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Pancreatic Stone Protein Testing Market Size and Forecast, by Technique (ELISA, Fluorometric Immunoassay), Disease Type (Sepsis, Acute Appendicitis, Diabetes, Optic Atrophy, Deafness), Age Group (Infant, Children, Adults, Geriatric), End-user (Hospitals, Specialty Clinics, Diagnostic Centers, Pathology Laboratories) - Growth Trends, Key Players, Regional Analysis 2026-2035

  • Report ID: 4566
  • Published Date: Nov 24, 2025
  • Report Format: PDF, PPT

Pancreatic Stone Protein Testing Market Outlook:

Pancreatic Stone Protein Testing Market size was over USD 4.43 billion in 2025 and is poised to exceed USD 5.9 billion by 2035, witnessing over 2.9% CAGR during the forecast period i.e., between 2026-2035. In the year 2026, the industry size of pancreatic stone protein testing is estimated at USD 4.55 billion.

Pancreatic-Stone-Protein-Testing-overview
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The growth of the market can be attributed to the globally rising prevalence of chronic diseases, caused by pancreatic stone formation. Some of these diseases include acute appendicitis, diabetes, gallstones, and optic atrophy, which is expected to drive the demand for global pancreatic stone protein testing market during the forecast period. It was observed that, in American Indians, gallstones are prevalent at a rate of about 55% to 65%, while the rate in white adults in developed countries is approximately 8% to 15%. Likewise, the rate of acute pancreatitis symptoms is higher in developing countries as well as in developed countries. For instance, the annual incidence of acute pancreatic in the U.S. ranges from 20 to 50 per 100,000 population.

The global pancreatic stone protein testing market size is expected to expand during the forecast period owing to its potential for detecting life-threatening diseases and monitoring the response to treatment. Additionally, the increasing cases of chronic & hereditary pancreatitis and pancreatic cancer worldwide are estimated to propel the growth of the global pancreatic stone protein testing market over the forecast period. According to the National Center for Biotechnology Information, a pancreatic cancer diagnosis is the seventh leading cause of cancer-related death in the world. There have been 458,918 new cases of pancreatic cancer recorded globally in 2018, and there are estimated to be 355,317 new cases occurring until the year 2040. Furthermore, assay techniques such as ELISA and immunoassay devices are some of the global pancreatic stone protein testing market trends expected to fuel the market growth during the forecast period.

Key Pancreatic Stone Protein Testing Market Insights Summary:

  • Regional Insights:

    • By 2035, North America is projected to secure the majority revenue share in the  pancreatic stone protein testing market supported by extensive technological adoption, a large patient pool, and robust healthcare infrastructure, attributed to rising awareness and strong regional healthcare spending.

  • Segment Insights:

    • The sepsis segment is estimated to hold the largest revenue share by 2035 in the  pancreatic stone protein testing market, propelled by the escalating global burden of sepsis and rising emphasis on early diagnostic practices.
    • The adults segment is anticipated to command a significant share by 2035, influenced by the higher incidence and severity of acute pancreatitis among aging populations.

  • Key Growth Trends:

    • Growing Prevalence of Diabetes Globally with Changing food habits
    • Increasing Geriatric Population Around the World which Reduces Immunity

  • Major Challenges:

    • Higher Cost of Pancreatic Stone Protein (PSP) Testing
    • Highly Sensitive Testing Devices

  • Key Players: CUSABIO TECHNOLOGY LLC, LifeSpan BioSciences, Inc, Abbexa Limited, Boster Biological Technology CO LTD, Aviva Systems Biology Corporation, Glenmed Professional Healthcare Solutions., CREATIVE DIAGNOSTICS, Inc, Biomol GmbH, AMS Biotechnology (Europe) Limited.

Global Pancreatic Stone Protein Testing Market Forecast and Regional Outlook:

  • Market Size & Growth Projections:

    • 2025 Market Size: USD 4.43 billion
    • 2026 Market Size: USD 4.55 billion
    • Projected Market Size: USD 5.9 billion by 2035
    • Growth Forecasts: 2.9%

  • Key Regional Dynamics:

    • Largest Region: North America (Majority Revenue Share by 2035)
    • Fastest Growing Region: North America
    • Dominating Countries: United States, China, Germany, United Kingdom, Japan
    • Emerging Countries: India, Brazil, South Korea, Mexico, Indonesia

    • Last updated on : 24 November, 2025

Growth Drivers

  • Growing Prevalence of Diabetes Globally with Changing food habits
  • The World Health Organization states that 422 million people worldwide are diabetic; each year, about 1.5 million people die of diabetes.
  • The rising need for pancreatic stone protein testing in diabetic patients, particularly in Type 3c, also known as pancreatogenic diabetes is expected to drive the market growth during the forecast period. It is estimated that there are more people with type 3c diabetes than type 1 diabetes, and patients with pancreatitis diseases have about a 27 to 79% chance of developing type 3c diabetes, which is further estimated to promote the adoption of pancreatic stone protein testing for diabetic patients.
  • Increasing Geriatric Population Around the World which Reduces Immunity - According to the World Health Organization, the number of people aged over 60 years was 1 billion in 2019 and is expected to increase to 2.1 billion by 2050. 
  • Change in Lifestyle, Increasing Consumption of Alcohol Among People – As per WHO, alcohol is a cause of more than 200 serious medical conditions. Worldwide, 3 million deaths are attributed to excessive alcohol consumption every year, which is 5.3 percent of all deaths.
  • Increasing Cases of Pancreatic Cancer with Lack of Early Diagnosis – Pancreatic stone protein testing also acts as cancer biomarkers, thus the surge in the number of pancreatic cancer cases is further expected to drive the market’s growth. As of 2022, nearly 62,000 people were diagnosed with pancreatic cancer and approximately 49,500 of them died in a similar year in the United States.
  • Globally Increasing Health Care Expenditure to Improve the Health of People - In 2019, according to data provided by the World Bank, global health expenditures had grown from 9.7% of the world's GDP in 2018 to 9.83% in 2019.

Challenges

  • Higher Cost of Pancreatic Stone Protein (PSP) Testing
  • Highly Sensitive Testing Devices 
  • Accuracy Issues with PSP Biomarkers 

The PSP test may give false or misdiagnosed results as some of the symptoms of the disease are similar to Parkinson’s disease, Alzheimer’s disease, and neurodegenerative disorders. Sometimes the memory issues and change in behavior are misdiagnosed as symptoms of depression or dementia instead of PSP by the physicians. Hence, these factors of misdiagnosis are projected to limit the market growth in the coming years.

Pancreatic Stone Protein Testing Market Size and Forecast:

Report Attribute Details

Base Year

2025

Forecast Year

2026-2035

CAGR

2.9%

Base Year Market Size (2025)

USD 4.43 billion

Forecast Year Market Size (2035)

USD 5.9 billion

Regional Scope

  • North America (U.S., and Canada)
  • Asia Pacific (Japan, China, India, Indonesia, Malaysia, Australia, South Korea, Rest of Asia Pacific)
  • Europe (UK, Germany, France, Italy, Spain, Russia, NORDIC, Rest of Europe)
  • Latin America (Mexico, Argentina, Brazil, Rest of Latin America)
  • Middle East and Africa (Israel, GCC North Africa, South Africa, Rest of the Middle East and Africa)
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Pancreatic Stone Protein Testing Market Segmentation:

Disease Type Segment Analysis

The global pancreatic stone protein market is segmented and analyzed for demand and supply by disease type into sepsis, acute appendicitis, diabetes, optic atrophy, and deafness. Amongst these segments, the sepsis disease segment is expected to garner the largest revenue by the end of 2035, backed by the growing number of cases of sepsis around the globe, and increasing awareness among people about the early diagnosis of sepsis. The World Health Organization (WHO) estimates that every year, more than 49 million people suffer from sepsis, resulting in 11 million deaths worldwide. In recent years, the number of patients with severe sepsis has increased from 25% to 42%. Sepsis is a more common disease that causes infection and affects the immune system of the body. Moreover, sepsis is a bacterial or viral infection that causes traumatic injury. The infection triggers the immune system and initiates the release of chemicals and immune mediators into the bloodstream to fight the infection. This leads to inflammation, blood clots, and bleeding from blood vessels that cause organ damage.

Age Group Segment Analysis

The global pancreatic stone protein market is also segmented and analyzed for demand and supply by age group into infant, children, adults, and geriatric. Amongst these segments, the adults segment is expected to garner a significant share. The elderly population is suffering from acute pancreatitis compared to younger people. The high risk of malnutrition in the elderly or aging population supports immunodeficiency making them more prone to the development of organ dysfunction. The severity of the disease is also very high in older people may be owing to atypical symptoms, reduced pancreatic protein production, impairment in immunity, and bacterial translocation.  The mortality rate of patients with acute pancreatitis in people aged 60-70 years is 0.8 per year which is approximately 20 times that in people aged under 20 as per estimations in 2019 across the globe. Further, the frequent cause of biliary lithiasis, lithogenic bile, and dilation of the bile duct, are common reasons for the incidence of acute pancreatitis in aged people. Alcohol consumption, idiopathic pancreatitis caused by genetic polymorphisms, environmental chemicals, and smoking habits are other also estimated to increase the risk of acute pancreatitis in the elderly. The high incidence of pancreatitis will lead to pancreatic failure or stone formation rising the aged patient population. All these factors drive the market segment’s growth during the forecast period.

Our in-depth analysis of the global market includes the following segments:

                    By Technique
  • Elisa
  • Fluorometric Immunoassay

                   By Diseases Type
  • Sepsis
  • Acute Appendicitis
  • Diabetes
  • Optic Atrophy
  • Deafness

                   By Age Group
  • Infant
  • Children
  • Adults
  • Geriatric

 

                   By End User
  • Hospitals
  • Specialty Clinics
  • Diagnostic Centers
  • Pathology Laboratories
Vishnu Nair
Vishnu Nair
Head - Global Business Development

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Pancreatic Stone Protein Testing Market - Regional Analysis

North American Market Insights

North America industry is likely to dominate majority revenue share by 2035. The growth of the market can be attributed majorly to the high adoption of technological advancements, a large patient pool, and a well-developed healthcare infrastructure. According to the National Health Expenditure (NHE), healthcare spending in the United States increased by 9.7% in 2020, and this represents 19.7% of the nation's gross domestic product (GDP). Moreover, increasing awareness among the population, a strong economy, and a large number of key market players in the region are other factors anticipated to fuel the growth of the global pancreatic stone protein testing market in the region during the forecast period. The rising awareness of people on early diagnosis and government initiatives to improve patient healthcare in the region are projected to rise the market growth. Moreover, the increasing disposable income of many middle-class people to afford their health needs rises the standards of living. Therefore, rising knowledge among people with internet penetration and the digitalization of everything has a huge impact on disease diagnosis and treatments. Hence, it is expected to boost the market’s growth in the region.

Pancreatic-Stone-Protein-Testing-Market-Scope (1)
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Pancreatic Stone Protein Testing Market Players:

    • RayBiotech Life, Inc.

      • Company Overview
      • Business Strategy
      • Key Product Offerings
      • Financial Performance
      • Key Performance Indicators
      • Risk Analysis
      • Recent Development
      • Regional Presence
      • SWOT Analysis
    • CUSABIO TECHNOLOGY LLC
    • LifeSpan BioSciences, Inc
    • Abbexa Limited
    • Boster Biological Technology CO LTD
    • Aviva Systems Biology Corporation
    • Glenmed Professional Healthcare Solutions.
    • CREATIVE DIAGNOSTICS, Inc
    • Biomol GmbH
    • AMS Biotechnology (Europe) Limited

Recent Developments

  • CREATIVE DIAGNOSTICS, Inc’s range of antibiotics ELISA kits can be used to detect antibiotic residues very accurately. Bio-production processes can benefit from these kits for impurity detection.

  • Glenmed Professional Healthcare Solutions to elaborate on how new forms of technologies and ongoing innovation are impacting the medical world by analyzing technology trends from recent decades.

  • Report ID: 4566
  • Published Date: Nov 24, 2025
  • Report Format: PDF, PPT
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Frequently Asked Questions (FAQ)

In the year 2026, the industry size of pancreatic stone protein testing is estimated at USD 4.55 billion.

The global pancreatic stone protein testing market size was over USD 4.43 billion in 2025 and is anticipated to witness a CAGR of around 2.9%, crossing USD 5.9 billion revenue by 2035.

By 2035, North America is projected to secure the majority revenue share in the Pancreatic Stone Protein Testing Market, supported by extensive technological adoption, a large patient pool, and robust healthcare infrastructure, attributed to rising awareness and strong regional healthcare spending.

Key players in the market include CUSABIO TECHNOLOGY LLC, LifeSpan BioSciences, Inc, Abbexa Limited, Boster Biological Technology CO LTD, Aviva Systems Biology Corporation, Glenmed Professional Healthcare Solutions., CREATIVE DIAGNOSTICS, Inc, Biomol GmbH, AMS Biotechnology (Europe) Limited.

Pancreatic Stone Protein Testing Market Report Scope

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