U.S. Compounding Pharmacies Market - By Pharmacy Type (503A, 503B), By Sterility (Sterile, Non-sterile), By Product (Oral, Topical, Rectal, Parenteral, Nasal, Ophthalmic, Otic), By Application, By Compounding Type, By Therapeutic Area & Forecast, 2022-2030

U.S. Compounding Pharmacies Market Size

U.S. Compounding Pharmacies Market size surpassed USD 5.2 billion in 2021 and is expected to witness a 5.9% CAGR from 2022 to 2030. Increasing awareness regarding compounded medication and rising adoption rate of such medicines will boost the U.S. compounding pharmacies business. Other factors such as increase in the number of prescriptions dispensed, shortage of certain commercially formulated drugs or discontinuation of drugs by manufacturers will positively influence the overall market growth.
 

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Rise in the elderly population and age-related chronic diseases and increasing health expenditure in the U.S. have popularized the demand for compounded medications. Patients are seeking for compounded pharmacies to gain medications with alternative dosages, personalized route of administration, and alternative ingredients to avoid allergies that may be otherwise caused from commercially available drug formulations. These factors have contributed to the U.S. compounding pharmacies market expansion.
 

Amid COVID-19 pandemic the demand for compounded medications increased. This can be attributed to the increased demand for several medications for treatment of COVID-19, along with other reasons such as reduced manufacturing capabilities due to restrictions and shortage of commercially available drugs.
 

For instance, according to the U.S. Food and Drug Administration (FDA) report, the U.S. has dealt with a drug shortage for several years, and the COVID-19 outbreak has exacerbated the situation. This shortage is primarily caused by supply chain disruption, manufacturing process delays and discontinuity, quality issues, and difficulties in obtaining raw materials.
 

Hence, drug shortages created additional opportunities for the U.S. compounding pharmacies business. Also, FDA issued a temporary guidance policy to the federal facilities and state-licensed pharmacies, including hospital pharmacies and compounding pharmacy that are not registered with FDA as outsourcing facilities for compounding of certain medication for hospitalized patients for the duration of the public health emergency, due to shortage of drugs required for patient treatment.
 

A compounding pharmacy is a specific type of pharmacy, that makes customized medications. These medications are prescribed to meet specific need of a patient that cannot be met by commercially available FDA approved drugs. In the U.S., compounding practice is popular owing to increasing demand of personalized medications and the convenience of using compounded drugs.
 

Increasing drug shortage in the country is expected to accelerate the U.S. compounding pharmacies market statistics

Drug shortages have a significant impact on healthcare providers and more so on patients. All categories of drugs, that include essential lifesaving drugs, antimicrobials, oncology medicine, cardiovascular drugs, analgesics, opioids, are liable to drug shortage. The causes of drug shortages are many, such as supply demand issue, regulatory issues, manufacturing difficulties, lack of raw material supply are some reasons among many other. Drug shortages pose a significant threat to public health that can delay, and in some cases even deny care needed for patients. In such scenarios, compounding pharmacies play an essential role to tackle drug shortage crisis.
 

Drug shortage has been an ongoing problem in the U.S. and has been a major concern to healthcare organizations. For instance, as per the University of Utah Drug Information Services, 129 drug shortages were reported in the U.S. in 2020. Similarly, according to FDA’s CBER (Center for Biologics Evaluation and Research) and FDA’s CDER (Center for Drug Evaluation and Research) the number of new drug shortages tracked was 41 in 2021.
 

There has been a constant effort by FDA and other organizations to mitigate drug shortage crisis. Compounding pharmacies can play an important role to step in and address drug shortages when they occur. Increasing shortages of several drugs and rising demand of medications are key factors that will boost the U.S. compounding pharmacies market revenue over the forecast years.
 

U.S. Compounding Pharmacies Market Analysis

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The U.S. compounding pharmacies market, based on pharmacy type, is classified into 503 A and 503B. The 503B pharmacy type segment accounted for around 56.5% market share in 2021 and the trend will continue to rise over the forecast years. A 503B is a compounding pharmacy that is registered with FDA as a 503B outsourcing facility. Registration with FDA enables a facility to compound and distribute drugs with or without a patient-specific prescription.
 

Such facilities can manufacture large batches of drugs to be sold to healthcare facilities for office use only. These pharmacies are allowed to manufacture larger batches of compounded medications to lower their manufacturing costs, thereby passing the savings onto consumers. Such benefits attract patients towards compounded medications and thereby fueling the market progression.
 

Moreover, according to study conducted by the U.S. Department of Health and Human Services, it was reported that most hospitals, nearly 89% obtained non-patient-specific compounded from outsourcing facilities. Such instances will foster the U.S. compounding pharmacies business.
 

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Based on sterility, U.S. compounding pharmacies market are classified into sterile and non-sterile. The non-sterile segment accounted for over USD 3.5 billion revenue in 2021. Non-sterile compounded medications include solutions, suspensions, ointments, creams, powders, suppositories, capsules, and tablets. The major advantage of non-sterile compounding medication is the ability to modify route of administration based on patient convenience.
 

In addition, customizing strength of dosage, addition of favoring and removal of allergic components from the medication are some other benefits offered by non-sterile compounding medications. Since the regulations around non-sterile compounded medications are less strict than sterile doses, the sale of non-sterile medications is higher contributing to segmental expansion.
 

Based on product, the U.S. compounding pharmacies market is segmented into oral, topical, rectal, parenteral, nasal, ophthalmic, and otic. Among them, the oral segment accounted for around USD 1.7 billion in 2021. This can be attributed to the rising demand for oral route of drug administration.
 

Oral drug administration offers several benefits such as self-administration, pain-free, and it is one of safest means of drug administration among other forms. Similarly, availability of several medications in oral form, such as solid preparations that include capsules, tablets, powder, etc. and liquid preparations such as syrups, suspensions, etc. as compared to other dosage forms fuels the segmental outlook.
 

Based on compounding type, the U.S. compounding pharmacies industry is categorized into Pharmaceutical Ingredient Alteration (PIA), Currently Unavailable Pharmaceutical Manufacturing (CUPM), Pharmaceutical Dosage Alteration (PDA) and others. Among these Pharmaceutical Ingredient Alteration (PIA) recorded over 35.4% market share in 2021.
 

Pharmaceutical Ingredient Alteration (PIA) offers a major advantage of compounding medication. It allows addition or deletion of specific drugs in a medication to formulate patient specific medicine as per the patient need. This is highly beneficial in substituting certain drugs that the patient might be allergic to. Such benefits of compounded medications enhance the U.S. industry landscape.
 

Based on application, the U.S. compounding pharmacies market is categorized into pediatric, adult, geriatric and veterinary. The adult segment accounted for over 45.7% market share in 2021. Adults are prone to several lifestyle related chronic diseases owing to their sedentary lifestyle and food habits.
 

Additionally, increasing number of adults suffer from nutritional deficiencies. Such nutritional deficiencies can be easily tackled with patient specific compounded medications to fulfill nutritional requirements in adults. Therefore, companies are organizing events to aware adults about problems associated with nutrition deficiency.
 

Furthermore, adults prefer compounded nutritional supplements to avoid their need to take several medications, since a single medication is formulated to meet all their nutritional needs. This accelerates the progression of the U.S. compounding pharmacies industry.
 

The U.S. compounding pharmacies, based on therapeutic area is classified into hormone replacement, pain management, dermatology applications, specialty drugs, nutritional supplements, and others. Out of these, the pain management segment is expected to grow at a 5.6% CAGR during the analysis period. The segmental growth is high owing to rising prevalence of chronic pain geriatric population as well as adult population.
 

For instance, as per the National Health Interview Survey, in 2019, 50.2 million adults (20.5%) reported chronic pain on most days in the U.S. The common pain areas were knee, back pain, foot, and hip. Also, compounded medications provide best solution for pain relief. Cream from of compounded medication provides instant relief from pain when applied directly at the site of pain.
 

Moreover, compounding pharmacy collaborate with a healthcare provider to create customized pain management treatment options and customizable dosages to offer pain management medications. Such scenarios will propel the overall market size.
 

U.S. Compounding Pharmacies Market Share

Some of the key market players operating in the U.S. compounding pharmacies industry include:

• Athenex Pharma Solutions (Athenex Inc.)
• B Braun Melsungen AG
• Clinigen Group PLC
• Dougherty’s Pharmacy Inc
• Fagron
• Fresenius Kabi
• ImprimisRx (Harrow Health, Inc.)
• Institutional Pharmacy Solutions
• ITC Compounding Pharmacy
• Lorraine’s Pharmacy
• McGuff Company Inc (McGuff Compounding Pharmacy Services)
• Nephron Pharmaceuticals Corporation
• Pencol Compounding Pharmacy
• QuVa Pharma
• Rx3 Compounding Pharmacy
• Triangle Compounding Pharmacies
• Wedgewood Village Pharmacy

among others. These market participants devise various strategies coupled with continuous innovations and product improvements to maintain competitive edge in the market.
 

Some of the recent industry developments:

• In January 2022, Nephron Pharmaceuticals Corporation launched new syringe presentation, Cyclic Olefin Copolymer syringe (COC) under Nephron 503B Outsourcing Facility operation. The firm is set to launch 8.4% Sodium Bicarbonate Injection in a COC syringe. This strategy will enable the company to enhance its product portfolio in the compounding pharmacies market growth.
   
• In May 2020, Wedgewood Pharmacy announced acquisition with Zoo, Wildlife specializations to acquire 503B outsourcing facility and state-licensed pharmacy. This strategy enhanced the company’s product portfolio, thereby propelling the market growth.
   

The U.S compounding pharmacies market research report includes an in-depth coverage of the industry with estimates & forecast in terms of revenue in USD from 2017 to 2030, for the following segments:

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By Pharmacy Type

• 503A
• 503B

By Sterility

• Sterile
• Non-sterile

By Product

• Oral 
  • Solid preparations
    • Tablets
    • Capsules
    • Granules
    • Powder
    • Others 
• Liquid preparations 
  • Solutions
  • Suspension
  • Emulsion
  • Syrup
  • Others
• Topical
  • Ointments
  • Creams
  • Gels
  • Pastes
  • Others 
• Rectal 
  • Suppositories
  • Enema
  • Others
• Parenteral
  • LVP
  • SVP 
• Nasal
• Ophthalmic
• Otic

By Application

• Pediatric
• Adult
• Geriatric
• 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 applications
• Specialty drugs
• Nutritional supplements
• Others