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세계의 조제 약국 시장 규모 : 조제 유형별, 치료 영역별, 용도별, 지역별·예측Global Compounding Pharmacy Market Size By Compounding Type, By Therapeutic Area (Pain Management, Hormone Replacement Therapy ), By Application, By Geographic Scope And Forecast |
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세계의 조제 약국 시장 규모는 2024년에 115억 5,000만 달러로 평가되며, 2026-2032년에 CAGR 5.70%로 성장하며, 2032년에는 180억 달러에 달할 것으로 예측됩니다.
조제약국은 약사가 환자 개개인의 필요에 따라 맞춤형 의약품을 제조하는 전문 시설입니다. 대량 생산되는 의약품과 달리, 조제 의약품은 시중에서 판매되지 않을 수 있는 특정 용량, 제형 또는 전달 방법을 제공하기 위해 성분을 조합하거나 변경하여 제조됩니다. 특정 알레르겐이 없는 약, 다른 강도의 약 또는 정제 대신 액체나 크림과 같은 다른 형태의 약이 필요한 환자에게는 이 진료가 필수적입니다.
조제 약국은 피부과, 호르몬 대체요법, 소아과, 수의학 등 틈새 의료 분야에서 널리 활용되고 있습니다. 맞춤 치료가 가능하므로 환자 고유의 의료 문제에 대응하는 데 있으며, 매우 중요한 존재가 되고 있습니다. 고령화, 만성질환 증가, 맞춤형 의료의 부상으로 인해 조제 의약품에 대한 수요는 확대될 것으로 예측됩니다. 자동화 및 품질관리 향상과 같은 기술 발전과 함께 조제 약국은 헬스케어에서 더 큰 역할을 수행하며 환자 치료 결과를 개선할 수 있는 혁신적인 솔루션을 제공할 수 있을 것으로 보입니다.
세계 조제 약국 시장을 형성하는 주요 시장 역학은 다음과 같습니다.
주요 시장 성장 촉진요인
만성질환 증가와 맞춤형 의료: 만성질환 증가와 맞춤형 의료 증가는 조제 의약품 수요를 촉진하고 있습니다. 미국 질병예방통제센터(CDC)에 따르면 2018년 기준 미국 성인의 51.8%가 최소 1개 이상의 만성질환을 앓고 있으며, 27.2%는 여러 개의 만성질환을 앓고 있습니다. 이러한 만성질환의 높은 유병률은 조제약국이 제공할 수 있는 맞춤형 의약품에 대한 수요를 창출하고 있습니다.
고령화 진행: 고령자는 특수 의약품을 필요로 하는 경우가 많기 때문에 고령화는 조제 약국 시장의 중요한 촉진요인입니다. 미국 인구조사국은 2030년까지 베이비붐 세대가 모두 65세 이상이 되어 노인 인구의 규모가 확대되고 주민 5명 중 1명이 정년퇴직 연령에 도달할 것으로 예측했습니다. 이러한 인구통계학적 변화로 인해 고령자 맞춤형 조제 의약품에 대한 수요가 증가할 것으로 보입니다.
FDA 승인 의약품 부족: 의약품 부족은 헬스케어 산업에서 지속적인 문제로 대두되고 있으며, 이는 약국에 기회를 가져다주며, FDA의 의약품 부족 데이터베이스에 따르면 2021년 현재 115개 품목의 의약품이 부족합니다. 미국 의료시스템약사회(ASHP)는 2021년 12월 31일 기준 211개 품목의 의약품이 부족하다고 보고했습니다. 이러한 의약품 부족으로 인해 의료 서비스 프로바이더는 종종 대체품을 찾기 위해 조제 약국에 의존하게 됩니다.
주요 과제
규제 준수: 지역, 주, 연방 정부의 다양한 규제를 준수하는 것은 가장 큰 과제 중 하나입니다. 약국은 FDA나 USP와 같은 기관에서 정한 기준을 충족해야 합니다. 이를 위해서는 비용이 많이 드는 시설 업그레이드와 지속적인 교육이 필요합니다. 규정 준수에 실패할 경우, 처벌, 평판 손상 또는 폐업으로 이어져 전체 경영에 영향을 미칠 수 있습니다.
품질관리: 성분과 배합이 다양하므로 조제된 약품의 일관된 품질을 보장하기 어렵습니다. 불충분한 품질관리는 환자에게 부작용이나 부작용을 초래할 수 있습니다. 약국은 강력한 시스템과 검사에 투자해야 하며, 이는 오류의 위험을 증가시키는 동시에 운영 비용을 증가시킵니다.
공급망 혼란: 조제 약국은 전 세계에서 조달되는 원자재에 의존하고 있습니다. 지정학적 문제, 운송 지연, 공급 부족과 같은 혼란은 업무에 지장을 초래할 수 있습니다. 제약 등급의 원료를 제한적으로만 사용할 수 있는 경우, 고가의 대체품이 필요하며, 가격 책정 및 고객 유지에 영향을 미칠 수 있습니다.
주요 동향
의약품 맞춤화: 투약 형태, 강도, 성분 등 환자 개개인의 필요에 따라 의약품을 조정하는 맞춤형 의료가 증가하는 추세입니다. 이러한 추세는 대량 생산된 의약품으로는 대응할 수 없는 고유한 병증에 대해 환자들이 보다 정확한 치료를 요구하게 되고, 조제 서비스에 대한 수요가 증가함에 따라 성장을 가속할 것입니다.
생물학적 동일성 호르몬에 대한 수요 증가: 생물학적 동일성 호르몬 대체요법(BHRT)은 특히 호르몬 불균형에 대한 자연적 해결책을 찾는 노인들 사이에서 인기가 높아지고 있습니다. 조제 약국은 맞춤형 BHRT 제제를 만들 수 있으며, 이 확대되는 시장에 진입할 수 있으며, 기존 의약품으로는 얻을 수 없는 맞춤형 옵션을 제공할 수 있습니다.
소아 및 노인 의료에 대한 관심 증가: 소아 및 노인 환자 모두 액상, 츄어블 정제 등 특정 용법 및 용량의 맞춤형 의약품을 필요로 하는 경우가 많습니다. 조제 약국은 이러한 맞춤형 제제를 만드는 데 중요한 역할을 담당하고 있으며, 의료 서비스 프로바이더가 이러한 취약한 연령층에 대한 맞춤형 치료를 점점 더 중요하게 여기면서 수요를 주도하고 있습니다.
Compounding Pharmacy Market size was valued at USD 11.55 Billion in 2024 and is projected to reach USD 18 Billion by 2032, growing at a CAGR of 5.70 % from 2026 to 2032.
A compounding pharmacy is a specialized facility where pharmacists create customized medications tailored to individual patient needs. Unlike mass-produced pharmaceuticals, compounded medications are prepared by combining or altering ingredients to provide specific dosages, formulations, or delivery methods that may not be commercially available. This practice is essential for patients who require medications free from certain allergens, different dosage strengths, or alternative forms such as liquids or creams instead of pills.
Compounding pharmacies are widely used in niche medical fields like dermatology, hormone replacement therapy, pediatrics, and veterinary medicine, where standard medications may not suffice. Their ability to personalize treatments has made them crucial in addressing patient-specific medical challenges. The demand for compounded medications is expected to grow due to an aging population, increasing chronic diseases, and the rise of personalized medicine. With advancements in technology, such as automation and improved quality control, compounding pharmacies are likely to play a greater role in healthcare, offering innovative solutions that enhance patient outcomes.
The key market dynamics that are shaping the global compounding pharmacy market include:
Key Market Drivers:
Increasing Prevalence of Chronic Diseases and Personalized Medicine: The rise in chronic diseases and the growing trend towards personalized medicine are driving the demand for compounded medications. According to the Centers for Disease Control and Prevention (CDC), as of 2018, 51.8% of U.S. adults had at least one chronic condition, and 27.2% had multiple chronic conditions. This high prevalence of chronic diseases creates a need for tailored medications that compounding pharmacies can provide.
Growing Aging Population: The aging population is a significant driver for the compounding pharmacy market, as older adults often require specialized medications. The U.S. Census Bureau projects that by 2030, all baby boomers will be older than 65, expanding the size of the older population so that 1 in every 5 residents will be of retirement age. This demographic shift is likely to increase the demand for compounded medications tailored to the needs of older adults.
Shortages of FDA-Approved Drugs: Drug shortages have become a persistent problem in the healthcare industry, creating opportunities for compounding pharmacies to fill the gap. According to the FDA's drug shortages database, as of 2021, there were 115 drugs in shortage. The American Society of Health-System Pharmacists (ASHP) reported even higher numbers, with 211 active drug shortages as of December 31, 2021. These shortages often lead healthcare providers to turn to compounding pharmacies for alternatives.
Key Challenges:
Regulatory Compliance: Compliance with varying local, state, and federal regulations is one of the biggest challenges. Pharmacies must meet standards set by organizations like the FDA and USP. This can involve costly facility upgrades and continuous training. Failure to comply can result in penalties, reputational damage, or even closure, affecting the overall operation.
Quality Control: Ensuring consistent quality in compounded medications is difficult due to variability in ingredients and formulations. Poor quality control can lead to adverse effects or inefficacy in patients. Pharmacies must invest in robust systems and testing, adding operational costs while increasing the risk of errors.
Supply Chain Disruptions: Compounding pharmacies rely on raw materials sourced globally. Any disruptions, such as geopolitical issues, transportation delays, or supply shortages, can hinder operations. Limited availability of pharmaceutical-grade ingredients may result in costly alternatives, affecting pricing and customer retention.
Key Trends:
Customization of Medications: Personalized medicine is a growing trend, where medications are tailored to individual patient's needs, including dosage forms, strengths, and ingredients. This trend drives growth as patients seek more precise treatments for unique medical conditions that cannot be met by mass-produced pharmaceuticals, increasing demand for compounding services.
Rising Demand for Bioidentical Hormones: Bioidentical hormone replacement therapy (BHRT) is gaining popularity, particularly among aging populations seeking natural solutions for hormone imbalances. Compounding pharmacies can create customized BHRT formulations, tapping into this expanding market and offering tailored options that aren't available through conventional pharmaceuticals.
Increased Focus on Pediatric and Geriatric Care: Both pediatric and geriatric patients often require tailored medications in specific dosages or formats, such as liquid forms or chewable tablets. Compounding pharmacies play a crucial role in creating these custom formulations, driving demand as healthcare providers increasingly turn to personalized treatments for these vulnerable age groups.
Here is a more detailed regional analysis of the global compounding pharmacy market:
North America:
North America, especially the United States, is leading the compounding pharmacy market due to several key factors. One major driver is the rising prevalence of chronic diseases, with the Centers for Disease Control and Prevention (CDC) noting that 60% of adults in the U.S. have at least one chronic condition, and 40% have multiple conditions. This trend creates a substantial demand for personalized medications, which compounding pharmacies can uniquely provide. As the CDC projects that by 2030, 171 million Americans will have multiple chronic conditions, the need for specialized pharmaceutical services is expected to grow significantly.
The aging population in North America is a critical factor fueling demand for compounded medications. The U.S. Census Bureau anticipates that by 2030, one in five residents will be over the age of 65, which will naturally increase healthcare expenditures. The Centers for Medicare & Medicaid Services (CMS) reported a 9.7% growth in healthcare spending in 2020, reaching $4.1 trillion, with projections of $6.2 trillion by 2028.
Persistent drug shortages reported by the FDA are prompting healthcare providers to turn to compounding pharmacies for alternatives. The regulatory environment, particularly through the Drug Quality and Security Act (DQSA) of 2013, has also bolstered market growth by enhancing the legitimacy and safety standards of compounding pharmacies. Combined with a growing trend toward personalized medicine-where 25% of new drugs approved in 2021 were tailored therapies-the landscape is ripe for continued growth in the North American compounding pharmacy market.
Asia Pacific:
The Asia Pacific region is witnessing significant growth in the compounding pharmacy market, primarily driven by the rising burden of chronic diseases. The World Health Organization (WHO) highlights those non-communicable diseases (NCDs) account for 71% of global deaths, with low- and middle-income countries in this region being disproportionately affected. By 2030, the WHO projects that deaths from NCDs in Southeast Asia will rise to 10.4 million annually, up from 8.5 million in 2012. This escalating health crisis creates a substantial demand for personalized medications, which compounding pharmacies are uniquely positioned to supply. The rapidly aging population, expected to more than double from 630 million in 2020 to approximately 1.3 billion by 2050, adds to this demand, especially in countries like Japan, where nearly 38% of the population will be over 65 by 2050.
In addition to health trends, increasing healthcare expenditures in the region are bolstering the compounding pharmacy market. With healthcare spending in East Asia and the Pacific rising from 6.45% of GDP in 2010 to 7.13% in 2019, investment in specialized pharmaceutical services is expected to grow significantly. The Asia Pacific pharmaceutical market is anticipated to reach $385 billion by 2026, creating ample opportunities for compounding pharmacies. The regulatory landscape is also evolving, with countries like Australia implementing new regulations to ensure quality and safety in compounded medications. Drug shortages further enhance the market potential, as healthcare providers increasingly seek alternatives from compounding pharmacies amid significant medicine shortages reported by regulatory bodies.
The Global is Segmented on the basis of Compounding Type, Therapeutic Area, Application, And Geography.
Based on Compounding Type, the market is fragmented into Sterile Compounding and Non-Sterile Compounding. Sterile compounding is dominating the market due to the increasing demand for customized injectable medications, intravenous (IV) therapies, and other sterile formulations required for patients with specific health conditions, such as cancer or chronic diseases. Strict regulatory standards and the need for quality assurance further enhance the prominence of sterile compounding in the healthcare landscape. Non-sterile compounding is rapidly growing as healthcare providers and patients seek personalized oral medications, topical creams, and other formulations tailored to individual needs, particularly in pediatrics and dermatology. The increasing focus on patient-centered care and the rise in chronic conditions that require individualized treatment plans are propelling the demand for both sterile and non-sterile compounding.
Based on Therapeutic Area, the market is divided into Pain Management and Hormone Replacement Therapy (HRT). The compounding pharmacy market is prominently driven by the therapeutic areas of pain management and hormone replacement therapy (HRT), both of which are experiencing significant growth. Pain management is a critical area as the increasing prevalence of chronic pain conditions, such as arthritis and neuropathy, has led to a heightened demand for personalized pain relief options that compounded medications can provide, especially for patients who may not respond well to standard treatments. Hormone replacement therapy is rapidly expanding, particularly among aging populations seeking to manage symptoms of menopause and andropause. Compounding pharmacies can tailor hormone formulations to meet individual patient needs, ensuring optimal efficacy and minimizing side effects. The growing awareness and acceptance of personalized treatment options in both pain management and HRT are driving substantial growth in these segments of the compounding pharmacy market.
Based on Application, the market is segmented into Veterinary Medicine and Pediatrics. The compounding pharmacy market is significantly influenced by the applications in veterinary medicine and pediatrics, with both segments experiencing growing demand. In veterinary medicine, compounded medications are essential for customizing treatments for pets with unique health needs, such as specific dosages or formulations that are not commercially available. The pediatrics segment is expanding as children often require specialized dosages and formulations, such as liquids or flavored medications, to ensure proper administration and compliance. As awareness of the benefits of personalized medicine increases among healthcare providers and pet owners, the demand for compounded medications in these applications is expected to rise.
The "Global Compounding Pharmacy Market" study report will provide valuable insight with an emphasis on the global market. The major players in the market are Fagron, B. Braun Melsungen AG, Nephron Pharmaceuticals Corporation, Fresenius Kabi, PharMEDium Services, QuVa Pharma, Triangle Compounding Pharmacies, Pencol ii Pharmacy, Smith Drug Company, and Rx3 Compounding Pharmacy. The competitive landscape section also includes key development strategies, market share, and market ranking analysis of the above-mentioned players globally.
Our market analysis also entails a section solely dedicated to such major players wherein our analysts provide an insight into the financial statements of all the major players, along with product benchmarking and SWOT analysis. The competitive landscape section also includes key development strategies, market share, and market ranking analysis of the above-mentioned players globally.