Sterility Testing Market - Global Industry Analysis, Size, Share, Trends, Analysis, Growth, and Forecast 2017 - 2025

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Sterility Testing Market - Global Industry Analysis, Size, Share, Trends, Analysis, Growth, and Forecast 2017 - 2025

Status : March, 2020 | Biotechnology | PPT format

Report Digest


Sterility Testing Market – Snapshot

Sterility refers to the non-appearance of viable microorganisms. This testing confirms that products are free from any kind of viable microorganisms. The process of ensuring sterility is extremely harsh for active ingredients. In a bid to ascertain that the sterility test has been done correctly and is valid, bacteriostasis and fungistasis testing are conducted.

Confirmation of the presence of antimicrobial characteristics in a test article is done through sterility testing. Sterility testing needs to be carried out in an environment of clean room or through the procedure of direct inoculation or with the help of an isolator utilizing the procedure of membrane filtration.

Sterility testing is considered extremely considered crucial for tissue materials, preparations, pharmaceuticals, and medical devices, which drives the global sterility testing market over the period of forecast. These products need to be completely sterile due to the nature of their use.

Different types of testing that are found in the global sterility testing market are mentioned below

  • Membrane Filtration Sterility Testing – It is a method that has emerged as popular choice for certain kinds of products like filterable pharmaceuticals.
  • Direct Transfer Sterility Testing – This particular testing method is suitable for use in non-filterable pharmaceutical products and medical devices. Non-filterable pharmaceutical products comprise creams, ointments, powders, and solid dosage forms.
  • Fluid Path Sterility Testing - This method is mostly utilized for hollow tubes like infusion and transfusion assemblies. This testing method is used in which immersion is not a feasible choice.

The global sterility testing market is dominated by North America and Europe, where rise in the number of approvals for drugs are expected to fuel the market.

The sterility testing market in North America is followed by Europe. The factor that contributes to this growth is the increasing approvals of the drug in the North American region predict to set the regional market for sterility testing. 

Sterility testing discovers application for use on cell banks, raw materials, and final medication offerings. Besides, it is additionally utilized for testing different preparations, articles, and substances which require to be made sterile according to the laws by the United States Pharmacopeia (USP) and European Pharmacopeia (EP). All natural parenteral preparations made for human usage, experience sterility testing to reveal the nonappearance or nearness of superfluous suitable microorganisms with tainting ability. Sterility tests can be executed in a an isolator or a cleanroom surrounding utilizing direct inoculation or membrane filtration techniques. The approval of a sterility test is performed with the assistance of bacteriostasis and fungistasis testing. The testing additionally checks for the presence of any antimicrobial property inside a test article that would hinder the discovery of microbial living beings amid a sterility examination.

Among the many factors regarded in charge of driving the development of the world sterility testing market could be the increase in the launch of new medications, rising innovative work activities in life science, and substantial amplification of the biotechnology and pharmaceutical industries. Owing to great development observed in the biotech and pharma divisions, by application, the organic and pharmaceutical manufacturing market had gained a huge amount share in year 2016. Around the same time, the membrane filtration market by test had gained huge share due to rapid development in the biotechnology and pharmaceutical end-use areas. Because of the propelling slant toward kit-based testing and repeat purchase prerequisite, the market for reagents and units is foreseen to gain a noteworthy share within the forecast period from 2017 to 2025.

Global Sterility Testing Market: Overview

Sterility testing finds application for use on raw materials, cell banks, and final drug offerings. However, it is also used for testing various articles, preparations, and substances which are needed to be made sterile as per the laws penned down by the European Pharmacopoeia (EP) and United States Pharmacopoeia (USP). All biological parenteral preparations formulated for human use undergo sterility testing for the purpose of revealing the absence or presence of extraneous viable microorganisms with contamination capability. Sterility tests can be executed in a cleanroom environment or an isolator using membrane filtration or direct inoculation methods. 

The validation of a sterility test is performed with the help of bacteriostasis and fungistasis testing. The testing also helps to check for the presence of any antimicrobial property within a test article that would impede the discovery of microbial organisms during a sterility examination. 

Global Sterility Testing Market: Key Trends

Some of the top factors deemed responsible for driving the growth of the world sterility testing market could be the rising research and development activities in life science, surge in the launch of new drugs, and tangible magnification of the biotechnology and pharmaceutical sectors. 

On account of the impressive growth witnessed in the biotech and pharma sectors, by application, the biological and pharmaceutical manufacturing market had acquired a mammoth share in 2016. In the same year, the membrane filtration market by test had secured a king-sized share on the back of the swift growth earned by the biotechnology and pharmaceutical end-use sectors. Due to the advancing inclination toward kit-based testing and repeat purchase requirement, the market for kits and reagents is anticipated to win a significant share by the end of the forecast period 2017 - 2025. 

Global Sterility Testing Market: Market Potential

Provider of cleanroom, analytical chemistry, and microbiology services, Avista Pharma Solutions, Inc. has recently announced its investment to extend service offerings and complement current capabilities for benefiting medical device and pharmaceutical clients. Avista Pharma CEO, Patrick Walsh was proud to make the announcement of the company’s US$4.0 mn expansion with a 4,200 sq. ft. of additional space at the 2017 Interphex global conference held in New York City. The enhanced facility will offer an International Standards Organization (ISO) 6 cleanroom for medical device sterility testing and isolator technology-enabled modular cleanroom area along with a new microbiology laboratory. 

Global Sterility Testing Market: Regional Outlook

The international sterility testing market is expected to reward Asia Pacific as a region with a higher growth rate, owing to the ballooning trend of pharmaceutical outsourcing to countries such as China and India. The success of Asia Pacific could also be attributed to the multiplying outlay on life science research. Nonetheless, North America could be a dominating geographical segment in the market followed by Rest of the World and Europe. The enlarging count of drug approvals in North America is predicted to set the tone of the regional market for sterility testing. 

Global Sterility Testing Market: Competitive Landscape

New entrants in the worldwide sterility testing market are prognosticated to face challenges because of the high degree of consolidation witnessed. Besides this, long-delayed approval procedures and stiff regulatory frameworks could be the other deterrents in the market. However, developing geographies such as Asia Pacific and the elevating level of pharmaceutical outsourcing are prophesied to help players tackle the challenges in the market. Thermo Fisher Scientific, Inc., WuXi AppTec, Sartorius AG, SGS SA, bioMérieux SA, Charles River Laboratories International, Inc., and Merck KgaA are some of the exceptional companies operating in the market.

The study presents a granular assessment and quantitative evaluation of:

  • Key growth factors and prominent trends
  • Size and share of key segments in overall market
  • Key challenges and winning imperatives
  • Factors shaping competitive landscape
  • Insights into how contours of market will change in coming years
  • Technological advances
  • New avenues and imminent investment pockets
  • Regulatory landscape shaping current and future strategies of companies

The region-wise assessment includes market dynamics in:

  • North America
  • Asia Pacific
  • Europe
  • Latin America
  • The Middle East and Africa

The study is prepared with the help of an extensive primary and secondary research. Primary research includes but not limited to interactions, interviews, surveys, and events. Opinions of policy makers and industry experts are carefully integrated into the insights to complement primary research. Volumes of secondary data gleaned through renowned paid sources, annual statements, reputed journals, and government documents offer insights into current dynamics and key evolution trajectories the market is likely to assume. The research employs various industry-wide analytics methods and well-established methodologies to ascertain the attractiveness of key segments. Further, it evaluates the lucrativeness of key regions and factors underlying their maturity. The insights notably include a detailed analysis of forces behind vendor differentiation and offers insight into investment-decision making by prominent players.

The report strives to enlighten businesses and industry stakeholders on multiple facets of the growth dynamic of the market, the key of which include answers to:

  • Which key factors will shape the competitive landscape?
  • Which trends will stimulate research and development activities in different geographies?
  • Which are the lucrative growth areas and what is the size of potential they are likely contribute to the overall market?
  • Which disruptions in market growth are likely to come with the new business models?
  • Which are some of the recent overhauls in policies that may change the course of the market significantly?
  • Which are the geographies that will form sizable sources of new streams to new and established players alike?
  • How are top players likely to realign their strategy to counter the forces of competition?
  • Which key strategies emerging players are likely to focus on to consolidate their position?
  • Which changes in end-user preferences might affect the status quo held by the leading players?
  • Which are some of the game-changing innovations influencing the projected share and revenue of the market and its segments?

Note: Utmost care has invariably been taken to present data and arrive at statistics at all the TMR Research reports. Meanwhile, some recent developments and new industry trends may take time to be included in the reports.

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