無菌調剤薬局市場 - 2031 年の成長予測、統計および事実

  • Report Code : TIPRE00026302
  • Category : Pharmaceuticals
  • Status : Published
  • No. of Pages : 163
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[調査レポート]無菌調剤薬局市場は、2021年の39億6,870万米ドルから2028年までに61億9,859万米ドルに達すると予測されています。 2021 年から 2028 年にかけて 6.6% の CAGR で成長すると予想されています。



個別化医薬品の摂取量の増加や現場での無菌調合に関連する利点などの要因が市場の成長を推進します。しかし、製品のリコールと厳しい規制要件が市場の成長を妨げています。一方、カスタマイズされた製剤のための集中型または地域型調合センターの開発は、予測期間中に市場成長の有利な機会を生み出すでしょう。



北米は、期間中、無菌調合薬局市場での優位性を継続する可能性があります。 2021年から2028年。米国は北米市場で最大のシェアを占めており、予測期間中この傾向が続くと予想されます。これは主に、医薬品支出の増加と確立された医療インフラに起因します。たとえば、食品医薬品局 (FDA) は 503B を指定しています (記録のために、503B はアウトソーシング施設と呼ばれ、503B 薬局と呼ばれることもあり、新しいレベルの患者ケアを確立するために FDA によって厳しく監視されており、安全性)。また、米国の病院のほぼ 75% は、安定性を確保し、薬剤不足に対処し、すぐに投与できる薬剤を入手し、有効期間を延長するために、無菌調合製剤を 503B 施設に委託しています。さらに、高齢者人口の増加と市販品よりもカスタマイズされた製剤の採用の増加により、今後数年間で米国の無菌調合薬局市場の成長が促進されると予想されます。



戦略的洞察



滅菌調合薬局市場にとって有利な地域





市場洞察



オン-現場での無菌調合が市場の成長を促進



患者のニーズに応じてカスタマイズすることを目的とした静脈内溶液の場合、現場での調合と滅菌が不可欠であることがわかります。現場での製造により、初期の臨床医薬品開発の開始段階で医薬品原薬 (API) を被験者に導入することができます。無菌即時配合は、Good Manufacturing (GMP) 基準に従って設計された非経口治験製品の高価で長期にわたる開発に柔軟なオプションを提供します。通常、臨床研究用に非経口投与される API は GMP 条件下で製造されます。これにより、特定の用量に必要な最終製品の製造に必要な時間が短縮される可能性があります。



さらに、製剤を配合し、濾過して無菌静脈内溶液にすることは、製薬スポンサーおよび臨床現場の薬剤師との強力な協力を通じて成功裏に実現されます。



現場での無菌調合は世界市場で大きな注目を集めており、市場の成長に最も影響を与える要因の 1 つです。これは、無菌調合薬剤師が最新の研究活動、革新的な技術、品質管理規則、そして患者のニーズを満たす最高の成分の入手に重点を置いているためです。たとえば、全米薬局理事会協会 (NABP) は、無菌調合薬局の監視を改善するためのデータ共有システムを開発するために食品医薬品局 (FDA) から資金提供を受けることを発表しました。この新しいシステムは、米国における無菌調合に関連する情報の収集、管理、共有に役立つことが期待されています。このプロジェクトは、不適切に調合された医薬品から患者を優先させ、傷害のリスクを軽減することも目的としています。



製品ベースの洞察



製品ベースの無菌調合薬局市場は、注射薬と点滴薬に分かれます。注射薬セグメントは、2021年から2028年にかけてより大きな市場シェアを占めると予想されます。注射可能な薬剤は、作用機序がより速いため、非常に好ましい滅菌配合製品の一つです。患者への悪影響を避けるため、調合された注射薬(オフィスで希釈、混合、再構成され、調製される薬剤と定義される)は、病気や調合された成分の蔓延に対して適切な保護手段が維持されるような環境で調合されます。適切な強さとメイクアップを備えた薬。市場関係者は、市場の成長のために有機的および無機的な成長戦略を採用しています。たとえば、2019 年 9 月、QuVa Pharma, Inc. は、調合された滅菌注射製剤の生産能力が大幅に増加すると発表しました。



製品別の滅菌調合薬局の市場規模と予測 - 2021 年および 2028 年



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投与経路ベースの洞察



投与経路に基づいて、無菌調合薬局市場は静脈内、筋肉内、皮下に分類されます。静脈内セグメントは 2020 年に市場で最大のシェアを占めており、予測期間中もその優位性が続くと予測されています。ただし、筋肉内セグメントは、予測期間中に市場で最も高い CAGR を記録すると推定されています。薬物送達の筋肉内 (IM) 経路は、非経口注射の最も一般的な経路です。多くの抗生物質、術前鎮静剤、麻薬は筋肉内経路で投与されます。たとえば、2021 年 2 月、バイオジェンは、米国食品医薬品局 (FDA) が多発性硬化症 (MS) の治療に関与する「Plegridy (ペグインターフェロン ベータ 1a)」の新しい筋肉内 (IM) 注射を承認したと発表しました。



無菌調剤薬局市場で事業を展開する企業は、世界中で進化する顧客の需要を満たすために製品イノベーション戦略を採用しており、これにより世界市場でブランド名を維持することも可能になります。



製品ベース、無菌調合薬局市場は注射剤と輸液に二分されます。



投与経路に基づいて、無菌調合薬局市場は静脈内、筋肉内、皮下に分類されます。



無菌調合薬局市場規模 - 地域別





  • 北米

    • 米国

    • カナダ

    • メキシコ


  • ヨーロッパ

    • フランス

    • ドイツ

    • イタリア

    • イギリス

    • スペイン

    • < li>その他のヨーロッパ


  • アジア太平洋 (APAC)

    • 中国

    • インド

    • 韓国< /li>
    • 日本

    • オーストラリア

    • アジア太平洋地域のその他の地域



  • 中東およびアフリカ (MEA)

    • 南アフリカ

    • サウジアラビア

    • アラブ首長国連邦

    • MEAの残りの部分



  • 南部および中部アメリカ (SCAM)

    • ブラジル

    • アルゼンチン

    • その他のSCAM




会社概要





  • 株式会社ファグロン

  • 三角調剤薬局

  • B. Braun Melsungen AG

  • PharMedium Healthcare Holdings, Inc.

  • Fresenius Kabi AG

  • Avella Specialty Pharmacy

  • Pencol Compounding Pharmacy

  • パビリオン調剤薬局 LLC

  • ペース薬局

  • SandsRx


Report Coverage
Report Coverage

Revenue forecast, Company Analysis, Industry landscape, Growth factors, and Trends

Segment Covered
Segment Covered

This text is related
to segments covered.

Regional Scope
Regional Scope

North America, Europe, Asia Pacific, Middle East & Africa, South & Central America

Country Scope
Country Scope

This text is related
to country scope.

Frequently Asked Questions


What is the regional market scenario of the sterile compounding pharmacies market?

Global sterile compounding pharmacies market is segmented by region into North America, Europe, Asia Pacific, Middle East & Africa, and South & Central America. In North America, the U.S. is the largest market for sterile compounding pharmacies market. The US is estimated to hold the largest share in the sterile compounding pharmacies market during the forecast period. The presence of top players and favorable regulations related to product approvals coupled with commercializing new products are the contributing factors for the regional growth. Additionally, the increasing number of R&D activities is the key factor responsible for the Asia-Pacific regional growth for sterile compounding pharmacies accounting fastest growth of the region during the coming years.

Who are the key players in the sterile compounding pharmacies market?

Fagron, Inc., Triangle Compounding Pharmacy, B. Braun Melsungen AG, PharMedium Healthcare Holdings, Inc., Fresenious Kabi AG, Avella Specialty Pharmacy, Pencol Compounding Pharmacy, Pavilion Compounding Pharmacy, LLC., Pace Pharmacy, and SandsRx are among the leading companies operating in the global sterile compounding pharmacies market

Which route of administration segment held the largest revenue (US$ Mn) in the sterile compounding pharmacies market?

The intravenous segment dominated the global sterile compounding pharmacies market and accounted for the largest revenue of 2,954.51 Mn in 2021.

What is meant by the sterile compounding pharmacies market?

Sterile compounding pharmacies involve creating a medication in an environment free from viruses, bacteria, or any other potentially infectious microorganisms. Such a type of compounding is intended for medications that will be administered either through an IV or an injection.

What are the driving factors for the sterile compounding pharmacies market across the globe?

Rising uptake of personalized medicines and the benefits of on-sterile compounding are the most significant factors responsible for the overall market growth.

Which segment led the sterile compounding pharmacies market?

Based on product type, injectable drugs took the forefront lead in the worldwide market by accounting largest share in 2020 and is expected to continue to do so till the forecast period.

The List of Companies - sterile compounding pharmacies market

  1. Fagron, Inc.
  2. Triangle Compounding Pharmacy
  3. B. Braun Melsungen AG
  4. PharMedium Healthcare Holdings, Inc.
  5. Fresenious Kabi AG
  6. Avella Specialty Pharmacy
  7. Pencol Compounding Pharmacy
  8. Pavilion Compounding Pharmacy, LLC.
  9. Pace Pharmacy
  10. SandsRx                                    

The Insight Partners performs research in 4 major stages: Data Collection & Secondary Research, Primary Research, Data Analysis and Data Triangulation & Final Review.

  1. Data Collection and Secondary Research:

As a market research and consulting firm operating from a decade, we have published and advised several client across the globe. First step for any study will start with an assessment of currently available data and insights from existing reports. Further, historical and current market information is collected from Investor Presentations, Annual Reports, SEC Filings, etc., and other information related to company’s performance and market positioning are gathered from Paid Databases (Factiva, Hoovers, and Reuters) and various other publications available in public domain.

Several associations trade associates, technical forums, institutes, societies and organization are accessed to gain technical as well as market related insights through their publications such as research papers, blogs and press releases related to the studies are referred to get cues about the market. Further, white papers, journals, magazines, and other news articles published in last 3 years are scrutinized and analyzed to understand the current market trends.

  1. Primary Research:

The primarily interview analysis comprise of data obtained from industry participants interview and answers to survey questions gathered by in-house primary team.

For primary research, interviews are conducted with industry experts/CEOs/Marketing Managers/VPs/Subject Matter Experts from both demand and supply side to get a 360-degree view of the market. The primary team conducts several interviews based on the complexity of the markets to understand the various market trends and dynamics which makes research more credible and precise.

A typical research interview fulfils the following functions:

  • Provides first-hand information on the market size, market trends, growth trends, competitive landscape, and outlook
  • Validates and strengthens in-house secondary research findings
  • Develops the analysis team’s expertise and market understanding

Primary research involves email interactions and telephone interviews for each market, category, segment, and sub-segment across geographies. The participants who typically take part in such a process include, but are not limited to:

  • Industry participants: VPs, business development managers, market intelligence managers and national sales managers
  • Outside experts: Valuation experts, research analysts and key opinion leaders specializing in the electronics and semiconductor industry.

Below is the breakup of our primary respondents by company, designation, and region:

Research Methodology

Once we receive the confirmation from primary research sources or primary respondents, we finalize the base year market estimation and forecast the data as per the macroeconomic and microeconomic factors assessed during data collection.

  1. Data Analysis:

Once data is validated through both secondary as well as primary respondents, we finalize the market estimations by hypothesis formulation and factor analysis at regional and country level.

  • Macro-Economic Factor Analysis:

We analyse macroeconomic indicators such the gross domestic product (GDP), increase in the demand for goods and services across industries, technological advancement, regional economic growth, governmental policies, the influence of COVID-19, PEST analysis, and other aspects. This analysis aids in setting benchmarks for various nations/regions and approximating market splits. Additionally, the general trend of the aforementioned components aid in determining the market's development possibilities.

  • Country Level Data:

Various factors that are especially aligned to the country are taken into account to determine the market size for a certain area and country, including the presence of vendors, such as headquarters and offices, the country's GDP, demand patterns, and industry growth. To comprehend the market dynamics for the nation, a number of growth variables, inhibitors, application areas, and current market trends are researched. The aforementioned elements aid in determining the country's overall market's growth potential.

  • Company Profile:

The “Table of Contents” is formulated by listing and analyzing more than 25 - 30 companies operating in the market ecosystem across geographies. However, we profile only 10 companies as a standard practice in our syndicate reports. These 10 companies comprise leading, emerging, and regional players. Nonetheless, our analysis is not restricted to the 10 listed companies, we also analyze other companies present in the market to develop a holistic view and understand the prevailing trends. The “Company Profiles” section in the report covers key facts, business description, products & services, financial information, SWOT analysis, and key developments. The financial information presented is extracted from the annual reports and official documents of the publicly listed companies. Upon collecting the information for the sections of respective companies, we verify them via various primary sources and then compile the data in respective company profiles. The company level information helps us in deriving the base number as well as in forecasting the market size.

  • Developing Base Number:

Aggregation of sales statistics (2020-2022) and macro-economic factor, and other secondary and primary research insights are utilized to arrive at base number and related market shares for 2022. The data gaps are identified in this step and relevant market data is analyzed, collected from paid primary interviews or databases. On finalizing the base year market size, forecasts are developed on the basis of macro-economic, industry and market growth factors and company level analysis.

  1. Data Triangulation and Final Review:

The market findings and base year market size calculations are validated from supply as well as demand side. Demand side validations are based on macro-economic factor analysis and benchmarks for respective regions and countries. In case of supply side validations, revenues of major companies are estimated (in case not available) based on industry benchmark, approximate number of employees, product portfolio, and primary interviews revenues are gathered. Further revenue from target product/service segment is assessed to avoid overshooting of market statistics. In case of heavy deviations between supply and demand side values, all thes steps are repeated to achieve synchronization.

We follow an iterative model, wherein we share our research findings with Subject Matter Experts (SME’s) and Key Opinion Leaders (KOLs) until consensus view of the market is not formulated – this model negates any drastic deviation in the opinions of experts. Only validated and universally acceptable research findings are quoted in our reports.

We have important check points that we use to validate our research findings – which we call – data triangulation, where we validate the information, we generate from secondary sources with primary interviews and then we re-validate with our internal data bases and Subject matter experts. This comprehensive model enables us to deliver high quality, reliable data in shortest possible time.

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