U.S. Compounding Pharmacies Market Likely to Booming Worldwide by 2027 | PharMEDium Services, LLC, Institutional Pharmacy Solutions, Cantrell Drug Company

A certified pharmacist in a compounding pharmacy changes, blends, or mixes APIs to produce a medication that is tailored to the needs of a specific patient.

The demand for the U.S. compounding pharmacies market was projected to be worth US$ 3,859.2 million in 2018, with a CAGR of 5.7 percent forecast to hit US$ 6,355.9 million by the end of 2027.

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Drivers

The U.S. compounding pharmacies market is expected to rise in response to rising demand for pain relief therapies in dosages not approved by the FDA in the United States. The U.S. Food and drug Administration (FDA) has not licensed compounded medications for pain relief, but they are controlled by the State Pharmacies Board. Health recommendations such as the Medical Treatment Use Schedule (MTUS) Chronic Pain Guidelines discourage the use of pain relievers including gabapentin and baclofen. Compounding pharmacies, on the other hand, use these compounds and their derivatives to increase their market share.

Opportunities

R&D of drugs in novel mediums/forms and dosages for the treatment of different diseases is supposed to provide market players with a lucrative growth opportunity.

Restraints

The development of the compounding pharmacy market in the U.S. is projected to be hampered by increasing constraints on the production of complicated formulations. The Food and Drug Administration (FDA) prohibits compounding pharmacies from producing certain kinds of medications, like clones of FDA-approved prescription drugs, even though they are on the FDA's shortage list, and complex dosage forms including extended release devices, transdermal patches, liposomal products, and most biologics.

Key Takeaways

The Oral Medication segment of the US compounding pharmacies market was worth US$ 1,538.8 million in 2018 and is forecast to grow at a CAGR of 6.3 percent to US$ 2,666.8 million by 2027.
Since oral therapy is a comfortable route of administration and is widely adopted by patients, the oral drug category is projected to rise significantly due to increased demand and acceptance rates.

The Topical Medication segment of the US compounding pharmacies market was worth US$ 1,581.3 million in 2018, and is forecast to grow at a CAGR of 6.1 percent to US$ 2,694.4 million by 2027.
Topical prescriptions are a simple and efficient way to deliver medications to specific areas.
Topical administration allows drugs to reach the bloodstream more quickly than oral administration since the gastrointestinal tract and metabolism processes are bypassed. Over the forecast period, these factors are believed to assist the segment's growth.

The mouthwashes segment of the US compounding pharmacies market was worth US$ 521.7 million in 2018, and is forecast to grow at a CAGR of 4.0 percent to US$ 742.6 million by 2027.
Due to factors such as a smaller number of products compared to other segments and a strong preference for other types of treatment, the mouthwashes segment is expected to rise slowly and steadily.

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Trends

Compounding medications such as "bio-identical" hormones are in high demand due to the geriatric population. Popular hormone conditions such as menopausal symptoms, men's wellbeing (andropause), and weight loss can all be treated with these compounding medications.
Compounding services are gradually being outsourced to FDA 503B-certified bulk drug processing facilities in the U.S.

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 offers advice 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).

Competitive Landscape

Key companies contributing in the U.S. compounding pharmacies market are Institutional Pharmacy Solutions, Triangle Compounding Pharmacies, PharMEDium Services, LLC, and Cantrell Drug Company.

Key Developments

Pentec Health, Inc., a sterile compounding pioneer with an FDA-registered 503B Outsourcing Facility, added California to their list of 43 approved states in April 2019.

Pentec Health, Inc. reported in September 2018 that several items from their 503B outsourcing plant, including various strengths of Ropivacaine Hcl and Bupivacaine Hcl, are now available.

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