췌외분비기능 부전 진단 시장 규모, 점유율, 동향 분석 리포트 : 진단 방법별, 최종 용도별, 지역별, 부문별 예측(2024-2030년)

Exocrine Pancreatic Insufficiency Diagnostics Market Growth & Trends:

The global exocrine pancreatic insufficiency diagnostics market size is anticipated to reach USD 5.44 billion by 2030 and is growing at a CAGR of 7.2% from 2024 to 2030, according to a new report by Grand View Research, Inc. Exocrine pancreatic insufficiency (EPI) diagnostics are crucial for identifying and managing the condition, especially considering its high prevalence in various patient populations and its association with several underlying causes. One of the major driving factors for diagnostics is the prevalence of patients with chronic pancreatitis. Studies have shown that EPI is prevalent in about 60% to 90% of patients diagnosed with chronic pancreatitis within 10 to 12 years of diagnosis. Chronic pancreatitis is a significant contributor to EPI, and its relatively high prevalence underscores the importance of early detection and management.

Furthermore, advanced pancreatic cancer is another condition strongly associated with the disease. Research indicates that between 66% to 92% of patients with advanced pancreatic cancer develop EPI. Early diagnosis of EPI in these patients can lead to better management of symptoms and improved quality of life. Inflammatory bowel disease (IBD) is also linked to EPI, with studies suggesting that between 14% and 74% of IBD patients may suffer from EPI. Timely diagnosis and treatment of exocrine pancreatic insufficiency in these patients can help alleviate symptoms and improve nutritional status.

In addition, patients undergoing bariatric surgery are at risk of developing EPI despite receiving enzymatic and nutritional supplements. This highlights the importance of ongoing monitoring and diagnostic testing to identify exocrine pancreatic insufficiency in this patient population. Moreover, the prevalence of EPI in patients with HIV/AIDS is estimated to be between 26% and 45%. Early detection of exocrine pancreatic insufficiency in these individuals is essential for optimizing nutritional status and overall health outcomes.

The diverse range of conditions associated with EPI underscores the need for comprehensive diagnostic approaches. Factors driving the demand for exocrine pancreatic insufficiency diagnostics include high prevalence in various patient populations, the association with chronic conditions such as chronic pancreatitis and pancreatic cancer, and the importance of early detection for effective management and improved patient outcomes. As diagnostic technologies advance, early detection and personalized management will become increasingly feasible, leading to better patient care and outcomes.

Key market players such as ChiRhoClin, Inc., Certest Biotec, ScheBo Biotech AG, Immundiagnostik AG, and Laboratory Corporation of America Holdings are at the forefront of innovation in exocrine pancreatic insufficiency diagnostics. These companies are constantly focusing on expanding their products. For instance, in June 2021, CERTEST BIOTEC announced to participate and showcase its product with latest developments at 71st Annual Scientific Meeting and Exhibition of Clinical Laboratories of the AACC held from August 4 to 8 in California.

Exocrine Pancreatic Insufficiency Diagnostics Market Report Highlights:

• Based on diagnostic method, the laboratory tests segment dominated the overall market with the highest revenue share in 2023. This can be attributed to the extensive advancements such as automation in the laboratory, disposable kits, sample collections & storage, and assays
• Growing R&D in EPI diagnostics is projected to propel market growth over the forecast period
• The introduction of new techniques and assays and the integration of established technologies signifies a significant step forward in diagnostics. As awareness about pancreatic disorders continues to grow, fueled by advancements in diagnostic technologies, the U.S. market for stool tests in EPI diagnostics is poised for continued expansion in the coming years
• The hospitals and clinics end-use segment dominated the market in 2023, driven by several factors. Increased awareness among healthcare professionals and patients about symptoms and risk factors has led to higher diagnosis rates in these settings. Accessibility of diagnostic services in hospitals and clinics facilitates widespread screening and testing for exocrine pancreatic insufficiency, and advancements in diagnostic technologies enhance the accuracy and efficiency of EPI detection, further driving growth in this segment
• North America dominated the market owing to factors such as advanced healthcare infrastructure, rising prevalence of target diseases, and favorable regulatory environment

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. Regional scope
  • 1.2.4. 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
  • 1.4.5. Details of primary research
    • 1.4.5.1. Data for primary interviews in North America
    • 1.4.5.2. Data for primary interviews in Europe
    • 1.4.5.3. Data for primary interviews in Asia Pacific
    • 1.4.5.4. Data for primary interviews in Latin America
    • 1.4.5.5. Data for Primary interviews in MEA
• 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
  • 2.2.3. Regional Outlook
• 2.3. Competitive Insights

Chapter 3. 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 disease awareness
    • 3.2.1.2. Focus on early detection
    • 3.2.1.3. Increasing cases of exocrine pancreatic insufficiency
  • 3.2.2. Market Restraint Analysis
    • 3.2.2.1. Regulatory hurdles and compliance requirements
    • 3.2.2.2. Underdiagnosis and misdiagnosis
• 3.3. 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
  • 3.3.3. Pricing Analysis
  • 3.3.4. Volume Analysis (Laboratory-based Testing Devices)

Chapter 4. Exocrine Pancreatic Insufficiency Diagnostics Market: Diagnostic Method Estimates & Trend Analysis

• 4.1. Segment Dashboard
• 4.2. Global Exocrine Pancreatic Insufficiency Diagnostics Market Movement Analysis
• 4.3. Global Exocrine Pancreatic Insufficiency Diagnostics Market by Diagnostic Method Outlook
• 4.4. Laboratory Tests
  • 4.4.1. Laboratory tests market estimates and forecasts 2018 - 2030 (USD Million)
  • 4.4.2. Indirect Pancreatic Function Tests
    • 4.4.2.1. Market estimates and forecasts 2018 - 2030 (USD Million)
    • 4.4.2.2. Stool Tests
    • 4.4.2.2.1. Market estimates and forecasts 2018 - 2030 (USD Million)
    • 4.4.2.3. Blood Tests
    • 4.4.2.3.1. Market estimates and forecasts 2018 - 2030 (USD Million)
  • 4.4.3. Other Tests
    • 4.4.3.1. Market estimates and forecasts 2018 - 2030 (USD Million)
• 4.5. Imaging Tests
  • 4.5.1. Imaging tests market estimates and forecasts 2018 - 2030 (USD Million)
  • 4.5.2. CT scans
    • 4.5.2.1. Market estimates and forecasts 2018 - 2030 (USD Million)
  • 4.5.3. MRI
    • 4.5.3.1. Market estimates and forecasts 2018 - 2030 (USD Million)
  • 4.5.4. Endoscopic Ultrasound for pancreatic function tests
    • 4.5.4.1. Market estimates and forecasts 2018 - 2030 (USD Million)

Chapter 5. Exocrine Pancreatic Insufficiency Diagnostics Market: End-use Estimates & Trend Analysis

• 5.1. Segment Dashboard
• 5.2. Global Exocrine Pancreatic Insufficiency Diagnostics Market Movement Analysis
• 5.3. Global Exocrine Pancreatic Insufficiency Diagnostics Market by End-use Outlook
• 5.4. Hospitals & Clinics
  • 5.4.1. Hospitals & Clinics market estimates and forecasts 2018 - 2030 (USD Million)
• 5.5. Diagnostic Laboratories
  • 5.5.1. Diagnostic laboratories market estimates and forecasts 2018 - 2030 (USD Million)
• 5.6. Research Institutes
  • 5.6.1. Research Institutes market estimates and forecasts 2018 - 2030 (USD Million)

Chapter 6. Exocrine Pancreatic Insufficiency Diagnostics Market: Regional Estimates & Trend Analysis by Diagnostic Method, and End-use

• 6.1. Regional Dashboard
• 6.2. Market Size, & Forecasts Trend Analysis, 2018 to 2030:
• 6.3. North America
  • 6.3.1. U.S.
    • 6.3.1.1. Key country dynamics
    • 6.3.1.2. Regulatory framework/ reimbursement structure
    • 6.3.1.3. Competitive scenario
    • 6.3.1.4. U.S. market estimates and forecasts 2018 - 2030 (USD Million)
  • 6.3.2. Canada
    • 6.3.2.1. Key country dynamics
    • 6.3.2.2. Regulatory framework/ reimbursement structure
    • 6.3.2.3. Competitive scenario
    • 6.3.2.4. Canada market estimates and forecasts 2018 - 2030 (USD Million)
• 6.4. Europe
  • 6.4.1. UK
    • 6.4.1.1. Key country dynamics
    • 6.4.1.2. Regulatory framework/ reimbursement structure
    • 6.4.1.3. Competitive scenario
    • 6.4.1.4. UK market estimates and forecasts 2018 - 2030 (USD Million)
  • 6.4.2. Germany
    • 6.4.2.1. Key country dynamics
    • 6.4.2.2. Regulatory framework/ reimbursement structure
    • 6.4.2.3. Competitive scenario
    • 6.4.2.4. Germany market estimates and forecasts 2018 - 2030 (USD Million)
  • 6.4.3. France
    • 6.4.3.1. Key country dynamics
    • 6.4.3.2. Regulatory framework/ reimbursement structure
    • 6.4.3.3. Competitive scenario
    • 6.4.3.4. France market estimates and forecasts 2018 - 2030 (USD Million)
  • 6.4.4. Italy
    • 6.4.4.1. Key country dynamics
    • 6.4.4.2. Regulatory framework/ reimbursement structure
    • 6.4.4.3. Competitive scenario
    • 6.4.4.4. Italy market estimates and forecasts 2018 - 2030 (USD Million)
  • 6.4.5. Spain
    • 6.4.5.1. Key country dynamics
    • 6.4.5.2. Regulatory framework/ reimbursement structure
    • 6.4.5.3. Competitive scenario
    • 6.4.5.4. Spain market estimates and forecasts 2018 - 2030 (USD Million)
  • 6.4.6. Denmark
    • 6.4.6.1. Key country dynamics
    • 6.4.6.2. Regulatory framework/ reimbursement structure
    • 6.4.6.3. Competitive scenario
    • 6.4.6.4. Denmark market estimates and forecasts 2018 - 2030 (USD Million)
  • 6.4.7. Sweden
    • 6.4.7.1. Key country dynamics
    • 6.4.7.2. Regulatory framework/ reimbursement structure
    • 6.4.7.3. Competitive scenario
    • 6.4.7.4. Sweden market estimates and forecasts 2018 - 2030 (USD Million)
  • 6.4.8. Norway
    • 6.4.8.1. Key country dynamics
    • 6.4.8.2. Regulatory framework/ reimbursement structure
    • 6.4.8.3. Competitive scenario
    • 6.4.8.4. Norway market estimates and forecasts 2018 - 2030 (USD Million)
• 6.5. Asia Pacific
  • 6.5.1. Japan
    • 6.5.1.1. Key country dynamics
    • 6.5.1.2. Regulatory framework/ reimbursement structure
    • 6.5.1.3. Competitive scenario
    • 6.5.1.4. Japan market estimates and forecasts 2018 - 2030 (USD Million)
  • 6.5.2. China
    • 6.5.2.1. Key country dynamics
    • 6.5.2.2. Regulatory framework/ reimbursement structure
    • 6.5.2.3. Competitive scenario
    • 6.5.2.4. China market estimates and forecasts 2018 - 2030 (USD Million)
  • 6.5.3. India
    • 6.5.3.1. Key country dynamics
    • 6.5.3.2. Regulatory framework/ reimbursement structure
    • 6.5.3.3. Competitive scenario
    • 6.5.3.4. India market estimates and forecasts 2018 - 2030 (USD Million)
  • 6.5.4. Australia
    • 6.5.4.1. Key country dynamics
    • 6.5.4.2. Regulatory framework/ reimbursement structure
    • 6.5.4.3. Competitive scenario
    • 6.5.4.4. Australia market estimates and forecasts 2018 - 2030 (USD Million)
  • 6.5.5. Thailand
    • 6.5.5.1. Key country dynamics
    • 6.5.5.2. Regulatory framework/ reimbursement structure
    • 6.5.5.3. Competitive scenario
    • 6.5.5.4. Thailand market estimates and forecasts 2018 - 2030 (USD Million)
  • 6.5.6. South Korea
    • 6.5.6.1. Key country dynamics
    • 6.5.6.2. Regulatory framework/ reimbursement structure
    • 6.5.6.3. Competitive scenario
    • 6.5.6.4. South Korea market estimates and forecasts 2018 - 2030 (USD Million)
• 6.6. Latin America
  • 6.6.1. Brazil
    • 6.6.1.1. Key country dynamics
    • 6.6.1.2. Regulatory framework/ reimbursement structure
    • 6.6.1.3. Competitive scenario
    • 6.6.1.4. Brazil market estimates and forecasts 2018 - 2030 (USD Million)
  • 6.6.2. Mexico
    • 6.6.2.1. Key country dynamics
    • 6.6.2.2. Regulatory framework/ reimbursement structure
    • 6.6.2.3. Competitive scenario
    • 6.6.2.4. Mexico market estimates and forecasts 2018 - 2030 (USD Million)
  • 6.6.3. Argentina
    • 6.6.3.1. Key country dynamics
    • 6.6.3.2. Regulatory framework/ reimbursement structure
    • 6.6.3.3. Competitive scenario
    • 6.6.3.4. Argentina market estimates and forecasts 2018 - 2030 (USD Million)
• 6.7. MEA
  • 6.7.1. South Africa
    • 6.7.1.1. Key country dynamics
    • 6.7.1.2. Regulatory framework/ reimbursement structure
    • 6.7.1.3. Competitive scenario
    • 6.7.1.4. South Africa market estimates and forecasts 2018 - 2030 (USD Million)
  • 6.7.2. Saudi Arabia
    • 6.7.2.1. Key country dynamics
    • 6.7.2.2. Regulatory framework/ reimbursement structure
    • 6.7.2.3. Competitive scenario
    • 6.7.2.4. Saudi Arabia market estimates and forecasts 2018 - 2030 (USD Million)
  • 6.7.3. UAE
    • 6.7.3.1. Key country dynamics
    • 6.7.3.2. Regulatory framework/ reimbursement structure
    • 6.7.3.3. Competitive scenario
    • 6.7.3.4. UAE market estimates and forecasts 2018 - 2030 (USD Million)
  • 6.7.4. Kuwait
    • 6.7.4.1. Key country dynamics
    • 6.7.4.2. Regulatory framework/ reimbursement structure
    • 6.7.4.3. Competitive scenario
    • 6.7.4.4. Kuwait market estimates and forecasts 2018 - 2030 (USD Million)

Chapter 7. Competitive Landscape

• 7.1. Recent Developments & Impact Analysis, By Key Market Participants
• 7.2. Company/Competition Categorization
• 7.3. Vendor Landscape
  • 7.3.1. List of key distributors and channel partners
  • 7.3.2. Key customers
  • 7.3.3. Key company market share analysis, 2023
  • 7.3.4. ChiRhoClin
    • 7.3.4.1. Company overview
    • 7.3.4.2. Financial performance
    • 7.3.4.3. Product benchmarking
    • 7.3.4.4. Strategic initiatives
  • 7.3.5. Certest Biotec
    • 7.3.5.1. Company overview
    • 7.3.5.2. Financial performance
    • 7.3.5.3. Product benchmarking
    • 7.3.5.4. Strategic initiatives
  • 7.3.6. ScheBo Biotech AG
    • 7.3.6.1. Company overview
    • 7.3.6.2. Financial performance
    • 7.3.6.3. Product benchmarking
    • 7.3.6.4. Strategic initiatives
  • 7.3.7. Immundiagnostik AG
    • 7.3.7.1. Company overview
    • 7.3.7.2. Financial performance
    • 7.3.7.3. Product benchmarking
    • 7.3.7.4. Strategic initiatives
  • 7.3.8. Laboratory Corporation of America Holdings
    • 7.3.8.1. Company overview
    • 7.3.8.2. Financial performance
    • 7.3.8.3. Product benchmarking
    • 7.3.8.4. Strategic initiatives
  • 7.3.9. Boster Biological Technology
    • 7.3.9.1. Company overview
    • 7.3.9.2. Financial performance
    • 7.3.9.3. Product benchmarking
    • 7.3.9.4. Strategic initiatives
  • 7.3.10. ALPCO Diagnostics
    • 7.3.10.1. Company overview
    • 7.3.10.2. Financial performance
    • 7.3.10.3. Product benchmarking
    • 7.3.10.4. Strategic initiatives
  • 7.3.11. Quest Diagnostics Incorporated
    • 7.3.11.1. Company overview
    • 7.3.11.2. Financial performance
    • 7.3.11.3. Product benchmarking
    • 7.3.11.4. Strategic initiatives
  • 7.3.12. DiaSorin S.p.A.
    • 7.3.12.1. Company overview
    • 7.3.12.2. Financial performance
    • 7.3.12.3. Product benchmarking
    • 7.3.12.4. Strategic initiatives
  • 7.3.13. ARUP Laboratories
    • 7.3.13.1. Company overview
    • 7.3.13.2. Financial performance
    • 7.3.13.3. Product benchmarking
    • 7.3.13.4. Strategic initiatives
  • 7.3.14. Verisana Laboratories
    • 7.3.14.1. Company overview
    • 7.3.14.2. Financial performance
    • 7.3.14.3. Product benchmarking
    • 7.3.14.4. Strategic initiatives
  • 7.3.15. Alpha Laboratories
    • 7.3.15.1. Company overview
    • 7.3.15.2. Financial performance
    • 7.3.15.3. Product benchmarking
    • 7.3.15.4. Strategic initiatives