마이코플라스마 검사 시장 예측(-2032년) : 제품별, 기술별, 용도별, 최종사용자별, 지역별 세계 분석

According to Stratistics MRC, the Global Mycoplasma Testing Market is accounted for $1198.07 million in 2025 and is expected to reach $2599.30 million by 2032 growing at a CAGR of 11.7% during the forecast period. Mycoplasma testing is a crucial quality control method used in pharmaceutical and biotechnology production to find out whether cell cultures, vaccines, and biopharmaceutical products are contaminated with Mycoplasma. Because they lack a cell wall, mycoplasmas are a class of bacteria that are difficult to identify using conventional microbiological techniques and resistant to many common antibiotics. Mycoplasma contamination can change how cells metabolize, stop them from growing, and affect the safety of products or the outcomes of experiments. Moreover, the dependability and security of biological products and research materials are guaranteed by a variety of testing techniques, including enzymatic assays, culture methods, and PCR.

According to ATCC, Mycoplasma contamination of continuous cell cultures ranges from 15-35%, with primary cell cultures exhibiting a minimum 1% contamination rate, and emphasizes routine testing throughout production to ensure both safety and experimental reliability.

Market Dynamics:

Driver:

Growing use of research based on cells

Mycoplasma testing is now essential in both academic and commercial labs due to the extensive use of mammalian cell cultures in drug discovery, cancer research, toxicology, vaccine development, and personalized medicine. Erroneous conclusions, distorted experimental data, changed gene expression, and impaired reproducibility can all result from contaminated cell lines. This high frequency emphasizes how crucial routine screening procedures are to maintaining the integrity of research findings. To preserve the caliber and dependability of experimental systems, Mycoplasma testing has become commonplace in the majority of molecular biology and biomedical labs.

Restraint:

Expensive advanced testing techniques

The high cost of sophisticated detection technologies like digital PCR, real-time PCR, and next-generation sequencing (NGS) is one of the main factors limiting the market for Mycoplasma testing. Despite having higher speed and sensitivity, these techniques necessitate a large initial investment in specialized tools, chemicals, and skilled workers. The adoption of routine Mycoplasma testing is often limited by the inability of small and medium-sized biopharmaceutical companies, academic institutions, and low-budget laboratories in developing nations to afford these systems. Moreover, frequent maintenance, calibration, and validation of these sophisticated instruments raise operating costs.

Opportunity:

Creation of high-throughput systems and automation

The creation of high-throughput, automated Mycoplasma testing platforms offers a significant chance to solve issues with biomanufacturing's scalability and efficiency. Biopharma firms are looking for solutions that decrease manual handling and turnaround time while enhancing reproducibility due to rising batch volumes, strict release schedules, and an increase in testing frequency. Additionally, large-scale CDMOs and biologics manufacturers will be very interested in companies that can provide integrated Mycoplasma detection modules that are compatible with manufacturing execution systems (MES) and quality management systems (QMS).

Threat:

Strong competition from other techniques for contamination detection

Alternative microbial contamination detection technologies with multiplexing capabilities or wider coverage are putting more and more pressure on the market. Many bacteria, viruses, fungi, and mycoplasma can all be detected simultaneously in a single assay by more recent platforms that use next-generation sequencing (NGS) or metagenomic analysis. Despite their infancy, these all-encompassing techniques are gaining traction with major biomanufacturers looking for comprehensive contamination monitoring systems. Furthermore, the failure of conventional and single-target Mycoplasma testing kits to keep up with integrated and multiparametric solutions could result in a loss of market share.

Covid-19 Impact:

The COVID-19 pandemic affected the mycoplasma testing market in a variety of ways. On the one hand, routine testing operations were momentarily slowed, particularly in academic and small biotech settings, by the disruption of global supply chains and limitations on lab access. There was less of an urgent need for contamination testing because many clinical trials and the production of biologics unrelated to COVID-19 were postponed. But the pandemic also brought to light the significance of strong quality control in the manufacturing of biologics and vaccines, which led to a rise in investments in quality assurance, including mycoplasma testing, and biologics infrastructure.

The polymerase chain reaction (PCR) segment is expected to be the largest during the forecast period

The polymerase chain reaction (PCR) segment is expected to account for the largest market share during the forecast period because of its great sensitivity, specificity, quick turnaround time, and capacity to identify a variety of Mycoplasma species. In the production of biologics and cell therapy procedures, PCR is regarded as the gold standard for contamination detection. However, PCR is more sensitive than enzyme-linked immunosorbent assay (ELISA), which is praised for its affordability and ease of use. In research contexts, both direct and indirect assays are commonly employed.

The cell line testing segment is expected to have the highest CAGR during the forecast period

Over the forecast period, the cell line testing segment is predicted to witness the highest growth rate. The growing use of mammalian cell lines in the production of vaccines, monoclonal antibodies, and biologics-all of which need stringent contamination screening-is what is causing this growth. Despite being crucial for biosafety, virus testing is steadily increasing because of its wider focus on pathogens and the regulatory need for advanced therapies. Although end-of-production cell testing is less common than upstream cell line testing, it is still essential for verifying batch sterility. Because cell line testing is integrated into early stages of bioproduction, it continues to be the application with the fastest rate of growth.

Region with largest share:

During the forecast period, the North America region is expected to hold the largest market share, driven by its strong R&D expenditures, established biopharmaceutical sector, and strict regulatory standards upheld by organizations such as the FDA. Many CROs, CDMOs, and biologics manufacturers in the area need regular contamination screening at every stage of production. A developed regulatory framework, growing investments in cell and gene therapies, and the widespread use of sophisticated molecular diagnostics all contribute to market dominance. Furthermore, the presence of important players and strong academic research supports early adoption of cutting-edge testing solutions and technological advancement, securing North America's dominant position in the global market.

Region with highest CAGR:

Over the forecast period, the Asia Pacific region is anticipated to exhibit the highest CAGR. The growing demand for biologics, growing manufacturing capacities in nations like China, India, and Japan, and growing investments in pharmaceutical and biotechnology research are the main drivers of this quick growth. Mycoplasma testing services and products are also becoming more popular in these nations due to stricter regulations and increased awareness of contamination control. Additionally, propelling market expansion are the cost advantages that the region's emerging economies provide, which make it a favored location for contract manufacturing organizations (CMOs) and contract research organizations (CROs).

Key players in the market

Some of the key players in Mycoplasma Testing Market include Thermo Fisher Scientific, Inc., Becton, Dickinson, and Company (BD), Eurofins Scientific, Agilent Technologies, F. Hoffmann-La Roche Ltd., Clongen Laboratories, LLC, Bionique Testing Laboratories, Inc., Lonza Group Ltd., Merck KGaA, Charles River Laboratories International, Inc., Bio-Rad Laboratories, Inc, PromoCell GmbH, Norgen Biotek Corp., Sartorius AG and Minerva Biolabs GmbH.

Key Developments:

In February 2025, Thermo Fisher Scientific Inc. has announced a 10-year virtual power purchasing agreement (VPPA) with renewable energy developer, X-ELIO. The agreement aims to increase the access to renewable electricity across the healthcare and pharmaceutical supply chains. Expected to be operational in early 2026, the project will include a cohort of three partners across both sectors.

In October 2024, BD (Becton, Dickinson and Company) announced it has reached an agreement to resolve the vast majority of its existing hernia litigation. Terms of the settlement agreement, which are confidential, include cases in both the Rhode Island consolidated litigation and the federal multidistrict litigation in Ohio.

In October 2024, Eurofins Scientific has reached an agreement with SYNLAB to acquire its clinical diagnostics operations in Spain. The transaction is subject to customary conditions, including regulatory approvals, and is expected to close in 2025. SYNLAB's clinical diagnostics operations in Spain provide clinical diagnostics testing, including genetics and anatomical pathology services, throughout the country, achieving revenues of approximately €140m in 2023.

Products Covered:

• Instruments
• Kits & Reagents
• Service

Techniques Covered:

• Polymerase Chain Reaction (PCR)
• Enzyme-linked Immunosorbent Assay (ELISA)
• Direct Assay
• Indirect Assay
• Microbial Culture Techniques
• Enzymatic Methods
• DNA Staining

Applications Covered:

• Cell Line Testing
• Virus Testing
• End of Production Cells Testing
• Other Applications

End Users Covered:

• Academic Research Institutes
• Cell Banks
• Contract Research Organizations
• Pharmaceutical & Biotechnology Companies
• Other End Users

Regions Covered:

• North America
  • US
  • Canada
  • Mexico
• Europe
  • Germany
  • UK
  • Italy
  • France
  • Spain
  • Rest of Europe
• Asia Pacific
  • Japan
  • China
  • India
  • Australia
  • New Zealand
  • South Korea
  • Rest of Asia Pacific
• South America
  • Argentina
  • Brazil
  • Chile
  • Rest of South America
• Middle East & Africa
  • Saudi Arabia
  • UAE
  • Qatar
  • South Africa
  • Rest of Middle East & Africa

What our report offers:

• Market share assessments for the regional and country-level segments
• Strategic recommendations for the new entrants
• Covers Market data for the years 2024, 2025, 2026, 2028, and 2032
• Market Trends (Drivers, Constraints, Opportunities, Threats, Challenges, Investment Opportunities, and recommendations)
• Strategic recommendations in key business segments based on the market estimations
• Competitive landscaping mapping the key common trends
• Company profiling with detailed strategies, financials, and recent developments
• Supply chain trends mapping the latest technological advancements

Free Customization Offerings:

All the customers of this report will be entitled to receive one of the following free customization options:

• Company Profiling
  • Comprehensive profiling of additional market players (up to 3)
  • SWOT Analysis of key players (up to 3)
• Regional Segmentation
  • Market estimations, Forecasts and CAGR of any prominent country as per the client's interest (Note: Depends on feasibility check)
• Competitive Benchmarking
  • Benchmarking of key players based on product portfolio, geographical presence, and strategic alliances

Table of Contents

1 Executive Summary

2 Preface

• 2.1 Abstract
• 2.2 Stake Holders
• 2.3 Research Scope
• 2.4 Research Methodology
  • 2.4.1 Data Mining
  • 2.4.2 Data Analysis
  • 2.4.3 Data Validation
  • 2.4.4 Research Approach
• 2.5 Research Sources
  • 2.5.1 Primary Research Sources
  • 2.5.2 Secondary Research Sources
  • 2.5.3 Assumptions

3 Market Trend Analysis

• 3.1 Introduction
• 3.2 Drivers
• 3.3 Restraints
• 3.4 Opportunities
• 3.5 Threats
• 3.6 Product Analysis
• 3.7 Application Analysis
• 3.8 End User Analysis
• 3.9 Emerging Markets
• 3.10 Impact of Covid-19

4 Porters Five Force Analysis

• 4.1 Bargaining power of suppliers
• 4.2 Bargaining power of buyers
• 4.3 Threat of substitutes
• 4.4 Threat of new entrants
• 4.5 Competitive rivalry

5 Global Mycoplasma Testing Market, By Product

• 5.1 Introduction
• 5.2 Instruments
• 5.3 Kits & Reagents
  • 5.3.1 PCR Assays
  • 5.3.2 Nucleic Acid Detection Kits
  • 5.3.3 Stains
  • 5.3.4 Elimination Kits
  • 5.3.5 Standards & Controls
• 5.4 Service

6 Global Mycoplasma Testing Market, By Technique

• 6.1 Introduction
• 6.2 Polymerase Chain Reaction (PCR)
• 6.3 Enzyme-linked Immunosorbent Assay (ELISA)
• 6.4 Direct Assay
• 6.5 Indirect Assay
• 6.6 Microbial Culture Techniques
• 6.7 Enzymatic Methods
• 6.8 DNA Staining

7 Global Mycoplasma Testing Market, By Application

• 7.1 Introduction
• 7.2 Cell Line Testing
• 7.3 Virus Testing
• 7.4 End of Production Cells Testing
• 7.5 Other Applications

8 Global Mycoplasma Testing Market, By End User

• 8.1 Introduction
• 8.2 Academic Research Institutes
• 8.3 Cell Banks
• 8.4 Contract Research Organizations
• 8.5 Pharmaceutical & Biotechnology Companies
• 8.6 Other End Users

9 Global Mycoplasma Testing Market, By Geography

• 9.1 Introduction
• 9.2 North America
  • 9.2.1 US
  • 9.2.2 Canada
  • 9.2.3 Mexico
• 9.3 Europe
  • 9.3.1 Germany
  • 9.3.2 UK
  • 9.3.3 Italy
  • 9.3.4 France
  • 9.3.5 Spain
  • 9.3.6 Rest of Europe
• 9.4 Asia Pacific
  • 9.4.1 Japan
  • 9.4.2 China
  • 9.4.3 India
  • 9.4.4 Australia
  • 9.4.5 New Zealand
  • 9.4.6 South Korea
  • 9.4.7 Rest of Asia Pacific
• 9.5 South America
  • 9.5.1 Argentina
  • 9.5.2 Brazil
  • 9.5.3 Chile
  • 9.5.4 Rest of South America
• 9.6 Middle East & Africa
  • 9.6.1 Saudi Arabia
  • 9.6.2 UAE
  • 9.6.3 Qatar
  • 9.6.4 South Africa
  • 9.6.5 Rest of Middle East & Africa

10 Key Developments

• 10.1 Agreements, Partnerships, Collaborations and Joint Ventures
• 10.2 Acquisitions & Mergers
• 10.3 New Product Launch
• 10.4 Expansions
• 10.5 Other Key Strategies

11 Company Profiling

• 11.1 Thermo Fisher Scientific, Inc.
• 11.2 Becton, Dickinson, and Company (BD)
• 11.3 Eurofins Scientific
• 11.4 Agilent Technologies
• 11.5 F. Hoffmann-La Roche Ltd.
• 11.6 Clongen Laboratories, LLC
• 11.7 Bionique Testing Laboratories, Inc.
• 11.8 Lonza Group Ltd.
• 11.9 Merck KGaA
• 11.10 Charles River Laboratories International, Inc.
• 11.11 Bio-Rad Laboratories, Inc.
• 11.12 PromoCell GmbH
• 11.13 Norgen Biotek Corp.
• 11.14 Sartorius AG
• 11.15 Minerva Biolabs GmbH