This testing is commonly applied to raw materials used to produce pharmaceuticals and medical devices. Raw materials, such as water, excipients, and other components, can be potential sources of pyrogen contamination. Testing these materials at the outset helps prevent downstream issues in the manufacturing process. Continuous monitoring of the manufacturing process is crucial to identifying and addressing potential sources of pyrogen contamination. In-process testing ensures that any deviations from quality standards are detected promptly, allowing corrective actions to be implemented in real time.
Furthermore, this testing is an integral component of quality control measures. It plays a significant role in batch release testing, an extensive examination process ensuring adherence to regulatory standards for pharmaceutical or medical device products before commercialization. In addition, sterilization processes are employed to eliminate microbial contaminants, including pyrogens, from pharmaceuticals and medical devices. This testing is used to validate the effectiveness of sterilization methods and ensure that the products are free from pyrogenic contamination post-sterilization.
The U.S. is a global hub for biotechnology research and development. Ongoing advancements in biotechnology research, including gene therapies, cell-based therapies, and personalized medicine, may result in the development of novel products that require thorough this testing before reaching the market. As per Statistics Canada, in 2020, the R&D pharmaceutical sector provided $15.9 billion in GVA to the Canadian economy, up 5.8% from $15.0 billion in 2019. In 2020, the output generated by the Canadian R&D pharmaceutical sector increased by $1.5 billion from the previous year to just under $30 billion. Thus, the rising biotechnology sector and increasing R&D in the pharmaceutical sector in North America will assist in expansion of the regional market.
The US market dominated the North America Pyrogen Testing Market, by Country in 2022, and would continue to be a dominant market till 2030; thereby, achieving a market value of $674.6 Million by 2030. The Canada market is experiencing a CAGR of 9.6% during (2023 - 2030). Additionally, The Mexico market would exhibit a CAGR of 8.4% during (2023 - 2030).
Based on Product & Service, the market is segmented into Reagents & Kits, Services, and Instruments. Based on Test Type, the market is segmented into LAL Test, Rabbit Pyrogen Test, and Others. Based on End User, the market is segmented into Pharmaceutical & Biotechnology Companies, Medical Device Companies, and Others. Based on countries, the market is segmented into U.S., Mexico, Canada, and Rest of North America.
List of Key Companies Profiled
- Merck KGaA
- Charles River Laboratories International, Inc.
- Genscript Biotech Corporation
- WuXi AppTec Co., Ltd.
- Lonza Group Ltd.
- Fujifilm Holdings Corporation
- Eurofins Scientific SE
- Thermo Fisher Scientific, Inc.
- Seikagaku Corp.
- InvivoGen SAS
Market Report Segmentation
By Product & Service- Reagents & Kits
- Services
- Instruments
- LAL Test
- Rabbit Pyrogen Test
- Others
- Pharmaceutical & Biotechnology Companies
- Medical Device Companies
- Others
- US
- Canada
- Mexico
- Rest of North America
Table of Contents
Companies Mentioned
- Merck KGaA
- Charles River Laboratories International, Inc.
- Genscript Biotech Corporation
- WuXi AppTec Co., Ltd.
- Lonza Group Ltd.
- Fujifilm Holdings Corporation
- Eurofins Scientific SE
- Thermo Fisher Scientific, Inc.
- Seikagaku Corp.
- InvivoGen SAS
Methodology
LOADING...