U.S. Compounding Pharmacies Market — Insights 

A pharmacy that is operated by a licensed pharmacist, licensed physician or a person under the guidance of a licensed pharmacist is called compounding pharmacy.

The U.S. 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

Lack of essential medicines for the treatment of critical diseases is expected to boost growth of the U.S. compounding pharmacies market. For instance, according to a report of 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% said they had rescheduled non-urgent or emergent procedures. Such scenario leads to use of readily available compounded medications, which is expected to boost growth of the U.S. compounding pharmacies market.

Increasing demand for hormone replacement therapy (HRT) is also expected to boost growth of the U.S. compounding pharmacies market over the forecast period. HRT is an effective way to relieve symptoms of perimenopause and menopause. Major active pharmaceutical ingredients currently in demand for HRT include progesterone, estradiol, estrogen, and testosterone. Bio-identical HRT is also used to reduce aging process. Therefore, increasing geriatric population is also expected to boost growth of the market. For instance, 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.

Statistics:

Topical Medication segment held dominant position in the U.S. compounding pharmacies market in 2018, accounting for 41.0% share in terms of value, followed by Oral Medication

U.S. Compounding Pharmacies  | Coherent Market Insights

U.S. Compounding Pharmacies Market: Restraints

Adoption of unsafe compounding practices is a major factor hindering growth of the U.S. compounding pharmacies market.

Moreover, increasing product warnings in sterile compounding has led to decrease in sales of compounded injectable drugs, which is also expected to hinder growth of the market. For instance, the U.S. FDA expanded an original warning on using Becton-Dickinson (BD) general use syringes of sizes 1mL, 3mL, 5mL, 10mL, 20mL, and 30mL. The agency noted that interaction with the rubber stopper in some lots of these syringes may adversely impact drug potency if filled in syringes and not used immediately.

U.S. Compounding Pharmacies Market: Opportunities

The U.S. compounding pharmacies market is expected to witness a CAGR of ~6% over the forecast period. This is attributed to upcoming products and therapeutic areas that are yet to be tapped into by branded manufacturers such as those related to geriatric and long-term care drugs and innovative HRT applications.

It is necessary to gain U.S. FDA approval and follow CGMP guidelines to increase drug and brand value. Therefore, market players may focus on abiding to stipulated FDA norms and also be prepared for surprise inspections.

U.S. Compounding Pharmacies  | Coherent Market Insights

Statistics:

For any segment information:

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

U.S. Compounding Pharmacies Market: Market Trends/Key Takeaways

In the U.S. compounding pharmacies market, conventional compounding pharmacies operate without the supervision of the U.S. FDA. The State Boards of Pharmacy regulate the conventional compounding, also known as ‘within border’ compounding. The U.S. Pharmacoepia (USP) has set the standard pharmacy compounding practices in most states.

Compounding pharmacies operate in five formats: independent store, compounding department 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.

U.S. Compounding Pharmacies Market: Regulations

Compounding pharmacies in the U.S. are regulated by the State Boards of Pharmacies.

Traditional Compounding (503A)

  • The State Pharmacies Board regulates traditional compounding pharmacies under section 503A
  • These boards are also responsible for day-to-day functioning of pharmacies
  • These pharmacies cannot legally engage in sterile compounding
  • These pharmacies cannot manufacture drugs and APIs in bulk

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.         

Key Developments

In July 2019, PharMEDium Services, LLC announced to recall 45 lots of 0.5 mg/mL HYDROmorphone HCl in 0.9% Sodium Chloride 1 mL in 3 mL BD Syringe to the user level. The recall was due to presence of sulfite in PharMEDium’s electronic customer ordering system that claimed to be sulfite-free.

In July 2019, The U.S. FDA announced new regulations at Pharmacy Compounding Regulation: A Fresh Look at Guidance, Compliance, and Enforcement Webinar after it found 11 adulteration violations including visibly dirty surfaces and non-sterile cleaning methods in ISO 5 areas at Triad Rx.

Compounding pharmacies consist of creation/compounding of pharmaceutical products tailored to fit the needs of the patient. Compounding pharmacies is a type of personalized medicine and caters to specific needs of the patients. Compounding of pharmaceutical products presents as a solution for patients with problems such as inability to swallow pills, gluten allergy, short supply drugs, and others. Patients having allergies associated with commonly used medicine fillers such as casein, gluten, and dyes can be avoided in compounding pharmacy as you can avoid use of such components. Compounding pharmacy solutions providers, and companies are indulged in research and development of novel treatment options with the use of advanced technology. For instance, TOMI Environmental Solutions, Inc. (company specializing in disinfection and decontamination) has implemented its SteraMist iHP technology in multiple compounding pharmacies in December 2019 to adhere to USP 795, USP 797, USP 800, and Good Manufacturing Practices (GMP) standards. These factors are expected to support U.S. compounding pharmacies market growth over the forecast period.

Restraints of the U.S. Compounding Pharmacies Market

One of the major restraints of this market is that these products are not approved by U.S. Food & Drug Administration (FDA). Moreover, recently in November 2019, a study results of sampling of levothyroxine (LT4) liquid formulations obtained from compounding pharmacies were highlighted at American Thyroid Association (ATA) 89th Annual Meeting. Results showed substantial variation in the active drug components of such products, which could be a health risk. These factors are expected to restrain growth of the market over the forecast period.

Key features of the study:

  • This report provides in-depth analysis of the U.S. compounding pharmacies market and provides market size (US$ Million) and compound annual growth rate (CAGR %) for the forecast period (2019–2027), considering 2018, as the base year
  • It elucidates potential revenue opportunity across different segments and explains attractive investment proposition matrix for this market
  • This study also provides key insights about market drivers, restraints, opportunities, new product launches or approval, regional outlook, and competitive strategy adopted by leading players
  • It profiles leading players in the U.S. compounding pharmacies market based on the following parameters – company overview, financial performance, product portfolio, geographical presence, distribution strategies, key developments, and strategies, and future plans
  • Key companies covered as a part of this study include Avella Specialty Pharmacy, Fagron N.V., Central Admixture Pharmacy Services, Inc., Wedgewood Pharma, Institutional Pharmacy Solutions, Lorraine’s Pharmacy, PharMEDium Services LLC, Village Compounding Pharmacy, Triangle Compounding Pharmacy, and Vertisis Custom Pharmacy
  • Insights from this report would allow marketers and the management authorities of companies to make informed decision regarding future product launches, technology up-gradation, market expansion, and marketing tactics
  • The U.S. compounding pharmacies market report caters to various stakeholders in this industry including investors, suppliers, product manufacturers, distributors, new entrants, and financial analysts.
  • Stakeholders would have ease in decision-making through various strategy matrices used in analyzing the assistive reproductive technology market.

Detailed Segmentation

  •  U.S. Compounding Pharmacies Market, By Medication:
    • Oral Medication
      • Capsules
      • Tablets
      • Mixtures
      • Lollipops
      • Lozenges
    • Topical Medication
      • Gels
      • Ointments
      • Cream
      • Lotions
    • Mouthwashes
    • Suppositories
  •  U.S. Compounding Pharmacies Market, By Therapeutic Area:
    • Pain Management
    • Hormone Replacement Therapy (HRT)
  • U.S. Compounding Pharmacies Market, By Application:
    • Medication for Adults
    • Medication for Veterinary
    • Medication for Children
    • Medication for Geriatric
  • Company Profiles
    • Avella Specialty Pharmacy *
      • Company Overview
      • Product Portfolio
      • Financial Performance
      • Key Strategies
      • Recent Developments
    • Fagron N.V.
    • Central Admixture Pharmacy Services, Inc.
    • Wedgewood Pharma
    • Institutional Pharmacy Solutions
    • Lorraine’s Pharmacy
    • PharMEDium Services LLC
    • Village Compounding Pharmacy
    • Triangle Compounding Pharmacy
    • Vertisis Custom Pharmacy

“*” marked represents similar segmentation in other categories in the respective section.

Research Methodology

Coherent Market Insights followsa comprehensive research methodology focused on providing the most precise market analysis. The company leverages a data triangulation model which helps company to gauge the market dynamics and provide accurate estimates. Key components of the research methodologies followed for all our market reports include:

  • Primary Research (Trade Surveys and Experts Interviews)
  • Desk Research
  • Proprietor Data Analytics Model

In addition to this, Coherent Market Insights has access to a wide range of the regional and global reputed paid data bases, which helps the company to figure out the regional and global market trends and dynamics. The company analyses the industry from the 360 Degree Perspective i.e. from the Supply Side and Demand Side which enables us to provide granular details of the entire ecosystem for each study. Finally, a Top-Down approach and Bottom-Up approach is followed to arrive at ultimate research findings.


Data Triangulation Methodology | Coherent Market Insights

Coherent Market Insights desk research is based on a principle set of research techniques:

  • National level desk research: It Includes research analysis of regional players, regional regulatory bodies, regional trade associations, and regional organization.
  • Multinational level desk research: The research team keeps a track of multinational players, global regulatory bodies, global trade associations, and global organization.

Coherent Market Insights has a large amount of in-house repository of industry database. This is leveraged as a burner for initiating a new research study. Key secondary sources include:

  • Governmental bodies, National and international social welfare institutions, and organizations creating economic policies among others.
  • Trade association, National and international media and trade press.
  • Company Annual reports, SEC filings, Corporate Presentations, press release, news, and specification sheet of manufacturers, system integrators, brick and mortar - distributors and retailers, and third party online commerce players.
  • Scientific journals, and other technical magazines and whitepapers.

Market Analysis | Coherent Market Insights

Preliminary Data Mining

The raw data is obtained through the secondary findings, in house repositories, and trade surveys. It is then filtered to ensure that the relevant information including industry dynamics, trends, and outlook is retained for further research process.

Data Standardization

Holistic approach is used to ensure that the granular and uncommon parameters are taken into consideration to ensure accurate results. The information from the paid databases are further combined to the raw data in order to standardize it.

Coherent Statistical model

We arrive at our final research findings through simulation models. Coherent Data Analytics Model is a statistical tool that helps company to forecast market estimates. Few of the parameters considered as a part of the statistical model include:

  • Micro-economic indicators
  • Macro-economic indicators
  • Environmental indicators
  • Socio-political indicators
  • Technology indicators

Data Processing

Once the findings are derived from the statistical model, large volume of data is process to confirm accurate research results. Data analytics and processing tools are adopted to process large chunk of collected informative data. In case, a client customizes the study during the process, the research finding till then are benchmarked, and the process for new research requirement is initiated again.

Data Validation

This is the most crucial stage of the research process. Primary Interviews are conducted to validate the data and analysis. This helps in achieving the following purposes:

  • It provides first-hand information on the market dynamics, outlook, and growth parameters.
  • Industry experts validates the estimates which helps the company to cement the on-going research study.
  • Primary research includes online surveys, face-to face interviews, and telephonic interviews.

The primary research is conducted with the ecosystem players including, but not limited to:

  • Raw Material Suppliers
  • Manufacturers
  • System Integrators
  • Distributors
  • End-users