Mycoplasma Testing Market Size, Share & Trends Analysis By Product (Instruments, Kits & Reagents), By Technology (PCR, ELISA, Direct Assay, Microbial Culture), By Application, By End-use, By Region, And Segment Forecasts, 2023 - 2030

Report Overview

The global mycoplasma testing market size was estimated at USD 841.35 million in 2022 and is expected to grow at a compound annual growth rate (CAGR) of 13.4% from 2023 to 2030. The market growth has been largely influenced by rising R&D investments. The life sciences sector is experiencing a major increase in research activity due to rising healthcare costs. Furthermore, the need for mycoplasma tests is being driven by the adoption of new technologies for drug research and development and advancements in cell culture technology. For instance, in February 2023, SwiftDx introduced a novel mycoplasma detection kit. The newly launched SwiftDx Mycoplasma Detection Kit provides a faster and more convenient solution for detecting mycoplasma contamination through a lateral flow test.

The COVID-19 outbreak has adversely affected all industries and economies, and it continues to negatively impact the global economy. However, biopharmaceutical and related markets have not been significantly impacted when compared to other industries. According to a study published in May 2022, there is a co-relation between mycoplasma testing numbers and COVID-19-related Non-Pharmaceutical Interventions (NPIs). This study analyzed the incidence of M. pneumonia after the implementation of COVID-19 NPIs. This survey showed that there has been a decrease in M. pneumoniae detection during the pandemic. This reduction was observed globally between March 2020 and March 2021. This reduction is majorly due to the restricted transmission of M. pneumonia, resulting in a significant reduction in M. pneumoniae infections across the globe.

As a result of innovative approaches and substantial investments by operating players, mycoplasma testing market is witnessing an increasing attention. For instance, seven of the top 10 best-selling drugs in early 2020 were biologics. This is representative of the emergence of biologics in the global market. Cell lines play a crucial role in the production of various biologic products, such as monoclonal antibodies, viral vaccines, and cytokines, which are used for medicinal or therapeutic purposes. Mycoplasma strains have an extensive effect on metabolism, physiology, and gene expression of cell lines. Thus, it is necessary to check mycoplasma contamination in biopharmaceutical production. Microbiological monitoring is required throughout the manufacturing process. Thus, increasing requirement for mycoplasma testing in biopharmaceutical production workflow has created lucrative opportunities for product and service providers in mycoplasma testing market.

Increasing R&D investments by key companies and rising research costs are likely to encourage firms to adopt highly efficient mycoplasma testing tools. For instance, Bristol-Myers Squibb started investing in production of investigational medicines to support clinical trials. In addition, with the advent of biosimilars, because of lucrative R&D investment, it has become imperative to conduct safety testing to ensure that a product meets the standards to ensure efficacy, safety, and overall public health. In December 2020, Merck KGaA broadened its manufacturing footprint with a combined investment of over USD 45.6 million (EUR 40 million) at its Massachusetts and New Hampshire production facilities in the U.S. The sites were intended to produce several biopharmaceutical manufacturing products and enhance the company’s production capacities. This is expected to further improve the penetration of mycoplasma testing tools.

Furthermore, the market for mycoplasma testing is driving due to the rising number of respiratory tract infections around the world. In a variety of chronic diseases and health conditions, various pathogenic mycoplasma species are among the most commonly identified co-infections. As per the CDC, in 2021, the number of deaths due to chronic lower respiratory diseases was 152,657. The number of deaths from respiratory illnesses, pulmonary disease, and tuberculosis has increased, and these figures are likely to increase in the next years, which is expected to spur the expansion of the mycoplasma testing market. Furthermore, key players in this market are anticipating an increase in demand for improved diagnostics for non-pulmonary therapies, which will drive the worldwide market in the near future.

Product Insights

The kits and reagents segment captured the highest revenue share of 50.93% in 2022, due to the high demand for these products in mycoplasma detection, as well as their high cost. Various market players have developed mycoplasma detection kits catering specifically to the needs of researchers and biologic manufacturers, which is fueling segment growth. Due to the growing availability of automated equipment for the detection of mycoplasma, instruments are predicted to experience substantial growth during the projected period.

A better method that enables quick detection and produces results quickly is provided by PCR systems. For instance, the CFX96 Touch Real-Time PCR Detection System from Bio-Rad Laboratories is based on PCR. It is a versatile and accurate PCR detection system with six channels that combines cutting-edge optical technique with exact temperature control. As a result, both multiplex as well as singleplex reactions can be detected using a method that is trustworthy and sensitive. Thus, propelling the mycoplasma testing market growth.

Technology Insights

The PCR segment dominated the mycoplasma testing market with a revenue share of 32.38% in 2022 and exhibits the fastest growth rate during the projected period. This approach allows the separation of other contaminating DNA while allowing the detection of various mycoplasma species. It offers test findings that are highly efficient and specific. Some of the key benefits provided by this technology include ease of use and quick detection. For instance, the Merck KGaA-developed LookOut Mycoplasma PCR Detection Kit that makes it easier to detect contamination with Ureaplasma, Mycoplasma, and Acholeplasma in cell-derived biologicals and cell culture lines.

ELISA technology is expected to gain considerable market share during the forecast period as it facilitates easy detection with the use of labeled probes or antibodies for mycoplasma detection. In some instances, PCR and ELISA tests are combined to form PCR-ELISA, a photometric enzyme-based immunoassay that facilitates the detection of PCR-amplified mycoplasma DNA in samples. Functional advantages, cost-effectiveness, and ability to detect a wide range of strains are few factors propelling segment growth during the forecast period.

Application Insights

The cell line testing segment accounted for the largest share of 41.46% in 2022, as well as the fastest growth rate throughout the forecast period, owing to the increase in research projects being done in the field of cell culture. For instance, the federal funding agency in Canada for health research, Canadian Institutes of Health Research (CIHR), has supported many health researchers in Canada with around USD 981 million in investments. The National Research Council’s Industrial Research and Assistance Program (NRC-IRAP) is also offering technical support to several Canadian life science companies including small and medium-scale involved in product development and innovation.

A surge in mycoplasma contamination in cell culture is also anticipated to cause it to see the largest growth during the projection period. Toxin development and changes in metabolite production in cell culture can be caused by mycoplasma contamination. As a result, cell line testing and authentication are given the utmost significance in the biopharmaceutical and pharmaceutical industries.

End-use Insights

The pharmaceutical and biotechnology companies segment received the highest revenue shares of 35.36% in 2022, as well as the fastest CAGR throughout the forecast period. Because these firms have made significant investments in R&D efforts, which have fostered advancements in the field of drug development research. These businesses carry out quality tests on raw materials to manage biological safety. Furthermore, the prevalence of disorders like rheumatoid arthritis and psoriasis is rising, which is contributing to the growth of the biopharmaceutical industry.

Due to the expanding research services offered by these firms, contract research organizations (CROs) are predicted to grow profitably over the projected period. In order to ensure the sterility of cultures used in preclinical research and biopharmaceutical development, they mandate the use of mycoplasma tests, ensuring the caliber of the outsourced testing services.

Regional Insights

North America dominated the market and accounted for revenue share of 39.08% in 2022. Due to its established healthcare sector and the increased incidence of respiratory disorders, this area is predicted to enhance its market share. The existence of multinational pharmaceutical and biotech companies as well as increased investment in R&D activities in the region are additional factors promoting the expansion of this region.

Asia Pacific is estimated to witness an exponential CAGR during the projected timeframe, which can be attributed to increase in healthcare spending and rise in the demand for better infrastructure in laboratory & clinical research. Furthermore, regulatory policies imposed by healthcare organizations favoring improvements in biosafety quality are likely to surge growth opportunities in the future. In addition, emerging markets such as India are also witnessing lucrative opportunities in this sector. the Indian government is implementing a variety of strategic efforts to encourage more Research and innovation for the development of new medication, propels the market growth.

Key Companies & Market Share Insights

Key players in this market are implementing various strategies including partnerships through mergers and acquisitions, geographical expansion, and strategic collaborations to expand their market presence. For instance, Infinity Laboratories increased its capabilities in April 2020 by starting to offer Mycoplasma testing. The leading market players' capabilities will increase as a result of the adoption of key tactics like expansion, collaborations, acquisitions, and others, spurring market expansion. Similarly, in April 2023,Agathos Biologics announced it’s offering of analytical testing services to life science researchers. Agathos exclusively utilizes QIAcuity instrumentation and assays developed by QIAGEN. Furthermore, Agathos has formed a collaboration with QIAGEN to conduct testing and validation for mycoplasma and recombinant adeno-associated viral vector (rAAV) assays. Some of the key players in the global mycoplasma testing market include:

• Thermo Fisher Scientific, Inc.

• Merck KGaA

• Lonza Group AG

• Charles River Laboratories International, Inc.

• PromoCell GmbH

• American Type Culture Collection

• Asahi Kasei Medical Co., Ltd.

• Sartorius AG

• InvivoGen

• Eurofins Scientific

Mycoplasma Testing Market Report Scope

Global Mycoplasma Testing Market Report Segmentation

This report forecasts revenue growth at global, regional, and country levels and provides an analysis of the latest trends and opportunities in each of the sub-segments from 2018 to 2030. For the purpose of this study, Grand View Research has segmented the global mycoplasma testing market report on the basis of product, technology, application, end-use, and region:

• Product Outlook (Revenue, USD Million, 2018 - 2030)

  • Instruments

  • Kits & Reagents

    •       PCR Assays

    •       Nucleic Acid Detection Kits

    •       Stains

    •       Elimination Kits

    •       Standards & Controls

    •       Others

  • Services

• Technology Outlook (Revenue, USD Million, 2018 - 2030)

  • PCR

  • ELISA

  • Direct Assay

  • Indirect Assay

  • Microbial Culture Techniques

  • Enzymatic Methods

• Application Outlook (Revenue, USD Million, 2018 - 2030)

  • Cell Line Testing

  • Virus Testing

  • End of Production Cells Testing

  • Others

• End-use Outlook (Revenue, USD Million, 2018 - 2030)

  • Academic Research Institutes

  • Cell Banks

  • Contract Research Organizations

  • Pharmaceutical & Biotechnology Companies

  • Others

• Regional Outlook (Revenue, USD Million, 2018 - 2030)

  • North America

    • U.S.

    • Canada

  • Europe

    • Germany

    • UK

    • Spain

    • France

    • Italy

    • Denmark

    • Sweden

    • Norway

  • Asia Pacific

    • Japan

    • China

    • India

    • South Korea

    • Thailand

    • Australia

  • Latin America

    • Brazil

    • Mexico

    • Argentina

  • MEA

    • South Africa

    • Saudi Arabia

    • UAE

    • Kuwait