U.S. Compounding Pharmacies Market — Insights
A pharmacy that is operated by a licensed pharmacist, licensed physician or a person under the guidance of a licensed pharmacist is called compounding pharmacy.
The U.S. compounding pharmacies market is estimated to account for US$ 3,859.2 Mn in 2018 and is expected to grow at a CAGR of 5.7% to reach US$ 6,355.9 Mn by the end of 2027.
U.S. Compounding Pharmacies Market: Drivers
Lack of essential medicines for the treatment of critical diseases is expected to boost growth of the U.S. compounding pharmacies market. For instance, according to a report of the U.S. Food and Drug Administration (FDA): Drug Shortages: Root Causes and Potential Solutions 2019, 56% of hospitals reported they had changed patient care or delayed therapy in light of drug shortages and 36.6% said they had rescheduled non-urgent or emergent procedures. Such scenario leads to use of readily available compounded medications, which is expected to boost growth of the U.S. compounding pharmacies market.
Increasing demand for hormone replacement therapy (HRT) is also expected to boost growth of the U.S. compounding pharmacies market over the forecast period. HRT is an effective way to relieve symptoms of perimenopause and menopause. Major active pharmaceutical ingredients currently in demand for HRT include progesterone, estradiol, estrogen, and testosterone. Bio-identical HRT is also used to reduce aging process. Therefore, increasing geriatric population is also expected to boost growth of the market. For instance, according to a 2018 U.S. Census Bureau report, geriatric population in the U.S. is expected to reach 78.0 million in 2035 compared to the population of 76.4 million of people under the age of 18.
Topical Medication segment held dominant position in the U.S. compounding pharmacies market in 2018, accounting for 41.0% share in terms of value, followed by Oral Medication
U.S. Compounding Pharmacies Market: Restraints
Adoption of unsafe compounding practices is a major factor hindering growth of the U.S. compounding pharmacies market.
Moreover, increasing product warnings in sterile compounding has led to decrease in sales of compounded injectable drugs, which is also expected to hinder growth of the market. For instance, the U.S. FDA expanded an original warning on using Becton-Dickinson (BD) general use syringes of sizes 1mL, 3mL, 5mL, 10mL, 20mL, and 30mL. The agency noted that interaction with the rubber stopper in some lots of these syringes may adversely impact drug potency if filled in syringes and not used immediately.
U.S. Compounding Pharmacies Market: Opportunities
The U.S. compounding pharmacies market is expected to witness a CAGR of ~6% over the forecast period. This is attributed to upcoming products and therapeutic areas that are yet to be tapped into by branded manufacturers such as those related to geriatric and long-term care drugs and innovative HRT applications.
It is necessary to gain U.S. FDA approval and follow CGMP guidelines to increase drug and brand value. Therefore, market players may focus on abiding to stipulated FDA norms and also be prepared for surprise inspections.
For any segment information:
The Oral Medication segment was valued at US$ 1,538.8 in the U.S. compounding pharmacies market in 2018 and is expected to reach US$ 2,666.8 by 2027 at a CAGR of 6.3%.
U.S. Compounding Pharmacies Market: Market Trends/Key Takeaways
In the U.S. compounding pharmacies market, conventional compounding pharmacies operate without the supervision of the U.S. FDA. The State Boards of Pharmacy regulate the conventional compounding, also known as ‘within border’ compounding. The U.S. Pharmacoepia (USP) has set the standard pharmacy compounding practices in most states.
Compounding pharmacies operate in five formats: independent store, compounding department in hospital, part of a big retail drug manufacturer chain, store with an online order-delivery system, and multiple-location shops. In the U.S., compounding pharmacies are majorly found in independent store format.
U.S. Compounding Pharmacies Market: Regulations
Compounding pharmacies in the U.S. are regulated by the State Boards of Pharmacies.
Traditional Compounding (503A)
- The State Pharmacies Board regulates traditional compounding pharmacies under section 503A
- These boards are also responsible for day-to-day functioning of pharmacies
- These pharmacies cannot legally engage in sterile compounding
- These pharmacies cannot manufacture drugs and APIs in bulk
U.S. Compounding Pharmacies Market: Competitive Landscape
Major players operating in the U.S. compounding pharmacies market include, PharMEDium Services, LLC, Institutional Pharmacy Solutions, Cantrell Drug Company, and Triangle Compounding Pharmacies.
In July 2019, PharMEDium Services, LLC announced to recall 45 lots of 0.5 mg/mL HYDROmorphone HCl in 0.9% Sodium Chloride 1 mL in 3 mL BD Syringe to the user level. The recall was due to presence of sulfite in PharMEDium’s electronic customer ordering system that claimed to be sulfite-free.
In July 2019, The U.S. FDA announced new regulations at Pharmacy Compounding Regulation: A Fresh Look at Guidance, Compliance, and Enforcement Webinar after it found 11 adulteration violations including visibly dirty surfaces and non-sterile cleaning methods in ISO 5 areas at Triad Rx.