The Global Polymyxin Resistance Testing Industry is valued at USD 137.6 million in 2025. It is expected to grow at a CAGR of 6.2% and reach USD 250.9 million by 2035. In 2024, the polymyxin resistance testing industry witnessed notable advancements in diagnostic accuracy, with growing adoption of molecular methods for faster detection.
Regulatory support for antimicrobial resistance (AMR) surveillance also improved globally. Furthermore, key players focused on R&D collaborations to develop next-gen resistance assays.
Between 2025 and 2035, the industry is expected to expand steadily, driven by increasing global concern over antimicrobial resistance and the clinical urgency to manage drug-resistant infections effectively. Rising hospital-acquired infections and the growing burden of multidrug-resistant Gram-negative bacteria will intensify demand for rapid and reliable testing methods.
Integration of AI and automation into diagnostic workflows is anticipated to boost testing throughput and precision. Asia-Pacific is likely to emerge as a high-growth region due to increasing healthcare expenditure and rising awareness of AMR-related challenges.
Additionally, expanding access to diagnostic tools in low- and middle-income countries will further support industry penetration. The decade will likely witness innovation in point of care testing formats and next generation sequencing applications tailored for resistance profiling.
Collaborations between diagnostic companies and public health organizations will continue shaping the competitive landscape and fostering new product launches.
| Metric | Value |
|---|---|
| Industry Value (2025E) | USD 137.6 million |
| Industry Value (2035F) | USD 250.9 million |
| CAGR (2025 to 2035) | 6.2% |
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The polymyxin resistance testing industry is set to grow steadily due to rising global concerns over antimicrobial resistance, particularly in multidrug-resistant Gram-negative infections. The key driver is the increasing need for rapid, accurate diagnostics to guide effective antibiotic use. Diagnostic companies and healthcare providers stand to benefit, while regions with limited access to advanced testing risk falling behind in infection control.
Over the forecast period from 2025 to 2035, the polymyxin resistance testing industry is expected to experience strong demand across all product categories, driven by increased focus on combating antimicrobial resistance. The testing systems are expected to dominate the polymyxin resistance testing industry with a CAGR of 6.4% from 2025 to 2035.
Testing systems will continue to hold a significant share, supported by rising hospital investments in advanced laboratory infrastructure. These systems are becoming more integrated, offering automated platforms for higher throughput and faster turnaround results.
Test kits and identification panels are gaining traction due to their ease of use, portability, and rapid diagnostic capabilities, making them suitable for both centralized and decentralized testing environments.
As the need for immediate decision-making grows in clinical settings, their role becomes even more vital. Reagents and consumables will see consistent growth, propelled by recurring demand and their essential role in every testing workflow.
These products ensure the continuous operation of test systems and kits, and their replenishment forms a critical revenue stream for suppliers. The expansion of routine AMR screening programs, especially in emerging healthcare systems, will further support the growth of all product categories, creating a well-rounded and resilient industry landscape.
The Broth Microdilution (BMD) segments are expected to grow at significant rate due to its greater adoption as compared other testing methods within the polymyxin resistance testing industry with a CAGR of 7.0% from 2025 to 2035. During 2025 to 2035, various testing methods will remain central to the industry’s evolution as laboratories strive to enhance diagnostic precision and reduce turnaround times.
Broth Microdilution (BMD) will retain prominence as the reference standard for polymyxin resistance testing due to its reliability and ability to provide quantitative data on minimum inhibitory concentrations.
Disk diffusion will maintain relevance, particularly in resource-limited settings, due to its low cost and ease of use. PCR’s ability to detect specific resistance genes aligns well with the global shift toward precision medicine. The adoption of multiplex PCR and real-time platforms will enhance resistance profiling and support timely clinical interventions.
Over the next decade, laboratories will likely adopt hybrid diagnostic workflows that combine phenotypic and genotypic methods, ensuring broader detection capabilities and improved resistance management strategies.
The academic & research institutions segment is expected to dominate the polymyxin resistance testing industry with a CAGR of 7.0% from 2025 to 2035. Clinical laboratories will remain the dominant end users of polymyxin resistance testing, driven by increased patient loads and the urgency to diagnose multidrug-resistant infections.
These labs are under mounting pressure to deliver rapid, reliable results, and they are investing in both automated platforms and molecular tools to meet these demands.
Academic and research institutions will also play a crucial role, especially in developing innovative testing protocols and exploring novel resistance mechanisms. As global attention toward antimicrobial resistance intensifies, these institutions will secure more grants and collaborative opportunities to advance research.
Pharmaceutical and biotech companies will increasingly adopt resistance testing in drug development and surveillance studies, especially for pipeline antibiotics and combinational therapies.
Food and environmental testing laboratories will expand their usage as regulatory bodies enforce stricter monitoring of antibiotic residues and resistant pathogens across the supply chain. Veterinary diagnostic laboratories will also grow as resistance testing becomes a routine part of animal health surveillance, aligning with One Health approaches to curb AMR across human, animal, and environmental domains.
Accelerate Adoption of Molecular Testing Platforms
Stakeholders should prioritize investment in rapid molecular diagnostics, especially PCR-based systems, to enhance detection speed and resistance profiling accuracy. Fast-track partnerships with tech providers to expand laboratory capacity and improve patient outcomes through early interventions.
Align Offerings with Evolving AMR Surveillance Frameworks
Stay tightly aligned with global and regional AMR monitoring mandates. Adapt product development and marketing strategies to meet new clinical guidelines and public health goals, ensuring compliance and industry relevance.
Expand Through Strategic Collaborations and Licensing Deals
Focus on M&A, R&D partnerships, and distribution alliances to penetrate emerging industrys and diversify testing portfolios. Leverage collaborations with academic institutions and biotech firms to co-develop next generation testing formats and broaden the customer base.
| Risk | Probability - Impact |
|---|---|
| Regulatory delays in product approvals | Medium - High |
| Supply chain disruptions for reagents | High - Medium |
| Slow adoption in low-resource settings | High - High |
| Priority | Immediate Action |
|---|---|
| Expand molecular diagnostics line | Run feasibility study for PCR-based resistance panels |
| Strengthen global AMR collaborations | Initiate discussions with WHO-linked AMR programs and research labs |
| Improve reagent supply stability | Launch supplier redundancy and local manufacturing pilot |
To stay ahead in the polymyxin resistance testing industry, leadership must accelerate strategic investments in molecular diagnostics, expand global partnerships, and embed flexibility into supply chains. The growing urgency around antimicrobial resistance is reshaping regulatory and clinical expectations, demanding faster, more precise diagnostics.
This intelligence signals a clear pivot point-where early alignment with AMR policy, targeted innovation, and agile distribution will separate industry leaders from laggards. Boards should recalibrate their five-year roadmap now to secure technology access, diversify geographic reach, and elevate their competitive positioning in the global diagnostic value chain.
(Surveyed Q4 2024, n=480 stakeholder participants evenly distributed across diagnostic manufacturers, hospital labs, public health bodies, and pharmaceutical companies in North America, Western Europe, India, and Southeast Asia)
Global Priorities:
87% of stakeholders globally cited rapid turnaround time as a critical factor in test selection. 79% emphasized the need for alignment with AMR surveillance protocols from WHO and regional health agencies.
Regional Variance:
In North America, 72% of stakeholders prioritized workflow integration with automated lab systems, compared to only 41% in Southeast Asia. In Western Europe, 84% of participants ranked regulatory compliance (e.g., EU IVDR) as essential, while in India, 67% focused on cost-efficiency to enable wider access across tier-2 and tier-3 cities. Public hospitals in Southeast Asia highlighted test accessibility and basic infrastructure compatibility as top concerns.
High Variance:
In North America, 65% of hospital labs had already adopted PCR-based resistance assays, citing faster detection and gene-level accuracy. In Western Europe, 53% reported piloting NGS-based workflows, especially in national AMR monitoring programs. India showed a slower pace of advanced adoption, with only 27% using PCR, mainly in private tertiary-care hospitals. In Southeast Asia, just 19% had access to automated molecular platforms, attributing the gap to both cost barriers and limited infrastructure.
ROI Perception Split:
74% of Western Europe stakeholders believed investment in automation was worth the returns in terms of clinical outcomes and patient safety, while only 36% in India expressed the same confidence. Among pharma firms, 62% indicated that molecular diagnostics would be key in clinical trials and drug resistance mapping by 2030.
Global Consensus:
70% of respondents favored ready-to-use molecular panels for minimizing prep time and contamination risk.
Regional Preferences:
In Western Europe, 58% preferred enzyme-stabilized dry reagents to support decentralized deployment. North America leaned towards high-sensitivity liquid reagents compatible with closed-system analyzers. In India and Southeast Asia, hybrid test kits combining manual broth dilution methods with basic molecular tools were preferred by 61%, citing both cost and reliability.
Shift in Packaging Preferences:
Across all regions, there is a visible trend toward smaller batch sizes and flexible kit formats, helping to reduce wastage and enable scalable testing in outbreaks.
Common Challenge:
91% of stakeholders cited escalating input costs (e.g., enzymes, specialty reagents) as a serious concern.
Regional Insights:
In North America and Europe, 68% of labs were open to paying a 10-15% premium for improved accuracy and automation. In contrast, 76% of respondents in India and Southeast Asia favored base models under USD 12/test, especially for routine screening.
Alternate Procurement Models:
46% of public labs in Southeast Asia and 38% in India expressed interest in leasing diagnostic systems or pay-per-test models, compared to just 19% in North America where direct capital investments were preferred.
Manufacturers:
Distributors:
End-Users (Hospitals & Labs):
Global Alignment:
71% of diagnostic manufacturers are allocating R&D budgets to low-cost molecular testing platforms and AI-assisted interpretation software.
Regional Divergence:
High Consensus:
All stakeholders agree on the urgency of improving test turnaround times, enhancing cost-efficiency, and addressing reagent supply volatility.
Key Variances:
North America is automation-led, Western Europe is regulation- and sustainability-driven, while India and Southeast Asia require affordability-first models with hybrid test options.
Strategic Insight:
A segmented go-to-industry strategy is vital-premium automated PCR kits in North America, green-certified modular platforms in Europe, and dual-format cost-sensitive kits in emerging Asia will be necessary to unlock region-specific growth potential.
| Countries/Region | Policies, Regulations & Certifications Impacting the Market |
|---|---|
| United States | The FDA regulates diagnostic devices under its In Vitro Diagnostic (IVD) framework. Recent CDC guidelines on antimicrobial resistance have prompted hospitals to adopt advanced polymyxin testing. Labs participating in federal programs must comply with CLIA (Clinical Laboratory Improvement Amendments). There is growing alignment with the National Action Plan for Combating Antibiotic-Resistant Bacteria (CARB), encouraging the use of standardized AMR diagnostics. |
| Canada | Health Canada mandates licensing for all IVDs, including polymyxin resistance assays. The industry is guided by the Canadian Antimicrobial Resistance Surveillance System (CARSS), which supports routine resistance testing and data reporting to public health agencies. Labs require accreditation through ISO 15189. |
| Germany | Subject to EU IVDR (In Vitro Diagnostic Regulation), which has replaced the previous IVDD directive. The IVDR requires conformity assessments and notified body approval for high-risk diagnostics. Polymyxin resistance tests fall under Class B or higher depending on method and use case. Germany’s AMR strategy (DART 2030) further mandates regular screening in hospitals. |
| France | France adheres to EU IVDR. The Haute Autorité de Santé (HAS) supports early uptake of validated diagnostic tools for AMR detection. National guidelines require resistance testing for critical care units. Certified laboratories must operate under strict ISO/EN standards and support real-time data reporting for public health tracking. |
| India | The Central Drugs Standard Control Organization (CDSCO) regulates diagnostics, though enforcement for AMR diagnostics is limited. There are no mandatory certifications for polymyxin tests yet, but NABL accreditation (ISO 15189) is encouraged. The Indian Council of Medical Research (ICMR) has issued guidelines under its AMR surveillance network, indirectly pushing adoption of resistance testing in tertiary hospitals. |
| Japan | The Pharmaceuticals and Medical Devices Agency (PMDA) requires approval for diagnostic kits under the Pharmaceutical Affairs Law. However, AMR-related diagnostics are still categorized as low priority unless linked to reimbursed treatment pathways. National action plans have limited binding regulations, making industry penetration more dependent on hospital policy. |
| South Korea | The Ministry of Food and Drug Safety (MFDS) oversees diagnostic approvals. AMR diagnostics must comply with Korea’s national AMR management program, especially in public hospitals. While PCR and molecular kits require formal approval, culture-based tests have fewer regulatory barriers. Reimbursement for AMR testing is still evolving. |
| United Kingdom | Post-Brexit, the UK follows its own Medical Device Regulations (UK MDR 2002), with transition aligned to EU IVDR. The UK Health Security Agency mandates data sharing for AMR surveillance. The NHS strongly encourages adoption of validated polymyxin resistance tests in critical and high-risk care units. CE marking (or UKCA) is required for commercial use. |
| Southeast Asia (general) | Regulation varies widely. Singapore has formal IVD registration under the Health Sciences Authority (HSA), while countries like Indonesia and Vietnam have minimal diagnostic oversight. WHO-supported AMR programs influence procurement. No region-wide mandatory certification exists, though hospitals often follow ISO or WHO procurement standards. |
| Company | Estimated Global Market Share (%) |
|---|---|
| Thermo Fisher Scientific | 21.3% |
| bioMérieux | 17.8% |
| BD (Becton, Dickinson and Company) | 14.6% |
| Liofilchem S.r.l. | 11.2% |
| HiMedia Laboratories | 9.5% |
| Merck KGaA (MilliporeSigma) | 8.9% |
| ELITechGroup | 6.4% |
| Creative Diagnostics | 4.1% |
| Others | 6.2% |
The USA polymyxin resistance testing industry is anticipated to grow at a CAGR of around 6.7% over the forecast period of 2025 to 2035. This growth is due to strict antimicrobial stewardship programs, high awareness on antimicrobial resistance (AMR), as well as tremendous support from the federal government through CDC’s Antibiotic Resistance Lab Network.
The USA is ahead in rapid diagnostics integration and has penetrated tertiary hospitals and reference labs. FDA regulations and CLIA-certified labs offer a more structured pathway for new entrants.” The further opening of R&D for diagnostics addressing polymyxin resistance is also being driven by public-private partnerships.
Provided systemic reimbursement coverage for AMR diagnostics while served in national surveillance system framework, making the USA an essential growth front with discernible risk reduction and investment returns.
The polymyxin resistance testing industry in the United Kingdom is projected to grow at a CAGR of around 6.3% during 2025 to 2035. The post-Brexit freedom of HS to choose their regulatory pathway has translated into accelerated EU IVDR-like standards in UK MDR 2002, that has favored competitive industry access.
NHS funding of AMR surveillance and infection control programs, including the importance of high-throughput and standardized testing across this space.
Rapid diagnostics for resistant pathogens are advocated by the UK Health Security Agency, and CE/UKCA-marked tests are rolled into a fast track for pivotal supply. Diagnostics companies are working with academic and research institutions which generate localized innovation.
Compounding this issue, with robust public health mandates hospital networks are shifting toward centralized reporting of AMR data, increasing the use of resistance assays, notably specifically those for polymyxins on ICU ward and infectious disease wards.
The polymyxin resistance testing industry in France is anticipated to grow at a CAGR of around 6.4% over the forecast period of 2025 to 2035. The country’s focus on AMR as part of its national health strategy mandates routine monitoring of AMR in all public hospitals and promotes standardized resistance testing. French laboratories fall under the EU IVDR, which allows for the use of only validated and certified diagnostics.
Both phenotypic and genotypic testing methods are facilitated by France's existing hospital network and well-established diagnostic capabilities. France represents a key industry in Western Europe due to public funding allocated to laboratory modernization and participation in EU-wide AMR surveillance networks. Increasing recognition of the need for polymyxin stewardship among healthcare providers also fuels diagnostic demand.
The Germany polymyxin resistance testing industry is anticipated to expand at a CAGR of ~6.5% over the forecast period of 2025 to 2035. The country boasts a well-developed diagnostic ecosystem at play, with early uptake of IVDR-compliant systems and large capacity clinical laboratories.
According to the DART 2030 (German Antibiotic Resistance Strategy), hospitals are required to conduct regular resistance screenings, including at least for last-line antibiotics like the polymyxins.
Germany has a decentralized healthcare system with the regional purchasing of advanced diagnostics, and reimbursement models that encourage hospital labs to use the rapid resistance detection platforms. Partnerships between academic centres and diagnostics companies are fast-tracking the validation of new assays.
Germany is an attractive industry for advanced testing solutions due to high end infrastructure and an increasing threat from multidrug-resistant Gram-negative infections.
The Italy polymyxin resistance testing industry is projected to grow at a CAGR of nearly 6.1% through 2025 to 2035. Multidrug-resistant infections are a major national problem, particularly in intensive care units, and there is an urgent need for resistance diagnostics. The country adheres to EU IVDR and has heightened the focus of its national health service (SSN) on hospital infection control measures.
As part of the joint European action plan for recovery under the EU Recovery and Resilience Facility, healthcare diagnostics and microbiology labs are getting a technological facelift. Broth microdilution and PCR-based methods for detection of polymyxin resistance are now implemented in several regional public hospitals.
Diagnostic penetration is improving through awareness campaigns and physician training on AMR management. On the upside, regional differences in adoption have been observed, with the northern industry adopting IT solutions at a faster pace than the south, resulting in non-uniform growth of the industry.
New Zealand’s industry for polymyxin resistance testing is projected to grow at a CAGR of approximately 5.6% from 2025 to 2035. While relatively small in size, the country has a well-regulated healthcare system and rising concern about antimicrobial resistance. The Ministry of Health’s AMR action plan has emphasized early detection through diagnostics, particularly in tertiary hospitals.
New Zealand follows ISO standards for lab accreditation, and public labs receive government funding for AMR surveillance. The diagnostic demand is concentrated in urban centers with better-equipped facilities. With support from regional health authorities, the industry is likely to expand through imports of certified phenotypic and genotypic test kits. However, limited local manufacturing and procurement bottlenecks may impact the pace of adoption.
In South Korea, the polymyxin resistance testing industry is forecast to grow at a CAGR of 6.4% during the 2025 to 2035 period. The government has actively supported antimicrobial resistance surveillance under its National Action Plan. Major public and university hospitals have adopted advanced diagnostic platforms for AMR detection, including molecular assays for polymyxin resistance.
The Ministry of Food and Drug Safety ensures regulatory oversight for all AMR-related tests, with streamlined processes for domestic manufacturers. Growing prevalence of multidrug-resistant infections in long-term care and ICU settings is pushing demand for accurate testing. Government funding for AI-enabled diagnostics and public-private collaborations are supporting test development and clinical adoption, making South Korea a regional leader in AMR diagnostics.
The polymyxin resistance testing industry in Japan is expected to rise at a CAGR of around 5.9% from 2025 to 2035. Japan has a relatively conservative approach to diagnostic adoption, but growing concern over hospital-acquired infections is changing the landscape. The Ministry of Health, Labour and Welfare supports national AMR surveillance, and major hospitals are gradually incorporating molecular assays for polymyxin resistance.
Regulatory processes under PMDA are structured but time-consuming, affecting new entrants. However, domestic firms are investing in R&D for genotypic test kits tailored for local needs. Public-private partnerships are emerging to advance automation and improve throughput in clinical labs. With aging infrastructure being updated and increasing government attention to AMR, the industry is poised for moderate but stable growth.
China’s polymyxin resistance testing industry is projected to expand at a CAGR of 6.6% from 2025 to 2035. The country faces a high AMR burden due to antibiotic overuse, particularly in secondary and tertiary hospitals. The National Health Commission has issued guidelines for rational antibiotic use, encouraging diagnostic-driven stewardship.
While regulatory oversight has tightened under the National Medical Products Administration (NMPA), local players dominate the diagnostic manufacturing landscape. Public hospitals are under pressure to implement AMR testing, including for polymyxins, as part of national quality benchmarks.
Rising investments in healthcare infrastructure and lab modernization, particularly in Tier 1 and Tier 2 cities, will drive adoption. Collaborations with global diagnostic firms are also increasing access to validated resistance panels.
The polymyxin resistance testing industry in Australia is forecast to grow at a CAGR of about 6.2% from 2025 to 2035. The Australian Commission on Safety and Quality in Health Care has prioritized AMR diagnostics as part of its National Safety and Quality Health Service (NSQHS) Standards. Laboratories across the country are increasingly adopting EU or FDA-approved test kits, including broth microdilution systems and PCR-based detection tools.
ISO-accredited diagnostic labs receive public funding under Medicare for AMR surveillance. Australia’s strong infection control framework, combined with nationwide hospital networks and digital integration, provides a favorable environment for industry growth. Demand is especially strong in teaching hospitals and reference labs, where polymyxin resistance is tracked routinely in sepsis and ICU patients.
The increasing prevalence of multidrug-resistant Gram-negative bacterial infections and rising awareness around antimicrobial stewardship are key factors accelerating the demand for polymyxin resistance testing. Hospitals and diagnostic labs are under growing pressure to quickly identify resistance to last-resort antibiotics like polymyxins.
Broth Microdilution (BMD) remains the gold standard due to its accuracy, but laboratories are also using Disk Diffusion, Etest, and PCR-based methods for faster turnaround and genetic-level insights into resistance mechanisms.
Clinical laboratories form the core user base, followed by academic and research institutions, pharmaceutical companies, food and environmental testing labs, and veterinary diagnostic centers, each leveraging testing for surveillance, development, or compliance.
Stringent regulatory frameworks and national action plans to combat antimicrobial resistance are compelling healthcare systems to incorporate polymyxin resistance testing as part of routine diagnostics and infection control protocols.
Yes, countries like the USA, Germany, and South Korea have advanced adoption due to strong healthcare infrastructure and policy mandates, while regions like Latin America and parts of Asia are gradually scaling up capabilities amid rising resistance rates.
Testing Systems, Test Kits & Identification Panels, Reagents & Consumables
Broth Microdilution (BMD), Disk Diffusion, Etest (Broth Microdilution + Disk Diffusion), Polymerase Chain Reaction (PCR).
Clinical Laboratories, Academic & Research Institutions, Pharmaceutical/Biotech Companies, Food & Environmental Testing Laboratories, Veterinary Diagnostic Laboratories.
North America, Latin America, Europe, East Asia, South Asia, Oceania, The Middle East & Africa.
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