The global Procalcitonin Assay Industry is valued at USD 316.4 million in 2025. It is expected to grow at a CAGR of 6.2% and reach USD 584.5 million by 2035. In 2024, the PCT assay industry witnessed significant traction due to the increasing prevalence of sepsis and respiratory infections.
Diagnostic labs continued expanding their molecular testing capabilities, while regulatory bodies streamlined approval pathways for novel biomarkers. Growing awareness among clinicians further propelled adoption rates across both developed and emerging economies.
From 2025 to 2035, the global procalcitonin assay industry is expected to sustain steady growth, driven by rising demand for early infection diagnostics and effective antibiotic stewardship programs. Advancements in point-of-care testing technologies and integration of AI-driven diagnostic platforms are anticipated to improve test accuracy and turnaround times, boosting overall industry penetration.
Additionally, the growing geriatric population and expanding critical care infrastructure, especially in Asia-Pacific and Latin America, will support long-term industry expansion.
| Attribute | Details |
|---|---|
| Industry Value (2025E) | USD 316.4 million |
| Industry Value (2035F) | USD 584.5 million |
| CAGR (2025 to 2035) | 6.2% |
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The procalcitonin (PCT) assay industry is on a steady growth path, driven primarily by rising global cases of sepsis and the growing need for early, accurate infection diagnostics. Increasing adoption of PCT testing in hospitals and critical care settings, along with advancements in point-of-care technologies, are expanding industry access. Diagnostic companies and healthcare providers stand to benefit, while players slow to innovate or adapt to regulatory standards may lose competitive ground.
Serum sample dominated the procalcitonin (PCT) assay market with a market share of 34.2% in 2024.The serum segment is expected to dominate the PCT assay industry due to its routine use in clinical diagnostics and its compatibility with most automated platforms.
Plasma also continues to gain traction owing to its quick turnaround and consistent results, particularly in acute care settings. Cell culture medium plays a growing role in research applications, supporting the development of new infection models and treatment pathways.
Other biological fluids, such as cerebrospinal or pleural fluids, see limited yet significant adoption for specialized diagnostic needs. The increasing incidence of systemic infections and growing emphasis on early sepsis detection are pushing labs to adopt PCT testing across a wider variety of biological matrices.
As healthcare infrastructure improves in emerging industries, the standardization and automation of sample processing is further expected to support the expansion of this segment. Labs are investing in multipurpose platforms capable of processing diverse samples, driving overall growth.
Based on products, test kits have dominated the category withholding a significant share of the market at around 68.7% at the end of 2024. Test kits will remain the primary revenue-generating product within the procalcitonin assay industry, supported by consistent demand across hospitals and diagnostics labs.
ELISA, CLIA, immunochromatography, and rapid test kits all contribute to segment growth, with each offering unique turnaround times and levels of sensitivity. Analyzer and instrument sales are also rising, particularly in emerging economies where infrastructure modernization is underway.
These devices are crucial for automating processes and improving test accuracy, especially in high-throughput settings. Consumables will continue to see stable demand as they are essential for routine test operations, including reagents and calibration materials.
Manufacturers are focusing on producing compact, cost-effective, and user-friendly devices, enabling wider industry reach. The shift toward decentralization of testing is likely to support product innovation, especially in rapid and point-of-care formats. Together, these product categories form the technological backbone of the PCT assay ecosystem.
By purpose, the clinical use segment is expected to continue leading the market over a CAGR of 6.0% throughout the projected timeframe. Clinical use will continue to be the primary driver of the PCT assay industry, owing to its critical role in diagnosing sepsis, lower respiratory infections, and guiding antibiotic therapy decisions.
Hospitals and emergency care units rely heavily on PCT testing to determine infection severity and adjust treatments accordingly, which supports broader implementation. Although research use only (RUO) applications hold a smaller share, this segment is poised to grow due to increased investment in biomarker discovery and infection-related R&D.
Academic institutions and private research labs are exploring PCT's utility beyond bacterial infections, potentially expanding its relevance to viral or inflammatory conditions.
As global healthcare systems emphasize antimicrobial stewardship and evidence-based diagnostics, clinical use cases will dominate industry dynamics. However, the RUO segment will continue to generate interest, particularly for exploratory studies and the development of next-generation diagnostic panels.
The hospitals have led the procalcitonin (PCT) assay market as the leading end user with a market share of 36.7% in 2024. Hospitals will remain the largest end-user segment for PCT assays, driven by the growing demand for infection monitoring in intensive care units and emergency departments. Their high patient inflow and the need for rapid diagnostic decisions make PCT testing a critical tool for clinicians.
Specialty clinics are gradually incorporating PCT assays to support targeted treatments, especially in immunocompromised or high-risk patient populations. Diagnostic laboratories are witnessing increasing test volumes as centralized testing becomes more cost-effective and efficient.
These labs also benefit from automation and scale, positioning them as important contributors to overall industry growth. Academic and research institutes are expected to expand their usage of PCT assays for investigative and validation purposes.
Their involvement will be instrumental in identifying new diagnostic applications and refining assay technologies. The end-user landscape is evolving with growing interdisciplinary collaboration, and this ecosystem is critical for advancing PCT-based diagnostics.
Imperative #1: Accelerate Diagnostic Innovation
Executives should prioritize investment in next-generation procalcitonin assay technologies, particularly those compatible with point-of-care and rapid testing environments. Fast, accurate, and user-friendly diagnostics will meet growing clinical demand and support early infection intervention.
Imperative #2: Align with Antimicrobial Stewardship Trends
Stakeholders must align their offerings with global efforts to reduce antibiotic misuse. This means refining assays for better clinical decision support and engaging with health systems to demonstrate cost-effectiveness and impact on treatment outcomes.
Imperative #3: Expand Through Partnerships and M&A
Companies should seek strategic collaborations with diagnostics labs, hospitals, and device manufacturers to enhance industry penetration. Consider acquiring or partnering with regional firms to localize manufacturing, expand distribution networks, and increase regulatory efficiency.
| Risk | Probability - Impact |
|---|---|
| Regulatory delays in product approval | Medium - High |
| Inaccurate test results leading to clinical distrust | Low - High |
| Supply chain disruptions affecting kit availability | Medium - Medium |
| Priority | Immediate Action |
|---|---|
| Expand Rapid Testing Portfolio | Conduct feasibility for scaling PCT rapid kit production |
| Regulatory Streamlining | Engage with regional regulators to fast-track approval pipelines |
| Market Access in APAC | Build distributor network in Southeast Asia and India |
The procalcitonin assay industry is poised for steady, innovation-led growth over the next decade, driven by rising infection rates, demand for early diagnostics, and global efforts to optimize antibiotic use. To stay competitive, stakeholders must shift focus from legacy lab-based solutions to more agile, decentralized platforms-particularly in high-growth regions.
This intelligence suggests a roadmap centered around rapid test innovation, strategic collaborations, and region-specific regulatory strategies. Prioritizing clinical value and operational scalability will define industry leadership in the coming years.
(Surveyed Q4 2024, n=450 stakeholder participants evenly distributed across diagnostic manufacturers, hospitals, diagnostic labs, and healthcare professionals across the US, EU-5, India, and Southeast Asia)
Regional Variance:
High Variance:
Convergent & Divergent ROI Views:
Consensus:
Serum emerged as the dominant sample type across all regions due to broad compatibility with existing diagnostic workflows.
Regional Variance:
Instrument and Consumables Use:
While test kits drive most of the industry, 58% of USA and EU-based labs plan to invest in high-throughput analyzers and reliable consumables to reduce testing delays and human error.
Shared Challenges:
91% of stakeholders globally flagged rising reagent and kit prices (notably due to supply chain disruptions) as a major pain point.
Regional Differences:
Manufacturers:
Hospitals & Labs:
Healthcare Providers:
Alignment:
77% of global manufacturers plan to expand their rapid diagnostic portfolios, including portable and cartridge-based PCT kits.
Divergence:
High Consensus:
Diagnostic speed, accuracy, and cost pressures are universally relevant. Automation and integration are clear performance drivers, but pricing and access remain roadblocks.
Key Variances:
Strategic Insight:
Regional customization-through differentiated product design, localized manufacturing, and tailored go-to-industry strategies-is essential for stakeholders seeking scalable growth in the PCT assay industry.
| Countries/Region | Policy & Regulatory Impact |
|---|---|
| United States | The FDA classifies PCT assays as Class II medical devices, requiring 510(k) clearance. Recent sepsis management guidelines and CMS quality metrics (e.g., SEP-1 bundle compliance) have accelerated hospital adoption. Increasing scrutiny on diagnostic performance is delaying time-to-industry for new entrants. |
| European Union (EU-5) | The EU's In Vitro Diagnostic Regulation (IVDR), fully effective from May 2022, imposes stringent clinical performance and post-industry surveillance requirements. CE-IVD marking is mandatory. Compliance has increased costs and slowed new product launches, especially for smaller manufacturers. |
| India | Regulated under CDSCO and categorized as Class C IVDs (moderate risk). Importers and local manufacturers must obtain Form MD-14/15 for manufacturing/import license. Lack of a clear reimbursement framework and limited enforcement create inconsistency in clinical use across states. |
| China | Governed by the NMPA (formerly CFDA), PCT assays require clinical trial data and local performance validation. Recent reforms to expedite innovative IVDs have helped top players, but local manufacturing preference affects foreign entrants. NMPA approval is essential. |
| Japan | Overseen by the PMDA and MHLW, PCT tests are regulated as IVDs requiring clinical evidence and real-world performance data. Shonin or Ninsho certification is mandatory depending on classification. Reimbursement inclusion under the national insurance system is crucial for industry success. |
| South Korea | Managed by the MFDS. Diagnostic kits require KGMP compliance and MFDS clearance. Local clinical evaluation is essential. The government promotes infection diagnostics under national AMR (antimicrobial resistance) reduction plans, indirectly boosting demand for PCT testing. |
| Southeast Asia (e.g., Thailand, Malaysia, Indonesia) | Regulatory maturity varies. Malaysia requires registration under MeDC@St, while Indonesia mandates local trials for PCT tests. Absence of uniform frameworks delays regional entry. Governments support infection control programs, creating a slow but growing demand base. |
| Company | Market Share (%) |
|---|---|
| Thermo Fisher Scientific | 28.4% |
| Roche Diagnostics | 23.1% |
| bioMérieux | 18.7% |
| Siemens Healthineers | 11.2% |
| Danaher (Beckman Coulter) | 8.5% |
| Other Players | 10.1% |
The USA procalcitonin marketplaces (assays) are anticipated to grow at a CAGR of 6.5% for the forecast period of 2025 to 2035. Increase in adoption of sepsis biomarkers in emergency and critical care units, integration of diagnostic tools with EMRs, and increased focus on value-based care are some of the factors that are likely to fuel the growth of this industry.
This makes access and innovation difficult especially with big players like Thermo Fisher, Roche and Beckman Coulter. The presence of reimbursement support for sepsis diagnosis, increasing hospital consolidation and the rising awareness for antimicrobial resistance further solidify industry penetration.
Automated, high-throughput platforms are being adopted in clinical labs and academic institutions at a rapid pace.Robust FDA oversight governs their quality - and the incorporation of AI into diagnostic workflows is emerging as a differentiator for sophisticated clinical decision-making.
The UK procalcitonin assay industry is expected to expand at a CAGR of 5.8%. NHS efforts to unify sepsis detection approaches across hospitals and implement testing for biomarkers in primary care underpin industry growth. Before Brexit, this regulation was in effect throughout the EU and continues to play a role in determining product quality standards. Roche and bioMérieux have good commercial visibility, partnering with NHS Trusts.
Moreover, antibiotic stewardship programs in accordance with NICE guidelines are fueling the industry growth for PCT as a diagnostic aid. The demand is strong in both public and private labs and the UK NHS digital transformation strategy to harness the potential of AI driven diagnostics is expected to notably add to the industry value over the next 10 years.
The procalcitonin assay industry in France is projected to witness a CAGR of 6.3% during the period of 2025 to 2035. A surge in government initiatives in infection control within hospitals, and active involvement in EU weapons to fight against microbial resistance catalyzes government activeness in the industry. Hospitals are required to adhere to stringent biomarker guidelines for suspected sepsis patients, creating demand for high-quality, CE-marked kits.
Key diagnostic players have localized alliances to ensure supply chain continuity. Under Assurance Maladie, the French reimbursement system favors advanced diagnostics that have substantial clinical support, which increases uptake and adoption rates.
As a French based firm, the company has a considerable share and is on the rise with innovations and partnerships. High ICU admission rates and government funding for lab automation further drive growth.
Germany’s procalcitonin assay industry will grow at the highest CAGR in Western Europe, at 6.6%, between 2025 and 2035. Growth is supported by advanced healthcare infrastructure, early technology adoption, and favorable reimbursement incentives in the GKV statutory system.
PCT assays have been broadly established in German hospitals, particularly in emergency and critical care units, and for the diagnosis of sepsis and monitoring of antibiotic therapy. The country has similarly seen increased use in outpatient diagnostics and private laboratories.
The IVDR is ensuring a high of quality product leading to advantages for global brands with naturally, proven clinical evidence. The German States' push for diagnostics' digitization along with AI-based triage models is projected to create additional traction for integrated PCT solutions.
Procalcitonin Assayed industry in Italy is expected to observe growth at a CAGR of 6.0% over the forecast period from 2025 to 2035. National antimicrobials stewardship programs and the increased investment in point-of-care testing in public hospitals are facilitating growth.
Although global industry penetration is lower than in Germany or France, government initiatives to include PCT in sepsis outcomes are boosting worldwide adoption.
Most Italian laboratories are slowly moving from manual to automation platforms with regional-level procurement alliances to bolster procurement spend. Although healthcare spending is under economic constraints in many countries, PCT tests are increasingly integrated into standard clinical practice and undergoing favorable reimbursement under the Servizio Sanitario Nazionale (SSN). Strategic partnerships with kits manufactured in the EU have also helped to offset supply bottlenecks and ensure continuity.
The procalcitonin assay industry in New Zealand is projected to grow at a CAGR of 5.3% from 2025 to 2035. The relatively modest growth reflects the country’s smaller population size but stable adoption in public health settings. The New Zealand Ministry of Health has prioritized antimicrobial resistance control and hospital infection prevention, positioning PCT testing as a viable diagnostic tool.
Laboratories under the District Health Boards are adopting rapid diagnostic kits, though reliance on imported kits presents pricing and supply constraints. Partnerships with Australian suppliers and improved funding under Pharmac are supporting gradual expansion. The move towards digital diagnostics, along with national initiatives for evidence-based care, will continue to support industry growth in the coming decade.
South Korea is anticipated to witness a CAGR of 6.4% in its procalcitonin assay industry from 2025 to 2035. The country’s strong diagnostic infrastructure, government-backed infection surveillance programs, and fast-track regulatory pathways make it a high-growth region. Major hospitals have adopted automated PCT systems for early sepsis detection and respiratory infection triage.
The government’s emphasis on precision diagnostics and integration of biomarkers into national health programs boosts usage. Reimbursement coverage under the National Health Insurance Service (NHIS) and growing private hospital investments in diagnostic modernization further aid adoption. Korean manufacturers are also entering the industry with competitively priced kits, creating a dynamic, tech-driven environment for PCT expansion.
The Japanese industry is forecasted to grow at a CAGR of 5.6% between 2025 and 2035. Though technologically advanced, Japan's industry sees moderate growth due to conservative healthcare spending and a cautious regulatory stance. PCT assays are widely used in academic hospitals and large urban healthcare centers, particularly for pneumonia and sepsis screening. However, the uptake in rural clinics and general practices remains limited.
The Pharmaceuticals and Medical Devices Agency (PMDA) enforces high clinical evidence standards for IVD approval. Reimbursement decisions under the national insurance scheme heavily influence adoption trends. Nonetheless, the country’s aging population and rising infection rates are prompting gradual increases in demand, especially for portable and rapid diagnostic kits.
China’s procalcitonin assay industry is estimated to grow at a CAGR of 6.7% from 2025 to 2035, among the highest globally. This surge is propelled by national sepsis detection mandates, expansive hospital infrastructure, and rising awareness of antimicrobial resistance. Tier I and Tier II hospitals are increasingly deploying automated platforms for routine infection diagnostics.
The National Medical Products Administration (NMPA) has streamlined diagnostic approvals, and government subsidies for local manufacturing have improved access to affordable PCT kits. The growth of private diagnostics labs and integration of PCT into community health services are further fueling adoption. China's push for self-sufficiency in MedTech and strategic partnerships with multinational firms create a vibrant, competitive landscape.
Australia is likely to experience a CAGR of 5.7% in the procalcitonin assay industry between 2025 and 2035. The industry benefits from a well-funded public healthcare system and structured sepsis care pathways promoted by the Australian Commission on Safety and Quality in Health Care. Adoption is concentrated in tertiary hospitals and pathology labs that emphasize antimicrobial stewardship.
Medicare coverage for PCT testing remains selective but expanding. The country’s proximity to Asian supply hubs ensures smoother logistics for diagnostics equipment. Regulatory oversight by the Therapeutic Goods Administration (TGA) ensures clinical reliability. Private pathology groups are also contributing to demand with growing use of rapid kits in ambulatory care and outpatient centers.
The growth is primarily driven by the rising prevalence of bacterial infections and sepsis, increasing demand for early diagnostic tools, and advancements in immunoassay technologies that enable faster and more accurate detection of procalcitonin levels.
Hospitals, diagnostic laboratories, specialty clinics, and academic research institutes are the major users, utilizing PCT assays for infection diagnosis, antibiotic stewardship, and clinical research applications.
Technological innovation, including the development of rapid test kits and automated analyzers, is enhancing efficiency, enabling point-of-care testing, and reducing turnaround times for critical diagnostic decisions.
Yes, regions like North America and Europe show higher adoption due to well-established healthcare infrastructure, while countries in Asia-Pacific are witnessing rapid uptake fueled by healthcare investments and growing awareness.
Regulatory approvals, such as CE marking in Europe and FDA clearance in the USA, play a crucial role in product deployment. Additionally, national guidelines for sepsis management are further promoting the usage of PCT testing.
Serum, Plasma, Cell Culture Medium, Other Biological Fluids
Test Kits (Procalcitonin ELISA Test Kits, Procalcitonin CLIA Kits, PCT Immunochromatography Kits, PCT Rapid Test Kits), Analyzer & Instruments, Consumables
Clinical Use, Research Use Only
Hospital, Specialty Clinics, Academic and Research Institute, Diagnostics Laboratories
North America, Latin America, Europe, East Asia, South Asia, Oceania, The Middle East & Africa
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Procalcitonin (PCT) Assay Market
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