Dublin, Jan. 21, 2026 (GLOBE NEWSWIRE) -- The "Pharmaceutical Contract Manufacturing Organization (CMO) - Market Share Analysis, Industry Trends & Statistics, Growth Forecasts (2026-2031)" has been added to ResearchAndMarkets.com's offering.
The pharmaceutical contract manufacturing organization (CMO) market is poised for significant growth. Projected to expand from USD 184.44 billion in 2025 to USD 196.33 billion in 2026, the market is set to reach USD 268.37 billion by 2031, demonstrating a CAGR of 6.45% from 2026 to 2031.
This growth is driven by strategic industry realignment, with companies increasingly outsourcing production to specialized partners. This shift is supported by venture-capital investments in virtual biotechs, the approval of advanced therapies, and expanded high-potency API pipelines. Cost pressures, regulatory demands, and the need for state-of-the-art technology have further motivated collaborations. Companies that offer integrated development, scale-up, and fill-finish services while maintaining global standards are positioned to maximize opportunities.
Accelerating Small and Mid-Sized Pharma Outsourcing
With FDA compliance costs rising post the 2024 overhaul, mid-sized plants face increased quality expenses, leading them to outsource strategically, especially in oncology and rare diseases. This has paved the way for contract manufacturers to implement hybrid fee-for-service and risk-sharing models, benefiting from consistent pipeline inflows.
Rising Biologics Pipeline Complexity
The intricacies of advanced biologics like multi-specific antibodies necessitate specialized infrastructure. With Samsung Biologics investing USD 2.4 billion in bioreactor capacity expansion, the market prepares for the growing demand for turnkey solutions in biologics life cycles.
Capacity Bottlenecks in Fill-Finish Lines
The high utilization rates and long lead times for complex injectables pose challenges, emphasizing the need for multi-year investments in sterile suites and technological upgrades to alleviate supply constraints.
Other drivers and restraints include:
- Increasing venture-capital-backed virtual biotechs
- High-potency APIs demand spike
- Regulatory inspection and remediation costs
API manufacturing represented 41.98% of the market share in 2025, maintaining demand across generic and branded drugs. The market for advanced therapies, driven by one-time curative potentials, is expanding rapidly at a projected 8.22% CAGR. Biologics hold an intermediate position, bolstered by biosimilar adoption and novel formats.
Regional insights reveal North America possessing 39.85% of 2025's revenue, playing a pivotal role due to its regulatory expertise and infrastructure. Meanwhile, the Asia-Pacific region is projected as the fastest-growing, with an 8.91% CAGR, fueled by investments in China, India, and South Korea.
Key Topics Covered
1 INTRODUCTION
1.1 Study Assumptions and Market Definition
1.2 Scope of the Study
2 RESEARCH METHODOLOGY
3 EXECUTIVE SUMMARY
4 MARKET LANDSCAPE
4.1 Market Overview
4.2 Market Drivers
4.3 Market Restraints
4.4 Industry Value Chain Analysis
4.5 Regulatory Landscape
4.6 Technological Outlook
4.7 Porter's Five Forces Analysis
4.8 Impact of Macroeconomic Factors
4.9 Investment Analysis
5 MARKET SIZE AND GROWTH FORECASTS (VALUE)
5.1 By Service Type
5.2 By Drug Molecule Type
5.3 By Scale of Operation
5.4 By End User
5.5 By Therapeutic Area
5.6 By Geography
6 COMPETITIVE LANDSCAPE
6.1 Market Concentration
6.2 Strategic Moves
6.3 Market Share Analysis
6.4 Company Profiles
7 MARKET OPPORTUNITIES AND FUTURE OUTLOOK
7.1 White-Space and Unmet-Need Assessment
A selection of companies mentioned in this report includes, but is not limited to:
- Lonza Group Ltd.
- Catalent Inc.
- Thermo Fisher Scientific Inc.
- Samsung Biologics Co. Ltd.
- WuXi Biologics (Cayman) Inc.
- Recipharm AB
- Jubilant Pharmova Ltd.
- Boehringer Ingelheim GmbH
- Pfizer CentreOne (Pfizer Inc.)
- Baxter International Inc. (Baxter BioPharma Solutions)
- Aenova Holding GmbH
- PCI Pharma Services
- Cambrex Corporation
- Siegfried Holding AG
- Evonik Industries AG
- Alcami Corporation
- Ajinomoto Bio-Pharma Services
- Eurofins CDMO Alphora Inc.
- Famar SA
- Tapemark LLC
For more information about this report visit https://www.researchandmarkets.com/r/i9mndg
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