Mycoplasma Clinical Testing Market Size, Share, Opportunities, And Trends By Product (Polymerase Chain Reaction (PCR), Enzyme-Linked Immunosorbent Assays (ELISA), Enzymatic Methods, DNA Staining), By Application (Cell Line Testing, Virus Testing, Pathogen Detection, Blood Screening), By End-User (Hospitals, Clinical Laboratories, Research Institutes), By Regional Regulations (Food And Drug Administration (FDA), CE Mark, International Organization For Standardization (ISO)), And By Geography - Forecasts From 2024 To 2029

  • Published : Feb 2024
  • Report Code : KSI061616672
  • Pages : 142

The mycoplasma clinical testing market is expected to witness significant growth during the forecasted period.

Mycoplasma clinical testing plays a crucial role in identifying and diagnosing infections caused by Mycoplasma bacteria, particularly Mycoplasma pneumoniae. These tests are essential for confirming the presence of the bacteria in various clinical specimens, including respiratory samples, urogenital swabs, and blood. Mycoplasma infections are known to cause respiratory tract infections, pneumonia, and other illnesses, making accurate and timely diagnosis vital for appropriate medical intervention. Clinical testing methods commonly include polymerase chain reaction (PCR) assays, enzyme immunoassays (EIAs), and culture-based techniques. The results of mycoplasma clinical testing aid healthcare professionals in determining the most effective treatment strategies, contributing to improved patient outcomes. As respiratory infections and other diseases caused by Mycoplasma continue to pose health challenges, the significance of mycoplasma clinical testing remains paramount in the field of infectious disease diagnostics.

Market Drivers

  • Rising research and development in this area

The mycoplasma clinical testing market is propelled by substantial research and development investments made by biopharmaceutical companies. A study titled "Point-of-care molecular diagnosis of Mycoplasma pneumonia including macrolide sensitivity using quenching probe polymerase chain reaction," published in October 2021, highlighted the effectiveness of the Smart Gene system. According to the study, this system offers a rapid and precise assay for identifying the presence of M. pneumoniae and simultaneously detecting a point mutation at domain V of the 23S rRNA gene of M. pneumoniae. The Smart Gene system is deemed suitable for point-of-care testing in both hospital and outpatient settings. Consequently, such research findings, which underscore the potential of diagnostic testing for mycoplasma pneumonia, are expected to enhance their acceptance and, drive market growth.

  • Increasing cases of respiratory diseases

The increasing cases of respiratory diseases significantly contribute to the mycoplasma clinical testing market growth. As the prevalence of respiratory illnesses rises, there is a heightened need for accurate and timely diagnostic tools to identify the causative agents, such as mycoplasma. Mycoplasma infections, particularly Mycoplasma pneumoniae, are known to be a common cause of respiratory tract infections, including pneumonia and bronchitis. Healthcare providers, in response to the growing burden of respiratory diseases, increasingly rely on mycoplasma clinical testing to facilitate early and precise diagnosis. Rapid and accurate identification of mycoplasma infections is crucial for initiating appropriate treatment regimens, reducing the severity of respiratory illnesses, and preventing the spread of the infection. CDC data indicated that COVID-19 emerged as the primary cause of respiratory illnesses, with a 12% increase in emergency department visits, a 17% rise in hospitalizations, and a 10% increase in deaths attributed to COVID-19. Throughout the season, at least 7.1 million individuals fell ill with the flu, leading to 73,000 hospitalizations and 4,500 influenza-related deaths. Although RSV illnesses showed signs of slowing down in certain regions, there was an escalation in hospitalizations, particularly among young children and older adults.

North America is anticipated to hold a significant share of the market-

North America presently holds a leading position in the mycoplasma testing market, and this dominance is anticipated to persist in the coming years. The region is poised to expand its market share, driven by its well-established healthcare sector and the increasing incidence of respiratory diseases. Contributing factors to this growth include the presence of prominent global biotech companies and pharmaceutical entities, coupled with substantial investments in research and development activities within the region. Within North America, the United States commands the majority of the market share, attributed to a surge in healthcare expenditure and the rapid adoption of point-of-care testing. The introduction of new products in the country, such as the July 2020 launch of BIOFIRE MYCOPLASMA by bioMérieux, a cutting-edge test for mycoplasma detection in pharmaceutical products used for biotherapeutics, further augments mycoplasma testing procedures and contributes to market expansion.

Market Developments

  • In May 2022, the United States Food and Drug Administration granted clearance to Abbott for its Alinity m STI Assay. This assay has the capability to concurrently identify and distinguish four prevalent sexually transmitted infections (STIs), among them Mycoplasma genitalium (MG).
  • In April 2022, Performer Availability Screening Service, Inc. (PASS) collaborated with Spankchain to introduce a screening and treatment program for Mycoplasma genitalium infection within the Las Vegas performer community. The initiative is provided at no cost and is available for up to 1000 performers.

Market Segmentation

  • By Product
    • Polymerase Chain Reaction (PCR)
    • Enzyme-Linked Immunosorbent Assays (ELISA)
    • Enzymatic Methods
    • DNA Staining
  • By Application
    • Cell Line Testing
    • Virus Testing
    • Pathogen Detection
    • Blood Screening
  • By End-User
    • Hospitals
    • Clinical Laboratories
    • Research Institutes
  • By Regional Regulations
    • Food and Drug Administration (FDA)
    • CE Mark
    • International Organization for Standardization (ISO)
  • By Geography
    • North America
      • USA
      • Canada
      • Mexico
    • South America
      • Brazil
      • Argentina
      • Others
    • Europe
      • UK
      • Germany
      • France
      • Italy
      • Spain
      • Others
    • Middle East and Africa
      • Saudi Arabia
      • UAE
      • Others
    • Asia Pacific
      • Japan
      • China
      • India
      • South Korea
      • Taiwan
      • Thailand
      • Indonesia
      • Others


1.1. Market Overview

1.2. Market Definition

1.3. Scope of the Study

1.4. Market Segmentation

1.5. Currency

1.6. Assumptions

1.7. Base, and Forecast Years Timeline

1.8. Key Benefits to the stakeholder


2.1. Research Design

2.2. Research Processes


3.1. Key Findings

3.2. Analyst View


4.1. Market Drivers

4.2. Market Restraints

4.3. Porter’s Five Forces Analysis

4.3.1. Bargaining Power of Suppliers

4.3.2. Bargaining Power of Buyers

4.3.3. Threat of New Entrants

4.3.4. Threat of Substitutes

4.3.5. Competitive Rivalry in the Industry

4.4. Industry Value Chain Analysis

4.5. Analyst View


5.1. Introduction

5.2. Polymerase Chain Reaction (PCR) 

5.2.1. Market Trends and Opportunities

5.2.2. Growth Prospects

5.3. Enzyme-Linked Immunosorbent Assays (ELISA) 

5.3.1. Market Trends and Opportunities

5.3.2. Growth Prospects

5.4. Enzymatic Methods

5.4.1. Market Trends and Opportunities

5.4.2. Growth Prospects

5.5. DNA Staining

5.5.1. Market Trends and Opportunities

5.5.2. Growth Prospects


6.1. Introduction

6.2. Cell Line Testing

6.2.1. Market Trends and Opportunities

6.2.2. Growth Prospects

6.3. Virus Testing

6.3.1. Market Trends and Opportunities

6.3.2. Growth Prospects

6.4. Pathogen Detection

6.4.1. Market Trends and Opportunities

6.4.2. Growth Prospects

6.5. Blood Screening

6.5.1. Market Trends and Opportunities

6.5.2. Growth Prospects


7.1. Introduction

7.2. Hospitals

7.2.1. Market Trends and Opportunities

7.2.2. Growth Prospects

7.3. Clinical Laboratories

7.3.1. Market Trends and Opportunities

7.3.2. Growth Prospects

7.4. Research Institutes

7.4.1. Market Trends and Opportunities

7.4.2. Growth Prospects


8.1. Introduction

8.2. Food and Drug Administration (FDA) 

8.2.1. Market Trends and Opportunities

8.2.2. Growth Prospects

8.3. CE Mark

8.3.1. Market Trends and Opportunities

8.3.2. Growth Prospects

8.4. International Organization for Standardization (ISO) 

8.4.1. Market Trends and Opportunities

8.4.2. Growth Prospects


9.1. Introduction

9.2. North America

9.2.1. By Product

9.2.2. By Application

9.2.3. By End User

9.2.4. By Regional Regulations

9.2.5. By Country United States Market Trends and Opportunities Growth Prospects Canada Market Trends and Opportunities Growth Prospects Mexico Market Trends and Opportunities Growth Prospects

9.3. South America

9.3.1. By Product

9.3.2. By Application

9.3.3. By End User

9.3.4. By Regional Regulations

9.3.5. By Country Brazil Market Trends and Opportunities Growth Prospects Argentina Market Trends and Opportunities Growth Prospects Others Market Trends and Opportunities Growth Prospects

9.4. Europe

9.4.1. By Product

9.4.2. By Application

9.4.3. By End User

9.4.4. By Regional Regulations

9.4.5. By Country United Kingdom Market Trends and Opportunities Growth Prospects Germany Market Trends and Opportunities Growth Prospects France Market Trends and Opportunities Growth Prospects Italy Market Trends and Opportunities Growth Prospects Spain Market Trends and Opportunities Growth Prospects Others Market Trends and Opportunities Growth Prospects

9.5. Middle East and Africa

9.5.1. By Product

9.5.2. By Application

9.5.3. By End User

9.5.4. By Regional Regulations

9.5.5. By Country Saudi Arabia Market Trends and Opportunities Growth Prospects UAE Market Trends and Opportunities Growth Prospects Others Market Trends and Opportunities Growth Prospects

9.6. Asia Pacific

9.6.1. By Product

9.6.2. By Application

9.6.3. By End User

9.6.4. By Regional Regulations

9.6.5. By Country Japan Market Trends and Opportunities Growth Prospects China Market Trends and Opportunities Growth Prospects India Market Trends and Opportunities Growth Prospects South Korea Market Trends and Opportunities Growth Prospects Taiwan Market Trends and Opportunities Growth Prospects Thailand Market Trends and Opportunities Growth Prospects Indonesia Market Trends and Opportunities Growth Prospects Others Market Trends and Opportunities Growth Prospects


10.1. Major Players and Strategy Analysis

10.2. Market Share Analysis

10.3. Mergers, Acquisitions, Agreements, and Collaborations

10.4. Competitive Dashboard


11.1. Sartorius AG


11.3. ELITechGROUP

11.4. Bio-Rad Laboratories, Inc

11.5. Eurofins Scientific

11.6. Minerva Biolabs

11.7. Charles River Laboratories

11.8. Clongen Laboratories

11.9. BioFire Diagnostics

11.10. PromoCell GmbH

11.11. Lonza Bioscience

11.12. Agilent Technologies, Inc

Sartorius AG



Bio-Rad Laboratories, Inc

Eurofins Scientific

Minerva Biolabs

Charles River Laboratories

Clongen Laboratories

BioFire Diagnostics

PromoCell GmbH

Lonza Bioscience

Agilent Technologies, Inc