Mycoplasma Testing Market

Mycoplasma Testing Market Size (2023 to 2028)

The size of the global mycoplasma testing market is estimated to grow and be worth USD 1364.14 Million by 2028 from USD 750.31 Million in 2022. This figure is forecasted to be growing at a CAGR of 12.7% during the forecast period.

Mycoplasma Testing Market Share Insights:

• Based on the product, the Kits & Reagents segment had the largest share of 50.6% in 2022 and is expected to dominate the market during the forecast period
• Based on the Technique, Polymerase Chain Reaction (PCR) segment has captured the highest market share of 31.8% in 2022
• North America’s mycoplasma testing market is expected to be worth 400.89 million by 2027
• Asia Pacific mycoplasma testing market has the fastest growth rate of 14.74 during the forecast period

A mycoplasma test is for the detection of an active or recent infection that has been caused by Ureaplasma urealyticum or Mycoplasma hominis. There are a variety of mycoplasma infections, which are transmitted through sexual contact. Mycoplasma contamination has been a growing concern for most researchers for decades. Mycoplasma infection mainly originates from laboratory workers, as contamination with human mycoplasmas occurs faster. Therefore, mycoplasma testing involves using different ways, some of which may involve collecting different types of samples like a genital swab, body fluids, sputum, tissue samples, or joint fluids. A urine sample is required for the specific detection of Ureaplasma urealyticum.

MARKET DRIVERS:

Mycoplasma testing is carried out to combat further contamination, which is expected to increase the demand for related products and, hence, the global mycoplasma testing market.

The demand for mycoplasma test products is expected to increase shortly with growing investment in R & D in life sciences. As a result, tremendous opportunities in the life sciences segment are driving the market's growth. In addition, increased investment in the biotechnology and pharmaceutical industries and healthcare spending is expected to further fuel growth.

The increased research activities of pharmaceutical and biotechnology companies are reflected in adopting new technologies for drug discovery and development. For example, in 2019, Boehringer Ingelheim announced plans to invest approximately USD 261 million in its new Biological Development Center (BDC), located at its R&D site in Germany. Furthermore, Merck plans to invest $ 18 billion in R&D over the next five years, in addition to its annual investment of $ 7.2 billion. Therefore, a significant amount of R&D expenditure is expected to drive developments in this area, stimulating the demand for mycoplasma testing products.

Government initiatives in the form of awareness campaigns on chronic diseases, such as cancer, also promote research-based activities expected to boost the global mycoplasma testing market.

The National Research Council's Industrial Research and Assistance Program (NRC-IRAP) provides technological support to small and medium-sized life science companies in Canada involved in product development and innovation. According to Saudi Arabia's Vision 2040, its government promotes the growth of pharmaceutical industries, as only 35% of its drug needs are produced locally.

The increasing introduction of new technologies by key players is expected to further fuel the mycoplasma testing market growth.

Another factor that stimulates growth is the increased contamination of cell cultures. Due to the limitation of culture methods, researchers have been involved in identifying and developing faster and more accurate mycoplasma tests in recent years. These rapid test's main advantages would be high sensitivity, the ability to identify a wide range of mycoplasma species, and reduced cycle time, thus reducing production time. Nucleic Acid-Based Technology (NAT), which allows rapid detection of mycoplasmas in cell culture, is an example of an alternative method for culture-based assays. In 2019, the American Type Culture Collection announced its new polymerase chain reaction (PCR) -based service that helps detect contaminants in mycoplasma cell cultures.

Multiple government authorities progressively support research activities in the pharmaceutical and biotechnology departments. For example, the U.S. government provides financial support to global pharmaceutical companies to facilitate research activities to develop new drugs. In addition, in April 2020, the United States Food and Drug Administration (FDA) announced plans to change the regulations for the only test method used to detect mycoplasmas. According to the agency, the regulations are restrictive and avoid using other testing methods that could detect mycoplasmas accurately. These changes in biologics regulation are expected to improve mycoplasma testing's sensitivity and specificity by developing new technologies. Therefore, increasing government funding for pharmaceutical and biotechnology research has stimulated R & D activities, promoting the broad application of mycoplasma test products.

MARKET RESTRAINTS:

The success of mycoplasma testing depends primarily on the analysts' experience and the environmental conditions under which the test is performed. Therefore, Mycoplasma testing should be performed for optimum effectiveness by trained professionals with sufficient knowledge of this area's nuances. Furthermore, the handling of instruments used in mycoplasma tests also requires experience. Hence, the shortage of sufficiently skilled human resources poses a significant challenge to the growth of the mycoplasma testing market.

Impact of COVID-19 on the global mycoplasma testing market:

The sudden eruption of coronavirus (COVID-19) caused by the SARS-CoV-2 reagent affected many industries, particularly healthcare. The pandemic crisis has induced the medical sector to find a remedy for the dangerous infectious disease. The pandemic will unbiasedly impact the mycoplasma testing market growth during 2020 and 2021. Some of the COVID-19 patients may respond to antibiotics and anti-malaria treatment positively. They could be the outcome of the inhibition of Mycoplasma species and other bacterial infections in groups of patients. It may be helpful to use molecular tests to examine the appearance of mycoplasma species and other pathogenic bacteria frequently found in ordinary pneumonia among hospitalized COVID-19 patients. When obtained positive outcomes, patients need to be treated accordingly to develop responses clinically and patient results.

REPORT COVERAGE:

This market research report on the global mycoplasma testing market has been segmented and sub-segmented into the following categories and analyzed market size and forecast until 2027.

Mycoplasma Testing Market – By Product:

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

Based on the product type, the Kits & Reagents segment will likely have the largest share during the period. Some of the kits, such as the Mycoplasma Real-Time PCR Kit, have proven to be an ideal specific and sensitive kit for mycoplasma testing with the ability to give results in less than 5 hours. These rapid results also help minimize the impact of possible contaminations, being an alert system. In addition, it has the advantage of using one single test for different processes and batch release, making it an acceptable replacement for traditional culture methods with the same sensitivity criteria, requiring lesser hours of labor work throughout the manufacturing process. Thus, it is foreseen to drive market growth over the forecast period.

Among the kits and reagents, the PCR segment is anticipated to hold a significant market share over the forecast period. This is due to several notable advantages a PCR provides, such as reliability, simplicity, objectivity, high sensitivity, rapidity, and specificity.

Mycoplasma Testing Market – By Technique:

• PCR           
• ELISA          
• Direct Assays         
• Indirect Assays     
• Microbial culture techniques          
• Enzymatic Methods           
• DNA Staining         

Based on the Technique type, the Polymerase Chain Reaction (PCR) segment is expected to hold the highest share market and high CAGR value. It is attributed to the significant receiving rate of PCR due to the exact, speedy, and ease of modification. This PCR technique is used extensively for detecting Mycoplasma as this is very quick, cheap, and not influenced by cell culture conditions. In addition, there are several other advantages to using PCR for mycoplasma contamination testing. Some of the benefits of sequencing PCR products are improved sensitivity, speed, and objectivity of the test, which identifies the contaminant with higher efficient control for its removal.

Mycoplasma Testing Market – By Application:

• Cell Line Testing    
• Virus Testing         
• Cell Testing    

Based on the Application type, the cell line testing segment is expected to have a high CAGR value during the period. This application type's growth is based on factors like the growth rate of increasing pharmaceutical industries and clones derived from an individual antibody. In addition, the advantages of cell line tests include the detection of non-culturable organisms, increased sensitivity, and a larger volume of sample testing. Also, the easier identification of species of contaminating organisms with the help of culture on a cell line indicator without Mycoplasma is expected to help the market's growth over the forecast period.

Cell Testing considers the colonies formed in the sample after incubation positive for Mycoplasma. This segment is expected to grow profitably over the forecast period owing to its advantages like simplicity, high sensitivity, and cost-effectiveness of the test.

Mycoplasma Testing Market – By End User:

• Pharmaceutical Companies             
• Contract Research Organizations  
• Academic Research Institutes        
• Cell Banks

Based on the End-user, Pharmaceutical Companies share the highest market value attributed to the new innovative activities in the pharmaceutical and biotechnology companies. In addition, biopharmaceutical facilities require the application of eukaryotic cells such as Mycoplasma for vaccine production to test the effectiveness against organisms. This requires cell banks and virus seeds for bulk vaccines, which further disrupts the growth and metabolism of eukaryotic cells. Thus, Pharmaceutical Companies are anticipated to drive the growth of the market owing to the above factors.

Mycoplasma Testing Market – By Region:

• North America
• Europe
• Asia Pacific
• Latin America
• The Middle East and Africa

Geographically, North America dominates the global mycoplasma testing market, and Europe is not far behind.

In 2020, North America dominated the mycoplasma testing market due to increased healthcare spending and investment by the U.S. government to promote biopharmaceutical industries' research activities. Biopharmaceutical production in North America is also growing, requiring highly purified cultures to produce therapeutic products. According to the National Science Foundation, in 2020, the R & D sector in the United States experienced significant growth, which is expected to influence regional development positively.

The region of Europe is estimated to hold a significant market share in terms of revenue. This is attributed to increased demands for mycoplasma testing in the biopharmaceutical production flow, the increasing number of respiratory tract infections across the region, and the anticipation of critical players for an increased demand for enhanced diagnostics by the patient population.

Moreover, increased R&D investment by key companies, rising frequency of mortality rate due to tuberculosis, respiratory diseases, and lung diseases, and rising research costs for a variety of chronic diseases and health conditions, have created lucrative opportunities for the significant market players to further invest in the regional market. This is further expected to drive the growth of the mycoplasma testing market.

Asia-Pacific region is projected to have the fastest growth rate due to the enormous opportunities available in countries like China, India, and Japan. Asia-Pacific is anticipated to grow at a lucrative growth rate during the forecast period. It is due to the significant awareness and fundraising initiatives generated by countries like India. The Indian government is implementing several strategic initiatives to facilitate additional R & D activities to introduce new drugs. Also, healthcare organizations' regulatory policies that promote improved quality of biosafety are expected to increase growth opportunities shortly. For example, China has several regulatory bodies, such as the Ministry of Health, which oversee the approval of experiments and laboratories and oversight of biosafety. Increasing pharma and biotech companies and their investments in R&D and various government initiatives are expected to drive market growth.

The emerging markets in the region of Latin America are foreseen as lucrative opportunities for the growth of the mycoplasma testing market. Furthermore, rising cases of various species of pathogenic mycoplasmas are among the identified co-infections is likely to encourage companies the adoption of highly effective mycoplasma testing tools, further driving the growth of the regional market.

The mycoplasma testing market in the Middle East and Africa is presumed to grow steadily over the forecast period due to increasing innovation for developing new drugs and the rising frequency of cases of a person infected with Mycoplasma, especially in North African countries. Such factors are expected to drive the expansion of the mycoplasma testing market across the Middle East and Africa region over the forecast period.

KEY MARKET PARTICIPANTS:

Some of the noteworthy companies dominating the global mycoplasma testing market profiled in the report are Thermo Fisher Scientific Inc., Minerva Biolabs GmbH, Charles River Laboratories International, Inc., Gibraltar Laboratories, Sartorius AG, Lonza Group Ltd., Merck KGaA, Roche Diagnostics, SGS S.A., American Type Culture Collection, InvivoGen, PromoCell GmbH, WuXi AppTec. 

RECENT HAPPENINGS IN THE MARKET:

• In December 2022, BioMérieux and NecstGen partnered to develop C-Therapies Cellular and Genetic Testing. This would enable the production of safe and effective advanced therapies through rapid testing technologies. This is required to open the door for the complex therapeutic area for discovering revolutionary treatments on the use of hope for patients and doctors' cells from the patient. In addition, they aim to provide solutions to enable the marketing of safe drugs through various cell and gene therapies, which have helped in long-term treatments for diseases such as cancer and other rare diseases.
• In Dec 2022, Bioprocess Intl released guidelines for mycoplasma testing, providing companies with actionable and fast data for batch release and raw material testing, whose contamination has proven to be a risk for the manufacture of cell-based biologics.
• In May 2019, Roche Holding received FDA clearance for the Cobas 6800/8800 systems testing menu. This clearance is used for detecting patients with symptoms or no symptoms of Trichomonas Vaginalis and Mycoplasma genitalium DNA.