Sterility Testing Market size was valued at US$ 947.25 Mn in 2021 and the total revenue is expected to grow at 12.40% through 2022 to 2029, reaching nearly US$ 2413.21 Mn.Sterility Testing Market Overview:
Sterility testing is performed to kill pyrogen or any foreign particle like bacteria to avoid contamination. This test is performed to sterilize vaccines, consumables, medical tools, samples, and various others. The common method used is direct immersion, membrane filtration, and product flush. This test is mainly carried out in the pharmaceutical industry, and medical laboratories.To know about the Research Methodology :- Request Free Sample Report
Recent Trends of Sterility Testing Market:
• In September 2021, Nelson Labs, the leading global supplier of laboratory testing and services, have been newly declared, center of excellence for microbiological laboratory testing, and improved the sterilization capacity of its Wiesbaden plant in Germany. • In June 2021, bioMérieux SA, the global leader in the field of in vitro diagnostics, have been newly announced a genomic software solution that may assist microbiological labs in verification and press from listed raw data linked to SARS-CoV-2 variants.Sterility Testing Market Dynamics:
The growth of the pharmaceutical industry and biotechnology industry and rapid innovation are driving the growth of the sterility testing market. New clinical trials and drug launches are further boosting the market. Moreover, the market players are focusing on research and development and investing a huge revenue for better outcomes and this is supported by favorable government support to the pharmaceutical and biotech industry is likely to motivate the market and grow at a high pace and is creating opportunities for budding players to enter the market and invest. The high degree of consolidation to sustain in the market with major barrios like new entrants is acting as a restraining factor to the market. Moreover, time-consuming clinical trials and government authorization to novel drug innovations are further hampering the growth of the market for company players. Besides. Lack of skilled professionals to handle high technological machinery and operating system can hamper the growth of the market and is a major challenging factor in the sterility testing market.Sterility Testing Market Segment Analysis:
The Sterility Testing Market is segmented by Product, Test and End-Use. Based on the Product, the Sterility Testing Market is segmented into Instruments, Services, and Kits and Reagents. The Kits and Reagents segment held the largest market share of 85.9% in the global Sterility Testing in 2021. Due to wider acceptance and easy access. Moreover, repeated purchase of kits and reagent segments is further boosting the market growth of the product segment. Kits and reagents offer various benefits like low inventory cost, low shipping expense to reduce emission, rapid and ease of inoculation. The major benefit associated with the segment is time-saving, ready to use, no installation cost, skilled professional necessity. Hence, these factors boost the growth of the sterility testing market. Moreover, the high cost of reagents and kits is likely to hamper the growth of the sterility testing market. Based on the Test, the Sterility Testing Market is segmented into Membrane Filtration Sterility Testing and Direct Inoculation Sterility Testing. The Membrane Filtration Sterility Testing segment held the largest market share of xx% in 2021. Membrane filtration sterility testing involves the passing of test samples through a standard membrane that is capable of retaining microorganisms. Membrane filtration sterility testing is widely used for all-purpose like Vaccines, samples containing adjuvant gel. With membrane filtration, microorganisms are retained by a 0.45 µm pore size filter, and all inhibiting compounds are rinsed by using an appropriate rinsing solution. This testing is most preferred in pharmaceutical industries and gaining more attention due to wider benefits like accommodation of a large number of solutions up to 500ml removal of inhibitory substances that inhibit the growth of microorganisms by rinsing them in membrane filter with a suitable reagent. So, this major factor will drive the growth of urban segment in the global Sterility Testing during the forecast period. Direct Inoculation Sterility Testing held the 2nd largest market share in 2021. Based on the End-Use, the Sterility Testing Market is segmented into Pharmaceutical & Biotechnology and Medical Devices. The Pharmaceutical & Biotechnology segment held the largest market share of xx% in 2021. As Sterility testing is used in the identification of pyrogenic substances or any foreign particle harming the quality of the end-product. Parenteral products explicitly require sterility testing to make them free from pyrogen. Sterility testing is a key Good Manufacturing Practices (GMP) microbiology testing requirement for sterile pharmaceutical goods. Medical devices and materials to ensure safety for human life. Sterility testing is done for 14 days of long incubation as some of the bacteria are very slow in growth like propionibacterium acne. Propionibacterium acnes is a gram-positive bacteria, rod-shaped. These slow-growing bacteria are found in the acne of a human being.Sterility Testing Market Regional Insights:
North America dominate the Sterility Testing Market during the forecast period. North America is expected grow at a higher CAGR of 11.7% in the Sterility Testing Market during the forecast period 2022-2029. This growth is attributed to the presence of major market players in North America. Moreover, the presence of high-tech companies with high-end infrastructure is further boosting the market growth of the sterility testing market. Asia Pacific is also secondly expected to grow at a faster CAGR of xx% in the Sterility Testing Market. This growth is controlled by the coordination of regulatory agencies with International Conference of Harmonization (ICH) standards in budding nations is further boosting the market growth of Sterility testing in the regional market. Moreover, domestic pharmaceutical companies with growing economies are motivating the market growth of Asia Pacific in the forecast period. The objective of the report is to present a comprehensive analysis of the Sterility Testing Market to the stakeholders in the industry. The past and current status of the industry with the forecasted market size and trends are presented in the report with the analysis of complicated data in simple language. The report covers all the aspects of the industry with a dedicated study of key players that include market leaders, followers, and new entrants. PORTER, PESTEL analysis with the potential impact of micro-economic factors of the market have been presented in the report. External as well as internal factors that are supposed to affect the business positively or negatively have been analyzed, which will give a clear futuristic view of the industry to the decision-makers. The reports also helps in understanding the Sterility Testing Market dynamic, structure by analyzing the market segments and project the Sterility Testing Market size. Clear representation of competitive analysis of key players by product, price, financial position, product portfolio, growth strategies, and regional presence in the Sterility Testing Market make the report investor’s guide.Sterility Testing Market Scope: Inquire before buying
Sterility Testing Market Report Coverage Details Base Year: 2021 Forecast Period: 2022-2029 Historical Data: 2017 to 2021 Market Size in 2021: US $ 947.25 Bn. Forecast Period 2022 to 2029 CAGR: 12.4% Market Size in 2029: US $ 2413.2 Bn. Segments Covered: by Product • Instruments • Services • Kits and Reagents by Type • Membrane Filtration Sterility Testing • Direct Inoculation Sterility Testing by Application • Pharmaceutical & Biotechnology • Medical Devices Sterility Testing Market, by Region
• North America • Europe • Asia Pacific • South America • Middle East and AfricaSterility Testing Market Key Players
• Merck KGaA • Charles River Laboratories International, Inc. • bioMérieux SA • SGS S.A. • Sartorius AG • Thermo Fisher Scientific, Inc. • Cummins Filtration • Danaher • Nelson Laboratories • LLC • TOXIKON • WuXiAppTec • Rapid Micro Biosystems, Inc. • Baxter and Pace Analytical • GMD group • ARMÜR TEXTILE • NINESUN • BERK Grup Frequently Asked Questions: 1. Which region has the largest share in Global Sterility Testing Market? Ans: North America region held the highest share in 2021. 2. What is the growth rate of Global Sterility Testing Market? Ans: The Global Sterility Testing Market is expected to grow at a CAGR of 12.40% during forecast period 2022-2029. 3. What is scope of the Global Sterility Testing market report? Ans: Global Sterility Testing Market report helps with the PESTEL, PORTER, COVID-19 Impact analysis, Recommendations for Investors & Leaders, and market estimation of the forecast period. 4. Who are the key players in Global Sterility Testing market? Ans: The important key players in the Global Sterility Testing Market are – Merck KGaA, Charles River Laboratories International, Inc., bioMérieux SA, SGS S.A., Sartorius AG, Thermo Fisher Scientific, Inc., Cummins Filtration, Danaher, Nelson Laboratories, LLC, TOXIKON, WuXiAppTec, Rapid Micro Biosystems, Inc., Baxter and Pace Analytical, GMD group, ARMÜR TEXTILE, NINESUN, and BERK Grup 5. What is the study period of this market? Ans: The Global Sterility Testing Market is studied from 2021 to 2029.
1. Preface 1.1. Market Definition and Key Research Objectives 1.2. Research Highlights 2. Assumptions and Research Methodology 2.1. Report Assumptions 2.2. Abbreviations 2.3. Research Methodology 2.3.1. Secondary Research 2.3.1.1. Secondary data 2.3.1.2. Secondary Sources 2.3.2. Primary Research 2.3.2.1. Data from Primary Sources 2.3.2.2. Breakdown of Primary Sources 3. Executive Summary: Sterility Testing Market Size, by Market Value (US$ Mn) 3.1. Global Market Segmentation 3.2. Global Market Segmentation Share Analysis, 2021 3.2.1. Global 3.2.2. By Region (North America, Europe, Asia Pacific, South America, Middle East Africa) 3.3. Geographical Snapshot of the Sterility Testing Market 3.4. Geographical Snapshot of the Sterility Testing Market, By Manufacturer share 4. Sterility Testing Market Overview, 2021-2029 4.1. Market Dynamics 4.1.1. Drivers 4.1.1.1. Global 4.1.1.2. By Region (North America, Europe, Asia Pacific, South America, Middle East Africa) 4.1.2. Restraints 4.1.2.1. Global 4.1.2.2. By Region (North America, Europe, Asia Pacific, South America, Middle East Africa) 4.1.3. Opportunities 4.1.3.1. Global 4.1.3.2. By Region (North America, Europe, Asia Pacific, South America, Middle East Africa) 4.1.4. Challenges 4.1.4.1. Global 4.1.4.2. By Region (North America, Europe, Asia Pacific, South America, Middle East Africa) 4.1.5. Industry Trends and Emerging Technologies 4.1.6. Porters Five Forces Analysis 4.1.6.1. Threat of New Entrants 4.1.6.2. Bargaining Power of Buyers/Consumers 4.1.6.3. Bargaining Power of Suppliers 4.1.6.4. Threat of Substitute Products 4.1.6.5. Intensity of Competitive Rivalry 4.1.7. Value Chain Analysis 4.1.8. Technological Roadmap 4.1.9. Regulatory landscape 4.1.10. Impact of the Covid-19 Pandemic on the Sterility Testing Market 5. Supply Side and Demand Side Indicators 6. Sterility Testing Market Analysis and Forecast, 2021-2029 6.1. Sterility Testing Market Size & Y-o-Y Growth Analysis. 7. Sterility Testing Market Analysis and Forecasts, 2021-2029 7.1. Market Size (Value) Estimates & Forecast By Product, 2021-2029 7.1.1. Instruments 7.1.2. Services 7.1.3. Kits and Reagents 7.2. Market Size (Value) Estimates & Forecast By Test, 2021-2029 7.2.1. Membrane Filtration Sterility Testing 7.2.2. Direct Inoculation Sterility Testing 7.3. Market Size (Value) Estimates & Forecast By End-Use, 2021-2029 7.3.1. Pharmaceutical & Biotechnology 7.3.2. Medical Devices 8. Sterility Testing Market Analysis and Forecasts, By Region 8.1. Market Size (Value) Estimates & Forecast By Region, 2021-2029 8.1.1. North America 8.1.2. Europe 8.1.3. Asia-Pacific 8.1.4. Middle East & Africa 8.1.5. South America 9. North America Sterility Testing Market Analysis and Forecasts, 2021-2029 9.1. Market Size (Value) Estimates & Forecast By Product, 2021-2029 9.1.1. Instruments 9.1.2. Services 9.1.3. Kits and Reagents 9.2. Market Size (Value) Estimates & Forecast By Test, 2021-2029 9.2.1. Membrane Filtration Sterility Testing 9.2.2. Direct Inoculation Sterility Testing 9.3. Market Size (Value) Estimates & Forecast By End-Use, 2021-2029 9.3.1. Pharmaceutical & Biotechnology 9.3.2. Medical Devices 10. North America Sterility Testing Market Analysis and Forecasts, By Country 10.1. Market Size (Value) Estimates & Forecast By Country, 2021-2029 10.1.1. US 10.1.2. Canada 10.1.3. Mexico 11. U.S. Sterility Testing Market Analysis and Forecasts, 2021-2029 11.1. Market Size (Value) Estimates & Forecast By Product, 2021-2029 11.2. Market Size (Value) Estimates & Forecast By Test, 2021-2029 11.3. Market Size (Value) Estimates & Forecast By End-Use, 2021-2029 12. Canada Sterility Testing Market Analysis and Forecasts, 2021-2029 12.1. Market Size (Value) Estimates & Forecast By Product, 2021-2029 12.2. Market Size (Value) Estimates & Forecast By Test, 2021-2029 12.3. Market Size (Value) Estimates & Forecast By End-Use, 2021-2029 13. Mexico Sterility Testing Market Analysis and Forecasts, 2021-2029 13.1. Market Size (Value) Estimates & Forecast By Product, 2021-2029 13.2. Market Size (Value) Estimates & Forecast By Test, 2021-2029 13.3. Market Size (Value) Estimates & Forecast By End-Use, 2021-2029 14. Europe Sterility Testing Market Analysis and Forecasts, 2021-2029 14.1. Market Size (Value) Estimates & Forecast By Product, 2021-2029 14.2. Market Size (Value) Estimates & Forecast By Test, 2021-2029 14.3. Market Size (Value) Estimates & Forecast By End-Use, 2021-2029 15. Europe Sterility Testing Market Analysis and Forecasts, By Country 15.1. Market Size (Value) Estimates & Forecast By Country, 2021-2029 15.1.1. U.K 15.1.2. France 15.1.3. Germany 15.1.4. Italy 15.1.5. Spain 15.1.6. Sweden 15.1.7. CIS Countries 15.1.8. Rest of Europe 16. U.K. Sterility Testing Market Analysis and Forecasts, 2021-2029 16.1. Market Size (Value) Estimates & Forecast By Product, 2021-2029 16.2. Market Size (Value) Estimates & Forecast By Test, 2021-2029 16.3. Market Size (Value) Estimates & Forecast By End-Use, 2021-2029 17. France Sterility Testing Market Analysis and Forecasts, 2021-2029 17.1. Market Size (Value) Estimates & Forecast By Product, 2021-2029 17.2. Market Size (Value) Estimates & Forecast By Test, 2021-2029 17.3. Market Size (Value) Estimates & Forecast By End-Use, 2021-2029 18. Germany Sterility Testing Market Analysis and Forecasts, 2021-2029 18.1. Market Size (Value) Estimates & Forecast By Product, 2021-2029 18.2. Market Size (Value) Estimates & Forecast By Test, 2021-2029 18.3. Market Size (Value) Estimates & Forecast By End-Use, 2021-2029 19. Italy Sterility Testing Market Analysis and Forecasts, 2021-2029 19.1. Market Size (Value) Estimates & Forecast By Product, 2021-2029 19.2. Market Size (Value) Estimates & Forecast By Test, 2021-2029 19.3. Market Size (Value) Estimates & Forecast By End-Use, 2021-2029 20. Spain Sterility Testing Market Analysis and Forecasts, 2021-2029 20.1. Market Size (Value) Estimates & Forecast By Product, 2021-2029 20.2. Market Size (Value) Estimates & Forecast By Test, 2021-2029 20.3. Market Size (Value) Estimates & Forecast By End-Use, 2021-2029 21. Sweden Sterility Testing Market Analysis and Forecasts, 2021-2029 21.1. Market Size (Value) Estimates & Forecast By Product, 2021-2029 21.2. Market Size (Value) Estimates & Forecast By Test, 2021-2029 21.3. Market Size (Value) Estimates & Forecast By End-Use, 2021-2029 22. CIS Countries Sterility Testing Market Analysis and Forecasts, 2021-2029 22.1. Market Size (Value) Estimates & Forecast By Product, 2021-2029 22.2. Market Size (Value) Estimates & Forecast By Test, 2021-2029 22.3. Market Size (Value) Estimates & Forecast By End-Use, 2021-2029 23. Rest of Europe Sterility Testing Market Analysis and Forecasts, 2021-2029 23.1. Market Size (Value) Estimates & Forecast By Product, 2021-2029 23.2. Market Size (Value) Estimates & Forecast By Test, 2021-2029 23.3. Market Size (Value) Estimates & Forecast By End-Use, 2021-2029 24. Asia Pacific Sterility Testing Market Analysis and Forecasts, 2021-2029 24.1. Market Size (Value) Estimates & Forecast By Product, 2021-2029 24.2. Market Size (Value) Estimates & Forecast By Test, 2021-2029 24.3. Market Size (Value) Estimates & Forecast By End-Use, 2021-2029 25. Asia Pacific Sterility Testing Market Analysis and Forecasts, by Country 25.1. Market Size (Value) Estimates &Forecast By Country, 2021-2029 25.1.1. China 25.1.2. India 25.1.3. Japan 25.1.4. South Korea 25.1.5. Australia 25.1.6. ASEAN 25.1.7. Rest of Asia Pacific 26. China Sterility Testing Market Analysis and Forecasts, 2021-2029 26.1. Market Size (Value) Estimates & Forecast By Product, 2021-2029 26.2. Market Size (Value) Estimates & Forecast By Test, 2021-2029 26.3. Market Size (Value) Estimates & Forecast By End-Use, 2021-2029 27. India Sterility Testing Market Analysis and Forecasts, 2021-2029 27.1. Market Size (Value) Estimates & Forecast By Product, 2021-2029 27.2. Market Size (Value) Estimates & Forecast By Test, 2021-2029 27.3. Market Size (Value) Estimates & Forecast By End-Use, 2021-2029 28. Japan Sterility Testing Market Analysis and Forecasts, 2021-2029 28.1. Market Size (Value) Estimates & Forecast By Product, 2021-2029 28.2. Market Size (Value) Estimates & Forecast By Test, 2021-2029 28.3. Market Size (Value) Estimates & Forecast By End-Use, 2021-2029 29. South Korea Sterility Testing Market Analysis and Forecasts, 2021-2029 29.1. Market Size (Value) Estimates & Forecast By Product, 2021-2029 29.2. Market Size (Value) Estimates & Forecast By Test, 2021-2029 29.3. Market Size (Value) Estimates & Forecast By End-Use, 2021-2029 30. Australia Sterility Testing Market Analysis and Forecasts, 2021-2029 30.1. Market Size (Value) Estimates & Forecast By Product, 2021-2029 30.2. Market Size (Value) Estimates & Forecast By Test, 2021-2029 30.3. Market Size (Value) Estimates & Forecast By End-Use, 2021-2029 31. ASEAN Sterility Testing Market Analysis and Forecasts, 2021-2029 31.1. Market Size (Value) Estimates & Forecast By Product, 2021-2029 31.2. Market Size (Value) Estimates & Forecast By Test, 2021-2029 31.3. Market Size (Value) Estimates & Forecast By End-Use, 2021-2029 32. Analysis and Forecasts, 2021-2029 32.1. Market Size (Value) Estimates & Forecast By Product, 2021-2029 32.2. Market Size (Value) Estimates & Forecast By Test, 2021-2029 32.3. Market Size (Value) Estimates & Forecast By End-Use, 2021-2029 33. Middle East Africa Sterility Testing Market Analysis and Forecasts, 2021-2029 33.1. Market Size (Value) Estimates & Forecast By Product, 2021-2029 33.2. Market Size (Value) Estimates & Forecast By Test, 2021-2029 33.3. Market Size (Value) Estimates & Forecast By End-Use, 2021-2029 34. Middle East Africa Sterility Testing Market Analysis and Forecasts, by Country 34.1. Market Size (Value) Estimates & Forecast by Country, 2021-2029 34.1.1. South Africa 34.1.2. GCC Countries 34.1.3. Egypt 34.1.4. Nigeria 34.1.5. Rest of ME&A 35. South Africa Sterility Testing Market Analysis and Forecasts, 2021-2029 35.1. Market Size (Value) Estimates & Forecast By Product, 2021-2029 35.2. Market Size (Value) Estimates & Forecast By Test, 2021-2029 35.3. Market Size (Value) Estimates & Forecast By End-Use, 2021-2029 36. GCC Countries Sterility Testing Market Analysis and Forecasts, 2021-2029 36.1. Market Size (Value) Estimates & Forecast By Product, 2021-2029 36.2. Market Size (Value) Estimates & Forecast By Test, 2021-2029 36.3. Market Size (Value) Estimates & Forecast By End-Use, 2021-2029 37. Egypt Sterility Testing Market Analysis and Forecasts, 2021-2029 37.1. Market Size (Value) Estimates & Forecast By Product, 2021-2029 37.2. Market Size (Value) Estimates & Forecast By Test, 2021-2029 37.3. Market Size (Value) Estimates & Forecast By End-Use, 2021-2029 38. Nigeria Sterility Testing Market Analysis and Forecasts, 2021-2029 38.1. Market Size (Value) Estimates & Forecast By Product, 2021-2029 38.2. Market Size (Value) Estimates & Forecast By Test, 2021-2029 38.3. Market Size (Value) Estimates & Forecast By End-Use, 2021-2029 39. Rest of ME&A Sterility Testing Market Analysis and Forecasts, 2021-2029 39.1. Market Size (Value) Estimates & Forecast By Product, 2021-2029 39.2. Market Size (Value) Estimates & Forecast By Test, 2021-2029 39.3. Market Size (Value) Estimates & Forecast By End-Use, 2021-2029 40. South America Sterility Testing Market Analysis and Forecasts, 2021-2029 40.1. Market Size (Value) Estimates & Forecast By Product, 2021-2029 40.2. Market Size (Value) Estimates & Forecast By Test, 2021-2029 40.3. Market Size (Value) Estimates & Forecast By End-Use, 2021-2029 41. South America Sterility Testing Market Analysis and Forecasts, by Country 41.1. Market Size (Value) Estimates & Forecast by Country, 2021-2029 41.1.1. Brazil 41.1.2. Argentina 41.1.3. Rest of South America 42. Brazil Sterility Testing Market Analysis and Forecasts, 2021-2029 42.1. Market Size (Value) Estimates & Forecast By Product, 2021-2029 42.2. Market Size (Value) Estimates & Forecast By Test, 2021-2029 42.3. Market Size (Value) Estimates & Forecast By End-Use, 2021-2029 43. Argentina Sterility Testing Market Analysis and Forecasts, 2021-2029 43.1. Market Size (Value) Estimates & Forecast By Product, 2021-2029 43.2. Market Size (Value) Estimates & Forecast By Test, 2021-2029 43.3. Market Size (Value) Estimates & Forecast By End-Use, 2021-2029 44. Rest of South America Sterility Testing Market Analysis and Forecasts, 2021-2029 44.1. Market Size (Value) Estimates & Forecast By Product, 2021-2029 44.2. Market Size (Value) Estimates & Forecast By Test, 2021-2029 44.3. Market Size (Value) Estimates & Forecast By End-Use, 2021-2029 45. Competitive Landscape 45.1. Geographic Footprint of Major Players in the Sterility Testing Market 45.2. Competition Matrix 45.2.1. Competitive Benchmarking of Key Players By Price, Presence, Market Share, Applications and R&D Investment 45.2.2. New Product Launches and Product Enhancements 45.2.3. Market Consolidation 45.2.3.1. M&A by Regions, Investment and Verticals 45.2.3.2. M&A, Forward Integration and Backward Integration 45.2.3.3. Partnership, Joint Ventures and Strategic Alliances/ Sales Agreements 45.3. Company Profile : Key Players 45.3.1. Merck KGaA 45.3.1.1. Company Overview 45.3.1.2. Financial Overview 45.3.1.3. Geographic Footprint 45.3.1.4. Product Portfolio 45.3.1.5. Business Strategy 45.3.1.6. Recent Developments 45.3.2. Charles River Laboratories International, Inc. 45.3.3. bioMérieux SA 45.3.4. SGS S.A. 45.3.5. Sartorius AG 45.3.6. Thermo Fisher Scientific, Inc. 45.3.7. Cummins Filtration 45.3.8. Danaher 45.3.9. Nelson Laboratories 45.3.10. LLC 45.3.11. TOXIKON 45.3.12. WuXiAppTec 45.3.13. Rapid Micro Biosystems, Inc. 45.3.14. Baxter and Pace Analytical 45.3.15. GMD group 45.3.16. ARMÜR TEXTILE 45.3.17. NINESUN 45.3.18. BERK Grup 46. Primary Key Insights