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U.S. Compounding Pharmacies Market

Market Insights on U.S. Compounding Pharmacies covering sales outlook, demand forecast & up-to-date key trends

U.S. Compounding Pharmacies Market by Product (Oral Medication, Topical Medication, Injectable, Mouthwashes, Nasal, Ocular, Others), Pharmacy (503A Pharmacy, 503B Pharmacy) & Region - Forecast 2022 - 2028

U.S. Compounding Pharmacies Market Outlook- 2022-2028

[81 Pages Report] U.S. Compounding Pharmacies Market is projected to exceed US$ 4.64 Bn in 2020 and is expected to grow at over 5.1% CAGR between 2022 and 2028. Increasing focus on introducing innovative formulations to combat several diseases is driving the growth in the market.

Attribute

Details

U.S. Compounding Pharmacies Market Estimated Size in 2022

US$ 4.64 Bn

U.S. Compounding Pharmacies Market Projected Size in 2028

US$ 6.27 Bn

U.S. Compounding Pharmacies Market Historical CAGR (2013-2021)

5.8%

U.S. Compounding Pharmacies Market Value-based CAGR (2022-2028)

5.1%

Growing prevalence of chronic diseases such as cancer, coupled with increasing funding for compounding pharmacies in the U.S. will boost the market over the forecast period. The U.S compounding pharmacies market is expected to contribute over 43.5% of sales in global compounding pharmacies market.

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How The Market Progressed Till June 2022?

Particulars

Details

H1, 2021

5.30%

H1, 2022 Projected

5.36%

H1, 2022 Outlook

5.16%

BPS Change - H1, 2022 (O) – H1, 2022 (P)

(-) 20 ↓

BPS Change – H1, 2022 (O) – H1, 2021

(-) 14 ↓

FMI presents a comparative analysis of the market growth rates and development prospects in the U.S. market. The market is under the encouragement of demographic and improvement factors that matter to the growth of macro and industry factors. Some new developments in the market include increasing use of personalized medication and growing acceptance of compounding pharmacy services, particularly community cloud in the U.S.

According to FMI analysis, the U.S. compounding pharmacies market is expected to decline by 14 Basis Point Share (BPS) in H1- 2022 compared to H1-2021. However, a BPS change of only 20 BPS was observed when comparing H1-2022 Outlook and H1-2022 Projected growth. The main reasons for this drop in BPS are attributed to the changing regulatory specifications and lack of adequate regulatory standards concerning compounded medicines in the U.S. The necessity of enormous investment in the establishment of a well-equipped compounding pharmacy is another factor hampering the market growth.

In spite of these negative forecasts, some positive facts stay ahead for the industry including growing awareness and increasing adoption of compounded medicines, the surge in the number of prescriptions dispensed and the lack of commercially manufactured drugs or stoppage of drugs by manufacturers will have an overall positive impact in coming years.

2013-2021 U.S. Compounding Pharmacies Market Outlook In Comparison To 2022-2028 Growth Forecast

As per Future Market Insights (FMI), the demand in the U.S. compounding pharmacies market is projected to increase at 5.1% CAGR between 2022 and 2028. Growing popularity of customized medicine are expected to increase sales in the market by 1.5x over the forecast period.

Increasing awareness regarding health and improving healthcare infrastructure is also supporting the growth in the market. Personalised medicine, also known as customized medicine, offers better healthcare outcome to patients through precision medicine.

U.S. Compounding Pharmacies Market Download Report Brochure

Compounding enables the pharmacist to offer medicine as per the requirement of the patient, providing a better way to combat the disease. As the U.S. has a robust healthcare sector, demand for compounding pharmacies in the U.S. is expected to bolster over the forthcoming decade.

On account of the aforementioned factors, FMI estimates the U.S. compounding pharmacies to reach a valuation of US$ 6.27 Bn by the end of 2028.

Will Growing Need For Pain Management Drugs Bolster Sales?

Surging popularity of pain management therapies is one of the major factors fuelling the growth of the U.S. compounding pharmacies market.

Compounded pain management medicines are not approved by regulatory authorities such as the U.S. Food and Drug Administration (FDA). However, they are approved by the State Pharmacies Board and supervised by the same in the U.S.

For instance, compounding of chronic pain management drugs such as Gabapentin and Baclofen is not approved by medical guidelines such as Chronic Pain Guidelines.

Yet, compounding pharmacies are using these compounds as well as others to woo the consumers and increase their revenues. Subsequently, increasing shortage of prescription medicine in the U.S. is expected to aid the demand for pain management drugs, thereby, fuelling the growth in the market.

For instance, according to the publication of Pandemic and the Supply Chain, in 2020, following the outbreak of COVID-19, there was a shortage of over 100 drugs in the U.S. according to the FDA.

This has increased the demand for pain management drugs and compounding medicines in the U.S., and the trend is expected to continue over the assessment period.

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Growing Demand For Hormone Replacement Therapy Drugs To Boost U.S. Compounding Pharmacies Market

Increasing demand for hormone replacement therapy (HRT) drugs due to the availability of APIs in varying doses is boosting the U.S. compounding pharmacies market. Growing geriatric population and increased penetration of social media has influenced the consumers to opt for hormone replacement therapies.

Additionally, rising prevalence of breast and prostate cancer is also accelerating the demand for HRT drugs in the U.S. HRT drugs include active ingredients such as progesterone, estrogen, testosterone, and estradiol.

As people are becoming more conscious about their sexual well-being, demand for personalized HRT drugs is propelling. Also, increasing rate of procedures such as hysterectomy, testosterone replacement after andropause are resulting in higher demand for hormones such as progesterone.

Consequently, rapid aging in younger individuals due to high stress levels and fast-paced lifestyle is also spurring the demand for HRT drugs in the U.S. This is anticipated to create lucrative prospects for the U.S. compounding pharmacies market players.

Which Factors Are Restraining Growth In The U.S. Compounding Pharmacies Market?

Increasing regulatory policies and stringent norms by the FDA are expected to hamper the growth in the U.S. compounding pharmacies market. Customized medicines pharmacies are engaged in trans-boundary drug compounding which are not approved by regulatory authorities.

They are also involved in manufacturing of bulk drugs & ingredients that needs to be registered with the FDA, undergo mandatory inspections, and adhere to GMP guidelines. For instance, the FDA has stated that around 70% of registered firms have been inspected, among which 28 firms have been issued FDA Form 483s (non-adherence to cGMP regulations and unsafe compounding practices), 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 mandatory in the U.S.

Hence, regulatory pressures on compounding pharmacies are expected to impact the smaller businesses negatively due to unsafe compounding practices, impeding the growth in the market.

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Category-Wise Insights

Which Product Type Will Dominate the U.S Compounding Pharmacies Market?

“Oral and Tropical Medication to Contribute over 60% of the U.S. Compounding Pharmacies Sales”

In terms of product type, the oral medication and tropical medication segment is expected to be among the most prominent ones. Among these two, oral medication segment is likely to outpace the growth in tropical medication, finds FMI.

Growth in the oral medication segment is underpinned by increasing sales and expiry of blockbuster drugs. As per a research report, blockbuster drugs generated over US$ 1 billion sales annually.

Increasing prevalence of diabetes, cholesterol, cancer, and high blood pressure in the U.S. is propelling the sales of blockbuster drugs. This is anticipated to fuel the demand for oral medications in the U.S.

Besides this, increasing levels of experimentation in drug packaging and the development of multiple-ingredient compound drugs will also favour the growth in the segment.

Apart from oral medications, increasing demand for tropical compounding medicines, including gels and creams, will also boost the market.

As per FMI, the injectable segment in the U.S compounding pharmacies market will witness stable growth as compared to the other segments over the forecast period.

Which Therapeutic Area Will Increase the Revenues in the U.S. Compounding Pharmacies?

“Over 38% of U.S. Compounding Pharmacies Sales to be Contributed by Hormone Replacement Therapeutic Ara”

The hormone replacement therapy segment is the leading segment in terms of revenue in the U.S. compounding pharmacies market. Demand for HRT drugs is expected to propel the growth in the segment.

With growing aging population in the U.S., people are opting for HRT to reduce  side-effects such as hot flashes, pain issues, and to curb the growth of cancer in some cases. Rising prevalence of breast cancer has also increased the need for hormone replacement therapy in the U.S.

FMI estimates the sales in the hormone replacement therapeutic areas to command nearly of 2/5th of the U.S. compounding pharmacies market.

Which Type of Pharmacy is Gaining Traction in the U.S. Compounding Pharmacies Market?

Traditional Compounding Pharmacies, ‘503A’, to Operate without FDA’s Supervision”

Traditional compounding pharmacies, also known as ‘503A compounding pharmacies,’ are regulated by the State Boards of Pharmacy in the U.S. The standards set by the United States Pharmacopoeia (USP) are to be integrated into the day-to-day pharmacy compounding practice and are mandated by law in the country.

Extensive use in off-label production of branded prescription equivalents is also favouring the growth in the segment. Medication in these pharmacies can be produced under a patient prescription, which include cases of unavailable or discontinued drugs.

As these drugs are still in demand for treatments that require tailored dosages, sales are projected to increase over the forecast period. These compounding pharmacies are mostly operated within smaller towns, where the presence of large retail pharmacies is limited.

According to the Federal Food, Drug, and Cosmetic Act, these pharmacies are not operated or supervised under FDA. The law does not apply to a drug product which is compounded for an identified patient based on the unsolicited receipt of a valid prescription.

Which is the Chief Application in the U.S. Compounding Pharmacies Market?

“Nearly 82.9% of Revenue in the U.S. Compounding Pharmacies is Generated by Adults and Paediatric Medication”

In terms of application, as per Future Market Insights, the adult segment will account for over 53.9% of sales, thereby dominating the market. Demand for adult customized drugs is favouring the growth in the segment.

Besides this, the children segment is expected to be the second largest segment in the U.S. compounding pharmacies market. The segment is expected to generate over 29% of revenue in the market over the forecast period, followed by veterinary segment.

Over 10.2% of sales are expected to be contributed by veterinary medication in the U.S. compounding pharmacies market.

Competitive Landscape

Leading medical & pharmaceutical companies are collaborating with small compounding solution providers, hospitals, and research facilities to strengthen their market position and expand their product portfolio.

Some of the leading players are mainly focusing on geographic expansion and the usage of newer equipment according to the customer needs to gain a larger market share. Meanwhile, other key players are focusing on strengthening their position by collaborating with local hospitals to enhance their distribution networks. For instance:

  • In August 2021, Adamis Pharmaceuticals Corporation announced that it has entered into a definitive agreement to sell a significant portion of the assets of its subsidiary, US Compounding Inc., related to USC’s human compounding pharmaceutical business and customers, in exchange for US$15 million before transaction fees and expenses.

Scope Of Report

Attribute

Details

Forecast Period

2022-2028

Historical Data Available for

2013-2021

Market Analysis

US$ Bn for Value

Key Regions Covered

North America, Latin America, Western Europe, Eastern Europe, Asia Pacific excluding Japan, Japan, and MEA

Key Countries Covered

United States, Canada, Brazil, Mexico, Germany, UK, France, Italy, Spain, Nordic, Russia, Poland, China, India, Thailand, Indonesia, Australia and New Zealand, Japan, GCC countries, North Africa, South Africa, others.

Key Market Segments Covered

Product, Pharmacy Type, Application, and Sterility

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.

Pricing

Available upon Request

U.S. Compounding Pharmacies Market By Category

By Product :

  • Oral Medication
    • Solid Medication
      • Capsules
      • Tablets
      • Mixtures
      • Lollipops
      • Lozenges
    • Liquid Medication
      • Syrup
      • Solution/li>
      • 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

The global U.S. compounding pharmacies market is expected to reach a valuation around US$ 4.64 Bn in 2022.

Increasing prevalence of cancer and demand for hormone replacement therapy drugs will propel the sales in U.S. compounding pharmacies market.

As per FMI, sales of U.S. compounding pharmacies’ solution grew at 5.8% CAGR between 2013 and 2021.

In terms of application, the adult segment is expected to account for over 53.9% of global sales.

Table of Content

1. Executive Summary

      1.1. Market Outlook

      1.2. Analysis and Recommendations

2. Market Overview

      2.1. Market Coverage / Taxonomy

      2.2. Market Definition

3. Market Background

      3.1. Macro-Economic Factors

      3.2. Forecast Factors - Relevance & Impact

      3.3. Market Dynamics

              3.3.1. Drivers

              3.3.2. Restraints

              3.3.3. Opportunities

              3.3.4. Trends

4. Key Success Factors

      4.1. Key Regulatory Scenario

      4.2. 503A vs 503B Pharmacy Analysis

      4.3. PEST Analysis

5. U.S. Compounding Pharmacies Market Value Analysis 2013-2021 and Forecast, 2022-2028

      5.1. Historical Market Value (US$ Mn) Analysis, 2013-2021

      5.2. Current and Future Market Value (US$ Mn) Projections, 2022-2028

              5.2.1. Y-o-Y Growth Trend Analysis

              5.2.2. Absolute $ Opportunity Analysis

6. U.S. Compounding Pharmacies Market Analysis 2013-2021 and Forecast 2022-2028, by Product Type 

      6.1. Introduction / Key Findings

      6.2. Historical Market Size (US$ Mn) Analysis By Product Type, 2013 - 2021

      6.3. Current and Future Market Size (US$ Mn) Analysis and Forecast By Product Type, 2022 - 2028

              6.3.1. Oral Medication

                      6.3.1.1. Solid Medication

                                 6.3.1.1.1. Capsule

                                 6.3.1.1.2. Tablet

                                 6.3.1.1.3. Mixtures

                                 6.3.1.1.4. Lollipops

                                 6.3.1.1.5. Lozenges

                      6.3.1.2. Liquid Medication

                                 6.3.1.2.1. Syrup

                                 6.3.1.2.2. Solution

                                 6.3.1.2.3. Emulsion

                                 6.3.1.2.4. Suspension

              6.3.2. Topical Medication

                      6.3.2.1. Gels

                      6.3.2.2. Ointments

                      6.3.2.3. Creams

                      6.3.2.4. Lotions

              6.3.3. Injectables

              6.3.4. Mouthwashes

              6.3.5. Nasal

              6.3.6. Ocular

              6.3.7. Otic

              6.3.8. Suppositories and Enemas

      6.4. Market Attractiveness Analysis By Product Type

7. U.S. Compounding Pharmacies Market Analysis 2013-2021 and Forecast 2022-2028, by Pharmacy Type

      7.1. Introduction / Key Findings

      7.2. Historical Market Size (US$ Mn) Analysis By Pharmacy Type, 2013 - 2021

      7.3. Current and Future Market Size (US$ Mn) Analysis and Forecast By Pharmacy Type, 2022 - 2028

              7.3.1. 503A Pharmacy

              7.3.2. 503B Pharmacy

      7.4. Market Attractiveness Analysis By Pharmacy Type

8. U.S. Compounding Pharmacies Market Analysis 2013-2021 and Forecast 2022-2028, by Application

      8.1. Introduction / Key Findings

      8.2. Historical Market Size (US$ Mn) Analysis By Application, 2013 - 2021

      8.3. Current and Future Market Size (US$ Mn) Analysis and Forecast By Application, 2022 - 2028

              8.3.1. Adult

              8.3.2. Pediatric

              8.3.3. Geriatric

              8.3.4. Veterinary

      8.4. Market Attractiveness Analysis By Application

9. U.S. Compounding Pharmacies Market Analysis 2013-2021 and Forecast 2022-2028, by Sterility

      9.1. Introduction / Key Findings

      9.2. Historical Market Size (US$ Mn) Analysis By Sterility, 2013 - 2021

      9.3. Current and Future Market Size (US$ Mn) Analysis and Forecast By Sterility, 2022 - 2028

              9.3.1. Sterile

              9.3.2. Non-Sterile

      9.4. Market Attractiveness Analysis By Sterility

10. U.S. Compounding Pharmacies Market Analysis 2013-2021 and Forecast 2022-2028, by Therapeutic Area

      10.1. Introduction

      10.2. Historical Market Size (US$ Mn) Analysis By Therapeutic Area, 2013 - 2021

      10.3. Current Market Size (US$ Mn) Analysis and Forecast By Therapeutic Area, 2022 - 2028

              10.3.1. Hormone Replacement Therapy

              10.3.2. Pain Management

              10.3.3. Dermatology

              10.3.4. Oncology

              10.3.5. Haematology

              10.3.6. Dental

              10.3.7. Others

      10.4. Market Attractiveness Analysis By Therapeutic Area

11. Competition Analysis

      11.1. Competition Dashboard

      11.2. Competition Deep Dive

              11.2.1. Avella Specialty Pharmacy

              11.2.2. Central Admixture Pharmacy Services, Inc.

              11.2.3. Hoye's Pharmacy

              11.2.4. Vertisis Custom Pharmacy

              11.2.5. Smith Caldwell Drug Store

              11.2.6. Sixth Avenue Medical Pharmacy

              11.2.7. Cantrell Drug Company

              11.2.8. Clinigen Group

              11.2.9. Dougherty's Pharmacy

              11.2.10. Fagron N.V.

12. Assumptions and Acronyms Used

13. Research Methodology

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List of Tables

Table 01: 503A and 503B Pharmacy Comparative Analysis

Table 02: U.S. Compounding Pharmacies Market Value (US$ Mn) Analysis 2013-2021 and Forecast 2022–2028, By Product Type (1/2)

Table 03: U.S. Compounding Pharmacies Market Value (US$ Mn) Analysis 2013-2021 and Forecast 2022–2028, By Product Type (2/2)

Table 04: U.S. Compounding Pharmacies Market Value (US$ Mn) Analysis 2013-2021 and Forecast 2022–2028, By Pharmacy Type

Table 05: U.S. Compounding Pharmacies Market Value (US$ Mn) Analysis 2013-2021 and Forecast 2022–2028, By Sterility

Table 06: U.S. Compounding Pharmacies Market Value (US$ Mn) Analysis 2013-2021 and Forecast 2022–2028, By Application 

Table 07: U.S. Compounding Pharmacies Market Value (US$ Mn) Analysis 2013-2021 and Forecast 2022–2028, By Therapeutic Area 

Sabyasachi Ghosh
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List of Charts

Figure 01: U.S. Compounding Pharmacies Market Value Analysis (US$ Mn), 2013-2021

Figure 02: U.S. Compounding Pharmacies Market Value Forecast (US$ Mn), 2022-2028

Figure 03: U.S. Compounding Pharmacies Market Absolute $ Opportunity, 2022 - 2028

Figure 04: U.S. Compounding Pharmacies Market Value Share Analysis (%), By Product Type, 2022 (E)

Figure 05: U.S. Compounding Pharmacies Market Y-o-Y Analysis (%), By Product Type, 2022 -2028

Figure 06: U.S. Compounding Pharmacies Market Value (US$ Mn) Analysis 2013-2021 and Forecast 2022–2028, By Product Type

Figure 07: U.S. Compounding Pharmacies Market Attractiveness Analysis by Product Type, 2022-2028

Figure 08: U.S. Compounding Pharmacies Market Value Share Analysis (%), By Pharmacy Type, 2022 (E)

Figure 08: U.S. Compounding Pharmacies Market Y-o-Y Analysis (%), By Pharmacy Type, 2022 -2028

Figure 10: U.S. Compounding Pharmacies Market Value (US$ Mn) Analysis 2013-2021 and Forecast 2022–2028, By Pharmacy Type

Figure 11: U.S. Compounding Pharmacies Market Attractiveness Analysis by Pharmacy Type, 2022-2028

Figure 12: U.S. Compounding Pharmacies Market Value Share Analysis (%), By Sterility, 2022 (E)

Figure 13: U.S. Compounding Pharmacies Market Y-o-Y Analysis (%), By Sterility, 2022 -2028

Figure 14: U.S. Compounding Pharmacies Market Value (US$ Mn) Analysis 2013-2021 and Forecast 2022–2028, By Sterility

Figure 15: U.S. Compounding Pharmacies Market Attractiveness Analysis by Sterility, 2022-2028

Figure 16: U.S. Compounding Pharmacies Market Value Share Analysis (%), By Application, 2022 (E)

Figure 17: U.S. Compounding Pharmacies Market Y-o-Y Analysis (%), By Application, 2022 -2028

Figure 18: U.S. Compounding Pharmacies Market Value (US$ Mn) Analysis 2013-2021 and Forecast 2022–2028, By Application

Figure 19: U.S. Compounding Pharmacies Market Attractiveness Analysis by Application, 2022-2028

Figure 20: U.S. Compounding Pharmacies Market Value Share Analysis (%), By Therapeutic Area, 2022 (E)

Figure 21: U.S. Compounding Pharmacies Market Y-o-Y Analysis (%), By Therapeutic Area, 2022 -2028

Figure 22: U.S. Compounding Pharmacies Market Value (US$ Mn) Analysis 2013-2021 and Forecast 2022–2028, By Therapeutic Area

Figure 23: U.S. Compounding Pharmacies Market Attractiveness Analysis by Therapeutic Area, 2022-2028

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U.S. Compounding Pharmacies Market