GVR Report cover U.S. Anal Fistula Repair Procedures: Epidemiology, Utilization & Reimbursement Trends, 2021 - 2025Report

U.S. Anal Fistula Repair Procedures: Epidemiology, Utilization & Reimbursement Trends, 2021 - 2025

Report Overview

The U.S. anal fistula repair procedures market size was estimated at USD 173.4 million in 2025. Comprehensive insurance coverage and well-established colorectal care infrastructure in the U.S. improve patient access to advanced anal fistula repair procedures, thus supporting higher procedure volumes. Moreover, increasing use of minimally invasive procedures is improving clinical outcomes, reducing postoperative complications, and driving the demand for advanced anal fistula repair procedures. Crohn's disease is one of the leading causes of complex anal fistulas, as chronic inflammation penetrates the intestinal wall, forming abnormal tracts around the anal canal. According to data published in August 2025 by MyCrohnsandColitisTeam, citing the Crohn's & Colitis Foundation, nearly 1 in 100 people in the U.S. live with Crohn's disease, indicating a large patient population at risk of developing perianal fistulas that often require surgical intervention.

The U.S. anorectal fistula epidemiology model estimates the annual incidence and overall prevalence of the condition over 2021-2025, using a population-based approach incorporating demographic, clinical, and disease-specific evidence. The analysis further distinguishes patients by underlying etiology, particularly Crohn’s disease-associated fistula and cryptoglandular/non-Crohn’s fistula, to provide a clearer view of the addressable patient population and associated treatment pathways.

The table below presents the estimated U.S. anorectal fistula incidence and prevalence from 2021 to 2025, highlighting the annual new patient pool and the broader prevalent population.

 

2021

2022

2023

2024

2025

Incidence

27,846

 

Prevalence

55,691

Source: FDA, CMS, U.S. Census Bureau, ASCRS, NCBI, PMC, KFF, Investor Presentations, Primary Interviews, Grand View Research

CPT Volume Analysis - Total Procedure Counts

The analysis provides a five-year view of procedure activity across fistula-related CPT codes, with individual procedure volumes consolidated to determine the overall market activity. Tracking these volumes over time helps identify changes in procedure demand and the relative importance of each CPT code within the broader fistula repair procedure landscape.

The table below presents the annual volume of procedures across the selected CPT codes from 2021 to 2025, highlighting changes in overall procedure utilization.

CPT Code

2021

2022

2023

2024

2025

46280

13,758

 

 

 

 

46275

 

46288

46706

46707

Total

Source: Investor Presentations, Primary Interviews, Grand View Research

Crohn's-Associated Vs. Non-Crohn’s Procedure Volume Per CPT Code, 2021-2025

The analysis separates procedure activity based on the underlying association with Crohn's disease, providing insight into how much of the fistula repair volume is attributable to Crohn's-associated cases. This distinction is particularly relevant for assessing disease-driven procedure demand and understanding the composition of the overall fistula repair procedure pool.

The table below compares Crohn's-associated and non-Crohn's procedure volumes across the selected CPT codes from 2021 to 2025.

CPT Code

2021

2022

2023

2024

2025

46280

1,361

 

 

 

 

46275

 

46288

46706

46707

Total

Source: Investor Presentations, Primary Interviews, Grand View Research

Geographic Distribution of Procedures, 2021 - 2025

The geographic analysis helps identify states with comparatively high concentrations of fistula repair procedures and provides a basis for evaluating regional differences in procedure utilization. Examining annual volumes also highlights whether leading states have maintained, increased, or reduced their contribution to overall procedure activity during the historical period.

The table below ranks the top 10 U.S. states by total fistula repair procedure volume from 2021 to 2025, illustrating the geographic concentration of procedures.

State

2021

2022

2023

2024

2025

California

2,847

 

 

 

 

Texas

 

Florida

New York

Pennsylvania

North Carolina

Georgia

Illinois

Ohio

Michigan

Total

Source: Investor Presentations, Primary Interviews, Grand View Research

Site of Service Analysis, 2021 - 2025

The site-of-service analysis provides insight into where fistula repair procedures are performed across the U.S. healthcare system. Comparing volumes across ASCs, hospital outpatient departments, non-facility settings, and inpatient facilities helps assess the degree of outpatient versus hospital-based utilization and identify the settings that account for the largest share of procedures.

The table below analyzes fistula repair procedure volumes by site of service from 2021 to 2025, covering ASCs, HOPDs, private offices, and inpatient settings.

Site of Service

2021

2022

2023

2024

2025

ASC

10,087

 

 

 

 

HOPD

 

Non-Facility (Private office)

Inpatient

Total

Source: Investor Presentations, Primary Interviews, Grand View Research

Site of Service Split by CPT Code, 2021-2025

The analysis provides a more granular view of procedure location by linking individual CPT codes with their respective sites of service. This enables identification of CPT codes that are more frequently performed in ambulatory settings versus hospital-based environments and helps explain differences in procedure utilization patterns.

The table below presents the distribution of procedures across ASCs, HOPDs, private offices, and inpatient settings for the selected CPT codes from 2021 to 2025.

Site of Service

2021

2022

2023

2024

2025

ASC

6,201

 

 

 

 

HOPD

 

Non-Facility (Private office)

Inpatient

Total

Source: Investor Presentations, Primary Interviews, Grand View Research

Site of Service Distribution by Geography, 2021-2025

The regional analysis combines geographic and site-of-service perspectives to evaluate differences in procedure concentration across major U.S. regions. Variations in regional procedure volumes may reflect differences in population size, disease prevalence, healthcare infrastructure, specialist availability, and the availability of ambulatory and hospital-based treatment facilities.

The table below compares fistula repair procedure volumes across the South, West, Northeast, and Midwest regions from 2021 to 2025.

Region

2021

2022

2023

2024

2025

South

3,997

 

 

 

 

West

 

Northeast

Midwest

Total

Source: Investor Presentations, Primary Interviews, Grand View Research

Allowed Amounts & Reimbursement Analysis, 2025

The allowed-amount analysis provides a national reimbursement benchmark for the selected CPT codes. Differences in average allowed amounts reflect variations in procedural complexity, physician and facility resource requirements, and the underlying reimbursement structure associated with each type of fistula repair procedure.

The table below presents the national average allowed amount for each selected fistula repair CPT code in 2025, providing a benchmark for procedure-level reimbursement.

CPT

National Average Allowed Amount per CPT Code (USD)

46280

3,455

46275

 

46288

46706

46707

Source: Investor Presentations, Primary Interviews, Grand View Research

Allowed Amounts by Payer Type

Payer-level reimbursement analysis is useful for understanding how payment rates vary according to insurance coverage and reimbursement arrangements. Comparing commercial and government-sponsored payment categories provides a clearer view of the reimbursement environment and the potential impact of payer mix on procedure-level revenue.

The table below compares allowed amounts for selected fistula repair CPT codes across Commercial, Medicare FFS, Medicare Advantage/TPT, Medicaid, and self-pay/other payer categories.

CPT Code

Procedure

Commercial

Medicare FFS

Medicare Advantage / TPT

Medicaid

Self-Pay / Other

46280

Fistulotomy / complex fistulotomy

4,817

 

 

 

 

46275

 

46288

46706

46707

Source: Secondary Analysis, Primary Analysis, Grand View Research.

Payer Mix Analysis - Commercial vs. Medicare / TPT, 2025

The payer mix analysis evaluates the distribution of fistula repair procedures according to the source of payment. Understanding the relative contribution of commercial and government-sponsored payers, as well as self-pay and other sources, helps assess the underlying reimbursement landscape and the exposure of procedure volumes to changes in healthcare coverage patterns.

The table below presents the estimated 2025 fistula repair procedure volume by payer type, including Commercial, Medicare FFS, Medicare Advantage/TPT, Medicaid, and self-pay/other.

Payer

Estimated Procedure Volume, 2025

Commercial

13,879

Medicare FFS

 

Medicare Advantage / TPT

Medicaid

Self-pay / Other

Total

Source: Secondary Analysis, Primary Analysis, Grand View Research.

The CPT-level payer mix provides a more detailed assessment of how insurance coverage varies across individual procedures. Comparing commercial, Medicare, Medicaid, Medicare Advantage/TPT, and self-pay/other shares help identify differences in patient populations and reimbursement exposure across the selected fistula repair procedures.

The table below presents the percentage distribution of procedure volumes by payer type for each selected CPT code in 2025.

CPT Code

Commercial

Medicare FFS

Medicare Adv / TPT

Medicaid

Self-Pay / Other

46280

7,991

 

 

 

 

46275

 

46288

46706

46707

Source: Secondary Analysis, Primary Analysis, Grand View Research.

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