Product Code: GVR-4-68040-299-1
U.S. Exocrine Pancreatic Insufficiency Diagnostics Market Growth & Trends:
The U.S. exocrine pancreatic insufficiency diagnostics market size is expected to reach USD 2.39 billion by 2030, growing at a CAGR of 7.04% from 2024 to 2030, according to a new report by Grand View Research, Inc. Several factors are driving market growth, including increasing incidence of pancreatic diseases, technological advancements, and favorable government initiatives & funding. A key future trend in the industry is the integration of machine learning algorithms and Artificial Intelligence (AI) with diagnostic tools. For instance, AI-based software platforms like the gastroenterology-AI platform analyze medical imaging data from CT scans or MRIs to assist healthcare professionals in identifying signs of pancreatic insufficiency more accurately and efficiently. This technological trend is expected to enhance diagnostic accuracy, reduce interpretation errors, and improve patient outcomes in the future, thereby driving the demand for products over the forecast period.
As the market becomes increasingly competitive, consumer needs are at an all-time high for improved diagnostic instruments and consumables in terms of high yield & robust outcomes. New-age technologies, such as AI in CT scans and MRIs, are expected to impede the sales of older products, opening new R&D opportunities in the market. Price, compatibility, safety, and time taken to provide results are major factors differentiating new EPI testing technologies from existing ones, thereby gaining a competitive edge over them. For instance, ALPCO Diagnostics introduces state-of-the-art assays, including the Pancreatic Elastase (PE) Chemiluminescence ELISA and CLIA tests, designed to detect pancreatic elastase rapidly & accurately in the stool. These advanced assays offer healthcare professionals a reliable means of diagnosing EPI, facilitating prompt intervention and improved patient outcomes. However, companies are focusing on developing newer products with higher efficacy made available at lower costs.
U.S. Exocrine Pancreatic Insufficiency Diagnostics Market Report Highlights:
- Based on diagnostic method, the laboratory tests segment accounted for the largest revenue share in 2023. Laboratory tests include indirect pancreatic function tests and other tests such as genetic testing for pancreatitis (such as Hereditary Pancreatitis Gene Panel) and 13C-mixed triglyceride breath tests for diagnosing exocrine pancreatic insufficiency in patients.
- On the other hand, the indirect pancreatic function test segment, which includes blood tests and stool tests, is expected to grow at a significant CAGR during the forecast period.
- Based on end-use, the hospitals and clinics segment accounted for the largest revenue share in 2023.
- The presence of a strong network of hospitals & clinics throughout the country and the availability of skilled staff for diagnosing severe EPI are some of the key factors responsible for the high preference of hospitals & clinics for diagnosis and treatment.
- The market is characterized by a low-to-moderate level of merger and acquisition activity, indicating a landscape characterized by stable competition and a focus on internal development rather than external consolidation.
Table of Contents
Chapter 1. Methodology and Scope
- 1.1. Market Segmentation & Scope
- 1.2. Segment Definitions
- 1.2.1. Diagnostic Method
- 1.2.2. End-use
- 1.2.3. Estimates and forecasts timeline
- 1.3. Research Methodology
- 1.4. Information Procurement
- 1.4.1. Purchased database
- 1.4.2. GVR's internal database
- 1.4.3. Secondary sources
- 1.4.4. Primary research
- 1.5. Information or Data Analysis
- 1.5.1. Data analysis models
- 1.6. Market Formulation & Validation
- 1.7. Model Details
- 1.7.1. Commodity flow analysis (Model 1)
- 1.7.2. Approach 1: Commodity flow approach
- 1.7.3. Volume price analysis (Model 2)
- 1.7.4. Approach 2: Volume price analysis
- 1.8. List of Secondary Sources
- 1.9. List of Primary Sources
- 1.10. Objectives
Chapter 2. Executive Summary
- 2.1. Market Outlook
- 2.2. Segment Outlook
- 2.2.1. Diagnostic Method Outlook
- 2.2.2. End-use Outlook
- 2.3. Competitive Insights
Chapter 3. U.S. Exocrine Pancreatic Insufficiency Diagnostics Market Variables, Trends & Scope
- 3.1. Market Lineage Outlook
- 3.1.1. Parent market outlook
- 3.1.2. Related/ancillary market outlook
- 3.2. Market Dynamics
- 3.2.1. Market Driver Analysis
- 3.2.1.1. Increasing prevalence of target disease
- 3.2.1.2. Technological advancements
- 3.2.1.3. Growing awareness and screening initiatives
- 3.2.2. Market Restraint Analysis
- 3.2.2.1. Regulatory hurdles and compliance requirements
- 3.2.2.2. Underdiagnosis and misdiagnosis
- 3.3. U.S. Exocrine Pancreatic Insufficiency Diagnostics Market Analysis Tools
- 3.3.1. Industry Analysis - Porter's
- 3.3.1.1. Supplier power
- 3.3.1.2. Buyer power
- 3.3.1.3. Substitution threat
- 3.3.1.4. Threat of new entrant
- 3.3.1.5. Competitive rivalry
- 3.3.2. PESTEL Analysis
- 3.3.2.1. Political landscape
- 3.3.2.2. Technological landscape
- 3.3.2.3. Economic landscape
- 3.4. Regulatory Scenario
- 3.5. Reimbursement Scenario
- 3.6. Pricing Analysis
- 3.7. Target Population Analysis
Chapter 4. U.S. Exocrine Pancreatic Insufficiency Diagnostics Market: Diagnostic Method Estimates & Trend Analysis
- 4.1. U.S. Exocrine Pancreatic Insufficiency Diagnostics Market: Diagnostic Method Segment Dashboard
- 4.2. U.S. Exocrine Pancreatic Insufficiency Diagnostics Market: Diagnostic Method Movement Analysis
- 4.3. U.S. Exocrine Pancreatic Insufficiency Diagnostics Market Size & Trend Analysis, by Diagnostic Method, 2018 to 2030 (USD Million)
- 4.4. Laboratory Tests
- 4.4.1. Market estimates and forecasts 2018 to 2030 (USD Million)
- 4.4.2. Indirect Pancreatic Function Tests
- 4.4.2.1. Market estimates and forecasts 2018 to 2030 (USD Million)
- 4.4.2.2. Stool Tests
- 4.4.2.2.1. Market estimates and forecasts 2018 to 2030 (USD Million)
- 4.4.2.3. Blood Tests
- 4.4.2.3.1. Market estimates and forecasts 2018 to 2030 (USD Million)
- 4.4.3. Other Tests
- 4.4.3.1. Market estimates and forecasts 2018 to 2030 (USD Million)
- 4.5. Imaging Tests
- 4.5.1. Market estimates and forecasts 2018 to 2030 (USD Million)
- 4.5.2. CT Scans
- 4.5.2.1. Market estimates and forecasts 2018 to 2030 (USD Million)
- 4.5.3. MRI
- 4.5.3.1. Market estimates and forecasts 2018 to 2030 (USD Million)
- 4.5.4. Endoscopic Ultrasound for Pancreatic Function Tests
- 4.5.4.1. Market estimates and forecasts 2018 to 2030 (USD Million)
Chapter 5. U.S. Exocrine Pancreatic Insufficiency Diagnostics Market: End-use Estimates & Trend Analysis
- 5.1. U.S. Exocrine Pancreatic Insufficiency Diagnostics Market: End-use Segment Dashboard
- 5.2. U.S. Exocrine Pancreatic Insufficiency Diagnostics Market: End-use Movement Analysis
- 5.3. U.S. Exocrine Pancreatic Insufficiency Diagnostics Market Size & Trend Analysis, by End-use, 2018 to 2030 (USD Million)
- 5.4. Hospitals & Clinics
- 5.4.1. Market estimates and forecasts 2018 to 2030 (USD Million)
- 5.5. Diagnostic Laboratories
- 5.5.1. Market estimates and forecasts 2018 to 2030 (USD Million)
- 5.6. Research Institutes
- 5.6.1. Market estimates and forecasts 2018 to 2030 (USD Million)
Chapter 6. Competitive Landscape
- 6.1. Participant Categorization
- 6.2. Participant Overview
- 6.3. Financial Performance
- 6.4. Product Benchmarking
- 6.5. Heat Map Analysis
- 6.6. Vendor Landscape
- 6.6.1. List of key distributors and channel partners
- 6.6.2. Consumer behavior analysis
- 6.6.3. ChiRhoClin
- 6.6.3.1. Company overview
- 6.6.3.2. Financial performance
- 6.6.3.3. Product benchmarking
- 6.6.3.4. Strategic initiatives
- 6.6.4. Certest Biotec.
- 6.6.4.1. Company overview
- 6.6.4.2. Financial performance
- 6.6.4.3. Product benchmarking
- 6.6.4.4. Strategic initiatives
- 6.6.5. ScheBo Biotech AG
- 6.6.5.1. Company overview
- 6.6.5.2. Financial performance
- 6.6.5.3. Product benchmarking
- 6.6.5.4. Strategic initiatives
- 6.6.6. Immundiagnostik AG
- 6.6.6.1. Company overview
- 6.6.6.2. Financial performance
- 6.6.6.3. Product benchmarking
- 6.6.6.4. Strategic initiatives
- 6.6.7. Laboratory Corporation of America Holdings
- 6.6.7.1. Company overview
- 6.6.7.2. Financial performance
- 6.6.7.3. Product benchmarking
- 6.6.7.4. Strategic initiatives
- 6.6.8. Boster Biological Technology
- 6.6.8.1. Company overview
- 6.6.8.2. Financial performance
- 6.6.8.3. Product benchmarking
- 6.6.8.4. Strategic initiatives
- 6.6.9. ALPCO Diagnostics
- 6.6.9.1. Company overview
- 6.6.9.2. Financial performance
- 6.6.9.3. Product benchmarking
- 6.6.9.4. Strategic initiatives
- 6.6.10. Quest Diagnostics Incorporated
- 6.6.10.1. Company overview
- 6.6.10.2. Financial performance
- 6.6.10.3. Product benchmarking
- 6.6.10.4. Strategic initiatives
- 6.6.11. DiaSorin S.p.A.
- 6.6.11.1. Company overview
- 6.6.11.2. Financial performance
- 6.6.11.3. Product benchmarking
- 6.6.11.4. Strategic initiatives
- 6.6.12. ARUP Laboratories
- 6.6.12.1. Company overview
- 6.6.12.2. Financial performance
- 6.6.12.3. Product benchmarking
- 6.6.12.4. Strategic initiatives
- 6.6.13. Alpha Laboratories
- 6.6.13.1. Company overview
- 6.6.13.2. Financial performance
- 6.6.13.3. Product benchmarking
- 6.6.13.4. Strategic initiatives
- 6.6.14. Verisana Laboratories
- 6.6.14.1. Company overview
- 6.6.14.2. Financial performance
- 6.6.14.3. Product benchmarking
- 6.6.14.4. Strategic initiatives