Tuesday, 02 January 2024 12:17 GMT

Non-Sterile Compounding Pharmacy Market Size Expected To Reach USD 12.11 Bn By 2034


(MENAFN- GlobeNewsWire - Nasdaq) The global non-sterile compounding pharmacy market size is calculated at USD 6.41 billion in 2025 and is expected to reach around USD 12.11 billion by 2034, growing at a CAGR of 7.34% for the forecasted period.

Ottawa, Oct. 27, 2025 (GLOBE NEWSWIRE) -- The global non-sterile compounding pharmacy market

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Key Takeaways

  • North America held a major revenue of 50% share of the market in 2024.
  • Asia Pacific is expected to witness the fastest growth in the non-sterile compounding pharmacy market during the forecast period.
  • By dosage form, the oral solids segment held a major revenue of 36% share of the market in 2024.
  • By dosage form, the topicals segment is expected to witness the fastest growth in the market during the forecast period.
  • By therapeutic area, the hormonal replacement therapy (HRT) segment held a major revenue of 33% share of the market in 2024.
  • By therapeutic area, the dermatology segment is expected to witness the fastest growth in the market during the forecast period.
  • By type of compounding, the traditional compounding segment held a major revenue of 40% share of the market in 2024.
  • By type of compounding, the veterinary compounding segment is expected to witness the fastest growth in the market during the forecast period.
  • By sales channel, the direct/walk-in pharmacy segment held a major revenue of 44% share of the market in 2024.
  • By sales channel, the online/mail order services segment is expected to witness the fastest growth in the market during the forecast period.
  • By regulatory classification, the 503A compounding pharmacies segment held a major revenue of 58% share of the market in 2024.
  • By regulatory classification, the 503B outsourcing facilities segment is expected to witness the fastest growth in the market during the forecast period.

What is a Non-Sterile Compounding Pharmacy?

The non-sterile compounding pharmacy market is driven by growing demand for customized medicines that address unique patient needs. The non-sterile compounding pharmacy refers to the pharmacies developing tailored formulations as per the patient's needs, which do not require sterilization as they are not used on sterile body sites. They compound products such as personalized medications, allergen-free medications, topical products, etc.

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Key Metrics and Overview

Metric Details
Market Size in 2025 USD 6.41 Billion
Projected Market Size in 2034 USD 12.11 Billion
CAGR (2025 - 2034) 7.34 %
Leading Region North America
Market Segmentation By Dosage Form, By Therapeutic Area, By Type of Compounding, By Sales Channel, By Regulatory Classification, By Region
Top Key Players Advanced Pharmacy, Avella Specialty Pharmacy, BCP, CareFirst Specialty Pharmacy, Central Compounding Center, Cipla Medpro, Clinigen Group, Columbia Veterinary Pharmacy, Fagron, Innovation Compounding, ITC Compounding Pharmacy, Letco Medical, Medisca, National Custom Compounding, Pencol Compounding Pharmacy, PCCA, PharmScript, Rx3 Compounding Pharmacy, Triangle Compounding Pharmacy, Wedgewood Pharmacy

What are the Major Growth Drivers in the Non-Sterile Compounding Pharmacy Market?

The growing demand for personalized medicine

What are the Key Drifts in the Non-Sterile Compounding Pharmacy Market?

The market has been expanding due to the growing funding and collaborations to launch oral formulations developed in non-sterile compounding pharmacies.

  • In May 2025, a total of $1 million in a pre-Series A funding round was secured by Salt Oral Care, where the funding will be utilized to solidify its brand presence and enhance its R&D capabilities, as well as its product innovation.
  • In December 2024, to manufacture and deliver oral liquid formulations in the European market, a collaboration between Akums Drugs and Pharmaceuticals Limited was announced. Akums received an upfront payment of EUR 100 million, which will support its product development and regulatory site approvals, where approximately EUR 200 million accounted for the total value of the agreement.

What is the Significant Challenge in the Non-Sterile Compounding Pharmacy Market?

Safety concerns are the major limitation in the market. The products compounded in these pharmacies may show limited safety, efficacy, and quality, which can reduce their use and patient trust. Moreover, regulatory challenges, skilled personnel shortage, and limited insurance reimbursement are other market challenges.

Regional Analysis

Why did North America Dominate the Non-Sterile Compounding Pharmacy Market in 2024?

In 2024, North America captured the biggest revenue share of 50% in the market, driven by the presence of advanced healthcare infrastructure, which increased the use of non-sterile compounded drugs. To deal with the growing drug shortage and ensure compliance with the regulatory standard, the products from these pharmacies were preferred. Their demand also increased due to the growing demand for personalized products, which contributed to the market growth.

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What Made Asia Pacific Grow Fastest in the Non-Sterile Compounding Pharmacy Market in 2024?

Asia Pacific is expected to host the fastest growth in the market during the forecast period, due to growing diseases, which are increasing the demand for personalized treatment options. At the same time, the expanding healthcare is increasing the adoption of advanced technologies to enhance the quality and efficiency of compounded products. Thus, these factors are increasing the reliance on the non-sterile compounding pharmacies, enhancing the market growth.

Segmental Insights

By dosage form analysis

Why Did the Oral Solids Segment Dominate in the Non-Sterile Compounding Pharmacy Market in 2024?

By dosage form, the oral solids segment led the market with 36% share in 2024, due to their simple manufacturing process. Additionally, their stability decreased the need for specialized storage conditions. Moreover, they showed enhanced stability and precise dosing, with personalized doses and combinations.

By dosage form, the topicals segment is expected to show the highest growth in the market during the upcoming years. The growing skin disorders are increasing their use. Moreover, their patient-centric approach and self-medication are increasing their demand as well as their manufacturing.

By therapeutic area analysis

Which Therapeutic Area Type Segment Held the Dominating Share of the Non-Sterile Compounding Pharmacy Market in 2024?

By therapeutic area, the hormonal replacement therapy (HRT) segment held the dominating share of 33% in the market in 2024, driven by growing hormonal disorders. This increased their personalized treatment production and was manufactured in these pharmacies with lower complexities than sterile compounding. Growing patient awareness also increased their use.

By therapeutic area, the dermatology segment is expected to show the highest growth in the market during the upcoming years. With the growing skin disorders and beauty standards, the use of various topical dosage forms is increasing. The aging population is also driving their demand, increasing their production rates.

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By type of compounding analysis

What Made Traditional Compounding the Dominant Segment in the Non-Sterile Compounding Pharmacy Market in 2024?

By type of compounding, the traditional compounding segment led the market with a 40% share in 2024, as it is considered the core practice of community pharmacies. They contributed to the development of non-sterile dosage forms. This increased their production and use to tackle different diseases.

By type of compounding, the veterinary compounding segment is expected to show the highest growth in the market during the upcoming years. The growing pet ownership and increasing demand for palatable products are driving the veterinary compounding process. Growing awareness and demand for tailored formulations are also contributing to the same.

By Sales Channel Analysis

How the Direct/Walk-in Pharmacy Segment Dominated the Non-Sterile Compounding Pharmacy Market in 2024?

By sales channel, the direct/walk-in pharmacy segment held the largest share of 44% in the market in 2024, driven by patient-specific prescriptions. They also provided faster services, which helped in enhancing the patient outcomes. Moreover, guidance and counseling were also offered to the patients.

By sales channel, the online/mail order services segment is expected to show the highest growth in the market during the predicted time. They offer home deliveries, which enhances the patient's convenience. Additionally, their widespread availability is also improving access to the different types of medications.

By regulatory classification analysis

Why Did the 503A Pharmacies Segment Dominate in the Non-Sterile Compounding Pharmacy Market in 2024?

By regulatory classification, the 503A compounding pharmacies segment led the market with 58% share in 2024, due to the compounding of personalized medications. They also showed low regulatory burden, which enhanced their manufacturing practices. Moreover, their wide availability increased the reliance on them.

By regulatory classification, the 503B outsourcing facilities segment is expected to show the highest growth in the market during the predicted time. They help in the compounding of different types of medications for various therapeutic areas. Additionally, their compliance with regulatory standards is enhancing their use.

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Recent Developments in the Non-Sterile Compounding Pharmacy Market

  • In September 2025, to include advanced non-sterile compounding capabilities for oral and topical medications, the expansion of the state-of-the-art affiliated pharmacy was announced by LifeMD, Inc.
  • In January 2025, for the treatment of moderate to severe acute pain in adults, a first-in-class non-opioid analgesic oral tablet, that is Journavx, was approved by the U.S. Food and Drug Administration.

Non-Sterile Compounding Pharmacy Market Key Players List

  • BCP (Belmar Pharma Solutions)
  • Advanced Pharmacy
  • CareFirst Specialty Pharmacy
  • Avella Specialty Pharmacy
  • Clinigen Group
  • Central Compounding Center
  • Columbia Veterinary Pharmacy
  • Cipla Medpro (Compounding Division)
  • ITC Compounding Pharmacy
  • Fagron
  • Letco Medical
  • Innovation Compounding
  • Pencol Compounding Pharmacy
  • Medisca
  • PCCA (Professional Compounding Centers of America)
  • Wedgewood Pharmacy
  • National Custom Compounding
  • Rx3 Compounding Pharmacy
  • PharmScript
  • Triangle Compounding Pharmacy

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Segments Covered in The Report

By Dosage Form

  • Oral Solids
    • Capsules
    • Tablets
    • Troches/Lozenges
  • Oral Liquids
    • Solutions
    • Suspensions
    • Syrups
  • Topicals
    • Creams
    • Ointments
    • Gels
    • Lotions
  • Suppositories & Rectal Formulations
  • Nasal & Otic Preparations
  • Others (e.g., Sublingual, Transdermal Patches)

By Therapeutic Area

  • Hormone Replacement Therapy (HRT)
  • Pain Management
  • Dermatology
  • Pediatrics
  • Geriatrics
  • Gastroenterology
  • Veterinary Medicine
  • Others (e.g., Dentistry, ENT)

By Type of Compounding

  • Traditional Compounding
  • Specialty Compounding
  • Veterinary Compounding
  • Pediatric Compounding
  • Others (e.g., Sports Medicine, Alternative Medicine)

By Sales Channel

  • Direct/Walk-in Pharmacy
  • Prescriber-Based (Clinic-Supported)
  • Online/Mail Order Services
  • Others

By Regulatory Classification

  • 503A Compounding Pharmacies (Patient-specific, State-regulated)
  • 503B Outsourcing Facilities (Batch compounding, FDA-registered)

By Region

North America

  • U.S.
  • Canada

Asia Pacific

  • China
  • Japan
  • India
  • South Korea
  • Thailand

Europe

  • Germany
  • UK
  • France
  • Italy
  • Spain
  • Sweden
  • Denmark
  • Norway

Latin America

  • Brazil Mexico
  • Argentina

Middle East and Africa (MEA)

  • South Africa
  • UAE
  • Saudi Arabia
  • Kuwait

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