USA Compounding Pharmacies Market

USA Compounding Pharmacies Market Outlook from 2023 to 2033

The USA compounding pharmacies market size was projected to be worth USD 10,326.0 million in 2022. By the end of 2023, the market is likely to reach a valuation of USD 11,099.0 million. The global market for USA Compounding Pharmacies is likely to garner a 7.8% CAGR and reach a market worth USD 23,430.35 million by 2033.

Key Market Trends and Highlights

• Growing demand for personalized medications: Increasing patient demand for custom pharmaceuticals that meet their specific demands is propelling market expansion.
• Expanding veterinary compounding: The market for specialized pet pharmaceuticals is expanding as a result of rising consumer demand.
• Safety is ensured via regulatory oversight: Standards for quality and patient safety are upheld by strict rules and monitoring.
• Bioidentical hormone therapy: Growing interest in personalized hormone therapies, particularly for the management of menopause.
• Geriatric and pediatric care: There is a market niche for tailoring drugs to certain age groups.
• Filling up drug shortages: Compounding pharmacies in the USA fill the gap left by the lack of commercially available drugs.
• Enhanced pain management: Tailored pain treatment products are a rising market segment.

Attributes	Key insights
Estimated Market Value in 2022	USD 10,326.0 million
Expected Market Value in 2023	USD 11,099.0 million
Expected Market Value in 2033	USD 23,430.35 million
Value-based CAGR from 2023 to 2033	7.80%

2018 to 2022 Historical Analysis vs. 2023 to 2033 Market Forecast Projections

During the historical period, 2018 to 2022, the USA compounding pharmacies market grew at CAGR of 5.2%.

Report Attributes	Details
Market value in 2018	USD 8,430.81 million
Market value in 2022	USD 10,326.0 million
CAGR from 2018 to 2022	5.2%

The market is expanding because of rising health awareness and improved healthcare infrastructure. Precision medicine, commonly referred to as personalized medicine or tailored medicine, provides patients with superior healthcare results.

Through compounding, the pharmacist may tailor medications to each patient's needs, giving patients a greater chance to fight disease. The need for compounding pharmacies in the USA is anticipated to increase over the next ten years due to the country's strong healthcare industry.

The Food and Drug Administration (FDA) of the United States offers regulations for preserving the caliber of medicines. Each state has its own laws and rules governing the operation of a compounding pharmacy. These rules aid in increasing patients' trust in compounding pharmacies and are anticipated to boost demand for them over the projection period.

USA Compounding Pharmacies Market Key Drivers

• The market is expanding as a result of the rising demand for customized medication. By modifying drugs to meet the specific needs of each patient, personalized medicine seeks to enhance the safety and efficacy of pharmaceuticals.
• Patients with particular needs, such as those with allergies or intolerances to specific compounds, those who need treatment for uncommon orphan illnesses, and others, need compounded drugs that are specially formulated for their circumstances.
• Certain drugs that have been discontinued for primarily commercial reasons are still accessible through compounded pharmacies. For instance, the USA. FDA maintains a list of around 206 drugs that have been withdrawn from the market, including budesonide as well as ursodiol capsules, which compounded drugs may easily replace.
• The need for compounded drugs has grown as a result of the lack of commercially available treatments, particularly for chronic illnesses, which has helped the industry expand.
• The bulk of the reported medicine shortages were for drugs used to treat cardiovascular conditions. Pharmaceutical compounding is frequently viewed as the best way to deal with the pharmaceutical shortage and fill any gaps that result from it.
• For instance, the USA Food and Drug Administration (FDA) published a paper titled Drug Shortages: Root Causes and Potential Solutions. In 2019, hospitals stated that they had altered patient care or postponed therapy due to medication shortages, and 36.6% said that they had to postpone routine or emergency operations.
• Such a situation encourages the usage of easily accessible compounded drugs, which is anticipated to fuel the expansion of the compounding pharmacies market in the United States.

Challenges in the USA Compounding Pharmacies Market

• Increased product warnings for sterile compounding have resulted in lower sales of compounded injectable medications, which is projected to impede market growth.
• The FDA's increasingly strict regulations are anticipated to impede the expansion of the USA compounding pharmacies business. Regulatory bodies do not sanction the transboundary drug compounding practiced by pharmacies that specialize in customized medications.
• For example, the USA FDA updated a prior caution on the use of general-use Becton-Dickinson (BD) syringes in a variety of sizes ranging from 1mL to 30mL. The agency warned that filling these syringes with medication and not using them right away might result in a negative interaction with the rubber plug in some batches of these syringes.
• Factors as these can impede the market growth during the forecast period.

Category-wise Insights

The below table highlights how oral and tropical medication products is projected to lead the regional market in terms of product. These products acquired a 60.5% market share in 2022.

The hormone replacement therapeutics was estimated to have acquired 39% market share of the USA compounding pharmacies market. From the perspective of pharmacy type, the traditional compounding pharmacies is expected to gain traction. In 2022, these kinds of pharmacies were estimated to have gained 27.8% of the regional market share.

Category	Market share in 2022
Oral and Tropical Medication	60.5%
Hormone Replacement Therapeutics	39%
Traditional compounding pharmacies	27.8%

USA Compounding Pharmacies to Focus More on Oral and Tropical Medication

Based on product type, the oral and tropical medication segment is expected to continue leading the USA compounding pharmacies market. In 2022, the segment gained a regional market share above 60%.

Numerous medications can be taken orally in the form of liquids, tablets, capsules, or chewable tablets. The oral route is the one that is most frequently utilized since it is the most practical, typically the safest, and least costly.

The segment of oral medications is growing as a result of rising sales and the expiration of blockbuster medications. Over USD 1 billion in sales were earned yearly by blockbuster pharmaceuticals over the past five years.

Compounding pharmacies in the United States experience high demand for these medications. These drugs is mostly used to alleviate mild ailments like fever and joint pain. They also promote sleep, strengthen the immune system, lessen anxiety, and soothe itching. Skin irritations can also be treated with these drugs.

Tropical medications, on the other hand, like creams and gels are also gaining traction throughout the United States market for compounding pharmacies. Patients are generally afraid of the injections and the oral medicines, but not about the tropicals. Doctors, thus, prescribe the patients tropicals whenever feasible.

It is remarkable how frequently topical medications have been used recently. This is primarily attributable to the medication's shown superior benefits over disadvantages. After all, the skin generates both systemic and local effects, making it the perfect delivery route for drugs.

Hormone Replacement Therapeutics to Boost Sales for the USA Compounding Pharmacies Industry

Based on therapeutic area, hormone replacement therapeutics is expected to continue gaining traction in the USA compounding pharmacies market. In 2022, the segment gained a 39% market share.

In order to suit the individual demands of each patient, hormone replacement treatment frequently necessitates customized formulations. Compounding pharmacies are experts in making hormone treatments that are individually suited to the preferences as well as hormone levels of each patient.

In December 2022, prescriptions for hormone replacement therapy grew by 13.74% annually, from 5.02 per 1000 person-years-at-risk (PYAR) in 2010 to 18.17 per 1000 PYAR in 2021, according to the National Center for Biotechnology Information analysis.

With an older population in the United States, more individuals are choosing HRT to lessen side effects like hot flashes as well as pain problems, as well as, in certain circumstances, to slow the spread of cancer. The necessity for hormone replacement treatment in the United States has also grown due to the growing incidence of breast cancer.

503A or Traditional Pharmacies will be highly preferred by Consumers

In 2022, the traditional pharmacies segment acquired over 27% of the USA compounding pharmacies market share. The State Boards of Pharmacy in the United States of America govern traditional compounding pharmacies, sometimes referred to as "503A compounding pharmacies." Law in the nation that the standards established by the United States Pharmacopoeia (USP) be included into routine pharmacy compounding procedures requires it.

The segment's rise is also being aided by the widespread usage of branded prescription counterparts produced off-label. These pharmacies can supply medication on a patient's prescription, even in circumstances of unavailable or discontinued medications.

Sales of these medications are anticipated to rise throughout the projection period since they are still needed for treatments that need for customized dosing. These compounding pharmacies are often located in smaller communities with fewer major retail pharmacies.

The Federal Food, Drug, and Cosmetic Act states that the FDA is not in charge of managing or supervising these pharmacies. A drug product that is created for a specific patient based on the uninvited receipt of a legal prescription is exempt from the legislation.

Start-ups Scenario

Various new companies are setting up their dominance in the United States market for compounding pharmacies. Few of the notable start-ups have been mentioned below:

Company	Offerings/ Products
Fagron	A multinational corporation with operations in the United States, the company gives compounding pharmacies the ability to use top-notch materials and machinery for compounding.
CompounderRx	This start-up specializes in offering technological solutions to compounding pharmacies to streamline operations, increase compliance, and improve patient care.
Innovative Pharmacy Solutions	They provide software solutions made especially for compounding pharmacies, assisting them in managing compounding procedures, stock, and compliance.

Competitive Landscape

The existence of several independent pharmacies that exist in various locations throughout the United States has led to a highly fragmented industry.

The industry's players are putting an emphasis on growth and innovation while carrying out calculated business measures to maintain competition. A few of developments by some companies in this domain are provided.

Market Player	Key Development(s)
Harrow	In 2023, Harrow announced the availability of its patent-pending, future compounded Atropine formulations through ImprimisRx, a fully owned subsidiary of Harrow that specializes in compounding as well as mail-order pharmacies.
Nephron Pharmaceuticals Corporation	In 2022, the company revealed the introduction of a brand-new syringe presentation. This was as part of the massively profitable Nephron 503B Outsourcing Facility operation, continuing to capitalize on the momentum that comes with exponential expansion.
Fagron	In 2022, Fagron purchased a 503B outsourcing plant in Boston from Fresenius Kabi. The acquisition includes an inventory contract with Fresenius Kabi as well as all operational facets of the facility, involving clients, vendors, and about 80 staff.

Report Scope

Attribute	Details
Projected market value in 2023	USD 11,099.0 million
Projected market value in 2033	USD 23,430.35 million
Forecast CAGR from 2023 to 2033	7.8%
Forecast period	2023 to 2033
Historical period	2018 to 2022
Market analysis	Value in USD million
Key Market Segments	Product, Pharmacy Type, Application, Sterility, Region
Key Companies Profiled	Avella Specialty Pharmacy; Central Admixture Pharmacy Services Inc.; Hoye’s Pharmacy; Vertisis Custom Pharmacy; Smith Caldwell Drug Store; Sixth Avenue Medical Pharmacy; Cantrell Drug Company; Clinigen Group, Dougherty’s Pharmacy; Fagron N.V.

Segmentation Analysis of the USA Compounding Pharmacies Market

By Product:

• Oral Medication
  • Solid Medication
    • Capsules
    • Tablets
    • Mixtures
    • Lollipops
    • Lozenges
  • Liquid Medication
    • Syrup
    • Solution/Liquid
    • Emulsion
    • Suspension
  • Topical Medication
    • Gels
    • Ointments
    • Creams
    • Lotions
• Injectable
• Mouthwashes
• Nasal
• Ocular
• Otic
• Suppositories and Enemas

By Pharmacy Type:

• 503A Pharmacy
• 503B Pharmacy

By Application:

• Adults
• Pediatrics
• Geriatrics
• Veterinary

By Therapeutic Area:

• Hormone Replacement Therapy
• Pain Management
• Dermatology
• Oncology
• Hematology
• Dental
• Others

Frequently Asked Questions

What is the anticipated market value of the USA compounding pharmacies market in 2023?

The USA compounding pharmacies market is expected to reach USD 11099.0 million in 2023.

What is the expected CAGR for the USA compounding pharmacies market until 2033?

The USA compounding pharmacies market is set to expand by a CAGR of 7.80% by 2033.

What is the anticipated valuation of the market in 2033?

The USA compounding pharmacies industry is forecast to reach USD 23,430.35 million by 2033.

Which product is likely to dominate the USA Compounding Pharmacies market?

The oral and tropical medication acquired 60.5% in 2022 and the same trend will continue.

Which is the leading therapeutic area in the USA Compounding Pharmacies domain?

In 2022, hormone replacement therapy had 39% market share.