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The Non-Sterile Compounding Pharmacy market has witnessed notable trends in recent years, reflecting the evolving landscape of pharmaceutical compounding. Non-sterile compounding involves the customization of medications that do not require a sterile environment, catering to a wide range of patient needs. One prominent trend in this market is the increasing demand for personalized medications. Patients are seeking customized drug formulations that meet their specific health requirements, leading to a surge in the non-sterile compounding pharmacy sector. This trend is driven by a growing awareness among consumers about the benefits of personalized medicine, as it allows for tailored treatments based on individual factors such as age, allergies, and dosage preferences.
Furthermore, the adoption of advanced technologies has played a pivotal role in shaping market trends. Non-sterile compounding pharmacies are leveraging technology to enhance their compounding processes, ensuring precision and accuracy in medication preparation. Automated compounding systems and software solutions are gaining popularity, streamlining workflows and reducing the likelihood of errors. This technological integration not only improves the efficiency of non-sterile compounding pharmacies but also enhances the overall safety and quality of compounded medications.
Another significant trend is the increasing regulatory focus on compounding practices. Regulatory bodies are tightening their scrutiny of non-sterile compounding pharmacies to ensure compliance with safety and quality standards. This heightened regulatory environment is prompting pharmacies to invest in quality control measures, standardized processes, and staff training to meet and exceed regulatory requirements. The adherence to stringent regulatory guidelines is not only a legal necessity but also instills confidence in both healthcare professionals and patients regarding the safety and efficacy of compounded medications.
The market is also witnessing a shift in the supply chain dynamics of non-sterile compounding ingredients. Pharmaceutical ingredient suppliers are adapting to the changing landscape by providing a diverse range of high-quality ingredients for compounding purposes. The availability of a wide array of raw materials allows compounding pharmacists to create customized formulations, contributing to the market's growth. Moreover, partnerships between non-sterile compounding pharmacies and ingredient suppliers are becoming more common, fostering collaboration and ensuring a seamless supply chain.
In terms of market geography, there is a noticeable regional variation in the growth of non-sterile compounding pharmacies. Developed regions with established healthcare infrastructures are witnessing robust market expansion due to the increasing demand for personalized medications and advanced compounding technologies. On the other hand, emerging markets are experiencing a gradual but steady adoption of non-sterile compounding practices, driven by a growing awareness of personalized medicine and improving healthcare access.
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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