U.S. Compounding Pharmacies Market (By Pharmacy Type: 503A, 503B; By Product: Oral, Liquid Preparations, Topical, Rectal, Ophthalmic, Nasal, Otic; By Sterility: Sterile, Non-Sterile; By Compounding Type: PIA, CUPM, PDA, Others; By Therapeutic Area: Hormone replacement, Pain management, Dermatology, Pediatrics, Urology, Others; By End-User: Hospitals and Clinics, Specialty Clinics, Others) - Industry Analysis, Size, Share, Growth, Trends, Regional Outlook, and Forecast 2024-2033

U.S. Compounding Pharmacies Market Size and Forecast 2024 to 2033

The U.S. compounding pharmacies market size is projected to be worth around USD 10.76 billion by 2033 from USD 6.31 billion in 2024, at a CAGR of 6.1% from 2024 to 2033.

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 Therapeutic Area,The pain management segment holds the largest revenue share of over 32.19% in 2023
• By Application, the adult segment is expected to significantly boost during the anticipated timeframe.
• By Age Cohort, the adult segment holds the largest revenue share of over 44.18% in 2023.
• The pediatric segment is poised for the fastest CAGR from 2024 to 2033
• By Compounding Type,the Pharmaceutical Ingredient Alteration (PIA) segment held the largest revenue share of over 37.24% in 2023.
• The Pharmaceutical Dosage Alteration (PDA) segment is expected to witness significant growth from 2024 to 2033.

The market is expected to grow significantly, driven by increasing demand for personalized medications, rising chronic disease prevalence, and the growing geriatric population. Regulatory advancements supporting customized drug formulations and a shift towards patient-centric care are further boosting the market. Additionally, the shortage of commercially available drugs and advancements in pharmaceutical compounding technologies are anticipated to have a positive impact on market growth.

The demand for custom-made medicines, especially for sterile formulations used for injections, intravenous infusions, and intraocular or intrathecal administration, is increasing. According to the statistics published by the American Pharmacists Association in October 2021, over 56,000 community pharmacies were operating in the U.S., with 7,500 offering advanced compounding services. Compounding pharmacies need to use pharmaceutical-grade ingredients from FDA-registered facilities to maintain high standards of quality and safety.

The market is poised for growth due to the rise in drug shortages across critical categories such as oncology, cardiovascular, and antimicrobials. Factors such as supply-demand imbalances, regulatory issues, and manufacturing challenges have created a public health crisis by delaying necessary care. In response, compounding pharmacies are stepping in to fill supply gaps. For instance, the University of Utah identified 129 pharmaceutical shortages in 2020, and the FDA noted 41 new cases in 2021. As these shortages continue, compounding pharmacies is expected to become more important in providing access to necessary medications.

U.S. Compounding Pharmacies Market Report Scope

U.S. Compounding Pharmacies Market By Product Insights

Based on product, the oral medications segment dominated the US compounding pharmacies market, accounting for around 36.47% of the market share in 2023. The rising prevalence of various chronic diseases and increased preference for oral medications owing to their ease of use and easy storage have boosted the growth of this segment. The availability of various oral medications in the form of tablets, capsules, powder, and granules are some of the major and most preferred traditional forms of oral medications. The increasing demand for personalized medications among the various age groups is expected to foster the growth of the market in the upcoming years.

Liquid Preparations segment accounted for around 24.51% of the US compounding pharmacies market share in 2023 and is expected to be the fastest-growing segment during the forecast period. For doctors looking for a substitution for the more popular oral solid dose type, oral liquid solutions offer a versatile option. Compounding pharmacies may be required to manufacture oral liquids if an oral solid dose form is incorrect for a particular patient or if providing the patient's desired dosage is difficult. Tablets and prescriptions are typically difficult to swallow for children and the elderly. Due to liquid pharmaceuticals offering a more pleasant formulation & an easier delivery mechanism, these patient populations are able to consume their medications more readily. Patients occasionally require prescriptions that are not available over the counter, as well as certain drug combinations. Compounding chemists may develop these unique mixtures in liquid form to meet the needs of the patient.

• The oral medications segment was valued at USD 2.09 billion in 2023 and the growth rate of this segment is projected to be 6.2% during the forecast period.
• The topical medications segment reached USD 1.16 billion in 2023 and the growth rate of this segment is projected to be 6.2% from 2024 to 2033.

U.S. Compounding Pharmacies Market By Pharmacy Type Insights

Based on the pharmacy type, the 503A segment dominated the US compounding market in 2023. This segment is estimated to grow at a CAGR of 6.1% during the forecast period. The government restrictions on drug production and requirements of medicine prescriptions have led to the growth of the 503A segment in the market. It is highly used for domestic consumption and hence dominates the US market. The strict regulations for biannual monitoring and audit ensure the safety and quality of this product.

U.S. Compounding Pharmacies Market By Sterility Insights

Depending on the sterility, the US compounding pharmacies market was dominated by the non-sterile segment that accounted for a market share of around 5.9% in 2023. This segment includes processes such as reconstituting, combining, diluting, admixing, pooling, or otherwise modifying drugs or bulk substances to produce non-sterile preparations that differ from manufacturer specifications. This highlights the widespread use of non-sterile compounding in the market and emphasizes the critical need to adhere to regulatory standards to maintain product safety and effectiveness.

The sterile segment is expected to witness the highest growth rate during the forecast period. Sterile compounding is crucial for preparing medications intended for sensitive areas such as the bloodstream, eyes, lungs, or heart. This process requires highly trained pharmacists to work in controlled, sterile environments using specialized products to ensure the medications are completely free from contaminants. The growing emphasis on maintaining rigorous safety and efficacy standards for pharmaceuticals targeting these sensitive areas is driving increased demand for sterile compounding services..

U.S. Compounding Pharmacies Market By Therapeutic Area Insights

The pain management segment holds the largest revenue share of over 32.19% in 2023, primarily due to the increasing prevalence of chronic pain conditions and the limitations of standard pain relievers. Compounding pharmacies provide customized solutions, offering personalized dosages and tailored formulations that cater to patients’ specific needs. These pharmacies are particularly crucial for individuals requiring unique drug combinations, and delivery methods, or those with ingredient intolerances. As personalized pain management becomes more vital, the demand for customized treatments from compounding pharmacies continues to rise, driving market growth.

Furthermore, the nutritional supplements segment is projected to grow the fastest during the forecast period. The surge in demand for personalized medicine and custom nutritional formulations is fueling this segment's expansion. Compounding pharmacies are well-positioned to meet these demands, offering personalized supplements to address individual health concerns. The increasing focus on health consciousness and preventive healthcare among Americans further supports this trend, making tailored nutritional solutions a popular option for optimizing wellness and overall health.

U.S. Compounding Pharmacies Market, By Therapeutic Area, 2021-2023 (USD Billion)

U.S. Compounding Pharmacies Market By Age Cohort Insights

The adult segment holds the largest revenue share of over 44.18% in 2023. Adults are increasingly experiencing chronic lifestyle-related diseases linked to sedentary lifestyles and poor dietary habits, along with growing nutritional deficiencies. Adults are increasingly seeking customized compounded medications to address nutritional deficiencies and manage health conditions more effectively. Awareness campaigns by companies are further boosting demand for compounded nutritional supplements that offer comprehensive nutritional support.

Furthermore, the pediatric segment is poised for the fastest CAGR from 2024 to 2033. Pediatric patients often require specific dosages and formulations that standard medications do not offer. Compounding pharmacies meet these needs by providing tailored dosages, improved flavors for compliance, and allergen-free options for sensitive children. As the demand for personalized medications increases, compounding pharmacies are becoming essential in addressing the unique healthcare requirements of both adult and pediatric populations.

U.S. Compounding Pharmacies Market By Compounding Type Insights

The Pharmaceutical Ingredient Alteration (PIA) segment held the largest revenue share of over 37.24% in 2023. The rising demand for personalized medication stems from the recognition that standard treatments often fall short, leading patients and healthcare providers to seek customized solutions. Compounded medications, which allow for tailored dosages, preservative-free options, and enhanced formulations, are increasingly vital. This trend highlights the critical role of the PIA segment in addressing specific patient needs and reinforces its leading position in the market.

The Pharmaceutical Dosage Alteration (PDA) segment is expected to witness significant growth from 2024 to 2033. The growth of this segment is driven by the growing demand for tailored pharmaceutical solutions that address specific patient requirements, respond to medication shortages, and offer alternatives for patients with allergies or sensitivities to commercial medication formulations. Additionally, technological advancements in compounding equipment and techniques further boost this segment's growth, ensuring more accurate and safe medication customization.

U.S. Compounding Pharmacies Market Top Key Companies:

The market is fragmented due to diverse service offerings and varying state-based regulations. Specialized sectors like pediatrics, dermatology, and veterinary medicine heighten this fragmentation, each demanding unique skills and equipment. State-level regulatory complexities further escalate competitiveness among numerous local and regional pharmacies. Some emerging players are ScriptCo, Horizon Pharmacy, Eledon Pharmaceuticals, Inc., W.P Malone, Inc., and VITA PHARMACEUTICALS.

Key U.S. Compounding Pharmacies Companies:

• Avella Specialty Pharmacy
• Central Admixture Pharmacy Services, Inc.
• Clinigen Limited
• Fagron
• Fresenius Kabi USA
• ImprimisRx (Harrow Health, Inc.)
• PenCol Pharmacy
• Sixth Avenue Medical Pharmacy
• Triangle Compounding
• Vertisis Custom Pharmacy

U.S. Compounding Pharmacies Market Recent Developments

• In April 2024, Myonex acquired Saveway Compounding Pharmacy to enhance its portfolio and strengthen its position in the customized medication market. This acquisition aims to expand Myonex's service capabilities and market reach.
• In May 2023, Fresenius Kabi launched Diazepam Injection, USP in 10 mg per 2 mL Simplist prefilled syringes, available in the U.S. This new addition to the Simplist portfolio aims to streamline medication delivery and reduce the risk of errors with its ready-to-administer design.
• In February 2022, Fagron, a provider of pharmaceutical compounding, acquired Letco Medical, based in Wayne, PA, which supplies pharmaceutical raw materials and equipment for USD 34 million. This acquisition enhances Fagron's position in the U.S. Brands & Essentials market.

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 Age Cohort 

• Pediatric
• Adult
• Geriatric

By Therapeutic Area

• Hormone Replacement
• Pain Management
• Dermatology
• Pediatrics
• Urology
• Others

By End-User

• Hospitals and Clinics
• Specialty Clinics
• Others