The USA compounding pharmacies market is estimated to reach USD 5,156.2 million in 2024. It is estimated that revenue will increase at a CAGR of 7.8% between 2024 and 2034. The industry is anticipated to reach USD 10,659.3 million by 2034.
Compounding pharmacies in the United States are on an unwavering path to expanding progress led by the rapidly changing needs of patients and healthcare providers. The demand for formulation tailored for individual cases has become one of the more fundamental contributors to this growth.
Such motivation has driven patients closer to sourcing personalized pharmaceuticals for the management of their specific health situations, only fueling further growth of the compounding pharmacy space. These pharmacies will lend their hand in formulating personalized medicines that are noncommercial available, thereby fulfilling market growth.
USA Compounding Pharmacies Industry Assessment
| Attributes | Key Insights |
|---|---|
| Historical Size, 2023 | USD 4,897.4 million |
| Estimated Size, 2024 | USD 5,156.2 million |
| Projected Size, 2034 | USD 10,659.3 million |
| Value-based CAGR (2024 to 2034) | 7.8% |
One major factor fueling growth is the expanding demand for veterinary compounding, as specialized health care for animal species is on the rise. A growing demand for compounded medications for animals can now be found since veterinary medicine is quite sophisticated.
To respond to the challenge, compounding pharmacies are offering preparations that target special pet needs by offering species-specific formulations aimed at enhancing the growth of the market.
The emphasis on strict regulation of compounded medications has been an important contributor to the maintenance of the safety and quality of compounded medications. The regulatory framework surrounding compounding pharmacies in the United States is rigid to ensure patient safety and appropriate standards for quality control.
However, all these regulations are important to consumer confidence in compound pharmacists, as they are enforced both at the federal and state levels.
Another influential area contributing to market growth has been bioidentical hormone therapy (BHT), mainly in menopause management and hormonal imbalance.
The increased demand for personalized hormone-type therapies enabled the compounding pharmacist to customize hormone therapies-the additional factor contributing to market growth.
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The below table presents the expected CAGR for the USA compounding pharmacies market over several semi-annual periods spanning from 2024 to 2034. In the first half (H1) of the decade from 2023 to 2033, the business is predicted to surge at a CAGR of 8.5% followed by a slight decline in the growth rate which will grow at 8.2% in the second half (H2) of the same decade.
| Particular | Value CAGR |
|---|---|
| H1 | 8.5% (2023 to 2033) |
| H2 | 8.2% (2023 to 2033) |
| H1 | 7.8% (2024 to 2034) |
| H2 | 7.3% (2024 to 2034) |
Moving into the subsequent period, from H1 2024 to H2 2034, the CAGR is projected to decrease slightly to 7.8% in the first half and remain relatively moderate at 7.3% in the second half. In the first half (H1) the market witnessed a decrease of 70 BPS similar with the second half (H2), the market witnessed a decrease of 90 BPS.
Rising Awareness and Acceptance of Bioidentical Hormone Replacement Therapy to Fuel the Market
An increase in the general awareness about the merits of personalized hormone treatments is expected to be a strong driver behind the rise in appropriation and acceptance of hormone replacement therapy (HRT) treatments, especially responsibilities dedicated to bioidentical hormone replacement therapy (BHRT).
The last decade has borne witness to changing public perceptions, with many patients looking toward alternatives to traditional HRT. More women, particular those in menopause, are turning toward bioidentical hormones, which are chemically identical to naturally produced hormones, as a combination option that may be safer and more natural than the synthetic hormones used in conventional therapy.
Increased education by health professionals, the media, and advocates has made it known to many that BHRT are favorable because they will have fewer side effects and provide better symptom relief than traditional form hormone therapies.
Patients have become increasingly aware of the potential hazards associated with the use of synthetic HRT and are demanding medicines that suit the rhythm of natural hormone flow in their bodies.
Another factor contributing to the rise of BHRT treatments is the willingness of compounding pharmacies to prescribe individualized dosages and combinations of hormones to the patients.
As demand grows, compounding pharmacies will be able to offer customized hormone therapy solutions, addressing various symptoms related to menopause, perimenopause, and hormonal imbalances, including hot flashes, mood swings, and night sweats. Such customization is especially appealing to patients who fail to respond well if treated with standard therapy.
With more individuals seeking personalized natural treatment options, it expands the market for BHRT, thus making it one of the important crucial growth drivers.
Advancements in Technology for Enhanced Compounding Precision to Drive Market
Currently, the USA compounding pharmacies market is experiencing some innovative trends with an increasing rollout of advanced technologies meant to enhance the precision and efficiency of compounded medications.
In the history of compounding technology, there are many significant innovations, including the automated compounding system, which is defined as mixing and preparing of medication very precisely with the least chance for human error.
These systems are especially useful in settings with heavy drug demands, guaranteeing the safe preparation of accurate formulations with minimal chance of contamination or dosage inaccuracies.
Other options like 3D printing technologies are growing in popularity in compounding pharmacies, allowing the manufacture of complex and individualized drug compounds for patients that might be difficult to develop otherwise using traditional compounding techniques. They permit custom pill shapes, sizes, and dosages, thus resulting in personalized patient solutions.
Besides, complicated software solutions are being utilized to facilitate the work of pharmacy staff by assisting them in the complex calculations for dosage, continual tracking of inventory, and checking for quality. They help to ensure each compounded medication is manufactured to meet specific specifications and safety standards.
As these technologies evolve, they provide an opportunity for compounding pharmacies to not only improve operational efficiency but also design life-saving products-specific cancer care, customized pain management drugs, and modified dermatological therapies.
The acceptance of this sophisticated technology has resulted in the killing of two birds with one stone: providing a realization to compounded pharmacies for better-reader customization, a reduction in operating costs, and, above all, realization of the growing demand for precision medicine.
This trend will continue as technological enhancements exhibit themselves through growths, extending mounts towards an enhancing influence on patient outcomes and to provide improved quality services.
Opportunities in Service Expansion and Regulatory Compliance for Compounding Pharmacies
Diversification of service classification from just pharmacists to healthcare service providers for registered pharmacists will improve revenue and recognition base. Registered pharmacists may also be classified as healthcare service advisors, providing services such as therapy management and patient consultation.
In this regard, studies have revealed that when pharmacists are directly involved in patient care, they have demonstrated less adverse drug reactions and have experienced improved patient outcomes. This has also reduced overall healthcare costs for the public.
Self-nomination for inspection and clearing FDA approval process for adherence to cGMP guidelines is expected to increase drug and brand value for CPs (compounding pharmacies) in future. To achieve this, firms need to abide by stipulated FDA norms and also be prepared for surprise inspections.
Regulatory inspections of drug manufacturing facilities is expected to boost inclination by compounding pharmacies towards adherence to good manufacturing practices and thus increase consumer uptake for these drugs.
Safety Concerns and Regulatory Challenges in Compounded Drugs to Hinder Market Growth
The primary factor restraining usage of compounded drugs is unsafe compounding practices, which include compounding contaminations and non-adherence to GMP regulations. This is very prominent across sterile compounding involving injectable drugs and intravenous solutions.
Contaminated sterile environments lead to spread of pathogens and fungal infections, and have resulted in various hazards and drug-related deaths, thus dampening the prospects for CPs.
To avoid unsafe compounding practices, the USA FDA has made it mandatory for all outsourcing facilities manufacturing bulk drugs to be inspected and to secure cGMP certification.
Increase in number of restricted drugs is expected to dampen sales prospects of compounded drugs. In this regard, the USA FDA noted that it plans to add four drugs to its list of drugs “not allowed to be compounded” in bulk, by outsourcing facilities in June 2019.
These include aprotinin (Trasylol), ondansetron hydrochloride (Zofran), bromocriptine mesylate (Parlodel), and acetaminophen (Tylenol). An order prohibiting compounding of these drugs could reduce demand for common compounded drugs such as Tylenol.
Compounded drugs can increase patient health safety risks, thus impacting patient safety when launched quickly to mitigate a drug shortage. Around 75% of drugs shortages are for sterile injectable generic drugs, which are complex to compound safely.
Compounding sterile drugs, or drugs with sterile and non-sterile ingredients, requires special training and facilities, and involves significant risk to drug safety when sterile drugs are compounded in non-sterile environments. Recalls of potentially unsafe compounded medications can exacerbate shortage problems.
The USA compounding pharmacies industry recorded a CAGR of 6.4% between 2019 and 2023. According to the industry, USA compounding pharmacies generated USD 4,897.4 million in 2023, up from USD 3,986.8 million in 2019.
The USA compounding pharmacies market has seen drastic changes and shifts between 2019 and 2023 as a result of an increased demand for personalized medications, more intense regulation, and technological advancement.
One of the most noticeable historical trends is the rising demand for customized medications, with specific emphases in areas such as BHRT-pain management, pediatric, and geriatric care, with patients requiring specific formulations tailored to their health needs.
This transition towards personalized care would not have been possible without advances in technology, particularly in areas such as automated compounding systems, 3D printing, and precision software tools, allowing pharmacies to produce first-rate, individualized treatments more efficiently.
The market at the same time was witnessing an increased scrutiny from the regulators, particularly in sterile compounding involving injectables and intravenous solutions. The focus of the founders on compliance with cGMP in cutthroat competition and mandatory inspections of outsourcing facilities was imperative to attract and establish higher quality standards of compounded medications in accordance with regulative laws so as to make drug safety a priority in sterile drug compounding.
All of this focused action was essential to provide risk mitigation against contamination and drug-related safety issues.
Future trends will take over soon in the compounding pharmacies market. Another fundamental transitional trend is the upgrading of pharmacists' functions from traditional dispensers to active advisors on healthcare services such as therapy management and patient consultations.
This involvement of pharmacists in patient care reduces the incidence of adverse drug reactions and results in improved patient outcomes.
Another trend is the continuous emphasis on the adherence to regulatory compliance; pharmacies will be required to abide by tough FDA guidelines, which will include obtaining cGMP certification so as to guarantee safety and quality in drugs produced.
These trends combined with increasing patient demand for personalized healthcare solutions suggest that the USA compounding pharmacies market will continue to expand, focusing on both innovation and patient safety.
Tier 1 includes companies cumulatively hold around 34.7% share of the total market revenue. These companies are the largest players in the USA compounding market, with broad national or regional reach, significant infrastructure, and possibly a large share of both sterile and non-sterile compounding services. The companies that comprises tier I are Fagron N.V., Clinigen Group, Avella Specialty Pharmacy.
Tier 2 includes companies cumulatively hold around 27.5% share of the total market revenue. The companies that comprises tier II are Vertisis Custom Pharmacy, Dougherty’s Pharmacy, Hoye’s Pharmacy and others.
These companies are well-established and may have a strong regional presence or a focus on specialized compounding services, but their market share and reach are smaller compared to Tier 1 players.
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A description of the leading segments in the industry is provided in this section. Oral Medication held 58.4% of the value share in 2023 by product category whereas, hormone replacement therapeutics by therapy type are the leading type with high share of 34.2% in the market in 2023.
| Product | Oral Medication |
|---|---|
| Value Share (2024) | 58.4% |
In USA compounding pharmacies market, oral medication by product will dominate by 58.4% in 2024, due to their widespread use, ease of administration, and ability to address a broad range of medical needs. The oral route is the one that is most frequently utilized since it is the most practical, typically the safest, and least costly.
The segment of oral medications is growing as a result of rising sales and the expiration of blockbuster medications. Compounding pharmacies in the United States experience high demand for these medications.
These drugs is mostly used to alleviate mild ailments like fever and joint pain. They also promote sleep, strengthen the immune system, lessen anxiety, and soothe itching. Skin irritations can also be treated with these drugs.
| Therapeutic Type | USA Hormonal Replacement Therapy |
|---|---|
| Value Share (2024) | 42.2% |
In the compounding pharmacies market, HRT will be the leading type in 2024 with 42.2%. Hormone replacement therapy (HRT) is the most sought therapy type in compound pharmacy, mainly driven by increasing demand for personalized treatments for the conditions related to menopause and other hormone-related conditions.
The increased awareness on the benefits of bioidentical hormone replacement therapy (BHRT), which uses hormones that are chemically identical to those naturally produced in the body, has been the major driver. As traditional synthetic hormones have very many adverse effects, their demand coupling is in great pressure upon market growth.
HRT is completely personalized, compounded by pharmacies to tailor each patient's dosage and hormone combinations according to their requirements to enhance efficacy and safety. This is especially valuable when addressing hot flashes, mood swings, and sleep disturbances in menopausal women, and indeed applies to all hormone imbalances affecting both men and women.
HRT will continue to dominate dosing in the compounded pharmacy market as patients become more knowledgeable and demand therapies targeted toward their specific health needs.
The competition landscape for compounding pharmacies is becoming increasingly dynamic, with recent partnerships and regulatory approvals highlighting market growth in cannabis-derived compounds and psychedelics.
These developments reflect a broader industry trend toward securing compliance and expanding production capacities to meet rising demand for plant-based, pharmaceutical-grade ingredients.
Recent Industry Developments in the USA Compounding Pharmacies Market
In terms of product type, the industry is segregated into oral medication [solid medication (capsules, tablets, mixtures, lollipops, and lozenges), liquid medication (syrup, solution/liquid, emulsion, and suspension), topical medication (gels, ointments, creams, and lotions)], injectable, mouthwashes, nasal, ocular, otic, suppositories and enemas.
In terms of pharmacy type, the industry is segregated into 503A pharmacy, 503B pharmacy.
In terms of application, the industry is segregated into adults, pediatrics, geriatrics and veterinary
In terms of therapeutic type, the industry is segregated into hormone replacement therapy, pain management, dermatology, oncology, hematology, dental and others
The USA market is expected to increase at a CAGR of 7.8% between 2024 and 2034.
Oral medication segment is expected to occupy a 58.3% market share in 2024.
The market for compounding pharmacies in the United States is expected to reach USD 10,659.3 million by 2034.
The United States is forecast to see a CAGR of 5.2% during the assessment period.
The key players in the USA compounding pharmacies industry include Avella Specialty Pharmacy; Central Admixture Pharmacy Services Inc.; Hoye’s Pharmacy; Vertisis Custom Pharmacy; Smith Caldwell Drug Store; Sixth Avenue Medical Pharmacy; Cantrell Drug Company; Clinigen Group, Dougherty’s Pharmacy; Fagron N.V.
| Market Value for 2024 | USD 33,031.10 million |
|---|---|
| Projected Market Value for 2034 | USD 47,045.80 million |
| Value-based CAGR (2024 to 2034) | 3.6% |
| Market Value for 2024 | USD 110.6 million |
|---|---|
| Projected Market Value for 2034 | USD 178.4 million |
| Value-based CAGR (2024 to 2034) | 4.9% |
| Market Size, 2024 | USD 14,511 million |
|---|---|
| Projected Market Size, 2034 | USD 48,396 million |
| Value-based CAGR (2024 to 2034) | 12.8% |
| Market CAGR | 7.5% |
|---|---|
| Market Size (2032) | USD 71.78 Billion |
| Market Size (2021) | USD 24.26 Billion |
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