Pancreatic Stone Protein Testing Market Set to Reach USD 2.8 Billion by 2034 Amid Rising Sepsis Cases and Diagnostic Innovations

The global pancreatic stone protein (PSP) testing market is on a steady growth trajectory, estimated at USD 2.2 billion in 2024 and projected to reach USD 2.8 billion by 2034, expanding at a CAGR of 2.3%. This growth is underpinned by rising incidences of sepsis and acute inflammatory diseases, coupled with ongoing innovations in diagnostic technologies. The market is becoming a fertile ground for both established and emerging diagnostic manufacturers aiming to expand their global footprint and introduce next-generation testing solutions.

Pancreatic stone protein is a novel biomarker recognized for its superior diagnostic performance in detecting sepsis, a life-threatening condition caused by the body’s overwhelming response to infection. PSP testing offers greater specificity and sensitivity compared to conventional laboratory markers such as procalcitonin (PCT), making it increasingly indispensable in critical care diagnostics.

Rising Sepsis Incidence Driving Diagnostic Demand

Sepsis continues to be one of the leading causes of hospital mortality worldwide. According to ENDSEPSIS.org, the United States reports over 1.5 million cases annually, while the UK Sepsis Trust estimates around 245,000 cases each year. With an aging global population, the demand for rapid and reliable sepsis diagnosis has never been higher.

Early detection using PSP biomarkers has shown a marked improvement in patient survival rates, prompting hospitals and healthcare providers to integrate PSP testing into routine critical care monitoring. Companies like Thermo Fisher Scientific and Ray Biotech, Inc. are leading the charge by refining testing kits that deliver faster, more precise results in emergency and intensive care settings

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Government Support Accelerating Diagnostic Advancements

Global health authorities are amplifying their investments in sepsis management and diagnostic innovation. In the United States, the CDC allocated USD 3 million from the FY24 Congressional Budget to combat sepsis, while the UK government announced a £100 million fund for building 20 new research facilities aimed at accelerating public-private innovation in healthcare technologies.

These initiatives are encouraging both established diagnostic giants and emerging biotech startups to invest in PSP test development, particularly for point-of-care (POC) applications. Such funding not only fuels product innovation but also promotes wider accessibility of life-saving diagnostic technologies

Technological Innovations Revolutionizing the Market

The PSP testing industry is undergoing rapid technological evolution, with AI integration, multiplex assays, and telemedicine connectivity reshaping diagnostic capabilities.

AI-Powered Diagnostics:

Manufacturers are leveraging artificial intelligence to interpret PSP test results with greater accuracy and speed. AI-enabled platforms can analyze PSP levels in conjunction with other biomarkers to predict early warning signs of sepsis, minimizing human error and enabling data-driven clinical decisions.

Multiplex Assays:

Next-generation multiplex diagnostic assays are enabling simultaneous detection of multiple biomarkers, including PSP, C-reactive protein (CRP), and procalcitonin. This innovation reduces diagnostic costs and sample volumes, while improving workflow efficiency in ICUs and laboratories.

Telemedicine Integration:

The fusion of telemedicine and PSP testing is opening new avenues for remote diagnostics, particularly in under-resourced regions. Virtual consultation platforms such as Abbott’s NeuroSphere™ Virtual Clinic, approved by the U.S. FDA, highlight the industry’s movement toward remote patient management and digital healthcare accessibility.

Challenges: High Costs and Accessibility Gaps

Despite its potential, PSP testing adoption faces hurdles. The cost of PSP testing kits and devices remains significantly higher than conventional diagnostic options like CRP or PCT tests. This limits their deployment, especially in rural and developing regions with constrained healthcare budgets.

However, manufacturers are responding through strategic alliances and technology partnerships to develop cost-efficient PSP testing solutions. For instance, Creative Diagnostics and Abnova Corporation have partnered with biotechnology firms to design affordable and scalable diagnostic platforms aimed at underserved markets in Asia and Africa.

Segment Insights: Kits and Point-of-Care Devices Leading the Market

Product Type:

PSP testing kits dominate the market, holding 47.9% share in 2024, driven by advancements in ELISA-based and immunoassay technologies that offer high accuracy and faster turnaround times.

Application:

Among various applications, acute pancreatitis monitoring remains the fastest-growing segment, supported by the increasing incidence of the disease—estimated between 50,000 to 80,000 cases annually in the U.S., according to Pancreas.org.

Technology:

Point-of-care (POC) diagnostic devices are witnessing strong demand due to their portability, accuracy, and real-time testing capabilities, essential for critical care monitoring.

End-user:

Hospitals account for 38.9% of global demand in 2024, as they are the primary sites for sepsis detection and treatment. Diagnostic laboratories and research institutions are also emerging as crucial end-users for PSP-based assays.

Regional Outlook: Asia-Pacific Leading the Growth Curve

Asia-Pacific is expected to register the fastest growth, led by India (CAGR 3.2%), China, and Japan. Rapid healthcare infrastructure development, rising awareness of sepsis diagnosis, and government initiatives promoting medical innovation are driving regional expansion.

In Japan, the growing elderly population and the presence of advanced healthcare systems are contributing to the increased adoption of PSP testing kits from key suppliers such as AMS Biotechnology and Creative Diagnostics.

North America, particularly the United States, remains the largest market for PSP testing due to its advanced healthcare infrastructure and strong presence of market leaders like Thermo Fisher Scientific and Ray Biotech.

Meanwhile, Europe—led by Germany and the UK—is fostering growth through supportive healthcare policies, widespread adoption of multiplex assays, and strong awareness campaigns by organizations like UK Sepsis Trust.

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Competitive Landscape: Collaboration and Innovation Defining the Market

The PSP testing industry is characterized by strategic partnerships, mergers, and R&D investments.

• Thermo Fisher Scientific has expanded its diagnostic capabilities through the acquisition of PPD, reinforcing its commitment to precision diagnostics.
• Ray Biotech, Inc. is partnering with regional distributors to enhance accessibility in emerging markets.
• Abnova Corporation and Creative Diagnostics are collaborating with biotech firms to co-develop affordable testing solutions for developing regions.
• Lifespan Biosciences Inc. and CUSABIO TECHNOLOGY LLC continue to focus on biomarker innovation, strengthening their portfolios in immunodiagnostics.

As the competition intensifies, smaller biotech firms with niche expertise in PSP biomarker technologies are being courted by larger corporations, accelerating both innovation and global reach.

Outlook: The Next Frontier in Critical Care Diagnostics

The pancreatic stone protein testing market is evolving into a dynamic ecosystem where technology, policy, and innovation converge. As more manufacturers—both established players and new entrants—invest in AI integration, POC advancements, and telemedicine-ready diagnostics, the market is expected to play a pivotal role in reshaping critical care management globally.

By 2034, PSP testing is poised to become an integral component of sepsis diagnosis and acute care, offering clinicians faster, more reliable tools to save lives—marking a transformative era in precision healthcare diagnostics.

Key Players:

Ray Biotech, Inc. | Thermo Fisher Scientific Inc. | Lifespan Biosciences Inc. | Abnova Corporation | AMS Biotechnology (Europe) Ltd | CUSABIO TECHNOLOGY LLC | Boster Biological Technology | Creative Diagnostics Inc. | Abbexa Ltd.

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