Global Market Study on GMP Cell Banking Services

The U.S. Food and Drug Administration guidance on contract manufacturing

The U.S. Food and Drug Administration issued its first guidance for quality agreements between pharmaceutical companies and CMOs in November 2016. The following is the regulatory overview of the FDA regarding contract manufacturing.

All manufacturing facilities to ensure compliance with cGMP regulations
Requirement of a quality unit in pharmaceutical companies to monitor adherence to regulations by a CMO
Various ICH guidelines have been published that are relevant to cGMP recommendations for contract manufacturing arrangements
Requirement of quality unit activities to be in writing
Report Description

The main focus of this report is on the process workflow of cell banking services. Various checkpoints are in place during the overall cell banking process to ensure quality and consistency of culture, as well as on avoiding contaminants. To make this report an exclusive one, the expert team of analysts have given an optimistic scenario, likely scenario and conservative scenario. The analysts have segmented the market into two main categories – cell type and end user – and have analyzed these segments across the assessed regions. The report executive summary succinctly covers the market overview, overall market approach, target geographies and differentiating strategies of the global GMP cell banking services market key players. The executive summary section is followed by the market introduction and consists of a thorough description of the various types of cells.

The report presents a detailed analysis of the GMP cell banking services market scenario. This analysis includes Y-o-Y growth and absolute $ opportunity analysis for the projected period. The market dynamics section focuses on the drivers, restraints, opportunities and trends likely to impact the global GMP cell banking services market. The analysts have made sure to cover each and every segment in detail along with highlighting the market share analysis, BPS analysis and the Y-o-Y growth rate of global GMP cell banking services. Finally, the report concludes with key player profiles accompanied by market developments, an overview of business strategies and SWOT analysis.

Market Segmentation

By Region

North America
Latin America
Europe
Asia Pacific
MEA
By Cell Type

Mammalian
Microbial
Insect
Yeast
Avian
Stem Cell
Others
By End User

Biopharmaceutical Companies
Contract Manufacturing Organizations
Research Methodology

The global GMP cell banking services market value is calculated based on the cell banks used to develop biopharmaceuticals. However, the analysts have excluded cord cell banking services that are not a part of GMP based cell banking services. Indicators such as R&D expenditure, research funding from government and non-profit organizations, etc. have been considered to arrive at the estimated market numbers. All information has been triangulated through validation of primary research data. Yearly change in inflation rate has not been factored in while forecasting market numbers. Top-down approach has been used to calculate the market sizing, while bottom-up approach by GMP cell bank types has been used to counter-validate the market estimations.

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