturing Practice) 세포은행은 엄격한 규제 및 품질관리 기준 하에 세포주를 생성, 보존, 유지하는 것을 의미합니다. 이러한 서비스는 생물제제, 백신, 유전자치료제, 기타 치료제 제조에 사용되는 세포주가 오염되지 않고 장기간 무결성을 유지할 수 있도록 보장합니다.

바이오의약품 개발에서 세포주의 사용은 기초적인 역할을 하고 있으며, 특히 단클론 항체, 재조합 단백질, 유전자 치료용 바이러스 벡터의 생산에 있으며, 중요한 역할을 합니다. GMP 세포은행 프로세스에는 생물제제 생산 확대에 필수적인 마스터 세포은행(MCB)과 작업용 세포은행(WCB)의 생성이 포함됩니다. 세포주는 생존성과 유전적 안정성을 유지하기 위해 통제된 조건에서 보관되며, 여러 생산 배치에 걸쳐 일관성을 보장합니다. FDA 및 EMA와 같은 규제 당국의 요구 사항을 고려할 때, GMP 세포 은행은 컴플라이언스 기준을 충족하고 치료제의 안전성과 효능을 보장하며 시장 출시 과정을 가속화하기 위해 필수적입니다. 바이오의약품과 맞춤의료의 부상으로 바이오의약품 산업이 계속 확대되고 있는 가운데, GMP 세포은행 서비스는 이러한 첨단 치료법을 안전하고 안정적으로 생산하기 위해 필수적인 요소입니다.

기술 발전은 GMP 세포은행 서비스를 어떻게 강화하고 있는가?

기술 혁신은 GMP 세포은행 서비스의 효율성, 안전성, 확장성 향상에 중요한 역할을 하고 있으며, 바이오제약 기업이 치료제 생산을 위한 고품질 세포주를 쉽게 유지할 수 있도록 돕고 있습니다. 가장 영향력 있는 발전 중 하나는 자동화된 세포배양 시스템의 도입으로, 이를 통해 보다 정밀하고 재현성 높은 세포은행 프로세스가 가능해졌습니다. 자동화를 통해 인적 오류를 줄이고 세포은행이 최적의 조건에서 준비, 모니터링, 유지되므로 오염 위험과 세포주 특성의 변동을 최소화할 수 있습니다. 이는 일관성이 매우 중요한 대규모 생산 환경에서 특히 중요합니다.

냉동보존 기술도 발전하여 세포주의 생존율과 기능성을 손상시키지 않고 장기보존이 가능해졌습니다. 동결 보호제 배합과 동결 프로토콜의 개선으로 초저온에서의 세포 보존 능력이 향상되어 세포 손상을 유발하는 얼음 결정 형성의 위험이 감소했습니다. 이러한 발전으로 세포은행은 유전적, 표현형적 무결성을 유지하면서 장기간(종종 수십 년) 동안 생존 능력을 유지할 수 있습니다. 이는 생물학적 제조 공정의 재현성, 특히 수년 동안 고품질의 세포를 안정적으로 공급해야 하는 경우 매우 중요합니다.

GMP 세포은행에 고급 분석기술과 품질관리 기술의 통합도 이 분야에 혁명을 일으키고 있습니다. 차세대 염기서열 분석(NGS), 유세포분석(flow cytometry), 디지털 PCR(dPCR) 등의 기술을 활용하여 세포주를 보다 세밀하게 특성화하고, 마이코플라즈마나 바이러스와 같은 오염물질이 없고 유전적 동일성이 유지되고 있음을 보장합니다. 이러한 고급 분석 기술을 통해 세포 은행의 품질을 보다 엄격하게 모니터링할 수 있으며, 바이오 제약 기업은 세포주의 건전성과 안정성에 대한 자세한 정보를 얻을 수 있습니다. 이러한 수준의 관리는 유전자 치료나 세포 치료와 같은 첨단 치료제 개발에서 특히 중요한데, 세포주의 작은 변화도 최종 제품의 효능과 안전성에 영향을 미칠 수 있기 때문입니다.

또한 문서화 및 데이터 관리 시스템의 발전으로 GMP 세포은행 서비스의 추적성과 규제 준수성이 향상되고 있습니다. 최신 소프트웨어 플랫폼을 통해 초기 특성 평가부터 동결보관 및 보관에 이르는 세포은행 관련 전 과정을 종합적으로 문서화할 수 있게 되었습니다. 이러한 시스템을 통해 바이오 제약기업은 자사 세포은행의 이력 추적이 용이해져 규제 가이드라인을 준수하고 FDA, EMA 등 기관의 감사를 원활하게 진행할 수 있습니다. 세포주에 대한 완벽한 관리와 추적성을 입증할 수 있는 능력은 생물제제의 규제 승인과 치료제의 장기적인 성공을 보장하는 데 필수적입니다.

GMP 세포은행 서비스가 생물제제의 안전성, 안정성, 확장성 확보에 중요한 이유는 무엇인가?

GMP 세포은행 서비스가 생물제제의 안전성, 안정성, 확장성을 보장하는 데 있으며, 매우 중요한 이유는 일관된 고품질의 치료제를 생산하기 위한 관리된 컴플라이언스 대응 시스템을 제공하기 때문입니다. 단클론 항체, 백신, 유전자 치료제와 같은 생물제제 제조에서 세포주는 이러한 복잡한 분자를 생산하는 생물학적 공장으로 사용됩니다. 이러한 세포주가 오염되지 않고, 유전적으로 안정적이며, 재현 가능한 성능을 발휘할 수 있도록 보장하는 것은 생물제제의 성공적인 개발 및 제조에 필수적입니다.

바이오 제약 산업에서 안전은 최우선 과제이며, GMP 세포은행 서비스는 세포주 오염 및 변동성과 관련된 위험을 줄이기 위해 매우 중요합니다. 박테리아, 바이러스, 마이코플라즈마 등의 오염물질은 바이오의약품의 안전성과 유효성을 저해하여 환자에게 유해한 결과를 초래하거나 규제 당국의 회수 조치로 이어질 수 있습니다. GMP 세포은행은 치료용 제품 생산에 사용되기 전에 세포주가 오염물질이 없는지 철저하게 테스트하고 검증하는 것을 보장합니다. 이러한 엄격한 테스트 및 모니터링 프로세스는 오염 위험을 줄이고, 바이오 제약 회사가 환자를 위해 안전하고 신뢰할 수 있는 바이오의약품을 생산할 수 있도록 보장합니다.

안정성은 GMP 세포은행이 제공하는 중요한 장점 중 하나입니다. 생물제제는 임상시험 및 상업화 수요를 충족시키기 위해 시간이 지남에 따라 일관되게 생산되어야 하며, 종종 여러 생산 배치에 걸쳐 생산되는 경우가 많습니다. 마스터 세포은행(MCB)과 워킹 세포은행(WCB)을 구축하여 제조에 사용되는 세포주가 장기적으로 유전적으로 안정적이고 기능적으로 신뢰할 수 있도록 보장합니다. 마스터 세포은행을 동결보존하고, 이 소스로부터 작업용 세포은행을 생성함으로써 바이오제약 기업은 세포주 생성 후 몇 년이 지난 후에도 제조 공정의 일관성을 유지할 수 있습니다. 이러한 안정성은 생물제제의 전체 수명주기 동안 품질과 효능을 유지하는 데 필수적입니다.

생물제제의 상업적 생산에서도 시장 수요에 대응하기 위해서는 치료제를 대량으로 생산할 수 있는 능력이 필수적이며, 확장성은 매우 중요합니다. GMP 세포은행 서비스는 고품질의 세포주를 일관되고 확장 가능한 형태로 공급함으로써 바이오의약품의 대량 생산을 가능하게 합니다. 마스터 세포은행에서 작업용 세포은행을 생성함으로써 바이오제약 기업은 모든 규모의 제조에 확장 및 사용 가능한 세포를 즉시 공급할 수 있는 체제를 갖추게 됩니다. 이러한 확장성은 유전자 치료나 세포 치료와 같은 첨단 치료법 개발에서 특히 중요하며, 대량 세포를 일관된 배치로 생산할 수 있는 능력이 상업적 성공의 열쇠가 됩니다.

또한 GMP 세포은행 서비스는 엄격한 품질관리 및 문서화 기준을 준수하여 규제 준수를 지원합니다. 바이오제약 기업은 생물제제를 시장에 출시하기 전에 규제 당국에 자사의 세포주가 안전하고 안정적이며 충분히 특성화되었음을 증명해야 합니다. GMP를 준수하는 세포은행은 이러한 규제 요건을 충족하는 데 필요한 문서화 및 추적성을 제공하여 바이오 제약 기업이 승인 절차를 효율적으로 진행할 수 있도록 보장합니다. GMP 세포은행 없이는 규제 당국이 설정한 엄격한 기준을 충족하기 어렵고, 생물제제의 개발 및 상업화가 위험에 처할 수 있습니다.

GMP 세포은행 서비스 시장의 성장을 이끄는 요인은 무엇인가?

GMP 세포은행 서비스 시장의 성장을 이끄는 주요 요인으로는 생물제제 및 첨단 치료법에 대한 수요 증가, 맞춤형 의료의 부상, 세계 임상시험의 확대, 바이오의약품 개발을 규제하는 엄격한 환경 등을 들 수 있습니다. 첫째, 모노클로널 항체, 백신, 유전자치료제 등 생물제제에 대한 수요 증가가 GMP 세포은행 시장의 주요 촉진요인입니다. 바이오 제약사들이 파이프라인을 확장하고 더 많은 생물제제를 도입함에 따라 이러한 복잡한 치료제의 생산을 지원하는 신뢰할 수 있고 규정을 준수하는 세포은행 서비스에 대한 필요성이 증가하고 있습니다. 세포은행은 개발, 임상시험, 상업적 생산을 통해 생물제제의 일관성과 품질을 보장하기 위해 필수적입니다.

둘째, 맞춤형 의료의 부상은 GMP 세포은행 서비스 수요에 기여하고 있습니다. CAR-T 세포치료나 유전자 편집 치료와 같은 개인맞춤형 치료는 환자 특이적 또는 유전자 조작된 세포주 사용이 요구되는 경우가 많습니다. GMP 세포은행 서비스는 이러한 세포주의 품질과 안전성을 유지하고 개인 맞춤형 치료에 사용할 수 있는 안정된 상태를 보장하는 데 중요한 역할을 합니다. 바이오의약품 산업이 개인 맞춤형 치료로 전환하는 가운데, 환자 맞춤형 생물제제 생산을 지원하는 고품질 GMP 세포은행의 필요성은 더욱 커질 것입니다.

세계 임상시험의 확대도 GMP 세포은행 시장의 성장을 가속하는 요인 중 하나입니다. 임상시험이 더욱 국제화되고 더 많은 환자군을 대상으로 하는 만큼, 바이오제약기업은 치료제에 대한 수요 증가에 대응하기 위해 생산능력을 확대해야 합니다. GMP 세포은행 서비스는 일관된 고품질의 생물제제를 대규모로 생산하는 데 필요한 기반을 제공하고, 공급 부족이나 품질 문제로 인한 중단 없이 임상시험이 진행될 수 있도록 보장합니다. 또한 보다 진보된 치료법이 임상시험 단계에 진입함에 따라 충분한 특성 평가가 이루어지고 GMP를 준수하는 세포 은행의 필요성이 점점 더 중요해지고 있습니다.

바이오의약품 개발을 규제하는 엄격한 환경도 GMP 세포은행 서비스에 대한 수요를 촉진하고 있습니다. 미국 식품의약국(FDA), 유럽의약품청(EMA) 등 규제 당국은 바이오제약 기업이 바이오의약품 제조에 사용하는 세포주가 엄격한 품질 기준을 충족한다는 것을 입증할 것을 요구하고 있습니다. GMP 세포은행은 이러한 세포주가 철저하게 테스트되고, 문서화되어 있으며, 규제 가이드라인을 준수하고, 승인 절차가 지연될 위험을 줄일 수 있도록 보장합니다. 생물제제에 대한 규제 요건이 더욱 복잡해짐에 따라 GMP를 준수하는 세포은행 서비스에 대한 수요는 더욱 증가할 것으로 예측됩니다.

결론적으로 GMP 세포은행 서비스 시장의 성장은 생물제제 및 첨단 치료법에 대한 수요 증가, 맞춤형 의료의 부상, 세계 임상시험의 확대, 그리고 바이오의약품 개발을 규제하는 엄격한 환경에 의해 촉진되고 있습니다. 바이오 제약 산업이 계속 진화하고 고품질의 안전하고 효과적인 치료제 생산을 우선시하는 가운데, GMP 세포은행 서비스는 이러한 생명을 구하는 치료법의 개발 및 상용화를 지원하는 핵심적인 역할을 하게 될 것입니다.

부문 :

세포 유형(포유류, 미생물, 효모, 곤충, 조류, 기타 세포 유형), 최종 용도(바이오의약품 기업, 수탁제조 기관)

조사 대상 기업의 예

  • Austrianova Singapore Pte Ltd.
  • Charles River Laboratories International, Inc.
  • Eurofins Scientific SE
  • Goodwin Biotechnology, Inc.
  • Lonza Group AG
  • Merck KgaA
  • Paragon Bioservices, Inc.
  • SGS India Pvt. Ltd.
  • ViruSure GmbH
  • WuXi AppTec

AI 통합

검증된 전문가 컨텐츠와 AI 툴을 통해 시장 및 경쟁 정보 분석을 혁신하고 있습니다.

Market Glass, Inc.는 LLM이나 산업 전문 SLM을 쿼리하는 일반적인 방식에 의존하지 않고, 전 세계 도메인 전문가들이 엄선한 컨텐츠 리포지토리를 구축했습니다. 여기에는 동영상 전사, 블로그, 검색엔진 조사, 그리고 방대한 양의 기업 데이터, 제품/서비스 데이터, 시장 데이터 등이 포함됩니다.

관세 영향 계수

Market Glass, Inc.가 본사 소재지, 생산기지, 수출입(완제품 및 OEM)을 기반으로 기업의 경쟁 변화를 예측하면서 지역적 시장에 대한 관세의 영향을 반영했습니다. 이러한 복잡하고 다면적인 시장 현실은 수입원가(COGS) 증가, 수익성 하락, 공급망 재편 등 경쟁사에게 다양한 영향을 미치며, 미시적 및 거시적 시장 역학에도 영향을 미칩니다.

목차

제1장 조사 방법

제2장 개요

  • 시장 개요
  • 주요 기업
  • 시장 동향과 촉진요인
  • 세계 시장 전망

제3장 시장 분석

  • 미국
  • 캐나다
  • 일본
  • 중국
  • 유럽
  • 프랑스
  • 독일
  • 이탈리아
  • 영국
  • 기타 유럽
  • 아시아태평양
  • 세계의 기타 지역

제4장 경쟁

KSA 25.12.01

Global GMP Cell Banking Services Market to Reach US$2.2 Billion by 2030

The global market for GMP Cell Banking Services estimated at US$939.4 Million in the year 2024, is expected to reach US$2.2 Billion by 2030, growing at a CAGR of 15.0% over the analysis period 2024-2030. Biopharmaceutical Companies End-Use, one of the segments analyzed in the report, is expected to record a 14.6% CAGR and reach US$1.5 Billion by the end of the analysis period. Growth in the Contract Manufacturing Organizations End-Use segment is estimated at 16.0% CAGR over the analysis period.

The U.S. Market is Estimated at US$260.6 Million While China is Forecast to Grow at 14.0% CAGR

The GMP Cell Banking Services market in the U.S. is estimated at US$260.6 Million in the year 2024. China, the world's second largest economy, is forecast to reach a projected market size of US$328.2 Million by the year 2030 trailing a CAGR of 14.0% over the analysis period 2024-2030. Among the other noteworthy geographic markets are Japan and Canada, each forecast to grow at a CAGR of 13.0% and 12.8% respectively over the analysis period. Within Europe, Germany is forecast to grow at approximately 10.7% CAGR.

Global GMP Cell Banking Services Market - Key Trends and Drivers Summarized

Why Are GMP Cell Banking Services Becoming Crucial in Biopharmaceutical Development and Therapeutics?

GMP cell banking services are becoming essential in the biopharmaceutical industry due to the increasing demand for safe, reliable, and high-quality cell lines for therapeutic development. But why are these services so critical today? GMP (Good Manufacturing Practice) cell banking refers to the creation, storage, and maintenance of cell lines under stringent regulatory and quality control standards. These services ensure that cell lines used in the production of biologics, vaccines, gene therapies, and other therapeutics are free from contamination and retain their integrity over time.

In biopharmaceutical development, the use of cell lines is foundational, particularly in the production of monoclonal antibodies, recombinant proteins, and viral vectors for gene therapy. The process of GMP cell banking involves generating master cell banks (MCBs) and working cell banks (WCBs), which are critical for scaling up the production of biologics. Cell lines are preserved under controlled conditions to maintain their viability and genetic stability, ensuring consistency across multiple production batches. Given the regulatory requirements from agencies such as the FDA and EMA, GMP cell banking is indispensable for meeting compliance standards, ensuring the safety and efficacy of therapeutics, and accelerating their path to market. As the biopharmaceutical industry continues to expand with the rise of biologics and personalized medicine, GMP cell banking services are integral to the safe and reliable production of these advanced therapies.

How Are Technological Advancements Enhancing GMP Cell Banking Services?

Technological advancements are playing a significant role in improving the efficiency, safety, and scalability of GMP cell banking services, making it easier for biopharmaceutical companies to maintain high-quality cell lines for therapeutic production. One of the most impactful advancements is the use of automated cell culture systems, which allow for more precise and reproducible cell banking processes. Automation reduces human error and ensures that cell banks are prepared, monitored, and maintained under optimal conditions, minimizing the risk of contamination or variation in cell line characteristics. This is particularly important in large-scale production environments where consistency is critical.

Cryopreservation techniques have also advanced, allowing for the long-term storage of cell lines without compromising their viability or functionality. Improvements in cryoprotectant formulations and freezing protocols have enhanced the ability to store cells at ultra-low temperatures, reducing the risk of ice crystal formation, which can damage cells. These advancements ensure that cell banks remain viable for extended periods, often decades, while preserving their genetic and phenotypic integrity. This is vital for the reproducibility of biologic manufacturing processes, especially when a consistent supply of high-quality cells is required over the course of several years.

The integration of advanced analytics and quality control technologies into GMP cell banking is also revolutionizing the field. Techniques such as next-generation sequencing (NGS), flow cytometry, and digital PCR (dPCR) are being used to characterize cell lines more thoroughly, ensuring that they are free from contaminants like mycoplasma or viruses and that their genetic identity is preserved. These advanced analytics allow for better monitoring of cell bank quality, providing biopharmaceutical companies with detailed information on the health and stability of their cell lines. This level of control is particularly important in the development of advanced therapies like gene and cell therapies, where even minor variations in the cell line can impact the efficacy and safety of the final product.

Additionally, advancements in documentation and data management systems are improving the traceability and regulatory compliance of GMP cell banking services. Modern software platforms allow for the comprehensive documentation of all processes involved in cell banking, from initial characterization to cryopreservation and storage. These systems make it easier for biopharmaceutical companies to track the history of their cell banks, ensuring compliance with regulatory guidelines and facilitating audits by agencies like the FDA or EMA. The ability to demonstrate full control and traceability over cell lines is essential for gaining regulatory approval for biologics and ensuring the long-term success of therapeutic products.

Why Are GMP Cell Banking Services Critical for Ensuring the Safety, Stability, and Scalability of Biologics?

GMP cell banking services are critical for ensuring the safety, stability, and scalability of biologics because they provide a controlled and compliant system for producing consistent, high-quality therapeutic products. In the production of biologics-such as monoclonal antibodies, vaccines, and gene therapies-cell lines are used as the biological factories that produce these complex molecules. Ensuring that these cell lines are free from contamination, genetically stable, and capable of reproducible performance is essential for the successful development and manufacturing of biologics.

Safety is a primary concern in the biopharmaceutical industry, and GMP cell banking services are crucial for mitigating risks related to contamination and variability in cell lines. Contaminants such as bacteria, viruses, and mycoplasma can compromise the safety and efficacy of biologics, potentially leading to adverse patient outcomes or regulatory recalls. GMP cell banking ensures that cell lines are thoroughly tested and validated for the absence of contaminants before being used in the production of therapeutic products. This rigorous testing and monitoring process reduces the risk of contamination and ensures that biopharmaceutical companies can produce safe, reliable biologics for patients.

Stability is another key benefit provided by GMP cell banking. Biologics must be produced consistently over time, often across multiple manufacturing batches, to meet the demands of clinical trials and commercialization. The establishment of master and working cell banks guarantees that the cell lines used in production remain genetically stable and functionally reliable over time. By cryopreserving the master cell bank (MCB) and creating working cell banks (WCB) from this source, biopharmaceutical companies can ensure that their production processes remain consistent, even years after the initial creation of the cell line. This stability is essential for maintaining the quality and efficacy of biologics throughout their lifecycle.

Scalability is also critical in the commercial production of biologics, where the ability to produce large quantities of therapeutic products is essential for meeting market demand. GMP cell banking services enable the large-scale production of biologics by providing a consistent and scalable supply of high-quality cell lines. The creation of working cell banks from a master cell bank ensures that biopharmaceutical companies have a ready supply of cells that can be expanded and used for manufacturing at any scale. This scalability is particularly important in the development of advanced therapies like gene and cell therapies, where the ability to produce consistent batches of cells at large volumes is key to commercial success.

Additionally, GMP cell banking services support regulatory compliance by adhering to strict quality control and documentation standards. Biopharmaceutical companies must demonstrate to regulatory agencies that their cell lines are safe, stable, and well-characterized before they can bring biologics to market. GMP-compliant cell banks provide the necessary documentation and traceability to meet these regulatory requirements, ensuring that biopharmaceutical companies can navigate the approval process efficiently. Without GMP cell banking, it would be challenging to meet the rigorous standards set by regulatory agencies, putting the development and commercialization of biologics at risk.

What Factors Are Driving the Growth of the GMP Cell Banking Services Market?

Several key factors are driving the growth of the GMP cell banking services market, including the increasing demand for biologics and advanced therapies, the rise of personalized medicine, the expansion of clinical trials globally, and the stringent regulatory environment governing biopharmaceutical development. First, the growing demand for biologics-such as monoclonal antibodies, vaccines, and gene therapies-is a major driver of the GMP cell banking market. As biopharmaceutical companies expand their pipelines to include more biologics, there is an increasing need for reliable and compliant cell banking services to support the production of these complex therapeutics. Cell banks are critical for ensuring the consistency and quality of biologics throughout their development, clinical trials, and commercial production.

Second, the rise of personalized medicine is contributing to the demand for GMP cell banking services. Personalized therapies, such as CAR-T cell therapies and gene-editing treatments, often require the use of patient-specific or genetically engineered cell lines. GMP cell banking services play a key role in maintaining the quality and safety of these cell lines, ensuring that they remain stable and viable for use in personalized treatments. As the biopharmaceutical industry continues to shift toward individualized therapies, the need for high-quality GMP cell banks will grow to support the production of patient-specific biologics.

The expansion of clinical trials globally is another factor driving the growth of the GMP cell banking market. As clinical trials become more international and involve larger patient populations, biopharmaceutical companies must scale up their production capabilities to meet the increased demand for therapeutic products. GMP cell banking services provide the infrastructure needed to produce consistent, high-quality biologics at scale, ensuring that clinical trials can proceed without interruptions due to supply shortages or quality issues. Additionally, as more advanced therapies enter clinical trials, the need for well-characterized, GMP-compliant cell banks is becoming even more critical.

The stringent regulatory environment governing biopharmaceutical development is also fueling the demand for GMP cell banking services. Regulatory agencies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) require biopharmaceutical companies to demonstrate that their cell lines meet strict quality standards before they can be used in the production of biologics. GMP cell banking ensures that these cell lines are thoroughly tested, documented, and compliant with regulatory guidelines, reducing the risk of delays in the approval process. As regulatory requirements for biologics become more complex, the demand for GMP-compliant cell banking services is expected to grow.

In conclusion, the growth of the GMP cell banking services market is driven by the increasing demand for biologics and advanced therapies, the rise of personalized medicine, the expansion of global clinical trials, and the stringent regulatory environment governing biopharmaceutical development. As the biopharmaceutical industry continues to evolve and prioritize the production of high-quality, safe, and effective therapeutics, GMP cell banking services will play a central role in supporting the development and commercialization of these life-saving treatments.

SCOPE OF STUDY:

The report analyzes the GMP Cell Banking Services market in terms of units by the following Segments, and Geographic Regions/Countries:

Segments:

Cell Type (Mammalian, Microbial, Yeast, Insect, Avian, Other Cell Types); End-Use (Biopharmaceutical Companies, Contract Manufacturing Organizations)

Geographic Regions/Countries:

World; United States; Canada; Japan; China; Europe (France; Germany; Italy; United Kingdom; and Rest of Europe); Asia-Pacific; Rest of World.

Select Competitors (Total 41 Featured) -

  • Austrianova Singapore Pte Ltd.
  • Charles River Laboratories International, Inc.
  • Eurofins Scientific SE
  • Goodwin Biotechnology, Inc.
  • Lonza Group AG
  • Merck KgaA
  • Paragon Bioservices, Inc.
  • SGS India Pvt. Ltd.
  • ViruSure GmbH
  • WuXi AppTec

AI INTEGRATIONS

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Instead of following the general norm of querying LLMs and Industry-specific SLMs, we built repositories of content curated from domain experts worldwide including video transcripts, blogs, search engines research, and massive amounts of enterprise, product/service, and market data.

TARIFF IMPACT FACTOR

Our new release incorporates impact of tariffs on geographical markets as we predict a shift in competitiveness of companies based on HQ country, manufacturing base, exports and imports (finished goods and OEM). This intricate and multifaceted market reality will impact competitors by increasing the Cost of Goods Sold (COGS), reducing profitability, reconfiguring supply chains, amongst other micro and macro market dynamics.

TABLE OF CONTENTS

I. METHODOLOGY

II. EXECUTIVE SUMMARY

  • 1. MARKET OVERVIEW
    • Trade Shocks, Uncertainty, and the Structural Rewiring of the Global Economy
    • Global Economic Update
    • GMP Cell Banking Services - Global Key Competitors Percentage Market Share in 2025 (E)
    • Competitive Market Presence - Strong/Active/Niche/Trivial for Players Worldwide in 2025 (E)
  • 2. FOCUS ON SELECT PLAYERS
  • 3. MARKET TRENDS & DRIVERS
    • Rising Demand for GMP Cell Banking Services Driven by Growth in Biopharmaceuticals
    • Innovations in Cell Preservation and Storage Techniques Enhance Service Offerings
    • Growth in Outsourcing of Cell Banking Services by Pharmaceutical Companies
    • Market Opportunities in Emerging Regions with Expanding Healthcare Sectors
    • Consumer Trends Toward Advanced Therapeutic Medicinal Products (ATMPs)
    • Future Directions: Integration of Blockchain for Traceability in Cell Banking
    • Innovations in Cryopreservation Technologies for Enhanced Cell Recovery
    • Impact of Biobanking on the Development of Regenerative Medicine
    • Expansion of Cell Banks for Rare Disease Research and Therapy Development
  • 4. GLOBAL MARKET PERSPECTIVE
    • TABLE 1: World Recent Past, Current & Future Analysis for Biopharmaceutical Companies by Geographic Region - USA, Canada, Japan, China, Europe, Asia-Pacific and Rest of World Markets - Independent Analysis of Annual Sales in US$ Thousand for Years 2024 through 2030 and % CAGR
    • TABLE 2: World 6-Year Perspective for Biopharmaceutical Companies by Geographic Region - Percentage Breakdown of Value Sales for USA, Canada, Japan, China, Europe, Asia-Pacific and Rest of World for Years 2025 & 2030
    • TABLE 3: World Recent Past, Current & Future Analysis for Contract Manufacturing Organizations by Geographic Region - USA, Canada, Japan, China, Europe, Asia-Pacific and Rest of World Markets - Independent Analysis of Annual Sales in US$ Thousand for Years 2024 through 2030 and % CAGR
    • TABLE 4: World 6-Year Perspective for Contract Manufacturing Organizations by Geographic Region - Percentage Breakdown of Value Sales for USA, Canada, Japan, China, Europe, Asia-Pacific and Rest of World for Years 2025 & 2030
    • TABLE 5: World Recent Past, Current & Future Analysis for Mammalian by Geographic Region - USA, Canada, Japan, China, Europe, Asia-Pacific and Rest of World Markets - Independent Analysis of Annual Sales in US$ Thousand for Years 2024 through 2030 and % CAGR
    • TABLE 6: World 6-Year Perspective for Mammalian by Geographic Region - Percentage Breakdown of Value Sales for USA, Canada, Japan, China, Europe, Asia-Pacific and Rest of World for Years 2025 & 2030
    • TABLE 7: World Recent Past, Current & Future Analysis for Microbial by Geographic Region - USA, Canada, Japan, China, Europe, Asia-Pacific and Rest of World Markets - Independent Analysis of Annual Sales in US$ Thousand for Years 2024 through 2030 and % CAGR
    • TABLE 8: World 6-Year Perspective for Microbial by Geographic Region - Percentage Breakdown of Value Sales for USA, Canada, Japan, China, Europe, Asia-Pacific and Rest of World for Years 2025 & 2030
    • TABLE 9: World Recent Past, Current & Future Analysis for Yeast by Geographic Region - USA, Canada, Japan, China, Europe, Asia-Pacific and Rest of World Markets - Independent Analysis of Annual Sales in US$ Thousand for Years 2024 through 2030 and % CAGR
    • TABLE 10: World 6-Year Perspective for Yeast by Geographic Region - Percentage Breakdown of Value Sales for USA, Canada, Japan, China, Europe, Asia-Pacific and Rest of World for Years 2025 & 2030
    • TABLE 11: World Recent Past, Current & Future Analysis for Insect by Geographic Region - USA, Canada, Japan, China, Europe, Asia-Pacific and Rest of World Markets - Independent Analysis of Annual Sales in US$ Thousand for Years 2024 through 2030 and % CAGR
    • TABLE 12: World 6-Year Perspective for Insect by Geographic Region - Percentage Breakdown of Value Sales for USA, Canada, Japan, China, Europe, Asia-Pacific and Rest of World for Years 2025 & 2030
    • TABLE 13: World Recent Past, Current & Future Analysis for Avian by Geographic Region - USA, Canada, Japan, China, Europe, Asia-Pacific and Rest of World Markets - Independent Analysis of Annual Sales in US$ Thousand for Years 2024 through 2030 and % CAGR
    • TABLE 14: World 6-Year Perspective for Avian by Geographic Region - Percentage Breakdown of Value Sales for USA, Canada, Japan, China, Europe, Asia-Pacific and Rest of World for Years 2025 & 2030
    • TABLE 15: World Recent Past, Current & Future Analysis for Other Cell Types by Geographic Region - USA, Canada, Japan, China, Europe, Asia-Pacific and Rest of World Markets - Independent Analysis of Annual Sales in US$ Thousand for Years 2024 through 2030 and % CAGR
    • TABLE 16: World 6-Year Perspective for Other Cell Types by Geographic Region - Percentage Breakdown of Value Sales for USA, Canada, Japan, China, Europe, Asia-Pacific and Rest of World for Years 2025 & 2030
    • TABLE 17: World GMP Cell Banking Services Market Analysis of Annual Sales in US$ Thousand for Years 2015 through 2030
    • TABLE 18: World Recent Past, Current & Future Analysis for GMP Cell Banking Services by Geographic Region - USA, Canada, Japan, China, Europe, Asia-Pacific and Rest of World Markets - Independent Analysis of Annual Sales in US$ Thousand for Years 2024 through 2030 and % CAGR
    • TABLE 19: World 6-Year Perspective for GMP Cell Banking Services by Geographic Region - Percentage Breakdown of Value Sales for USA, Canada, Japan, China, Europe, Asia-Pacific and Rest of World Markets for Years 2025 & 2030

III. MARKET ANALYSIS

  • UNITED STATES
    • GMP Cell Banking Services Market Presence - Strong/Active/Niche/Trivial - Key Competitors in the United States for 2025 (E)
    • TABLE 20: USA Recent Past, Current & Future Analysis for GMP Cell Banking Services by End-Use - Biopharmaceutical Companies and Contract Manufacturing Organizations - Independent Analysis of Annual Sales in US$ Thousand for the Years 2024 through 2030 and % CAGR
    • TABLE 21: USA 6-Year Perspective for GMP Cell Banking Services by End-Use - Percentage Breakdown of Value Sales for Biopharmaceutical Companies and Contract Manufacturing Organizations for the Years 2025 & 2030
    • TABLE 22: USA Recent Past, Current & Future Analysis for GMP Cell Banking Services by Cell Type - Mammalian, Microbial, Yeast, Insect, Avian and Other Cell Types - Independent Analysis of Annual Sales in US$ Thousand for the Years 2024 through 2030 and % CAGR
    • TABLE 23: USA 6-Year Perspective for GMP Cell Banking Services by Cell Type - Percentage Breakdown of Value Sales for Mammalian, Microbial, Yeast, Insect, Avian and Other Cell Types for the Years 2025 & 2030
  • CANADA
    • TABLE 24: Canada Recent Past, Current & Future Analysis for GMP Cell Banking Services by End-Use - Biopharmaceutical Companies and Contract Manufacturing Organizations - Independent Analysis of Annual Sales in US$ Thousand for the Years 2024 through 2030 and % CAGR
    • TABLE 25: Canada 6-Year Perspective for GMP Cell Banking Services by End-Use - Percentage Breakdown of Value Sales for Biopharmaceutical Companies and Contract Manufacturing Organizations for the Years 2025 & 2030
    • TABLE 26: Canada Recent Past, Current & Future Analysis for GMP Cell Banking Services by Cell Type - Mammalian, Microbial, Yeast, Insect, Avian and Other Cell Types - Independent Analysis of Annual Sales in US$ Thousand for the Years 2024 through 2030 and % CAGR
    • TABLE 27: Canada 6-Year Perspective for GMP Cell Banking Services by Cell Type - Percentage Breakdown of Value Sales for Mammalian, Microbial, Yeast, Insect, Avian and Other Cell Types for the Years 2025 & 2030
  • JAPAN
    • GMP Cell Banking Services Market Presence - Strong/Active/Niche/Trivial - Key Competitors in Japan for 2025 (E)
    • TABLE 28: Japan Recent Past, Current & Future Analysis for GMP Cell Banking Services by End-Use - Biopharmaceutical Companies and Contract Manufacturing Organizations - Independent Analysis of Annual Sales in US$ Thousand for the Years 2024 through 2030 and % CAGR
    • TABLE 29: Japan 6-Year Perspective for GMP Cell Banking Services by End-Use - Percentage Breakdown of Value Sales for Biopharmaceutical Companies and Contract Manufacturing Organizations for the Years 2025 & 2030
    • TABLE 30: Japan Recent Past, Current & Future Analysis for GMP Cell Banking Services by Cell Type - Mammalian, Microbial, Yeast, Insect, Avian and Other Cell Types - Independent Analysis of Annual Sales in US$ Thousand for the Years 2024 through 2030 and % CAGR
    • TABLE 31: Japan 6-Year Perspective for GMP Cell Banking Services by Cell Type - Percentage Breakdown of Value Sales for Mammalian, Microbial, Yeast, Insect, Avian and Other Cell Types for the Years 2025 & 2030
  • CHINA
    • GMP Cell Banking Services Market Presence - Strong/Active/Niche/Trivial - Key Competitors in China for 2025 (E)
    • TABLE 32: China Recent Past, Current & Future Analysis for GMP Cell Banking Services by End-Use - Biopharmaceutical Companies and Contract Manufacturing Organizations - Independent Analysis of Annual Sales in US$ Thousand for the Years 2024 through 2030 and % CAGR
    • TABLE 33: China 6-Year Perspective for GMP Cell Banking Services by End-Use - Percentage Breakdown of Value Sales for Biopharmaceutical Companies and Contract Manufacturing Organizations for the Years 2025 & 2030
    • TABLE 34: China Recent Past, Current & Future Analysis for GMP Cell Banking Services by Cell Type - Mammalian, Microbial, Yeast, Insect, Avian and Other Cell Types - Independent Analysis of Annual Sales in US$ Thousand for the Years 2024 through 2030 and % CAGR
    • TABLE 35: China 6-Year Perspective for GMP Cell Banking Services by Cell Type - Percentage Breakdown of Value Sales for Mammalian, Microbial, Yeast, Insect, Avian and Other Cell Types for the Years 2025 & 2030
  • EUROPE
    • GMP Cell Banking Services Market Presence - Strong/Active/Niche/Trivial - Key Competitors in Europe for 2025 (E)
    • TABLE 36: Europe Recent Past, Current & Future Analysis for GMP Cell Banking Services by End-Use - Biopharmaceutical Companies and Contract Manufacturing Organizations - Independent Analysis of Annual Sales in US$ Thousand for the Years 2024 through 2030 and % CAGR
    • TABLE 37: Europe 6-Year Perspective for GMP Cell Banking Services by End-Use - Percentage Breakdown of Value Sales for Biopharmaceutical Companies and Contract Manufacturing Organizations for the Years 2025 & 2030
    • TABLE 38: Europe Recent Past, Current & Future Analysis for GMP Cell Banking Services by Cell Type - Mammalian, Microbial, Yeast, Insect, Avian and Other Cell Types - Independent Analysis of Annual Sales in US$ Thousand for the Years 2024 through 2030 and % CAGR
    • TABLE 39: Europe 6-Year Perspective for GMP Cell Banking Services by Cell Type - Percentage Breakdown of Value Sales for Mammalian, Microbial, Yeast, Insect, Avian and Other Cell Types for the Years 2025 & 2030
    • TABLE 40: Europe Recent Past, Current & Future Analysis for GMP Cell Banking Services by Geographic Region - France, Germany, Italy, UK and Rest of Europe Markets - Independent Analysis of Annual Sales in US$ Thousand for Years 2024 through 2030 and % CAGR
    • TABLE 41: Europe 6-Year Perspective for GMP Cell Banking Services by Geographic Region - Percentage Breakdown of Value Sales for France, Germany, Italy, UK and Rest of Europe Markets for Years 2025 & 2030
  • FRANCE
    • GMP Cell Banking Services Market Presence - Strong/Active/Niche/Trivial - Key Competitors in France for 2025 (E)
    • TABLE 42: France Recent Past, Current & Future Analysis for GMP Cell Banking Services by End-Use - Biopharmaceutical Companies and Contract Manufacturing Organizations - Independent Analysis of Annual Sales in US$ Thousand for the Years 2024 through 2030 and % CAGR
    • TABLE 43: France 6-Year Perspective for GMP Cell Banking Services by End-Use - Percentage Breakdown of Value Sales for Biopharmaceutical Companies and Contract Manufacturing Organizations for the Years 2025 & 2030
    • TABLE 44: France Recent Past, Current & Future Analysis for GMP Cell Banking Services by Cell Type - Mammalian, Microbial, Yeast, Insect, Avian and Other Cell Types - Independent Analysis of Annual Sales in US$ Thousand for the Years 2024 through 2030 and % CAGR
    • TABLE 45: France 6-Year Perspective for GMP Cell Banking Services by Cell Type - Percentage Breakdown of Value Sales for Mammalian, Microbial, Yeast, Insect, Avian and Other Cell Types for the Years 2025 & 2030
  • GERMANY
    • GMP Cell Banking Services Market Presence - Strong/Active/Niche/Trivial - Key Competitors in Germany for 2025 (E)
    • TABLE 46: Germany Recent Past, Current & Future Analysis for GMP Cell Banking Services by End-Use - Biopharmaceutical Companies and Contract Manufacturing Organizations - Independent Analysis of Annual Sales in US$ Thousand for the Years 2024 through 2030 and % CAGR
    • TABLE 47: Germany 6-Year Perspective for GMP Cell Banking Services by End-Use - Percentage Breakdown of Value Sales for Biopharmaceutical Companies and Contract Manufacturing Organizations for the Years 2025 & 2030
    • TABLE 48: Germany Recent Past, Current & Future Analysis for GMP Cell Banking Services by Cell Type - Mammalian, Microbial, Yeast, Insect, Avian and Other Cell Types - Independent Analysis of Annual Sales in US$ Thousand for the Years 2024 through 2030 and % CAGR
    • TABLE 49: Germany 6-Year Perspective for GMP Cell Banking Services by Cell Type - Percentage Breakdown of Value Sales for Mammalian, Microbial, Yeast, Insect, Avian and Other Cell Types for the Years 2025 & 2030
  • ITALY
    • TABLE 50: Italy Recent Past, Current & Future Analysis for GMP Cell Banking Services by End-Use - Biopharmaceutical Companies and Contract Manufacturing Organizations - Independent Analysis of Annual Sales in US$ Thousand for the Years 2024 through 2030 and % CAGR
    • TABLE 51: Italy 6-Year Perspective for GMP Cell Banking Services by End-Use - Percentage Breakdown of Value Sales for Biopharmaceutical Companies and Contract Manufacturing Organizations for the Years 2025 & 2030
    • TABLE 52: Italy Recent Past, Current & Future Analysis for GMP Cell Banking Services by Cell Type - Mammalian, Microbial, Yeast, Insect, Avian and Other Cell Types - Independent Analysis of Annual Sales in US$ Thousand for the Years 2024 through 2030 and % CAGR
    • TABLE 53: Italy 6-Year Perspective for GMP Cell Banking Services by Cell Type - Percentage Breakdown of Value Sales for Mammalian, Microbial, Yeast, Insect, Avian and Other Cell Types for the Years 2025 & 2030
  • UNITED KINGDOM
    • GMP Cell Banking Services Market Presence - Strong/Active/Niche/Trivial - Key Competitors in the United Kingdom for 2025 (E)
    • TABLE 54: UK Recent Past, Current & Future Analysis for GMP Cell Banking Services by End-Use - Biopharmaceutical Companies and Contract Manufacturing Organizations - Independent Analysis of Annual Sales in US$ Thousand for the Years 2024 through 2030 and % CAGR
    • TABLE 55: UK 6-Year Perspective for GMP Cell Banking Services by End-Use - Percentage Breakdown of Value Sales for Biopharmaceutical Companies and Contract Manufacturing Organizations for the Years 2025 & 2030
    • TABLE 56: UK Recent Past, Current & Future Analysis for GMP Cell Banking Services by Cell Type - Mammalian, Microbial, Yeast, Insect, Avian and Other Cell Types - Independent Analysis of Annual Sales in US$ Thousand for the Years 2024 through 2030 and % CAGR
    • TABLE 57: UK 6-Year Perspective for GMP Cell Banking Services by Cell Type - Percentage Breakdown of Value Sales for Mammalian, Microbial, Yeast, Insect, Avian and Other Cell Types for the Years 2025 & 2030
  • REST OF EUROPE
    • TABLE 58: Rest of Europe Recent Past, Current & Future Analysis for GMP Cell Banking Services by End-Use - Biopharmaceutical Companies and Contract Manufacturing Organizations - Independent Analysis of Annual Sales in US$ Thousand for the Years 2024 through 2030 and % CAGR
    • TABLE 59: Rest of Europe 6-Year Perspective for GMP Cell Banking Services by End-Use - Percentage Breakdown of Value Sales for Biopharmaceutical Companies and Contract Manufacturing Organizations for the Years 2025 & 2030
    • TABLE 60: Rest of Europe Recent Past, Current & Future Analysis for GMP Cell Banking Services by Cell Type - Mammalian, Microbial, Yeast, Insect, Avian and Other Cell Types - Independent Analysis of Annual Sales in US$ Thousand for the Years 2024 through 2030 and % CAGR
    • TABLE 61: Rest of Europe 6-Year Perspective for GMP Cell Banking Services by Cell Type - Percentage Breakdown of Value Sales for Mammalian, Microbial, Yeast, Insect, Avian and Other Cell Types for the Years 2025 & 2030
  • ASIA-PACIFIC
    • GMP Cell Banking Services Market Presence - Strong/Active/Niche/Trivial - Key Competitors in Asia-Pacific for 2025 (E)
    • TABLE 62: Asia-Pacific Recent Past, Current & Future Analysis for GMP Cell Banking Services by End-Use - Biopharmaceutical Companies and Contract Manufacturing Organizations - Independent Analysis of Annual Sales in US$ Thousand for the Years 2024 through 2030 and % CAGR
    • TABLE 63: Asia-Pacific 6-Year Perspective for GMP Cell Banking Services by End-Use - Percentage Breakdown of Value Sales for Biopharmaceutical Companies and Contract Manufacturing Organizations for the Years 2025 & 2030
    • TABLE 64: Asia-Pacific Recent Past, Current & Future Analysis for GMP Cell Banking Services by Cell Type - Mammalian, Microbial, Yeast, Insect, Avian and Other Cell Types - Independent Analysis of Annual Sales in US$ Thousand for the Years 2024 through 2030 and % CAGR
    • TABLE 65: Asia-Pacific 6-Year Perspective for GMP Cell Banking Services by Cell Type - Percentage Breakdown of Value Sales for Mammalian, Microbial, Yeast, Insect, Avian and Other Cell Types for the Years 2025 & 2030
  • REST OF WORLD
    • TABLE 66: Rest of World Recent Past, Current & Future Analysis for GMP Cell Banking Services by End-Use - Biopharmaceutical Companies and Contract Manufacturing Organizations - Independent Analysis of Annual Sales in US$ Thousand for the Years 2024 through 2030 and % CAGR
    • TABLE 67: Rest of World 6-Year Perspective for GMP Cell Banking Services by End-Use - Percentage Breakdown of Value Sales for Biopharmaceutical Companies and Contract Manufacturing Organizations for the Years 2025 & 2030
    • TABLE 68: Rest of World Recent Past, Current & Future Analysis for GMP Cell Banking Services by Cell Type - Mammalian, Microbial, Yeast, Insect, Avian and Other Cell Types - Independent Analysis of Annual Sales in US$ Thousand for the Years 2024 through 2030 and % CAGR
    • TABLE 69: Rest of World 6-Year Perspective for GMP Cell Banking Services by Cell Type - Percentage Breakdown of Value Sales for Mammalian, Microbial, Yeast, Insect, Avian and Other Cell Types for the Years 2025 & 2030

IV. COMPETITION

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