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The Non-Sterile Compounding Pharmacy market is influenced by various market factors that play a crucial role in shaping its dynamics. One of the key drivers of this market is the increasing demand for personalized medications. As patients' needs become more diverse, compounded medications offer a tailored solution to address specific health concerns. This trend has led to a rise in the number of non-sterile compounding pharmacies, as they cater to individuals requiring customized formulations.
Moreover, regulatory considerations significantly impact the non-sterile compounding pharmacy market. Stringent regulations and compliance standards set by health authorities govern the production and distribution of compounded medications. Adhering to these regulations is paramount for pharmacies to ensure the safety and efficacy of their products. Changes in regulatory frameworks can affect market dynamics, influencing the entry of new players and shaping the competitive landscape.
The advancements in pharmaceutical technology also contribute to the market's growth. As technology evolves, non-sterile compounding pharmacies can leverage innovative equipment and processes to enhance the efficiency and precision of medication compounding. This not only improves the quality of compounded medications but also allows pharmacies to meet the increasing demand for such services.
Economic factors play a pivotal role in the non-sterile compounding pharmacy market as well. Affordability and accessibility of compounded medications are influenced by economic conditions. Patients may opt for compounded medications as a cost-effective alternative to commercially available drugs, particularly when facing high co-pays or limited insurance coverage. Economic fluctuations can impact consumer spending on healthcare, affecting the demand for compounded medications and the overall market growth.
Furthermore, the market is shaped by the evolving landscape of healthcare practices. Non-sterile compounding pharmacies often collaborate with healthcare providers to offer patient-specific solutions. The increasing integration of compounding services into mainstream healthcare practices further drives market growth. Healthcare professionals recognize the value of personalized medications in achieving better patient outcomes, contributing to the expansion of the non-sterile compounding pharmacy market.
Competition within the market is another influential factor. The presence of multiple players fosters innovation and encourages pharmacies to differentiate themselves by offering unique services or specialized formulations. Market competition can lead to improvements in quality standards, pricing strategies, and service offerings, ultimately benefiting both pharmacies and consumers.
Market factors are also influenced by consumer awareness and education. As patients become more informed about the benefits of compounded medications, the demand for non-sterile compounding pharmacy services is likely to increase. Pharmacies that invest in educating consumers about the advantages of personalized medications can gain a competitive edge and contribute to the overall market growth.
Non-Sterile Compounding Pharmacy Market Highlights:
Global Non-Sterile Compounding Pharmacy Market Overview
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.
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.
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 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.)
- PHARMEDIUM (U.S.)
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 0.87 billion.
Intended Audience
- Compounding pharmacy
- Hospitals
- Medical Research Laboratories
- Research and Development (R&D) Companies
- Market Research and Consulting Service Providers
- Potential Investors
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