Global Compounding Pharmacy Market By Therapeutic Area (Pain Management, Dermal Disorders, Hormone Replacement, Nutritional Supplements, and Others), By Route of Administration (Oral, Parenteral, Topical, and Others), By Application (Pediatric, Adult, Geriatric, and Veterinary), By Compounding Type (Pharmaceutical Ingredient Alteration, Pharmaceutical Dosage Alteration, and Others), Region and Companies – Industry Segment Outlook, Market Assessment, Competition Scenario, Trends and Forecast 2024-2033

Report Overview

The Global Compounding Pharmacy Market size is expected to be worth around USD 21.5 billion by 2033 from USD 13.1 billion in 2023, growing at a CAGR of 5.1% during the forecast period 2024 to 2033.

The rising significance of compounding in improving medication adherence significantly contributes to the market’s expansion. Medication adherence can be challenging due to various factors, such as difficulties in swallowing, taste preferences, or allergies to certain ingredients in commercially available drugs.

Compounding pharmacies address these challenges by creating personalized medications tailored to individual needs, and offering customized dosage forms, flavors, and allergen-free options to enhance patient acceptance and compliance. The increasing demand for personalized medicine further drives market growth, as personalized treatments aim to improve the safety and effectiveness of medications by catering to each patient’s unique requirements.

For patients with specific needs, including allergies, intolerances, or those requiring treatments for rare or orphan diseases, compounded medications provide critical solutions. Additionally, compounded pharmacies offer alternatives for discontinued medications, such as budesonide and ursodiol capsules, which are no longer commercially available. The shortage of commercial medications, particularly for chronic conditions, has increased the reliance on compounded solutions.

According to the 2022 Medicine Shortage Survey by the Pharmaceutical Group of the European Union (PGEU), medication shortages were reported in all 29 survey countries, with cardiovascular medications being the most affected. Pharmaceutical compounding serves as a viable solution to address these shortages and fill the gaps left by the lack of available commercial medications.

Key Takeaways

• Market Size: The Compounding Pharmacy Market size is expected to be worth around USD 21.5 billion by 2033 from USD 13.1 billion in 2023
• Market Growth: The market growing at a CAGR of 5.1% during the forecast period 2024 to 2033.
• Therapeutic Area Analysis: The hormone replacement segment led in 2023, claiming a market share of 38.4% owing to several factors.
• Route of Administration Analysis: The oral held a significant share of 43.2% due to several key factors.
• Application Analysis: The adult segment had a tremendous growth rate, with a revenue share of 45.7%
• Compounding Type Analysis: The pharmaceutical dosage alteration segment grew at a substantial rate, generating a revenue portion of 52.8% due to various factors.
• Regional Analysis: North America dominated the market with the highest revenue share of 40.1% owing to several key factors.

By Therapeutic Area Analysis

The hormone replacement segment led in 2023, claiming a market share of 38.4% owing to several factors. An increasing prevalence of hormonal imbalances and related conditions, such as menopause and thyroid disorders, propels the demand for customized hormone therapies. Advances in pharmaceutical science and personalized medicine contribute to the development of tailored hormone treatments that address individual patient needs more effectively.

The rising awareness of hormone replacement therapy’s benefits and the growing acceptance of personalized approaches in medicine further support this growth. As the population ages and the incidence of hormone-related conditions increases, the need for specialized and customized treatments is anticipated to grow. The focus on improving patient outcomes and quality of life will likely drive further innovations and expansions in this segment.

By Route of Administration Analysis

The oral held a significant share of 43.2% due to several key factors. Oral medications offer a user-friendly and non-invasive method of delivery, which enhances patient compliance and convenience. The development of advanced oral formulations and the ability to customize dosages for individual needs support the growing demand for oral compounding solutions.

Additionally, the increasing prevalence of chronic diseases and conditions requiring long-term medication drives the need for effective oral treatment options. The flexibility of oral administration in delivering both standard and customized formulations contributes to its continued popularity. The overall trend towards personalized medicine and patient-centric approaches is likely to further bolster the growth of the oral segment.

By Application Analysis

The adult segment had a tremendous growth rate, with a revenue share of 45.7% owing to the increasing prevalence of chronic conditions and diseases that predominantly affect adults, such as cardiovascular diseases, diabetes, and arthritis. The demand for customized medications that address specific adult health issues and the trend toward personalized medicine enhances the need for tailored pharmaceutical solutions.

Additionally, the focus on improving patient outcomes and providing individualized care further supports the expansion of this segment. As healthcare continues to evolve towards more personalized approaches, the adult application segment is expected to grow in response to the specific needs of this demographic.

By Compounding Type Analysis

The pharmaceutical dosage alteration segment grew at a substantial rate, generating a revenue portion of 52.8% due to various factors. The increasing demand for personalized medicine requires modifications in dosage forms to meet individual patient needs effectively. Customized dosage alterations help address specific health conditions and improve patient adherence by tailoring medications to unique requirements.

Advancements in compounding technologies and techniques facilitate more precise and effective dosage modifications. The growing emphasis on personalized care and the need to address a wide range of patient preferences contribute to the segment’s expansion. As the focus on patient-centric treatment approaches continues, the demand for pharmaceutical dosage alterations is likely to rise.

Key Market Segments

By Therapeutic Area

• Pain Management
• Dermal Disorders
• Hormone Replacement
• Nutritional Supplements
• Others

By Route of Administration

• Oral
• Parenteral
• Topical
• Others

By Application

• Pediatric
• Adult
• Geriatric
• Veterinary

By Compounding Type

• Pharmaceutical Ingredient Alteration
• Pharmaceutical Dosage Alteration
• Others

Drivers

Rising Prevalence of Chronic Diseases and Growth in Geriatric Population

The rising prevalence of chronic diseases and the growth in the geriatric population drive the compounding pharmacy market significantly. As the global population ages, the demand for personalized medications to address age-related conditions increases. For instance, the Union for International Cancer Control (UICC) reports that over 703 million individuals are currently aged 65 or older, comprising 9.1% of the world’s population. By 2050, this number is expected to reach 15.9% or approximately 1.5 billion people.

Additionally, the World Health Organization highlights that more than 50% of cancer patients are over 65 years old, due to the accumulation of aging-related risk factors and reduced cellular repair capabilities. The increasing number of elderly individuals with chronic conditions generates a growing need for customized treatment solutions, positioning compounding pharmacies as essential providers of tailored medications.

Restraints

Stringent Rules and Regulations

Increasing regulatory scrutiny and stringent rules impose significant restraints on the compounding pharmacy market. Regulatory bodies enforce rigorous standards to ensure drug safety and efficacy, which can impede the operational flexibility of compounding pharmacies. For example, the U.S. Food and Drug Administration (FDA) and similar authorities impose strict guidelines for compounding practices, including detailed record-keeping and quality control measures.

These regulations are expected to continue tightening, potentially increasing operational costs and complexity for compounding pharmacies. The challenge of navigating these stringent requirements while maintaining compliance can hamper market growth and limit the ability of compounding pharmacies to adapt quickly to evolving patient needs.

Opportunities

Growing Collaboration among Key Players

Increasing collaboration among key players presents a significant opportunity for the compounding pharmacy market. Strategic partnerships enhance capabilities and expand service offerings, allowing for better responses to market demands. For example, in February 2023, Wedgewood Pharmacy acquired Front Range Laboratories (FRL), a well-established testing facility with over 25 years of experience supporting compounding pharmacies.

This acquisition integrates FRL’s expertise in analytical, microbiological, and stability testing with Wedgewood Pharmacy’s comprehensive services. Such collaborations are expected to foster innovation and improve service quality, providing compounding pharmacies with enhanced resources and capabilities to meet diverse and growing market needs.

Impact of Macroeconomic / Geopolitical Factors

Macroeconomic and geopolitical factors exert significant influence on the compounding pharmacy market, both positively and negatively. Economic growth promotes investment in healthcare infrastructure and services, creating opportunities for compounding pharmacies to expand. However, economic downturns reduce consumer spending and healthcare budgets, limiting access to personalized medication services.

Geopolitical tensions, such as trade restrictions and global supply chain disruptions, can hinder the availability of essential raw materials and pharmaceutical ingredients needed for compounded medications. Regulatory environments also vary across regions, with stricter regulations potentially increasing operational costs.

On the positive side, healthcare reforms and government support for personalized medicine have created growth opportunities. Despite the challenges, growing awareness about tailored medications and the increasing demand for customized treatments provide a solid foundation for market expansion in the coming years.

Latest Trends

Growing Demand for Hormone Replacement Treatment

Growing demand for hormone replacement treatment is a recent trend driving the compounding pharmacy market. The increasing prevalence of hormonal imbalances, particularly among aging populations, has led to a surge in demand for personalized hormone therapies.

According to a December 2022 study published by the National Center for Biotechnology Information, hormone replacement treatment prescriptions grew by 13.64% annually from 5.01 per 1000 person-years-at-risk (PYAR) in 2010 to 18.16 per 1000 PYAR in 2021. This rising demand for hormone therapy is anticipated to fuel the need for custom-compounded medications tailored to individual hormonal needs.

The trend aligns with the broader movement towards personalized medicine, where patients seek more precise and targeted treatment solutions. As awareness about the benefits of hormone replacement therapy continues to increase, the market for custom compounding services is likely to see substantial growth.

Regional Analysis

North America is leading the Compounding Pharmacy Market

North America dominated the market with the highest revenue share of 40.1% owing to several key factors. The rise in demand for personalized medications, particularly for patients with specific health needs that commercial drugs cannot meet, played a crucial role in this expansion.

According to the American Pharmacists Association, as of October 2021, over 56,000 community pharmacies were operating in the U.S., with 7,500 offering advanced compounding services. This widespread availability of specialized services allowed for greater access to customized treatments, driving market growth.

Additionally, the increasing prevalence of chronic conditions and allergies, coupled with the aging population in North America, fueled the demand for compounded medications. Advancements in pharmaceutical technology and a supportive regulatory framework further contributed to the market’s expansion in the region.

The Asia Pacific region is expected to experience the highest CAGR during the forecast period

Asia Pacific is expected to experience robust growth during the forecast period. The region’s expanding healthcare infrastructure and rising demand for personalized medicine are expected to drive this growth. An increasing number of patients in Asia Pacific are seeking customized treatments, particularly for chronic diseases, which conventional medicines do not always address effectively.

Additionally, the growing awareness of the benefits of compounding among healthcare professionals and patients is anticipated to boost demand. Government initiatives to enhance healthcare access and pharmaceutical services, especially in developing nations, will likely support the market’s expansion. Moreover, the rise in disposable incomes and the region’s large population base present opportunities for further market development. These factors combined are estimated to propel the growth of compounding pharmacies in the Asia Pacific region.

Key Regions and Countries

North America

• US
• Canada

Europe

• Germany
• France
• The UK
• Spain
• Italy
• Russia
• Netherland
• Rest of Europe

Asia Pacific

• China
• Japan
• South Korea
• India
• Australia
• New Zealand
• Singapore
• Thailand
• Vietnam
• Rest of APAC

Latin America

• Brazil
• Mexico
• Rest of Latin America

Middle East & Africa

• South Africa
• Saudi Arabia
• UAE
• Rest of MEA

Key Players Analysis

The major players in the Compounding Pharmacy Market are actively engaged in the development and introduction of innovative products, as well as implementing strategic initiatives aimed at enhancing their competitive positioning. Key players in the compounding pharmacy market focus on expanding their product offerings by developing personalized medications tailored to individual patient needs.

They invest in advanced compounding technologies and automation to improve precision and efficiency in medication preparation. Strategic partnerships with healthcare providers and hospitals allow them to broaden their reach and enhance service delivery. Companies also emphasize regulatory compliance to ensure product safety and gain trust within the medical community.

Additionally, marketing efforts target educating both patients and healthcare professionals about the benefits of compounded medications.

Top Key Players

• Wedgewood Pharmacy
• Rx3 Compounding Pharmacy
• Lorraine’s Pharmacy
• Institutional Pharmacy Solutions
• ImprimisRx
• Harrow
• Fagron NV
• Empower Pharma
• Dougherty’s Pharmacy, Inc.
• Braun Medical Inc.

Recent Developments

• In February 2024, Empower Pharma agreed to acquire a facility in East Windsor, New Jersey, from Eugia US Manufacturing LLC and entered into a contract manufacturing agreement. This move supports Empower’s aim to expand its personalized compounded medicine offerings. The acquisition highlights the increasing focus on personalized medicine in the compounding pharmacy market and how strategic expansions and partnerships can drive market growth.
• In September 2023, LO3 Capital provided growth capital through a senior subordinated debt investment to Empower Pharmacy, aimed at expanding patient access to affordable compounded medication. This financial support underlines the importance of investment in driving market expansion, enabling compounding pharmacies to enhance their capabilities and meet the growing demand for quality, customized medications.
• In February 2023, Harrow introduced new boric acid- and preservative-free next-generation compounded atropine formulations. These formulations can be stored at room temperature for up to 180 days and maintain a physiological pH of 5.5. ImprimisRx, a fully-owned subsidiary of Harrow, currently offers these patent-pending formulations. This development showcases innovation in the compounding pharmacy market, driving growth through advanced, patient-friendly solutions that meet specific healthcare needs while offering convenience in storage and use.
• In July 2022, Fagron expanded its U.S. presence by acquiring a 503B outsourcing facility in Boston from Fresenius Kabi. This acquisition has enhanced Fagron’s ability to provide sterile compounding services across the U.S., contributing to the company’s broader footprint in the market. The acquisition aligns with the growing demand for sterile compounded medications and highlights how expansions can foster significant growth in the compounding pharmacy sector.
• In March 2022, Fagron opened a technologically advanced facility in Colombia, strengthening the company’s position in personalized medicine within the region. The new facility allows Fagron to better serve the local market with innovative, tailored healthcare solutions. This expansion underscores the increasing importance of personalized medicine in the compounding pharmacy market and the role of advanced facilities in meeting the demand for customized treatment options.
• In December 2021, ImprimisRx expanded its partnership with EyePoint Pharmaceuticals to enhance the U.S. marketing and sales of DEXYCU, an FDA-approved injectable steroid. This collaboration has bolstered demand for DEXYCU and enriched ImprimisRx’s product portfolio, emphasizing how strategic alliances and expanding product offerings contribute to the growth of the compounding pharmacy market by increasing the availability of specialized treatments.

Report Scope