U.S. Compounding Pharmacies Market Size By Pharmacy Type (503A, 503B), By Sterility (Sterile, Non-sterile), By Product (Oral [Solid preparations, Liquid preparations], Topical [Ointments, Creams, Gels, Pastes], Rectal [Suppositories, Enema], Parenteral [LVP, SVP], Nasal, Ophthalmic, Otic), By Application (Paediatric, Adult, Geriatric, Veterinary), By Compounding Type (Pharmaceutical Ingredient Alteration [PIA], Currently Unavailable Pharmaceutical Manufacturing [CUPM], Pharmaceutical Dosage Alteration [PDA]), By Therapeutic Area (Hormone Replacement, Pain Management, Dermatology, Specialty Drugs, Nutritional Supplements) Industry Analysis Report, Application Potential, Competitive Market Share & Forecast, 2020 – 2026

Industry Trends

U.S. Compounding Pharmacies Market size crossed USD 4.7 Billion in 2019 and is projected to grow at over 5.7% CAGR from 2020 to 2026.
 

Compounding pharmacies create specialized medications, different from commercially available pharmaceuticals, for individual patients. A licenced physician manufactures such medications in compounding facilities after considering patient’s health needs and market availability.
 

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Some patients are allergic to fillers such as gluten, dyes and casein used in commercial medicines. Moreover, patients often require medicines in dosage form and strength different from the commercially available drugs. As the compounding pharmacies can prepare and supply medications in such scenario, the U.S. compounding pharmacies market will witness robust growth with increasing demand for personalized medicines.
 

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Growing acceptance of personalized medicines in the U.S. will boost the market growth

Growing acceptance of personalized medicines will foster the market growth over the forecast period. Personalized medicine or precision medicine is an emerging approach for disease prevention and treatment. Compounding pharmacies prepare and provide customized compounds that enable better health outcomes for majority of patients especially young infants, aged individuals, and allergy sufferers.
 

Compounding allows recipients to request for drugs tailored for their specific needs and according to the specification of ingredients and administration route. Popularity of compounded formulations in the U.S. market, especially if the broad distribution of standardized drugs is challenging and will expand the market growth.
 

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Limitations of 503A compounding pharmacies curbs the U.S. market growth

503A compounding pharmacy segment accounted for around USD 2.1 billion in 2019. Over the years the 503A U.S. compounding pharmacies has seen sluggish market growth due to government limitations on drug manufacturing and requirement of authorized prescription.
 

503A compounding pharmacies are facilities wherein medication is formulated for individual patient. Theses pharmacies are prohibited from dispensing medication for office use that limit their product line. Moreover, 503A facilities require biannual environmental monitoring and audit in order to ensure product safety and quality that further impede its market growth.
 

Growing adoption of compounded sterile products will foster the U.S. compounding pharmacies market growth

The compounding pharmacies, based on sterility is bifurcated into sterile, and non-sterile. Sterile segment is anticipated to experience around 7% CAGR over the projected timeline. Rising prevalence of chronic diseases augments need for large volume and small volume sterile parenteral, compounded as per patient requirements, thereby propelling the market growth.
 

Growing number of patients suffering from illness and deaths due to substandard sterile compounded preparations led the government to take necessary regulatory actions. For instance, in February 2018, the Board of Pharmacy Specialties (BPS) announced new specialty for compounded sterile preparations (CSP) pharmacists to ensure quality of the compounded medications. Such initiatives are expected to drive the market growth.  
 

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Benefits of oral compounded drugs will propel the market

Oral segment in the U.S. compounding pharmacies market exceeded USD 1.5 billion revenue in 2019. Significant number of compounded medications for treatment of pain management and aches are available and preferred in tablet or capsule form.
 

The oral dosage forms allow pharmacists to formulate drugs, such as flavoured medication for children. The flavouring of the oral medicines makes them palatable and easy to consume, thereby driving the market growth.
 

Increasing acceptance of compounded drugs in vets will propel the market growth

Veterinary compounding segment valued at around USD 1 billion in 2019. The compounding pharmacies provide treatment for animals in case of unavailability of government-approved medications.
 

Dosage forms of commercially available medications are approved for use in some species but do not fit for use in other species like exotic animals or cats. During such situations compounding pharmacies provides specifically formulated drugs for such animal species.
 

Diminished side-effects of drugs in pharmaceutical ingredient alteration will drive the market growth

Pharmaceutical ingredient alteration (PIA) segment dominated over 35% of the total U.S. compounding pharmacies market share in 2019. Pharmaceutical ingredient alteration includes medication that is compounded for individuals that are allergic to certain ingredients present in the commercially marketed drugs.
 

Certain commercially available drugs such as antibiotics, NSAIDs, HIV drugs and chemotherapy drugs can cause allergies or side effects among the patients. Omitting designer dyes and preservatives during compounding lowers the allergic reactions as well as cost of the compounded drugs.
 

Clinical benefits to women through compounded drugs will propel the hormonal segment growth

Hormone replacement segment accounted for around USD 1.3 billion in 2019, due to aid provided by compounded drugs to women during hormonal imbalance.
 

Compounded hormone replacement therapy (HRT) can be used as per the varying hormone levels in the different patients. It can use hormones that have same chemical structure as that of hormones naturally occurring in the body.
 

Moreover, compounding pharmacies can aid a woman to start and maintain a hormone replacement routine that brings hormones back into balance. This is expected to drive the industry growth.
 

Prominent industry players operating in the compounding pharmacies sector focus on delivering effective medications to sustain market competition

Some of the eminent market players include B. Braun Medical, US Compounding Pharmacy, Dougherty's Pharmacy, Fagron, Fresenius Kabi, Institutional Pharmacy Solutions, ImprimisRx, McGuff Company, Pencol Compounding Pharmacy, PharMEDium Healthcare Holdings, Rx3 Compounding Pharmacy, Triangle Compounding Pharmacies, and Wedgewood Village Pharmacy.
 

These market players strategically implement various organic and inorganic growth strategies to garner more revenue and sustain market competition.
 

Some of the recent industry developments:

• In March 2016, B. Braun launched the Apex Compounding System. The launch of this system was specifically designed to address the immediate needs of critically ill patients, while also meeting the critical needs of pharmacists. It provided the company an upper hand in the industry.
   

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 2015 to 2026, for the following segments:
 

Market by Pharmacy Type, 2015 – 2026 (USD Million)

• 503A
• 503B

Market by Sterility, 2015 – 2026 (USD Million)

• Sterile          
• Non-sterile

Market by Product, 2015 – 2026 (USD Million)

• Oral
  • Solid preparations
    • Tablets
    • Capsules
    • Granules
    • Powder
    • Others
  • Liquid preparation
    • Solutions
    • Suspensions
    • Emulsions
    • Syrup
    • Others
• Topical
  • Ointment
  • Creams
  • Gels
  • Pastes
  • Others
• Rectal
  • Suppositories
  • Enema
  • Others
• Parenteral
  • Large volume parenteral
  • Small volume parenteral
• Ophthalmic
• Nasal
• Otic

Market by Compounding Type, 2015 – 2026 (USD Million)

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

Market by Application, 2015 – 2026 (USD Million)

• Pediatric
• Adult
• Geriatric
• Veterinary

Market by Therapeutic Area, 2015 – 2026 (USD Million)

• Hormone replacement
• Pain management
• Dermatology
• Specialty drugs
• Nutritional supplements
• Others