North America and EU Sterile Injectables CMO Market to hit US$ 22.37 Billion by 2033 | Top Companie are Recipharm AB, Jubilant HollisterStier, Grand River Aseptic Manufacturing, and Afton Scientific

North America and Europe sterile injectables CMO market size reached US$ 9.83 Billion in 2024 from US$ 9.15 Billion in 2023 and is expected to reach US$ 22.37 Billion by 2033, growing at a CAGR of 9.8% during the forecast period 2025-2033.

DataM Intelligence has released its latest report on the "North America and Europe Sterile Injectables CMO Market Size 2025," providing a detailed analysis of market trends, key growth drivers, competitive landscape, and regional insights. The report includes market size (value and volume), CAGR projections, and emerging opportunities that help businesses identify growth areas and build effective strategies. Backed by data-driven insights and future outlook, this study serves as a valuable resource for companies looking to stay competitive and capitalize on market potential.

Vetter announced capacity expansion projects in the U.S. and Germany to enhance its aseptic injectable filling operations, while Catalent has invested over $350 million to expand its sterile fill-finish facilities across the U.S. and Europe.

North America: Recent Industry Developments - Sterile Injectables CMO Market
✅ October 2025: Catalent Inc. expanded its Bloomington, Indiana facility to enhance sterile injectable vial filling capacity for biologics and mRNA-based drugs.
✅ September 2025: Thermo Fisher Scientific announced a $400 million upgrade to its Greenville, North Carolina site, increasing fill-finish efficiency for complex injectables.
✅ August 2025: Baxter BioPharma Solutions partnered with Moderna to provide large-scale aseptic fill-finish services for next-generation vaccines.
✅ July 2025: Pfizer CentreOne introduced new sterile injectable lines focusing on oncology and biosimilar contract manufacturing.
✅ June 2025: Emergent BioSolutions expanded its Maryland site with additional lyophilization and aseptic filling capabilities.

Europe: Recent Industry Developments
✅ October 2025: Recipharm (Sweden) launched a new sterile injectables facility in France dedicated to biologics and parenteral drug products.
✅ September 2025: Vetter Pharma (Germany) invested €300 million to add aseptic filling lines for high-potency biologics.
✅ August 2025: Siegfried AG (Switzerland) completed expansion of its Hameln, Germany plant to meet rising outsourcing demand for sterile injectables.
✅ July 2025: Lonza (Switzerland) partnered with AstraZeneca to advance sterile injectable outsourcing for oncology pipelines.
✅ June 2025: Fareva (France) gained EMA approval for upgraded aseptic lines supporting advanced biologic formulations.

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Latest M&A Highlights

Catalent acquired a large site from Novo Holdings A/S in December 2024, expanding sterile fill-finish capacity to support biologics and weight-loss drug production.​

Simtra BioPharma Solutions acquired 65 acres near Bloomington, Indiana, in July 2025 for a new injectable manufacturing plant expansion contributing over 300,000 sq ft.​

ESTEVE CDMO acquired Regis Technologies in July 2025 to expand small-molecule API CDMO services in the U.S.​

Norbrook (Northern Ireland) invested £1.3 million in 2024 to upgrade sterile injectable veterinary manufacturing suites to meet EU GMP Annex 1 standards.

Key Market Highlights

North America led the sterile injectables CMO market, accounting for 59.51% of total revenue in 2024.

By therapeutic area, the oncology segment held the largest share, contributing 32.39% of market revenue in 2024.

Key Player:

Catalent, Inc, Lonza, Vetter Pharma, Thermo Fisher Scientific Inc., Recipharm AB, Jubilant HollisterStier, Grand River Aseptic Manufacturing, and Afton Scientific

Key Industry Developments:

According to a recent NCBI analysis, the manufacturing cost of vaccines-covering raw materials, labor, facility, and overhead-was estimated at US$0.12 per ampoule and US$0.35 per vial. Demand for sterile injectable formats continues to grow, especially in North America by 2025, driven by the increasing use of monoclonal antibodies, ADCs, checkpoint inhibitors, and cell & gene therapies, all of which require precise sterile delivery systems.

In September 2024, Norbrook (Northern Ireland) upgraded its sterile injectable facility with a £1.3 million investment, adding a modular cleanroom and advanced HVAC systems to meet the latest EU GMP Annex 1 standards for veterinary products.

Meanwhile, Simtra BioPharma Solutions (formerly Baxter BioPharma) announced a US$250 million expansion in February 2024 to boost sterile fill-finish capacity in Bloomington, Indiana, addressing rising biologics demand. Additionally, in April 2024, Baxter launched 10 new injectable products across critical therapy areas, reinforcing the growing need for advanced sterile manufacturing in the U.S.

Forecast Projection:

The global North america and Europe Sterile Injectables CMO market is set to witness strong growth from 2025 to 2032. After maintaining steady momentum in 2024, the market is expected to accelerate as key industry players implement strategic initiatives to boost adoption. Companies that adapt to these emerging trends will be well-positioned to capture new opportunities and enhance their revenue potential throughout the forecast period.

Market Intelligence Research Process:

The North america and Europe Sterile Injectables CMO Market Report by DataM Intelligence offers a comprehensive analysis built on a mix of primary and secondary research. It explores key factors driving the industry, including government policies, market trends, competitive landscape, technological advancements, and upcoming innovations. This in-depth study uncovers both growth opportunities and potential challenges, helping businesses navigate market fluctuations and make data-driven decisions for sustainable success.

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Key Segmentations:

By Product Type; (Small Molecules and Large Molecules)

By Dosage Form: (Liquid Injectables, Pre-filled Syringes, Lyophilized Injectables, and Others)

By Therapeutic Area: (Oncology, Cardiology, Neurology, Pain Management, Endocrinology, Autoimmune Diseases, and Others)

FDA Updates and Regulatory Landscape

FDA approvals are accelerating for sterile injectable biologics and biosimilars, contributing to high demand for GMP-compliant fill-finish capacity.​

Stringent EU GMP Annex 1 guidelines on sterility assurance and containment drive facility modernization in Europe.​

Advanced manufacturing technologies like Restricted Access Barrier Systems (RABS) and isolators are being widely adopted to meet evolving regulatory expectations

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FAQ's

Q1: How large is the North america and Europe Sterile Injectables CMO Market?

Ans: The North america and Europe Sterile Injectables CMO Market size was valued at US$ 9.83 Billion in 2024 and is projected to grow to US$ 22.37 Billion by 2033.

Q2: How quickly is the North america and Europe Sterile Injectables CMO Market expanding?

Ans: The North america and Europe Sterile Injectables CMO Market is forecasted to grow at a CAGR of 9.8% between 2025 and 2032, showing Annual growth momentum

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Reimbursement and Procurement Trends

Reimbursement policies for injectable biologics including oncology, autoimmune, and rare disease drugs support sustained growth of sterile injectable market segments.​

Large pharma and biotech companies increasingly sign long-term supply agreements with CMOs emphasizing flexibility, integrated development-to-commercialization service models, and compliance.​

Procurement is focused on suppliers with dual-region operational footprint (U.S., EU) enabling supply chain resilience amid geopolitical and pandemic-related uncertainties.​

Digital transformation and data transparency in supply agreements are key focus areas to ensure regulatory traceability and quality assurance.

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