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.

The US compounding pharmacies market is estimated to account for US$ 3,859.2 Mn in 2018 and is expected to grow at a CAGR of 5.7% to reach US$ 6,355.9 Mn by the end of 2027.

U.S. Compounding Pharmacies Market: Drivers

Increasing demand for pain management therapies in dosages not permitted by the U.S. FDA is expected to boost growth of the U.S. compounding pharmacies market. Compounded drugs used in pain management are not approved by the U.S. FDA and fall under the supervision of State Pharmacies Board. For example, medical guidelines such as the Medical Treatment Utilization Schedule (MTUS) Chronic Pain Guidelines do not support the use of compounds such as Gabapentin and Baclofen for pain management. However, these compounds and their variants are used by compounding pharmacies to enhance their market share.

U.S. Compounding Pharmacies Market: Opportunities

R&D of drugs in innovative medium/forms and varying dosages for the treatment of various diseases is expected to offer lucrative growth opportunity of market players.

U.S. Compounding Pharmacies Market: Restraints

Increasing restrictions on manufacturing of complex formulations is expected to hinder growth of the U.S. compounding pharmacies market. The U.S. FDA restricts compounding pharmacies from manufacturing certain types of drugs that include copies of FDA-approved prescription drugs, even if they appear on FDA’s shortage list and complex dosage forms such as extended release products, transdermal patches, liposomal products, and most biologics.

Key Takeaways:

Oral Medication segment in the U.S. compounding pharmacies market was valued at US$ 1,538.8 Mn in 2018 and is expected to reach US$ 2,666.8 Mn by 2027 at a CAGR of 6.3%.

Oral medication segment is expected to witness significant growth owing to higher demand and adoption rate as oral treatment is a convenient route of administration and is highly accepted by the patients.

Topical Medication segment in the U.S. compounding pharmacies market was valued at US$ 1,581.3 Mn in 2018 and is expected to reach US$ 2,694.4 Mn by 2027 at a CAGR of 6.1%.

Topical medications is a convenient way of drug administration and is highly effective targeted therapy. Drugs can easily enter into the blood stream through topical administration as gastrointestinal tract and metabolism steps are bypassed through topical delivery as opposed to the oral administration. These factors are expected to support growth of the segment over the forecast period.

Mouthwashes segment in the U.S. compounding pharmacies market was valued at US$ 521.7 Mn in 2018 and is expected to reach US$ 742.6 Mn by 2027 at a CAGR of 4.0%.

Mouthwashes segment is expected to witness slow and steady growth due to factors such as lesser number of products compared to other segments and high preference to other forms of the medications.

U.S. Compounding Pharmacies Market: Trends

Increasing geriatric population has led to high demand for compounding drugs such as ‘bio-identical’ hormones. These compounding drugs can also be used in the treatment of common hormonal disorders such as menopausal symptoms, men’s health (andropause), and weight loss.

Hospitals in the U.S. are increasingly outsourcing compounding services to U.S. FDA 503B-certified bulk drug manufacturing facilities in the country.

U.S. 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).

U.S. Compounding Pharmacies Market: Competitive Landscape

Major players operating in the U.S. compounding pharmacies market include, PharMEDium Services, LLC, Institutional Pharmacy Solutions, Cantrell Drug Company, and Triangle Compounding Pharmacies among others. 

Key Developments:

In April 2019, Pentec Health, Inc., an established leader in sterile compounding with an FDA registered 503B Outsourcing Facility, added California to their list of 43 licensed states.

In September 2018, Pentec Health, Inc. announced the availability of multiple products from their 503B outsourcing facility that include multiple strengths of Ropivacaine Hcl and Bupivacaine Hcl.

Segmentation

Scope of the report

  • By Medication
    • Oral Medication
      • Capsules
      • Tablets
      • Mixtures
      • Lollipops
      • Lozenges
    • Topical Medication
      • Gels
      • Ointments
      • Cream
      • Lotions
    • Mouthwashes
    • Suppositories
  • By Therapeutic Area
    • Pain Management
    • Hormone Replacement Therapy (HRT)
  • By Application
    • Medication for Adults
    • Medication for Veterinary
    • Medication for Children
    • Medication for Geriatric

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