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.
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.
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.
This Future Market Insights report examines the U.S. compounding pharmacies market for the period 2015–2021. The primary objective of the report is to offer updates and information related to market opportunities in the U.S compounding pharmacies market.
The U.S. compounding pharmacies market report provides insights about compounded drugs, which are customized medicines, prepared by a pharmacist, or a physician and are available in strengths not commercially available. These medicines are easily available at community pharmacies and are known to provide personalized relief. Compounded drugs are available in various forms such as oral applications (capsules, mixtures, etc.), topical applications (creams, gels, lotions, ointments, etc.), and suppositories. These drugs can be formulated for both human beings and animals. The U.S. compounded drug market is expected to expand at a CAGR of 5.7% over the forecast period (2015–2021) to account for US$ 4,812.2 Mn by 2021.
To understand and assess the opportunities in this market, the report is categorically split into three sections, namely, market analysis by product and therapeutic area. The report analyzes the U.S. compounding pharmacies market in terms of market value (US$ Mn).
The report starts with an overview of the U.S. compounding pharmacies market and its usage in various applications. In the same section, FMI covers the U.S. compounding pharmacies market performance in terms of revenue. This section includes, FMI’s analysis of key trends, drivers and restraints from supply and demand perspectives.
The next section of the report analyzes the market on the basis of product type and presents the forecast in terms of value for all the years till 2021. Product types covered in the report are as follows:
The next section of the report analyzes the market on the basis of application segments and presents the forecast in terms of value for the following six years. Drug applications covered in the report are as follows:
Post applications, the section of the report that follows analyzes the market on the basis of therapeutic areas and it in terms of value for the forecast period. Therapeutic areas covered in the report are as follows:
When developing the market forecast, the starting point involves sizing the current market, which forms the basis for the forecast of how the market is anticipated to take shape in the near future. For this, FMI referred to several subject matter experts in the compounding pharmacy domain. Given the characteristics of the market, we triangulated the outcome based on different analysis based on supply side, demand side and dynamics of the market such as regulations and GMP guidelines of the compounding pharmacies market. Quantification of data has been considered along with provision of quality insights collected directly from the market through discussion with pharmacists, suppliers, physicians and subject matter experts. This is how market analysis for the forecast period is carried out.
We have also taken into consideration year-on-year growth based on historical growth analysis to understand predictability of the market and to identify right opportunities in the U.S. compounding pharmacies market.
As previously highlighted, the market for U.S. compounding pharmacies is split into various segments on the basis of application, product and therapeutic area. All these segments have been analyzed in terms of Basis Point Share (BPS) to understand the individual segments’ relative contribution to market growth. This detailed level of information is important for identification of various key trends in the U.S. compounding pharmacies market.
Additionally, the absolute dollar opportunity provided in the report is critical and is expected to help in assessing the level of opportunity that a provider can look to achieve from a sales perspective in the U.S. compounding pharmacies market.
Furthermore, FMI has developed the market attractiveness index for all three segments, namely, application, therapeutic area and product segments. This index helps in identifying the real opportunities in the market.
In the final section of the report, the U.S. compounding pharmacies market landscape is included to provide report audiences with a dashboard view, based on categories of providers in the U.S. compounding pharmacies product portfolio; their key developments and strategies have also been included, wherever possible. Key market participants covered in the report are PharMEDium Services, LLC, Institutional Pharmacy Solutions, Cantrell Drug Company, and Triangle Compounding Pharmacies