Published :
Tables : 78
Figures : 25
Category : Healthcare
No. of Pages : 180
Report Code : HC-1184
Bioburden Testing Market Introduction: Global Bioburden Testing Market is anticipated to witness value over USD 1.3 billion during the forecast period 2020 to 2027 with a CAGR of over 11%. Bioburden testing is the study of the microbial count present on the surface of any material or product. The term is used for testing the contamination in pharmaceutical products, food and beverages, medical devices, etc. Bioburden testing is mandatory as per ICH (International Conference on Harmonization) guidelines for the manufacturing and distribution of food and drugs along with medical devices. For an FDA ( Food and Drug Administration) approval the bioburden testing as per ICH guidelines must be followed. This is the key factor driving the bioburden testing market. Growth in the pharmaceutical products, food and beverages, medical devices across the globe are factors contributing to bioburden market growth and are positively influencing the CAGR. The risk of microbial contamination in healthcare products and hence the related safety concerns can not be ignored. It is the key factor driving the market. The consumables like culture media and reagents are estimated to contribute as a major part of the market growth across the globe. Culture media and reagents are basic ingredients used for bioburden testing. Any negligence in the safety and sterility conditions of the product creates severe health problems and a huge loss in the market. To avoid such consequences, bioburden testing is the key. The contamination in raw materials is detected by anaerobic count testing. The safety and economic concerns related to raw materials have driven the preference for anaerobic count testing in the market. The rising demand for anaerobic count testing is one of the key elements driving its contribution to the market. Pharmaceutical and biotechnology companies contribute to the large share of the bioburden testing market worldwide. Pharma companies involve bioburden testing at every step of manufacturing starting from raw materials to finished products. This is the major feature that drives the growth of the market. North America is estimated to hold a large share in the market. The rise in research and development activities and massive investments in these activities play a major role in market growth. The increasing scope for pharma industries in Asia Pacific s one of the dominating factors responsible for the market to grow. Major Market Players are: Charles River, Merck KGaA, SGS SA, Wuxi Apptec, BD, North American Science Associates Inc. (NAMSA), Nelson Laboratories, LLC, Thermo Fisher Scientific, Biomérieux SA, Pacific Biolabs. Bioburden Testing Market Segmentation: By Product Consumables Instruments By Test Type Aerobic count testing Anaerobic count testing Fungi/ Mold count testing Spore count testing By Application Raw material testing Medical device testing In-process material testing Sterilization validation testing Equipment cleaning validation By End User Pharmaceutical and biotechnology companies Medical device manufacturers Contract manufacturing organizations Manufacturers of Food & Beverage and Agricultural Products Microbial Testing Laboratories By Region North America Europe Asia Pacific Rest of the world Competitive Landscape: Tier 1 players- established companies in the market with a major market share Tier 2 players Emerging players which are growing rapidly New Entrants FutureWise Key Takeaways: New advancements in bioburden testing methods Investment in bioburden consumables products Collaboration bioburden testing organization Objectives of the Study: To provide with an exhaustive analysis on the bioburden testing market by product, by test type, by application, by end user and by region To cater comprehensive information on factors impacting market growth (drivers, restraints, opportunities, and industry-specific restraints) To evaluate and forecast micro-markets and the overall market To predict the market size, in key regions (along with countries)— North America, Europe, Asia Pacific, and the rest of the world To record evaluate and competitive landscape mapping-product launches, technological advancements, mergers and expansions Profiling of companies to evaluate their market shares, strategies, financials and core competencies Flexible Delivery Model: We have a flexible delivery model and you can suggest changes in the scope/table of content as per your requirement The customization Mobility Care offered are free of charge with purchase of any license of the report You can directly share your requirements/changes to the current table of content to: sales@futurewiseresearch.com
Global Bioburden Testing Market is anticipated to witness value over USD 1.3 billion during the forecast period 2020 to 2027 with a CAGR of over 11%.
Bioburden testing is the study of the microbial count present on the surface of any material or product. The term is used for testing the contamination in pharmaceutical products, food and beverages, medical devices, etc. Bioburden testing is mandatory as per ICH (International Conference on Harmonization) guidelines for the manufacturing and distribution of food and drugs along with medical devices.
For an FDA ( Food and Drug Administration) approval the bioburden testing as per ICH guidelines must be followed. This is the key factor driving the bioburden testing market.
Growth in the pharmaceutical products, food and beverages, medical devices across the globe are factors contributing to bioburden market growth and are positively influencing the CAGR. The risk of microbial contamination in healthcare products and hence the related safety concerns can not be ignored. It is the key factor driving the market.
The consumables like culture media and reagents are estimated to contribute as a major part of the market growth across the globe. Culture media and reagents are basic ingredients used for bioburden testing. Any negligence in the safety and sterility conditions of the product creates severe health problems and a huge loss in the market. To avoid such consequences, bioburden testing is the key.
The contamination in raw materials is detected by anaerobic count testing. The safety and economic concerns related to raw materials have driven the preference for anaerobic count testing in the market. The rising demand for anaerobic count testing is one of the key elements driving its contribution to the market.
Pharmaceutical and biotechnology companies contribute to the large share of the bioburden testing market worldwide. Pharma companies involve bioburden testing at every step of manufacturing starting from raw materials to finished products. This is the major feature that drives the growth of the market.
North America is estimated to hold a large share in the market. The rise in research and development activities and massive investments in these activities play a major role in market growth. The increasing scope for pharma industries in Asia Pacific s one of the dominating factors responsible for the market to grow.
Major Market Players are:
Charles River, Merck KGaA, SGS SA, Wuxi Apptec, BD, North American Science Associates Inc. (NAMSA), Nelson Laboratories, LLC, Thermo Fisher Scientific, Biomérieux SA, Pacific Biolabs.
Bioburden Testing Market Segmentation:
By Product
By Test Type
By Application
By End User
By Region
Competitive Landscape:
FutureWise Key Takeaways:
Objectives of the Study:
Flexible Delivery Model:
1. Market Introduction 1.1. Objectives of the Study 1.2. Market Definition 1.3. Market Scope 1.3.1. Years Considered for the Study 1.3.2. Market Covered 1.4. Currency 1.5. Limitations 1.6. Stakeholders 2. Research Methodology 2.1. Research Data 2.1.1. Secondary Data 2.1.1.1. Key Data from Secondary Sources 2.1.2. Primary Data 2.1.2.1. Key Data from Primary Sources 2.2. Market Size Estimation 2.3. Market Breakdown and Data Triangulation 2.4. Assumptions for the Study 3. Executive Summary 3.1. Market Outlook 3.2. Segment Outlook 3.3. Competitive Insights 4. Global Bioburden Testing Market Variables, Trends & Scope 4.1. Market Lineage Outlook 4.2. Penetration and Growth Prospect Mapping 4.3. Industry Value Chain Analysis 4.4. Cost Analysis Breakdown 4.5. Technology Overview 4.6. Regulatory Framework 4.6.1. Reimbursement Framework 4.6.2. Standards and Compliances 5. Global Bioburden Testing Market Overview 5.1. Market Dynamics 5.1.1. Market Driver Analysis 5.1.1.1. Increasing focus of Bioburden Testing Companies on Brand Protection 5.1.1.2. Untapped Opportunities in Emerging Regions 5.1.2. Market Restraint Analysis 5.1.2.1. High Cost Associated with Implementation of Predictive Analysis 5.1.3. Industry Challenges 5.1.3.1. Presence of Ambiguous Regulatory Framework 6. Global Bioburden Testing Market Analysis Tools 6.1. Industry Analysis - Porter’s 6.1.1. Supplier Power 6.1.2. Buyer Power 6.1.3. Substitution Threat 6.1.4. Threat from New Entrants 6.1.5. Competitive Rivalry 6.2. Pestel Analysis 6.2.1. Political Landscape 6.2.2. Environmental Landscape 6.2.3. Social Landscape 6.2.4. Technology Landscape 6.2.5. Legal Landscape 6.3. Major Deals And Strategic Alliances Analysis 6.3.1. Joint Ventures 6.3.2. Mergers and Acquisitions 6.3.3. Licensing and Partnership 6.3.4. Technology Collaborations 6.3.5. Strategic Divestments 6.4. Market Entry Strategies 6.5. Case Studies 7. Global Bioburden Testing Market, By Product Historical Analysis and Forecast 2020-2027 (USD Million) 7.1 Consumables 7.1.1. Culture Media, Reagents, and Kits 7.1.2. Other Consumables 7.2 Instruments 7.1.1. Automated Microbial Identification Systems 7.1.2. Pcr Instruments 7.1.3. Microscopes 7.1.4. Other Instruments 8. Global Bioburden Testing Market, By Test Type Historical Analysis and Forecast 2020-2027 (USD Million) 8.1 Aerobic count testing 8.2 Anaerobic count testing 8.3. Fungi/ Mold count testing 8.4. Spore count testing 9. Global Bioburden Testing Market, By Application Historical Analysis and Forecast 2020-2027 (USD Million) 9.1 Raw material testing 9.2 Medical device testing 9.3 In-process material testing 9.4 Sterilization validation testing 9.5 Equipment cleaning validation 10. Global Bioburden Testing Market, By End-User Historical Analysis and Forecast 2020-2027 (USD Million) 10.1. Pharmaceutical and biotechnology companies 10.2. Medical device manufacturers 10.3. Contract manufacturing organizations 10.4. Manufacturers of Food & Beverage and Agricultural Products 10.5. Microbial Testing Laboratories 10.6. Medical device manufacturers 11. North America Market Analysis 2015–2019 and Forecast 2020–2027 (USD Million) 11.1. Introduction 11.2. Historical Market Size (USD Million) Analysis By Country, 2015-2019 11.2.1. U.S.A 11.2.2. Canada 11.2.3. Mexico 11.3. Market Size (USD Million) Forecast for North America 2020-2027 12. Latin America Market Analysis 2015–2019 and Forecast 2020–2027 (USD Million) 12.1. Introduction 12.2. Historical Market Size (USD Million) Analysis By Country, 2015-2019 12.2.1. Brazil 12.2.2. Venezuela 12.2.3. Argentina 12.2.4. Rest of Latin America 12.3. Market Size (USD Million) Forecast for Latin America 2020-2027 13. Europe Market Analysis 2015–2019 and Forecast 2020–2027 (USD Million) 13.1. Introduction 13.2. Historical Market Size (USD Million) Analysis By Country, 2015-2019 13.2.1. Germany 13.2.2. U.K 13.2.3. France 13.2.4. Italy 13.2.5. Spain 13.2.6. Russia 13.2.7. Poland 13.2.8. Rest of Europe 13.3. Market Size (USD Million) Forecast for Europe 2020-2027 14. Asia Pacific Market Analysis 2015–2019 and Forecast 2020–2027 (USD Million) 14.1. Introduction 14.2. Historical Market Size (USD Million) Analysis By Country, 2015-2019 14.2.1. Japan 14.2.2. China 14.2.3. India 14.2.4. Australia and New Zealand 14.2.5. ASEAN 14.2.6. Rest of Asia Pacific 14.3. Market Size (USD Million) Forecast for Asia Pacific 2020-2027 15. Middle East and Africa Market Analysis 2015–2019 and Forecast 2020–2027 (USD Million) 15.1. Introduction 15.2. Historical Market Size (USD Million) Analysis By Country, 2015-2019 15.2.1. Saudi Arabia 15.2.2. UAE 15.2.3. South Africa 15.2.4. Egypt 15.3. Market Size (USD Million) Forecast for MEA 2020-2027 16. Company Profiles (Competition Dashboard, Competitors Deep Dive, Product Connected Devices and Disease Indication Portfolio, Financial Layouts) 16.1 Charles River 16.1.1. Company Overview (HQ, Business Segments, Employee Strength) 16.1.2. Product Portfolio 16.1.3. SWOT Analysis 16.1.4. Financial Overview 16.1.5. Strategic Overview 16.2 Merck KGaA 16.2.1. Company Overview (HQ, Business Segments, Employee Strength) 16.2.2. Product Portfolio 16.2.3. SWOT Analysis 16.2.4. Financial Overview 16.2.5. Strategic Overview 16.3 SGS SA 16.3.1. Company Overview (HQ, Business Segments, Employee Strength) 16.3.2. Product Portfolio 16.3.3. SWOT Analysis 16.3.4. Financial Overview 16.3.5. Strategic Overview 16.4 Wuxi Apptec 16.4.1. Company Overview (HQ, Business Segments, Employee Strength) 16.4.2. Product Portfolio 16.4.3. SWOT Analysis 16.4.4. Financial Overview 16.4.5. Strategic Overview 16.5 BD 16.5.1. Company Overview (HQ, Business Segments, Employee Strength) 16.5.2. Product Portfolio 16.5.3. SWOT Analysis 16.5.4. Financial Overview 16.5.5. Strategic Overview 16.6 North American Science Associates Inc. (NAMSA) 16.6.1. Company Overview (HQ, Business Segments, Employee Strength) 16.6.2. Product Portfolio 16.6.3. SWOT Analysis 16.6.4. Financial Overview 16.6.5. Strategic Overview 16.7 Nelson Laboratories, LLC 16.7.1. Company Overview (HQ, Business Segments, Employee Strength) 16.7.2. Product Portfolio 16.7.3. SWOT Analysis 16.7.4. Financial Overview 16.7.5. Strategic Overview 16.8 Thermo Fisher Scientific 16.8.1. Company Overview (HQ, Business Segments, Employee Strength) 16.8.2. Product Portfolio 16.8.3. SWOT Analysis 16.8.4. Financial Overview 16.8.5. Strategic Overview 16.9 Biomérieux SA 16.9.1. Company Overview (HQ, Business Segments, Employee Strength) 16.9.2. Product Portfolio 16.9.3. SWOT Analysis 16.9.4. Financial Overview 16.9.5. Strategic Overview 16.10 Pacific Biolabs 16.10.1. Company Overview (HQ, Business Segments, Employee Strength) 16.10.2. Product Portfolio 16.10.3. SWOT Analysis 16.10.4. Financial Overview 16.10.5. Strategic Overview 17. FutureWise SME Key Takeaway Points for Client
UK : +44 141 628 9353 US : +1 347 709 4931
OR
Excel Dataset
Infographics
PDF Report
Market Overview
PowerPoint Presentation
Consumer Perception and Procurement
Competitive Analysis
What’s Next
Market Data Forecast
Risks and Opportunity Assessment
Market Trends and Dynamics