Bioprocess Validation Market Size, Share & Trends Analysis Report, By Testing Type (Extractables & Leachables Testing, Bioprocess Residuals Testing), By Stage, By Mode, By Region, and Segment Forecasts, 2024-2032
- Published Date:Jan-2024
- Pages: 116
- Format: pdf
- Report ID: PM3013
- Base Year: 2023
- Historical Data: 2019-2022
Report Outlook
The global bioprocess validation market was valued at USD 444.67 million in 2023 and is expected to grow at a CAGR of 9.40% during the forecast period of 2023-2032.
Strict regulatory standards for producing safe and high-quality vaccines and pharmaceutical goods drive the industry. The growing cooperation also boosts the sector among the major market players for product introduction. Additionally, market expansion is enabled by increased R&D spending. Documenting all the procedures, activities, and supporting data used to develop biological and biopharmaceutical products is termed bioprocess validation. The documentation is completed in compliance with cGMP norms and US FDA recommendations. It ensures that compliance is maintained throughout the whole process of product testing.
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An essential component of bioprocess validation is the evaluation of APIs and contaminants. The fundamental goal of validation is to ensure that each step in the processing of bioproducts is assessed and that high-quality products are given while keeping the documentation of science. During the bioprocess validation, the bioproducts' quality, safety, and effectiveness are maintained. The COVID-19 outbreak's lockdown, trade restrictions, and travel restrictions have had an adverse impact on the global economy. COVID-19 has had a favorable effect on the worldwide bioprocess validation market. This is because there is an increasing need for medicines and vaccines to address the new SARS-CoV-2 virus.
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Industry Dynamics
Growth Drivers
Rigorous safety and quality standards, rising biopharmaceutical demand, and soaring demand for outsourcing bioprocess validation are the key drivers. Around 1,279 medications are recalled worldwide, per the data published by the FDA Drug Recall Statistics as of July 2021. Between 2012 and 2021, the FDA issued 12,028 medication recalls in the US. Before items are launched, they must be validated, and the general public's safety must be guaranteed. Because of this, bioprocess validation is essential for verifying the accuracy of therapeutic effectiveness and safety data. Additionally, two key drivers driving the market's expansion are the rising demand for types of tests in R&D activities, the increasing R&D expenditure, and the expanding trend of outsourcing laboratory testing services.
The extensive implementation of bioprocess validation throughout the healthcare industry is supplemented by the growing prevalence of numerous chronic illnesses and the expanding need for biopharmaceuticals, promoting market expansion. Another growth-promoting element is the extensive use of bioprocess validation by pharmaceutical and CMO businesses to monitor the precision, purity, effectiveness, and safety of medicines when producing innovative vaccines and biosimilars, particularly during COVID-19.
Report Segmentation
The market is primarily segmented based on testing type, stage, mode, and region.
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By Testing Type |
By Stage |
By Mode |
By Region |
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Bioprocess Residual Testing holds the majority market share
The bioprocess residuals testing category dominates the market with a significant market share in 2022. Impurities are tested as residual impurities, including buffer contents, anti-foam agents, and upstream and downstream impurities resulting from cell culture. Drug, vaccine, and therapeutic goods produced by the biotechnology, biopharmaceutical, and pharmaceutical sectors are in high demand because they must be impurity-free, secure, and high-quality.
Extractables and Leachables account for the fastest-growing market
One of the significant reasons for this is because the US FDA standards and current good manufacturing practice recommendations are in place. As a result, there is a need for bioproducts of verified quality. The production of cGMP-certified bioproducts by the biopharmaceutical and biotechnology industries expands the market. It is also crucial to recognize the risks found in closed processing systems and packaging that harm bioproducts products throughout the drug discovery process. This fuels global industrial growth during the forecast period.
Continued Process Verification is expected to have the maximum market share in the forecast period
Data collection, storage, processing, and analysis for each batch are all included in the process segment that continues to be verified. Additionally, this process' automation fosters sector expansion. For instance, the most crucial stage of bioprocess validation is process design. To operate a process effectively, strict procedures with concepts and paths for manufacturing the process are essential. The category is increasing at the quickest rate due to rigorous procedure and process design that aims to produce excellent products.
North America is predicted to have the largest regional market share
In 2022, North America led the market due to significant outsourcing services. This causes growth in biologics manufacturing and life sciences research, which fuels the world market. Furthermore, North America's biopharmaceutical and biotechnology industries have received FDA approval. Additionally, the sector is boosted by increased government financing for clinical studies and the bioprocess validation process. The market is boosted by the presence of most of the leading companies in North America, including Thermo Fisher Scientific, Danaher Corporation, and Europhins.
Asia Pacific is expected to register the highest growth rate over the study period. This results from developments, rising healthcare costs, and financing for R&D established by government organizations. The government initiatives for expanding and developing the biopharmaceutical industry in the Asia Pacific area are further supported by the increased knowledge of the advantages of vaccines and biopharmaceutical medications to treat chronic diseases. Also, due to the lower manufacturing costs and higher output, countries like China & India are developing into new industrial hubs. The Asia-Pacific region's rapid industrialization and economic growth are estimated to impact the global bioprocess validation market.
Competitive Insight
Some of the key players in the global players include Eurofins Scientific, Charles River Laboratories, Sartorius, Thermo Fisher Scientific, Lonza, Danaher Corporation, SGS, Merck, Toxikon Corporation, and Cobetter Filtration Equipment.
Recent Developments
In September 2022, Danaher Corporation announced a merger with Cytiva & Pall to create a Bioprocess juggernaut worth USD 7.5 Billion. This merger intends to build this sector's "broadest" and "deepest" product portfolio. The development of the broadest portfolio includes the creation of an entire end-to-end workflow, including the cleanroom, the shell, the building, and the attachments.
In June 2022, Jefferson Institute for Bioprocessing and Plymouth Group announced to provide their training program at Budd Bioworks. This partnership will create opportunities to support the life science sector in Philadelphia.
In July 2022, Vaccizone announced a partnership with Exothera to exploit the latter's Scale-X technology to develop & manufacture the former's COVID vaccine with the bioprocess validation.
In January 2022, Thermo Fisher announced the complete acquisition of PeproTech, a leading developer and manufacturer of recombinant proteins. This acquisition will complement the bioscience business of the acquirer and will help them cater better to the customers in the market.
Bioprocess Validation Market Report Scope
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Report Attributes |
Details |
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Market size value in 2024 |
USD 485.13 Million |
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Revenue forecast in 2032 |
USD 993.22 Million |
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CAGR |
9.40% from 2024 - 2032 |
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Base year |
2023 |
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Historical data |
2019 - 2022 |
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Forecast period |
2024 - 2032 |
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Quantitative units |
Revenue in USD million and CAGR from 2024 to 2032 |
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Segments covered |
By Testing Type, By Stage, By Mode, By Region |
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Regional scope |
North America, Europe, Asia Pacific, Latin America; Middle East & Africa |
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Key companies |
Eurofins Scientific, Inc., Sartorius AG, Merck KGaA, Thermo Fisher Scientific Inc., Lonza, Danaher Corporation, Charles River Laboratories, SGS S.A., Toxikon Corporation, Cobetter Filtration Equipment Co., Ltd. |
FAQ's
Key segments are testing type, stage, mode, and region.
Bioprocess Validation Market Size Worth $993.22 Million in 2032
The global bioprocess validation market expected to grow at a CAGR of 9.3% during the forecast period of 2023-2032.
North America is leading the global market
key driving factor are Increase In The Number Of Clinical Trials For Vaccine Development and Increasing demand for biopharmaceuticals.
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