In a compounding pharmacy, a licensed pharmacist alters, combines or mixes APIs to create a drug that is customized to meet the needs of an individual patient.
Global Compounding Pharmacies Market is estimated to account for US$ 13,304.8 Mn in terms of value by the end of 2027.
Global Compounding Pharmacies Market: Drivers
Lack of essential medicines for the treatment of critical diseases is expected to boost growth of the global compounding pharmacies market. For instance, according to a report of the U.S. Food and Drug Administration (FDA): Drug Shortages: Root Causes and Potential Solutions 2019, 56% of hospitals reported they had changed patient care or delayed therapy in light of drug shortages and 36.6% said they had rescheduled non-urgent or emergent procedures. Such scenario leads to use of readily available compounded medications, which is expected to boost growth of the U.S. compounding pharmacies market.
Global Compounding Pharmacies Market: Opportunities
Key players in the market can also focus on R&D of products related to geriatric and long-term care and innovative Hormone replacement therapy (HRT) applications to expand their product portfolio.
Global Compounding Pharmacies Market: Restraints
Use of compounded pharmacy drugs in routine surgery has reportedly led to loss of eyesight. Such side effects of compounded pharmacy drugs are expected to hinder growth of the market.
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Topical Medication segment in the global compounding pharmacies market was valued at US$ 3,335.4 Mn in 2018 and is expected to reach US$ 5,784.9 Mn by 2025 at a CAGR of 5.6 %. The growth of the segment is attributed to increasing demand for topical pain management drug products
Pain management segment in the global compounding pharmacies market was valued at US$ 4,980.2 Mn in 2014 and is expected to reach US$ 7,894.4 Mn by 2027 at a CAGR of 4.7%. The growth of the segment is attributed to increasing incidence of chronic and acute pain
Global Compounding Pharmacies Market: Trends
The U.S. FDA issued a draft guidance that addresses instances in which the agency does not intend to take action for violations by pharmacists and veterinarians compounding or overseeing the compounding of animal drugs from bulk drug substances. Moreover, the companies are required to follow current good manufacturing practice (cGMP) while producing all animal drugs.
Availability of FDA-approved drugs is expected to reduce reliability on compounded drugs, which is affecting growth of the market. For instance, in December 2019, Eton Pharmaceuticals, Inc. commercialized Biorphen, the first and only FDA-approved ready-to-use formulation of phenylephrine for the treatment of clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia. The availability of Biorphen reduces the need for hospitals to rely on compounders to provide unapproved compounded phenylephrine.
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Global Compounding Pharmacies Market: Regulations
In the U.S., a pharmacy can register as an “outsourcing facility” under the Drug Quality and Security Act (2013) Section 503B only if:
It complies with cGMP requirements
Inspected and approved by the U.S. FDA
Follows a legal reporting schedule of adverse events to the U.S. FDA
Such a facility can perform legal sterile compounding of drugs and interstate drug shipments. Moreover, the compounding pharmacies regulations in the U.S. are evolving after the formation of Pharmacy Compounding Advisory Committee (PCAC). The PCAC advices on scientific, technical, and medical issues that are related to drug compounding under Section 503A and Section 503B of the Food, Drug, and Cosmetic Act (FDCA).
Global Compounding Pharmacies Market: Competitive Landscape
Major players operating in the global compounding pharmacies market include, Central Admixture Pharmacy Services, Fagron, Fresenius Kabi AG, PharMEDium Services, LLC, Institutional Pharmacy Solutions, Cantrell Drug Company, Triangle Compounding Pharmacies, and Lorraine’s Pharmacy.
Global Compounding Pharmacies Market: Key Developments
Key players in the market are focused on geographical expansion through M&A activities. For instance, in April 2018, Fagron acquired Humco, a developer, manufacturer and supplier of patented delivery vehicles and branded pharmaceutical products in the U.S.
Key players in the market are also focused on adopting partnership strategies to enhance their product portfolio. For instance, in July 2019, Guardian Pharmacy Services partnered with TruCare LTC Pharmacy. The partnership expands Guardian’s Midwest footprint and marks its first venture into Michigan.
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