U.S. Compounding Pharmacies Market Size, Share, CAGR, Report 2024 to 2033

According to Vision Research Reports, the U.S. compounding pharmacies market size was estimated at USD 5.79 billion in 2023 and it is expected to increase around USD 10.39 billion by 2033 with 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.

Understanding the Concept of Compounding Pharmacies

Compounding pharmacies play a vital role in healthcare by customizing medications to suit the unique requirements of patients. Unlike mass-produced drugs, compounded medications are formulated based on specific prescriptions, dosage strengths, and delivery forms. This personalized approach is particularly beneficial for individuals with allergies, sensitivities, or those requiring specialized formulations not commercially available.

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Key Pointers

  • In 2023, the oral medications segment dominated the market, capturing the highest market share at 37%.
  • Among pharmacy types, the 503A segment secured over 74% of the revenue share in 2023.
  • The non-sterile segment commanded the largest revenue share of 5.9% in 2023, based on sterility classification.
  • The adult segment is anticipated to experience significant growth with a remarkable compound annual growth rate (CAGR) during the forecast period.

There are two main types of compounding pharmacies in the U.S.:

  • 503A pharmacies: These pharmacies compound medications for individual patients based on a doctor's prescription.
  • 503B pharmacies: These pharmacies are registered with the FDA as outsourcing facilities and can manufacture large batches of compounded drugs to be sold to healthcare facilities for office use only.

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U.S. Compounding Pharmacies Market Top Trends

  • Rising Demand for Personalized Medicine: Compounded medications offer a unique advantage in that they can be tailored to a patient's specific needs. This is especially beneficial for patients with allergies, who have difficulty swallowing pills, or require medication in a dosage form not commercially available.
  • Increasing Awareness: Growing awareness of compounded medications among both patients and healthcare providers is fueling market growth. Patients are increasingly seeking out customized treatment options, while healthcare providers are recognizing the benefits of compounded medications for specific patient populations.
  • Drug Shortages and Discontinuations: The U.S. has experienced frequent drug shortages in recent years, which has led to increased demand for compounded alternatives. Additionally, some pharmaceutical companies may discontinue production of certain medications due to low profitability, creating another gap that compounding pharmacies can fill.
  • Growth of 503B Outsourcing Facilities: 503B pharmacies are well-positioned for future growth as they can produce larger batches of compounded medications for hospitals and other healthcare facilities. This efficiency allows them to meet the growing demand for compounded medications in a cost-effective manner.
  • Focus on Safety and Regulations: The U.S. Food and Drug Administration (FDA) plays a vital role in ensuring the safety and quality of compounded medications. Expect to see continued focus on stricter regulations and guidelines for compounding pharmacies to ensure patient safety.

Product Insights

The oral medications segment emerged as the leading player in the US compounding pharmacies market, capturing around 37% of the market share in 2023. This growth is fueled by the increasing prevalence of chronic diseases and the rising preference for oral medications due to their convenience and easy storage. Tablets, capsules, powder, and granules are among the various forms contributing significantly to this segment, as they remain traditional and favored options for oral administration. Furthermore, the rising demand for personalized medications across different age groups is expected to further boost growth in this segment in the coming years.

On the other hand, the Liquid Preparations segment accounted for approximately 24.48% of the US compounding pharmacies market share in 2023 and is projected to experience the fastest expansion during the forecast period. Oral liquid solutions serve as versatile alternatives for healthcare practitioners seeking options beyond oral solid dose forms. Compounding pharmacies play a vital role in formulating oral liquids when solid doses are not suitable for specific patients or when achieving the desired dosage proves challenging. Notably, children and the elderly often struggle with swallowing tablets and capsules, making liquid formulations preferable for easier consumption. Additionally, liquid pharmaceuticals offer a more palatable formulation and facilitate simpler administration, meeting the needs of diverse patient populations.

Pharmacy Type Insights

In 2023, the 503A segment emerged as the frontrunner in the US compounding market, asserting dominance among pharmacy types. Projections suggest that this segment is set to sustain its growth momentum, with an estimated Compound Annual Growth Rate (CAGR) of 6.12% during the forecast period. The rise of the 503A segment can be attributed to government-imposed restrictions on drug production and the obligatory requirement for medication prescriptions, driving its expansion within the market. Notably, the 503A segment primarily serves domestic consumption, consolidating its position in the US market. Furthermore, strict regulations mandating biannual monitoring and audits act as safeguards to ensure the safety and quality of products within this segment.

Sterility Insights

In terms of sterility, the US compounding pharmacies market witnessed the non-sterile segment leading the pack, securing a market share of approximately 5.9% in 2023.

However, the sterile segment is set for significant growth in the forecast period. This increase can be attributed to the rising prevalence of chronic conditions like cancer and cardiovascular diseases, which are expected to generate substantial demand for sterile compounded medications in the near future. Moreover, the increasing adoption of ophthalmic and parenteral medications contributes to the rising importance of sterile compounding pharmacies, further propelling 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, compounding pharmacies also play a critical role in various other areas such as oncology, hematology, dental care, and more. 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 encounter significant challenges beyond the disease itself, with chemotherapy's adverse effects compromising their overall health and well-being. Oncology compounding addresses these complexities by customizing drug combinations and treatments to meet the specific needs of patients, thus alleviating the burden of medication management.

Furthermore, the pain medications segment reached US$ 0.89 billion in 2023 and is expected to grow at a compound annual growth rate (CAGR) of 6.43% from 2024 to 2033. Pain serves as 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 offer convenience, they may lead to 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

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