The Microbiology CRO Services market size is projected to reach US$ 11.51 billion by 2031 from US$ 5.52 billion in 2023. The market is expected to register a CAGR of 9.6% during 2023–2031. The integration of artificial intelligence and machine learning is likely to act as a future trend in the market.
Microbiology CRO Services Market Analysis
Microbial testing CROs offer specialized services, including bacterial identification, antimicrobial susceptibility testing, sterility testing, bioburden testing, and molecular testing, to support these research and development efforts. The increasing demand for personalized medicine, targeted therapies, and implantable devices is also increasing the need for microbial testing CROs to provide customized testing services. Thus, increasing research and development investments fuel the microbiology CRO market growth. Moreover, the increasing number of clinical trials and the practice of outsourcing trials to CROs is contributing to the market growth.
Microbiology CRO Services Market Overview
Germany is expected to register the highest CAGR in the microbiology CRO services market in Europe during the forecast period. Germany is expected to be among the significant contributors to the growth of the microbiology CRO services market owing to the increasing number of clinical trials. According to Clinical Trials Arena, Germany held ~3.9% of the total clinical trials carried out worldwide in 2021. Germany has a massive patient pool and a high demand for quality healthcare. Coordinating centers for clinical trials were set up as part of a new funding program under the Federal Ministry of Education and Research to further encourage academic clinical research. The Federal Institute for Drugs and Medical Devices or the Paul-Ehrlich Institute approves clinical trials in Germany, depending on the product to be investigated. Sofpromed, a full-service CRO, states that Germany is considered one of the best countries in the EU to run clinical trials (within the top three countries in Europe in a number of clinical studies). By June 2021, the US clinical trial portal (clinicaltrials.gov) had registered 21,470 clinical studies with at least one German site. Microbiological testing is crucial in Europe for ensuring quality control, regulatory compliance, and minimizing the risk of microbial contamination.
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Microbiology CRO Services Market: Strategic Insights
Market Size Value in US$ 5.52 Billion in 2023 Market Size Value by US$ 11.51 Billion by 2031 Growth rate CAGR of 9.6% from 2023 to 2031 Forecast Period 2024-2031 Historic Period 2021-2022
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Microbiology CRO Services Market: Strategic Insights
| Market Size Value in | US$ 5.52 Billion in 2023 |
| Market Size Value by | US$ 11.51 Billion by 2031 |
| Growth rate | CAGR of 9.6% from 2023 to 2031 |
| Forecast Period | 2024-2031 |
| Historic Period | 2021-2022 |
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Microbiology CRO Services Market Drivers and Opportunities
Rising Practice of Outsourcing Clinical Studies with Massive Number of Trials Drive Market Growth
According to the National Library of Medicine (NLM), ~52,000 new studies were registered with NLM (ClinicalTrials.gov) in 2020, and the number increased to ~58,000 in 2023. In January 2023, the NLM reported 38,837 active clinical trials in the US and 105,172 active trials worldwide. According to the European Medicine Agency, in the European Union (EU), ~4,000 clinical trials are authorized annually, of which about 60% of studies are associated with the pharmaceutical industry. An upsurge in the number of clinical trials can be attributed to the rising prevalence of chronic diseases worldwide, which creates an immense demand for more effective treatments.
The increasing complexity of clinical trials makes the proper execution and monitoring of operations carried out in research-based organizations crucial. To avoid errors due to improper execution, many research-based organizations outsource clinical trials to clinical research organizations (CROs). Furthermore, CROs assist in successfully implementing clinical trials by offering deep subject matter expertise at high-quality facilities. They have gradually become an important part of the clinical trial industry through their efficient and cost-effective operations that benefit trial sponsors. According to a blog published by Thermo Fisher Scientific, in 2022, CROs executed ~3 out of 4 clinical trials to reassure the clinical programs of drug developers; provide a wealth of expertise; drive time and cost efficiencies; and deliver customized, high-quality data. Thus, the increasing number of clinical trials and the practice of outsourcing trials to CROs to boost cost-effectiveness and reduce errors drive the microbiology CRO market.
Advancements in Microbiology Testing Technology to Offer Opportunities for Microbiology CRO Services Market
The advancements in microbiology testing technology have revolutionized the pharmaceutical and medical device industries. These advancements enable faster, more accurate, and cost-effective detection of microorganisms. A few critical advancements in microbiology testing technology are mentioned below:
• Molecular Diagnostics: Next-generation sequencing (NGS) and polymerase chain reaction (PCR) technologies have enabled rapid detection of microorganisms, allowing for earlier identification of contamination and reduced product recall rates.
• Automated Systems: Automated systems, such as microbiology analyzers and robotic systems, have increased efficiency, reduced labor costs, and improved accuracy in testing.
• Rapid Microbiological Methods: Techniques such as ATP bioluminescence, PCR-based methods, and mass spectrometry have accelerated microbial identification, reducing the time of results from days to hours or even minutes.
• Microbial Identification Systems: Advanced microbial identification systems such as matrix-assisted laser desorption/ionization-time of flight (MALDI-TOF) mass spectrometry have improved accuracy and speed in identifying microorganisms.
The abovementioned advancements in microbiology testing technology have improved the accuracy, speed, and efficiency of testing. These improvements enable the pharmaceutical and medical device industries to reduce product recall rates, improve product quality, enhance patient safety, increase efficiency and reduce costs, and accelerate product development and launch timelines. This, in turn, has opened up new avenues for pharmaceutical companies to ensure the quality and safety of their products and for medical device manufacturers to ensure the sterility and biocompatibility of their devices.
Microbiology CRO Services Market Report Segmentation Analysis
Key segments that contributed to the derivation of the microbiology CRO services market analysis are service type, application, microorganisms, and end user.
- Based on service type, the microbiology CRO services market is segmented into assay development, custom viral stock production, microbial testing, and others. The assay development segment held the largest share of the market in 2023.
- By application, the microbiology CRO services market is segmented into clinical, medical device, and others. The clinical segment held the largest share of the market in 2023.
- In terms of microorganisms, the microbiology CRO services market is categorized into bacteria, fungi, viruses, and parasites. The bacteria segment dominated the market in 2023.
- Based on end user, the market is segmented into biotech and pharmaceutical companies, medical device companies, and others. The biotech and pharmaceutical companies segment held the largest share of the market in 2023.
Microbiology CRO Services Market Share Analysis by Geography
The geographic scope of the microbiology CRO services market report is mainly divided into five regions: North America, Asia Pacific, Europe, South & Central America, and the Middle East & Africa. North America dominated the market in 2023. The microbiology CRO market in North America is segmented into the US, Canada, and Mexico. The US is the largest microbiology CRO market and is estimated to dominate the market during the forecast period. The microbiology CRO market growth in the US is driven by the adoption of modern technologies by CROs, the surging number of clinical trials, and increasing investment in research and development by pharmaceutical and biotechnological companies. Also, strategic initiatives by market players play a significant role in supporting the microbiology CRO market growth. For instance, in February 2024, ICON plc acquired Clinical Research Management, Inc. (ClinicalRM). ClinicalRM offers comprehensive research solutions to various US government agencies. The company has extensive expertise in basic and applied research, infectious diseases, vaccine development, testing, and responding to bio-threats. They have collaborated with both government and commercial customers to address the threat of global viral epidemics.
Microbiology CRO Services Market Report Scope
Microbiology CRO Services Market News and Recent Developments
The microbiology CRO services market is evaluated by gathering qualitative and quantitative data post primary and secondary research, which includes important corporate publications, association data, and databases. A few of the developments in the microbiology CRO services market are listed below:
- Frontage Laboratories, Inc. and its subsidiary, Frontage Canada, Inc., acquired Nucro-Technics Inc. and its affiliate, Nucro-Technics Holdings, Inc., a pharmaceutical contract research organization offering various services. (Source: Frontage Laboratories, Inc; Company Website; August 2023)
- Pacific BioLabs announced the launch of In Vitro Services. These In Vitro Services offer in vitro, cell-based assays supporting the pharmaceutical, biopharma, and medical device industries. The addition of this group to the PBL testing portfolio increases and is complimentary to well-established testing capabilities in our Microbiology, Analytical/Bioanalytical, and In Vivo departments. (Source: Pacific BioLabs, Company Website, May 2022)
Microbiology CRO Services Market Report Coverage and Deliverables
The "Microbiology CRO Services Market Size and Forecast (2021–2031)" report provides a detailed analysis of the market covering below areas:
- Microbiology CRO services market size and forecast at global, regional, and country levels for all the key market segments covered under the scope
- Microbiology CRO services market trends, as well as market dynamics such as drivers, restraints, and key opportunities
- Detailed PEST and SWOT analysis
- Microbiology CRO services market analysis covering key market trends, global and regional framework, major players, regulations, and recent market developments
- Industry landscape and competition analysis covering market concentration, heat map analysis, prominent players, and recent developments for the microbiology CRO services market
- Detailed company profiles
Report Coverage
Revenue forecast, Company Analysis, Industry landscape, Growth factors, and Trends
Segment Covered
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to segments covered.
Regional Scope
North America, Europe, Asia Pacific, Middle East & Africa, South & Central America
Country Scope
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to country scope.
Frequently Asked Questions
The market is expected to register a CAGR of 9.6% during 2023–2031.
The microbiology CRO services market is expected to reach US$ 11.51 billion by 2031.
Microbiologics, Melbec Microbiology, Emery Pharma, TheraIndx Lifesciences Pvt. Ltd., AVERIN BIOTECH, Statens Serum Institut, ImQuest BioScience, PACIFIC BIOLAB, Innovotech Inc, and BluTest Laboratories Ltd. are among the key players in the market.
The rise in partnerships and collaborations with service providers is expected to be a prime trend in the market in the coming years.
The rising practice of outsourcing clinical studies with a massive number of trials and surging research and development investments are among the most significant factors fueling the market growth.
North America dominated the market in 2023.
The Insight Partners performs research in 4 major stages: Data Collection & Secondary Research, Primary Research, Data Analysis and Data Triangulation & Final Review.
- Data Collection and Secondary Research:
As a market research and consulting firm operating from a decade, we have published many reports and advised several clients across the globe. First step for any study will start with an assessment of currently available data and insights from existing reports. Further, historical and current market information is collected from Investor Presentations, Annual Reports, SEC Filings, etc., and other information related to company’s performance and market positioning are gathered from Paid Databases (Factiva, Hoovers, and Reuters) and various other publications available in public domain.
Several associations trade associates, technical forums, institutes, societies and organizations are accessed to gain technical as well as market related insights through their publications such as research papers, blogs and press releases related to the studies are referred to get cues about the market. Further, white papers, journals, magazines, and other news articles published in the last 3 years are scrutinized and analyzed to understand the current market trends.
- Primary Research:
The primarily interview analysis comprise of data obtained from industry participants interview and answers to survey questions gathered by in-house primary team.
For primary research, interviews are conducted with industry experts/CEOs/Marketing Managers/Sales Managers/VPs/Subject Matter Experts from both demand and supply side to get a 360-degree view of the market. The primary team conducts several interviews based on the complexity of the markets to understand the various market trends and dynamics which makes research more credible and precise.
A typical research interview fulfils the following functions:
- Provides first-hand information on the market size, market trends, growth trends, competitive landscape, and outlook
- Validates and strengthens in-house secondary research findings
- Develops the analysis team’s expertise and market understanding
Primary research involves email interactions and telephone interviews for each market, category, segment, and sub-segment across geographies. The participants who typically take part in such a process include, but are not limited to:
- Industry participants: VPs, business development managers, market intelligence managers and national sales managers
- Outside experts: Valuation experts, research analysts and key opinion leaders specializing in the electronics and semiconductor industry.
Below is the breakup of our primary respondents by company, designation, and region:
Once we receive the confirmation from primary research sources or primary respondents, we finalize the base year market estimation and forecast the data as per the macroeconomic and microeconomic factors assessed during data collection.
- Data Analysis:
Once data is validated through both secondary as well as primary respondents, we finalize the market estimations by hypothesis formulation and factor analysis at regional and country level.
- 3.1 Macro-Economic Factor Analysis:
We analyse macroeconomic indicators such the gross domestic product (GDP), increase in the demand for goods and services across industries, technological advancement, regional economic growth, governmental policies, the influence of COVID-19, PEST analysis, and other aspects. This analysis aids in setting benchmarks for various nations/regions and approximating market splits. Additionally, the general trend of the aforementioned components aid in determining the market's development possibilities.
- 3.2 Country Level Data:
Various factors that are especially aligned to the country are taken into account to determine the market size for a certain area and country, including the presence of vendors, such as headquarters and offices, the country's GDP, demand patterns, and industry growth. To comprehend the market dynamics for the nation, a number of growth variables, inhibitors, application areas, and current market trends are researched. The aforementioned elements aid in determining the country's overall market's growth potential.
- 3.3 Company Profile:
The “Table of Contents” is formulated by listing and analyzing more than 25 - 30 companies operating in the market ecosystem across geographies. However, we profile only 10 companies as a standard practice in our syndicate reports. These 10 companies comprise leading, emerging, and regional players. Nonetheless, our analysis is not restricted to the 10 listed companies, we also analyze other companies present in the market to develop a holistic view and understand the prevailing trends. The “Company Profiles” section in the report covers key facts, business description, products & services, financial information, SWOT analysis, and key developments. The financial information presented is extracted from the annual reports and official documents of the publicly listed companies. Upon collecting the information for the sections of respective companies, we verify them via various primary sources and then compile the data in respective company profiles. The company level information helps us in deriving the base number as well as in forecasting the market size.
- 3.4 Developing Base Number:
Aggregation of sales statistics (2020-2022) and macro-economic factor, and other secondary and primary research insights are utilized to arrive at base number and related market shares for 2022. The data gaps are identified in this step and relevant market data is analyzed, collected from paid primary interviews or databases. On finalizing the base year market size, forecasts are developed on the basis of macro-economic, industry and market growth factors and company level analysis.
- Data Triangulation and Final Review:
The market findings and base year market size calculations are validated from supply as well as demand side. Demand side validations are based on macro-economic factor analysis and benchmarks for respective regions and countries. In case of supply side validations, revenues of major companies are estimated (in case not available) based on industry benchmark, approximate number of employees, product portfolio, and primary interviews revenues are gathered. Further revenue from target product/service segment is assessed to avoid overshooting of market statistics. In case of heavy deviations between supply and demand side values, all thes steps are repeated to achieve synchronization.
We follow an iterative model, wherein we share our research findings with Subject Matter Experts (SME’s) and Key Opinion Leaders (KOLs) until consensus view of the market is not formulated – this model negates any drastic deviation in the opinions of experts. Only validated and universally acceptable research findings are quoted in our reports.
We have important check points that we use to validate our research findings – which we call – data triangulation, where we validate the information, we generate from secondary sources with primary interviews and then we re-validate with our internal data bases and Subject matter experts. This comprehensive model enables us to deliver high quality, reliable data in shortest possible time.
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