Dublin, Jan. 22, 2026 (GLOBE NEWSWIRE) — The “Small Molecules Contract Development and Manufacturing Organization – Market Share Analysis, Industry Trends & Statistics, Growth Forecasts (2026-2031)” has been added to ResearchAndMarkets.com’s offering.
The Small Molecules Contract Development and Manufacturing Organization (CDMO) market is projected to increase from USD 193.64 billion in 2025 to USD 207.16 billion in 2026 and to achieve USD 290.61 billion by 2031, with a 6.98% CAGR from 2026 to 2031. This growth is fueled by pharmaceutical industry shifts toward outsourcing complex API synthesis and drug product manufacturing, enabling higher-value R&D investments. The emphasis on continuous manufacturing, AI-driven process optimization, and regulatory focus on supply chain resilience boosts demand for superior CDMOs.
The December 2024 acquisition of Catalent by Novo Holdings for USD 16.5 billion highlights the significance of CDMOs as vital infrastructure for next-generation therapeutics. While scale advantages are noted, the market also sees specialization pressures. Currently, small-molecule drug-product services make up over half of the revenue; however, early-stage pipeline support and integrated CMC solutions are experiencing the fastest growth. Geographically, North America leads in revenue, whereas Asia-Pacific demonstrates the most substantial growth trajectory, benefiting from cost-efficient capacity improvements and government policies attracting multinational initiatives.
Global Market Trends and Insights
Outsourcing in API & FDF Manufacturing
This trend signifies the shift of manufacturing from strategic to outsourced operations, with pharmaceutical companies reallocating resources to discovery platforms and clinical programs. The Cambrex-Eli Lilly dedicated-capacity pact exemplifies Big Pharma’s inclination to secure external capacity. As traditional manufacturing expertise declines within organizations, pharmaceutical companies rely on CDMOs with robust regulatory records, premium pricing, and reliability. This trend supports CDMO expansion plans, emphasizing scale for pipeline breadth and global launches.
Oncology Approval Surge Post-2025
The FDA granted 91% of its novel small-molecule approvals in 2024 for oncology, a momentum that is expected to persist as precision medicine matures. High-potency APIs necessitate stringent containment and specialized equipment, a domain mastered by select CDMOs. Olon’s EUR 25 million ultra-potent facility activation in 2025 reflects necessary infrastructure investment in this sector. Advanced regulatory guidelines motivate innovators to partner with CDMOs possessing in-house expertise, enhancing revenue visibility for specialized service providers.
Export-Control Tightening on Synthesis Equipment
U.S. export regulations restrict shipments of certain synthesis equipment, affecting regions flagged for diversion risks. These changes create delays for APAC startups but provide Western CDMOs with near-term advantages due to existing restricted assets. The policy adjustments may influence global supply resilience, highlighting regional growth disparities.
Additional Market Drivers and Restraints
- Cost-Advantaged Capacity Expansions in APAC
- AI-Driven Process Optimization
- Senior QC Chemist Shortage Increasing Costs
Segment Analysis
In 2025, small-molecule drug-product services accounted for 52.02% of the market, rising at a 7.33% CAGR to 2031. Demand for comprehensive chemistry, manufacturing, and controls solutions is evident as drug-product manufacturing, particularly oral-solid-dose projects, continues to dominate. Complex formulations create market entry barriers, ensuring incumbents’ advantage.
Integrated provider ecosystems, stemming from strategic capacity expansions like the BioCina-NovaCina merger, cater to evolving sponsor needs. They integrate drug product mandates, supporting capex initiatives for cutting-edge technologies. This landscape sustains the market size while motivating API specialists to acquire advanced capabilities.
Drug-substance development sustained 48.35% of 2025 revenues, while drug-product formulation expanded at a rapid pace. Analytical and regulatory services, though smaller in revenue, offer high margins amidst evolving global guidelines. EUROAPI’s collaboration with SpiroChem sets a benchmark in CRO-CDMO convergence.
Packaging and serialization have gained strategic importance due to track-and-trace mandates. CDMOs equipped with advanced IT connectivity benefit from increased revenue and client compliance protection, underscoring service-portfolio breadth as a vital factor for market share elevation.
The market report segments the global CDMO market by Product, Service Type, Stage of Development, Therapeutic Area, and Geography, with forecasts in USD terms.
Geography Analysis
North America held 41.88% revenue in 2025, driven by regulatory familiarity and local production incentives. Initiatives like the BIOSECURE Act advance marketplace reshoring, despite high labor expenses. Multistate packages encourage capital investments, enhancing the region’s draw.
Asia-Pacific projects the highest 7.72% CAGR, supported by cost advantages and regulatory incentives. South Korea’s MFDS aligns CDMO capabilities with ICH standards, fostering competitiveness. Dual-site strategies manage geopolitical risk, balancing cost and security.
Europe exhibits stability through regulatory backing and energy-efficiency initiatives. Industry developments, like Dottikon’s CHF 700 million 2024 investment, reveal CDMO readiness for environmental and compliance challenges, bolstering the region’s footprint.
A selection of companies mentioned in this report includes, but is not limited to:
- Lonza Group
- Catalent Inc.
- Thermo Fisher Scientific (Patheon)
- WuXi AppTec
- Cambrex Corporation
- Siegfried Holding
- Recipharm AB
- Samsung Biologics (Chemical Division)
- PCI Pharma Services
- Jubilant Pharmova (Jubilant Pharma)
- Olon S.p.A
- CordenPharma
- Piramal Pharma Solutions
- Sterling Pharma Solutions
- Almac Group
- PharmaZell – Novasep
- Asymchem
- Curia Global
- Sai Life Sciences
- Eurofins CDMO
For more information about this report visit https://www.researchandmarkets.com/r/jqr1va
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- Small Molecules Contract Development And Manufacturing Organization
