Non-sterile compounding requires clean environment for the preparation of drugs or other products. However, maintaining clean workplace is essential during the formulation of non-sterile compounding as per the standard specified by the regulatory bodies governing the use of ingredients. About 125 simple formulas for non-sterile compounds are formulated in the U.S. Pharmacopeia. The pediatricians and veterinarians commonly prescribe the non-sterile compounding products.

The U.S. & Europe non-sterile compounding pharmacy market is expected to grow at a CAGR of 2.65% during the forecast period. Compounding involves the customization of the medicine based on the physician prescription. The pharmacist customizes the dosage or strength and reformulates the drug by excluding unwanted ingredients to which the patient is allergic, or may change the form of the medicine for the patients who are unable to swallow the oral medications.

In pharmacy, the compounding pharmacists have to comply with the standards set by the regulatory authorities. The Drug Enforcement Administration (DEA) monitors the use of any controlled substances for the preparation of compounded medications. The U.S. Pharmacopeia (USP) Convention issues standards that apply to the compounding.

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Non-Sterile Compounding Pharmacy Market – Top Vendors

Some of the key players in this market are Fagron (the Netherlands), B.Braun Melsungen AG (Germany), Fresenius Kabi AG (Germany), TRUE NATURE HOLDING, INC (U.S), Dougherty's Pharmacy Inc. (U.S.), and PHARMEDIUM (U.S.).

Regional Analysis:

America is the largest market for non-sterile compounding pharmacy owing to the rising demand for customized medicine, and rising number of hospital-based compounding pharmacies. As per the Center for Diseases Control and Prevention (CDC) in 2015, 30.3 million Americans, i.e., 9.4% of the population had diabetes. Additionally, 1.25 million American children and adults had type 1 diabetes. Key market players are engaged in a number of strategy such as mergers & acquisitions, for instance, Fresenius Kabi AG, a company based in Germany, acquired the U.S. based generic drugs manufacturer Akorn, Inc. to expand its wings in the U.S.

Europe is the second largest non-sterile compounding pharmacy market. In Europe, the number of chronic diseases such as diabetes, drug allergies, and rising awareness about the availability of compounded medications is increasing. Furthermore, availability of funds for research and development activities strengthens the market growth. According to European Academy of Allergy and Clinical Immunology (EAACI), around 2.6% hospitalization registered due to adverse drug effects while the prevalence of drug allergy in the hospitalized patients is around 10% in the Europe. As per European Academy of Allergy and Clinical Immunology, 150 million European Union (EU) citizens have the chronic allergic disease.


Non-sterile compounding requires clean environment for the preparation of drugs or other products. However, maintaining clean workplace is essential during the formulation of non-sterile compounding as per the standard specified by the regulatory bodies governing the use of ingredients. About 125 simple formulas for non-sterile compounds are formulated in the U.S. Pharmacopeia. The pediatricians and veterinarians commonly prescribe the non-sterile compounding products.

Segmentation:

The U.S. & Europe non-sterile compounding pharmacy market is segmented by product, application, and end user.

By type, the market is segmented into oral medication, topical medication, otologic/nasal medication, and others. The oral medications are further segmented into solid and liquid preparations. The topical medications include ointments, creams, gels, pastes, and others.

By application, the market is segmented into pain medication, hormone replacement therapy, and others.

By end user, the market is segmented into hospitals, compounding pharmacy, and others.

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