According to latest research by Future Market Insights (FMI), the global compounding pharmacies market is estimated to have accounted around US$ 8 Bn in terms of value during 2018. The report on the U.S. compounding pharmacies market also projects that the market will grow at a CAGR of approximately 5% during the period 2018-2028.
The U.S. compounding pharmacies
market revenue is expected to increase at a robust growth rate over the next
few years despite the reporting of several adverse events and drug mismanagement-related
deaths. The U.S. compounding pharmacies market is expected to gain popularity
in several regions of the U.S. due to upcoming products and therapeutic areas
that are yet to be tapped by branded manufacturers. Focus on factors, such as
the availability of drugs in innovative medium/forms and the administration of varying
dosages for various indications, are expected to drive the adoption of newer
dosage forms of compounded medications.
The growing popularity of pain
management therapies is fuelling the growth of U.S. compounding pharmacies
market. Compounded pain management drugs are not FDA-approved, however, they
come under the State Pharmacies Board supervision in the U.S. For example,
medical guidelines such as the Chronic Pain Guidelines stated by the Medical
Treatment Utilization Schedule (MTUS) do not support the use of compounds such
as Gabapentin and Baclofen for pain management. However, compounding pharmacies
use these compounds as well as several others in varying strengths to attract
customers and increase their revenue.
Moreover, an increase in the shortage
of prescription medicine is expected to upsurge the demand for compounding
pharmacies. According to the U.S. FDA, only 154 drugs were in short supply or
not available in 2007, as compared to 456 in 2012. Currently, the number of
drugs in short supply is around 300. Medicinal drought is prominent in the U.S.
as compared to other countries, which is also fuelling the revenue growth of the
U.S. compounding pharmacies market.
On the other hand, increasing
regulatory pressures are expected to hamper the growth of the U.S. compounding
pharmacies market. Compounding pharmacies are engaged in trans-boundary drug
compounding, and the manufacturing of bulk drugs & ingredients need to be
registered with the FDA, undergo mandatory inspections, and abide by GMP
guidelines. For instance, the FDA has stated that around 70% of registered
firms have been inspected, of which 28 firms have been issued FDA Form 483s
(non-adherence to cGMP regulations and unsafe compounding practices), and five
warning letters, which implies a very high rate of action. Compounding
pharmacies registering with the FDA could serve to increase credibility.
However, inspections and compliance with good manufacturing practices is
compulsory. Regulatory pressures on compounding pharmacies are expected to
force the smaller ones to close their business primarily due to unsafe
compounding practices, which are likely to directly impact patient safety.
By product type, oral medication is
the expected to dominate the U.S. compounding pharmacies market in term of
revenue, which is then followed by topical medication. The injectable segment
by product type of the U.S. compounding pharmacies market is projected to grow
at a significant rate as compared to other segments. The hormone replacement
therapy segment is the leading segment in terms of revenue among all the
therapeutic area segments of the U.S. compounding pharmacies market, and is
estimated to gain a 38.4% revenue share in 2019. Among the pharmacy type
segments, the 503A pharmacy segment is expected to gain a major revenue share as
compared to the 503B pharmacy segment over the forecast period. By application,
the adults segment is estimated to dominate the U.S. compounding pharmacies
market, followed by the paediatrics segment. The veterinary segment is expected
to grow at a faster pace as compared to the other application segments of the
U.S. compounding pharmacies market.
The U.S. compounding pharmacies market report tracks some of the key companies operating in the market, which include Avella Specialty Pharmacy, Central Admixture Pharmacy Services, Inc., Fagron N.V., Wedgewood Pharma, PharMEDium Services LLC, Doughertys Pharmacy, Institutional Pharmacy Solutions, Lorraine’s Pharmacy, Village Compounding Pharmacy, Triangle Compounding Pharmacy, Olympia Pharmacy, Hoye’s Pharmacy, Vertisis Custom Pharmacy, Smith Caldwell Drug Store, AIS HealthCare, Soleo Health, Millers Pharmacy, Centene Corporation, Infinity Care Solutions, Triumph Pharmacy, and Sixth Avenue Medical Pharmacy.
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