Global Sterility Testing Pumps Market

Report ID : 1061 | Published : 2021-07-22 | Pages: 190 | Format: PDF/EXCEL

Sterility testing is used to ensure the absence of contaminants in biologics and medical devices. Sterility testing pumps are used for sterility testing in clean room benchtops, laminar flow hoods, isolators and clean rooms. They usually consist of a bottle holder, drain tray, communication hub (consisting of USB port, fuse holder, ethernet and communication ports etc.), and a user interface. The test units are optimised for open and closed containers. The closed system is used for the sterility testing of pharmaceutical products. The system is based on the membrane filter method. By this means the main risk of a secondary contamination and false positive results is eliminated. Currently available products in the market are Steritest Symbio Pump (Merck), Sterisart Sterility testing pumps (Sartorius) and HTY-APL01, HTY-APL02, HTY-APL01ISO, HTY-APL02ISO, HTY-2000B, HTY-601 (Hangzhou Tailin Bioengineering Equipments),LT-STP-08 (Lotus tech) etc. Steritest Symbio Pumps were launched in August 2014 by Merck Millipore. Sterility testing pumps by Tailin Bioengineering received CE approval in April 2014.

Nearly all kinds of products can be tested with the system, including Large-volume parenteral solutions and small-volume parenteral solutions in plastic or glass bottles, ampoules, collapsible bags,  and vials, Pre-filled syringes, Lyophilized and other soluble products in ampoules or vials, Antibiotics in ampoules or vials, Medical devices and Difficult-to-dissolve powders etc.

The global sterility testing pumps market is segmented on the basis of area of use, types of products to be tested and geography. Area of use segment is further sub-segmented into Laminar flow hood (LFH version), Isolator (ISL version), and Multiple configurations (Universal) version. Multiple configurations version is expected to grow in future since it can be adjusted in both isolator and laminar flow hood setting. Also, this version can be used with other types of pumps. Types of products segment can be divided into following types: Microbiology products, where peristaltic pumps are used for sample and media transfer and pharmaceutical products, for which a completely closed system is used for sterility testing or reusable sterility test systems are used for the sterility testing of injection and infusion solutions. Pharmaceutical products segment is expected to hold a major share. As the therapeutic segment oncology and biologics have major focus of the pharmaceutical industries, sterile injectables have become a larger component in pharmaceutical industry’s pipeline, making sterility testing a primary and stringent requirement.

Geographically market is further segmented into North America, Europe, Asia Pacific, Latin America and Middle East & Africa. North America holds the largest revenue share mainly due to factors such as presence of key pharmaceutical and biotechnology industries involved in active research and development activities, presence of a proactive healthcare system requiring stringent control on quality of drug formulation and strict guidelines by the USFDA regarding environmental monitoring and product qualities in pharmaceutical industries. For Europian Union, Germany is the major contributor in this market owing to the fact that two major players in the market viz. Merck and Sartorius are headqurtered in the country. The Asian market will witness growth primarily due to the increasing expenditure on life science research in the region and growing trend of pharmaceutical outsourcing to Asian countries like India and China, also, Tailin Bioengineering equipments from China being one of the promising sterility testing pump manufacturer.

The market will be driven by increased number of pharmaceutical and biotechnology companies, increased number of newer drugs and formulations, increasing R&D in life sciences and increasing government support.

Market players leading in sterility testing pump manufacturing are Sartorius, Merck, Lotus Tech and Hangzhou Tailin Bioengineering Equipments with strong suppliers in the market like Trafalgar scientific (Sartorius), Fisher scientific (Sartorius) etc.

  • Merck
  • Sartorius
  • Hangzhou Tailin Bioengineering Equipments
  • Lotus tech
  • Other Prominent Player

Global Sterility Testing Pump Market Segmentation

Global Sterility Testing Pump Market Outlook (Value (US$ Mn) and Volume (No. of Units) 2019 – 2030) By Type of product to be tested

  • Microbiology products
  • Therapeutics Products
  • Pharmaceutical Products

Global Sterility Testing Pump Market Outlook (Value (US$ Mn) and Volume (No. of Units) 2019 – 2030) By Area of Use

  • Laminar flow hood (LFH version)
  • Isolator (ISL version),
  • Multiple configurations (Universal) version

Global Sterility Testing Pump Market Outlook (Value (US$ Mn) and Volume (No. of Units) 2019 – 2030) By Region

  • Europe
    • K.
    • Germany
    • France
    • Italy
    • Spain
    • Russia
    • Rest of Europe0311
  • North America
    • S.
    • Canada
  • Asia Pacific
    • India
    • China
    • Japan
    • South Korea
    • Australia & New Zealand
    • Rest of Asia Pacific
  • Latin America
    • Brazil
    • Mexico
    • Rest of Latin America
  • Middle East & Africa
    • GCC Countries
    • South Africa
    • Rest of Middle East & Africa

InsightAce Analytic follows a standard and comprehensive market research methodology focused on offering the most accurate and precise market insights. The methods followed for all our market research studies include three significant steps – primary research, secondary research, and data modeling and analysis - to derive the current market size and forecast it over the forecast period. In this study, these three steps were used iteratively to generate valid data points (minimum deviation), which were cross-validated through multiple approaches mentioned below in the data modeling section.

Through secondary research methods, information on the market under study, its peer, and the parent market was collected. This information was then entered into data models. The resulted data points and insights were then validated by primary participants.

Based on additional insights from these primary participants, more directional efforts were put into doing secondary research and optimize data models. This process was repeated till all data models used in the study produced similar results (with minimum deviation). This way, this iterative process was able to generate the most accurate market numbers and qualitative insights.

Secondary research

The secondary research sources that are typically mentioned to include, but are not limited to:

  • Company websites, financial reports, annual reports, investor presentations, broker reports, and SEC filings.
  • External and internal proprietary databases, regulatory databases, and relevant patent analysis
  • Statistical databases, National government documents, and market reports
  • Press releases, news articles, and webcasts specific to the companies operating in the market

The paid sources for secondary research like Factiva, OneSource, Hoovers, and Statista

Primary Research:

Primary research involves telephonic interviews, e-mail interactions, as well as face-to-face interviews for each market, category, segment, and subsegment across geographies

The contributors who typically take part in such a course include, but are not limited to: 

  • Industry participants: CEOs, CBO, CMO, VPs, marketing/ type managers, corporate strategy managers, and national sales managers, technical personnel, purchasing managers, resellers, and distributors.
  • Outside experts: Valuation experts, Investment bankers, research analysts specializing in specific markets
  • Key opinion leaders (KOLs) specializing in unique areas corresponding to various industry verticals
  • End-users: Vary mainly depending upon the market

Data Modeling and Analysis:

In the iterative process (mentioned above), data models received inputs from primary as well as secondary sources. But analysts working on these models were the key. They used their extensive knowledge and experience about industry and topic to make changes and fine-tuning these models as per the product/service under study.

The standard data models used while studying this market were the top-down and bottom-up approaches and the company shares analysis model. However, other methods were also used along with these – which were specific to the industry and product/service under study.

To know more about the research methodology used for this study, kindly contact us/click here.

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