Mycoplasma Testing Market Size & Share, by Application (Cell Line, Virus Testing, End of Production Testing); Technique (PCR, ELISA, Microbial Culture, Enzymatic Methods); Products & Services (Assays, Kits, Reagents, Instruments, Services); End-user (Biopharmaceutical Company, Cell Banks, CROs) - Global Supply & Demand Analysis, Growth Forecasts, Statistics Report 2023-2035

  • Report ID: 4969
  • Published Date: Jun 01, 2023
  • Report Format: PDF, PPT

Global Market Size, Forecast, and Trend Highlights Over 2023 - 2035

Mycoplasma Testing Market size is expected to cross USD 2 Billion by the end of 2035, registering 12% CAGR from 2023 to 2035. In in the year 2022, the industry size of mycoplasma testing was USD 840 Million. The market is growing owing to rising demand for biosimilars and biologics. The production of biologics and biosimilars requires the use of various raw materials, including cell culture media, growth factors, and additives. These materials are the potential source of mycoplasma contamination. In correspondence, mycoplasma testing becomes crucial to ensure the safer use of these raw materials.

Moreover, the rising globalization of clinical trials brings new opportunities for the mycoplasma testing market growth. The world is fostering research initiatives through international collaboration. This leads to the exchange of cell lines, samples, and reagents among countries and increases the risk of mycoplasma contamination. Thus, the test is used to preserve the integrity of shared material.


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Global Mycoplasma Testing Sector: Growth Drivers and Challenges

Growth Drivers

  • Rising Concern Associated with Cell Culture Contamination – Mycoplasma is the bacteria that contaminate the cell culture, and mycoplasma testing is an essential step in preventing cell contamination and its detrimental effects on the research. According to FDA, ATCC, and other research, around 5 - 30% of all cell cultures nowadays are infected with mycoplasma species solely. In a single case, the prevalence of viral contamination of popular cell lines topped 25%.
  • Increasing Spending in Pharmaceutical R&D Activities– Increased expenditure leads to more complex and advanced research projects, as the complexity of cell culture increases the need for mycoplasma testing also rises as a part of the quality control measure.  Global R&D spending in pharmaceutical studies reached around 238 billion US dollars in 2021.
  • Technological Advancement in Mycoplasma Testing –Technology innovation has improved the efficiency accuracy and accessibility of mycoplasma testing, thus bringing lucrative opportunities for the industry. For instance, Sartorius developed a Micorsart Mycoplasma qPCR detection assay that enables early detection of contamination of even non-culturable mycoplasma.

Challenges

  • High Cost of Mycoplasma Testing- Many research laboratories and academic institutions often have limited budgets, and the high cost of mycoplasma testing can stain its usage and hamper the market growth. For instance, the cost of a biological sample is around USD 125, and the cost of a patient specimen is nearly USD 210.
  • Lack of skilled technicians
  • Higher Loyalty to Existing Brand is Limiting the Opportunity for New Entrants

Mycoplasma Testing Market: Key Insights

Base Year

2022

Forecast Year

2023-2035

CAGR

~12%

Base Year Market Size (2022)

~USD 840 Million

Forecast Year Market Size (2035)

 ~USD 2.0 Billion

Regional Scope

  • North America (U.S., and Canada)
  • Latin America (Mexico, Argentina, Rest of Latin America)
  • Asia-Pacific (Japan, China, India, Indonesia, Malaysia, Australia, Rest of Asia-Pacific)
  • Europe (U.K., Germany, France, Italy, Spain, Russia, NORDIC, Rest of Europe)
  • Middle East and Africa (Israel, GCC North Africa, South Africa, Rest of the Middle East and Africa)
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Mycoplasma Testing Segmentation

Application (Cell Line, Virus Testing, End of Production Testing)

The cell line segment is estimated to gain the largest market share of about ~55% in the year 2035. The growth of the segment is expected due to the rising demand for monoclonal antibodies. For instance, monoclonal antibodies have been proven efficient in constraining COVID-19. Anti-SARS-CoV-2 monoclonal antibodies, such as REGEN-COV, have gained success to prevent infection in domestic contacts and to reduce the risk of hospitalization or death associated with COVID-19. Testing cell lines used for monoclonal antibod production ensures the prevention of mycoplasma contamination and interference with cell growth and antibody expression.

Technique (PCR, ELISA, Microbial Culture, Enzymatic Methods)

The PCR segment is expected to garner a tremendous share of around ~40% in the year 2035. The PCR technique recognizes the various species of mycoplasma by isolating the additional contaminated DNA. The results gained by the PCR (polymerase chain reaction) technique are highly reliant, moreover, the results are quick to achieve and the technique is easy to use.

Our in-depth analysis of the market includes the following segments:

    Application

  • Cell Line
  • Virus Testing
  • End of Production Testing

   Technique

  • PCR
  • ELISA
  • Microbial Culture
  • Enzymatic Methods

    Product & Services

  • Assays, Kits, & Reagents
  • Instruments
  • Services

    End User

  • Biopharmaceutical Company
  • Cell Banks
  • Contract Research Organization (CROs)

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Mycoplasma Testing Industry - Regional Synopsis

North American Market Statistics

The North America mycoplasma testing market is poised to be the largest with a share of about 37% by the end of 2035. The presence of various biotech and pharmaceutical companies and increased investment in R&D will push the formation of new drugs and antibodies, recombinant proteins, and cell-based therapies. The need for mycoplasma testing increases correspondingly to ensure the safety and quality of these products. The Department of Health and Human Services in the United States will put USD 40 million to broaden the role of biomanufacturing in the development of active pharmaceutical ingredients (APIs), antibiotics, and essential pharmaceuticals.

APAC Market Analysis

The Asia Pacific mycoplasma testing market is estimated to be the second largest, registering a share of about 26% over the forecast period. The increased knowledge of the effects of infectious substances, as well as regulatory restrictions enforced by healthcare organizations to improve biosafety quality, are driving the demand for mycoplasma testing. WHO's Regional Office for South East Asia (SEARO) arranged two regional trainings to assist biosafety, concentrating on infectious material shipping, and bio-risk assessment.

European Market Forecast

Further, the mycoplasma testing market in Europe is projected to hold a notable share between 2023 and 2035. The market growth in the region is due to strict adherence to good laboratory practices (GLP), and good manufacturing practices (GMP) by all the biotech and pharma companies. Hence, mycoplasma testing is considered an essential component of these practices to ensure product safety.

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Companies Dominating the Global Mycoplasma Testing Landscape

top-features-companies
    • Thermo Fisher Scientific, Inc.
      • Company Overview
      • Business Strategy
      • Key Product Offerings
      • Financial Performance
      • Key Performance Indicators
      • Risk Analysis
      • Recent Development
      • Regional Presence
      • SWOT Analysis
    • Merck KGaA
    • Lonza Group Ltd.
    • PromoCell GmbH
    • Asahi Kasei Corporation
    • Sartorius AG
    • InvivoGen
    • Eurofins Scientific
    • SwiftDx
    • Agathos Biologics

In-the-news

In The News

  • October 2022: SwiftDx announced the launch of new mycoplasma contamination testing. It is a lateral flow test, that had adopted the PCR techniques. It is easier to use and provides accurate results within minutes. The test has been fully evaluated and validated by the University of Cambridge.
  • April 2023: Agathos Biologics announced the launch of advanced analytical testing services for research in the field of life sciences. It employs digital PCR (dPCR) technology to provide the most accurate sensitivity and precision in nucleic acid measurement.

Author Credits:  Abhishek Verma, Hetal Singh


  • Report ID: 4969
  • Published Date: Jun 01, 2023
  • Report Format: PDF, PPT

Frequently Asked Questions (FAQ)

Increasing expenditure on new biotech research, advancing technology of mycoplasma testing, and globalization of research are the major factors driving the market growth.

The market size of mycoplasma testing is anticipated to attain a CAGR of ~12% over the forecast period, i.e., 2023 – 2035.

T he major players in the market are Thermo Fisher Scientific, Inc, Merck KGaA,, Lonza Group Ltd., PromoCell GmbH, Asahi Kasei Corporation, Sartorius AG, InvivoGen, Eurofins Scientific, SwiftDx, and Agathos Biologics.

The company profiles are selected based on the revenues generated from the product segment, the geographical presence of the company which determines the revenue generating capacity as well as the new products being launched into the market by the company.

The market is segmented by application, technique, product & services, end user.

The cell line segment is anticipated to garner the largest market size by the end of 2035 and display significant growth opportunities.

Lack of skilled workers and high cost of testing are estimated to be the growth hindering factors for the market expansion.

The market in the North American region is projected to hold the largest market share by the end of 2035 and provide more business opportunities in the future.
Mycoplasma Testing Market Report Scope
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