by The global mycoplasma testing market offers a wide range of products that play a vital role in pharmaceutical, biotechnology and research industries by detecting and eliminating mycoplasma contamination in cell culture. Cell-based assays are commonly used in the development and manufacturing of biotherapeutic products and detecting mycoplasma is crucial to ensure product quality and safety. The market provides kits and reagents for polymerase chain reaction (PCR)-based, microbiological and non-microbiological techniques for mycoplasma detection procedures. Advancements in PCR-based detection methods have significantly improved sensitivity and reduced the time required for testing.
The Global Mycoplasma Testing Market Sizeis estimated to be valued at US$ 997.8 MN in 2024 and is expected to exhibit a CAGR of 9.7% over the forecast period 2024 to 2031.
Key Takeaways
Key players operating in the Global Mycoplasma Testing Market Size are Charles River Laboratories International, Merck KGaA, Lonza Group Ltd, Roche Diagnostics, Thermo Fisher Scientific, Merck, InvivoGen, Creative Bioarray.
The market offers opportunities for growth driven by rising R&D investments in cell-based research and biologics manufacturing. Additionally, stringent regulations requiring mycoplasma testing at different stages of product development and manufacturing further support market expansion.
Technological advancements in PCR and other detection techniques have made mycoplasma testing more sensitive and high-throughput. Introduction of microfluidics-based PCR systems and automated detection platforms are expected to boost adoption rates.
Market drivers:
The global mycoplasma testing market is primarily driven by increasing demand for biotherapeutic products and rising investments in cell-based research. Stringent regulatory guidelines mandating mycoplasma screening pre- and post-production to ensure product purity and safety also support market growth. As biologics manufacturing increases worldwide, the need for specialized mycoplasma detection solutions will continue surging over the forecast period.
Current Challenges in Global Mycoplasma Testing Market:
The global mycoplasma testing market faces many challenges in terms of regulations, sensitivity, and contamination issues. Regulatory bodies like the FDA impose stringent regulations for screening mycoplasma contamination in cell culture production. Any contamination can hamper product quality, resulting in expensive recalls and lawsuits. Laboratories also face the challenge of designing highly sensitive assays to detect both mycoplasma species as well as very low contamination levels. Mycoplasma infects cell cultures easily and eradicating it completely is difficult as it hides inside the host cells. This persistent nature of contamination poses continuous monitoring challenges. Standardization of detection methods is another issue as many alternative techniques are available with varying performance parameters.
SWOT Analysis
Strength: Sensitive techniques like PCR and digital PCR enable detection of very low contamination levels. Traditional assays continue to serve basic screening needs.
Weakness: Contamination risks exist at every stage from cell culturing to production. Eradication is difficult due to persistent nature.
Opportunity: Emerging economies show growing biopharmaceutical industry and cell culture-based vaccines, driving testing demand.
Threats: Stringent regulations on sterility and quality require costly compliance. New emerging mycoplasma species remain untested.
Geographical Regions
North America dominates the global market with the largest share in terms of value due to widespread biopharmaceutical industry and stringent FDA regulations for mycoplasma testing. The presence of leading market players and availability of advanced technologies further boost market growth.
Asia Pacific is poised to be the fastest growing regional market during the forecast period owing to increasing biological research, expanding biomanufacturing facilities and rising biosimilars industry in countries like China, India and South Korea. Growing biopharma industry, favorable funding scenarios and improving regulatory guidelines are fueling the APAC market.
Note:
1. Source: Coherent Market Insights, Public sources, Desk research
2. We have leveraged AI tools to mine information and compile it
