U.S. Mycoplasma Testing Market Size, Share & COVID-19 Impact Analysis, By Product (Instruments and Reagents & Kits), By Testing Method (PCR-based, Culture-based, and Others), By Application (Cell Culture, Vaccine Testing, Virus Testing, and Others), and By End-user (Biopharmaceutical & Biotechnology Companies, Cell Banks, Contract Research & Contract Manufacturing Organizations, and Others), and Country Forecast, 2023-2030

The U.S. mycoplasma testing market size was worth USD 372.4 million in 2022 and is projected to grow at a CAGR of 5.4% during the forecast period.

The concern about mycoplasma contamination of cell cultures and samples is increasing among healthcare facilities, including biopharmaceutical production facilities, academic laboratories, and others. The features of mycoplasma, such as resistance to most antibiotics, absence of cell wall, smaller size, and others, make it difficult to detect the presence of contamination in the cell cultures and samples.

• According to a 2022 article published by Cell Press, around 10-35% of the cell lines in the culture and samples in the laboratories are contaminated with mycoplasma.

The robust efforts of market players to address this concern and cater to the rising demand among healthcare facilities are anticipated to favor the growth of the U.S. mycoplasma testing market. Additionally, the COVID-19 pandemic supported the demand in the laboratories and research facilities in the country owing to increased sample collection and cell culturing.

LATEST TRENDS

Integration of Advanced Technologies and Skillset Among Market Players to Drive Market Growth

The increased demand for advanced testing kits due to rising concern among healthcare researchers is driving collaborations among the market players to integrate the technology and develop advanced test kits for detection. The increasing focus of the market players on introducing advanced technology is another trend observed in the market. In November 2022, BIOMÉRIEUX SA presented a regulatory submission strategy for the implementation and validation of new PCR-based technology for mycoplasma testing of different products.

• For instance, in December 2021, Asahi Kasei Corporation acquired Bionique Testing Laboratories LLC, a U.S.-based mycoplasma testing services provider, with an aim to broaden the product offerings in testing services.

DRIVING FACTORS

Increasing R&D Activities Among Healthcare Settings to Foster Market Demand

Research and development activities in various healthcare settings, including clinical laboratories and research laboratories, have increased tremendously, especially after the COVID-19 pandemic. The growth is attributed to the growing prevalence of chronic conditions, such as cancer and autoimmune conditions, among other outbreaks in the country, which is resulting in a high demand for novel drugs and therapies.

The rising number of cell culture laboratories and small-scale research laboratories, along with the expansion of biologic manufacturing facilities by major key players in the country, is driving the demand for mycoplasma testing kits in the market.

• For instance, in February 2023, Bionova Scientific, a U.S.-based biopharmaceutical CDMO, expanded its biologics manufacturing capacity to strengthen its research activities.

RESTRAINING FACTORS

Limited Skilled Professionals to Perform the Test to Hamper Market Growth

Most of the test kits for mycoplasma testing require specialized personnel with skills and extensive hands-on time for sample preparation. Along with this, the higher turnaround time for culture-based detection of mycoplasma from the samples is another challenge that may hinder the demand for these tests in the market. Moreover, the market may be deterred due to the high costs associated with mycoplasma testing kits and products in the country.

• For instance, the price of testing kits by SouthernBiotech ranges around USD 200-210, and similarly, the kits by Alstem Bio cost around USD 260-400.

SEGMENTATION

By Product Analysis

Based on product, the market is bifurcated into instruments and reagents & kits.

The reagents & kits segment held the largest share in 2022. The segment’s growth is attributed to the growing number of research activities in the country and the rising R&D expenditure. The rising adoption of mycoplasma testing kits and products by researchers among various healthcare facilities is one of the major factors augmenting the growth of the segment.

• According to a 2022 report published by Research America, the U.S. medical and health R&D reached around USD 245.1 billion in 2020, witnessing an increase of around 10.7% as compared to the previous year.

By Testing Method Analysis

Based on testing method, the market is segmented into PCR-based, culture-based, and others.

The PCR-based testing method segment accounted for the highest U.S. mycoplasma testing market share in 2022. The awareness regarding the method and introduction of new testing kits using the technique favors the segment growth during the forecast period.

• In November 2022, BIOMÉRIEUX SA conducted a webinar presenting the regulatory submission strategy and implementation for a PCR-based technology for mycoplasma testing.

By Application Analysis 

Based on application, the market is segmented into cell culture, vaccine testing, virus testing, and others.

The cell culture segment is expected to dominate the market with a high CAGR during the forecast period with the increasing R&D activities by pharmaceutical and biotechnological companies and other healthcare facilities. The increasing cell culture contamination and awareness regarding the mycoplasma testing kits and products are some of the factors expected to support the growth of the segment.

• In August 2022, Thermo Fisher Scientific Inc. expanded its call culture media manufacturing site in New York. The facility aims to foster the development and production of biotherapeutics and vaccines.

By End-user Analysis

Based on end-user, the market is segmented into biopharmaceutical & biotechnology companies, cell banks, contract research & contract manufacturing organizations, and others.

The contract research organizations & contract manufacturing organizations segment dominated the market and is expected to grow at a considerable growth rate during the forecast period. The rising collaborations of pharmaceutical companies with contract research organizations & contract manufacturing organizations to outsource the manufacturing of drugs, vaccines, and therapies is one of the prominent factors favoring the growth of the segment.

• In July 2023, Texcell North America, a part of Texcell Group, one of the leading contract research organizations, completed the manufacturing of its new facility in North America.

KEY INDUSTRY PLAYERS

The market is fragmented, with several players with a wide product portfolio. Some of the major players operating in this market include Merck KGaA, Thermo Fisher Scientific Inc., Lonza, and F. Hoffmann-La Roche Ltd.

The rise in the demand for testing kits and reagents in laboratories among various healthcare facilities is resulting in an increased focus of these players on developing and introducing advanced products.

Sartorius AG, BIOMÉRIEUX SA, and Asahi Kasei Corporation are a few other players operating in the market focused on expanding their product portfolio and brand presence in the country to cater to the rising demand for mycoplasma testing kits. 

LIST OF KEY COMPANIES PROFILED:

• Merck KGaA (Germany)


• Lonza (Switzerland)


• F. Hoffmann-La Roche Ltd. (Switzerland)


• Thermo Fisher Scientific Inc. (U.S.)


• Sartorius AG (Germany)


• BIOMÉRIEUX  (France)


• Asahi Kasei Corporation (Japan)

KEY INDUSTRY DEVELOPMENTS: 

• June 2023 – Lonza collaborated with Vertex Pharmaceuticals Incorporated to manufacture Vertex’s investigational stem cell therapies for type 1 diabetes.


• June 2022 – Asahi Kasei Corporation acquired Bionova Scientific, a U.S.-based biopharmaceutical CDMO, with an aim to increase its footprint in the country.


• July 2020 – BIOMÉRIEUX SA launched the BIOFIRE mycoplasma test for mycoplasma detection for use in the pharmaceutical industry.

REPORT COVERAGE

The U.S. mycoplasma testing market research report provides a detailed analysis of the market. It focuses on key aspects such as an overview of the clinical trials, biologics pipeline, and technological advancements, among others. Additionally, it includes the latest trends in the market, new product launches, key industry developments such as mergers, partnerships, acquisitions and the impact of COVID-19 on the market. In addition to the aforementioned factors, it encompasses several factors that have contributed to the growth of the market over recent years.

Report Scope & Segmentation