U.S. Compounding Pharmacies Market (By Pharmacy Type: 503A, 503B; By Product: Oral, Liquid Preparations, Liquid Preparations, Rectal, Parenteral, Ophthalmic, Nasal, Otic; 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 2022 – 2030

The U.S. compounding pharmacies market size was valued at US$ 5.17 billion in 2021 and is expected to surpass around US$ 8.3 billion by 2030 with a registered CAGR of 5.41% from 2022 to 2030.

Growth Factors:

Increasing focus of industry players on introducing innovative and customized formulations that are effective in treating several diseases will propel the market growth. Rising prevalence of cancer along with growing public and private initiatives for compounding pharmacies will further enhance the market expansion. Increased drug shortages due to long lead times, scarcity of raw materials, delayed production, and surged drug failure rate will boost the market revenue.

Owing to the rising cases of COVID-19, the need for compounded pharmacies has also increased across the U.S. The FDA has allowed registered outsourcing facilities to compound specific medications used to treat critically ill patients in hospitals in response to the growing demand for drugs. According to the U.S. FDA, the supply of FDA-approved medicines and medicines compounded by outsourcing facilities may not be sufficient to fully address the need for drugs used to treat hospitalized patients.
 

Rising geriatric population base along with improved longevity will be the major factor accelerating the market value. As per the Population Reference Bureau, geriatric population in the U.S. is expected to reach 24% of total population by 2060. Longevity of the population has improved on account of decline in fertility rate and increased life expectancy. Additionally, affordable costs of compounding pharmacies proved beneficial for the overall industry growth over the forecast period. Higher proportion of people inclined towards compounding pharmacies and growing demand to look younger and youthful has resulted in augmented demand for anti-aging products across the U.S., favouring the market share. However, issues related to safety standards may impact the market demand.

Report Scope of the U.S. Compounding Pharmacies Market

Report Coverage

Details

Market Size in 2021

USD 5.17 Billion

Revenue Projection By 2030

USD 8.3  Billion

Growth Rate

CAGR of 5.41% from 2022 to 2030

Base Year

2021

Historical data

2017 - 2020

Forecast Period

2022 to 2030

Segments Covered

Pharmacy Type, Product, Sterility, Application, Compounding Type, Therapeutic Area 

Companies Mentioned

 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

 

Limitations associated with 503A pharmacy type may impede the market progression

The 503A segment in the U.S. compounding pharmacies market is predicted to witness 3.1% growth rate till 2030 as 503A compounding pharmacies are facilities wherein medication is formulated for domestic consumption. Compounding pharmacies has seen slothful the market growth owing to government limitations on drug manufacturing and requirement of authorized prescription. 503A pharmacies are banned from dispensing medication for office purpose that limit its product line, limiting its industry demand. In addition, these pharmacies require biannual environmental monitoring and audit for ensuring product quality and safety.
 Rising demand for sterile medications will create robust growth opportunities

The sterile dosage form accounted for USD 1.9 billion in 2021. Growing incidence of chronic ailments such as cardiac and cancer diseases will stimulate the demand for sterile medications. Increasing demand for sterile compounding pharmacies due to adoption of parenteral and ophthalmic medications for several treatments will further fuel the industry revenue.
 Parenteral segment is anticipated to upsurge the market expansion

The parenteral segment held 19% of the U.S. compounding pharmacies market share in 2021. Compounding ophthalmic care medications such as glaucoma medicines makes it affordable, thereby surging its acceptance rate. Moreover, compounded dosage forms such as glaucoma drops helps elderly patient minimize individual’s pressure along with confusion over several medications and dosing schedules, favouring the market value. Compounding ophthalmic medications are accessible in various dosage forms such as oral tablets, capsules injections and drops. Hence, growing availability of several dosage forms in ophthalmic care will drive the segment growth.

The paediatric segment is estimated to attain a CAGR of 8.2% through 2030. Children majorly find it interesting to swallow tablets and sometimes commercially available preparations are not be palatable. Hence, children may prefer customized compounded prescriptions as pharmacists develop flavoured, sugar-free dosage forms based on children’s needs, thereby increasing the market demand. Availability of several forms of customized medication for children include gummy treats, topical gels, effervescent drinks, oral liquids, will surge preference towards compounded pharmacies.

 

The hormone replacement segment in the U.S. compounding pharmacies market was valued around USD 1.5 billion in 2020. Growing usage of hormone replacement in the treatment of several diseases including cancer, and in maintaining the hormonal levels in menopause, will enhance the need for compounding pharmacies. The increasing geriatric population base coupled with rising life expectancy has led to rise in number of patients suffering from hormonal imbalance. Hence, escalating potential for hormone replacement therapy will stimulate the demand for compounding pharmacies.
 

Increasing drug shortages will influence the market size

The currently unavailable pharmaceutical manufacturing segment crossed USD 1 billion in 2021. Medications may be unavailable due to several reasons such as manufacturing problems, discontinuation of certain medications owing to interruptions and decreased usage in supply chain. Rising number of chronic diseases requiring emergency medications along with surging drug shortages will foster the segment revenue.  
 

Presence of leading industry player’s across the U.S. proves beneficial for the market growth

Rising acceptance of compounding pharmacies coupled with favorable reimbursement policies across the U.S. will drive the demand for compounding pharmacies. In addition, technological advancements will lead to surge in effective compounding pharmacies, thereby augmenting the industry growth. The presence of leading companies along with well established healthcare infrastructure and facilities will fuel the market value.

Key Market Developments

  • In May 2021, Wedgewood Pharmacy completed the acquisitions with Zoo, Wildlife specializations for acquisition of 503B outsourcing facilities and state licensed pharmacy. This strategy aimed at strengthening the market position on the company.
  • In November 2021, B Braun formed a strategic alliance with Grifols to integrate the B Braun’s Safe Infusion Systems with Grifols’ automated compounding portfolio for ensuring the safety of automated drug delivery.
  • In August 2021, Adamis Pharmaceuticals entered into a definitive agreement for selling a significant portion of assests of its subsidiary, US Compounding Inc.

The major players in the market are constantly involved in various developmental strategies such as partnerships, collaborations, agreement, mergers, and acquisitions to gain competitive advantage over others, strengthen their position in the market, and strengthen their product portfolio.

Some of the prominent players in the US compounding pharmacies market include:

  • 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

Segments Covered in the Report

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

Key Points Covered in U.S. Compounding Pharmacies Market Study:

  • Growth of U.S. Compounding Pharmacies in 2022
  • Market Estimates and Forecasts (2017-2030)
  • Brand Share and Market Share Analysis
  • Key Drivers and Restraints Shaping Market Growth
  • Segment-wise
  • Competition Mapping and Benchmarking
  • Recommendation on Key Winning Strategies
  • COVID-19 Impact on Demand for U.S. Compounding Pharmacies and How to Navigate
  • Key Product Innovations and Regulatory Climate
  • U.S. Compounding Pharmacies Consumption Analysis
  • U.S. Compounding Pharmacies Production Analysis
  • U.S. Compounding Pharmacies and Management