USD 298.91 Million
Mycoplasma Testing Market Size, Share, Growth Analysis, By Product & Service(Assays, Kits, & Reagents (NAT Assays, Kits), By Technique(Nucleic Acid Testing, Enzyme-Linked Immunosorbent Assay, Staining, Other Techniques), By Application(Cell Line Testing, Virus Testing, End-Of-Production Cell Testing), By End User(Pharmaceutical & Biotechnology Companies, Contract Research Organizations, Academic & Research Institutes, Cell Banks & Laboratories), By Region - Industry Forecast 2024-2031
Report ID:
SQMIG35I2219 |
Region:
Global |
Published Date: September, 2024
Pages:
219
|Tables:
66
|Figures:
75
Mycoplasma Testing Market Insights
Global Mycoplasma Testing Market size was valued at USD 829.6 million in 2022 and is poised to grow from USD 9110.23 million in 2023 to USD 1911.78 million by 2031, growing at a CAGR of 9.72% during the forecast period (2024-2031).
Growth and innovations in the diagnostic sector have created an opportunity for mycoplasma testing market size because of the rising contaminations of mycoplasma within the pharmaceutical and biotechnology industry producing mycoplasma testing products. Main mycoplasma testing market growth drivers include rising research initiatives in the biotechnology and the biopharmaceutical industries, and the higher demand of the mycoplasma testing kits by the biopharmaceutical industry. The mycoplasma testing market share will increase due to emerging markets because of the better infrastructure for healthcare, an increased unmet healthcare demands, and the rising incidence of mycoplasma contamination. As a matter of fact, rules and regulations mandating testing for biologics and vaccines for mycoplasma contamination have been published by regulatory bodies, including the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA). Due to this, a heightened demand for mycoplasma testing has been witnessed in the biopharmaceutical sector. Also, technical innovations are inclined to lead to the mycoplasma testing market share, including faster and more accurate procedures and equipment for mycoplasma testing. The latest instance is Minerva Biolabs GmbH's VenorGeM Advance assay, highly sensitive and specific, which targets mycoplasma contamination in biological matrices of cell cultures.
US Mycoplasma Testing Market is poised to grow at a sustainable CAGR for the next forecast year.
Market Snapshot - 2024-2031
Global Market Size
Largest Segment
Cell Line Testing
Fastest Growth
Cell Line Testing
Growth Rate
14% CAGR
Global Mycoplasma Testing Market ($ Bn)
Country Share for North America Region (%)
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Mycoplasma Testing Market Segmental Analysis
Global Mycoplasma Testing Market is segmented by Product & Service, Technique, Application, End User, and Region. Based on Product & Service, the market is segmented into Assays, Kits, & Reagents (NAT Assays, Kits, & Reagents; Enzyme-Linked Immunosorbent Assays, Kits, & Reagents, Elimination Kits, Stains, Other Assays, Kits, & Reagents), Instruments, Services. Based on Technique, the market is segmented into Nucleic Acid Testing, Enzyme-Linked Immunosorbent Assay, Staining, Other Techniques. Based on Application, the market is segmented into Cell Line Testing, Virus Testing, End-Of-Production Cell Testing. Based on End User, the market is segmented into Pharmaceutical & Biotechnology Companies, Contract Research Organizations, Academic & Research Institutes, Cell Banks & Laboratories. Based on region, the market is segmented into North America, Europe, Asia Pacific, Latin America and Middle East & Africa.
Mycoplasma Testing Market Analysis by Application
Industry growth and R&D spending were stimulated by growth in demand in the research initiatives of cell culture. In 2023, the cell line testing segment experienced the highest growth rate and highest market share at 41.65%. Testing is a necessity for identifying Mycoplasma, which, if done, would boost industry growth and more R&D spending. Almost USD 981 million was spent by the Canadian Institutes of Health Research (CIHR) for funding various health research projects across the country. Furthermore, NRC-IRAP offers technical support to the cell companies in Canada that are small and medium-sized. This kind of support stimulates innovation and development of new products in the cell industry.
The end-of-production cells testing segment ranked the second mycoplasma testing market share position in 2023. Critical stability and contamination assessments are a few of the tests crucial for proving the product’s safety. This procedure ensures that products comply with safety requirements through evaluation of the genetic stability of recombinant cells post-manufacturing, and it addresses possible contamination problems in the production system. The importance of end-of-product cell testing is predicted to drive further market growth as the demand for quality assurance grows, emphasizing the need to determine product stability and ensure the absence of contamination in biopharmaceutical manufacturing.
Mycoplasma Testing Market Analysis by End User
The pharmaceutical and biotechnology companies segment led the highest compound annual growth rate in the period under forecast with a 35.56% revenue share in the year 2023. It is being driven by considerable advancements in drug development that are being propelled by such corporations making notable investments in R&D. They assure biological safety of their products by subjecting raw materials to stringent quality testing, meeting legal requirements, and thereby improve product reliability. At the same time, as companies seek solutions to these pressing issues affecting healthcare, the incidence of chronic diseases such as psoriasis and rheumatoid arthritis will rise further, pushing demand for new treatments and into the biopharmaceutical sector through 2023.
However, the contract research organizations (CROs) segment is expected to grow profitably in the mycoplasma testing industry. This is mainly because of the increasingly broad scope of research services offered to pharmaceutical and biotechnology companies. Such CROs provided critical services that are needed to be able to ensure the launch of a new therapy. They have to provide commercialization support for biologic assays and also biopharmaceutical development. Of these organizations, specialist tests, including mycoplasma testing, are undertaken to ensure the integrity and sterility of the cultures used in preclinical research and biopharmaceutical development. With an increasing number of CROs, the quality and accessibility of outsourced testing services enhance, driving the market growth and increasing the overall efficiency of the drug development process.
Global Mycoplasma Testing Market By Application
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Mycoplasma Testing Market Regional Insights
According to the mycoplasma testing market forecast, North America led the market in 2023 with a revenue share of 39.04%. A combination of several factors leads to a high market share. Prevalence of respiratory disorders is also at a high level and the rising investment in biotechnology by major companies since its wide application in cancer research and developing novel biologics, vaccines, and drugs. Besides, through the development and integration of strict regulatory requirements, companies such as the FDA and the U.S. Department of Health and Human Services, in collaboration with the Centers for Disease Control and Prevention and the National Institutes of Health, continually advance standards on the testing of biological and microbiological safety of biomedical laboratories.
Asia-Pacific is predicted to grow at the highest CAGR during the forecast period. It is expected that the future development prospects would be spurred by the implementation of biosafety quality improvement-friendly regulatory mandates adopted by the health care organizations. It is with better infrastructures in place and better maintenance at higher levels of product safety that it would be anticipated to have a positive effect on the adoption of mycoplasma testing under the National Biotechnology Development Strategy-through government-led initiatives toward becoming a prime industrial power. Moreover, these developments were expected to ensure the continued industrial growth in the pharmaceutical and biologics industries and to bring long-term health benefits to humans. Further scope for development is perceived with the fact that there exist biological safety specific guidelines for the given research areas which include cell culture and recombinant DNA research.
Global Mycoplasma Testing Market By Geography
- Largest
- Fastest
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Mycoplasma Testing Market Dynamics
Mycoplasma Testing Market Drivers
Expanding Research & Development Activities
- Demand for mycoplasma testing is increasing, driven by an upsurge in the research and development of biological products in biotechnology and pharmaceuticals, including cell-based medicines and vaccines. As more and more researchers increasingly rely on cell lines for manufacturing, the requirement for a mycoplasma infection-free cell line stream has become necessary. As businesses grow through giving increased priority to quality assurance during their research operations, market demand is rising along with the need for rigorous testing methodologies.
Rising Awareness of Contamination Risks
- Increased awareness by scientists, manufacturers, and regulatory agencies of the threats mycoplasma contamination poses is driving demand for mycoplasma testing. Through education and outreach programs that have focused attention on the potential effects that contamination might have on product safety and efficacy, quality in biopharmaceutical manufacture has been better assured by increased use of tests.
Restraints
Lack of Availability of Trained Personnel
- The lack of skilled people with modern testing methodologies is a hindrance to the mycoplasma testing industry. Appropriate testing procedures require the application of professional knowledge, and an acute shortage of personnel appropriately trained may hamper its implementation. This might limit the adoption of mycoplasma testing solutions-the more so for developing nations which lack the materials for training skilled people.
Market Fragmentation
- This highly fragmented mycoplasma testing industry contains a large number of small firms offering a variety of test types. It could be difficult for businesses looking for integrated services from a trustworthy supplier to make decisions because of the level of fragmentation, as it complicates choices. Standardization may be difficult because of differences in the performance and quality levels of providers and, therefore, may limit the mycoplasma testing market growth.
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Mycoplasma Testing Market Competitive Landscape
Established and emerging companies compete with each other in the mycoplasma testing industry, introducing competition. Companies often depend on strategic alliances and innovative testing methods to firmly position themselves within the market. Regional companies are also becoming more aggressive as they expand their ranges to suit local customers.
Mycoplasma Testing Market Top Player’s Company Profiles
- Merck KGaA
- Roche Diagnostics (A Division of F. Hoffmann-La Roche Ltd.)
- Charles River Laboratories International, Inc.
- Lonza Group Ltd.
- Thermo Fisher Scientific, Inc.
- Eurofins Scientific Group
- Sartorius Stedim Biotech S.A.
- Agilent Technologies, Inc.
- Meridian Bioscience, Inc.
- American Type Culture Collection
- Bionique Testing Laboratories, Inc.
- InvivoGen
- PromoCell GmbH
- Biological Industries Israel Beit Haemek Ltd.
- Clongen Laboratories, LLC
- Creative Bioarray
- Nelson Laboratories Fairfield, Inc. (A Part of Sotera Health)
- Norgen Biotek Corporation
- Biotools B & M Labs, S.A.
- GenBio (A Part of ExonHit Therapeutics SA)
- GeneCopoeia, Inc.
- Minerva Biolabs GmbH
- Mycoplasma Experience
- Savyon Diagnostics
- ScienceCell Research Laboratories
Mycoplasma Testing Market Recent Developments
- Agathos Biologics, in April 2023, announced that it will provide analytical testing services for life science research professionals. The only tests Agathos uses are the QIAgen-developed tests and the QIAcuity instrument. Additionally, Agathos and QIAGEN have partnered up to validation tests and validate for recombinant adeno-associated viral vector and mycoplasma tests.
- Thermo Fisher Scientific, Inc. launched TrueMark STI Select Panel in February 2023. It identifies four of the most commonly contagious sexually transmitted diseases on a single panel through the polymerase chain reaction. The two organisms it detects are Mycoplasma genitalium and Chlamydia trachomatis.
- Merck KGaA invested more than USD 427.3 million (EUR 399 million) in its life science R&D facilities in December 2022. The financing will supply businesses with further resources to develop the latest testing technologies, including mycoplasma.
Mycoplasma Testing Key Market Trends
- Integration of Automation in Testing: Automation in the operations of laboratories and testing operations such as mycoplasma testing is now quite a routine affair. Automated systems ensure reduction of testing time to a level that is significantly lower, productivity increases sharply, and human errors are considerably minimized. The expanding interest of biopharmaceutical companies in enhancing process efficiency with uniform quality will keep on boosting their demand for mycoplasma testing technology companies.
- Collaborations and Strategic Partnerships: One of the key mycoplasma testing market trends is collaborations and strategic partnerships. There is a growing partnership and strategic partnerships between testing service companies and pharmaceutical companies. The purpose of this is to combine resources with expertise so as to develop mycoplasma testing options which are more effective. Pooling together their expertise enables organizations to enhance regulation compliance, testing capacity, and safer goods on the market earlier.
Mycoplasma Testing Market SkyQuest Analysis
SkyQuest’s ABIRAW (Advanced Business Intelligence, Research & Analysis Wing) is our Business Information Services team that Collects, Collates, Correlates, and Analyses the Data collected by means of Primary Exploratory Research backed by robust Secondary Desk research.
As per SkyQuest analysis, the mycoplasma testing market report forecasts that due to increased regulatory vigilance and quality assurance concerns in the biopharmaceutical market, the mycoplasma testing market is predicted to be highly growth oriented. With enhanced R&D activity, there will be increased demand for complex techniques for testing and ensuring efficacy and safety of medicinal goods. However, high-cost testing and lack of skilled people could be the major undermining factors toward the growth of the industry. In this respect, stakeholders would predict to concentrate on automation and strategic alliances also to successfully overcome the challenges. Thus, strategic models of this type in a dynamic environment can improve operational efficacy, promote innovation, and eventually help create safer and more efficient biopharmaceuticals.
| Report Metric | Details |
|---|---|
| Market size value in 2022 | USD 829.6 million |
| Market size value in 2031 | USD 1911.78 million |
| Growth Rate | 9.72% |
| Base year | 2023 |
| Forecast period | 2024-2031 |
| Forecast Unit (Value) | USD Million |
| Segments covered |
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| Regions covered | North America (US, Canada), Europe (Germany, France, United Kingdom, Italy, Spain, Rest of Europe), Asia Pacific (China, India, Japan, Rest of Asia-Pacific), Latin America (Brazil, Rest of Latin America), Middle East & Africa (South Africa, GCC Countries, Rest of MEA) |
| Companies covered |
|
| Customization scope | Free report customization with purchase. Customization includes:-
|
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Table Of Content
Executive Summary
Market overview
- Exhibit: Executive Summary – Chart on Market Overview
- Exhibit: Executive Summary – Data Table on Market Overview
- Exhibit: Executive Summary – Chart on Mycoplasma Testing Market Characteristics
- Exhibit: Executive Summary – Chart on Market by Geography
- Exhibit: Executive Summary – Chart on Market Segmentation
- Exhibit: Executive Summary – Chart on Incremental Growth
- Exhibit: Executive Summary – Data Table on Incremental Growth
- Exhibit: Executive Summary – Chart on Vendor Market Positioning
Parent Market Analysis
Market overview
Market size
- Market Dynamics
- Exhibit: Impact analysis of DROC, 2021
- Drivers
- Opportunities
- Restraints
- Challenges
- Exhibit: Impact analysis of DROC, 2021
- SWOT Analysis
KEY MARKET INSIGHTS
- Technology Analysis
- (Exhibit: Data Table: Name of technology and details)
- Pricing Analysis
- (Exhibit: Data Table: Name of technology and pricing details)
- Supply Chain Analysis
- (Exhibit: Detailed Supply Chain Presentation)
- Value Chain Analysis
- (Exhibit: Detailed Value Chain Presentation)
- Ecosystem Of the Market
- Exhibit: Parent Market Ecosystem Market Analysis
- Exhibit: Market Characteristics of Parent Market
- IP Analysis
- (Exhibit: Data Table: Name of product/technology, patents filed, inventor/company name, acquiring firm)
- Trade Analysis
- (Exhibit: Data Table: Import and Export data details)
- Startup Analysis
- (Exhibit: Data Table: Emerging startups details)
- Raw Material Analysis
- (Exhibit: Data Table: Mapping of key raw materials)
- Innovation Matrix
- (Exhibit: Positioning Matrix: Mapping of new and existing technologies)
- Pipeline product Analysis
- (Exhibit: Data Table: Name of companies and pipeline products, regional mapping)
- Macroeconomic Indicators
COVID IMPACT
- Introduction
- Impact On Economy—scenario Assessment
- Exhibit: Data on GDP - Year-over-year growth 2016-2022 (%)
- Revised Market Size
- Exhibit: Data Table on Mycoplasma Testing Market size and forecast 2021-2027 ($ million)
- Impact Of COVID On Key Segments
- Exhibit: Data Table on Segment Market size and forecast 2021-2027 ($ million)
- COVID Strategies By Company
- Exhibit: Analysis on key strategies adopted by companies
MARKET DYNAMICS & OUTLOOK
- Market Dynamics
- Exhibit: Impact analysis of DROC, 2021
- Drivers
- Opportunities
- Restraints
- Challenges
- Exhibit: Impact analysis of DROC, 2021
- Regulatory Landscape
- Exhibit: Data Table on regulation from different region
- SWOT Analysis
- Porters Analysis
- Competitive rivalry
- Exhibit: Competitive rivalry Impact of key factors, 2021
- Threat of substitute products
- Exhibit: Threat of Substitute Products Impact of key factors, 2021
- Bargaining power of buyers
- Exhibit: buyers bargaining power Impact of key factors, 2021
- Threat of new entrants
- Exhibit: Threat of new entrants Impact of key factors, 2021
- Bargaining power of suppliers
- Exhibit: Threat of suppliers bargaining power Impact of key factors, 2021
- Competitive rivalry
- Skyquest special insights on future disruptions
- Political Impact
- Economic impact
- Social Impact
- Technical Impact
- Environmental Impact
- Legal Impact
Market Size by Region
- Chart on Market share by geography 2021-2027 (%)
- Data Table on Market share by geography 2021-2027(%)
- North America
- Chart on Market share by country 2021-2027 (%)
- Data Table on Market share by country 2021-2027(%)
- USA
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Canada
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Europe
- Chart on Market share by country 2021-2027 (%)
- Data Table on Market share by country 2021-2027(%)
- Germany
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Spain
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- France
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- UK
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Rest of Europe
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Asia Pacific
- Chart on Market share by country 2021-2027 (%)
- Data Table on Market share by country 2021-2027(%)
- China
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- India
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Japan
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- South Korea
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Rest of Asia Pacific
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Latin America
- Chart on Market share by country 2021-2027 (%)
- Data Table on Market share by country 2021-2027(%)
- Brazil
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Rest of South America
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Middle East & Africa (MEA)
- Chart on Market share by country 2021-2027 (%)
- Data Table on Market share by country 2021-2027(%)
- GCC Countries
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- South Africa
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Rest of MEA
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
KEY COMPANY PROFILES
- Competitive Landscape
- Total number of companies covered
- Exhibit: companies covered in the report, 2021
- Top companies market positioning
- Exhibit: company positioning matrix, 2021
- Top companies market Share
- Exhibit: Pie chart analysis on company market share, 2021(%)
- Total number of companies covered
Methodology
For the Mycoplasma Testing Market, our research methodology involved a mixture of primary and secondary data sources. Key steps involved in the research process are listed below:
1. Information Procurement: This stage involved the procurement of Market data or related information via primary and secondary sources. The various secondary sources used included various company websites, annual reports, trade databases, and paid databases such as Hoover's, Bloomberg Business, Factiva, and Avention. Our team did 45 primary interactions Globally which included several stakeholders such as manufacturers, customers, key opinion leaders, etc. Overall, information procurement was one of the most extensive stages in our research process.
2. Information Analysis: This step involved triangulation of data through bottom-up and top-down approaches to estimate and validate the total size and future estimate of the Mycoplasma Testing Market.
3. Report Formulation: The final step entailed the placement of data points in appropriate Market spaces in an attempt to deduce viable conclusions.
4. Validation & Publishing: Validation is the most important step in the process. Validation & re-validation via an intricately designed process helped us finalize data points to be used for final calculations. The final Market estimates and forecasts were then aligned and sent to our panel of industry experts for validation of data. Once the validation was done the report was sent to our Quality Assurance team to ensure adherence to style guides, consistency & design.
Analyst Support
Customization Options
With the given market data, our dedicated team of analysts can offer you the following customization options are available for the Mycoplasma Testing Market:
Product Analysis: Product matrix, which offers a detailed comparison of the product portfolio of companies.
Regional Analysis: Further analysis of the Mycoplasma Testing Market for additional countries.
Competitive Analysis: Detailed analysis and profiling of additional Market players & comparative analysis of competitive products.
Go to Market Strategy: Find the high-growth channels to invest your marketing efforts and increase your customer base.
Innovation Mapping: Identify racial solutions and innovation, connected to deep ecosystems of innovators, start-ups, academics, and strategic partners.
Category Intelligence: Customized intelligence that is relevant to their supply Markets will enable them to make smarter sourcing decisions and improve their category management.
Public Company Transcript Analysis: To improve the investment performance by generating new alpha and making better-informed decisions.
Social Media Listening: To analyze the conversations and trends happening not just around your brand, but around your industry as a whole, and use those insights to make better Marketing decisions.
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