The U.S. 503B compounding pharmacies market size was estimated at US$ 1.16 billion in 2024 and is projected to reach US$ 2.25 billion by 2033, expanding at a compound annual growth rate (CAGR) of 7.63% from 2025 to 2034. The growing focus on patient safety, adherence to regulatory compliances, and rising demand for personalized medicine drive the growth of the market.
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Market Overview
In U.S., the Food and Drug Administration (FDA) regulates 503B compounding pharmacies through the CGMP regulations. 503B compounding pharmacies are known as manufacturing pharmacies that can produce large batches of medications without prescriptions. These pharmacies are governed by Section 503B of the Drug Quality and Security Act. They must follow U.S. FDA’s regulations and goods manufacturing practices (GMP) to ensure the quality, safety, and efficacy of medications.
The U.S. 503B compounding pharmacies market is experiencing rapid growth due to the rising demand for personalized medicine. An increase in the number of people suffering from chronic diseases and the growing geriatric population also contribute to market expansion. In addition, the shortage of commercially available drugs encourages healthcare providers to seek compounded alternatives from 503B compounding pharmacies.
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Major Trends in the U.S. 503B Compounding Pharmacies Market
Growing Geriatric Population:
According to the U.S. Census Bureau, the number of people ages 100 and above is projected to more than quadruple over the next three decades, from an estimated 101,000 in 2024 to about 422,000 in 2054. Currently, approximately 62 million adults ages 65 and older live in the U.S., accounting for 18% of the population, and is expected to reach 84 million by 2054, making up an estimated 23% of the population.
Thus, the growing geriatric population in the country is a major factor boosting the growth of the market. Most of the aged population develop or suffer from some age-related chronic issues, like blood pressure, diabetes, and cardiovascular problems. This directly reflects an increase in demand for medications. The availability of compounded alternatives and safety standards of 503B compounding pharmacies help keep up with the increase in demand.
Demand for Customized Compounded Medications:
Due to the increasing awareness amongst people about the benefits of personalized medicine, there is a high demand for customized compounded medications that are tailored to individual patient needs. The increased demand for personalized medicine has been an important factor driving the growth of the market. With the increasing prevalence of chronic and genetic diseases, investments in research and development activities are increasing to develop personalized medicine. Personalized medicine is a patient-centric care approach customized to suit a specific individual and their health needs. 503B compounding pharmacies can cater to a large patient base by providing customized compounded medications.
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Advancements in Technology:
Advancements in technology have been key to the growth of the pharmaceutical industry in the last few years. The integration of advanced technologies accelerates research and development activities, enhances safety and quality, streamlines manufacturing and production processes, and reduces the time and cost required to produce medications. Adopting artificial intelligence (AI) technologies and robotics helps increase compounded drugs' accuracy, safety, and effectiveness. Therefore, technological advancements aid 503B compounding pharmacies in developing high-quality drug formulations, making them more appealing to healthcare providers.
Future Outlook
503B pharmacies play a crucial role in the U.S. healthcare industry. The U.S. 503B compounding pharmacies market is expected to expand at a rapid pace in the coming years. The growth of the market can be attributed to various factors. Firstly, the shortage of certain medications encourages healthcare providers to seek compounded alternatives from 503B pharmacies. Secondly, the rising geriatric population and the increasing cases of chronic diseases. In addition, the shortage of certain drugs nationwide is boosting the demand for alternative compounded medications. The country’s well-established healthcare infrastructure and the presence of leading pharmaceutical companies further influence the market.
There is a rapid expansion of outpatient settings, such as clinics and ambulatory surgical centers (ASCs). This may boost the demand for sterile compounded products. Regulatory support from the U.S. Government and regulatory bodies like FDA further support market growth. Furthermore, key players operating in the market are focusing on expanding their business across the country, influencing the market.
• In July 2024, an established company with a national network of 503A and 503B compounding pharmacies, Revelation Pharma, announced the acquisition of Florida-based Taylors Pharmacy and Washington-based Key Compounding Pharmacy. This strategic acquisition enables Revelation Pharma to expand its operation across the U.S.
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Competitive Landscape & Major Breakthroughs in the Market
The U.S. 503B compounding pharmacies market continues to evolve rapidly. Some of the prominent players competing in the market include SCA Pharma, Revelation Pharma, Nephron Pharmaceuticals Corporation, Athenex, Inc., Wells Pharma of Houston LLC, Olympia Pharmacy, and Fagron Compounding Pharmacies. These companies are focusing on strategic partnerships, mergers, and innovations to expand their footprints.
In February 2024, Empower Pharma announced its plan to purchase a facility in East Windsor, New Jersey, from Eugia US Manufacturing LLC and enter into a contract manufacturing relationship with an aim for large-scale expansion. This 170,000 square foot facility will help Empower Pharma increase its 503A, 503B, and CDMO operations capabilities. Shaun Noorian, Chief Executive Officer and Founder of Empower Pharma, said, “This state-of-the-art facility will enable us to bring the highest levels of capacity and supply chain resilience to both our 503A and 503B business lines, while supporting our new partnership with Eugia Pharma and the growing demand of outsourced medicine for thousands of pharmacies throughout the country."
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Recent Developments
• In September 2024, Nivagen Pharmaceuticals, Inc., a US-based specialty pharmaceuticals company, sold its MedisourceRx business unit, an FDA-registered 503B outsourcing facility, to Hims & Hers Health, Inc.
• In April 2024, an established global clinical trial supply company, Myonex, announced the completion of the acquisition of Saveway Compounding Pharmacy based in Newark, Del. The pharmacy will operate as SaveWay Compounding Pharmacy, a Myonex company.
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