Growth in conditions like diabetes, cancer, and arthritis that require specialized formulations is estimated to drive the growth of the market in the near future. Increasing patient preference for customized medications tailored to specific needs (e.g., dosage, form, allergens) has been estimated to drive the growth of the U.S. compounding pharmacies market over the forecast period.
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The U.S. compounding pharmacies market has been growing significantly in the past few years. Increased demand for compounded pain medications amid restrictions on opioids and concerns over addiction. Growth in hormone replacement therapies (HRT), including treatments for menopause and testosterone deficiency. People going through perimenopause and menopause can more easily access care and essential medications without having to make in-person appointments thanks to this unique offering, which serves as a virtual menopause and midlife health clinic. It also saves members time and money.
The increasing demand for customized medications is also playing a huge role in market growth. Compounded drugs can be easily personalized, delivering exact dosages and specific strengths, as well as even being changed in form (oral, topical, etc.) depending on patient requirements. This is especially important in an aging American population, with elders often requiring therapeutics and drugs in customized forms or dosages. Compounding pharmacies can prepare medications for conditions commonly found in the elderly, such as chronic pain, hormone imbalances, and age-related diseases.
Many commercial medications are discontinued or face supply chain issues, leading to a demand for compounded alternatives. Compounding pharmacies also assist in filling the gap in certain regions in the United States where healthcare coverage is sparse. Doses for pediatric drugs, in particular, are often in low supply. These pharmacies also help pick up the slack during drug shortages, especially for those with specific formulations and strengths.
In order to determine the underlying causes of shortages and work with manufacturers, regulators, and legislators to create solutions, key players in the space are concentrating on openness and data-driven insights. Towfic also emphasized the main conclusions of USP's 2024 annual Drug Shortages Report, which showed that shortages are occurring for an average of three years and that more than half of them involve generic sterile injectables, a class that has a big influence on health systems. By discouraging manufacturer participation, economic factors in particular, low drug prices were found to be key contributors to these shortages.
Supportive policies in some regions encourage compounding for unmet medical needs. Compliance with USP <795>, <797>, and <800> standards for quality and safety. Evolving FDA and USP regulations (USP <795>, <797>, and <800>) are shaping the U.S. compounding pharmacies market, ensuring safety and sterility in compounding practices. The Drug Quality and Security Act (DQSA) of 2013 has increased oversight of compounding pharmacies, driving market consolidation.
AI is making waves in the U.S. compounding pharmacies market. Artificial intelligence can analyze patient history, allergies, and drug interactions to create more precise, personalized formulations. Machine learning algorithms can optimize dosage adjustments based on real-time patient data, improving efficacy. AI-driven computer vision systems can detect contamination or inconsistencies in compounded medications.
Automated compliance tracking ensures adherence to FDA regulations and United States Pharmacopeia standards, which result in reduced regulatory risks. AI can simulate molecular interactions to refine drug formulations, leading to more stable and effective compounded medications. Algorithms can predict the best excipients to enhance solubility, bioavailability, and shelf life. AI-powered forecasting can predict demand for specific compounded medications, reducing waste and shortages. Smart inventory systems can automatically reorder raw materials based on real-time usage data.
AI-driven chatbots and virtual assistants can provide medication counseling and answer patient queries about compounded drugs. AI-powered telehealth platforms can streamline e-prescriptions and customized treatment plans, reducing wait times. Key players in the space are also using tools such as Medicine Supply Maps, an Al-driven platform that forecasts shortage threats, and financial incentives to maintain the manufacture of necessary pharmaceuticals in order to address these issues.
AI can predict and identify potential drug shortages, helping pharmacies preemptively compound substitutes before shortages occur. AI-driven robotic arms can improve the accuracy and sterility of sterile compounding procedures. Automated dosing and dispensing systems minimize human error in compounding. AI accelerates research on alternative formulations for patients with rare diseases or medication sensitivities. Machine learning models can predict the stability and compatibility of newly compounded drug combinations before clinical testing. Pharmacy Compounding.
U.S. Compounding Pharmacies Market Key Takeaways:
· By type, the 503A segment registered the maximum market share in 2024.
· By type, the 503B segment is estimated to expand the fastest CAGR in the market over the forecast period.
· By therapeutic area, the pain management segment contributed the largest market share in 2024.
· By age, the adult segment accounted for a considerable share of the market in 2024.
· By sterility, the sterile segment registered the maximum market share in 2024.
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U.S. Compounding Pharmacies Market Trends
• Increased Regulatory Oversight: Regulatory bodies are intensifying oversight to ensure the safety and efficacy of compounded medications. Pharmacies are adopting stricter quality control measures to comply with evolving standards. There is also a heightened focus on implementing comprehensive quality assurance protocols, including regular testing and adherence to stringent standards, to maintain medication safety and effectiveness.
• Advanced Technology Integration: The adoption of automation and robotic systems is streamlining compounding processes, reducing errors, and enhancing operational efficiency. This is especially useful in personalized medicine, with the growing demand for tailored treatments leading to an increase in compounded medications designed to meet individual patient needs, such as specific dosages and formulations.
• Addressing Drug Shortages: Compounding pharmacies are playing a crucial role in mitigating drug shortages by providing alternative formulations of medications that are in limited supply. players in the U.S. compounding pharmacies market, such as Pfizer, are introducing several estrogen-based menopausal hormone treatments in the United States for prescription-based access in compounding pharmacies, with the aim of broadening customer reach. Moreover, in April 2024, Baxter International Inc., a leader in injectables, anesthesia, and drug compounding, announced the launch of five injectable products in the United States as part of its ongoing pharmaceutical portfolio expansion.
U.S. Compounding Pharmacies Market Report Scope
|
Report Coverage |
Details |
|
Market Size in 2025 |
USD 5,670 Million |
|
Market Size by 2034 |
USD 8,720 Million |
|
Growth Rate from 2025 to 2034 |
4.9% |
|
Base Year |
2024 |
|
Forecast Period |
2025 to 2034 |
|
Segments Covered |
By Pharmacy Type, By Product, By Sterility, By Compounding Type, By Therapeutic Area, and By End-User |
Market Segmentation
Type Insights
The 503A segment registered its dominance over the market. 503A pharmacies focus on patient-specific prescriptions, catering to individuals with unique medical needs. Growth in personalized medicine, including hormone replacement therapy (HRT) and pediatric formulations, drives demand. Most compounding pharmacies in the U.S. are 503A facilities operating within community and hospital settings. These pharmacies serve local patients and have established relationships with healthcare providers.
503A pharmacies can modify dosage forms, remove allergens, and create specialized drug formulations that are unavailable commercially. Growing patient preferences for dye-free, preservative-free, and lactose-free medications boost this segment. 503A pharmacies provide patient-specific solutions that mass manufacturers do not offer.
The 503B segment is anticipated to grow with the highest CAGR in the market during the studied years. 503B pharmacies must adhere to Current Good Manufacturing Practice (CGMP) regulations, ensuring higher quality and sterility standards. Hospitals and health systems prefer 503B products because they meet stricter safety and quality assurance requirements. Hospitals and surgical centers require ready-to-use, sterile medications with inconsistent supply.
The rise of oncology, pain management, and hormone replacement therapies (HRT) has increased demand for high-volume compounded medications. 503B facilities specialize in sterile compounding, making them preferred suppliers for complex, high-risk medications. More hospitals and healthcare networks are outsourcing their sterile compounding needs to 503B pharmacies due to cost and compliance pressures. This reduces in-house pharmacy compounding risks while ensuring a reliable, FDA-compliant drug supply. 503B pharmacies provide uniform, batch-tested medications, ensuring consistent potency and sterility across large healthcare networks.
Therapeutic Area Insights
In terms of therapeutic area, the pain management segment held a dominant presence in the market in 2024. Patients often require specific dosages, combinations, or alternative formulations that commercial medications do not provide. Compounded pain medications can be tailored to individual pain tolerance levels and medical conditions. With the opioid crisis leading to stricter regulations on narcotics, physicians seek customized, non-opioid pain relief options.
Compounded pain medications can include multiple active ingredients in one formulation, reducing the need for multiple prescriptions. Commercial pain medications often contain dyes, preservatives, and fillers that cause allergic reactions or gastrointestinal issues. Compounded medications can be made preservative-free, gluten-free, or lactose-free to meet patient needs.
The nutritional supplements segment is anticipated to grow with the highest CAGR in the market during the studied years. More consumers seek customized vitamin and mineral formulations tailored to their age, health conditions, and lifestyle needs. Patients and healthcare providers emphasize preventive medicine to manage chronic diseases like diabetes, cardiovascular disorders, and osteoporosis.
Compounded supplements help address nutrient deficiencies before they develop into health issues. Many commercial supplements contain fillers, preservatives, artificial colors, and allergens that some patients cannot tolerate. Compounded nutritional supplements can be made dye-free, gluten-free, sugar-free, or hypoallergenic. Holistic medicine practitioners and functional medicine doctors are increasingly prescribing customized supplements for their patients.
Age Insights
The adult segment accounted for a considerable share of the market in 2024. Adults (especially those over 40) are more likely to develop chronic conditions like diabetes, cardiovascular diseases, arthritis, and autoimmune disorders. Compounded medications provide personalized treatment solutions for these long-term conditions.
Chronic pain conditions, including neuropathy, fibromyalgia, and arthritis, are more prevalent in adults. Compounded pain relief options, such as topical creams (lidocaine, ketoprofen, diclofenac) and transdermal patches, provide customized relief with fewer systemic side effects. Adults seek customized anti-aging solutions, including NAD+, collagen, peptide therapies, and antioxidant supplements. Adults are turning to integrative medicine for holistic, personalized treatment approaches, increasing the demand for custom compounded prescriptions and supplements.
The pediatric segment is expected to grow at the fastest rate in the U.S. compounding pharmacies market during the forecast period of 2024 to 2034. Many commercially available medications come in fixed doses that are not suitable for infants, toddlers, and young children. Compounded medications allow pharmacists to adjust doses based on the child’s age, weight, and specific medical needs. Many children have allergies or sensitivities to ingredients like gluten, lactose, artificial dyes, and preservatives found in commercial drugs.
Compounding Type Insights
The Pharmaceutical Ingredient Alteration (Pharmaceutical Ingredient Alteration (PIA)) segment led the U.S. compounding pharmacies market. Many patients are allergic to dyes, preservatives, gluten, lactose, or other excipients in commercial drugs. Pharmaceutical Ingredient Alteration (PIA) allows pharmacists to remove these unwanted ingredients while maintaining the drug’s effectiveness. Patients with autoimmune diseases, autism, or metabolic disorders often react negatively to certain pharmaceutical additives.
Pharmacies can recreate essential medications using alternative ingredients while ensuring bioequivalence. Some patients struggle with poor medication absorption due to gastrointestinal conditions (e.g., Crohn’s disease, IBS). Pharmaceutical Ingredient Alteration (PIA) allows pharmacists to reformulate drugs using alternative delivery methods (e.g., sublingual, transdermal, or liquid formulations) for better absorption. Children and elderly patients often require milder or alternative formulations to standard medications.
The Pharmaceutical Dosage Alteration (PDA) segment is projected to expand rapidly in the market in the coming years. Commercially available medications come in fixed strengths, which may not suit all patients. Pharmaceutical Dosage Alteration (PDA) allows pharmacists to customize dosages based on a patient’s age, weight, metabolism, and medical condition. This is especially beneficial for pediatrics, geriatrics, and patients with organ dysfunction (e.g., liver or kidney disease) who require precise dosing.
· The U.S. experiences frequent drug shortages, especially for specialty or less profitable drugs. Pharmaceutical dosage Alterations (PDA) allow compounding pharmacies to recreate medications in alternative forms when manufacturers discontinue them. Custom dermatology formulations (e.g., compounded acne, anti-aging, or scar treatments).
Sterility Insights
The sterile segment registered its dominance over the U.S. compounding pharmacies market in 2024. In order to prepare pharmaceuticals for delicate locations like the heart, lungs, eyes, or circulation, sterile compounding is essential. Highly skilled pharmacists must use specialist goods in sterile, controlled settings during this process to guarantee that the drugs are totally free of impurities. Sterile compounding services are becoming more and more in demand as a result of the increased focus on upholding strict safety and efficacy criteria for medications that target these delicate areas.
The non-sterile segment is predicted to witness significant growth in the market over the forecast period. This section covers procedures that create non-sterile preparations that deviate from manufacturer requirements, such as reconstituting, mixing, diluting, admixing, pooling, or otherwise altering medications or bulk materials. This demonstrates how common non-sterile compounding is in the market and how important it is to follow legal requirements to preserve the efficacy and safety of products.
Related Reports:
• Bulk-Drug Compounding Market: https://www.statifacts.com/outlook/bulk-drug-compounding-market
• U.S. Dermatological Drugs Market: https://www.statifacts.com/outlook/us-dermatological-drugs-market
• U.S. Active Pharmaceutical Ingredients Market: https://www.statifacts.com/outlook/us-active-pharmaceutical-ingredients-market
• U.S. Pharmaceutical Market: https://www.statifacts.com/outlook/us-pharmaceutical-market
• Cardiovascular Drugs Market: https://www.statifacts.com/outlook/cardiovascular-drugs-market
U.S. Compounding Pharmacies Market Players
• 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
Recent Developments:
• In October 2024, Novo Nordisk C3 requested that the U.S. Food and Drug Administration prohibit compounding pharmacies from producing imitations of its well-known medications for diabetes and weight reduction because they are too complicated for those producers to safely make. In order to fulfill demand, U.S. regulations permit compounders to mix, combine, or modify prescription ingredients to replicate brand-name medications that are in short supply. For a large portion of 2024, the United States has had a scarcity of Novo's Wegovy and the diabetic medication Ozempic, which are both chemically known as semaglutide.
• In February 2025, The first-ever board certification in hazardous compounding is proudly offered by the Board of Pharmacy Technician Specialists (PTS), establishing a new standard for quality and security in pharmacy practice. Pharmacy technicians who successfully finish the certification process will be awarded the Board Certified Hazardous Compounding Pharmacy Technician (BCHCPT) certificate, which attests to their proficiency in the safe and efficient handling and preparation of hazardous drugs. BCHCPT Online Pharmacy technicians are essential in making sure that dangerous prescriptions are prepared safely, especially as the demand for high-risk medications rises. By validating their abilities and expertise, this certification aims to help people advance their careers and fulfill the strictest safety and compliance requirements.
Segments Covered in the Report:
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 therapy
• Pain management
• Specialty drugs
• Dermatology
• Nutritional Supplements
• Others
By End-User
• Hospitals and Clinics
• Specialty Clinics
• Others
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