The Non-Sterile Outsourcing Market Size is valued at USD 7.50 Bn in 2023 and is predicted to reach USD 10.81 Bn by the year 2031 at an 4.8% CAGR during the forecast period for 2024-2031.
A compounded medication product can be either non-sterile or sterile and contains one or more active ingredients. While it is possible to manufacture compounded sterile products internally, an alternative is to contract with a 503B outsourcing facility outside the health system to prepare these drugs. FDA approval and labeling requirements can be waived for drugs compounded by these facilities, though they must still adhere to current good manufacturing practice (CGMP) standards. Non-sterile outsourcing involves contracting the manufacturing, formulation, and packaging of non-sterile pharmaceutical products to external businesses, as these items do not require a sterile environment during production.
The rising demand for personalized medicine and customized drug formulations is creating significant opportunities for non-sterile outsourcing, enabling pharmaceutical companies to offer tailored products, such as specific dosage forms, strengths, and combinations that meet patient-specific needs. Additionally, non-sterile outsourcing allows companies to enter new markets, particularly in regions with emerging healthcare needs, by partnering with local experts who can navigate complex regulatory landscapes and manage supply chain logistics. Furthermore, outsourcing non-sterile manufacturing helps companies reduce overhead costs associated with maintaining and operating production facilities, investing in equipment, and hiring specialized personnel.
The Non-Sterile Outsourcing Market is segmented based on the dosage form, application, end user. Based on the dosage form, the market is divided oral, ear & eye, nasal, topical, parenteral. Based on the application market is categorized into human medication, nutraceuticals, cosmetics, medical devices, veterinary health. Based on the end user, the market divided into pharmaceutical companies, human, veterinary, cosmeceuticals, companies, nutraceutical companies, medical device manufacturers.
Based on the dosage form, the market is divided into oral, ear & eye, nasal, topical, parenteral. Among these, the oral segment is expected to have the highest growth rate during the forecast period. Oral segment divided into mixtures, linctures, syrups, elixirs, mouth washes/gargles, drops. Oral formulations, such as tablets, capsules, and liquids, are the most common and widely used drug delivery method due to their ease of administration, patient compliance, and relatively low production costs. This widespread usage drives significant demand for outsourcing the manufacturing, formulation, and packaging of oral non-sterile products. Oral medications are used to treat a wide range of conditions across various therapeutic areas, making them versatile and widely applicable. This broad usage drives a substantial need for outsourced production to meet market demand.
Based on the application market is categorized into human medication, nutraceuticals, cosmetics, medical devices, veterinary health. Among these, the human medicine segment dominates the market. Human medications, particularly non-sterile oral formulations like tablets and capsules, are in constant demand across global healthcare systems. The need to produce these medications at scale to meet population health needs drives significant outsourcing activity. There is a great demand for large-scale, reliable production of human drugs, which is frequently outsourced. These medications cover a wide variety of therapeutic areas, from acute therapies to chronic illnesses like diabetes and hypertension.
Asia Pacific has a well-developed manufacturing infrastructure, with numerous contract manufacturing organizations (CMOs) and facilities that specialize in non-sterile production. This established network supports efficient and scalable outsourcing solutions. The Asia Pacific region has a rapidly growing pharmaceutical market driven by increasing healthcare needs, a rising population, and expanding economies. This growth drives demand for outsourced non-sterile products to meet both local and global needs.
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Report Attribute |
Specifications |
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Market Size Value In 2023 |
USD 7.50 Bn |
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Revenue Forecast In 2031 |
USD 10.81 Bn |
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Growth Rate CAGR |
CAGR of 4.8% from 2024 to 2031 |
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Quantitative Units |
Representation of revenue in US$ Bn and CAGR from 2024 to 2031 |
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Historic Year |
2019 to 2023 |
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Forecast Year |
2024-2031 |
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Report Coverage |
The forecast of revenue, the position of the company, the competitive market structure, growth prospects, and trends |
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Segments Covered |
By Dosage Form, and Application, End -user |
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Regional Scope |
North America; Europe; Asia Pacific; Latin America; Middle East & Africa |
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Country Scope |
U.S.; Canada; U.K.; Germany; China; India; Japan; Brazil; Mexico; France; Italy; Spain; South Korea; South East Asia |
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Competitive Landscape |
AbbVie Pharmaceutical Contract Manufacturing, Aenova Group, APPCO Pharmaceutical Corporation, Atral Pharmaceutical, Aurigene Pharmaceutical Services (Dr. Reddy’s), Biological E. Ltd., BioPlus Life Sciences, Bora Pharmaceuticals, Cambrex Corporation, COC Farmaceutici, Contract Pharmaceuticals Limited (CPL), DPT Laboratories, Ltd., Eurofins, JGL d.d., Mikart, PharmaVision (Vizyon Holding), Pierre Fabre, TriRx Pharmaceutical Services, UI Pharmaceuticals, Wasdell Group, Aphena Pharma, Syngene International |
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Customization Scope |
Free customization report with the procurement of the report and modifications to the regional and segment scope. Particular Geographic competitive landscape. |
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Pricing and Available Payment Methods |
Explore pricing alternatives that are customized to your particular study requirements. |
Chapter 1. Methodology and Scope
1.1. Research Methodology
1.2. Research Scope & Assumptions
Chapter 2. Executive Summary
Chapter 3. Global Non-Sterile Outsourcing Market Snapshot
Chapter 4. Global Non-Sterile Outsourcing Market Variables, Trends & Scope
4.1. Market Segmentation & Scope
4.2. Drivers
4.3. Challenges
4.4. Trends
4.5. Investment and Funding Analysis
4.6. Industry Analysis – Porter’s Five Forces Analysis
4.7. Competitive Landscape & Market Share Analysis
4.8. Impact of Covid-19 Analysis
Chapter 5. Market Segmentation 1: by Dosage Form Estimates & Trend Analysis
5.1. by Dosage Form & Market Share, 2019 & 2031
5.2. Market Size (Value (US$ Mn)) & Forecasts and Trend Analyses, 2019 to 2031 for the following by Dosage Form:
5.2.1. Oral
5.2.1.1. Mixtures
5.2.1.2. Linctures
5.2.1.3. Syrups
5.2.1.4. Elixirs
5.2.1.5. Mouth Washes/Gargles
5.2.1.6. Drops
5.2.2. Ear & Eye
5.2.2.1. Drops
5.2.2.2. Lotions
5.2.3. Nasal
5.2.3.1. Drops
5.2.3.2. Sprays
5.2.4. Topical
5.2.4.1. Gel
5.2.4.2. Cream
5.2.5. Parenteral
Chapter 6. Market Segmentation 2: by End User Estimates & Trend Analysis
6.1. by End User & Market Share, 2019 & 2031
6.2. Market Size (Value (US$ Mn)) & Forecasts and Trend Analyses, 2019 to 2031 for the following by End User:
6.2.1. Pharmaceutical Companies
6.2.1.1. Human
6.2.1.2. Veterinary
6.2.2. Cosmeceuticals Companies
6.2.3. Nutraceutical Companies
6.2.4. Medical Device Manufacturers
Chapter 7. Market Segmentation 3: by Application Estimates & Trend Analysis
7.1. by Application & Market Share, 2019 & 2031
7.2. Market Size (Value (US$ Mn)) & Forecasts and Trend Analyses, 2019 to 2031 for the following by Application:
7.2.1. Human Medication
7.2.2. Nutraceuticals
7.2.3. Cosmetics
7.2.4. Medical Devices
7.2.5. Veterinary Health
Chapter 8. Non-Sterile Outsourcing Market Segmentation 4: Regional Estimates & Trend Analysis
8.1. North America
8.1.1. North America Non-Sterile Outsourcing Market Revenue (US$ Million) Estimates and Forecasts by Dosage Form, 2024-2031
8.1.2. North America Non-Sterile Outsourcing Market Revenue (US$ Million) Estimates and Forecasts by End User, 2024-2031
8.1.3. North America Non-Sterile Outsourcing Market Revenue (US$ Million) Estimates and Forecasts by Application, 2024-2031
8.1.4. North America Non-Sterile Outsourcing Market Revenue (US$ Million) Estimates and Forecasts by country, 2024-2031
8.2. Europe
8.2.1. Europe Non-Sterile Outsourcing Market Revenue (US$ Million) Estimates and Forecasts by Dosage Form, 2024-2031
8.2.2. Europe Non-Sterile Outsourcing Market Revenue (US$ Million) Estimates and Forecasts by End User, 2024-2031
8.2.3. Europe Non-Sterile Outsourcing Market Revenue (US$ Million) Estimates and Forecasts by Application, 2024-2031
8.2.4. Europe Non-Sterile Outsourcing Market Revenue (US$ Million) Estimates and Forecasts by country, 2024-2031
8.3. Asia Pacific
8.3.1. Asia Pacific Non-Sterile Outsourcing Market Revenue (US$ Million) Estimates and Forecasts by Dosage Form, 2024-2031
8.3.2. Asia Pacific Non-Sterile Outsourcing Market Revenue (US$ Million) Estimates and Forecasts by End User, 2024-2031
8.3.3. Asia-Pacific Non-Sterile Outsourcing Market Revenue (US$ Million) Estimates and Forecasts by Application, 2024-2031
8.3.4. Asia Pacific Non-Sterile Outsourcing Market Revenue (US$ Million) Estimates and Forecasts by country, 2024-2031
8.4. Latin America
8.4.1. Latin America Non-Sterile Outsourcing Market Revenue (US$ Million) Estimates and Forecasts by Dosage Form, 2024-2031
8.4.2. Latin America Non-Sterile Outsourcing Market Revenue (US$ Million) Estimates and Forecasts by End User, 2024-2031
8.4.3. Latin America Non-Sterile Outsourcing Market Revenue (US$ Million) Estimates and Forecasts by Application, 2024-2031
8.4.4. Latin America Non-Sterile Outsourcing Market Revenue (US$ Million) Estimates and Forecasts by country, 2024-2031
8.5. Middle East & Africa
8.5.1. Middle East & Africa Non-Sterile Outsourcing Market Revenue (US$ Million) Estimates and Forecasts by Dosage Form, 2024-2031
8.5.2. Middle East & Africa Non-Sterile Outsourcing Market Revenue (US$ Million) Estimates and Forecasts by End User, 2024-2031
8.5.3. Middle East & Africa Non-Sterile Outsourcing Market Revenue (US$ Million) Estimates and Forecasts by Application, 2024-2031
8.5.4. Middle East & Africa Non-Sterile Outsourcing Market Revenue (US$ Million) Estimates and Forecasts by country, 2024-2031
Chapter 9. Competitive Landscape
9.1. Major Mergers and Acquisitions/Strategic Alliances
9.2. Company Profiles
9.2.1. AbbVie Pharmaceutical Contract Manufacturing
9.2.2. Aenova Group
9.2.3. APPCO Pharmaceutical Corporation
9.2.4. Atral Pharmaceutical
9.2.5. Aurigene Pharmaceutical Services (Dr. Reddy’s)
9.2.6. Biological E. Ltd.
9.2.7. BioPlus Life Sciences
9.2.8. Bora Pharmaceuticals
9.2.9. Cambrex Corporation
9.2.10. COC Farmaceutici
9.2.11. Contract Pharmaceuticals Limited (CPL)
9.2.12. DPT Laboratories, Ltd.
9.2.13. Eurofins
9.2.14. JGL d.d.
9.2.15. Mikart
9.2.16. PharmaVision (Vizyon Holding)
9.2.17. Pierre Fabre
9.2.18. TriRx Pharmaceutical Services
9.2.19. UI Pharmaceuticals
9.2.20. Wasdell Group
9.2.21. Other Prominent Players
Global Non-Sterile Outsourcing Market- By Type,
Global Non-Sterile Outsourcing Market – By Application,
Global Non-Sterile Outsourcing Market – By End User,
Global Non-Sterile Outsourcing Market – By Region
North America-
Europe-
Asia-Pacific-
Latin America-
Middle East & Africa-
InsightAce Analytic follows a standard and comprehensive market research methodology focused on offering the most accurate and precise market insights. The methods followed for all our market research studies include three significant steps – primary research, secondary research, and data modeling and analysis - to derive the current market size and forecast it over the forecast period. In this study, these three steps were used iteratively to generate valid data points (minimum deviation), which were cross-validated through multiple approaches mentioned below in the data modeling section.
Through secondary research methods, information on the market under study, its peer, and the parent market was collected. This information was then entered into data models. The resulted data points and insights were then validated by primary participants.
Based on additional insights from these primary participants, more directional efforts were put into doing secondary research and optimize data models. This process was repeated till all data models used in the study produced similar results (with minimum deviation). This way, this iterative process was able to generate the most accurate market numbers and qualitative insights.
Secondary research
The secondary research sources that are typically mentioned to include, but are not limited to:
The paid sources for secondary research like Factiva, OneSource, Hoovers, and Statista
Primary Research:
Primary research involves telephonic interviews, e-mail interactions, as well as face-to-face interviews for each market, category, segment, and subsegment across geographies
The contributors who typically take part in such a course include, but are not limited to:
Data Modeling and Analysis:
In the iterative process (mentioned above), data models received inputs from primary as well as secondary sources. But analysts working on these models were the key. They used their extensive knowledge and experience about industry and topic to make changes and fine-tuning these models as per the product/service under study.
The standard data models used while studying this market were the top-down and bottom-up approaches and the company shares analysis model. However, other methods were also used along with these – which were specific to the industry and product/service under study.
