According to a recent report by nova one advisor, the U.S. compounding pharmacies market size was exhibited at USD 5.95 billion in 2023 and is projected to hit around USD 10.76 billion by 2033, growing at a CAGR of 6.1% during the forecast period 2024 to 2033.
According to a recent report by nova one advisor, the U.S. compounding pharmacies market size was exhibited at USD 5.95 billion in 2023 and is projected to hit around USD 10.76 billion by 2033, growing at a CAGR of 6.1% during the forecast period 2024 to 2033.
The growth of the U.S. compounding pharmacies market is propelled by adherence to industry standards such as the United States Pharmacopeia (USP) Convention and good manufacturing practice (CGMP) regulations, ensuring the quality and safety of compounded drugs. These pharmacies prove invaluable during drug shortages by providing alternative formulations to manufactured drugs, thus meeting patient and healthcare provider needs.
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Market Overview
The U.S. compounding pharmacies market is experiencing rapid growth driven by the increasing demand for custom-made medicines. With millions of medications compounded annually to cater to the unique needs of patients, compounding pharmacies play a vital role in providing access to medication for individuals who cannot use commercially available formulations due to dosing requirements, allergies, or rare diseases. Particularly crucial for sterile medications administered via injection, intravenous infusion, intraocular, or intrathecal routes, compounding services are offered by approximately 7,500 community-based pharmacies out of around 56,000 in the U.S. Some estimates suggest that over 32,000 pharmacies nationwide offer some form of compounding. Compounding pharmacies must use pure, pharmaceutical-grade ingredients manufactured in FDA-registered facilities to ensure quality and safety. This market overview underscores the significant growth potential and importance of compounding pharmacies in meeting diverse patient needs while adhering to stringent regulatory standards.
U.S. Compounding Pharmacies Market Key Takeaways
- By Product, the oral medications segment dominated the market with the largest market share of 36.47% in 2023.
- By Pharmacy Type, 503A segment accounted for more than 73.28% of revenue share in 2023.
- By Sterility, the non-sterile segment dominated the market with the highest revenue of 72.58% in 2023.
- By Application, the adult segment is expected to significantly boost during the anticipated timeframe.
- By therapeutic area, the others segment dominated the market in 2023.
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U.S. Compounding Pharmacies Market Dynamics
Driver
Important role of compounding pharmacies in healthcare
The demand for personalized medicine, coupled with the essential role of compounding pharmacies in addressing specific patient needs, fuels the continuous growth of the U.S. compounding pharmacies market. With a rising need for tailored pain medications and the capability of compounding pharmacies to provide customized solutions, the market shows promising expansion prospects. Additionally, the expertise of well-trained professionals in compounding pharmacies becomes indispensable in situations of drug shortages or when commercially available drugs do not meet patient requirements due to allergies or discontinuation. These factors collectively contribute to the sustained growth trajectory of the U.S. compounding pharmacies market, emphasizing its indispensable value within the healthcare landscape.
- In October 2023, FarmaKeio Custom Compounding enhanced healthcare services through the acquisition of a state-of-the-art compounding pharmacy.
Restraint
Quality and safety concerns
In serving critical medical needs, compounded drugs lack the same safety, quality, and effectiveness assurances as approved drugs, posing potential health risks to patients. Instances of poor compounding practices can result in severe drug quality issues like contamination or excessive active ingredient levels, leading to serious patient harm or even fatalities. The reliance on compounded drugs by practitioners in hospitals and clinics when FDA-approved alternatives are not suitable for patients further hampers the growth potential of the U.S. compounding pharmacies market, highlighting the imperative for enhanced quality control and regulatory oversight within the industry.
Opportunity
Advancement in healthcare
Pharmaceutical compounding emerges as a vital component of pharmacy practice, offering a pathway to access essential medicines and commercially unavailable products. With the ability to customize medications for individualized therapy, compounding spans a spectrum of complexity, from simple tablet crushing to sterile product compounding in controlled environments. This versatility allows compounding to be conducted across various settings, including pharmacies, hospital wards, outpatient clinics, and FDA-regulated facilities. Leveraging the practitioner-patient-pharmacist relationship, compounded medications are prescribed, and compounded plans are developed to meet specific patient needs. With licensed pharmacy professionals overseeing or performing compounding, the U.S. compounding pharmacies market is poised for growth, presenting opportunities to cater to the evolving healthcare landscape with tailored medication solutions.
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Report Highlights
By Product Insights
In the U.S. compounding pharmacies market, the oral medications segment stands out as a dominant force. Particularly, there’s notable interest among pharmacy compounding stakeholders in addressing demand and supply challenges for pain and fever oral suspension medications, as acknowledged by the FDA. Compounded drugs containing acetaminophen or ibuprofen must comply with all relevant requirements outlined in section 503A of the FD&C Act. This segment caters to patients who encounter difficulties swallowing tablets and capsules, offering a wide range of medications compounded as oral liquids. This product insight highlights the significance of oral medications within the compounding pharmacies market, emphasizing the industry’s responsiveness to patient needs and regulatory standards.
The liquid preparations segment is expected to be the fastest-growing segment in the U.S. compounding pharmacies market. This growth can be attributed to compounded preparations being suspensions, containing visible particles rather than being solutions at the molecular level. Consequently, these liquids couldn’t be filtered to remove bacteria and fungi, posing challenges for ensuring sterility. Particularly critical in cases where the preparation is injected directly into the spine, stringent limitations apply regarding the addition of preservatives or other additives to prevent fungal growth. This product insight underscores the importance of addressing sterility concerns in compounded liquid preparations, highlighting the need for innovative solutions to maintain product safety and efficacy within this burgeoning market segment.
By Pharmacy Type Insights
In the U.S. compounding market, the 503A segment has emerged as the dominant force based on pharmacy type. This segment, governed by regulatory guidelines outlined in FD&C Act Section 503A, emphasizes industry good practices to ensure safe compounding. The guidance provided in “503A Compounding – Regulatory Basis and Industry Good Practices for Pharmacies” facilitates pharmacies’ understanding of FDA regulations necessary for compliant operations. Specifically, 503A pharmacies prioritize the implementation of quality systems across all stages, from managing incoming materials and maintaining facilities and equipment to ensuring proper storage, shipping, and transport procedures. This pharmacy insight underscores the importance of regulatory compliance and quality assurance practices in driving the success of 503A pharmacies within the compounding market.
By Sterility Insights
In the U.S. compounding pharmacies market, the non-sterile segment has asserted dominance based on sterility considerations in 2023. This segment encompasses processes such as combining, admixing, diluting, pooling, reconstituting, or otherwise altering drugs or bulk drug substances to create non-sterile preparations, diverging from manufacturer-provided labelling. This insight underscores the prevalence of non-sterile compounding practices within the market, highlighting the importance of adhering to regulatory standards to ensure product safety and efficacy.
In the forecast period, the sterile segment is anticipated to experience the highest growth rate within the U.S. compounding pharmacies market, underscoring its critical significance. Sterile compounding plays a pivotal role in the preparation of medications intended for sensitive areas of the body, such as the bloodstream, eyes, lungs, or heart. This process involves highly trained pharmacists utilizing sterile products within a controlled, sterile environment to ensure the creation of sterile medications. This insight emphasizes the increasing demand for sterile compounding services, driven by the imperative to maintain the highest standards of safety and efficacy in pharmaceutical preparations targeting sensitive bodily regions.
By Therapeutic Area Insights
In the U.S. compounding pharmacies market, the others segments, such as oncology, haematology, and dental, dominated in 2023, reflecting the diverse needs of patients and healthcare providers. Oncology compounding plays a crucial role in alleviating the challenges associated with neoplastic drugs, offering tailored medications to address individual patient requirements. Similarly, dental compounding enables customization of treatments, providing dentists with the flexibility to alleviate procedural anxiety, offer pain relief, and deliver other treatments via personalized dosages. This therapeutic insight underscores the importance of compounding in meeting the unique therapeutic needs of patients across various medical specialties, enhancing treatment efficacy and patient outcomes while addressing specific clinical requirements.
In the forecast period, the pain management segment is expected to be the fastest-growing within the U.S. compounding pharmacies market, indicating a significant demand for personalized pain relief solutions. Pharmacy compounding presents patients with customized options for pain medication, offering relief from chronic pain or the side effects associated with standard pain medications. As the art and science of preparing tailored medications, compounding provides valuable benefits to individuals for whom pain management is a daily necessity, with research indicating that 100 million Americans suffer from chronic pain and approximately 1 in 10 experience persistent pain for three months or more, the growth of the pain management segment underscores the crucial role of compounding in addressing the diverse therapeutic needs of patients, ultimately enhancing their quality of life and treatment outcomes.
U.S. Compounding Pharmacies Market, By Therapeutic Area, 2021-2023 (USD Billion)
| By Therapeutic Area | 2021 | 2022 | 2023 |
| Hormone Replacement | 1.02 | 1.08 | 1.15 |
| Pain Management | 0.84 | 0.89 | 0.94 |
| Dermatology | 0.47 | 0.50 | 0.53 |
| Pediatrics | 0.33 | 0.35 | 0.37 |
| Urology | 0.28 | 0.30 | 0.32 |
| Others | 2.25 | 2.36 | 2.47 |
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U.S. Compounding Pharmacies Market Recent Developments
- In April 2024, Myonex, a renowned international provider of supplies for clinical trials, successfully acquired Safeway Compounding Pharmacy located in Newark, Delaware. The pharmacy will be run by Myonex under the name SaveWay Compounding Pharmacy. This acquisition expands patient access throughout the entire United States and helps patients obtain trial medication and equipment, all in an effort to support clinical trial sponsors’ trial designs with direct-to-patient (DTP) and home healthcare provider (HHP) capabilities.
- In July 2023, Fagron expanded its US sterile compounding footprint with an East Coast acquisition.
- In March 2023, Medios acquired a Dutch market leader in pharmaceutical compounding services.
U.S. Compounding Pharmacies Market Top Key Companies:
- Triangle compounding pharmacy
- Fagron
- B. Braun melsungen ag
- Fresenius kabi ag
- Pencol Compounding Pharmacy
- US Compounding Inc.
- Avella specialty pharmacy
- Institutional pharmacy solutions, llc
- Pharmedium services llc
- Vertisis custom pharmacy
U.S. Compounding Pharmacies Market Report Segmentation
This report forecasts revenue growth at country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2021 to 2033. For this study, Nova one advisor, Inc. has segmented the U.S. Compounding Pharmacies market.
By Pharmacy Type
- 503A
- 503B
By Product
- Oral
- Capsules
- Granules
- Tablets
- Powder
- Others
- Liquid Preparations
- Emulsion
- Syrup
- Solutions
- Suspension
- Others
- Topical
- Gels
- Ointments
- Creams
- Pastes
- Others
- Rectal
- Enema
- Suppositories
- Others
- Ophthalmic
- Nasal
- Otic
By Sterility
- Sterile
- Non-Sterile
By Compounding Type
- Pharmaceutical Ingredient Alteration (PIA)
- Currently Unavailable Pharmaceutical Manufacturing (CUPM)
- Pharmaceutical Dosage Alteration (PDA)
- Others
By Therapeutic Area
- Hormone Replacement
- Pain Management
- Dermatology
- Pediatrics
- Urology
- Others
By End-User
- Hospitals and Clinics
- Specialty Clinics
- Others
Frequently Asked Questions
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- We conduct cross-sectional analysis by examining data from different individuals at a single point in time to identify patterns and trends across diverse segments of the market.
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