The U.S. 503B compounding pharmacies market has witnessed significant growth in recent years due to the increasing need for personalized medications. 503B compounding pharmacies or outsourcing facilities are specialized pharmacies that are allowed to produce large volumes of medications strictly based on the receipt of a valid prescription for an individually identified patient. These pharmacies offer compounded medications which allow pharmacists to alter dosage form, flavors, delivery systems, potency, and other characteristics to meet patient-specific needs. This has led to rising demand for compounded medications for various therapeutic applications such as pain management, hormone replacement therapy, dermatology, and veterinary medicines.
The global U.S. 503B compounding pharmacies market is estimated to be valued at US$ 1060.51 billion in 2023 and is expected to exhibit a CAGR of 6.3% over the forecast period 2023 to 2030, as highlighted in a new report published by Coherent Market Insights.
Market Dynamics
Rising demand for customized medications and focus on specialty medications are expected to drive the growth of the U.S. 503B compounding pharmacies market over the forecast period. 503B compounding pharmacies play a crucial role in fulfilling unmet medical needs by producing compounded formulations as prescribed by physicians when an FDA-approved drug may be unsuitable. This allows patients to receive individually tailored therapies specifically designed for their unique medical needs. The healthcare industry has also shifted its focus towards specialty medications in recent years owing to changing disease patterns and increasing emphasis on precision medicine. This, along with growing geriatric population prone to chronic diseases, supplements the demand for specialized and personalized compounded therapies, thereby supporting market growth.
Segment Analysis
The U.S. 503B compounding pharmacies market is dominated by the sterile and non-sterile segments. The sterile segment accounts for over 60% share as most of the drugs supplied by 503B compounding pharmacies require sterility. The demand for sterile drugs is high due to rising incidence of chronic diseases that require injections and intravenous therapies.
PEST Analysis
Political: The pharmaceutical industry is highly regulated in the US to ensure drug safety and efficacy. The FDA has issued the CGMP regulations in 2019 to strengthen the standards and oversight of 503B compounding pharmacies.
Economic: Rising healthcare spending in the US along with an aging population drives the demand for compounding drugs to meet specialized medical needs. The market size is expected to grow at 6.3% annually and reach US$ 1060.51 billion by 2023 supported by economic growth.
Social: Increasing incidence of chronic and lifestyle diseases has enhanced the need for tailored medication. 503B compounding pharmacies help meet the needs of patients who cannot use FDA-approved drugs due to allergies and intolerances.
Technological: 503B facilities utilize advanced technologies like clean rooms, laminar air-flow workbenches for sterility assurance and quality production in large volumes. Adoption of automated compounding systems has improved efficiency.
Key Takeaways
The U.S. 503B Compounding Pharmacies Market Share is expected to witness high growth due to rising demand for specialized medications that cannot be met through FDA-approved drugs. The sterile segment dominates owing to the large volume of injectable and intravenous therapies used for chronic diseases.
Regional analysis: The Western region currently accounts for over 45% market share led by states like California, Texas and Florida having high healthcare infrastructure and expenditure. The rising geriatric population in these states drives the demand for compounded drugs.
Key players: Key players operating in the U.S. 503B compounding pharmacies market are Merck & Co., Inc., Ferring Pharmaceuticals, Inc., EMD Serono, Inc., Pfizer Inc., Novartis AG. Merck & Co., Inc. is a market leader owing to its wide product portfolio and strong distribution network across the US.
For more details on the report, Read- https://www.pressreleasebulletin.com/u-s-503b-compounding-pharmacies-market-overview/
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