“The bioprocess validation market is estimated to grow at a CAGR of 14.6%”
The global bioprocess validation market is exceeded USD 180 million in 2019 and is projected to be valued over USD 360 million by 2024, at a CAGR of 14.6% during the forecast period. The growth of the bioprocess validation services market is driven primarily by the stringent safety and quality regulations governing product certification and testing across the biopharmaceutical and pharmaceutical industries. This has also stimulated the demand for the outsourcing of bioprocess validation services. The rising R&D spending in the life science industry has contributed to this demand significantly, while the growing demand for bioprocess validation in emerging countries and patent expiries have ensured steady market growth. However, the issues related to extractable and leachable testing affect market growth to a certain extent during the forecast period.

“Extractables/leachables testing services segment to witness the highest growth during the forecast period”
The combination systems segment is estimated to grow at the highest CAGR during the forecast period. This can primarily be attributed to increasing outsourcing of testing services by biopharmaceutical manufacturers; the presence of regulatory mandates and guidelines regarding the testing of extractables & leachables; and growing product safety, identity, purity, and quality; and the increasing risk of product adulteration related requirement.

“Filter elements segment to grow at the highest CAGR in the bioprocess validation market, by process component”
The major factors driving the demand for filter elements in bioprocess validation are stringent regulations and industry standards for biopharmaceutical products; increasing usage of a variety of filters in bioprocessing; and the high demand for the evaluation of specific filter elements and their impact on the final drug product owing to the factors such as safety and efficacy of biopharmaceutical products.



“APAC market to witness the highest growth during the forecast period”
The Asia Pacific is estimated to be the fastest-growing regional market for bioprocess validation during the forecast period. The growing biopharmaceutical manufacturing capabilities in Asian countries, increasing demand for outsourcing bioprocess validation, growing life science research specific to biologics, increasing investments by pharmaceutical & biotechnology companies, rising awareness about the advantages of biopharmaceutical drugs, increasing number of CROs & CDMOs, and the favorable government initiatives to promote the growth of the pharmaceutical & biotechnology industries in several APAC countries are some of the major factors driving the growth of this market.

A breakdown of the primary participants in this report is provided below:

  • By Company Type: Tier 1–46%, Tier 2–33%, and Tier 3–21%
  • By Designation: C-level–43%, Director Level–35%, and Others–22%
  • By Region: North America–34%, Europe–26%, Asia Pacific–19%, Latin America–11%, and the Middle East & Africa–10%

The prominent players operating in the global bioprocess validation market are Merck KGaA (Germany), SGS S.A. (Switzerland), Eurofins Scientific (Luxembourg), Sartorius Stedim Biotech (France), Pall Corporation (US), Cobetter Filtration Equipments Co., Ltd. (China), Toxikon Corporation (US), DOC S.r.l. (Italy), MEISSNER FILTRATION PRODUCTS, INC. (US), and Thermo Fisher Scientific (US).

Research Coverage:

  • This report analyzes the market for various bioprocess validation and their adoption patterns. It aims at estimating the size and future growth potential of the global bioprocess validation market as well as its segments (by test type, process component, end-user, and region).
  • The report also includes an in-depth competitive analysis of key market players along with their company profiles, service offerings, and recent developments.


Reasons To Buy the Report
This report will enrich established firms as well as new entrants/smaller firms to gauge the pulse of the market, which, in turn, would help them garner a greater share. Firms purchasing the report could use one, or any combination of the below mentioned five strategies for strengthening their market presence.

  • Market Penetration: Comprehensive information on the service portfolios offered by the top players in the global bioprocess validation market
  • Service Development/Innovation: Detailed insights on the upcoming trends, R&D activities, and service launches in the global bioprocess validation market
  • Market Development: Comprehensive information on the lucrative emerging regions
  • Market Diversification: Exhaustive information about new services, growing geographies, and recent developments in the global bioprocess validation market
  • Competitive Assessment: In-depth assessment of services offered, market shares, growth strategies, and revenue analysis of leading players in the global bioprocess validation market