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 global compounding pharmacies market is estimated to account for US$ 13,304.8 Mn in terms of value by the end of 2027.
Global Compounding Pharmacies Market: Drivers
Global shortage of essential drugs is expected to propel growth of the global compounding pharmacies market over the forecast period. For instance, according to the Department of Health and Social Care (DHSC), in November 2019, NHS was facing shortage' of lifesaving drugs that include treatments for cancer, heart conditions and epilepsy.
Increasing prevalence of chronic diseases is expected to boost growth of the market. For instance, according to the World Health Organization, 8.1 million new cases of cancer and 9.6 million deaths due to the disease were recorded in 2018.
North America region held dominant position in the global compounding pharmacies market in 2018, accounting for 65.5% share in terms of value, followed by Europe.
Figure 1. Global Compounding Pharmacies Market Value (US$ Mn), by Region, 2018
Global Compounding Pharmacies Market: Restraints
Increasing restrictions on manufacturing of complex formulations is expected to hinder growth of the global compounding pharmacies market. For instance, the U.S. FDA noted that compounding drugs containing API acetaminophen in excess of 325mg, which may lead to liver injuries in certain patients. Therefore, it restricts compounding pharmacies from manufacturing certain types of drugs that include copies of FDA-approved prescription drugs, even if they appear on FDA’s shortage list and complex dosage forms such as extended release products, transdermal patches, liposomal products, and most biologics.
Moreover, increasing product recall is also expected to hinder growth of the market. For instance, in August 2019, the U.S. FDA requested recall of sterile compounded drug products produced by Pacifico National Inc. and dba AmEx Pharmacy.
Global Compounding Pharmacies Market: Opportunities
R&D of drugs in innovative medium/forms and varying dosages for the treatment of various diseases is expected to offer lucrative growth opportunity of market players. For instance, in November 2018, AMC, a hospital in Amsterdam focused on producing compounding drugs, received permission from the Dutch Health and Youth Care Inspectorate to produce an equivalent of chenodeoxycholic acid (CDCA) if the used resources meet the quality standards.
Moreover, compounding pharmacies need to adopt hybrid retail formats along with a compounding department in order to diversify their business base. Compounding pharmacies can also focus more on non-sterile compounding to avoid mishaps due to sterile compounding.
The Topical Medication segment was valued at US$ 3,335.4 Mn in the global compounding pharmacies market in 2018 and is expected to reach US$ 5,784.9 Mn by 2027 at a CAGR of 5.6%.
Global Compounding Pharmacies Market: Market Trends/Key Takeaways
Hospitals in the U.S. are expected to increase outsourcing of compounding services to the U.S. FDA 503B-certified bulk drug manufacturing facilities in the U.S.
The market is also witnessing development of innovative pain management compounded drugs, constituting of unique and currently unapproved combinations. These medications are expected to witness increasing demand from sports medicines and oncology domains.
Global Compounding Pharmacies Market: Regulations
The EU Court of Justice is currently contemplating on mandating that bulk drug substances cannot be manufactured by compounding pharmacies unless they possess a proper manufacturing authorization. These should be accompanied with proper toxicity and pharmacovigilance data. In this regard, France is planning to permit pharmacists to substitute cheaper biosimilars on production of prescriptions for biologics
Global Compounding Pharmacies Market: Competitive Landscape
Major players operating in the global compounding pharmacies market include, Central Admixture Pharmacy Services, Fagron, Fresenius Kabi AG, PharMEDium Services, LLC, Institutional Pharmacy Solutions, Cantrell Drug Company, Triangle Compounding Pharmacies, and Lorraine’s Pharmacy.
Global Compounding Pharmacies Market: Key Developments
Key players in the market are focused on geographical expansion through M&A activities. For instance, in May 2019, Fagron entered into an agreement to acquire Central de Drogas, S.A. de C.V., a leading supplier of raw materials to compounding pharmacies and the pharmaceutical industry in Mexico.
In April 2019, Pentec Health, Inc., an established leader in sterile compounding with an FDA registered 503B Outsourcing Facility, added California to their list of 43 licensed states.