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U.S. 503b Compounding Pharmacies Market By Molecule (Esmolol, Vancomycin, Epinephrine, Fentanyl/ Bupivacaine, Adenocaine, Morphine, Amiodarone, Bupivacaine, Lidocaine), and Other Molecules), By Packaging (Vials, Prefilled Syringes, Ampoules, Syringes, and Others) By Region – Growth, Share, Opportunities & Competitive Analysis, 2024 – 2032

Summary
Table Of Content

Key Highlights of the report

How are the major segments performing in the U.S. 503b compounding pharmacies market?

In 2022, the phenylephrine segment accounted for the largest market share as it is widely used to relieve nasal discomfort.
In 2022, the prefilled syringes segment was anticipated to hold a prominent share in the U.S. 503b compounding pharmacies market. Increasing demands for efficient, easy-to-use drug delivery devices and healthcare professionals’ efforts to reduce hospital errors.

What is the Market Size of U.S. 503b Compounding Pharmacies regarding value?

The U.S. 503b compounding pharmacies market is anticipated to grow at a substantial CAGR of 7.80% in the upcoming years. The U.S. 503b compounding pharmacies industry was estimated to be worth USD 1.1 billion in 2022 and was expected to be worth USD 1.9 billion by 2030.

How is US Market Performing in the 503b Compounding Pharmacies market?

In 2022, compounding pharmacies in the U.S. are seeing increased demand for pain management drugs. According to the National Health Interview Survey, in 2019, 50.2 million Americans (20.5%) reported chronic pain on most days. Knees, backs, feet, and hips are the most common areas of pain. Compounded medications are also a good method of relieving pain. Creams from compounded medications provide instant relief when applied directly to the affected area. Further, compounding pharmacies collaborate with healthcare providers to create customized pain management treatment options and dosages. Such scenarios are expected to drive market growth in the next few years.

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How is the economy impacting the U.S. 503b Compounding Pharmacies growth?

Pharmacy staff is struggling to fill the demand for medicines during times of covid-19 pandemic. Because of this, 503B outsourcing facilities are invaluable partners for hospitals and health systems in addressing drug scarcity and its impact on patients during this pandemic. According to the Drug Quality and Security Act, passed in 2013, 503B outsourcing facilities could compound nonsterile and sterile drug products in advance of their providers’ needs if they met certain standards established by the federal government. With the surge in demand for critical care medicines caused by the pandemic, 503B facilities can supply hospitals when commercial manufacturers cannot supply.

What is the competitive environment of the U.S. 503b Compounding Pharmacies market?

The U.S. 503b compounding pharmacies industry’s competitive environment provides information on the entire economic profit made by suppliers and businesses, the sales and revenues created in this sector, the U.S. 503b compounding pharmacies market share, the business organization summary, the introduction of new products, and the opportunities for the industrial U.S. 503b compounding pharmacies market. For instance, in January 2022, in the Nephron 503B Outsourcing Facility operation, Nephron Pharmaceuticals Corporation launched a new syringe presentation, the Cyclic Olefin Copolymer Syringe (COC). In addition to 8.4% sodium bicarbonate injection, the company will also introduce a COC syringe for this product. By pursuing this strategy, the company will be able to grow its product portfolio in compounding pharmacies. Furthermore, in May 2022, A 503B outsourcing facility and a state-licensed pharmacy were acquired by Edgewood Pharmacy through Zoo, Wildlife Specializations. This strategy increased the company’s product portfolio, accelerating its market growth.

Executive Summary

What are the key trends in the U.S. 503b Compounding Pharmacies market?

Over the forecast period, the U.S. 503B Compounding Pharmacies market is expected to grow due to an increased drug shortage. For example, the Drug Shortages Task Force of the U.S. Food and Drug Administration 2019 report titled ‘Drug Shortages: Root Causes and Potential Solutions’ explains that drug shortages are caused by a lack of incentives to produce less profitable drugs and logistical and regulatory obstacles. As stated in the report, hospitals must pay more for branded and alternative drugs when there is a shortage of low-cost generic drugs or obtain medications from compounding facilities. Therefore, such instances could contribute to the market’s growth in the near future.

How are Pharma Manufacturers Teaming Up with Stakeholders in U.S. 503b Compounding Pharmacies Market?

As geriatric patients suffering from chronic diseases demand more pain management therapies, the market is expected to grow over the forecast period. Chronic pain is a major concern among older adults suffering from chronic diseases, according to Progress in Neuro-Psychopharmacology and Biological Psychiatry Journal: 2019. CDC (The Centers for Disease Control and Prevention) reports that in 2018, the population aged 60 years and older had the highest number of pain management therapies prescribed. The market is projected to grow during the forecast period due to increasing product approvals and launches. For instance, in November 2020, Fagron Compounding Pharmacies launched new intravenous bags (IV bags) containing Fentanyl Hydromorphone and Midazolam. Furthermore, the company plans to add hormones, chemicals, and norepinephrine to its IV bag offerings. According to a the U.S. Food and Drug Administration (FDA), the U.S. has been suffering from a drug shortage for several years, and the outbreak of COVID-19 has made it worse. In addition to supply chain disruptions, manufacturing process delays and discontinuities, quality issues, and difficulties obtaining raw materials, shortages are often caused by supply chain disruptions. As a result of drug shortages, compounding pharmacies in the U.S. have gained additional opportunities. In addition, FDA has issued temporary guidance to federal facilities and state-licensed pharmacies, including hospital pharmacies and compounding pharmacies, that are not registered as outsourcing facilities with FDA. As a result of a shortage of drugs required for patient treatment, compounding certain medications for hospitalized patients was required during the public health emergency.

Which are the key investments by the U.S. 503b Compounding Pharmacies market players?

Leading players operating in the U.S. 503b compounding pharmacies market focus on expanding 503b compounding. Apart from this, players are concentrating on strategic mergers and acquisitions, collaborations and creating awareness among pharmacies via different associations formed to promote smart practices to serve more end users in the domestic market to gain a competitive edge. For instance, in May 2020, Wedgwood Pharmacy acquired Zoo, Wildlife Specializations to acquire 503B outsourcing facilities and a state-licensed pharmacy to enhance the company’s market position.

Some major players in the U.S. 503b compounding pharmacies market are Central Admixture Pharmacy Services, Inc., Avella Specialty Pharmacy, Atlas Pharmaceuticals, Empower Pharmacy, Carie Boyd’S Prescription Shop, Edge Pharma, Imprimis NJOF, Nephron Pharmaceuticals Corporation, QuVa Pharma, Olympia Pharmacy, ASP Cares, Fagron Compounding Pharmacies, Athenex, Inc., IntegraDose Compounding services, Wells Pharma of Houston, LLC, US Compounding Inc., and SCA Pharma.

What are the Major Driving Factors for the U.S. 503b Compounding Pharmacies Market?

Increasing investments by the key market players in research and development will boost the growth of the US compounding pharmacy market as they innovate and customize formulations to treat various diseases effectively. Market growth is significantly accelerated by the rising prevalence of cancer among the US population. In addition, the growing acceptance of compounding pharmacies in the US is fueled by favorable government reimbursement policies. In addition, the growth of effective compounding pharmacies is being driven by technological advancements. Combined with the strong healthcare infrastructure in the US, the US compounding pharmacy market is growing due to the presence of leading market players.

What are the Major Risks for the U.S. 503b Compounding Pharmacies Market?

As a result of increasing product recalls, the U.S. 503B compounding pharmacy market is expected to slow down. For example, in August 2019, the U.S. Food and Drug Administration requested a recall of sterile compounded drug products produced by Pacifico National Inc. This Melbourne-based outsourcing facility operates as AmEx Pharmacy. Because of significant quality and sterility concerns, compounded ophthalmic and other drug products pose unnecessary risks.

Which is the key packaging in the U.S. 503b Compounding Pharmacies market?

The prefilled syringes segment is expected to hold a prominent share of the U.S. 503b compounding pharmacies market during the forecast period. The pharmaceutical industry seeks new and more convenient ways to deliver drugs, which has led to the rapid growth of prefilled syringes as a unit-dose medication option. In its article published in June 2022 on self-care interventions, the World Health Organization noted that self-injectable contraception could reduce unintended pregnancy rates. Increasing efforts of healthcare professionals to reduce hospital errors and growing demand for easy-to-use drug delivery devices are driving the market.

What is the regulatory landscape for the U.S. 503b Compounding Pharmacies market?

The FDA authorizes 503A pharmacies to provide sterile medicines under patient-specific conditions to fill each patient’s unique prescription. They are also approved for use at home by the FDA. The FDA does not require 503A pharmacies to register with the FDA, nor do they need to follow current good manufacturing practices (cGMP). These regulatory relaxations will boost the demand for 503A compounding pharmacies.

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What are the major players planning for the future of the U.S. 503b Compounding Pharmacies market?

Growing regional existence and investment in downstream applications are anticipated to deliver a competitive edge in the market. It was announced in January 2022 that Athenex would manufacture its 503B products at its Dunkirk facility under a preliminary agreement with ImmunityBio, Inc. Through this partnership, the company will gain a competitive advantage and expand its product line.

REPORT ATTRIBUTE	DETAILS
U.S. 503b Compounding Pharmacies Market by Value	Yes
U.S. 503b Compounding Pharmacies Market, Tornado Analysis	Yes
U.S. 503b Compounding Pharmacies Market, STAR Analysis	Yes
U.S. 503b Compounding Pharmacies Market, SRC Analysis	Yes
U.S. 503b Compounding Pharmacies Market Pricing Analysis	Yes (On Demand)
U.S. 503b Compounding Pharmacies Market Segment Analysis	By Molecule (Esmolol, Vancomycin, Epinephrine, Fentanyl/ Bupivacaine, Adenocaine, Morphine, Amiodarone, Bupivacaine, Lidocaine, Heparin, Ketamine, Dextrose, Hydromorphone, BKK (Bupivacaine, ketorolac, Ketamine), RKK (Ropivacaine, Ketorolac, Ketamine), RCK (Ropivacaine, Clonidine, Ketorolac), and Other Molecules) By Packaging (Vials, Prefilled Syringes, Ampoules, Syringes, and Others)
U.S. 503b Compounding Pharmacies Market Key Companies	Central Admixture Pharmacy Services, Inc., Nephron Pharmaceuticals Corporation, QuVa Pharma, Olympia Pharmacy, ASP Cares, Fagron Compounding Pharmacies, Athenex, Inc., Avella Specialty Pharmacy, Atlas Pharmaceuticals, Empower Pharmacy, Carie Boyd’S Prescription Shop, Edge Pharma, Imprimis NJOF, IntegraDose Compounding services, Wells Pharma of Houston, LLC, US Compounding Inc., and SCA Pharma.
U.S. 503b Compounding Pharmacies Market Competitive Landscape	Market Share Analysis Competitive Benchmarking Key Players Market Positioning Geographical Presence Analysis Major Strategies Adopted

Segmentation of U.S. 503b Compounding Pharmacies Market-

U.S. 503b Compounding Pharmacies Market – By Molecule

Acetaminophen
Phenylephrine
Midazolam
Esmolol
Vancomycin
Epinephrine
Adenocaine
Fentanyl/ Bupivacaine
Morphine
Amiodarone
Heparin
Ketamine
Dextrose
Hydromorphone
Bupivacaine
Lidocaine
BKK (Bupivacaine, ketorolac, Ketamine)
RCK (Ropivacaine, Clonidine, Ketorolac)
RKK (Ropivacaine, Ketorolac, Ketamine)
Other Molecules

U.S. 503b Compounding Pharmacies Market – By Packaging

Vials
Prefilled Syringes
Ampoules
Syringes
Others

Table of Content
CHAPTER NO. 1 : INTRODUCTION 14
1.1.1. Report Description 14
Purpose of the Report 14
USP & Key Offerings 14
1.1.2. Key Benefits for Stakeholders 14
1.1.3. Target Audience 15
1.1.4. Report Scope 15

CHAPTER NO. 2 : EXECUTIVE SUMMARY 16

2.1. 503b Compounding Pharmacies Market Snapshot 16
2.1.1. U.S. 503b Compounding Pharmacies Market, 2018 – 2032 (USD Million) 17

CHAPTER NO. 3 : GEOPOLITICAL CRISIS IMPACT ANALYSIS 18
3.1. Russia-Ukraine and Israel-Palestine War Impacts 18

CHAPTER NO. 4 : 503B COMPOUNDING PHARMACIES MARKET – INDUSTRY ANALYSIS 19
4.1. Introduction 19
4.2. Market Drivers 20
4.2.1. Driving Factor 1 Analysis 20
4.2.2. Driving Factor 2 Analysis 21
4.3. Market Restraints 22
4.3.1. Restraining Factor Analysis 22
4.4. Market Opportunities 23
4.4.1. Market Opportunity Analysis 23
4.5. Porter’s Five Forces Analysis 24
4.6. Value Chain Analysis 25
4.7. Buying Criteria 26

CHAPTER NO. 5 : MANUFACTURING COST ANALYSIS 27
5.1. Manufacturing Cost Analysis 27
5.2. Manufacturing Process 27

CHAPTER NO. 6 : ANALYSIS COMPETITIVE LANDSCAPE 28
6.1. Company Market Share Analysis – 2023 28
6.1.1. U.S. 503b Compounding Pharmacies Market: Company Market Share, by Volume, 2023 28
6.1.2. U.S. 503b Compounding Pharmacies Market: Company Market Share, by Revenue, 2023 29
6.1.3. U.S. 503b Compounding Pharmacies Market: Top 6 Company Market Share, by Revenue, 2023 29
6.1.4. U.S. 503b Compounding Pharmacies Market: Top 3 Company Market Share, by Revenue, 2023 30
6.2. U.S. 503b Compounding Pharmacies Market Company Volume Market Share, 2023 31
6.3. U.S. 503b Compounding Pharmacies Market Company Revenue Market Share, 2023 32
6.4. Company Assessment Metrics, 2023 33
6.4.1. Stars 33
6.4.2. Emerging Leaders 33
6.4.3. Pervasive Players 33
6.4.4. Participants 33
6.5. Start-ups /SMEs Assessment Metrics, 2023 33
6.5.1. Progressive Companies 33
6.5.2. Responsive Companies 33
6.5.3. Dynamic Companies 33
6.5.4. Starting Blocks 33
6.6. Strategic Developments 34
6.6.1. Acquisitions & Mergers 34
New Product Launch 34
Regional Expansion 34
6.7. Key Players Product Matrix 35

CHAPTER NO. 7 : PESTEL & ADJACENT MARKET ANALYSIS 36
7.1. PESTEL 36
7.1.1. Political Factors 36
7.1.2. Economic Factors 36
7.1.3. Social Factors 36
7.1.4. Technological Factors 36
7.1.5. Environmental Factors 36
7.1.6. Legal Factors 36
7.2. Adjacent Market Analysis 36

CHAPTER NO. 8 : 503B COMPOUNDING PHARMACIES MARKET – BY MOLECULE SEGMENT ANALYSIS 37
8.1. 503b Compounding Pharmacies Market Overview, by Molecule Segment 37
8.1.1. 503b Compounding Pharmacies Market Revenue Share, By Molecule, 2023 & 2032 38
8.1.2. 503b Compounding Pharmacies Market Attractiveness Analysis, By Molecule 39
8.1.3. Incremental Revenue Growth Opportunity, by Molecule, 2024 – 2032 39
8.1.4. 503b Compounding Pharmacies Market Revenue, By Molecule, 2018, 2023, 2027 & 2032 40
8.2. Acetaminophen 41
8.3. Phenylephrine 42
8.4. Midazolam 43
8.5. Esmolol 44
8.6. Vancomycin 45
8.7. Epinephrine 46
8.8. Adenocaine 46
8.9. Fentanyl/ Bupivacaine 46
8.10. Morphine 46
8.11. Amiodarone 46
8.12. Heparin 46
8.13. Ketamine 46
8.14. Dextrose 46
8.15. Hydromorphone 46
8.16. Bupivacaine 46
8.17. Lidocaine 46
8.18. BKK (Bupivacaine, ketorolac, Ketamine) 46
8.19. RCK (Ropivacaine, Clonidine, Ketorolac) 46
8.20. RKK (Ropivacaine, Ketorolac, Ketamine) 46
8.21. Others 46

CHAPTER NO. 9 : 503B COMPOUNDING PHARMACIES MARKET – BY PACKAGING SEGMENT ANALYSIS 47
9.1. 503b Compounding Pharmacies Market Overview, by Packaging Segment 47
9.1.1. 503b Compounding Pharmacies Market Revenue Share, By Packaging, 2023 & 2032 48
9.1.2. 503b Compounding Pharmacies Market Attractiveness Analysis, By Packaging 49
9.1.3. Incremental Revenue Growth Opportunity, by Packaging, 2024 – 2032 49
9.1.4. 503b Compounding Pharmacies Market Revenue, By Packaging, 2018, 2023, 2027 & 2032 50
9.2. Vials 51
9.3. Prefilled Syringes 52
9.4. Ampoules 53
9.5. Syringes 54
9.6. Others 55

CHAPTER NO. 10 : 503B COMPOUNDING PHARMACIES MARKET – U.S. ANALYSIS 56
10.1. Molecule 56
10.1.1. U.S. 503b Compounding Pharmacies Market Revenue, By Molecule, 2018 – 2023 (USD Million) 56
10.2. U.S. 503b Compounding Pharmacies Market Revenue, By Molecule, 2024 – 2032 (USD Million) 56
10.3. Packaging 57
10.3.1. U.S. 503b Compounding Pharmacies Market Revenue, By Packaging, 2018 – 2023 (USD Million) 57
10.3.2. U.S. 503b Compounding Pharmacies Market Revenue, By Packaging, 2024 – 2032 (USD Million) 57

CHAPTER NO. 11 : COMPANY PROFILES 58
11.1. Central Admixture Pharmacy Services, Inc. 58
11.1.1. Company Overview 58
11.1.2. Product Portfolio 58
11.1.3. Swot Analysis 58
11.1.4. Business Strategy 59
11.1.5. Financial Overview 59
11.2. Nephron Pharmaceuticals Corporation 60
11.3. QuVa Pharma 60
11.4. Olympia Pharmacy 60
11.5. ASP Cares 60
11.6. Fagron Compounding Pharmacies 60
11.7. Athenex, Inc. 60
11.8. Optum 60
11.9. Atlas Pharmaceuticals 60
11.10. Empower Pharmacy 60
11.11. Carie Boyd’S Prescription Shop 60
11.12. Edge Pharma 60
11.13. IntegraDose Compounding services 60
11.14. Wells Pharma 60
11.15. SCA Pharma 60
11.16. Imprimis NJOF 60
11.17. Others 60

CHAPTER NO. 12 : RESEARCH METHODOLOGY 61
12.1. Research Methodology 61
12.1.1. Phase I – Secondary Research 62
12.1.2. Phase II – Data Modeling 62
Company Share Analysis Model 63
Revenue Based Modeling 63
12.1.3. Phase III – Primary Research 64
12.1.4. Research Limitations 65
Assumptions 65

List of Figures
FIG NO. 1. U.S. 503b Compounding Pharmacies Market Revenue, 2018 – 2032 (USD Million) 18
FIG NO. 2. Porter’s Five Forces Analysis for U.S. 503b Compounding Pharmacies Market 25
FIG NO. 3. Value Chain Analysis for U.S. 503b Compounding Pharmacies Market 26
FIG NO. 4. Manufacturing Cost Analysis 28
FIG NO. 5. Manufacturing Process 28
FIG NO. 6. Company Share Analysis, 2023 29
FIG NO. 7. Company Share Analysis, 2023 30
FIG NO. 8. Company Share Analysis, 2023 30
FIG NO. 9. Company Share Analysis, 2023 31
FIG NO. 10. 503b Compounding Pharmacies Market – Company Volume Market Share, 2023 32
FIG NO. 11. 503b Compounding Pharmacies Market – Company Revenue Market Share, 2023 33
FIG NO. 12. 503b Compounding Pharmacies Market Revenue Share, By Molecule, 2023 & 2032 39
FIG NO. 13. Market Attractiveness Analysis, By Molecule 40
FIG NO. 14. Incremental Revenue Growth Opportunity by Molecule, 2024 – 2032 40
FIG NO. 15. 503b Compounding Pharmacies Market Revenue, By Molecule, 2018, 2023, 2027 & 2032 41
FIG NO. 16. U.S. 503b Compounding Pharmacies Market for Acetaminophen, Revenue (USD Million) 2018 – 2032 42
FIG NO. 17. U.S. 503b Compounding Pharmacies Market for Phenylephrine, Revenue (USD Million) 2018 – 2032 43
FIG NO. 18. U.S. 503b Compounding Pharmacies Market for Midazolam, Revenue (USD Million) 2018 – 2032 44
FIG NO. 19. U.S. 503b Compounding Pharmacies Market for Esmolol, Revenue (USD Million) 2018 – 2032 45
FIG NO. 20. U.S. 503b Compounding Pharmacies Market for Vancomycin, Revenue (USD Million) 2018 – 2032 46
FIG NO. 21. 503b Compounding Pharmacies Market Revenue Share, By Packaging, 2023 & 2032 49
FIG NO. 22. Market Attractiveness Analysis, By Packaging 50
FIG NO. 23. Incremental Revenue Growth Opportunity by Packaging, 2024 – 2032 50
FIG NO. 24. 503b Compounding Pharmacies Market Revenue, By Packaging, 2018, 2023, 2027 & 2032 51
FIG NO. 25. U.S. 503b Compounding Pharmacies Market for Vials, Revenue (USD Million) 2018 – 2032 52
FIG NO. 26. U.S. 503b Compounding Pharmacies Market for Prefilled Syringes, Revenue (USD Million) 2018 – 2032 53
FIG NO. 27. U.S. 503b Compounding Pharmacies Market for Ampoules, Revenue (USD Million) 2018 – 2032 54
FIG NO. 28. U.S. 503b Compounding Pharmacies Market for Syringes, Revenue (USD Million) 2018 – 2032 55
FIG NO. 29. U.S. 503b Compounding Pharmacies Market for Others, Revenue (USD Million) 2018 – 2032 56
FIG NO. 30. Research Methodology – Detailed View 62
FIG NO. 31. Research Methodology 63

List of Tables
TABLE NO. 1. : U.S. 503b Compounding Pharmacies Market: Snapshot 16
TABLE NO. 2. : Drivers for the 503b Compounding Pharmacies Market: Impact Analysis 20
TABLE NO. 3. : Restraints for the 503b Compounding Pharmacies Market: Impact Analysis 22
TABLE NO. 4. : U.S. 503b Compounding Pharmacies Market Revenue, By Molecule, 2018 – 2023 (USD Million) 56
TABLE NO. 5. : U.S. 503b Compounding Pharmacies Market Revenue, By Molecule, 2024 – 2032 (USD Million) 56
TABLE NO. 6. : U.S. 503b Compounding Pharmacies Market Revenue, By Packaging, 2018 – 2023 (USD Million) 57
TABLE NO. 7. : U.S. 503b Compounding Pharmacies Market Revenue, By Packaging, 2024 – 2032 (USD Million) 57

Frequently Asked Questions

How does COVID-19 Impact the U.S. 503b Compounding Pharmacies market?

As pharmacies struggle to fulfill the demand for medicines during the covid-19 pandemic, 503B outsourcing facilities have proven crucial to health systems and hospital pharmacies during the covid-19 pandemic to help address drug scarcity and its impact on patients.

What are the key drivers for the growth of the U.S. 503b Compounding Pharmacies market?

Which is the major segment in the U.S. 503b Compounding Pharmacies market by molecule?

The phenylephrine segment had a major share in the market in 2022.

Which is the major segment in the U.S. 503b Compounding Pharmacies market by packaging?

The Prefilled Syringes segment had a major share in the market.

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