Mycoplasma Testing Market Size, Share & Industry Growth Report, 2030

Name: Mycoplasma Testing Market Size, Share & Industry Growth Report, 2030
Creator: Mordor Intelligence
License: https://www.mordorintelligence.com/privacy-policy

Mycoplasma Testing Market Size and Share

Market Overview

Study Period	2019 - 2030
Market Size (2025)	USD 1.13 Billion
Market Size (2030)	USD 1.93 Billion
Growth Rate (2025 - 2030)	11.27% CAGR
Fastest Growing Market	Asia Pacific
Largest Market	North America
Market Concentration	Medium
Major Players *Disclaimer: Major Players sorted in no particular order Image © Mordor Intelligence. Reuse requires attribution under CC BY 4.0.

Mycoplasma Testing Market Summary — Image © Mordor Intelligence. Reuse requires attribution under CC BY 4.0.

Mycoplasma Testing Market Analysis by Mordor Intelligence

The Mycoplasma Testing Market size is estimated at USD 1.13 billion in 2025, and is expected to reach USD 1.93 billion by 2030, at a CAGR of 11.27% during the forecast period (2025-2030).

Heightened regulatory scrutiny on biologics manufacturing, expanding cell- and gene-therapy production, and growing preference for rapid nucleic-acid methods underpin this trajectory. Regulatory agencies, led by the FDA and EMA, require validated mycoplasma detection at multiple points in the product lifecycle, turning compliance into a non-discretionary spend for biomanufacturers fda.gov. Digital PCR and automated sample-to-answer platforms accelerate lot-release timelines, while the outsourcing trend transfers testing workloads to contract organizations that can scale capacity quickly. Regional manufacturing expansions in China, India, and Singapore combine with tax incentives to spur laboratory build-outs, yet shortages of skilled molecular QA personnel and high automation costs temper adoption rates in smaller facilities. Competitive dynamics favor vendors able to bundle instruments, kits, and services, boosting cross-selling potential and consolidating customer relationships.

Key Report Takeaways

By product and service, kits and reagents held a 46.17% revenue share in 2024, whereas services are projected to expand at a 14.68% CAGR to 2030.
By technology, qPCR led with 64.39% of the mycoplasma testing market share in 2024, while digital PCR is forecast to grow at 16.26% through 2030.
By application, cell-line quality control accounted for 41.62% of the mycoplasma testing market size in 2024; gene and cell therapy manufacturing will rise at a 17.82% CAGR between 2025 and 2030.
By end user, biopharma & biotechnology companies accounted for 65.29% of the mycoplasma testing market size in 2024; contract manufacturing organizations recorded the fastest growth, progressing at 15.45% CAGR to 2030.
By geography, North America commanded 40.81% share of the mycoplasma testing market in 2024, yet Asia-Pacific is advancing at an 18.62% CAGR through 2030.

Global Mycoplasma Testing Market Trends and Insights

Drivers Impact Analysis

Driver	(~) % Impact on CAGR Forecast	Geographic Relevance	Impact Timeline
Expansion of biopharma and cell & gene therapy facilities	+2.8%	Global, concentrated in North America & EU	Medium term (2-4 years)
Regulatory mandates require mycoplasma release testing	+2.1%	Global, led by FDA/EMA jurisdictions	Short term (≤ 2 years)
Increasing incidents of cell-culture contamination	+1.9%	Global, high-volume manufacturing hubs	Short term (≤ 2 years)
Rising demand for rapid, high-sensitivity PCR assays	+1.7%	North America & EU, expanding to APAC	Medium term (2-4 years)
Decentralised QC labs in emerging biotech hubs	+1.2%	APAC core, spill-over to MEA	Long term (≥ 4 years)
VC-backed growth of synthetic biology start-ups	+0.9%	North America & EU, emerging in APAC	Long term (≥ 4 years)

Source: Mordor Intelligence

Expansion of Biopharma and Cell & Gene Therapy Manufacturing Facilities

Capacity ramp-ups in autologous and allogeneic therapy plants have multiplied sample volumes that require 100% batch testing. Contamination prevalence in cell cultures ranges between 15% and 35%, and FDA guidance now mandates mycoplasma testing after pooling and prior to washing, increasing sampling frequency.^{[1]American Type Culture Collection, “Cell Culture Contamination Studies,” atcc.org} Continuous perfusion bioreactors raise real-time monitoring needs, pushing demand for automated analyzers that handle higher throughputs with minimal human intervention. Facility roll-outs in emerging markets must complete qualification studies, creating greenfield demand for third-party test services. Together, these trends add 2.8 percentage points to the forecast CAGR.

Regulatory Mandates Require Mycoplasma Release Testing for Biologics

The FDA’s laboratory developed tests rule and EMA guidance for advanced therapy medicinal Products require validated assays from a master cell bank to a finished drug.^{[2]Federal Register Editorial Team, “Laboratory Developed Tests; Final Rule,” federalregister.gov} The European Medicines Agency's guidelines for Advanced Therapy Medicinal Products mandate comprehensive mycoplasma testing throughout the manufacturing process, from master cell banks to final product release. These regulatory changes create non-discretionary demand for testing services, as manufacturers cannot release products without demonstrating mycoplasma absence through validated methods. Compliance spending accelerates through 2027 as phased LDT oversight takes effect.The phased implementation of new LDT regulations over four years creates predictable demand growth as laboratories upgrade their testing capabilities to maintain compliance.

Increasing Incidents of Cell-Culture Contamination

Industry case studies document filtration bypass, DNA persistence, and charge-variant shifts in monoclonal antibodies following undetected contamination.^{[3]Wiley Editors, “Charge Variants in Contaminated mAbs,” onlinelibrary.wiley.com} Economic fallout includes batch destruction, facility shutdowns, and regulatory inspections, prompting proactive screening policies. High-density cultures and longer residence times in intensified processes further elevate risk, translating into more frequent interim tests.

Rising Demand for Rapid, High-Sensitivity PCR-Based Assays

Digital PCR detects ≤10 CFU/mL without reference curves, providing absolute quantification that meets release-testing precision needs. Platforms such as the BIOFIRE Mycoplasma system report results in 60 minutes, condensing lot-release cycles. AI-driven analytics streamline interpretation and cut false positives. Regulatory nods, e.g., Health Canada’s clearance of Roche MycoTOOL, validate these technologies for commercial adoption.

Restraints Impact Analysis

Restraint	(~) % Impact on CAGR Forecast	Geographic Relevance	Impact Timeline
High capital expenditure for automated systems	-1.8%	Global, smaller labs affected	Short term (≤ 2 years)
False-positive/-negative retest delays	-1.4%	Global, high-volume sites	Medium term (2-4 years)
Skilled molecular-QA workforce shortages	-1.1%	North America & EU, rising in APAC	Long term (≥ 4 years)
Regulatory lag on microfluidic and next-gen assays	-0.8%	Global, jurisdiction-specific	Medium term (2-4 years)

Source: Mordor Intelligence

High Capital Expenditure for Implementing Automated Detection Systems

Entry-level automated analyzers cost USD 100,000–500,000, with annual service contracts topping USD 50,000. Smaller CTLs and academic labs struggle to justify such outlays, prolonging reliance on manual culture methods. FDA LDT compliance adds validation costs and strains capital budgets, curbing near-term uptake. Smaller contract testing laboratories face particular challenges in justifying automation investments given their limited sample volumes and diverse testing requirements. The complexity of validating automated systems for regulatory compliance adds significant time and cost burdens, with validation studies typically requiring 6-12 months and specialized expertise.

False-Positive/-Negative Retest Delays

DNA carry-over and cross-contamination trigger confirmatory workflows that erode the speed advantage of PCR, while false negatives threaten patient safety and invite regulatory scrutiny. Discordant results between culture and molecular assays extend release timelines by weeks, especially when investigation protocols lack standardisation. Regulatory agencies' requirements for investigation of atypical results can delay product releases by weeks or months, particularly when multiple testing methods yield conflicting outcomes. The industry's transition from culture-based to molecular methods introduces new sources of variability that require extensive method validation and comparison studies to establish confidence in results.

Segment Analysis

By Product & Service: Outsourced Services Gain Momentum

Kits and reagents maintained a 46.17% share in 2024, underlining their consumable nature within the Mycoplasma testing market. The Services segment is set to expand at 14.68% CAGR as biomanufacturers delegate method validation and routine screening to accredited laboratories. High regulatory hurdles and evolving assay formats encourage companies to buy expert capacity instead of building it. Eurofins’ network of 45+ global sites illustrates how scale produces cost-efficiencies that individual firms cannot replicate.

Automation-ready instruments show steady but slower growth because purchasers often tie them to long-term reagent contracts. The BIOFIRE platform and Rapid Micro Biosystems’ vial-reader appeal by blending speed with pharmacopeial compliance. As services grow, kit vendors align with third-party labs under reagent-rental models that lock in supply revenues. This synergy consolidates buyer–supplier dependencies and drives volume in both categories.

Market Share by Product and Service — Image © Mordor Intelligence. Reuse requires attribution under CC BY 4.0.

By Technology: Digital PCR Disrupts Legacy Workflows

qPCR holds 64.39% of the 2024 Mycoplasma testing market share thanks to entrenched protocols and broad instrument availability. Digital PCR, with a 16.26% growth rate, mitigates standard-curve errors and detects rare events vital for gene-therapy lots. Sensitivity gains resonate with regulatory auditors seeking robust quantification. Conventional PCR remains a budget choice for legacy facilities, while ELISA and DNA staining stay relevant in niche academic applications. Next-generation sequencing promises multiplex pathogen screens but awaits regulatory consensus.

Regulatory bodies now accept nucleic-acid methods equivalent to culture for release testing, catalysing digital PCR uptake. Instrument makers invest in microfluidic chip formats that slice reaction mixes into thousands of partitions, lowering detection thresholds. AI augmentation further lessens operator skill barriers, unlocking broader lab adoption.

By Application: Gene Therapy Drives Highest Upside

Cell-line quality control dominated the mycoplasma testing market in 2024, with a 41.62% share. Yet gene and cell therapy manufacturing will outpace all other uses at a 17.82% CAGR. Extended culture durations, autologous workflows, and multi-step manipulations amplify contamination risk, compelling frequent in-process checks. Regulatory guidance treats each manufacturing step as a potential contamination window, swelling sample numbers.

Bioproduction batch-release testing remains a staple, while raw-material & media testing gains share as firms recognise upstream vectors such as animal-origin components. Vaccine and virus manufacturers broaden surveillance alongside rising viral-vector therapeutics pipelines. Academic discovery work sits outside stringent release rules but still demands periodic screening to protect research integrity.

Market Share by Application — Image © Mordor Intelligence. Reuse requires attribution under CC BY 4.0.

By End User: CMOs Capture Outsourcing Wave

Biopharma and biotechnology Companies accounted for 65.29% of the end-user segment in 2024, yet CMOs will grow the fastest at 15.45% CAGR as virtual biotech firms rely on third parties from plasmid prep through fill-finish. The Mycoplasma testing market size for contract labs widens when projects scale from pre-clinical to commercial runs.

Diagnostic and reference labs diversify into biologics support, chasing higher-margin industry work. Cell banks guard against line cross-contamination because a single tainted master cell bank can invalidate years of submissions. Workforce shortages push even large pharma to outsource surge testing during tech-transfer or facility shutdown periods, reinforcing the CMO growth curve.

Geography Analysis

North America led with 40.81% of 2024 revenue as FDA oversight, mature bioprocessing infrastructure, and early technology adoption underpin stable demand. The region’s biocluster density and capital availability encourage rapid replacement of culture methods with automated PCR systems. Service providers leverage proximity to innovators, enabling just-in-time sample logistics and compliance audits.

Europe follows with a cohesive regulatory framework from the EMA and harmonised pharmacopoeias that facilitate multi-country lot release. The Mycoplasma testing market size tied to EU gene-therapy trials rises as Germany, Spain, and the United Kingdom host GMP facilities. Vendors cater to multi-language documentation and serialization demands, spurring informatics-enabled assay platforms.

Asia-Pacific represents the fastest-growing arena, expanding at 18.62% CAGR. China’s cell-therapy sector benefits from government priority listings, while India’s production-linked incentive schemes attract vaccine exporters. Singapore’s decentralized QC labs shorten turnaround times for regional biologics plants. Fragmented regulations necessitate local validation, favouring global companies that co-locate service hubs.

South America and the Middle East & Africa trail in absolute revenue but offer untapped upside as domestic vaccine programs and biosimilar plants proliferate. Logistics hurdles and limited cold-chain infrastructure slow penetration of rapid PCR devices, yet public-health investments could unlock future orders once training and service networks mature.

Growth Rate by Region — Image © Mordor Intelligence. Reuse requires attribution under CC BY 4.0.

Competitive Landscape

The mycoplasma testing market is moderately fragmented. Thermo Fisher Scientific, Charles River Laboratories, and Merck KGaA combine broad reagent portfolios with global technical-service teams, anchoring them atop instrument and kit sales. Danaher’s 2024 merger of Cytiva and Pall created a USD 7.5 billion bioprocess powerhouse that unifies filtration, culture media, and testing under one umbrella.

Specialised laboratories such as Eurofins Scientific and SGS scale through multi-site GMP accreditations, capturing outsourced workloads that require geographic proximity to filling lines. Their competitive edge lies in turnkey validation packages that compress client timelines. Smaller innovators like Minerva Biolabs focus on reagent-only niches, while Rapid Micro Biosystems targets high-throughput QC labs with automated reader systems.

Acquisition activity intensifies as firms chase end-to-end platform breadth. bioMérieux’s 2025 buyout of SpinChip Diagnostics adds ultra-fast immunoassay capability to complement its BIOFIRE molecular suite, positioning the company for sample-to-answer dominance. AI partnerships aim to trim interpretation errors and reduce retest frequency, providing another lever for differentiation.

Mycoplasma Testing Industry Leaders

Bionique Testing Laboratories Inc.
Thermo Fisher Scientific Inc.
Eurofins Scientific
Merck KGaA
ATCC
*Disclaimer: Major Players sorted in no particular order

Mycoplasma Testing Market Concentration — Image © Mordor Intelligence. Reuse requires attribution under CC BY 4.0.

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Recent Industry Developments

January 2025: bioMérieux completed the acquisition of SpinChip Diagnostics ASA for EUR 111 (USD 127.3) million, enhancing its point-of-care diagnostics capabilities with rapid immunoassay technology that delivers results from whole blood samples in 10 minutes. The acquisition strengthens bioMérieux's position in the mycoplasma testing market by expanding its diagnostic platform portfolio and accelerating development of rapid testing solutions for biopharmaceutical applications.
July 2024: SGS North America expanded its biologics testing capabilities at the Lincolnshire Center of Excellence, enhancing instrumentation and expertise to support growing biopharmaceutical market demand. The expansion includes advanced mycoplasma testing capabilities and positions SGS to capture increased demand from both small and large molecule testing applications.
February 2024: Standard BioTools Inc. partnered with Next Gen Diagnostics to automate pathogen whole genome sequencing, reducing bacterial sequencing costs to under USD 10 per sample. The partnership addresses bottlenecks in sample preparation and bioinformatics that impact mycoplasma testing efficiency and scalability.
March 2024: – US BioTek Laboratories acquired RealTime Laboratories, a pioneer in mycotoxin testing, expanding its diagnostic testing portfolio and geographic reach. The acquisition enhances US BioTek's capabilities in contamination testing and provides access to advanced testing technologies relevant to mycoplasma detection applications.

Table of Contents for Mycoplasma Testing Industry Report

1. Introduction

1.1 Study Assumptions & Market Definition
1.2 Scope of the Study

2. Research Methodology

3. Executive Summary

4. Market Landscape

4.1 Market Overview
4.2 Market Drivers
- 4.2.1 Expansion of Biopharma and Cell & Gene Therapy (CGT) Manufacturing Facilities
- 4.2.2 Regulatory Mandates Require Mycoplasma Release Testing for Biologics
- 4.2.3 Increasing Incidents of Cell-Culture contamination
- 4.2.4 Rising Demand for Rapid, High-Sensitivity PCR-Based Assays
- 4.2.5 Decentralised QC Labs in Emerging Biotech Hubs
- 4.2.6 Venture Capital–Backed Proliferation of Synthetic Biology Startups
4.3 Market Restraints
- 4.3.1 High Capital Expenditure (CAPEX) for Implementing Automated Detection Systems
- 4.3.2 False-Positive/-Negative Retest Delays
- 4.3.3 Skilled Molecular-QA Workforce Shortages
- 4.3.4 Regulatory Lag Surrounding Approval of Microfluidic and Next-Gen Assays
4.4 Porter’s Five Forces Analysis
- 4.4.1 Threat of New Entrants
- 4.4.2 Bargaining Power of Buyers
- 4.4.3 Bargaining Power of Suppliers
- 4.4.4 Threat of Substitutes
- 4.4.5 Intensity of Competitive Rivalry

5. Market Size & Growth Forecasts (Value in USD)

5.1 By Product & Service
- 5.1.1 Instruments
- 5.1.1.1 Real-time PCR Systems
- 5.1.1.2 Rapid Microfluidic Analyzers
- 5.1.1.3 Automated Detection Platforms
- 5.1.1.4 Other Instruments
- 5.1.2 Kits & Reagents
- 5.1.2.1 PCR Assay Kits
- 5.1.2.2 ELISA Kits
- 5.1.2.3 Enzymatic Assay Kits
- 5.1.2.4 Fluorescent‐Staining Reagents
- 5.1.2.5 Others
- 5.1.3 Services
5.2 By Technology
- 5.2.1 Conventional PCR
- 5.2.2 qPCR
- 5.2.3 Digital PCR
- 5.2.4 ELISA
- 5.2.5 Enzymatic Methods
- 5.2.6 DNA Staining
- 5.2.7 Next-Generation Sequencing
- 5.2.8 Other NAATs
5.3 By Application
- 5.3.1 Cell-Line Quality Control
- 5.3.2 Bioproduction Batch-Release Testing
- 5.3.3 Raw-Material & Media Testing
- 5.3.4 Gene & Cell Therapy Manufacturing
- 5.3.5 Vaccine & Virus Testing
- 5.3.6 Other Applications
5.4 By End User
- 5.4.1 Biopharma & Biotechnology Companies
- 5.4.2 Contract Manufacturing Organizations (CMOs)
- 5.4.3 Academic & Research Institutes
- 5.4.4 Cell Banks & Repositories
- 5.4.5 Diagnostic & Reference Laboratories
5.5 By Geography
- 5.5.1 North America
- 5.5.1.1 United States
- 5.5.1.2 Canada
- 5.5.1.3 Mexico
- 5.5.2 Europe
- 5.5.2.1 Germany
- 5.5.2.2 United Kingdom
- 5.5.2.3 France
- 5.5.2.4 Italy
- 5.5.2.5 Spain
- 5.5.2.6 Rest of Europe
- 5.5.3 Asia-Pacific
- 5.5.3.1 China
- 5.5.3.2 Japan
- 5.5.3.3 India
- 5.5.3.4 Australia
- 5.5.3.5 South Korea
- 5.5.3.6 Rest of Asia-Pacific
- 5.5.4 Middle East & Africa
- 5.5.4.1 GCC
- 5.5.4.2 South Africa
- 5.5.4.3 Rest of Middle East & Africa
- 5.5.5 South America
- 5.5.5.1 Brazil
- 5.5.5.2 Argentina
- 5.5.5.3 Rest of South America

6. Competitive Landscape

6.1 Market Concentration
6.2 Market Share Analysis
6.3 Company Profiles (includes Global level Overview, Market level overview, Core Segments, Financials as available, Strategic Information, Market Rank/Share for key companies, Products & Services, and Recent Developments)
- 6.3.1 Thermo Fisher Scientific Inc.
- 6.3.2 Charles River Laboratories Intl. Inc.
- 6.3.3 Merck KGaA
- 6.3.4 Lonza Group Ltd.
- 6.3.5 Eurofins Scientific SE
- 6.3.6 Sartorius AG
- 6.3.7 Agilent Technologies
- 6.3.8 ATCC
- 6.3.9 PromoCell GmbH
- 6.3.10 Minerva Biolabs GmbH
- 6.3.11 bioMérieux SA
- 6.3.12 Bionique Testing Laboratories Inc.
- 6.3.13 WuXi AppTec
- 6.3.14 SGS SA
- 6.3.15 Danaher Corporation
- 6.3.16 Rapid Micro Biosystems
- 6.3.17 MicroBioLogics Inc.
- 6.3.18 InvivoGen
- 6.3.19 Mycoplasma Experience Ltd.

7. Market Opportunities & Future Outlook

7.1 White-space & Unmet-Need Assessment

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Global Mycoplasma Testing Market Report Scope

The term 'mycoplasma' refers to a class of bacteria commonly present in cell culture. More correctly known as mollicutes, these bacteria lack a cell wall, making them resistant to commonly used antibiotics, such as penicillin. Mycoplasma is easily spread through droplets during cell culture and can survive in dried form for months. Mycoplasma contamination is difficult to see with a microscope and requires specific testing to be detected. Contamination can have a profound impact on experimental work. The mycoplasma testing market is segmented by technology (PCR, ELISA, enzymatic methods, DNA staining, and other technologies), product (instruments, kits, and reagents), application (cell line testing, bioproduction testing, and other applications), and geography (North America, Europe, Asia - Pacific, Middle East, and Africa, and South America). The market report also covers the estimated market sizes and trends for 17 countries across major regions globally. The report offers the value (in USD million) for the above segments.

By Product & Service	Instruments	Real-time PCR Systems
		Rapid Microfluidic Analyzers
		Automated Detection Platforms
		Other Instruments

	Kits & Reagents	PCR Assay Kits
		ELISA Kits
		Enzymatic Assay Kits
		Fluorescent‐Staining Reagents
		Others
	Services
By Technology	Conventional PCR
	qPCR
	Digital PCR
	ELISA
	Enzymatic Methods
	DNA Staining
	Next-Generation Sequencing
	Other NAATs
By Application	Cell-Line Quality Control
	Bioproduction Batch-Release Testing
	Raw-Material & Media Testing
	Gene & Cell Therapy Manufacturing
	Vaccine & Virus Testing
	Other Applications
By End User	Biopharma & Biotechnology Companies
	Contract Manufacturing Organizations (CMOs)
	Academic & Research Institutes
	Cell Banks & Repositories
	Diagnostic & Reference Laboratories

By Geography	North America	United States
		Canada
		Mexico

	Europe	Germany
		United Kingdom
		France
		Italy
		Spain
		Rest of Europe

	Asia-Pacific	China
		Japan
		India
		Australia
		South Korea
		Rest of Asia-Pacific

	Middle East & Africa	GCC
		South Africa
		Rest of Middle East & Africa

	South America	Brazil
		Argentina
		Rest of South America

By Product & Service

Instruments	Real-time PCR Systems
	Rapid Microfluidic Analyzers
	Automated Detection Platforms
	Other Instruments
Kits & Reagents	PCR Assay Kits
	ELISA Kits
	Enzymatic Assay Kits
	Fluorescent‐Staining Reagents
	Others
Services

By Technology

Conventional PCR

qPCR

Digital PCR

ELISA

Enzymatic Methods

DNA Staining

Next-Generation Sequencing

Other NAATs

By Application

Cell-Line Quality Control

Bioproduction Batch-Release Testing

Raw-Material & Media Testing

Gene & Cell Therapy Manufacturing

Vaccine & Virus Testing

Other Applications

By End User

Biopharma & Biotechnology Companies

Contract Manufacturing Organizations (CMOs)

Academic & Research Institutes

Cell Banks & Repositories

Diagnostic & Reference Laboratories

By Geography

North America	United States
	Canada
	Mexico
Europe	Germany
	United Kingdom
	France
	Italy
	Spain
	Rest of Europe
Asia-Pacific	China
	Japan
	India
	Australia
	South Korea
	Rest of Asia-Pacific
Middle East & Africa	GCC
	South Africa
	Rest of Middle East & Africa
South America	Brazil
	Argentina
	Rest of South America

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Key Questions Answered in the Report

What is the current size of the mycoplasma testing market?

The market is valued at USD 1.13 billion in 2025 and is forecast to reach USD 1.93 billion by 2030.

Which segment is growing the fastest?

Gene & Cell Therapy Manufacturing is projected to grow at 17.82% CAGR due to strict contamination-control requirements.

Why are CMOs gaining share in mycoplasma testing?

Biotech firms are outsourcing manufacturing and quality control to CMOs to access validated laboratories without large capital outlays, pushing CMO demand up at 15.45% CAGR.

How do regulatory mandates influence market growth?

FDA and EMA rules make mycoplasma testing mandatory before product release, creating non-discretionary spending that raises overall market CAGR.

Which technology is disrupting traditional methods?

Digital PCR offers absolute quantification with detection limits around 10 CFU/mL, expanding at 16.26% CAGR as labs replace culture-based assays.

What restrains rapid adoption of automated platforms?

High upfront costs of USD 100,000–500,000 and shortages of trained molecular-QA staff delay automation, particularly in smaller labs.

Page last updated on: June 23, 2025