Global Non-Sterile Outsourcing Market Insights Forecasts to 2033

• The Global Non-Sterile Outsourcing Market Size was Valued at USD 7.43 Billion in 2023
• The Market Size is Growing at a CAGR of 4.72% from 2023 to 2033
• The Worldwide Non-Sterile Outsourcing Market Size is Expected to Reach USD 11.78 Billion by 2033
• North America is Expected to Grow the fastest during the forecast period.

The Non-Sterile Outsourcing Market Size is Anticipated to Exceed USD 11.78 Billion by 2033, Growing at a CAGR of 4.72% from 2023 to 2033. A compounded pharmaceutical product that contains one or more active components can be either sterile or non-sterile. Expanding drug development costs, decreasing internal capabilities, stricter governmental regulations, and low-cost service delivery to contract research organizations (CROs) and contract manufacturing organizations (CMOs) are among the key reasons driving market expansion.

Market Overview

Non-sterile outsourcing develops outside companies to manufacture, formulate, and package non-sterile pharmaceutical products that do not need a sterile environment to be produced. The other probability is to engage with a 503B outsourcing facility outside the health system to make these medications, even if it is feasible to manufacture compounded sterile products domestically. For medications made by these facilities, FDA clearance and labeling requirements may be avoided; nevertheless, current good manufacturing practice (CGMP) standards must be followed. Medical contract manufacturing outsourcing will grow as expected of the rapid growth of the biologics and imitation drug sectors as well as an increase in clinical research projects.

The non-sterile outsourcing market allows for increased product development flexibility as the landscape of targeted medicines changes. Batch sizes can fluctuate significantly over a short period of time during development and manufacturing, and adaptability is an industry driver. CMOs and CDMOs use agility to manage these swings effectively.

Opportunities

Non-sterile outsourcing has grown increasingly popular as a result of the growing need for personalized medicine and customized medication compositions. This allows pharmaceutical companies to seize the opportunity and provide specific medications with precise dose forms, strengths, and combinations that are suited to the needs of individual patients.

Challenges

Regulatory compliance and quality assurance in the non-sterile outsourcing sector include the challenges of maintaining cGMP guidelines, navigating a changing regulatory environment, and guaranteeing patient safety. They are therefore one of the main obstacles to market expansion.

Report Coverage

This research report categorizes the market for the non-sterile outsourcing market based on various segments and regions forecasts revenue growth and analyzes trends in each submarket. The report analyses the key growth drivers, opportunities, and challenges influencing the non-sterile outsourcing market. Recent market developments and competitive strategies such as expansion, product launch, and development, partnership, merger, and acquisition have been included to draw the competitive landscape in the market. The report strategically identifies and profiles the key market players and analyses their core competencies in each sub-segment of the non-sterile outsourcing market.

Driving Factors

The non-sterile outsourcing market is propelled due to several factors, such as contractual research and manufacturing firms investing in individuals, facilities, and technology to gain a sizable piece of the healthcare outsourcing business. Another substantial factor is the increasing number of chronic diseases, increased need for personalized medicine, and growing elderly population, which is also driving the market expansion.

Restraining Factors

The non-sterile outsourcing market is hampered by several factors including the increasing regulatory pressure, greater failure rates, and rising drug development costs all have significant impacts on market dynamics and speed up market expansion.

Market Segmentation

The non-sterile outsourcing market share is classified into dosage form, application, and end user.

• The oral segment accounted for the largest revenue share over the prediction period.

Based on the dosage form, the non-sterile outsourcing market is classified into oral, ear & eye, nasal, topical, and parenteral. Among these, the oral segment accounted for the largest revenue share over the prediction period. The oral segment accounted for the largest share due to tablets, capsules, and liquids are the most prevalent and generally used medication delivery methods because to their ease of administration, patient compliance, and low production costs. This extensive use generates a high demand for outsourcing the production, formulation, and packaging of oral non-sterile products.

• The human medication segment is predicted to grow at the highest CAGR during the forecast period.

Based on the application, the non-sterile outsourcing market is categorized into human medication, nutraceuticals, cosmetics, medical devices, and veterinary health. Among these, the human medication segment is predicted to grow at the highest CAGR during the forecast period. Human medications are continually desired in healthcare systems around the world, especially non-sterile oral formulations like tablets and capsules. There is a lot of outsourcing activity since these drugs must be produced in large quantities to address population health demands. There is a high demand for dependable, large-scale human medication production, which is usually outsourced.

• The pharmaceutical companies segment holds the highest market share through the projection period.

Based on the end-user, the non-sterile outsourcing market is divided into pharmaceutical companies, human, veterinary, cosmeceuticals companies, nutraceutical companies, and medical device manufacturers. Among these, the pharmaceutical companies segment holds the highest market share through the projection period. Pharmaceutical companies are probably to rise their spending on research and development to produce prospective novel drugs, while CROs will expand their investments to strengthen core skills, driving market demand.

Regional Segment Analysis of the Non-Sterile Outsourcing Market 

• North America (U.S., Canada, Mexico) 
• Europe (Germany, France, U.K., Italy, Spain, Rest of Europe)
• Asia-Pacific (China, Japan, India, Rest of APAC)
• South America (Brazil and the Rest of South America) 
• The Middle East and Africa (UAE, South Africa, Rest of MEA)

Asia Pacific is projected to hold the largest share of the non-sterile outsourcing market over the predicted timeframe.

Asia Pacific is projected to hold the largest share of the non-sterile outsourcing market over the forecast period. Numerous contract manufacturing organizations (CMOs) and facilities that specialize in non-sterile manufacture are part of Asia Pacific's well-established manufacturing infrastructure. This well-established network facilitates scalable and effective outsourcing options. A larger population, developing economies, and rising healthcare demands are driving the Asia Pacific region's pharmaceutical market's rapid growth. China dominates the worldwide non-sterile outsourcing market due to a number of significant drivers that have propelled expansion.

North America is expected to grow at the fastest CAGR growth in the non-sterile outsourcing market during the forecast period. A surge in R&D spending and the presence of strict regulations are two important reasons that are projected to increase demand for service outsourcing by regional biotechnology and pharmaceutical industries. Furthermore, it is anticipated that the country's growing number of CMOs and CROs will stimulate market expansion.

For instance, in June 2024, Bora Pharmaceuticals has widened its North American presence by acquiring an 87,000-square-foot sterile production facility in Baltimore, Maryland.

Competitive Analysis:

The report offers the appropriate analysis of the key organizations/companies involved within the non-sterile outsourcing market along with a comparative evaluation primarily based on their product offering, business overviews, geographic presence, enterprise strategies, segment market share, and SWOT analysis. The report also provides an elaborative analysis focusing on the current news and developments of the companies, which includes product development, innovations, joint ventures, partnerships, mergers & acquisitions, strategic alliances, and others. This allows for the evaluation of the overall competition within the market.

List of Key Companies

• AbbVie Pharmaceutical Contract Manufacturing
• Aurigene Pharmaceutical Services (Dr. Reddy’s)
• Bora Pharmaceuticals
• Cambrex Corporation
• Aenova Group
• BioPlus Life Sciences
• TriRx Pharmaceutical Services
• COC Farmaceutici
• UI Pharmaceuticals
• Contract Pharmaceuticals Limited (CPL)
• DPT Laboratories, Ltd.
• PharmaVision (Vizyon Holding)
• Syngene International
• Wasdell Group
• Others

Key Target Audience

• Market Players
• Investors
• End-users
• Government Authorities 
• Consulting And Research Firm
• Venture capitalists
• Value-Added Resellers (VARs)

Recent Developments

• In July 2024, Galvita announced a strategic partnership with the Aenova Group, an agreement development and manufacturing organization (CDMO). Improving the creation, formulation, and manufacturing of oral dosage forms is the partnership's goal.

• In June 2024, Bora Pharmaceuticals Co., Ltd. disclosed that it officially signed an agreement to acquire Emergent BioSolutions' sterile manufacturing facility in Baltimore-Camden, Maryland, forming part of the organization's significant commercial growth.

Market Segment

This study forecasts revenue at global, regional, and country levels from 2020 to 2033. Spherical Insights has segmented the non-sterile outsourcing market based on the below-mentioned segments: 

Global Non-Sterile Outsourcing Market, By Dosage Form

• Oral
• Ear & Eye
• Nasal
• Topical
• Parenteral

Global Non-Sterile Outsourcing Market, By Application

• Human Medication
• Nutraceuticals
• Cosmetics
• Medical Devices
• Veterinary Health

Global Non-Sterile Outsourcing Market, By End User

• Pharmaceutical Companies
• Human, Veterinary, Cosmeceuticals Companies
• Nutraceutical Companies
• Medical Device Manufacturers

Global Non-Sterile Outsourcing Market, By Regional Analysis

• North America
  • US
  • Canada
  • Mexico
• Europe
  • Germany
  • UK
  • France
  • Italy
  • Spain
  • Russia
  • Rest of Europe
• Asia Pacific
  • China
  • Japan
  • India
  • South Korea
  • Australia
  • Rest of Asia Pacific
• South America
  • Brazil
  • Argentina
  • Rest of South America
• Middle East & Africa
  • UAE
  • Saudi Arabia
  • Qatar
  • South Africa
  • Rest of the Middle East & Africa