US Compounding Pharmacies Market 2025 – 2034

Reports Description

The US Compounding Pharmacies Market is forecast to grow at a CAGR of 8.88% from 2025 to 2034. The market is expected to reach USD 13,808.0 Million by 2034, up from USD 6,363.6 Million in 2025.

Overview

The US Compounding Pharmacies market is mainly driven by the rapidly aging population, the presence of well-developed healthcare infrastructure, increasing investment in the Compounding Pharmacies, increasing awareness of healthcare, rising demand for personalized medicines and growing technological innovations.

Key Trends & Drivers

• Rising Demand for Personalized Medicine

Compounding is still very important because there is a growing need for personalized medicine, patient-specific therapies, and prescribers who want individualized doses, dosage forms, and combinations that mass-market manufacturers don’t offer. For example, the number of personalized medicines available will go from 312 in 2023 to 350 in 2025. This shows that therapies are quickly making it to the market. There are many things that are driving the demand for personalized medicines. For example, more people want personalized solutions, and there is a growing trend toward patient-centered care and precision medicine to avoid side effects.

Doctors and physicians are giving patients personalized medicines and treatments to improve health outcomes, lower side effects, and make it easier for patients to stick to their medication. The mass-produced drugs and medicines come in fixed doses and standard formulations, while compounded medications let healthcare providers customize treatments to meet the unique medical needs of each patient.

• ‌Rising Prevalence of Chronic Diseases

The changing demographics and increasing aging population are increasing the number of chronic disease patients. This will likely lead to more people needing compoundable pharmacies. There is a steady need for medications that are not easily available in stores because of things like more hormonal imbalances, skin disorders, and rare diseases. The CDC says that about 6 out of 10 Americans have at least one chronic disease, and 4 out of 10 have two or more.

According to the data published by the WHO more than 129 million people in the US have at least one serious long-term illness, like heart disease, cancer, diabetes, obesity, or high blood pressure. Chronic diseases that come with getting older, like heart disease, dementia, and arthritis, are becoming more common as people live longer. The stakeholders operating in the healthcare ecosystem are using compounding pharmacies and leveraging these gaps by providing solutions that are specific to each patient’s needs.

• Drug Shortages and Supply Disruptions

Supply chain problems and trade wars are to blame for the rising drug shortages and supply problems in the US As generic and brand-name drugs and other pharmaceutical products become harder to find, the need for compounded alternatives is rising. A recent high-profile example is compounded versions of injectable weight-loss drugs. These kinds of shortages can cause demand to spike quickly and by a lot.

The US often has problems with the supply chain and shortages of important medicines, including injectable and sterile preparations and specialty drugs. Drug shortages and supply chain problems are happening because of things like delays in production, not having enough raw materials, supply chain bottlenecks, demand and supply not being balanced, and strict rules.

Hospitals and clinics need a steady supply of drugs, so they often have to scramble when manufacturers can’t meet their needs. For example, the American Society of Health-System Pharmacists (ASHP) says that drug shortages are still a big problem in the US in 2025. There are 270 active drug shortages as of April. So, during public health emergencies and recent shortages of high-demand treatments like pain management drugs, oncology medications, and even injectable weight loss drugs, it became very clear that people were becoming more reliant on compounding. So, these things are likely to make more people want to use compoundable pharmacies during the time period.

Key Threats

• Heavy Regulatory Burden

 The US pharmaceutical industry is heavily regulated by federal as well as state regulations. The stringent FDA, USP standards, and Drug Quality and Security Act (DQSA) mainly regulate the compoundable pharmacies sector. These rules and regulations distinguish between 503A (patient-specific) and 503B (outsourcing) facilities. Furthermore, every state has its own set of rules and regulations pertaining to compoundable pharmacies; the stakeholders operating in the market are finding it very difficult to comply with such statewide regulations. Complying with these regulations requires heavy investment, infrastructure, and time.  Frequent inspections and evolving guidance increase compliance costs and create barriers for smaller players, thereby discouraging investment in the market.

• Heavy Competition from Branded/Generic Manufacturers:

The increasing influx of branded and generic drugs in the US market is creating heavy competition for existing pharma companies, thereby compounding pharmacies. The drug shortages are increasing in the US market due to the supply chain disturbances and trade barriers. The generic drug manufacturers are adopting resilient supply chain strategies such as expanding dosage offerings and reducing prices. Thus, in such a heavy competitive landscape, compounded alternatives may lose relevance, especially when insurers prefer covered commercial drugs. The growing litigations and lawsuits due to increasing IPR related concerns are expected to restrain the market growth. The branded drug manufacturers are continuously filing lawsuits against small-scale pharmacies and compounders, especially around high-demand drugs such as GLP-1 agonists, such as weight-loss injectables. Thus, such increasing legal uncertainty creates reputational and operational risks, discouraging aggressive expansion.

Opportunities

• Telehealth and digital clinic growth

The scale-up of telemedicine and online prescribing has increased patient access to compounded therapies (and enabled large direct-to-consumer compounders), amplifying market reach. Telehealth also raises quality/oversight concerns. The growing trend of personalized medicine trends coupled with the increasing tech-savvy population in the US is acting as an important driver of the US compounding pharmacies market. The rapid adoption of virtual healthcare practices, coupled with increasing technological integration and growing usage of video conferencing and other virtual healthcare practices, can enable the patients to consult physicians and specialists remotely, often bypassing geographic or mobility barriers. This shift has increased demand for customized medications, as doctors are prescribing therapies tailored to individual patient needs during teleconsultations.

For instance, according to a survey conducted by the US health department, more than 54% of Americans have had a telehealth visit, with 1 in 6 having had four or more in 2024. Furthermore, among those who have used telehealth, 89% say they were satisfied with their most recent visit, demonstrating the benefit of the technology. Thus, growing penetration of telehealth care solutions is expected to create lucrative opportunities for the market during the forecast period.

Segmentation Analysis

By Type ‌

• 503A: The Federal Food, Drug, and Cosmetic Act (FDCA) categorized the pharmacies as 503A traditional compounding pharmacy facilities, which prepare customized medications and pharmaceutical solutions based on a valid patient-specific prescription. These pharmacies operate primarily at the local or regional level, serving physicians, clinics, and individual patients. The 503A category of pharmacies caters its products to patients requiring non-standard dosages, alternative dosage forms, or removal of specific inactive ingredients. This segment is crucial in addressing unique patient requirements that commercial drugs cannot meet. ‌

• 503B: This segment held the highest market share in 2024 and is expected to keep its dominance during the forecast period. This segment is mainly used for outsourcing services. This category of pharmacies can manufacture and distribute the medicines. Furthermore, it can cater its pharmaceutical products directly to hospitals, surgery centres, and clinics that require large volumes of sterile and ready-to-use medications. 503B pharmacies play an increasingly vital role in addressing drug shortages, ensuring a reliable supply of sterile injectable pain management drugs, oncology treatments, and parenteral nutrition.

By Age

• ‌Pediatric: The pediatric age segment is acting as a significant growth driver in the US compoundable pharmacies market. Various factors such as increasing numbers of newborn diseases, growing awareness about childcare, increasing vaccination programs, and supportive policies are mainly boosting the demand for compoundable pharmacies in the pediatric age groups. Children often need medications and pharmaceuticals in the form of dosages, liquids, gummies, or topical preparations; the compounding pharmacy, through its customized solutions, provides such solutions. Additionally, compounding allows pharmacists to remove allergens, dyes, or unnecessary fillers that may cause adverse reactions in children.‌

• Adult: The adult population segment is a major consumer base of compoundable pharmacies. Increasing prevalence of chronic diseases, hormone imbalance situations, thyroid diseases, and dermatological issues are boosting the demand for customizable pharmaceutical solutions. For instance, in the US more than 38% of the adult population is suffering from prediabetes, including both diagnosed and undiagnosed cases. Thus, such a population requires long-term and lifestyle-focused compounded therapies. ‌

• Geriatric: The growing geriatric population in the US due to demographic shift is expected to drive the demand for personalized medicines and pharmaceutical solutions, thereby driving overall market growth. The aging population requires facing the pharmacy accessibility challenges in the US, difficulties in getting required tablets and medicines compounding pharmacies can help in addressing such problems by providing medicines, alternate dosages, liquid formulations, or transdermal delivery methods to improve compliance. For instance, as of 2024, there were 61.2 million Americans aged 65 and older. The share of the total US population that is age 65+ has increased to ~18.0% in 2024. Thus, such factors are expected to drive the overall market growth during the forecast period.

Impact of Recent Tariff Policies

The growing tariffs on pharmaceutical products and industry are creating a negative impact on the US compounding pharmacies. The sudden changes in the tariff policies and increasing trade tensions between the US and China are increasing the cost of the imported active pharmaceutical ingredients (APIs) and finished products, which could lead to higher prices for patients, potential drug shortages, and strained profit margins for the pharmacies.

The stakeholders operating in the market are facing the below-mentioned challenges due to the tariff policies. The increased raw material cost is due to the fact that overall pharmacies are heavily relying on the imported APIs, with over 80% coming from countries like China and India. The changing tariffs, such as 10% as a baseline and higher tariffs of up to 200-250%, are directly increasing the cost of these raw materials and packaging supplies.

The changing tariff policies are creating disturbances in the supply chain disruptions and shortages. The US pharmaceutical industry is already facing drug shortages, and tariffs could worsen this situation. Furthermore, these tariffs are increasing the overall imported cost of the APIs and other essential products, leading to a reduction in competition and potential shortages of essential medications.

Report Scope

Feature of the Report	Details
Market Size in 2025	USD 6,363.6 Million
Projected Market Size in 2034	USD 13,808.0 Million
Market Size in 2024	USD 5,898.23 Million
CAGR Growth Rate	8.88% CAGR
Base Year	2024
Forecast Period	2025-2034
Key Segment	By Type, Therapeutic Area, Age, Compounding Type, Sterility Type and Region
Report Coverage	Revenue Estimation and Forecast, Company Profile, Competitive Landscape, Growth Factors and Recent Trends
Buying Options	Request tailored purchasing options to fulfil your requirements for research.

Regional Analysis

• Northeast: This region includes various states such as New York, New Jersey, Massachusetts, Pennsylvania, Connecticut, Rhode Island, Vermont, etc. The Northeast region has the presence of well-established healthcare and pharmaceutical industries, dense metro populations, medical research centers, and specialty clinics and hospitals, which in turn is driving the demand for compoundable pharmacies for customized medications. Furthermore, this region has the highest per capita healthcare spending as compared to other states. For instance, in 2024, the New York per capita healthcare expenditure is estimated at $14,007 per person, one of the highest in the nation. Thus, such favourable factors are expected to drive the overall market growth.

• The Midwest: This region includes major states such as Illinois, Indiana, Iowa, Kansas, Michigan, and Minnesota. This region combines large hospital chains, advanced healthcare infrastructure, and the highest number of aging populations. Furthermore, many state governments have implemented the institutional policies to boost the demand for sterile injectables and chronic-care formulations, which in turn are expected to drive the demand for compounding pharmacies.

• South: The south region includes major states such as Delaware, Florida, Georgia, Maryland, North Carolina, and South Carolina, etc. This region is expected to grow at the fastest CAGR during the forecast period owing to the presence of a large medicated population in the region. Various factors such as high population growth, an increasing number of surgeries in the region, the presence of many pharmaceutical companies in the region, a large tourist patient inflow, and high numbers of ambulatory surgical centers that require ready-to-use sterile products are expected to drive the compounding pharmacies market during the forecast period.

• West: This region includes major states such as Alaska, California, Hawaii, Oregon, Washington, and Arizona, etc. The West region is led by California and Washington due to high demand for hormone replacement and telehealth-driven solutions. The california hosts many large compounding and outsourcing facilities, significant telemedicine providers, and an affluent patient base willing to pay out-of-pocket for bespoke therapies. Furthermore, the presence of a well-established biotechnology hub, increasing investment in healthcare expansion, and rapidly expanding clinics and the surgical industry are some of the factors expected to create lucrative opportunities for market growth during the forecast period.

Key Developments

• In Dec 2024, IRE Fresenius Kabi, an operating company of Fresenius launched the Epinephrine Injection, USP, which is now available in the United States as the first generic version of Epinephrine in a 1 mg/1 mL vial for US customers. Through these new product launches the company is aiming to enhance their product portfolio.

• ‌Recently, Central Admixture Pharmacy Services, Inc. a B. Braun company and the nation’s largest network of outsourcing admixture pharmacies, has today opened a new sterile compounding outsourcing facility in Phoenix, bringing nearly 400 jobs to the area.

Leading Players

The US Compounding Pharmacies Market is highly competitive, with a large number of product providers in the US. Some of the key players in the market include:

• ‌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
• Others

These firms apply a sequence of strategies to enter the market, including innovations, mergers, and acquisitions, as well as collaboration.

The US Compounding Pharmacies Market is segmented as follows:

By Type

• ‌503A
• ‌503B

By Therapeutic Area

• ‌Hormone replacement therapy
• ‌Pain management
• ‌Specialty drugs
• ‌Dermatolog
• ‌Nutritional Supplements
• ‌Others

By Age

• ‌Pediatric
• ‌Adult
• ‌Geriatric

By Compounding Type

• ‌Pharmaceutical Ingredient Alteration (PIA)
• ‌ Currently Unavailable Pharmaceutical Manufacturing (CUPM)
• ‌Pharmaceutical Dosage Alteration (PDA)
• ‌Others

By Sterility Type

• ‌Sterile
• ‌Non sterile

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