Sterility Indicators Market Size, Share, Trends, Growth, Production, Consumption, Revenue, Company Analysis and Forecast 2021-2030

The global Sterility Indicators market size is expected to be worth around US$ 3.24 billion by 2030, according to a new report by Vision Research Reports.

The global Sterility Indicators market size was valued at US$ 748.0 million in 2020 and is anticipated to grow at a CAGR of 12.9% during forecast period 2021 to 2030.

Growth Factors

Strict regulations regarding healthcare products and high emphasis on sterility parameters and measures for the prevention of Hospital Acquired Infections (HAIs) are projected to drive the market growth. Increasing number of geriatric population prone to chronic conditions is primarily driving the demand for drugs and medical devices globally. Governments in developing economies like India and China are focusing on providing cost-effective, high quality medications. The Union Cabinet of India has provided USD 13.16 billion to the National Health Mission (NHM) from April 2020 to March 2020. Currently, India has the highest U.S. Food and Drug Administration (FDA)-approved manufacturing facilities outside U.S. It also accounts for 22.0% of the overall approved U.S. FDA plants. Thus, demand for sterility testing services and products is anticipated to rise over the forecast period.

Increasing R&D activities drive demand for various sterilization processes in pharmaceutical and biotechnology industries. Sterilization of pharmaceutical manufacturing and packaging equipment is essential to kill all forms of microbial life and prevent contamination. Steam sterilization is by far the best and the most commonly used method for sterilization in pharmaceutical industry. 

Growing efforts to reduce burden of  is one of the high impact rendering market drivers. The concept of hospital sterile processing units is being adopted in developing regions such as China, India, and Middle Eastern countries. Steep rise in the number of sterilization procedures is expected to have a direct positive impact on the market. Introduction of advanced indicators significantly reduces the prices for their older versions. This drives their adoption in developing countries from Asia Pacific and Middle East and Africa, where cost constraint is a major factor. The cumulative effect of these activities is expected to result in increasing usage of sterility indicators, which, in turn, is fueling the market growth.

Report Highlights

The biological indicators segment captured the largest market share in 2017. The segment covers products such as spore ampoules,spore suspensions, self-contained vials, and spore strips. Biological indicators show reliable results as compared to chemical indicators. These are considered a gold standard for assessment of sterilization. Spore ampoules are used extensively as compared to other types. These contain highly resistant spores inside a container spore ampoules and can be used in a wide range of sterilization procedures such as steam and liquid sterilization and radiation. The ampoules consist of pH indicator and spores. These indicators are incubated after sterilization process and checked for presence of acid produced by spores.

The chemical indicators segment includes Class 1 to Class 5 indicators. Class 1 and 2 indicators have significant usage in steam and EtO sterilization techniques. These segments are expected to maintain their dominance in the market throughout the forecast period owing to growing application. Class 1 indicators are sub-segmented into tapes, strips, and others. The class 1 indicators are widely used and hence hold the largest market share. The segment is expected to expand at the fastest CAGR over the forecast period.

The heat sterilization segment captured the largest market share in 2020. Heat sterilization is the most commonly used traditional method. The growth of this segment can be attributed to the benefits of this technique, such as efficacy and ease. These techniques include autoclaving, pasteurization, and fractional sterilization methods. Over the past decade, moist sterilization techniques are increasingly being adopted owing to their applications in dairy and pharmaceutical industry and R&D organizations.

However, the low temperature sterilization segment is expected to witness the highest growth during the forecast period. Low temperature sterilization techniques have been evolving over the decade owing to advancements in the healthcare industry. In addition, use of expensive, complex, and delicate medical instruments that are difficult to sterilize are driving the demand for low temperature sterilization techniques.

The hospital segment captured the largest market share in 2020. This segment is anticipated to continue leading as sterilization procedures are repeatedly carried out in hospitals. Moreover, stringent regulatory guidelines for sterilization of class III medical devices, biologics and drugs are driving the sterility indicators market.

Increasing R&D and advent of complex equipment with rising intricacy of medical devices are driving the demand for effective sterilization procedures from pharmaceutical companies. Pharmaceutical and Medical devices companies perform sterility tests as part of quality control in product manufacture. Frequent product launches in the field of healthcare are anticipated to boost the market growth during the forecast period.

North America led the global market in 2020.High demand owing to frequent product launches in drug, medical devices and biologics, and reimbursement coverage are some of the factors driving the growth of this region. Constantly rising target patient population owing to aging is fueling the regional demand for medical products. High prevalence of chronic diseases coupled with high adoption of advanced treatment procedures is fueling the market growth in U.S. In addition, few of the giant players are based in the region, which is expected to help the region continue its dominance over the forecast period.

Asia Pacific, on the other hand, is expected to exhibit the fastest CAGR during the forecast period. China and India have a significant presence of local manufacturers, providing cost effective alternatives and intensifying the competition. In addition, booming medical tourism industry in the region owing to the availability of advanced healthcare treatments at a cost-efficient rate is expected to attract the target patient population to Asia Pacific.

Key Players

oligopolistic with a few international players. Major participants in this market are Getinge Group; Cantel Medical Corp.; 3M Company; Cardinal Health, Inc.; Matachana Group; Mesa Laboratories, Inc.; and Andersen Products, Inc.

Market Segmentation

• Type Outlook 

  • Chemical

    • Class 1

    • Class 2

    • Class 3

    • Class 4

    • Class 5

  • Biological

    • Spore Ampoules

    • Spore Suspensions

    • Self-contained Vials

    • Spore Strips

• Technique Outlook 

  • Heat

  • Low Temperature

  • Filtration

  • Radiation

  • Liquid

• End-user Outlook 

  • Hospitals

  • Pharmaceutical Companies

  • Medical device Companies

  • Clinical laboratories/Research Centers

  • Others

• Regional Outlook 

  • North America

    • U.S.

    • Canada

  • Europe

    • U.K.

    • Germany

    • Denmark

    • Greece

    • Spain

    • France

    • Italy

  • Asia Pacific

    • Japan

    • China

    • India

  • Latin America

    • Brazil

    • Mexico

    • Argentina

  • MEA

    • South Africa

    • UAE

    • Saudi Arabia

The Sterility Indicators market research report covers definition, classification, product classification, product application, development trend, product technology, competitive landscape, industrial chain structure, industry overview, national policy and planning analysis of the industry, the latest dynamic analysis, etc., and also includes major. The study includes drivers and restraints of the global market. It covers the impact of these drivers and restraints on the demand during the forecast period. The report also highlights opportunities in the market at the global level.

The report provides size (in terms of volume and value) of Sterility Indicators market for the base year 2020 and the forecast between 2021 and 2030. Market numbers have been estimated based on form and application. Market size and forecast for each application segment have been provided for the global and regional market.

This report focuses on the global Sterility Indicators market status, future forecast, growth opportunity, key market and key players. The study objectives are to present the Sterility Indicators market development in United States, Europe and China.

It is pertinent to consider that in a volatile global economy, we haven’t just conducted Sterility Indicators market forecasts in terms of CAGR, but also studied the market based on key parameters, including Year-on-Year (Y-o-Y) growth, to comprehend the certainty of the market and to find and present the lucrative opportunities in market.

In terms of production side, this report researches the Sterility Indicators capacity, production, value, ex-factory price, growth rate, market share for major manufacturers, regions (or countries) and type.

In terms of consumption side, this report focuses on the consumption of Sterility Indicators by regions (countries) and application.

Buyers of the report will have access to verified market figures, including global market size in terms of revenue and volume. As part of production analysis, the authors of the report have provided reliable estimations and calculations for global revenue and volume by Type segment of the global Sterility Indicators market. These figures have been provided in terms of both revenue and volume for the period 2017 to 2030. Additionally, the report provides accurate figures for production by region in terms of revenue as well as volume for the same period. The report also includes production capacity statistics for the same period.

With regard to production bases and technologies, the research in this report covers the production time, base distribution, technical parameters, research and development trends, technology sources, and sources of raw materials of major Sterility Indicators market companies.

Regarding the analysis of the industry chain, the research of this report covers the raw materials and equipment of Sterility Indicators market upstream, downstream customers, marketing channels, industry development trends and investment strategy recommendations. The more specific analysis also includes the main application areas of market and consumption, major regions and Consumption, major Chinese producers, distributors, raw material suppliers, equipment providers and their contact information, industry chain relationship analysis.

The research in this report also includes product parameters, production process, cost structure, and data information classified by region, technology and application. Finally, the paper model new project SWOT analysis and investment feasibility study of the case model.

Overall, this is an in-depth research report specifically for the Sterility Indicators industry. The research center uses an objective and fair way to conduct an in-depth analysis of the development trend of the industry, providing support and evidence for customer competition analysis, development planning, and investment decision-making. In the course of operation, the project has received support and assistance from technicians and marketing personnel in various links of the industry chain.

The Sterility Indicators market competitive landscape provides details by competitor. Details included are company overview, company financials, revenue generated, market potential, investment in research and development, new market initiatives, global presence, production sites and facilities, production capacities, company strengths and weaknesses, product launch, product width and breadth, application dominance. The above data points provided are only related to the companies’ focus related to Sterility Indicators market.

Prominent players in the market are predicted to face tough competition from the new entrants. However, some of the key players are targeting to acquire the startup companies in order to maintain their dominance in the global market. For a detailed analysis of key companies, their strengths, weaknesses, threats, and opportunities are measured in the report by using industry-standard tools such as the SWOT analysis. Regional coverage of key companies is covered in the report to measure their dominance. Key manufacturers of Sterility Indicators market are focusing on introducing new products to meet the needs of the patrons. The feasibility of new products is also measured by using industry-standard tools.

Key companies are increasing their investments in research and development activities for the discovery of new products. There has also been a rise in the government funding for the introduction of new Sterility Indicators market. These factors have benefited the growth of the global market for Sterility Indicators. Going forward, key companies are predicted to benefit from the new product launches and the adoption of technological advancements. Technical advancements have benefited many industries and the global industry is not an exception.

New product launches and the expansion of already existing business are predicted to benefit the key players in maintaining their dominance in the global market for Sterility Indicators. The global market is segmented on the basis of region, application, en-users and product type. Based on region, the market is divided into North America, Europe, Asia-Pacific, Latin America and Middle East and Africa (MEA).

In this study, the years considered to estimate the market size of Sterility Indicators are as follows:

• Historic Year: 2017-2020
• Base Year: 2021
• Forecast Year 2021 to 2030

Reasons to Purchase this Report:

- Market segmentation analysis including qualitative and quantitative research incorporating the impact of economic and policy aspects
- Regional and country level analysis integrating the demand and supply forces that are influencing the growth of the market.
- Market value USD Million and volume Units Million data for each segment and sub-segment
- Competitive landscape involving the market share of major players, along with the new projects and strategies adopted by players in the past five years
- Comprehensive company profiles covering the product offerings, key financial information, recent developments, SWOT analysis, and strategies employed by the major market players

Research Methodology:

In-depth interviews and discussions were conducted with several key market participants and opinion leaders to compile the research report.

This research study involved the extensive usage of both primary and secondary data sources. The research process involved the study of various factors affecting the industry, including the government policy, market environment, competitive landscape, historical data, present trends in the market, technological innovation, upcoming technologies and the technical progress in related industry, and market risks, opportunities, market barriers and challenges. The following illustrative figure shows the market research methodology applied in this report.

Market Size Estimation

Top-down and bottom-up approaches are used to estimate and validate the global market size for company, regional division, product type and application (end users).

The market estimations in this report are based on the selling price (excluding any discounts provided by the manufacturer, distributor, wholesaler or traders). Market share analysis, assigned to each of the segments and regions are achieved through product utilization rate and average selling price.

Major manufacturers & their revenues, percentage splits, market shares, growth rates and breakdowns of the product markets are determined through secondary sources and verified through the primary sources.

All possible factors that influence the markets included in this research study have been accounted for, viewed in extensive detail, verified through primary research, and analyzed to get the final quantitative and qualitative data. The market size for top-level markets and sub-segments is normalized, and the effect of inflation, economic downturns, and regulatory & policy changes or others factors are accounted for in the market forecast. This data is combined and added with detailed inputs and analysis from Vision Research Reports and presented in this report.

Market Breakdown and Data Triangulation

After complete market engineering with calculations for market statistics; market size estimations; market forecasting; market breakdown; and data triangulation. Extensive primary research was conducted to gather information and verify and validate the critical numbers arrived at. In the complete market engineering process, both top-down and bottom-up approaches were extensively used, along with several data triangulation methods, to perform market estimation and market forecasting for the overall market segments and sub-segments listed in this report.

Secondary Sources

Secondary Sources occupies approximately 25% of data sources, such as press releases, annual reports, Non-Profit organizations, industry associations, governmental agencies and customs data, and so on. This research study includes secondary sources; directories; databases such as Bloomberg Business, Wind Info, Hoovers, Factiva (Dow Jones & Company), TRADING ECONOMICS, and avention; Investing News Network; statista; Federal Reserve Economic Data; annual reports; investor presentations; and SEC filings of companies.

Primary Sources

 In the primary research process, various sources from both the supply and demand sides were interviewed to obtain qualitative and quantitative information for this report. The primary sources from the supply side include product manufacturers (and their competitors), opinion leaders, industry experts, research institutions, distributors, dealer and traders, as well as the raw materials suppliers and producers, etc.

The primary sources from the demand side include industry experts such as business leaders, marketing and sales directors, technology and innovation directors, supply chain executive, end users (product buyers), and related key executives from various key companies and organizations operating in the global market.

The study objectives of this report are:

• To analyze and study the global market capacity, production, value, consumption, status (2017-2020) and forecast (2021-2030);
• Focuses on the key manufacturers, to study the capacity, production, value, market share and development plans in future.
• Comprehensive company profiles covering the product offerings, key financial information, recent developments, SWOT analysis, and strategies employed by the major market players
• To define, describe and forecast the market by type, application and region.
• To analyze the global and key regions market potential and advantage, opportunity and challenge, restraints and risks.
• To identify significant trends and factors driving or inhibiting the market growth.
• To analyze the opportunities in the market for stakeholders by identifying the high growth segments.
• To strategically analyze each submarket with respect to individual growth trend and their contribution to the market
• To analyze competitive developments such as expansions, agreements, new product launches, and acquisitions in the market
• To strategically profile the key players and comprehensively analyze their growth strategies.