Compounding pharmacies produce drugs prepared by licensed pharmacist or under the guidance of a physician, tailored or customized to meet the needs of individual patients. Compounded drugs are prepared by altering, combining, or mixing the necessary active pharmaceutical ingredients in appropriate proportions. These medicines can be prepared as per prescriptions or without prescriptions. Most drug regulatory agencies across the world do not approve compounded medications, and do not verify the safety or effectiveness of compounded drugs. These drugs not usually covered by reimbursement schemes or by pharmaceutical benefit agencies.
Compounding pharmacies in the U.S. are estimated to account for market value of US$ 3,262.6 Mn by the end of 2015, and projected to witness stable growth due to rising demand for customized medications.
Drivers and Trends
A prime driver for growth of the compounding pharmacies market is drug shortages and this phenomenon is relatively prominent in the U.S. In this regard, the FDA noted that there are active drug shortages for over 300 essential drugs in the country and these shortages occur in spurts. Other factors fueling demand include availability of compounded drugs in multi-ingredient combinations for innovative therapeutic areas such as dermatology, hormone replacement therapy, etc. Furthermore, increasing demand for compounded regenerative medicines, which are mostly topical applications, is a prevalent trend across the globe. Innovative sub-therapeutic areas such as bio-identical hormone replacement therapy are also contributing to growing popularity of compounded drugs.
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Availability of compounded drugs in alternate forms such as a lollipops, transdermal applications, or sterile preparations and ease of usage of these drugs for various therapeutic areas and patient classes is further resulting in increased popularity of customized drugs.
Increasing need to conform to regulatory specifications is however becoming a necessity for compounding pharmacies in the U.S.
Analysis, By Product Type
On the basis of product type, the U.S. compounding pharmacies market is segmented into oral medication, topical medication, mouthwashes, and suppositories.
Oral medications constitute drugs that are administered through the mouth such as capsules, tablets, and tonics or mixtures. These are expected to exhibit increasing growth rates ranging from 4.7% to 8.4% over 2015–21.
Other products include topical medications that constitute medications applied on the skin. Rising demand for cosmo-dermatological applications and innovative therapeutic areas such as HRT are expected to drive the popularity of compounded topical drugs. Prices of these drugs vary significantly, e.g. US$ 100 to US$ 9,000 and above.
Mouthwashes and suppositories are expected to witness slightly lower growth rates owing to formulation rigidity resulting from regulatory restrictions. Popularity of non-sterile products is likely to increase due to increased security regarding product safety regulations from the U.S. FDA.
Analysis, By Application Area
By application area, the market can be divided into medications for adults, veterinary purposes, children, and geriatric drugs. Availability of compounded drugs in varying strengths and dosages are expected to contribute to growth of the compounded drugs market in the U.S. These applications are also available in varying product forms, which contribute to ease of drug administration.
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Analysis, By Therapeutic Area
In the current report, the market has been segmented into two main therapeutic areas, wherein compounded medications find maximum application. These include pain management segment and hormone replacement therapy (HRT) segment. The availability of pain management drugs in innovative product forms such as location-based medicines and transdermal applications, using ingredients not available commercially, contribute largely to fueling demand for compounded drugs. Popularity of HRT has increased considerably in the U.S., primarily among women aged between 40 and 49 years.
Key market participants covered in the report include, PharMEDium Services, LLC, Institutional Pharmacy Solutions, Cantrell Drug Company, and Triangle Compounding Pharmacies.