The global pancreatic elastase testing market was valued at USD 15.5 Million in 2022 and is expected to reach USD 36.2 Million by 2033. The ELISA kits with around 58.4% value share, has topped the global market within the product category in 2022 and is expected to grow at a CAGR of close to 7.9% over the forecast period (2023 to 2033)
Market Outlook
Key Market Attributes
| Market Size, 2022 | USD 15.5 Million |
|---|---|
| Market Size, 2023 | USD 16.5 Million |
| Market Size, 2033 | USD 36.2 Million |
| Value CAGR (2023 to 2033) | 8.1% |
A diagnostic technique for determining pancreatic elastase levels in stool samples is pancreatic elastase testing. It aids in evaluating pancreatic activity and identifying diseases like pancreatic insufficiency. The rising frequency of pancreatic illnesses and the rising desire for precise and non-invasive diagnostic procedures are driving a positive market outlook for pancreatic elastase testing.
The market is anticipated to expand as awareness of gastrointestinal health grows. Future growth of the market is probably going to be aided by technological development of portable and user-friendly testing kits.
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The global market for pancreatic elastase testing was around 1.0% of the overall USD 2.3 Billion of the global pancreatic cancer diagnostics market in 2022.
Semi Annual Market Update
| Particular | Value CAGR |
|---|---|
| H1 | 7.71% (2022 to 2032) |
| H2 | 8.29% (2022 to 2032) |
| H1 | 7.85% (2023 to 2033) |
| H2 | 8.43% (2023 to 2033) |
The sales analysis of the market from 2018–2022 reveals a growing demand for this specific protease synthetized by acinar cells. Pancreatic elastase-1 has gained prominence due to its stability and accuracy in assessing exocrine pancreatic function. Unlike other pancreatic enzyme preparations, immunoreactive elastase-1 is specific to humans and remains stable even after exogenous pancreatic enzyme treatment. Its measurement in stool using enzyme-linked immunosorbent assay (ELISA) offers a sensitive, specific, and cost-effective non-invasive testing method.
The market is predicted to continue growing from 2023 to 2033. Pancreatic elastase-1 testing is expected to keep increasing popularity due to its excellent sensitivity and specificity for exocrine pancreatic insufficiency. This test qualifies as a trustworthy diagnostic technique due to its accuracy, particularly in individuals with chronic pancreatitis verified by endoscopic retrograde cholangiopancreatography and computed axial tomography. Its rising popularity is partly due to its ability to deliver outcomes that are equivalent to those of oral pancreatic function tests like the pancreolauryl test.
Overall, the sales analysis and market forecast show how important pancreatic elastase-1 testing is becoming in determining exocrine pancreatic function. Healthcare professionals are beginning to notice its correctness and non-invasiveness, hence the market is anticipated to expand steadily between 2023 and 2033.
The market growth lies in addressing the diagnostic challenges posed by Chronic Pancreatitis (CP). Gastroenterologists frequently encounter patients with suspected CP based on equivocal imaging or laboratory findings, necessitating accurate diagnostic methods. While histologic specimens are difficult to obtain, tests of pancreatic function play a crucial role in diagnosing CP. Among these tests, the fecal elastase-1 (FE-1) assay stands out as a non-invasive, stable, and cost-effective method that specifically measures pancreatic elastase-1.
With its ability to assess pancreatic function even in the presence of enzyme supplementation, FE-1 offers an attractive solution for diagnosing CP and Exocrine Pancreatic Insufficiency (EPI). Studies have reported prevalence rates of EPI diagnosed by FE-1<200 μg/g in various populations, highlighting the potential for widespread usage.
The commercially available ELISA kit for FE-1 testing is covered by most commercial insurance carriers, making it accessible to a broad patient base. While FE-1 tests have known assay variability, advancements in technology and standardization efforts could improve their diagnostic accuracy. By addressing the diagnostic challenges of CP and EPI, the market has the opportunity to provide gastroenterologists with a reliable and non-invasive tool for accurate diagnosis. This could lead to increased adoption of FE-1 testing in clinical practice and contribute to the growth of the market.
The key opportunities for the pancreatic elastase testing services include the increasing prevalence of pancreatic disorders, rising awareness about digestive health, and advancements in diagnostic technologies. Additionally, the growing adoption of point-of-care testing and the expansion of healthcare infrastructure in developing regions provide opportunities for market expansion.
The development of non-invasive and cost-effective testing methods and the potential for early diagnosis and management of pancreatic diseases further contribute to the market's growth prospects. Furthermore, collaborations between diagnostic companies and research institutions for the development of innovative testing solutions can drive market growth in the future.
Principal Consultant
Factors restraining the demand for pancreatic elastase testing include limited awareness among patients and healthcare professionals about the importance of testing for pancreatic disorders, lack of routine screening for pancreatic diseases, and challenges in accessing specialized diagnostic tests.
Availability of alternative diagnostic methods and the relatively high cost of pancreatic elastase testing can also impact its demand. Furthermore, the complexity of interpreting test results and the need for proper patient preparation can hinder the adoption of this testing method. These factors collectively contribute to the limited uptake of pancreatic elastase testing in clinical practice.
Market Growth Outlook by Key Countries
| Countries | Value CAGR |
|---|---|
| United States | 9.2% |
| Germany | 10.2% |
| United Kingdom | 9.9% |
| Japan | 6.5% |
| China | 8.0% |
| India | 6.8% |
In 2022, the United States held a dominant global revenue in the North America market and contributed around USD 4.4 Million.
Acute and chronic pancreatitis cases are rising in the United States, making it a significant market for pancreatic elastase testing in the North American region. The demand for accurate testing is driven by the two most prevalent causes, alcohol use and gallstones. The American College of Gastroenterology's recommendations emphasize the requirement of thorough testing, including evaluations of triglyceride levels and genetic profiles for a range of age groups. The United States is positioned as a prominent market for pancreatic elastase testing solutions due to the prevalence of pancreatitis and extensive diagnostic processes.
Germany occupies 9.9% value share in North America in 2022, expenditure on pancreatic elastase testing in 2022 was USD 1.5 Million.
Germany is a key country in the market due to the high prevalence of acute and chronic pancreatitis cases.
Chronic pancreatitis also affects a significant portion of the population, leading to hospitalization rates. This prevalence is attributed to factors such as gallstone disease and alcohol abuse, contributing to the demand for accurate diagnosis and monitoring. As a result, Germany's substantial patient pool and evolving clinical practices make it a pivotal market for pancreatic elastase testing, aligning with the country's increasing focus on gastroenterological conditions.
In 2022, the China held a dominant global revenue in the East Asian market and contributed around USD 1.4 Million.
China's status as a substantial market for pancreatic elastase testing can be attributed to the high prevalence and significant impact of pancreatitis. Pancreatitis, characterized by inflammatory injury to the pancreas, has both acute and chronic forms. The incidence and mortality rates of pancreatitis in China, although moderate compared to global figures, contribute to a substantial disease burden.
Alcohol consumption, a prevalent risk factor, has notably increased the incidence of alcoholic pancreatitis. Recognizing the escalating disease burden and trends in alcohol-related pancreatitis is vital for effective disease control and health promotion efforts. Understanding these factors makes China a significant market for pancreatic elastase testing, aiding in early diagnosis and management of pancreatitis.
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Market Growth Outlook by Key Product
| Product | Value CAGR |
|---|---|
| ELISA Kits | 7.9% |
| Turbidimetric Kits | 8.4% |
| CLIA Kits | 8.2% |
| Rapid Test Kits | 13.2% |
By product, ELISA kits covered 58.4% market shares in world in 2022. ELISA kits are a pivotal product in the market. These kits enable accurate and efficient detection of pancreatic elastase levels, a crucial biomarker for pancreatitis diagnosis. ELISA (Enzyme-Linked Immunosorbent Assay) technology offers high sensitivity and specificity, allowing for precise quantification of elastase levels in patient samples.
ELISA kits play a vital role in early detection, monitoring, and management of pancreatitis, aiding clinicians in making informed decisions. Their reliable performance and user-friendly protocols make ELISA kits indispensable tools for healthcare professionals, contributing significantly to the effectiveness of diagnosing and managing pancreatic elastase-related disorders.
Market Growth Outlook by Key Indication
| Indication | Value CAGR |
|---|---|
| Chronic Pancreatitis | 7.5% |
| Type 1 Diabetes | 8.1% |
| Cystic Fibrosis | 9.3% |
| Others | 6.0% |
The market value of chronic pancreatitis indication in pancreatic elastase testing is USD 5.4 Million, representing for a sizable 34.6% market share in 2022. Chronic pancreatitis, a pivotal indication in the current market, is characterized by persistent inflammation of the pancreas.
The incidence and mortality rates of pancreatitis in China are noteworthy, driving the demand for accurate diagnostic tools like pancreatic elastase testing. The condition's link to alcohol consumption, a prevalent risk factor, further amplifies its significance. Early diagnosis and effective management of chronic pancreatitis are crucial to alleviate its substantial impact on patients and healthcare systems, underscoring the importance of its role in the Pancreatic Elastase Market.
Market Growth Outlook by Key Sample
| Sample | Value CAGR |
|---|---|
| Fecal | 8.4% |
| Blood | 5.0% |
In 2022, the market shares for pancreatic elastase testing through fecal testing reached a significant 92.5%, translating to a market value of USD 14.38 million.
Fecal samples are most commonly used in pancreatic elastase testing due to their practicality and accuracy. The stability of pancreatic elastase-1 throughout the intestinal tract ensures reliable results. The fecal elastase-1 assay, measuring pancreatic elastase-1 via ELISA, remains stable even in the presence of enzyme supplementation.
Research shows that fecal elastase-1 determination exhibits high sensitivity in diagnosing severe and moderate exocrine pancreatic insufficiency. It outperforms fecal chymotrypsin estimation in terms of sensitivity, though specificity for both tests is relatively low. Despite these limitations, fecal elastase-1 testing stands out as a valuable tool for assessing pancreatic function in patients, particularly in cases of significant impairment.
Market Growth Outlook by Key End User
| End User | Value CAGR |
|---|---|
| Hospitals | 9.3% |
| Diagnostics Laboratories | 7.8% |
| Specialty Clinics | 6.6% |
The hospitals have a considerable presence in the pancreatic elastase testing services, accounting for 37.5% of end users in 2022, and exhibiting a high CAGR of 9.3% over the forecast period.
Hospitals play a pivotal role in the market by serving as primary diagnostic centers for pancreatic diseases. These institutions provide the necessary infrastructure and medical expertise to perform elastase testing, enabling accurate diagnosis of pancreatic insufficiency.
As central hubs for patient care, hospitals facilitate timely testing, aiding in early disease detection and effective treatment planning. Their role in specimen collection, testing accuracy, and result interpretation greatly influences patient management and healthcare decisions, making hospitals indispensable for driving the growth and impact of the market.
Pancreatic elastase testing can be accelerated through innovations and mergers among healthcare providers, research facilities, and technology companies. Market expansion and the development of new applications are results of collaboration in research, development, and commercialization. Pancreatic elastase testing is a market where several sizable businesses compete.
Similarly, recent developments related to the company’s providing the pancreatic elastase testing services have been tracked by the team at Future Market Insights, which are available in the full report.
Related Market Growth Outlook Scenario
| Particulars | Value CAGR |
|---|---|
| Pancreatic Stone Protein Testing Market | 1.7% |
| Pancreatic Cancer Market | 13.5% |
| Fecal Pancreatic Elastase Testing Market | 7.6% |
| Attribute | Details |
|---|---|
| Forecast Period | 2023 to 2033 |
| Historical Data Available for | 2017 to 2022 |
| Market Analysis | USD Million for Value |
| Key Regions Covered | North America, Latin America, Europe, South Asia, East Asia, Oceania, Middle East and Africa (MEA) |
| Key Countries Covered | United States, Canada, Brazil, Mexico, Argentina, Germany, Italy, France, United Kingdom, Spain, BENELUX, Russia, China, Japan, South Korea, India, Indonesia, Thailand, Malaysia, Australia, New Zealand, GCC countries, Türkiye, Northern Africa and South Africa. |
| Key Market Segments Covered | Product, Indication, Sample, End User, and Region |
| Key Companies Profiled | ALPCO Diagnostics; DiaSorin; ScheBo Biotech AG; Immundiagnostik AG; Invivo Healthcare; DRG Instruments GMBH; Verisana Laboratories; BÜHLMANN Laboratories AG; CerTest Biotec S.L.; R-Biopharm AG; American Laboratory Products Company, Ltd.; Vitassay Healthcare, S.L.U. |
| Report Coverage | Market Forecast, Competition Intelligence, DROT Analysis, Market Dynamics and Challenges, Strategic Growth Initiatives |
| Pricing | Available upon Request |
The global market is worth USD 15.5 Million in 2022.
The global market estimates for 2023 is around USD 16.5 Million.
The global market is expected to reach USD 36.2 Million by 2033.
The global market grew at a CAGR of 4.9% between 2017 and 2022.
The United States dominated the global market contributing around USD 4.4 Million in 2022.
Germany holds nearly 9.9% market share in the global market in 2022.
China accounted for a market value share of around 8.9% in 2022, in the global market
With USD 5.4 million, chronic pancreatitis indication is driving pancreatic elastase testing market.
1. Executive Summary 2. Market Overview 3. Key Market Trends 4. Value-Added Insights 5. Market Background 6. Global Market Demand (in Value or Size in US$ Million) Analysis 2017 to 2022 and Forecast, 2023 to 2033 6.1. Y-o-Y Growth Trend Analysis 6.2. Absolute $ Opportunity Analysis 7. Global Market Analysis 2017 to 2022 and Forecast 2023 to 2033, By Product 7.1.1. ELISA Kits 7.1.2. Turbidimetric Kits 7.1.3. CLIA Kits 7.1.4. Rapid Test Kits 8. Global Market Analysis 2017 to 2022 and Forecast 2023 to 2033, By Indication 8.1. Chronic Pancreatitis 8.2. Type 1 Diabetes 8.3. Cystic Fibrosis 8.4. Others 9. Global Market Analysis 2017 to 2022 and Forecast 2023 to 2033, By Sample 9.1. Fecal 9.2. Blood 10. Global Market Analysis 2017 to 2022 and Forecast 2023 to 2033, By End User 10.1. Hospitals 10.2. Diagnostics Laboratories 10.3. Specialty Clinics 11. Global Market Analysis 2017 to 2022 and Forecast 2023 to 2033, By Region 11.1. North America 11.2. Latin America 11.3. Europe 11.4. South Asia 11.5. East Asia 11.6. Oceania 11.7. Middle East and Africa 12. North America Market Analysis 2017 to 2022 and Forecast 2023 to 2033 13. Latin America Market Analysis 2017 to 2022 and Forecast 2023 to 2033 14. Europe Market Analysis 2017 to 2022 and Forecast 2023 to 2033 15. South Asia Market Analysis 2017 to 2022 and Forecast 2023 to 2033 16. East Asia Market Analysis 2017 to 2022 and Forecast 2023 to 2033 17. Oceania Market Analysis 2017 to 2022 and Forecast 2023 to 2033 18. Middle East and Africa Market Analysis 2017 to 2022 and Forecast 2023 to 2033 19. Market Structure Analysis 20. Competition Analysis 20.1. ALPCO Diagnostics 20.2. DiaSorin 20.3. ScheBo Biotech AG 20.4. Immundiagnostik AG 20.5. Invivo Healthcare 20.6. DRG Instruments GMBH 20.7. Verisana Laboratories 20.8. BÜHLMANN Laboratories AG 20.9. CerTest Biotec S.L. 20.10. R-Biopharm AG 20.11. American Laboratory Products Company, Ltd. 20.12. Vitassay Healthcare, S.L.U. 21. Assumptions and Acronyms Used 22. Research Methodology
Healthcare
October 2024
REP-GB-9658
324 pages
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Pancreatic Elastase Testing Market
