U.S. Compounding Pharmacies Market (By Pharmacy Type; By Product; By Sterility: Sterile, Non-Sterile; By Compounding Type: PIA, CUPM, PDA, Others; By Application: Adult, Geriatric, Pediatric, Veterinary; By Therapeutic Area: Hormone replacement, Pain management, Dermatology, Others) - Industry Analysis, Size, Share, Growth, Trends, Regional Outlook, and Forecast 2024-2033

The U.S. compounding pharmacies market was estimated at USD 5.79 billion in 2023 and it is expected to surpass around USD 10.39 billion by 2033, poised to grow at a CAGR of 6.02% from 2024 to 2033. The U.S. compounding pharmacies market stands at the forefront of personalized medicine, catering to diverse patient needs through customized medications. With a focus on tailoring prescriptions to individual requirements, compounding pharmacies play a crucial role in filling the gaps left by mass-produced pharmaceuticals. 

Key Pointers

• By Product, the oral medications segment led the market with the highest market share of 37% in 2023.
• By Pharmacy Type, 503A segment accounted for more than 74% of revenue share in 2023.
• By Sterility, the non-sterile segment held the largest revenue share of 5.9% in 2023.
• By Application, the adult segment is predicted to grow at the remarkable CAGR during the forecast period

U.S. Compounding Pharmacies Market Growth

The growth of the U.S. compounding pharmacies market is propelled by several key factors. Firstly, there is a rising demand for personalized healthcare solutions, driven by the increasing prevalence of chronic diseases and the need for tailored medications to meet individual patient needs. Additionally, advancements in pharmaceutical compounding technology have enabled compounding pharmacies to offer a wider range of customized formulations, further driving market growth. Moreover, regulatory reforms aimed at enhancing the quality and safety standards of compounded medications have instilled greater confidence among healthcare providers and patients, fostering market expansion. Furthermore, shifting consumer preferences towards natural and alternative therapies have led to a growing demand for compounded formulations, presenting opportunities for market players to innovate and diversify their product offerings. Overall, these growth factors contribute to the dynamic and evolving landscape of the U.S. compounding pharmacies market.

U.S. Compounding Pharmacies Market Trends:

• Increased Demand for Personalized Medications: Growing preference for customized medications tailored to individual patient needs is driving the demand for compounding pharmacies.
• Expansion of Specialized Compounded Formulations: Compounding pharmacies are diversifying their offerings to include niche therapeutic areas such as dermatology, hormone replacement therapy, and pediatrics, meeting the demand for specialized medications.
• Adoption of Advanced Compounding Techniques: Advancements in pharmaceutical compounding technology are enabling compounding pharmacies to develop more sophisticated formulations, enhancing their capabilities and competitiveness.
• Focus on Quality and Safety Standards: There is a heightened emphasis on adherence to stringent quality and safety standards, with compounding pharmacies implementing robust quality control measures to ensure the integrity of compounded medications.
• Regulatory Reforms and Compliance: Regulatory reforms aimed at standardizing practices and enhancing oversight within the compounding industry are shaping market dynamics, necessitating compliance with evolving regulations and standards.
• Integration of Digital Technologies: Compounding pharmacies are increasingly adopting digital technologies to streamline operations, improve patient communication, and enhance service delivery, thereby optimizing efficiency and customer experience.

Product Insights

The oral medications segment emerged as the dominant force in the US compounding pharmacies market, commanding approximately 37% of the market share in 2023. This surge can be attributed to the escalating prevalence of chronic ailments and the growing preference for oral medications due to their convenience and storage ease. Various forms such as tablets, capsules, powder, and granules contribute significantly to this segment, being the traditional and favored options for oral administration. Moreover, the increasing demand for personalized medications across different age demographics is poised to drive further growth in this segment in the forthcoming years.

Meanwhile, the Liquid Preparations segment captured approximately 24.48% of the US compounding pharmacies market share in 2023 and is anticipated to witness the swiftest expansion throughout the forecast period. Oral liquid solutions serve as versatile alternatives for healthcare practitioners seeking alternatives to the prevalent oral solid dose forms. Compounding pharmacies play a crucial role in formulating oral liquids when solid doses are unsuitable for specific patients or when achieving the desired dosage proves challenging. Particularly, children and the elderly find tablets and capsules difficult to swallow, thereby favoring liquid formulations for enhanced ease of consumption. Additionally, liquid pharmaceuticals offer a more palatable formulation and facilitate easier administration, catering to the needs of diverse patient populations.

Pharmacy Type Insights

In 2023, the 503A segment emerged as the leading player in the US compounding market, boasting dominance based on pharmacy type. Projections indicate that this segment is poised to maintain its growth trajectory, with an estimated Compound Annual Growth Rate (CAGR) of 6.12% during the forecast period. The ascendancy of the 503A segment can be attributed to government-imposed restrictions on drug production and the mandatory requirement for medicine prescriptions, which have propelled its expansion within the market. Notably, the 503A segment primarily caters to domestic consumption, thereby solidifying its stronghold in the US market. Moreover, stringent regulations mandating biannual monitoring and audit serve as safeguards to ensure the safety and quality of products within this segment.

Sterility Insights

In terms of sterility, the US compounding pharmacies market saw the non-sterile segment leading the way, capturing a market share of approximately 5.9% in 2023.

However, the sterile segment is poised for notable growth during the forecast period. This surge can be attributed to the escalating incidence of chronic conditions such as cancer and cardiovascular diseases, which are anticipated to drive substantial demand for sterile compounded medications in the near future. Additionally, the rising adoption of ophthalmic and parenteral medications contributes to the growing prominence of sterile compounding pharmacies, further fueling the segment's growth trajectory throughout the forecast period.

Application Insights

In terms of application, the adult segment emerged as the dominant force in the US compounding pharmacies market in 2023. This can be attributed to the heightened prevalence of various chronic illnesses among the adult population in the United States. Moreover, increased healthcare expenditure and the growing adoption of health insurance policies among adults have further propelled the growth of this segment within the market.

Meanwhile, the pediatric segment is poised to present significant opportunities during the forecast period. The increasing preference for personalized compounded prescriptions and the formulation of flavored and sugar-free dosage forms by pharmacists are expected to drive demand for compounding pharmacies among children. Additionally, the easy availability of customized medications such as oral liquids, topical gels, gummy treats, and effervescent drinks is bolstering growth in the pediatric segment within the US market.

Therapeutic Area Insights

In addition to the aforementioned segments, there are other significant areas in which compounding pharmacies play a crucial role, including oncology, hematology, dental, and others. According to the International Diabetes Federation (IDF), the global number of adult diabetics was projected to reach 537 million in 2021, with a further increase to 643 million by 2030. Cancer patients often face considerable challenges beyond the disease itself, with chemotherapy's adverse effects compromising their overall health and well-being. Oncology compounding addresses these complexities by tailoring drug combinations and treatments to meet patients' specific needs, thereby minimizing the burden of medication management. Innovative formulations such as mouthwashes or topical creams are utilized for patients experiencing nausea, difficulty swallowing pills, or other conditions hindering traditional dosage methods.

Furthermore, the pain medications segment reached US$ 0.89 billion in 2023 and is anticipated to grow at a CAGR of 6.43% from 2024 to 2033. Pain is a primary symptom driving patients to seek medical assistance, and untreated acute pain can progress into chronic, challenging-to-manage conditions. While commercially available pain relief medications are convenient, they may induce undesirable side effects such as dizziness, drowsiness, or stomach irritation, particularly for chronic conditions like arthritis, fibromyalgia, and migraines.

U.S. Compounding Pharmacies Market 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

Recent Developments

• In November 2020, B Braun established a strategic partnership with Grifols to merge B Braun's Safe Infusion Systems with Grifols' automated compounding portfolio, aimed at enhancing the safety of automated drug delivery.
• In August 2021, Adamis Pharmaceuticals finalized a definitive agreement to sell a substantial portion of the assets of its subsidiary, US Compounding Inc.

U.S. Compounding Pharmacies Market Segmentations:

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
• Parenteral
• SVP
• LVP
• Ophthalmic
• Nasal
• Otic

By Sterility

• Sterile
• Non-Sterile

By Application

• Adult
• Geriatric
• Pediatric
• Veterinary

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
• Specialty drugs
• Nutritional supplements
• Others