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市場調査レポート
商品コード
1732186
調剤薬局の世界市場規模:調剤タイプ別、治療領域別、用途別、地域別・予測Global 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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調剤薬局の世界市場規模:調剤タイプ別、治療領域別、用途別、地域別・予測 |
出版日: 2025年04月29日
発行: Verified Market Research
ページ情報: 英文 202 Pages
納期: 2~3営業日
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世界の調剤薬局の市場規模は、2024年に115億5,000万米ドルと評価され、2026年~2032年にCAGR5.70%で成長し、2032年には180億米ドルに達すると予測されています。
調剤薬局は、薬剤師が個々の患者のニーズに合わせてカスタマイズされた医薬品を作成する専門施設です。大量生産される医薬品とは異なり、調剤薬は、市販されていない可能性のある特定の投与量、製剤、または送達方法を提供するために、成分を組み合わせたり変更したりすることによって調製されます。特定のアレルゲンを含まない薬、異なる強さの薬、あるいは錠剤の代わりに液体やクリームなどの代替形態を必要とする患者にとって、この診療は不可欠です。
調剤薬局は、皮膚科、ホルモン補充療法、小児科、獣医学などのニッチな医療分野で広く利用されています。治療を個別化できることから、患者固有の医療課題に対応する上で極めて重要な存在となっています。高齢化、慢性疾患の増加、個別化医療の台頭により、調剤薬の需要は拡大すると予想されます。自動化や品質管理の向上といった技術の進歩に伴い、調剤薬局はヘルスケアにおいてより大きな役割を果たすようになり、患者の転帰を向上させる革新的なソリューションを提供するようになると思われます。
世界の調剤薬局市場を形成している主な市場力学は以下の通りです:
主な市場促進要因
慢性疾患の増加と個別化医療:慢性疾患の増加と個別化医療への傾向の高まりが、調剤薬の需要を促進しています。米国疾病予防管理センター(CDC)によると、2018年現在、米国成人の51.8%が少なくとも1つの慢性疾患を有し、27.2%が複数の慢性疾患を有しています。このような慢性疾患の高い有病率は、調剤薬局が提供できるオーダーメイドの医薬品に対するニーズを生み出しています。
高齢化の進展:高齢者は特殊な薬を必要とすることが多いため、高齢化は調剤薬局市場の重要な促進要因です。米国国勢調査局は、2030年までにベビーブーム世代がすべて65歳以上になり、高齢者人口の規模が拡大し、住民の5人に1人が定年退職年齢になると予測しています。この人口動態の変化により、高齢者のニーズに合わせた調剤薬の需要が増加すると考えられます。
FDA承認薬の不足:医薬品不足はヘルスケア業界における根強い問題となっており、そのギャップを埋めるために調剤薬局にチャンスをもたらしています。FDAの医薬品不足データベースによると、2021年現在、115品目の医薬品が不足しています。米国医療システム薬剤師会(ASHP)は、2021年12月31日時点で211品目の医薬品が不足していると報告しています。このような医薬品不足により、ヘルスケア提供者はしばしば代替品を求めて調剤薬局に頼ることになります。
主な課題
規制の遵守:地域、州、連邦政府の様々な規制の遵守は最大の課題の1つです。薬局はFDAやUSPのような組織が定めた基準を満たさなければなりません。そのためには、費用のかかる施設のアップグレードや継続的なトレーニングが必要となります。コンプライアンスに失敗すると、罰則や風評被害、あるいは閉鎖につながり、経営全体に影響を及ぼす可能性があります。
品質管理:成分や配合にばらつきがあるため、調剤薬の一貫した品質を確保することは難しいです。不十分な品質管理は、患者への副作用や無効性につながる可能性があります。薬局は堅牢なシステムと検査に投資しなければならず、エラーのリスクを高めると同時に運営コストを増加させます。
サプライチェーンの混乱:調剤薬局は世界に調達される原材料に依存しています。地政学的問題、輸送の遅れ、供給不足などの混乱は、業務に支障をきたす可能性があります。医薬品グレードの原料が限定的にしか入手できない場合、高価な代替品が必要となり、価格設定や顧客維持に影響を及ぼす可能性があります。
主要動向
薬のカスタマイズ:個別化医療は増加傾向にあり、投薬形態、強さ、成分など、個々の患者のニーズに合わせて薬を調整します。この動向は、大量生産された医薬品では対応できない独自の病状に対して、患者がより正確な治療を求めるようになり、調剤サービスの需要が高まるにつれて成長を促進します。
生物学的同一性ホルモンに対する需要の高まり:バイオアイデンティカル・ホルモン補充療法(BHRT)は、特にホルモンバランスの乱れに対する自然な解決策を求める高齢者の間で人気が高まっています。調剤薬局は、カスタマイズされたBHRT製剤を作成することができ、この拡大する市場に参入し、従来の医薬品では入手できないオーダーメイドの選択肢を提供することができます。
小児・高齢者医療への注目の高まり:小児・高齢者患者ともに、液剤やチュアブル錠など、特定の用法・用量でオーダーメイドの薬剤を必要とすることが多いです。調剤薬局はこのようなオーダーメイドの製剤を作る上で重要な役割を担っており、ヘルスケア提供者がこのような脆弱な年齢層に対する個別化治療をますます重視するようになる中で、需要を牽引しています。
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.