Microbial cell culture or microbiological culture are the cell of bacteria and algae. These cell cultures are used to produce organic chemicals and proteins. Insect cell lines are derived from Drosophila melanogaster, Spodoptera frugiperda, and Trichoplusia ni for study of insect developmental biology, physiology, and microbial pathology and to produce vaccines.

Statistics:

The global GMP cell banking services market is estimated to account for US$ 1,326.8 Mn in terms of value by the end of 2027.

Global GMP Cell Banking Services Market: Drivers

Limited in-house storage and testing capabilities are expected to propel growth of the global GMP cell banking services market over the forecast period. Large biopharmaceutical companies have several manufacturing sites that typically produce commercially marketed therapeutics as well as material for clinical development. As a result, the in-house capacity for storage of GMP cell banks are limited.

Global GMP Cell Banking Services Market: Opportunities

Government initiatives to support the growth of the domestic biotechnology industry is expected to offer lucrative growth opportunities for players in the market. For instance, in March 2020, the state government of Telangana, India, announced its plans to increase the market value of biotech and life sciences industry from US$ 50 billion to US$ 100 billion.

Global GMP Cell Banking Services Market: Restraints 

Inconsistent demand for services is expected to hamper growth of the global GMP cell banking services market. Considering that outsourcing happens on a molecule-by-molecule basis, cell banking service providers experience fluctuating demand as large biopharmaceutical clients alternate between storage of cell banks in-house and outsourcing to service providers. The decision to outsource also depends on the performance of candidates in clinical trials, which can be quite unpredictable. Hence, service providers have to ensure a consistent source of revenue in these situations.

Key Takeaways:

The Mammalian cell type segment in the global GMP cell banking services market was valued at US$ 286.6 Mn in 2019 and is expected to reach US$ 917.8 Mn by 2027 at a CAGR of 15.7% during the forecast period. Increasing demand for stem cell is expected to propel the growth of the segment during the forecast period.

The Biopharmaceutical Companies segment held dominant position in the global GMP cell banking services market in 2019, accounting for 70.1% share in terms of value during the forecasted period. Increasing funding for R&D in rare diseases is expected to boost growth of the segment during the forecast period.

Market Trends

Major players in the market are focused on conducting training regarding culture media. For instance, in October 2019, Lonza Group Ltd. hosted a free 60-minute webinar addressing current concerns regarding the use of serum in cell culture media.

Major players in the market are also focused on expanding their production capacity. For instance, in March 2019, Goodwin Biotechnology, Inc. purchased the two-acre site where the company is based in order to expand its capacity to meet the needs of its long-term clients.

Regulations

U.S.

ICH guidelines issued by FDA

Various ICH guidelines have been published that are relevant to cGMP recommendations for contract manufacturing arrangements

  • ICH Q7: Companies evaluate contract facilities to ensure that contractor sites comply with CGMP for specific operations
  • ICH Q9: Offers a systematic approach to quality risk management as part of an effective quality system
  • ICH Q10: As part of a pharmaceutical quality system, the pharmaceutical company is ultimately responsible for ensuring that processes are in place to assure the control of outsourced activities and quality of purchased materials

21 CFR 211.22(d)

  • Requirement of quality unit activities to be in writing
  • cGMP regulations require that quality unit activities and procedures be in writing, and that these procedures be followed by contract manufacturing organizations. A quality agreement describes the owner’s and the contract facility’s roles and manufacturing activities under cGMP. From a CGMP perspective, manufacturing activities are the most important element in a quality agreement. The most critical pieces are quality and change control.

Global GMP Cell Banking Services Market: Competitive Landscape  

Major players operating in the global GMP cell banking services market include, WuXi AppTec Group, Charles River Laboratories International, Inc., Eurofins Scientific, Merck KGaA, Lonza Group Ltd., SGS Ltd., ViruSure GmbH, Austrianova, Goodwin Biotechnology Inc., and Paragon Bioservices, Inc.

Global GMP Cell Banking Services Market: Key Developments   

November 2019: Lonza Group Ltd. launched eCHO Basal Medium and Feed, a system designed to optimize protein production, in order to expand its cell culture media portfolio

November 2018: Goodwin Biotechnology, Inc. received contract from Radimmune Therapeutics to develop a process and manufacture Radimmune Therapeutics’ lead therapeutic oncology candidate for clinical development

Segmentation

Scope of the report

  • GMP Cell Banking Services Market, By Cell Type:
    • Mammalian
    • Microbial
    • Insect
    • Yeast
    • Avian
    • Stem Cell Type
    • Others
  • GMP Cell Banking Services Market, By End User:
    • Biopharmaceutical Companies
    • Contract Manufacturing Organizations 
  • GMP Cell Banking Services Market, By Region:
    • North America
      • By Cell Type
        • Mammalian
        • Microbial
        • Insect
        • Yeast
        • Avian
        • Stem Cell Type
        • Others
      • By End User
        • Biopharmaceutical Companies
        • Contract Manufacturing Organizations
      • By Country:
        • U.S.
        • Canada
    • Latin America
      • By Cell Type
        • Mammalian
        • Microbial
        • Insect
        • Yeast
        • Avian
        • Stem Cell Type
        • Others
      • By End User
        • Biopharmaceutical Companies
        • Contract Manufacturing Organizations
      • By Country:
        • Brazil
        • Mexico
        • Argentina
        • Rest of Latin America
    • Europe
      • By Cell Type
        • Mammalian
        • Microbial
        • Insect
        • Yeast
        • Avian
        • Stem Cell Type
        • Others
      • By End User
        • Biopharmaceutical Companies
        • Contract Manufacturing Organizations
      • By Country:
        • Germany
        • U.K.
        • France
        • Italy
        • Spain
        • Russia
        • Rest of Europe
    • Asia Pacific
      • By Cell Type
        • Mammalian
        • Microbial
        • Insect
        • Yeast
        • Avian
        • Stem Cell Type
        • Others
      • By End User
        • Biopharmaceutical Companies
        • Contract Manufacturing Organizations
      • By Country:
        • China
        • India
        • Japan
        • Australia
        • South Korea
        • ASEAN
        • Rest of Asia Pacific
    • Middle East
      • By Cell Type
        • Mammalian
        • Microbial
        • Insect
        • Yeast
        • Avian
        • Stem Cell Type
        • Others
      • By End User
        • Biopharmaceutical Companies
        • Contract Manufacturing Organizations
      • By Country:
        • GCC
        • Israel
        • Rest of Middle East
    • Africa
      • By Cell Type
        • Mammalian
        • Microbial
        • Insect
        • Yeast
        • Avian
        • Stem Cell Type
        • Others
      • By End User
        • Biopharmaceutical Companies
        • Contract Manufacturing Organizations
      • By Country:
        • South Africa
        • Central Africa
        • North Africa
  • Company Profiles
    • WuXi AppTec Group *
      • Company Overview
      • Product Portfolio
      • Key Highlights
      • Financial Overview
      • Strategies
    • Charles River Laboratories International, Inc.
    • Eurofins Scientific
    • Merck KGaA
    • Lonza Group Ltd.
    • SGS Ltd.
    • ViruSure GmbH
    • Austrianova
    • Goodwin Biotechnology Inc.
    • Paragon Bioservices, Inc.
  • “*” marked represents similar segmentation in other categories in the respective section.
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