Mycoplasma Testing Market

The global mycoplasma testing market size was valued at USD 708.26 million in 2020 and is projected to expand at a high CAGR during the forecast period, 2021 – 2028. The growth of the market is attributed to the rising R&D investments and increasing cell culture contamination. Growing introduction of novel technology from key players is projected to fuel the market growth.

With the limitation of cell cultural methods, the development and identification of accurate mycoplasma tests has been an important need in the recent years. The tests offer some major advantages such as cycle time reduction, high sensitivity, ability to identify wide range of mycoplasma species, and minimum production time besides reducing the spread of contamination. One of the alternate methods for culture-based testing is Nucleic Acid-based Technology (NAT), which provides faster detection of mycoplasma in cell culture. American Type Culture Collection in 2018 launched its new Polymerase Chain Reaction (PCR) service to enhance in finding contaminants in mycoplasma cell cultures.

Many government authorities are supporting biotechnological and pharmaceutical sectors to expand their research activities The US Food and Drug Administration (FDA) in April 2019 introduced a policy to alter the regulations that were affecting testing method used in detection of mycoplasma. According to the agency, this regulation prevented use of other testing methods, which proved to be in the improvement in mycoplasma detection tests. There are more than 190 mycoplasma species identified and out of which, only eight are dominating as they occupy around 96% of cell culture contaminations. For growing number of cell culture contamination, some factors are responsible such as cross-contamination due to faulty or broken laminar flow, dust, practices and aerosols. Additionally, the research works in laboratories is badly affected by mycoplasma contamination and testing of theses bacteria is required for generation of robust data in the field of biomedical research.

Market Trends, Drivers, Restraints, and Opportunities

• Rising concerns on cell culture contamination is one of the key drivers for the mycoplasma testing market growth.
• Rising adoption of advanced technology and growing demand for accurate, affordable and fast testing are estimated to drive the market growth.
• Increasing funding from government for R&D activities and existing vast application of mycoplasma testing products are key factors boosting the market.
• Rapid growth of many biotechnological, pharmaceutical, and academic institutes and growing outsourcing functions such as clinical trial management, drug discovery to CROs, R&D, and manufacturing are creating immense opportunities for the market players.
• Restriction entry for new entrants due to high degree of consolidation results in limited investments. This is projected to hamper the growth of the market.

Scope of the Report

The report on the mycoplasma testing market includes an assessment of the market, trends, segments, and regional markets. Overview and dynamics have also been included in the report.

Mycoplasma Testing Market Segment Insights

Kits & reagents segment to account for a key share

Based on products, the global mycoplasma testing market is divided into instruments, kits & reagents, and services. The kits & reagents segment is further classified as PCR assays, nucleic acid detection kits, stains, elimination kits, standards & controls, and others. In 2019, the kits & reagents segment is estimated to account for a large market share. Continuous buying of consumables for detecting mycoplasma in cell culture research work and other applications are key factors for the kits and reagents segment growth. Within the segment, the PCR assays helps in precise mycoplasma identification and gives results within few hours. PCR assays mostly uses electrophoresis, verifying bands of DNA fragments for the detection of mycoplasma. Meanwhile, the instruments segment is estimated to grow significantly during the forecast period owing to wide availability of automated instruments and growing demand for mycoplasma testing. For instance, CFX96 Touch Real-Time PCR Detection System was developed by Bio-Rad, which was meant particularly for PCR detection and flexible with six channels with combination of effective and advanced optical technology.

PCR segment to hold a significant market share

On the basis of technology, the market is divided into PCR, ELISA, direct assay, and microbial culture. The PCR segment is projected to hold a significant market share during the forecast period. Using this technology, multiple species of mycoplasma are detected by separating other contaminating DNA and ensuring efficient result. Moreover, the rapid detection and ease procedure handling PCR test are major factors pushing to rise demand for the technique. For instance, Merck KGaA developed kit named as LookOut Mycoplasma PCR Detection Kit, which provide facility of detection of Mycoplasma, Acholeplasma and Ureaplasma contamination in cell culture lines and cell-derived biological.

On the other hand, the direct assays segment is estimated to exhibit a high growth rate during the forecast period owing to delivery of effective and accurate results. Meanwhile, the microbial culture segment is also projected to register a high demand due to wide applications of the technology in mycoplasma contamination testing and growing research activities in the biopharmaceutical industry.

Cell line testing segment held a key share in the market

Based on applications, the global mycoplasma testing market is divided into cell line testing, virus testing, end of production cells testing, and others. The cell line testing segment accounted for a key revenue market share in 2019 and is expected to grow significantly during the forecast period due to increasing research activities in cell culture field and growing mycoplasma contamination in cell culture.

Meanwhile, the end of the production cell testing segment is estimated to exhibit a healthy growth rate over the forecast period due to increase in drug development and discovery clinical trials as well as increasing cell harvest process.  This segment includes techniques such as copy number, mRNA sequencing, and Southern Blotting for genetic analysis of the transgene.

Pharmaceutical & biotechnology companies to constitute a large market share

Based on end-users, the global mycoplasma testing market is divided into academic research institutes, cell banks, contract research organizations, pharmaceutical & biotechnology companies, and others. The pharmaceutical and biotechnology companies segment accounted for a major market share in 2019 and is anticipated to constitute a large market share in the coming years. These companies are increasingly focusing on their research activities to develop new technologies for development and discovery of drug. The companies are involved in quality checking of raw material for management of biological safety. Furthermore, growing prevalence of diseases such as psoriasis and rheumatoid arthritis is a key factor pushing the segment growth.

North America is expected to dominate the market

On the basis of regions, the global mycoplasma testing market is classified as Asia Pacific, North America, Latin America, Europe, and Middle East & Africa. In 2019 the market was dominated by North America and the trend is expected to continue in the coming years. Factor such as increasing investments and spending on healthcare especially from the US government to promote activities based on research in biopharmaceutical industries. In the region, biopharmaceutical players are growing that offer extremely purified cultures for production of therapeutics. Growing R&D sector from the players is expected to propel the regional market growth. On the other hand, the market in Asia Pacific is estimated to expand at a rapid growth rate over the forecast period due to rising awareness and generation of funding initiatives by governments from emerging economies such as India.

Segments

Segments Covered in the Report

The global mycoplasma testing market has been segmented on the basis of

Products

• Instruments
• Kits & Reagents
  • PCR Assays
  • Nucleic Acid Detection Kits
  • Stains
  • Elimination Kits
  • Standards & Controls
  • Others
• Services

Technology 

• PCR
• ELISA
• Direct Assay
• Indirect Assay
• Microbial Culture Techniques
• Enzymatic Methods

Applications

• Cell Line Testing
• Virus Testing
• End of Production Cells Testing
• Others

End-users  

• Academic Research Institutes
• Cell Banks
• Contract Research Organizations
• Pharmaceutical & Biotechnology Companies
• Others

Regions

• Asia Pacific
• North America
• Latin America
• Europe
• Middle East & Africa

Key Players

• TBionique Testing Laboratories, Inc.
• Lonza Group Ltd.
• Merck KGaA
• PromoCell GmbH
• ATCC (American Type Culture Collection)
• Biological Industries Israel Beit Haemek Ltd.
• Charles River Laboratories International, Inc.
• Thermo Fisher Scientific
• InvivoGen

Competitive Landscape

Some of the key market players include TBionique Testing Laboratories, Inc., Lonza Group Ltd., Merck KGaA, PromoCell GmbH, ATCC (American Type Culture Collection), Biological Industries Israel Beit Haemek Ltd., Charles River Laboratories International, Inc., Thermo Fisher Scientific, and InvivoGen.

Geographical expansions, mergers, acquisitions and new product development are major strategies implemented by key market players. For instance, Lonza extended its mycoplasma detection portfolio by introducing new luminometer Lucetta 2-a product in 2019. Boehringer Ingelheim, in 2018, published its plan for the investment of around 260 million for its new Biological Development Center (BDC) present in Germany at its R&D site. Over the next five years, Merck KGaA planned to invest in R&D around 15 billion as an extra investment to its annual investment of USD 7.2 billion.