Sterile Compounding Pharmacies Market Key Companies and SWOT Analysis by 2028

Historic Data: 2019-2020   |   Base Year: 2021   |   Forecast Period: 2022-2028

Sterile Compounding Pharmacies Market Forecast to 2028 - COVID-19 Impact and Global Analysis By Product (Injectable Drugs and Infusions) and Route of Administration (Intravenous, Intramuscular, and Subcutaneous), and Geography

  • Report Date : Dec 2021
  • Report Code : TIPRE00026302
  • Category : Life Sciences
  • Status : Published
  • Available Report Formats : pdf-format excel-format
  • No. of Pages : 163

[Research Report] The sterile compounding pharmacies market is projected to reach US$ 6,198.59 million by 2028 from US$ 3,968.70 million in 2021; it is expected to grow at a CAGR of 6.6% from 2021 to 2028.

Factors such as the rise in the uptake of personalized medicines and the benefits associated with on-site sterile compounding drive the growth of the market. However, product recalls and stringent regulatory requirements impede market growth. On the other hand, the development of centralized or regional compounding centers for customized formulations would create lucrative opportunities for market growth during the forecast period.

North America is likely to continue its dominance in the sterile compounding pharmacies market during 2021–2028. The US holds the largest share of the market in North America and is expected to continue this trend during the forecast period. This is primarily attributed to the rising pharmaceutical spending and the well-established healthcare infrastructure. For example, the Food and Drug Administration (FDA) has designated 503B (For records, 503B is referred to as an outsourcing facility and is sometimes referred to as 503B pharmacies and are strictly monitored by the FDA that establishes a new level of patient care and safety). Also, almost 75% of hospitals in the US outsource sterile compounding preparations to 503B facilities to ensure stability, cope up with drug shortages, obtain a ready-to-administer form of the drug, and extend shelf-life. Furthermore, the rising geriatric population and growing adoption of customized formulations over commercial products are expected to drive the growth of the US sterile compounding pharmacies market in the coming years.  


Customize This Report To Suit Your Requirement

You will get customization on any report - free of charge - including parts of this report, or country-level analysis, Excel Data pack, as well as avail great offers and discounts for start-ups & universities

Sterile Compounding Pharmacies Market: Strategic Insights

sterile-compounding-pharmacies-market
  • Get Top Key Market Trends of this report.
    This FREE sample will include data analysis, ranging from market trends to estimates and forecasts.

Market Insights

Benefits of On-Site Sterile Compounding Drive Market Growth

On-site compounding and sterilization can prove vital in case of an intravenous solution intended to be customized as per the patient's need. On-site manufacturing allows the active pharmaceutical ingredient (API) to be introduced to human subjects during the starting phases of early clinical drug development. Sterile extemporaneous compounding offers a flexible option to the costly, extended development of parenteral investigational products designed by the Good Manufacturing (GMP) standards. Typically, parenterally administered API for clinical studies are manufactured under GMP conditions. This potentially reduces the time required for producing a finished product needed for specific dosing.

Moreover, compounding and filtering a formulation into a sterile intravenous solution successfully is met through strong collaboration with the pharmaceutical sponsor and clinical site pharmacists, where sterility testing can be conducted efficiently.

On-site sterile compounding has gained significant attention in the global market and is one of the most impacting factors responsible for market growth. This is due to sterile compounding pharmacists are focusing more on the latest research activities, innovative techniques, quality control rules, and getting the best ingredients to meet patients' needs. For example, the National Association of Boards of Pharmacy (NABP) announced receiving funding from the Food and Drug Administration (FDA) to develop a data-sharing system to improve oversight of sterile compounding pharmacies. This new system is expected to assist in collecting, managing, and sharing information related to sterile compounding in the US. The project also aims to reduce the risk of injury, favoring patients from drug products that have been improperly compounded.

Product-Based Insights

Based on product, the sterile compounding pharmacies market is bifurcated into injectable drugs and infusions. The injectable drugs segment would account for a larger market share during 2021–2028. Injectable drugs are among the highly preferred sterile compounding products due to their faster mode of action. To avoid any adverse effects on the patients, compounded injectable drugs (defined as drugs that are diluted, mixed, reconstituted, and prepared in an office) are compounded in such an environment where appropriate safeguards are maintained against the spread of disease and components of compounded drugs that are the appropriate strength and makeup. Market players are adopting organic and inorganic growth strategies for market growth. For instance, in September 2019, QuVa Pharma, Inc. declared a considerable increase in capacity for compounded sterile injectable preparations.

Sterile Compounding Pharmacies Market Regional Insights

The regional trends and factors influencing the Sterile Compounding Pharmacies Market throughout the forecast period have been thoroughly explained by the analysts at The Insight Partners. This section also discusses Sterile Compounding Pharmacies Market segments and geography across North America, Europe, Asia Pacific, Middle East and Africa, and South and Central America.

sterile-compounding-pharmacies-market-global-geography
  • Get the Regional Specific Data for Sterile Compounding Pharmacies Market

Sterile Compounding Pharmacies Market Report Scope

Report Attribute Details
Market size in 2021 US$ 3.97 Billion
Market Size by 2028 US$ 6.2 Billion
Global CAGR (2021 - 2028) 6.6%
Historical Data 2019-2020
Forecast period 2022-2028
Segments Covered By Product
  • Injectable Drugs and Infusions
By Route of Administration
  • Intravenous
  • Intramuscular
  • Subcutaneous
Regions and Countries Covered North America
  • US
  • Canada
  • Mexico
Europe
  • UK
  • Germany
  • France
  • Russia
  • Italy
  • Rest of Europe
Asia-Pacific
  • China
  • India
  • Japan
  • Australia
  • Rest of Asia-Pacific
South and Central America
  • Brazil
  • Argentina
  • Rest of South and Central America
Middle East and Africa
  • South Africa
  • Saudi Arabia
  • UAE
  • Rest of Middle East and Africa
Market leaders and key company profiles
  • 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

  • Sterile Compounding Pharmacies Market Players Density: Understanding Its Impact on Business Dynamics

    The Sterile Compounding Pharmacies Market is growing rapidly, driven by increasing end-user demand due to factors such as evolving consumer preferences, technological advancements, and greater awareness of the product's benefits. As demand rises, businesses are expanding their offerings, innovating to meet consumer needs, and capitalizing on emerging trends, which further fuels market growth.

    Market players density refers to the distribution of firms or companies operating within a particular market or industry. It indicates how many competitors (market players) are present in a given market space relative to its size or total market value.

    Major Companies operating in the Sterile Compounding Pharmacies Market are:

    1. Fagron, Inc.
    2. Triangle Compounding Pharmacy
    3. B. Braun Melsungen AG
    4. PharMedium Healthcare Holdings, Inc.
    5. Fresenious Kabi AG

    Disclaimer: The companies listed above are not ranked in any particular order.


    sterile-compounding-pharmacies-market-cagr

    • Get the Sterile Compounding Pharmacies Market top key players overview

    Route of Administration-Based Insights

    Based on route of administration, the sterile compounding pharmacies market is segmented into intravenous, intramuscular, and subcutaneous. The intravenous segment held the largest share of the market in 2020 and is projected to continue its dominance during the forecast period. However, the intramuscular segment is estimated to register the highest CAGR in the market during the forecast period. The intramuscular (IM) route of drug delivery is the most common route for parenteral injection. Many antibiotics, preoperative sedatives, and narcotics are given through the intramuscular route. For instance, in February 2021, Biogen, announced that the US Food and Drug Administration (FDA) approved a new intramuscular (IM) injection for "Plegridy (peginterferon beta-1a) responsible for treating multiple sclerosis (MS).

    Companies operating in the sterile compounding pharmacies market adopt the product innovation strategy to meet the evolving customer demands across the world, which also permits them to maintain their brand name in the global market.

    Based on product, the sterile compounding pharmacies market is bifurcated into injectables and infusions.

    Based on route of administration, the sterile compounding pharmacies market is segmented into intravenous, intramuscular, and subcutaneous

    Sterile Compounding Pharmacies Market Size – by Geography

    • North America
      • US
      • Canada
      • Mexico
    • Europe
      • France
      • Germany
      • Italy
      • UK
      • Spain
      • Rest of Europe
    • Asia Pacific (APAC)
      • China
      • India
      • South Korea
      • Japan
      • Australia
      • Rest of APAC
    • Middle East and Africa (MEA)
      • South Africa
      • Saudi Arabia
      • UAE
      • Rest of MEA
    • South and Central America (SCAM)
      • Brazil
      • Argentina
      • Rest of SCAM


    Company Profiles

    • Fagron, Inc.
    • Triangle Compounding Pharmacy
    • B. Braun Melsungen AG
    • PharMedium Healthcare Holdings, Inc.
    • Fresenius Kabi AG
    • Avella specialty Pharmacy
    • Pencol Compounding Pharmacy
    • Pavilion Compounding Pharmacy LLC
    • Pace Pharmacy
    • SandsRx

    Frequently Asked Questions

    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.

    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 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

    Mrinal Kerhalkar
    Mrinal Kerhalkar
    Manager,
    Market Research & Consulting

    Mrinal is a seasoned research analyst with over 8 years of experience in Life Sciences Market Intelligence and Consulting. With a strategic mindset and unwavering commitment to excellence, she has built deep expertise in pharmaceutical forecasting, market opportunity assessment, and developing industry benchmarks. Her work is anchored in delivering actionable insights that empower clients to make informed strategic decisions.

    Mrinal’s core strength lies in translating complex quantitative datasets into meaningful business intelligence. Her analytical acumen is instrumental in shaping go-to-market (GTM) strategies and uncovering growth opportunities across the pharmaceutical and medical device sectors. As a trusted consultant, she consistently focuses on streamlining workflow processes and establishing best practices, thereby driving innovation and operational efficiency for her clients.

    • Historical Analysis (2 Years), Base Year, Forecast (7 Years) with CAGR
    • PEST and SWOT Analysis
    • Market Size Value / Volume - Global, Regional, Country
    • Industry and Competitive Landscape
    • Excel Dataset

    Testimonials

    Reason to Buy

    • Informed Decision-Making
    • Understanding Market Dynamics
    • Competitive Analysis
    • Identifying Emerging Markets
    • Customer Insights
    • Market Forecasts
    • Risk Mitigation
    • Boosting Operational Efficiency
    • Strategic Planning
    • Investment Justification
    • Tracking Industry Innovations
    • Aligning with Regulatory Trends
    Your Key Concerns Addressed - Question & Answer
    Can I view a sample of the report before purchasing?

    Yes! We provide a free sample of the report, which includes Report Scope (Table of Contents), report structure, and selected insights to help you assess the value of the full report. Please click on the "Download Sample" button or contact us to receive your copy.

    Is analyst support included with the purchase?

    Absolutely — analyst assistance is part of the package. You can connect with our analyst post-purchase to clarify report insights, methodology or discuss how the findings apply to your business needs.

    What are the next steps once I place an order?

    Once your order is successfully placed, you will receive a confirmation email along with your invoice.

    • For published reports: You’ll receive access to the report within 4–6 working hours via a secured email sent to your email.
    • For upcoming reports: Your order will be recorded as a pre-booking. Our team will share the estimated release date and keep you informed of any updates. As soon as the report is published, it will be delivered to your registered email.

    Can the report be tailored to suit my specific needs?

    We offer customization options to align the report with your specific objectives. Whether you need deeper insights into a particular region, industry segment, competitor analysis, or data cut, our research team can tailor the report accordingly. Please share your requirements with us, and we’ll be happy to provide a customized proposal or scope.

    In what format is the report delivered?

    The report is available in either PDF format or as an Excel dataset, depending on the license you choose.

    The PDF version provides the full analysis and visuals in a ready-to-read format. The Excel dataset includes all underlying data tables for easy manipulation and further analysis.
    Please review the license options at checkout or contact us to confirm which formats are included with your purchase.

    How secure is the payment process on your platform?

    Our payment process is fully secure and PCI-DSS compliant.

    We use trusted and encrypted payment gateways to ensure that all transactions are protected with industry-standard SSL encryption. Your payment details are never stored on our servers and are handled securely by certified third-party processors.
    You can make your purchase with confidence, knowing your personal and financial information is safe with us.

    Do you provide special pricing for buying multiple reports?

    Yes, we do offer special pricing for bulk purchases.
    If you're interested in purchasing multiple reports, we’re happy to provide a customized bundle offer or volume-based discount tailored to your needs. Please contact our sales team with the list of reports you’re considering, and we’ll share a personalized quote.

    Can I connect with your team to discuss the report before buying?

    Yes, absolutely.
    Our team is available to help you make an informed decision. Whether you have questions about the report’s scope, methodology, customization options, or which license suits you best, we’re here to assist. Please reach out to us at sales@theinsightpartners.com, and one of our representatives will get in touch promptly.

    Will I get a billing invoice upon purchase?

    Yes, a billing invoice will be automatically generated and sent to your registered email upon successful completion of your purchase.
    If you need the invoice in a specific format or require additional details (such as company name, GST, or VAT information), feel free to contact us, and we’ll be happy to assist.

    Is there support available if I can’t access my report?

    Yes, certainly.
    If you encounter any difficulties accessing or receiving your report, our support team is ready to assist you. Simply reach out to us via email or live chat with your order information, and we’ll ensure the issue is resolved quickly so you can access your report without interruption.

    Our Clients

    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                                    
    Sales Assistance
    US: +1-646-491-9876
    UK: +44-20-8125-4005
    Email: sales@theinsightpartners.com
    Chat with us
    DUNS Logo
    87-673-9708
    ISO Certified Logo
    ISO 9001:2015
    ISO Certified Logo