[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.
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Sterile Compounding Pharmacies Market: Strategic Insights
Market Size Value in US$ 3,968.70 million in 2021 Market Size Value by US$ 6,198.59 million by 2028 Growth rate CAGR of 6.6% from 2021 to 2028. Forecast Period 2021-2028 Base Year 2021
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Sterile Compounding Pharmacies Market: Strategic Insights
| Market Size Value in | US$ 3,968.70 million in 2021 |
| Market Size Value by | US$ 6,198.59 million by 2028 |
| Growth rate | CAGR of 6.6% from 2021 to 2028. |
| Forecast Period | 2021-2028 |
| Base Year | 2021 |
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Lucrative Regions for Sterile Compounding Pharmacies Market
- Sample PDF showcases the content structure and the nature of the information with qualitative and quantitative analysis.
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 Size and Forecast, by Product– 2021 and 2028
- Sample PDF showcases the content structure and the nature of the information with qualitative and quantitative analysis.
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
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
Report Coverage
Revenue forecast, Company Analysis, Industry landscape, Growth factors, and Trends
Segment Covered
Product, Route of Administration, and Geography
Regional Scope
North America, Europe, Asia Pacific, Middle East & Africa, South & Central America
Country Scope
Argentina, Australia, Brazil, Canada, China, France, Germany, India, Italy, Japan, Mexico, RoAPAC, RoE, RoMEA, RoSCAM, Saudi Arabia, South Africa, South Korea, Spain, United Arab Emirates, United Kingdom, United States
Frequently Asked Questions
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.
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
The intravenous segment dominated the global sterile compounding pharmacies market and accounted for the largest revenue of 2,954.51 Mn in 2021.
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.
Rising uptake of personalized medicines and the benefits of on-sterile compounding are the most significant factors responsible for the overall market growth.
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
- 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
- SandsRx
The Insight Partners performs research in 4 major stages: Data Collection & Secondary Research, Primary Research, Data Analysis and Data Triangulation & Final Review.
- Data Collection and Secondary Research:
As a market research and consulting firm operating from a decade, we have published many reports and advised several clients 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 organizations 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 the last 3 years are scrutinized and analyzed to understand the current market trends.
- 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/Sales 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:
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.
- 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.
- 3.1 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.
- 3.2 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.
- 3.3 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.
- 3.4 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.
- 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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