조제 약국 : 시장 점유율 분석, 업계 동향 및 통계, 성장 예측(2026-2031년)

According to Mordor Intelligence, the compounding pharmacy market size is expected to grow from USD 15.83 billion in 2025 to USD 16.78 billion in 2026 and is forecast to reach USD 22.08 billion by 2031 at 5.68% CAGR over 2026-2031.

This report is Segmented by Route of Administration (Oral, Topical, and More), Therapeutic Area (Pain Management, Hormone Replacement Therapy, and More), Sterility (Sterile, Non-Sterile), Age Group (Adult, Geriatric, Pediatric), End User (Hospitals & Clinics, and More), and Geography (North America, Europe, Asia-Pacific, MEA, South America). Market Forecasts are Provided in Terms of Value (USD).

Global Compounding Pharmacy Market Trends and Insights

Rising Drug-Shortage Frequency

The FDA reported 113 active shortages in 2024, with 15 new listings despite 283 averts, underscoring the structural fragility of the supply chain. Hospitals responded by pre-stocking compounded substitutes for oncology analgesics, anesthetics, and parenteral nutrition, transforming 503B partners into critical infrastructure. Longer shortage durations often stretching 18-24 months have spurred multi-hundred-million-dollar investments by manufacturers that now seek end-to-end control of both commercial and compounded output. These dynamics anchor a positive feedback loop for the compounding pharmacy market, where rising baseline demand sustains factory-scale sterile capacity and continuous quality upgrades.

Large-Scale Compounding of GLP-1 Agonists Amid Obesity-Drug Gaps

When commercial supplies of semaglutide and tirzepatide tightened in 2024, compounders filled the vacuum under drug-shortage exemptions, scaling robotic filling lines that later repurposed to other injectables once enforcement resumed. Although revenue from GLP-1 copies is receding, the episode validated the sector's agility, prompting payers and integrated delivery networks to view compounders as rapid-response buffers for future blockbuster gaps. The equipment and quality-system upgrades implemented during the GLP-1 surge now enhance throughput for oncology biologics and critical-care infusions, reinforcing long-term growth prospects for the compounding pharmacy market.

Escalating FDA & USP Compliance Costs

Revised USP 797 and 800 rules, effective 2024, forced upgrades to ISO-classified cleanrooms, environmental monitoring, and staff training, raising capital thresholds well beyond the reach of many independents. Fresenius Kabi invested USD 90 million in Wilson, North Carolina, and B. Braun allotted USD 70 million to its Pennsylvania plant to stay compliant. Heightened FDA inspection cadence, quarterly for 503B sites, adds further operating expense. While patient safety improves, a shrinking number of suppliers risks deepening shortages and dampening growth momentum for the compounding pharmacy market.

Other drivers and restraints analyzed in the detailed report include:

1. Growing Demand for Personalized Doses & Dosage Forms
2. Expansion of 503B Outsourcing Facilities for Hospital Supply
3. Rising Insurer Refusal to Reimburse Compounded Prescriptions

For complete list of drivers and restraints, kindly check the Table Of Contents.

Segment Analysis

The oral formulation segment accounted for 38.81% of the compounding pharmacy market size in 2025, reflecting its primacy in inpatient oncology, ICU, and surgical support. Hospital outsourcing to 503B partners, coupled with the widespread adoption of automated compounding devices, drives a 7.38% forecast CAGR for parenteral preparations. Oral formats retain leadership in chronic outpatient therapy but face slower 4% growth trajectories as commercial producers broaden their dose-strength lines. Demand for nasal sprays and sublingual troches is increasing in applications related to allergies and hormonal disorders. Yet, parenteral gains illustrate how sterility and precision tilt revenue toward high-complexity service providers within the compounding pharmacy market.

The American Society for Parenteral and Enteral Nutrition attributes lower sepsis rates to the use of closed-system parenteral nutrition, reinforcing the clinical preference for outsourced admixtures. Pediatric hospitals use flavored oral suspensions to enhance adherence, while veterinary prescribers choose transdermal gels to improve feline compliance. Nonetheless, capital-intensive parenteral workflows concentrate volume among fewer players, raising barriers for new entrants and cementing the segment's influence over overall compounding pharmacy market share.

Pain management generated 31.23% of 2025 revenue, banking on compounded topical analgesics that blend NSAIDs with anesthetics for opioid-averse patients. However, hormone replacement therapy is poised to deliver the fastest 7.86% CAGR, buoyed by the FDA's label revision that removed boxed warnings and normalized customized estrogen-progesterone regimens. Canadian data cite 92 recorded hormone shortages since 2017, underscoring a chronic supply imbalance that funnels patients to compounders.

Dermatology follows close behind, driven by compounding's ability to formulate patient-specific corticosteroid strengths and hydroquinone combinations. Oncology admixtures represent a lower-volume but higher-margin niche abetted by robotic aseptic lines. Pediatric and veterinary care is tailored via weight-based dosing and flavor customization, while nutritional supplements for metabolic disorders carve out a small but defensible niche within the compounding pharmacy industry.

Complete Report Scope:

• By Route of Administration
  • Oral
    • Capsules
    • Tablets
    • Granules / Powder
    • Syrups & Suspensions
  • Topical
    • Creams & Ointments
    • Gels
    • Lotions
    • Pastes
  • Parenteral
    • Small-Volume Parenteral
    • Large-Volume Parenteral
    • Prefilled Syringes
    • Ophthalmic Injectables
  • Nasal
    • Sprays
    • Drops
  • Other Route of Administration
• By Therapeutic Area
  • Pain Management
  • Hormone Replacement Therapy (HRT)
  • Dermal Disorders / Dermatology
  • Nutritional Supplements
  • Oncology / Specialty Drugs
  • Pediatrics
  • Veterinary
  • Others
• By Sterility
  • Sterile
    • High-Risk Sterile
    • Medium-Risk Sterile
    • Low-Risk Sterile
  • Non-Sterile
    • Hazardous Non-Sterile
    • Non-Hazardous Non-Sterile
• By Age Group
  • Adult
  • Geriatric
  • Pediatric
• By End User
  • Hospitals & Clinics
  • Specialty Clinics
  • Retail / Community Dispensing
  • Other End Users
• By Geography
  • North America
    • United States
    • Canada
    • Mexico
  • Europe
    • Germany
    • United Kingdom
    • France
    • Italy
    • Spain
    • Rest of Europe
  • Asia-Pacific
    • China
    • Japan
    • India
    • Australia
    • South Korea
    • Rest of Asia-Pacific
  • Middle East & Africa
    • GCC
    • South Africa
    • Rest of Middle East & Africa
  • South America
    • Brazil
    • Argentina
    • Rest of South America

Geography Analysis

North America maintained 37.44% of 2025 revenue, fortified by the United States' extensive 503B network, Canada's hormone shortages, and Mexico's maturing API hubs. Baxter's acquisition of PharMEDium, Fagron's investment in Wichita, and Nephron's 1 billion-unit South Carolina megasite exemplify the capital consolidation redefining regional competitive dynamics. Canada's shortage database logged two-digit annual deficits in hormone products, prolonging reliance on compounders for menopausal care. Mexico's lower-cost API exports support North American finished-dose plants, though U.S. import scrutiny keeps value capture stateside.

Asia-Pacific presents the fastest 9.26% CAGR, propelled by China's regulatory modernization, India's API dominance, and Japan's super-aged demographics craving dose customization. Australia's private insurers fund compounded bioidentical hormones under strict quality frameworks, while China's National Medical Products Administration tightens GMP parity, raising entry barriers yet boosting trust in domestic compounders. India's export restrictions on certain oncology agents temporarily squeeze global supply, revealing interdependence between regional API flows and worldwide compounding capacity.

Europe's mosaic of country-specific rules complicates scaling but rewards knowledgeable incumbents. Germany's historic Apotheke culture supports independent compounding, whereas the UK's National Health Service bundles demand through centralized tenders. EMA's Annex 1 revision elevates sterility protocols, nudging smaller hospital units toward outsourcing. The Middle East and Africa remain exploratory but attractive as Gulf Cooperation Council states embed pharmaceutical self-sufficiency goals in national plans. South American growth is steady, led by Brazil's chronic-disease burden and Argentina's favorable currency dynamics, although reimbursement inconsistencies still cap uptake compared to the compounding pharmacy market leaders.

1. Avella Specialty Pharmacy
2. B. Braun
3. Baxter
4. CAPS (Central Admixture)
5. Dougherty's Pharmacy
6. Empower Pharmacy
7. Fagron
8. Fresenius
9. Leiters Health
10. Nephron Pharmaceuticals
11. Olympia Pharmacy
12. Pencol Compounding
13. PharMEDium Services
14. QuVa Pharma
15. Rx3 Compounding
16. SCA Pharma
17. Triangle Compounding
18. US Compounding Inc.
19. Vertisis Custom Pharmacy
20. Wedgewood Pharmacy

Additional Benefits:

• The market estimate (ME) sheet in Excel format
• 3 months of analyst support

TABLE OF CONTENTS

1 Introduction

• 1.1 Study Assumptions & Market Definition
• 1.2 Scope of the Study

2 Research Methodology

3 Executive Summary

4 Market Landscape

• 4.1 Market Overview
• 4.2 Market Drivers
  • 4.2.1 Rising Drug-Shortage Frequency
  • 4.2.2 Growing Demand for Personalized Doses & Dosage Forms
  • 4.2.3 Expansion of 503B Outsourcing Facilities for Hospital Supply
  • 4.2.4 Uptake of Sterile Automated Compounding Technologies
  • 4.2.5 Consumer-Led Bio-Identical Hormone Therapy Boom
  • 4.2.6 Large-Scale Compounding of GLP-1 Agonists Amid Obesity-Drug Gaps
• 4.3 Market Restraints
  • 4.3.1 Escalating FDA & USP Compliance Costs
  • 4.3.2 PBM Steering Limiting Independent Pharmacy Access
  • 4.3.3 API Supply Bottlenecks for Specialty Actives
  • 4.3.4 Rising Insurer Refusal to Reimburse Compounded Prescriptions
• 4.4 Value / Supply-Chain Analysis
• 4.5 Regulatory Landscape
• 4.6 Technological Outlook
• 4.7 Porter's Five Forces Analysis
  • 4.7.1 Threat of New Entrants
  • 4.7.2 Bargaining Power of Buyers
  • 4.7.3 Bargaining Power of Suppliers
  • 4.7.4 Threat of Substitutes
  • 4.7.5 Competitive Rivalry

5 Market Size & Growth Forecasts

• 5.1 By Route of Administration
  • 5.1.1 Oral
    • 5.1.1.1 Capsules
    • 5.1.1.2 Tablets
    • 5.1.1.3 Granules / Powder
    • 5.1.1.4 Syrups & Suspensions
  • 5.1.2 Topical
    • 5.1.2.1 Creams & Ointments
    • 5.1.2.2 Gels
    • 5.1.2.3 Lotions
    • 5.1.2.4 Pastes
  • 5.1.3 Parenteral
    • 5.1.3.1 Small-Volume Parenteral
    • 5.1.3.2 Large-Volume Parenteral
    • 5.1.3.3 Prefilled Syringes
    • 5.1.3.4 Ophthalmic Injectables
  • 5.1.4 Nasal
    • 5.1.4.1 Sprays
    • 5.1.4.2 Drops
  • 5.1.5 Other Route of Administration
• 5.2 By Therapeutic Area
  • 5.2.1 Pain Management
  • 5.2.2 Hormone Replacement Therapy (HRT)
  • 5.2.3 Dermal Disorders / Dermatology
  • 5.2.4 Nutritional Supplements
  • 5.2.5 Oncology / Specialty Drugs
  • 5.2.6 Pediatrics
  • 5.2.7 Veterinary
  • 5.2.8 Others
• 5.3 By Sterility
  • 5.3.1 Sterile
    • 5.3.1.1 High-Risk Sterile
    • 5.3.1.2 Medium-Risk Sterile
    • 5.3.1.3 Low-Risk Sterile
  • 5.3.2 Non-Sterile
    • 5.3.2.1 Hazardous Non-Sterile
    • 5.3.2.2 Non-Hazardous Non-Sterile
• 5.4 By Age Group
  • 5.4.1 Adult
  • 5.4.2 Geriatric
  • 5.4.3 Pediatric
• 5.5 By End User
  • 5.5.1 Hospitals & Clinics
  • 5.5.2 Specialty Clinics
  • 5.5.3 Retail / Community Dispensing
  • 5.5.4 Other End Users
• 5.6 By Geography
  • 5.6.1 North America
    • 5.6.1.1 United States
    • 5.6.1.2 Canada
    • 5.6.1.3 Mexico
  • 5.6.2 Europe
    • 5.6.2.1 Germany
    • 5.6.2.2 United Kingdom
    • 5.6.2.3 France
    • 5.6.2.4 Italy
    • 5.6.2.5 Spain
    • 5.6.2.6 Rest of Europe
  • 5.6.3 Asia-Pacific
    • 5.6.3.1 China
    • 5.6.3.2 Japan
    • 5.6.3.3 India
    • 5.6.3.4 Australia
    • 5.6.3.5 South Korea
    • 5.6.3.6 Rest of Asia-Pacific
  • 5.6.4 Middle East & Africa
    • 5.6.4.1 GCC
    • 5.6.4.2 South Africa
    • 5.6.4.3 Rest of Middle East & Africa
  • 5.6.5 South America
    • 5.6.5.1 Brazil
    • 5.6.5.2 Argentina
    • 5.6.5.3 Rest of South America

6 Competitive Landscape

• 6.1 Market Concentration
• 6.2 Market Share Analysis
• 6.3 Company Profiles (includes Global level Overview, Market level overview, Core Segments, Financials as available, Strategic Information, Market Rank/Share for key companies, Products & Services, and Recent Developments)
  • 6.3.1 Avella Specialty Pharmacy
  • 6.3.2 B. Braun SE
  • 6.3.3 Baxter International Inc.
  • 6.3.4 CAPS (Central Admixture)
  • 6.3.5 Dougherty's Pharmacy
  • 6.3.6 Empower Pharmacy
  • 6.3.7 Fagron NV
  • 6.3.8 Fresenius Kabi AG
  • 6.3.9 Leiters Health
  • 6.3.10 Nephron Pharmaceuticals
  • 6.3.11 Olympia Pharmacy
  • 6.3.12 Pencol Compounding
  • 6.3.13 PharMEDium Services
  • 6.3.14 QuVa Pharma
  • 6.3.15 Rx3 Compounding
  • 6.3.16 SCA Pharma
  • 6.3.17 Triangle Compounding
  • 6.3.18 US Compounding Inc.
  • 6.3.19 Vertisis Custom Pharmacy
  • 6.3.20 Wedgewood Pharmacy

7 Market Opportunities & Future Outlook

• 7.1 White-Space & Unmet-Need Assessment