U.S. Compounding Pharmacies Market Share Analysis Report, 2023-2032
The U.S. compounding pharmacies market size was exhibited at USD 5.46 billion in 2022 and is projected to hit around USD 8.98 billion by 2032, growing at a CAGR of 5.11% during the forecast period 2023 to 2032.
Key Pointers:
Report Scope of the U.S. Compounding Pharmacies Market
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Report Coverage |
Details |
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Market Size in 2023 |
USD 5.73 Billion |
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Market Size by 2032 |
USD 8.98 Billion |
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Growth Rate from 2023 to 2032 |
CAGR of 5.11% |
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Base Year |
2022 |
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Forecast Period |
2023 to 2032 |
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Segments Covered |
By Pharmacy Type, By Sterility, By Product, By Application, By Compounding Type, By Therapeutic Area |
Increasing awareness regarding compounded medication and rising adoption rate of such medicines will boost the U.S. compounding pharmacies business. Other factors such as increase in the number of prescriptions dispensed, shortage of certain commercially formulated drugs or discontinuation of drugs by manufacturers will positively influence the overall market growth.
Rise in the elderly population and age-related chronic diseases and increasing health expenditure in the U.S. have popularized the demand for compounded medications. Patients are seeking for compounded pharmacies to gain medications with alternative dosages, personalized route of administration, and alternative ingredients to avoid allergies that may be otherwise caused from commercially available drug formulations. These factors have contributed to the U.S. compounding pharmacies market expansion.
Amid COVID-19 pandemic the demand for compounded medications increased. This can be attributed to the increased demand for several medications for treatment of COVID-19, along with other reasons such as reduced manufacturing capabilities due to restrictions and shortage of commercially available drugs.
For instance, according to the U.S. Food and Drug Administration (FDA) report, the U.S. has dealt with a drug shortage for several years, and the COVID-19 outbreak has exacerbated the situation. This shortage is primarily caused by supply chain disruption, manufacturing process delays and discontinuity, quality issues, and difficulties in obtaining raw materials.
Hence, drug shortages created additional opportunities for the U.S. compounding pharmacies business. Also, FDA issued a temporary guidance policy to the federal facilities and state-licensed pharmacies, including hospital pharmacies and compounding pharmacy that are not registered with FDA as outsourcing facilities for compounding of certain medication for hospitalized patients for the duration of the public health emergency, due to shortage of drugs required for patient treatment.
A compounding pharmacy is a specific type of pharmacy, that makes customized medications. These medications are prescribed to meet specific need of a patient that cannot be met by commercially available FDA approved drugs. In the U.S., compounding practice is popular owing to increasing demand of personalized medications and the convenience of using compounded drugs.
Drug shortages have a significant impact on healthcare providers and more so on patients. All categories of drugs, that include essential lifesaving drugs, antimicrobials, oncology medicine, cardiovascular drugs, analgesics, opioids, are liable to drug shortage. The causes of drug shortages are many, such as supply demand issue, regulatory issues, manufacturing difficulties, lack of raw material supply are some reasons among many other. Drug shortages pose a significant threat to public health that can delay, and in some cases even deny care needed for patients. In such scenarios, compounding pharmacies play an essential role to tackle drug shortage crisis.
Drug shortage has been an ongoing problem in the U.S. and has been a major concern to healthcare organizations. For instance, as per the University of Utah Drug Information Services, 129 drug shortages were reported in the U.S. in 2020. Similarly, according to FDA’s CBER (Center for Biologics Evaluation and Research) and FDA’s CDER (Center for Drug Evaluation and Research) the number of new drug shortages tracked was 42 in 2022.
There has been a constant effort by FDA and other organizations to mitigate drug shortage crisis. Compounding pharmacies can play an important role to step in and address drug shortages when they occur. Increasing shortages of several drugs and rising demand of medications are key factors that will boost the U.S. compounding pharmacies market revenue over the forecast years.
The U.S. compounding pharmacies market, based on pharmacy type, is classified into 503 A and 503B. The 503B pharmacy type segment accounted for around 57.5% market share in 2022 and the trend will continue to rise over the forecast years. A 503B is a compounding pharmacy that is registered with FDA as a 503B outsourcing facility. Registration with FDA enables a facility to compound and distribute drugs with or without a patient-specific prescription.
Such facilities can manufacture large batches of drugs to be sold to healthcare facilities for office use only. These pharmacies are allowed to manufacture larger batches of compounded medications to lower their manufacturing costs, thereby passing the savings onto consumers. Such benefits attract patients towards compounded medications and thereby fueling the market progression.
Moreover, according to study conducted by the U.S. Department of Health and Human Services, it was reported that most hospitals, nearly 90% obtained non-patient-specific compounded from outsourcing facilities. Such instances will foster the U.S. compounding pharmacies business.
Some of the prominent players in the U.S. compounding pharmacies Market include:
Segments Covered in the Report
This report forecasts the volume and revenue growth at the country level and provides an analysis of the latest industry trends in each of the sub-segments from 2018 to 2032. For this study, Nova one advisor has segmented the U.S. compounding pharmacies market.
By Pharmacy Type
By Sterility
By Product
By Application
By Compounding Type
By Therapeutic Area
Chapter 1. Introduction
1.1 Market definitions
1.2 Base estimates & working
1.3 Forecast parameters
1.4 Data validation
1.5 Data sources
1.5.1 Secondary
1.5.1.1 Paid sources
1.5.1.2 Unpaid sources
1.5.2 Primary
Chapter 2 Executive Summary
2.1 U.S. compounding pharmacies industry 3600 synopsis, 2020 – 2032
Chapter 3 US Compounding Pharmacies Industry Insights
3.1 Industry segmentation
3.2 Industry landscape, 2020 – 2032
3.3 Industry impact forces
3.3.1 Growth drivers
3.3.1.1 Increasing geriatric population and improved longevity
3.3.1.2 Growing acceptance of personalized medicines in U.S.
3.3.1.3 Increasing drug shortage in the country
3.3.1.4 Convenience of using compounded drugs
3.3.1.5 Growing demand for compounded bioidentical menopausal hormone therapy (BMHT) among women
3.3.2 Restraints
3.3.2.1 Issues related to safety standards of compounded drugs
3.3.2.2 Changing regulatory scenario
3.4 Growth potential analysis
3.4.1 By pharmacy type
3.4.2 By sterility
3.4.3 By product
3.4.4 By application
3.4.5 By compounding type
3.4.6 By therapeutic area
3.5 COVID-19 impact analysis
3.6 Regulatory landscape
3.7 Reimbursement landscape
3.8 Porter's analysis
3.9 Competitive landscape, 2022
3.10 PESTEL analysis
Chapter 4 US Compounding Pharmacies Market, By Pharmacy Type
4.1 Key segment trends
4.2 503A
4.2.1 Market size, by 503A, 2020-2032
4.3 503B
4.3.1 Market size, by 503B, 2020-2032
Chapter 5 US Compounding Pharmacies Market, By Sterility
5.1 Key segment trends
5.2 Sterile
5.2.1 Market size, by sterile, 2020-2032
5.3 Non-sterile
5.3.1 Market size, by non-sterile, 2020-2032
Chapter 6 US Compounding Pharmacies Market, By Product
6.1 Key segment trends
6.2 Oral
6.2.1 Market size, by oral, 2020-2032
6.2.2 Solid preparation
6.2.2.1 Market size, by solid preparation, 2020-2032
6.2.2.2 Tablets
6.2.2.2.1 Market size, by tablets, 2020 - 2032
6.2.2.3 Capsules
6.2.2.3.1 Market size, by capsules, 2020 - 2032
6.2.2.4 Granules
6.2.2.4.1 Market size, by granules, 2020 - 2032
6.2.2.5 Powder
6.2.2.5.1 Market size, by powder, 2020 - 2032
6.2.2.6 Others
6.2.2.6.1 Market size, by others, 2020 - 2032
6.2.3 Liquid preparation
6.2.3.1 Market size, by liquid preparation, 2020-2032
6.2.3.2 Solutions
6.2.3.2.1 Market size, by solutions, 2020 - 2032
6.2.3.3 Suspension
6.2.3.3.1 Market size, by suspension, 2020 - 2032
6.2.3.4 Emulsion
6.2.3.4.1 Market size, by emulsion, 2020 - 2032
6.2.3.5 Syrup
6.2.3.5.1 Market size, by syrup, 2020 - 2032
6.2.3.6 Others
6.2.3.6.1 Market size, by others, 2020 - 2032
6.2.4 Topical
6.2.4.1 Market size, by topical, 2020-2032
6.2.4.2 Creams
6.2.4.2.1 Market size, by creams, 2020 - 2032
6.2.4.3 Gels
6.2.4.3.1 Market size, by gels, 2020 - 2032
6.2.4.4 Pastes
6.2.4.4.1 Market size, by pastes, 2020 - 2032
6.2.4.5 Ointments
6.2.4.5.1 Market size, by ointments, 2020 - 2032
6.2.4.6 Others
6.2.4.6.1 Market size, by others, 2020 - 2032
6.2.5 Rectal
6.2.5.1 Market size, by rectal, 2020-2032
6.2.5.2 Suppositories
6.2.5.2.1 Market size, by suppositories, 2020 - 2032
6.2.5.3 Enemas
6.2.5.3.1 Market size, by enemas, 2020 - 2032
6.2.5.4 Others
6.2.5.4.1 Market size, by others, 2020 - 2032
6.2.6 Parenteral
6.2.6.1 Market size, by parenteral, 2020-2032
6.2.6.2 Small volume parenteral (SVP) solutions
6.2.6.2.1 Market size, by small volume parenteral (SVP) solutions, 2020 - 2032
6.2.6.3 Large volume parenteral (LVP) solutions
6.2.6.3.1 Market size, by large volume parenteral (SVP) solutions, 2020 - 2032
6.2.7 Nasal
6.2.7.1 Market size, by nasal, 2020-2032
6.2.8 Ophthalmic
6.2.8.1 Market size, by ophthalmic, 2020-2032
6.2.9 Otic
6.2.9.1 Market size, by otic, 2020-2032
Chapter 7 US Compounding Pharmacies Market, By Application
7.1 Key segment trends
7.2 Pediatric
7.2.1 Market size, by pediatric, 2020-2032
7.3 Adult
7.3.1 Market size, by adult, 2020-2032
7.4 Geriatric
7.4.1 Market size, by geriatric, 2020-2032
7.5 Veterinary
7.5.1 Market size, by veterinary, 2020-2032
Chapter 8 US Compounding Pharmacies Market, By Compounding Type
8.1 Key segment trends
8.2 Pharmaceutical Ingredient Alteration (PIA)
8.2.1 Market size, by pharmaceutical ingredient alteration (PIA), 2020-2032
8.3 Currently Unavailable Pharmaceutical Manufacturing (CUPM)
8.3.1 Market size, by currently unavailable pharmaceutical manufacturing (CUPM), 2020-2032
8.4 Pharmaceutical Dosage Alteration (PDA)
8.4.1 Market size, by pharmaceutical dosage alteration (PIA), 2020-2032
8.5 Others
8.5.1 Market size, by others, 2020-2032
Chapter 9 US Compounding Pharmacies Market, By Therapeutic Area
9.1 Key segment trends
9.2 Hormone replacement
9.2.1 Market size, by hormone replacement, 2020-2032
9.3 Pain management
9.3.1 Market size, by pain management, 2020-2032
9.4 Dermatology
9.4.1 Market size, by dermatology, 2020-2032
9.5 Specialty drugs
9.5.1 Market size, by specialty drugs, 2020-2032
9.6 Nutritional supplements
9.6.1 Market size, by nutritional supplements, 2020-2032
9.7 Others
9.7.1 Market size, by others, 2020-2032
Chapter 10 Company Profiles
10.1 Strategy dashboard, 2022
10.2 Athenex Pharma Solutions (Athenex Inc.)
10.2.1 Business overview
10.2.2 Financial data
10.2.3 Product landscape
10.2.4 Strategic outlook
10.2.5 SWOT analysis
10.3 B Braun Melsungen AG
10.3.1 Business overview
10.3.2 Financial data
10.3.3 Product landscape
10.3.4 SWOT analysis
10.4 Clinigen Group PLC
10.4.1 Business overview
10.4.2 Financial data
10.4.3 Product landscape
10.4.4 Strategic outlook
10.4.5 SWOT analysis
10.5 Dougherty’s Pharmacy, Inc.
10.5.1 Business overview
10.5.2 Financial data
10.5.3 Product landscape
10.5.4 SWOT analysis
10.6 Fagron
10.6.1 Business overview
10.6.2 Financial data
10.6.3 Product landscape
10.6.4 Strategic outlook
10.6.5 SWOT analysis
10.7 Fresenius Kabi
10.7.1 Business overview
10.7.2 Financial data
10.7.3 Product landscape
10.7.4 Strategic outlook
10.7.5 SWOT analysis
10.8 ImprimisRx (Harrow Health, Inc.)
10.8.1 Business overview
10.8.2 Financial data
10.8.3 Product landscape
10.8.4 Strategic outlook
10.8.5 SWOT analysis
10.9 Institutional Pharmacy Solutions
10.9.1 Business overview
10.9.2 Financial data
10.9.3 Product landscape
10.9.4 Strategic outlook
10.9.5 SWOT analysis
10.10 ITC Compounding Pharmacy
10.10.1 Business overview
10.10.2 Financial data
10.10.3 Product landscape
10.10.4 Strategic outlook
10.10.5 SWOT analysis
10.11 Lorraine’s Pharmacy
10.11.1 Business overview
10.11.2 Financial data
10.11.3 Product landscape
10.11.4 Strategic outlook
10.11.5 SWOT analysis
10.12 McGuff Company Inc (McGuff Compounding Pharmacy Services)
10.12.1 Business overview
10.12.2 Financial data
10.12.3 Product landscape
10.12.4 Strategic outlook
10.12.5 SWOT analysis
10.13 Nephron Pharmaceuticals Corporation
10.13.1 Business overview
10.13.2 Financial data
10.13.3 Product landscape
10.13.4 Strategic outlook
10.13.5 SWOT analysis
10.14 Pencol Compounding Pharmacy
10.14.1 Business overview
10.14.2 Financial data
10.14.3 Product landscape
10.14.4 Strategic outlook
10.14.5 SWOT analysis
10.15 QuVa Pharma
10.15.1 Business overview
10.15.2 Financial data
10.15.3 Product landscape
10.15.4 Strategic outlook
10.15.5 SWOT analysis
10.16 Rx3 Compounding Pharmacy
10.16.1 Business overview
10.16.2 Financial data
10.16.3 Product landscape
10.16.4 Strategic outlook
10.16.5 SWOT analysis
10.17 Triangle Compounding Pharmacies
10.17.1 Business overview
10.17.2 Financial data
10.17.3 Product landscape
10.17.4 Strategic outlook
10.17.5 SWOT analysis
10.18 Wedgewood Village Pharmacy, Inc.
10.18.1 Business overview
10.18.2 Financial data
10.18.3 Product landscape
10.18.4 Strategic outlook
10.18.5 SWOT analysis
Cross-segment Market Size and Analysis for
Mentioned Segments
Additional Company Profiles (Upto 5 With No Cost)
Additional Countries (Apart From Mentioned Countries)
Country/Region-specific Report
Go To Market Strategy
Region Specific Market DynamicsRegion Level Market Share Import Export AnalysisProduction AnalysisOthers