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Non-Sterile Compounding Pharmacy Market Analysis

ID: MRFR//3248-CR | 101 Pages | Author: Rahul Gotadki| October 2017

The non-sterile compounding pharmacy market is a dynamic and evolving sector that plays a crucial role in meeting the unique medication needs of patients. Market dynamics in this industry are influenced by various factors that shape its growth, trends, and competitive landscape. One key driver is the rising demand for customized medications, driven by factors such as allergies to certain ingredients, dosage preferences, or the unavailability of commercially manufactured drugs. This demand fuels the need for non-sterile compounding pharmacies, which specialize in preparing personalized medications tailored to individual patient requirements.

Regulatory changes also significantly impact the market dynamics of non-sterile compounding pharmacies. Continuous updates and revisions in regulations, standards, and guidelines by health authorities shape the operational landscape for these pharmacies. Adherence to strict regulatory requirements is essential for ensuring the safety and efficacy of compounded medications, and pharmacies must navigate these changes to maintain compliance and instill trust among patients and healthcare providers.

Technological advancements contribute to the market dynamics as well, enhancing the efficiency and precision of compounding processes. Automation and innovative compounding technologies streamline production, reduce errors, and enhance the overall quality of compounded medications. The integration of digital systems for prescription management and formulation calculations further modernizes non-sterile compounding pharmacies, making them more efficient and accurate in meeting patient needs.

Market competition is a crucial aspect of the non-sterile compounding pharmacy landscape. The industry is characterized by a mix of small independent pharmacies and larger, corporate entities. The competitive dynamics are influenced by factors such as service quality, turnaround time, pricing strategies, and the ability to establish strong relationships with healthcare professionals. Smaller compounding pharmacies often differentiate themselves by providing personalized and community-focused services, while larger entities may leverage economies of scale and broader geographic reach.

Patient awareness and education also play a vital role in shaping market dynamics. As patients become more informed about the availability of personalized medications through non-sterile compounding pharmacies, the demand for these services is likely to increase. Patient education initiatives by compounding pharmacies contribute to building trust and understanding, fostering a collaborative approach between patients, healthcare providers, and compounding pharmacists.

The non-sterile compounding pharmacy market is not without challenges. Quality control, standardization of processes, and ensuring the integrity of compounded medications are ongoing concerns. Additionally, reimbursement policies and insurance coverage for compounded medications can influence market dynamics, affecting patient access and affordability.

Looking ahead, the market dynamics of non-sterile compounding pharmacies are expected to continue evolving in response to changes in healthcare practices, advancements in pharmaceutical technology, and shifts in regulatory landscapes. The industry's ability to adapt to these dynamics, maintain high-quality standards, and effectively communicate its value to patients and healthcare providers will determine its sustained growth and success in meeting the diverse medication needs of individuals. As the healthcare landscape continues to transform, non-sterile compounding pharmacies are poised to play an increasingly integral role in delivering personalized, patient-centric healthcare solutions.

Covered Aspects:

Report Attribute/Metric Details

Non-Sterile Compounding Pharmacy Market Overview


The Non-Sterile Compounding Pharmacy Market is projected to reach USD 7,637.2 Million by 2030 at 5.7% CAGR during the forecast period 2022-2030.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.


FIGURE 1: U.S. & Europe Non-sterile Compounding Pharmacy Market by Application, 2016 (%) Non-Sterile Compounding Pharmacy Market Source: World Health Organization, Centers for Disease Control and Prevention, European Society of Clinical Microbiology and Infectious Diseases, U.S. National Library of Medicine, National Organization for Rare Disorders, The American Autoimmune Related Diseases Association, The International Society for Human and Animal Mycology, Expert Interview Market Research Future Analysis, Annual report, White paper, Company Presentation


Key Players in the U.S. & Europe non-sterile compounding pharmacy market


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.).


Non-Sterile Compounding Pharmacy Market Segment Insights


Non-Sterile Compounding Pharmacy Type Insights


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.


Non-Sterile Compounding Pharmacy Application Insights


By application, the Non-Sterile Compounding Pharmacy Market is segmented into pain medication, hormone replacement therapy, and others.


Non-Sterile Compounding Pharmacy End User Insights


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


Key Findings:



  • Pain management is expected to account for the largest market share of 50.3% in the U.S. and Europe non-sterile compounding pharmacy market

  • Hospitals occupy the largest market share and is expected to reach USD 871.97 million by 2023.


Research Methodology Source: World Health Organization, Centers for Disease Control and Prevention, European Society of Clinical Microbiology and Infectious Diseases, U.S. National Library of Medicine, National Organization for Rare Disorders, The American Autoimmune Related Diseases Association, The International Society for Human and Animal Mycology, Expert Interview Market Research Future Analysis, Annual report, White paper, Company Presentation


Research Methodology Non-Sterile Compounding Pharmacy Market- Source: World Health Organization, Centers for Disease Control and Prevention, European Society of Clinical Microbiology and Infectious Diseases, U.S. National Library of Medicine, National Organization for Rare Disorders, The American Autoimmune Related Diseases Association, The International Society for Human and Animal Mycology, Expert Interview Market Research Future Analysis, Annual report, White paper, Company Presentation


Intended Audience



  • Compounding pharmacy

  • Hospitals

  • Medical Research Laboratories

  • Research and Development (R&D) Companies

  • Market Research and Consulting Service Providers

  • Potential Investors


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.

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