Impact Analysis of Covid-19
The complete version of the Report will include the impact of the COVID-19, and anticipated change on the future outlook of the industry, by taking into the account the political, economic, social, and technological parameters.
According to the Journal of American Pharmacist Association: August 17, 2020, 'Pharmacy compounding describes the act of combining, mixing, or altering of the ingredients of a drug to create a new medication according to the needs of an individual patient'. Compounding of a product is done due to patient’s allergy for a specific ingredient in the commercially available products or the need for a different concentration, route of administration, or dosage form of the drug.
U.S. 503B Compounding Pharmacies Market - Impact of the Coronavirus (COVID-19) Pandemic
Coronavirus (COVID-19) outbreak was first reported on December 31, 2019, in Wuhan, China. The World Health Organization declared COVID-19, as pandemic on March 11, 2020.
According to the Coronavirus (COVID-19) Weekly Epidemiological Update by the World Health Organization, over 169,604,858 cases and 3,530,837 deaths due to coronavirus disease (COVID-19) were reported till May 30, 2021, across the globe.
Impact of COVID-19 on Demand and Supply of U.S 503B Compounding Drugs
The coronavirus (COVID 19) pandemic and lockdown in various countries across the globe have impacted the financial status of businesses in all sectors. Private healthcare sector is one of the main sector that has been majorly impacted by the COVID 19 pandemic. For instance, on April 16, 2020, the U.S. Food and Drug Administration (FDA) issued the guidance document ‘Temporary Policy for Compounding of Certain Drugs for Hospitalized Patients by Outsourcing Facilities during the COVID-19 Public Health Emergency’. During the pandemic, the U.S. FDA received reports from hospitals regarding difficulties in obtaining FDA-approved drugs due to increased demand and supply chain interruptions. Some of the drugs such as Ketamine hydrochloride and Lorazepam are already on the U.S. FDA drug shortage list. Therefore, in order to meet the increasing demand for drugs for the treatment of patients on ventilator support, during COVID-19 pandemic, the U.S. FDA allowed registered outsourcing facilities to compound 13 commonly used hospital drugs.
Moreover, the U.S. FDA also released guidelines in which the FDA will not take action against outsourcing facilities. These guidelines include conditions such as outsourcing facilities manufacturing compounding drug that is essentially a copy of an approved drug. Thus, increase in the preference of outsourcing facilities by the U.S. FDA for the manufacture of drugs that are currently in shortage is expected to drive the U.S. 503B compounding pharmacies market growth over the forecast period.
Furthermore, key players are indulged in inorganic activities such as partnerships. They are also engaged in launching new products in order to overcome the drug shortages during the COVID-19 pandemic. This is expected to drive growth of the market over the forecast period. For instance, in July, 2020, Piramal Critical Care (PCC), a company headquartered in India, entered into a strategic partnership with Medivant Healthcare, a U.S. based pharmaceutical outsourcing facility, for addressing severe shortage of injectable drugs in hospitals across the U.S. The focus of the companies is mainly on the distribution of single–dose injectable drugs in all the U.S. approved states that have a severe shortage in the supply of drugs for the treatment of COVID-19 patients.
The U.S. 503B compounding pharmacies market is estimated to be valued at US$ 919.0 Mn in 2021 and is expected to exhibit a CAGR of 7.3% during the forecast period (2021-2028)
Figure 1: U.S. 503B Compounding Pharmacies Market Share (%) Analysis, By Packaging Type, 2021
The increasing number of drug shortages in the U.S. is one of the major factor that is expected to drive the market growth over the forecast period.
Increased drug shortages in the U.S is expected to drive growth of U.S. 503B compounding pharmacies market over the forecast period. The U.S. Food and Drug Administration (FDA) defines a drug shortage as 'a period of time when the demand for the drug within the U.S. exceeds the supply of the drug'. There are various reasons that may lead to a drug shortage i.e., manufacturing issues, production delays, and issues surrounding the raw materials needed to manufacture the product being the most common. For instance, according to the Journal of the American Pharmacists Association: August 2020, drug shortages have had a major impact on the drug supply chain and patient’s access to medications. 71% of the clinicians in U.S. reported that they were unable to provide patients with the recommended drugs due to its shortage. This leads to receiving less effective drugs to treat patient’s condition or a delay in the patient treatment. Moreover, according to the same source, due to drug shortages, there has been several reports of medication errors where patient received the wrong dose.
U.S. 503B Compounding Pharmacies Market Report Coverage
||Market Size in 2021:
||US$ 919.0 Mn
|Historical Data for:
||2017 to 2020
||2021 to 2028
|Forecast Period 2021 to 2028 CAGR:
||2028 Value Projection:
||US$ 1,508.1 Million
- 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
- By Packaging Type: Vials, Prefilled Syringes, Ampoules, Syringes, Others
Central Admixture Pharmacy Services, Inc., 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., and SCA Pharma
- Increasing Drug Shortages in the U.S.
- Increasing Geriatric Population and Improved Longevity due to Customized Medicines
- Increasing strategic collaborations among the market players
- Increasing Product Launches and Approvals
|Restraints & Challenges:
- Increasing Product Recalls
- Risks associated with U.S. 503B compounding drugs
Increase in geriatric population drives the market growth of U.S. 503B Compounding Pharmacies
Also, an increase in geriatric population is expected to show growth of the market over the forecast period. For instance, according to the U.S. Census Bureau report, geriatric population in the U.S. was estimated to be over 54 million as on July 1, 2019.
Increase in number of product launches drives the market growth of U.S. 503B Compounding Pharmacies
Moreover, increasing number of product launches and approvals is expected to aid in the growth of the market over the forecast period. For instance, in May 2020, Central Admixture Pharmacy Services, Inc. launched three new compounded sterile preparations for the ICU patients, which are short in supply. The products are two vasodilators: Norepinephrine 8 mg added to 250 mL normal saline (NS), Vasopressin 50 units added to 50 mL NS, and a sedative: Midazolam 125 mg added to NS (1mg/mL).
Inorganic market strategies drives the market growth of U.S. 503B Compounding Pharmacies
Increasing strategic collaborations, mergers and acquisitions among the market players is expected to drive the growth of the U.S. 503B compounding pharmacies market over the forecast period. For instance, in 2018, Letco Medical, L.L.C., a supplier of quality compounding pharmacy products, entered into exclusive partnership with Sweetgrass GxP, a company indulged in providing regulatory services for compounding pharmacies. Under the partnership, Letco Medical, L.L.C. announced the launch of Letco’s Regulatory Solutions Program, which addresses the critical compliance needs of compounding pharmacies. The program involves USP<795>, <797>, <800> Compliance and Readiness Assessments; USP<795>, <797>, <800> Customizable SOP Libraries; Associate Training Programs Tailored for each Pharmacy; 503A and 503B Start-up and Expansion Support; 503B Outsourcing Compliance and Quality Assurance, and Mitigation & Remediation Services (FDA, DEA, State Boards of Pharmacy, etc.).
U.S. 503B Compounding Pharmacies Market – Restraints
Growth of the U.S. 503B compounding pharmacies market may be hampered, owing to the increasing product recalls, and safety concerns associated with U.S 503B compounding drugs. For instance, in 2019, Nephron Pharmaceuticals Corporation recalled number of injections containing fentanyl citrate because of potential glass contamination. The U.S. Food and Drug Administration (FDA) classified the contamination as Class II contamination i.e., the affected injections may cause medically reversible and adverse health consequences. Moreover, in 2015, the U.S. Food and Drug Administration (FDA) noted that compounding drugs containing API acetaminophen in excess of 325mg may lead to liver injuries in certain patients. Therefore, restricting 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.
Furthermore, the cost of the medicines and absence of reimbursement services are expected to hamper the growth of the market over the forecast period. Depending upon the product to be manufactured, the operating cost may be higher than the manufacturing cost of certain drugs, thus, making them costly as compared to the approved drugs available in the market. For instance, according to the Express Scripts Holding Company, a pharmacy benefit management organization: 2016, in the U.S., compounded drugs ranked as the third most expensive drug class in 2014 after diabetes and high cholesterol drugs.
Figure 2: U.S. 503B Compounding Pharmacies Market Value (%) Analysis, By Acetaminophen, 2021
U.S. 503B Compounding Pharmacies Market – Competitive Landscape
Major players operating in the U.S. 503B compounding pharmacies market include Central Admixture Pharmacy Services, Inc., 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., and SCA Pharma