U.S. Compounding Pharmacies Market ; Eminent Players - Pencol Compounding Pharmacy, Pentec Health, PharMEDium, Premier Pharmacy Labs, Rx3 Compounding Pharmacy, RXQ Compounding Pharmacy, Triangle Compounding Pharmacies, Wedgewood Village Pharmacy, Wells Ph
In U.S, compounded medications are not approved by the FDA so far, indeed, this regulatory agency has been working continuously to encourage compounding pharmacies with the implementation of new policies. Over the last few years, FDA has been dedicatedly striving toward the development of compliances for compounding pharmacies. In fact, recently, it has deployed new guidance documents that describe the fundamental scope, insanitary conditions, and effective inspection procedures required for maintaining the effectiveness and safety after the consumption of drugs. In order to comply with the guidelines provided by the FDA, players in the U.S. compounding pharmacies industry are planning to set up drug formulation workflow processes. The integration of safe handling procedures and effective formulations will further strengthen the U.S. compounding pharmacies industry outlook over the years ahead.
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Compounded drugs are important for the patients whose clinical requirement cannot be fulfilled by FDA-approved drugs. The patients suffering from the allergy need medicines without compromising on certain flavoring agents that further fuels the demand for compounded drugs which also play a critical role in case there is a shortage of FDA-approved medication. Say for instance, in the U.S., most of the FDA approved medicines have not been available in a liquid form that is primarily required for the elderly patients and children who cannot swallow pills.
Meanwhile, the main concern related to the compounding pharmacies is the huge number of unchecked compounds that have been largely available in the distribution centers. In accordance, the U.S. government has deployed some reforms that mandates compounding pharmacies to obtain a certification from the Pharmacy Compounding Accreditation Board (PCAB) or another equivalent regulatory body. In addition, the FDA has also sent a letter to the state pharmacy board to encourage outsourcing facilities to register with the FDA.
The registration potentially allows the so-called outsourcing facilities to sell their products in bulk to physicians and hospitals without a prescription for individual patients. Such perks provided by the regulatory bodies for encouraging compound pharmacies is poised to enhance the U.S. compounding pharmacies market size.
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Currently, as per the estimates by the American Pharmacists Association, there are nearly 7,500 pharmacies providing compounding services across U.S. The number will increase over the coming years as several smaller firms have been investing in the development of low-risk drugs that will significantly boost U.S. compounding pharmacies market share.
The regulatory compliances implemented by the governing bodies will help pharmacies develop potentially more effective compounded medications on a large scale over the years ahead. The increasing use of compounded medication for overcoming the risks associated with the consumption of regulated drugs on the health of the geriatric and pediatric populace will further expedite the industry size considerably. Powered by the lower manufacturing costs of these medicines, by the end of 2024, U.S. compounding pharmacies market will generate a revenue of more than USD 7 billion.
Chapter 1. Methodology
1.2. Market definitions
1.3. Forecast parameters
1.4. Data sources
184.108.40.206. Paid sources
220.127.116.11. Unpaid sources
Chapter 2. Executive Summary
2.1. U.S. compounding pharmacies industry 3600 synopsis, 2014 - 2025
Chapter 3. U.S. Compounding Pharmacies Industry Insights
3.1. Industry segmentation
3.2. Industry size and forecast, 2014 - 2025
3.3. Industry impact forces
3.3.1. Growth drivers
18.104.22.168. Increasing geriatric population and improved longevity
22.214.171.124. Growing acceptance of personalized medicines
126.96.36.199. Increasing drug shortage in the country
188.8.131.52. Convenience of using compounded drugs
184.108.40.206. Growing demand for compounded bioidentical menopausal hormone therapy (BMHT) among women
3.3.2. Industry pitfalls & challenges
220.127.116.11. Changing regulatory specifications
18.104.22.168. Issues related to safety standards of compounded drugs
3.4. Growth potential analysis
3.4.1. By pharmacy type
3.4.2. By sterility
3.4.3. By product
3.4.4. By application
3.4.5. By compounding type
3.4.6. By therapeutic area
3.5. Regulatory landscape
3.6. Reimbursement landscape
3.7. Innovative compounding technologies
3.7.1. Web-based quality management system
3.7.2. Digital tools
3.8. Porter's analysis
3.9. Competitive landscape, 2017
3.9.1. Strategy dashboard
3.10. PESTEL analysis
Chapter 4. U.S. Compounding Pharmacies Market, By Pharmacy Type
4.1. U.S. compounding pharmacies market share, by pharmacy type, 2017 & 2025
4.2. 503A compounding pharmacy
4.2.1. U.S. compounding pharmacies market size, 2014 - 2025 (USD Mn)
4.3. 503B compounding pharmacy
4.3.1. U.S. compounding pharmacies market size, 2014 - 2025 (USD Mn)
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