Procalcitonin Market

Market Overview

The global procalcitonin market size was valued at USD 256.23 million in 2023. It is estimated to reach USD 803.43 million by 2032, growing at a CAGR of 13.54% during the forecast period (2024–2032). A rise in infectious diseases such as sepsis, respiratory tract infections, and bacterial infections has driven the demand for procalcitonin tests, as this biomarker helps assess the severity of these conditions. Moreover, innovations in diagnostic equipment and laboratory automation have improved the efficiency and accuracy of procalcitonin tests, encouraging wider adoption. Technological advancements have also reduced turnaround times, contributing to quicker clinical decisions.

Highlights

• Procalcitonin Antibody dominates the type segment
• Medical Application dominates the application segment
• North America is the highest shareholder in the global market

Market Overview

Procalcitonin (PCT) is a 116-amino acid protein that serves as the precursor to calcitonin, a hormone primarily produced by parafollicular C cells in the thyroid gland, responsible for regulating calcium levels in the body. Procalcitonin itself is derived from pre-procalcitonin through endopeptidase cleavage. In adults, procalcitonin levels are generally low, typically below 0.1 ng/mL. Elevated procalcitonin levels—above 0.25 ng/mL—may indicate an ongoing infection, with levels over 0.5 ng/mL in children with urinary tract infections (UTIs) suggesting possible renal involvement.

Due to its specific response to bacterial infection, Procalcitonin's primary clinical use is to differentiate bacterial infections from other conditions like viral infections or noninfectious inflammatory stimuli. Following a bacterial infection, procalcitonin levels rise within 2-4 hours and remain detectable for up to 7 days. The typical half-life of procalcitonin is about 22-26 hours, and it is mainly degraded by proteolysis with limited renal excretion.

Given its rapid response to bacterial infections, procalcitonin has become a valuable diagnostic tool in various healthcare settings, including primary care, emergency departments, and intensive care units (ICUs). Procalcitonin levels can guide clinical decisions, particularly in the management of respiratory tract infections and sepsis. The use of procalcitonin-guided protocols has been shown to reduce antibiotic exposure time and decrease mortality rates in critically ill patients with respiratory tract infections.

Market Dynamics

Global Procalcitonin Market Drivers

Rising Rates of Sepsis and Related Infections

The growing prevalence of sepsis and other severe bacterial infections is a significant factor driving the global procalcitonin market. Severe sepsis, a potentially fatal illness brought on by the body's hyperbolic reaction to infection, continues to be a primary global cause of death and morbidity, especially for patients receiving critical care units (ICUs). Procalcitonin, a peptide precursor to the hormone calcitonin, serves as a critical biomarker that rises in response to bacterial infections, making it an invaluable tool for early detection, diagnosis, and management of sepsis. Healthcare providers utilize procalcitonin testing to differentiate between bacterial and viral infections, guide antibiotic treatment decisions, and monitor the effectiveness of medicinal interventions in septic patients. This ability to distinguish between bacterial and viral infections helps reduce unnecessary antibiotic use, a key factor in combating the global threat of antibiotic resistance.

As the incidence of sepsis and antibiotic resistance increases globally, so does the demand for procalcitonin assays and point-of-care testing devices, propelling market growth and acceptance in hospitals, clinics, and diagnostic laboratories. The ongoing need for early and accurate sepsis diagnosis underscores the importance of procalcitonin as a biomarker in critical care and emergency medicine. For example, a report published in The Lancet Infectious Diseases, titled "Global Sepsis Report Reveals Alarming Increase in Cases and Mortality Rates," highlighted the troubling rise in sepsis cases worldwide. The report's findings point to a growing need for effective tools to combat sepsis, further driving demand for procalcitonin testing.

Global Procalcitonin Market Restraint

Cost Concerns

Procalcitonin (PCT) testing has gained traction as a valuable diagnostic tool for bacterial infections. However, its higher cost compared to traditional infection markers can be a significant barrier to widespread adoption. This cost disparity is incredibly challenging in resource-limited environments, where healthcare budgets are constrained, and cost-effectiveness is paramount. The initial expense of PCT testing can deter healthcare providers from incorporating it into routine practice despite its potential to reduce antibiotic misuse and associated costs.

To foster broader adoption of procalcitonin testing, it's essential to consider its long-term benefits alongside the immediate cost. PCT testing can lead to more targeted antibiotic use, reducing unnecessary prescriptions and minimizing the risk of antibiotic resistance. This targeted approach can also improve patient outcomes by avoiding the side effects of unneeded antibiotics and reducing hospital stays due to adverse drug reactions. Moreover, PCT testing's ability to distinguish bacterial infections from viral or other non-bacterial causes can lead to accurate diagnoses and more efficient patient care.

However, demonstrating the cost-effectiveness of procalcitonin testing requires more robust research. Studies that explore the potential financial savings from reduced antibiotic use and shorter hospital stays can provide valuable insights into the overall economic impact of PCT testing. These studies can help healthcare systems understand the value proposition of procalcitonin testing and support its inclusion in standard diagnostic protocols.

Global Procalcitonin Market Opportunities

Growing Awareness and Adoption of PCT Testing

The adoption of procalcitonin (PCT) testing is expected to increase as healthcare professionals become more aware of the limitations of conventional infection markers and the benefits of distinguishing bacterial from non-bacterial infections. This growing awareness coincides with the increasing urgency to address antibiotic resistance, a critical issue in modern healthcare. PCT testing has emerged as a valuable tool for supporting antibiotic stewardship programs, helping reduce unnecessary antibiotic prescriptions and their associated risks. The financial benefits of PCT testing are derived from various sources. By reducing unnecessary antibiotic use, healthcare systems can avoid the costs associated with treating antibiotic-resistant infections, which are more complex and expensive to manage. Moreover, avoiding the complications that arise from inappropriate antibiotic use, such as adverse drug reactions or prolonged hospital stays, can lead to further cost savings.

A paper published in the Journal of Clinical Medicine titled "Rising Awareness of Procalcitonin Testing for Improved Antibiotic Stewardship" underscores the growing recognition among healthcare professionals of the advantages of PCT testing in promoting responsible antibiotic use. The research highlights how PCT testing can support antibiotic stewardship initiatives, improving patient care and reducing healthcare costs. As medical professionals become more familiar with PCT testing's benefits, the demand for this diagnostic tool is expected to rise. This increased adoption can play a significant role in combating antibiotic resistance and enhancing overall healthcare efficiency. Moreover, the use of PCT testing can lead to better patient outcomes by reducing unnecessary antibiotic exposure and its associated risks.

Regional Analysis

Based on region, the global procalcitonin market is bifurcated into North America, Europe, Asia-Pacific, Latin America, and the Middle East and Africa. 

North America Dominates the Global Market

North America is the most significant global procalcitonin market shareholder and is expected to expand substantially during the forecast period. In the United States, sepsis is a significant driver of inpatient hospital costs. As per the Centers for Disease Control and Prevention (CDC), approximately 1.71 million adults in the United States develop sepsis each year, with nearly 270,000 resulting in fatalities and one in three hospital deaths being linked to sepsis. It is also among the top five reasons for adult hospital admissions. Over the past decade, sepsis-related treatment costs have tripled to about USD 27 billion, indicating an urgent need for a comprehensive plan to address sepsis and reduce healthcare costs. The rapid increase in sepsis cases in North America underscores the necessity for efficient and cost-effective diagnostic tools.

Procalcitonin testing offers a solution, as it aids in early sepsis detection and helps guide targeted antibiotic treatment, reducing the overuse of antibiotics. This contributes to improved patient outcomes and can reduce the overall costs of sepsis treatment. A study published in Clinical Chemistry and Laboratory Medicine in March 2015 indicated that procalcitonin-guided care could have saved the United States USD 700,000 in 2014 compared to traditional care methods. In Canada, the sepsis burden is also substantial. According to the Canadian Sepsis Foundation, sepsis is one of the top 12 causes of death in the country, with 15% of patients in intensive care units (ICUs) being treated for sepsis. The rising incidence of sepsis across North America highlights the need for comprehensive diagnostic approaches, where procalcitonin testing can be crucial.

Europe is the second-largest region for procalcitonin sales, with sepsis presenting a significant health challenge. In the United Kingdom, the U.K. Sepsis Trust reports that five people die from sepsis every hour, totaling 52,000 deaths annually, and 25,000 children are affected by the condition. In Germany, sepsis is the third leading cause of death, accounting for 60,000 fatalities each year. A decrease in 10%, 20%, or 30% of sepsis admissions could lead to annual cost savings of 83 million euros, 166 million euros, or 249 million euros, respectively. Procalcitonin testing and guided antibiotic regimens could play a key role in achieving these cost savings and improving patient care. These statistics emphasize the importance of procalcitonin testing in reducing sepsis-related mortality and healthcare costs.

The expansion of procalcitonin market share in North America and Europe reflects the growing recognition of its role in enhancing clinical outcomes, reducing antibiotic overuse, and contributing to a more cost-effective approach to sepsis treatment. As awareness of the benefits of procalcitonin testing continues to grow, healthcare systems will increasingly adopt this tool to address the rising challenges posed by sepsis and related infections.

Segmental Analysis

The global procalcitonin market is bifurcated into product types, technology, end users, and applications.

Based on product type, the global procalcitonin market is segmented into procalcitonin antigen and procalcitonin antibody.

Procalcitonin Antigen dominates the market as a crucial biomarker for diagnosing bacterial infections, particularly sepsis, due to its direct clinical relevance. Its ability to provide precise and actionable results aids healthcare professionals in making informed decisions regarding antibiotic therapy initiation and management. Widely adopted diagnostic protocols and validated immunoassay formats ensure reliable and efficient detection of circulating Procalcitonin levels. This antigen-based approach not only enhances diagnostic accuracy but also supports therapeutic guidance by monitoring infection progression and treatment response. Overall, Procalcitonin Antigen's widespread use underscores its pivotal role in improving patient outcomes through targeted infection management strategies.

Based on technology, the global procalcitonin market is segmented into chemiluminescence immunoassay (CLIA), enzyme-linked fluorescent assay (ELFA), and others.

Chemiluminescence immunoassay (CLIA) technology leads the market due to its high sensitivity, specificity, and widespread adoption in clinical laboratories. CLIA-based procalcitonin tests utilize chemiluminescent reactions to quantify procalcitonin levels in patient samples with precision and speed. This technology is favored for its ability to handle large sample volumes efficiently, making it suitable for high-throughput testing environments such as hospitals and diagnostic laboratories. CLIA offers advantages like automation, minimal sample handling, and reduced turnaround time, enhancing workflow efficiency and diagnostic accuracy. Its robust performance in detecting procalcitonin levels supports clinical decision-making in sepsis management and other infectious diseases, solidifying CLIA as the dominant technology in the procalcitonin tests market.

Based on application, the global procalcitonin market is segmented into medical and scientific research.

Medical applications represent the dominant segment, encompassing the use of procalcitonin tests for diagnosing and managing bacterial infections, particularly sepsis and lower respiratory tract infections. Procalcitonin levels serve as critical biomarkers in medical settings, aiding in the differentiation between bacterial and viral infections and guiding antibiotic therapy decisions. Medical professionals rely on procalcitonin tests to assess disease severity, monitor treatment efficacy, and optimize patient care pathways. The growing burden of infectious diseases globally, coupled with increasing awareness of antimicrobial stewardship, drives the demand for accurate and timely diagnostic tools like procalcitonin tests in medical applications. Their role in improving clinical outcomes and reducing healthcare costs underscores their dominance in addressing critical healthcare challenges related to infectious disease management.

Based on end-users, the global procalcitonin market is segmented into hospitals, diagnostic laboratories, point-of-care testing (POCT), and others.

Hospitals are the dominant end-users of procalcitonin tests due to their central role in acute and critical care settings. Procalcitonin tests are extensively used in hospitals for rapid diagnosis of sepsis and other bacterial infections, facilitating early intervention and improved patient outcomes. Hospitals benefit from the comprehensive diagnostic capabilities offered by procalcitonin tests, which aid in timely decision-making and resource allocation. The availability of advanced laboratory infrastructure and trained medical personnel in hospitals supports the integration of procalcitonin testing into routine clinical practice. As frontline healthcare providers, hospitals prioritize the adoption of reliable and efficient diagnostic technologies like procalcitonin tests to enhance patient care quality and safety. Their continuous reliance on these tests underscores hospitals as the primary driver and dominant segment in the procalcitonin tests market.

Recent Developments

• April 2024 - A major milestone in its dedication to offering cutting-edge solutions to its clients has been reached, says Bio-Techne Corporation, a worldwide life sciences firm that supplies bioactive reagents and novel tools to the research and clinical diagnostic communities. Bio-Techne and Thermo Fisher Scientific, a top supplier of laboratory supplies and services in Europe, will sign a strategic distribution agreement on May 1, 2024.