U.S. Compounding Pharmacies Market
With a compound annual growth rate (CAGR) of XX% from 2024 to 2033, the global market for compounding pharmacies in the United States was valued at US$ XX billion in 2023 and is projected to reach US$ XX billion by 2033. Adherence to industry standards like the United States Pharmacopeia (USP) Convention and good manufacturing practice (CGMP) regulations, which guarantee the quality and safety of compounded medications, is what drives the expansion of the U.S. compounding pharmacy sector. These pharmacies serve patients' and healthcare providers' requirements by offering manufactured drug substitutes, which is extremely helpful during drug shortages.
Desire for reliable sources of compounded drugs is driven by some compounding pharmacies' deceptive claims regarding the safety or efficacy of their products, which is contributing to the market's growth. All things considered, the market's growth is propelled by its adherence to standards, capacity to handle drug shortages, and rising demand for compounded medications that are both safe and effective.

Market Overview
Rising need for specially formulated medications is propelling the compounding pharmacy industry in the United States to rapid expansion. Compounding pharmacies serve a critical role in supplying access to medication for those who cannot use commercially accessible formulations owing to dose requirements, allergies, or rare disorders. Each year, millions of pharmaceuticals are compounded to meet the specific needs of patients. Compounding services, which are provided by about 7,500 community-based pharmacies out of over 56,000 in the United States, are especially important for sterile drugs supplied via injection, intravenous infusion, intraocular, or intrathecal routes. According to some estimates, more than 32,000 pharmacies across the country provide compounding services.
Compounding pharmacies are required to employ pure, pharmaceutical-grade components made in facilities regulated with the FDA in order to guarantee both quality and safety. The market analysis highlights the noteworthy prospects for growth and significance of compounding pharmacies in fulfilling various patient requirements while complying with strict regulatory guidelines.
 

Report Highlights     
By Product
Oral drug category is a significant force in the U.S. compounding pharmacy market. The FDA has acknowledged that players in pharmacy compounding are particularly interested in addressing the issues of supply and demand for oral suspension drugs for pain and fever. Compounded medications that contain ibuprofen or acetaminophen have to adhere to all applicable regulations specified in FD&C Act section 503A. This category provides a large selection of drugs compounded as oral liquids to patients who have trouble swallowing pills and capsules. This product insight emphasizes the importance of oral pharmaceuticals in the market for compounding pharmacies and the industry's adaptability to patient needs and legal requirements.
In the compounding pharmacy market, the Liquid Preparations segment grew at the fastest rate throughout the forecast period. The reason for this expansion is that compounded preparations are not molecular solutions, but rather suspensions with visible particles. As a result, it was difficult to ensure sterility because these liquids could not be filtered to get rid of bacteria and fungi. Strict restrictions apply on the addition of preservatives or other additives to prevent fungal growth, which is especially important when the preparation is injected directly into the spine. This product insight emphasizes the necessity of finding creative ways to preserve product safety and efficacy in this rapidly expanding market sector, underscoring the significance of resolving sterility concerns in compounded liquid treatments.

By Pharmacy Type
Based on the type of pharmacy, the 503A segment has become the dominant force in the US compounding business. This segment highlights industry best practices to guarantee safe compounding and is governed by regulatory criteria specified in FD&C Act Section 503A. "503A Compounding – Regulatory Basis and Industry Good Practices for Pharmacies" offers information that makes it easier for pharmacies to comprehend the FDA rules that are required for operating in compliance. Particularly, 503A pharmacies place a high priority on putting quality processes in place at every level, from handling incoming materials and upkeep of buildings and equipment to making sure that shipping, storage, and transportation protocols are followed correctly. This pharmacy insight emphasizes how crucial quality assurance procedures and regulatory compliance are to the 503A pharmacies' performance in the compounding business.
 

By Sterility
Based on sterility considerations, the non-sterile category has established dominance in the US compounding pharmacy business. This section includes procedures that deviate from manufacturer-provided labeling by mixing, admixing, diluting, pooling, reconstituting, or changing medicines or bulk drug ingredients in any way to produce non-sterile preparations. This observation highlights the market's widespread use of non-sterile compounding techniques and emphasizes how crucial it is to follow legal requirements in order to guarantee the efficacy and safety of products.
Compounding pharmacy market is expected to grow at the fastest rate during the projected period, which emphasizes the crucial importance of the sterile segment. In the production of drugs meant for delicate body parts like the circulation, eyes, lungs, or heart, sterile compounding is essential. To ensure the production of sterile pharmaceuticals, this method entails highly skilled pharmacists using sterile goods in a controlled, sterile environment. This observation highlights the growing need for sterile compounding services due to the necessity of upholding the strictest safety and efficacy requirements in pharmaceutical compositions intended for delicate body areas.

By Therapeutic Area
Therapeutic areas like cancer, hematology, dentistry, and others are prominent in the US compounding pharmacy business, reflecting the variety of needs of both patients and healthcare practitioners. Compounding for oncology is essential in mitigating the difficulties arising from neoplastic drugs by providing customized pharmaceuticals to meet the specific needs of each patient. In a similar vein, dental compounding allows for treatment personalization, giving dentists the freedom to reduce patient anxiety during procedures, provide pain relief, and administer other therapies using customized dosages. This therapeutic insight emphasizes the value of compounding to meet patients' specific therapeutic needs in a variety of medical disciplines, improving patient outcomes and treatment efficacy while attending to particular clinical needs.
Within the compounding pharmacy market, the pain management category is expected to increase at the quickest rate during the projected period, suggesting a substantial need for individualized pain relief treatments. With pharmacy compounding, patients can receive personalized pain management alternatives that alleviate chronic pain or the negative effects of conventional painkillers. Compounding, the art and science of creating customized pharmaceuticals, offers significant advantages to people for whom pain treatment is a daily need.
Growing pain management market highlights the critical role that compounding plays in meeting patients' various therapeutic needs and improving their quality of life and treatment outcomes. According to research, 100 million Americans suffer from chronic pain, and about 10% of them have it for three months or longer.
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Source: https://clarkprofessionalpharmacy.com/compounding/pain-management-compounding/ 
Market Dynamics
Driver 
Important Role of Compounding Pharmacies in Healthcare  
The necessity for customized treatment and the critical function compounding pharmacies play in meeting individual patient needs are what drive the market's steady expansion in the United States. The demand for specialized painkillers is growing, and compounding pharmacies can offer specialized treatments, therefore the market has good growth potential. Furthermore, when commercially accessible medications do not suit patient needs because of allergies or cessation, the knowledge of skilled workers in compounding pharmacies becomes invaluable. These elements work together to support the compounding pharmacy industry's steady growth trajectory in the United States, highlighting its critical role in the healthcare system.
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Source:https://www.fdli.org/2017/12/involved-compound-pharmaceuticals-beware-law-enforcement-focused/ 
•    In October 2023, FarmaKeio Custom Compounding enhanced healthcare services through the acquisition of a state-of-the-art compounding pharmacy.
Source: https://markets.businessinsider.com/news/stocks/farmakeio-custom-compounding-enhances-healthcare-services-through-acquisition-of-state-of-the-art-compounding-pharmacy-1032725152

Restraints 
Quality and Safety Concerns 
Compounding medications present possible health risks to patients because they do not have the same safety, efficacy, or quality assurances as licensed medications when used to treat urgent medical requirements. Bad compounding techniques can lead to substantial problems with medicine quality, such as contamination or high quantities of active component, which can cause serious injury to patients or even fatalities. The U.S. compounding pharmacy market's growth potential is further hampered by practitioners' reliance on compounded medications in hospitals and clinics when FDA-approved alternatives are unsuitable for patients. This emphasizes the necessity of improved quality control and regulatory oversight within the sector.

Opportunities 
Advancement in Healthcare
As a means of obtaining necessary medications and goods that are not readily available on the market, pharmaceutical compounding becomes an important aspect of pharmacy practice. Compounding is the process of modifying drugs for specific treatment plans. It can range in complexity from a straightforward tablet crushing to the sterile product compounding in regulated settings. Compounding can be done in a variety of locations, such as pharmacies, hospital wards, outpatient clinics, and establishments subject to FDA regulations, thanks to its adaptability. Compounding plans are created to address individual patient needs and compounded pharmaceuticals are recommended by utilizing the interaction between the pharmacist, patient, and practitioner. The U.S. compounding pharmacy market is expected to increase, offering potential to provide customized prescription solutions to meet the changing needs of the healthcare industry. Compounding is overseen or performed by qualified pharmacy experts.

Recent Developments

•    In April 2024, Saveway Compounding Pharmacy was acquired by Myonex.
•    In July 2023, Fagron expanded its US sterile compounding footprint with an East Coast acquisition.
•    In March 2023, a Dutch market leader in pharmaceutical compounding services was acquired by Medios.

Key Players in the U.S. Compounding Pharmacies Market
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

Market Segmentation
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
Pain Management
Dermatology
Pediatrics
Urology
Others
By End-User
Hospitals and Clinics
Specialty Clinics
Others