Non-Sterile Compounding Pharmacy Market Size was valued at USD 13.1 Billion in 2023. The Global Non-Sterile Compounding Pharmacy industry is projected to grow from USD 14.03 Billion in 2024 to USD 24.28 Billion by 2032, exhibiting a compound annual growth rate (CAGR) of 7.91% during the forecast period (2024 - 2032).
The U.S. Pharmacopeia Convention (USP) formally defines compounding as ‘the preparation, mixing, assembling, altering, packaging, and labelling of a drug, drug-delivery device in accordance with a licensed practitioner's prescription, medication order, or initiative based on the practitioner/patient/ pharmacist/compounder relationship in the course of professional practice.’ Products manufactured by a compounding pharmacy are customized according to the patient need.
The market for non-sterile compounding pharmacy is driven by an increasing prevalence of chronic diseases such as diabetes, rising need for customized medicine and increasing geriatric population. Furthermore, the demand for anti-aging products that use custom compounded drugs is growing in the U.S. and Europe. However, the strict regulations governing the manufacturing of the compounded product and high prices restrain the market growth.
A lawsuit was filed by Lilly in September 2023 for the protection of patients. Lilly cannot verify the safety or efficacy of any product claiming to contain tirzepatide that is not our own branded product. Therefore, we have filed lawsuits to protect patients from such illegal practices and also prevent medical spas, wellness centers, and compounding pharmacies from illegal advertising and selling non-FDA-approved compounded products fraudulently representing themselves as Mounjaro (tirzepatide). It is important that these entities stop selling drug products contrary to consumer protection laws since they mislead their customers into believing that their drugs are just like Mounjaro in terms of the same side effects and clinical benefits.
On March 18, 2024, BCE Pharma Inc., Software and Compounding Consultant, a Canadian Leader providing an online quality management system, training & third-party auditing services for sterile and non-sterile compounding pharmacies; Stratix Labs which is a state-of-the-art biomaterials company manufacturing unique products that set industry benchmarks among other microbiology applications such as surface sampling competency testing are jointly announcing a partnership to offer surface sampling competency testing using Enverify™ standardized microbial-coated test surfaces. This collaboration between BCE Pharma and Stratix Labs provides practical solutions for sterile compounding pharmacists on how they can attain new USP requirements for surface sampling competency demonstration when combined with BCE Pharma’s training programs through the use of Enverify™ Sampling Competency Kit.
Hikma Pharmaceuticals PLC (“Hikma”), the multinational pharmaceutical company, announces today the launch of Hikma 503B – a new outsourced sterile compounding business focused on providing high-quality ready-to-administer injectable medications customized to meet the specific needs of United States patients. Sterile compounding refers to combining ingredients together or altering them so as to make them into ready-to-use formats suitable for healthcare providers where specialized manufacturing has been crucial in caring for patients. More of these medications are demanded by hospital pharmacists, physicians, and nurses, which has led to the growing US market for outsourced compounded sterile injectable medications, which is now estimated to be in excess of $2 billion per year.
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 Non-Sterile Compounding Pharmacy Market is segmented into pain medication, hormone replacement therapy, and others.
By end user, the market is segmented into hospitals, compounding pharmacy and others.
Non-Sterile Compounding Pharmacy Regional Insights
America is holding the first position in the Non-Sterile Compounding Pharmacy Market owing to the rising demand for customized medicine, increasing prevalence of chronic diseases such as diabetes, 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.
Europe is the second largest non-sterile compounding pharmacy market across the globe. In Europe, growing awareness about compounding pharmaceutical products for the treatment of chronic diseases such as diabetes, drug allergies, and increasing number of prescriptions for the compounded medications propel the growth of the market. According to the European Academy of Allergy and Clinical Immunology (EAACI), around 2.6% hospitalization happens due to adverse drug effects, while the prevalence of drug allergy in the hospitalized patients is about 10% in the Europe.
Key Findings:
Intended Audience
| Report Attribute/Metric | Details |
| Market Size | USD 24.28 Billion By 2032 |
| CAGR | 7.91% |
| Base Year | 2023 |
| Forecast Period | 2024-2032 |
| Historical Data | 2022 |
| Forecast Units | Value (USD Billion) |
| Report Coverage | Revenue Forecast, Competitive Landscape, Growth Factors, and Trends |
| Segments Covered | By type, By Applications, By End User and By Region |
| Geographies Covered | America and Europe |
| Key Vendors | 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.). |
| Key Market Opportunities | New product launches and R&D Amongst major key Players |
| Key Market Drivers | Increasing prevalence of chronic diseases, rising need for customized medicine and increasing geriatric population |
Non-Sterile Compounding Pharmacy Market Highlights:
Assistant Manager He holds an experience of about 7+ years in market research and business consulting, working under the spectrum of life sciences and healthcare domains. rahul conceptualizes and implements a scalable business strategy and provides strategic leadership to the clients. his expertise lies in market estimation, competitive intelligence, pipeline analysis, customer assessment, etc. in addition to the above, his other responsibility includes strategic tracking of high growth markets & advising clients on the potential areas of focus they could direct their business initiatives
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