The U.S. compounding pharmacies market sizewas valued at USD 6.31 billion in 2024 and is projected to reach USD 10.76 billion by 2033, registering a CAGR of 6.1% from 2024 to 2033. The U.S. compounding pharmacies market growth is attributed to the increasing demand for personalized medications and increasing preference towards patient-centric care
U.S. Compounding Pharmacies Market Key Takeaways
· By Product, the oral medications segment dominated the market with the largest market share of 36.47% in 2023.
· By Pharmacy Type, 503A segment accounted for more than 73.28% of revenue share in 2023.
· By Sterility, the non-sterile segment dominated the market with the highest revenue of 72.58% in 2023.
· By Therapeutic Area,The pain management segment holds the largest revenue share of over 32.19% in 2023
· By Application, the adult segment is expected to significantly boost during the anticipated timeframe.
· By Age Cohort, the adult segment holds the largest revenue share of over 44.18% in 2023.
· The pediatric segment is poised for the fastest CAGR from 2024 to 2033
· By Compounding Type,the Pharmaceutical Ingredient Alteration (PIA) segment held the largest revenue share of over 37.24% in 2023.
· The Pharmaceutical Dosage Alteration (PDA) segment is expected to witness significant growth from 2024 to 2033.
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The U.S. compounding pharmacies market is experiencing robust growth, driven by the increasing demand for personalized medications equipped to address individual patient needs. Compounding pharmacies have emerged as a critical player in addressing unique medical requirements that standard pharmaceutical products cannot fulfill, as healthcare continues to shift towards customized treatment solutions.
This market offers significant opportunities for expansion, investment, and innovation. Major growth drivers include the expanding adoption of sterile compounding for sensitive treatments, advancements in compounding technologies, and the increasing prevalence of chronic diseases.
One of the major opportunities driving the growth of the U.S. compounding pharmacies market is rising technological advancements in compounding techniques. The rising innovations in compounding technologies, such as improved drug formulation techniques, automated dispensing systems, and advancements in sterile compounding, are enhancing the safety and efficiency of compounded medications.
Artificial intelligence can play an important role in improving compounding pharmacies in the U.S. AI technologies ensure accuracy and consistency in the final product and precisely dispense and measure drug components. AI-generated systems can continuously correct and detect errors and monitor the compounding process. In addition, AI can analyze historical data to identify patterns and trends, reducing the risk of future errors and enabling continuous improvement in the compounding process. Future developments could see AI being used to automate more complex tasks, further minimizing the risk of errors and reducing the burden on human pharmacists.
Market Trends
· Rising demand for personalized medicine: The increasing focus on personalized healthcare, where medications are equipped for individual patient needs, is enhancing the market growth. This trend is driven by a rise in chronic diseases such as hormonal imbalances, diabetes, and pain that need customized treatments.
· Growing healthcare awareness: The demand for customized drugs is increasing, especially in managing complex and chronic medical issues, as patients become more aware of the advantages of compounded medications for specific health diseases.
Segment Insights
By Type Insights
Based on the pharmacy type, the 503A segment dominated the US compounding market in 2023. The segment growth in the U.S. is attributed to the increasing prevalence of chronic diseases and growing personalized healthcare. 503A pharmacies serve patient-specific needs, providing treatments for rare conditions, allergy-free compounds, and customized formulations for patients requiring unique dosages. 503A Pharmacies must have a Quality System and are required to adhere to specific chapters in the U.S. Pharmacopeia (USP).
This segment is estimated to grow at a CAGR of 6.1% during the forecast period. segment growth in the market is hospitals seeking consistent medication supplies for high patient volumes. The 503B segment addresses the demand for large-scale, reliable drug production, with the increasing need for ready-to-use and sterile medications for critical care. The compounding pharmacies serve healthcare facilities and hospitals by producing non-patient-specific and bulk compounded medications under strict regulatory standards.
By Sterility Insights
Depending on the sterility, the US compounding pharmacies market was dominated by the non-sterile segment that accounted for a market share of around 5.9% in 2023. The segment growth in the market is attributed to the growing emphasis on maintaining rigorous efficacy and safety standards for pharmaceutical targeting. Sterile compounding is vital for preparing medications intended for sensitive areas including heat, lungs, eyes, or bloodstream. To ensure the medications are completely free from contaminants, this procedure needs highly skilled pharmacists to work in sterile and controlled environments using specialized products.
The non-sterile segment is expected to grow fastest during the forecast period. This segment includes processes such as pooling, admixing, diluting, combining and reconstituting, or otherwise modifying bulk substances or drugs to produce non-sterile preparations that are different from manufacturer specifications. In addition, this emphasizes the critical need to adhere to regulatory standards to maintain product effectiveness and safety and highlights the wide use of non-sterile compounding in the market.
By Therapeutic Area Insights
The pain management segment holds the largest revenue share of over 32.19% in 2023. The segment growth in the market is attributed to the limitations of standard pain relievers and the increasing prevalence of chronic pain diseases. Compounding pharmacies offering personalized dosages, provide customized solutions and tailored formulations that cater to patients’ specific needs. In addition, the demand for customized treatments from compounding pharmacies continues to rise, as personalized pain management becomes more vital, further accelerating the segment growth.
The nutritional supplements segment is expected to grow fastest during the forecast period. The segment growth in the U.S. compounding pharmacies market in 2023 is driven by the increasing focus on preventive healthcare and health consciousness and increasing demand for custom nutritional formulations and personalized medicine. In addition, compounding pharmacies offering personalized supplements to meet individual health concerns and are well-positioned to address these demands further drive the segment growth.
U.S. Compounding Pharmacies Market, By Therapeutic Area, 2021-2023 (USD Billion)
|
By Therapeutic Area |
2021 |
2022 |
2023 |
|
Hormone Replacement |
1.02 |
1.08 |
1.15 |
|
Pain Management |
0.84 |
0.89 |
0.94 |
|
Dermatology |
0.47 |
0.50 |
0.53 |
|
Pediatrics |
0.33 |
0.35 |
0.37 |
|
Urology |
0.28 |
0.30 |
0.32 |
|
Others |
2.25 |
2.36 |
2.47 |
By Age Cohort Insights
The adult segment holds the largest revenue share of over 44.18% in 2023. The segment growth is attributed to the rising awareness campaigns by companies. To manage health conditions more effectively and address nutritional deficiencies, adults are increasingly seeking customized compounded medications. In addition, adults are increasingly witnessing chronic lifestyle-related diseases connected to poor dietary habits and sedentary lifestyles, along with increasing nutritional deficiencies.
The pediatric segment is expected to grow fastest during the forecast period. Compounding pharmacies are becoming essential in meeting the unique healthcare requirements of both pediatric and adult populations, as the demand for personalized medications increases. Pediatric patients often need specific formulations and dosages that standard medications don't offer. Compounding pharmacies address these needs by providing allergen-free options for sensitive children, improved flavors for compliance, and tailored dosages.
By Compounding Type Insights
The Pharmaceutical Ingredient Alteration (PIA) segment held the largest revenue share of over 37.24% in 2023. The growth in the market is driven by rising demand for personalized medication stems. Compounded medications, which allow for enhanced formulations, preservative-free options, and tailored dosages, are increasingly crucial. This trend enhances the vital role of the PIA segment in meeting specific reinforces and patient needs, leading its position in the market.
The Pharmaceutical Dosage Alteration (PDA) segment is expected to grow fastest during the forecast period. The segment growth in the market is driven by the rising technological advancements in compounding equipment and techniques and increasing demand for tailored pharmaceutical solutions that offer alternatives for patients with allergies or sensitivities, respond to medication shortages, and address specific patient requirements.
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U.S. Compounding Pharmacies Market Top Companies
· Avella Specialty Pharmacy
· Central Admixture Pharmacy Services, Inc.
· Clinigen Limited
· Fagron
· Fresenius Kabi USA
· ImprimisRx (Harrow Health, Inc.)
· PenCol Pharmacy
· Sixth Avenue Medical Pharmacy
· Triangle Compounding
· Vertisis Custom Pharmacy
U.S. Compounding Pharmacies Market Recent Developments
· In September 2024, the network of 503A and 503B compounding pharmacies launched a national wholesale service for healthcare providers. This service is designed to provide users with a streamlined ordering process when purchasing unique medications and compounding solutions.
· In September 2024, Wedgewood announced the addition of molnupiravir to its formulary. Originally developed for human viral infections. This often-fatal disease affects an estimated 15,000 US cats each year, posing a significant concern for veterinarians and cat owners alike.
U.S. Compounding Pharmacies Market Report Segmentation
This report forecasts revenue growth at country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2021 to 2033. For this study, Nova one advisor, Inc. has segmented the U.S. Compounding Pharmacies market.
By Pharmacy Type
· 503A
· 503B
By Product
· Oral
o Capsules
o Granules
o Tablets
o Powder
o Others
· Liquid Preparations
o Emulsion
o Syrup
o Solutions
o Suspension
o Others
· Topical
o Gels
o Ointments
o Creams
o Pastes
o Others
· Rectal
o Enema
o Suppositories
o Others
· Ophthalmic
· Nasal
· Otic
By Sterility
· Sterile
· Non-Sterile
By Compounding Type
· Pharmaceutical Ingredient Alteration (PIA)
· Currently Unavailable Pharmaceutical Manufacturing (CUPM)
· Pharmaceutical Dosage Alteration (PDA)
· Others
By Age Cohort
· Pediatric
· Adult
· Geriatric
By Therapeutic Area
· Hormone Replacement
· Pain Management
· Dermatology
· Pediatrics
· Urology
· Others
By End-User
· Hospitals and Clinics
· Specialty Clinics
· Others
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