U.S. 503B Compounding Pharmacies Market, by Molecule (Acetaminophen, Phenylephrine, Midazolam, Esmolol, Vancomycin, Epinephrine, Adenocaine, Fentanyl/Bupivacaine, Morphine, Amiodarone, Heparin, Ketamine, Dextrose, Hydromorphone, Bupivacaine, Lidocaine, BK

U.S. 503B Compounding Pharmacies Market, by Molecule (Acetaminophen, Phenylephrine, Midazolam, Esmolol, Vancomycin, Epinephrine, Adenocaine, Fentanyl/Bupivacaine, Morphine, Amiodarone, Heparin, Ketamine, Dextrose, Hydromorphone, Bupivacaine, Lidocaine, BKK (Bupivacaine, Ketorolac, and Ketamine), RCK (Ropivacaine, Clonidine, and Ketorolac), RKK (Ropivacaine, Ketorolac, and Ketamine), and Other Molecules), and by Packaging (Vials, Prefilled Syringes, Ampoules, Syringes, and Others) - Size, Share, Outlook, and Opportunity Analysis, 2022 - 2028

In the U.S. 503B compounding pharmacies market, conventional compounding pharmacies operate without the supervision of the U.S. Food and Drug Administration (FDA). The State Boards of Pharmacy regulate the conventional compounding, also known as ‘within border’ compounding. The U.S. Pharmacopeia (USP) has set the standard pharmacy compounding practices in most U.S. states. Compounding pharmacies operate in five formats: independent stores, compounding departments in hospital, part of a big retail drug manufacturer chain, store with an online order-delivery system, and multiple-location shops. In the U.S., compounding pharmacies are majorly found in independent store format.

Market Dynamics

The major drivers of U.S. 503B compounding pharmacies market include the increasing drug shortage and rising geriatric population in the U.S. For instance, according to a report by 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% hospitals said they had rescheduled non-urgent or emergent procedures. Such scenarios lead to the use of readily available compounded medications, which is expected to boost growth of the U.S. 503B compounding pharmacies market. Additionally, according to a 2018 U.S. Census Bureau report, geriatric population in the U.S. is expected to reach 78.0 million in 2035 compared to the population of 76.4 million of people under the age of 18. This is also expected to boost the U.S. 503B compounding pharmacies market growth.

Market players are focusing on launch of products, which is expected to strengthen their position in the U.S. 503B compounding pharmacies market. For instance, in 2018 Athenex, Inc. launched two products for the oncology supportive therapy in its 503B (outsourced sterile preparations): Epinephrine (2 mg and 4 mg) in 250 mL in 0.9% Sodium chloride and Norepinephrine (4 mg and 8 mg) in 250 mL in 0.9% Sodium chloride.

Market players are adopting strategies such as mergers and acquisitions to expand their product portfolio. For instance, on September 10, 2022, SCA Pharma signed an agreement with Kit Check, an automated and intelligent medication management solutions. This led to the addition of Kit Check’s embedded radio frequency identification (RFID) tag to all of its products, further ensuring the safety of 503B compounding drugs.
Market players are focusing on facility expansion to grow their market presence in U.S. 503B compounding pharmacies market. For instance, in 2017, Nephron Pharmaceuticals Corporation expanded its facility in West Columbia in an area of 36,000 square feet, by investing US$ 12.5 million which is expected to boost the growth potential of 503B compounding pharmacies market.

Key features of the study:
This report provides in-depth analysis of the U.S. 503B compounding pharmacies market, and provides market size (US$ Mn) and compound annual growth rate (CAGR) (%) for the forecast period (2022-2028), considering 2021 as the base year.
It elucidates potential revenue opportunity across different segments and explains attractive investment proposition matrix for this market. It provides valuable insights about market drivers, restraints, opportunities, regional outlook, and competitive strategies adopted by the leading players.
It profiles leading players in the U.S. 503B compounding pharmacies market based on the following parameters – company overview, financial performance, product portfolio, geographical presence, key developments, and future plans.
Insights from this report would allow marketers and management authorities of companies to make informed decisions with respect to future market expansions and marketing tactics.
The U.S. 503B compounding pharmacies market report caters to various stakeholders in this industry, including investors, product developers and manufacturers, distributors, healthcare organizations, research institutes, new entrants, and financial analysts.
Stakeholders would greatly benefit in decision making through various strategy matrices used in analyzing the U.S. 503B compounding pharmacies market.
Detailed Segmentation:
U.S. 503B compounding pharmacies Market Drugs Market, By Molecule:
Acetaminophen
Phenylephrine
Midazolam
Esmolol
Vancomycin
Epinephrine
Adenocaine
Fentanyl/Bupivacaine
Morphine
Amiodarone
Heparin
Ketamine
Dextrose
Hydromorphone
Bupivacaine
Lidocaine
BKK (Bupivacaine, Ketorolac, Ketamine)
RCK (Ropivacaine, Clonidine, Ketorolac)
RKK (Ropivacaine, Ketorolac, Ketamine)
Other Molecules

U.S. 503B compounding pharmacies Market Drugs Market, By Packaging:
Vials
Prefilled Syringes
Ampoules
Others

Company Profiles
Central Admixture Pharmacy Services, Inc.*
Company Highlights
Products Portfolio
Key Highlights
Financial Performance
Strategies
Nephron Pharmaceuticals Corporation
QuVa Pharma
Olympia Pharmacy
ASP Cares
Fagron Compounding Pharmacies
Athenex, Inc.
Avella Specialty Pharmacy
Atlas Pharmaceuticals
Empower Pharmacy
Carie Boyd’S Prescription Shop
Edge Pharma
Imprimis NJOF, LLC
IntegraDose Compounding Services, LLC
Wells Pharma of Houston, LLC
US Compounding Inc.
SCA Pharma
*Key pointers provided are also applicable to other companies covered in the scope of the report