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.
Competitive Landscape
Some of the Major Key Players in the Non-Sterile Outsourcing Market are
- AbbVie Pharmaceutical Contract Manufacturing
- Aenova Group
- Aphena Pharma
- 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
- Syngene International
- TriRx Pharmaceutical Services
- UI Pharmaceuticals
- Wasdell Group
Market Segmentation
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.
The Oral Segment Is Expected To Have The Highest Growth Rate During The Forecast Period
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.
The Human Medicine Segment Dominates The Market
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 The Largest Market Share During The Forecast Period.
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.
Recent Developments:
- In June 2024, Aterian Investment Partners, Contract Pharmaceuticals Limited, Canada, one of the top contract development and manufacturing companies in North America for non-sterile liquid and semi-solid dosage forms, was bought by a private investment entity.
- In July,2023, Aenova and Galvita have forged an effective strategic alliance. The collaboration aims to enhance oral dosage form development, formulation, and production.
Non-Sterile Outsourcing Market Report Scope
|
Report Attribute |
Specifications |
|
Market Size Value In 2023 |
USD 7.50 Bn |
|
Revenue Forecast In 2031 |
USD 10.81 Bn |
|
Growth Rate CAGR |
CAGR of 4.8% from 2024 to 2031 |
|
Quantitative Units |
Representation of revenue in US$ Bn and CAGR from 2024 to 2031 |
|
Historic Year |
2019 to 2023 |
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Forecast Year |
2024-2031 |
|
Report Coverage |
The forecast of revenue, the position of the company, the competitive market structure, growth prospects, and trends |
|
Segments Covered |
By Dosage Form, and Application, End -user |
|
Regional Scope |
North America; Europe; Asia Pacific; Latin America; Middle East & Africa |
|
Country Scope |
U.S.; Canada; U.K.; Germany; China; India; Japan; Brazil; Mexico; France; Italy; Spain; South Korea; South East Asia |
|
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 |
|
Customization Scope |
Free customization report with the procurement of the report and modifications to the regional and segment scope. Particular Geographic competitive landscape. |
|
Pricing and Available Payment Methods |
Explore pricing alternatives that are customized to your particular study requirements. |
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