The pharmaceutical CDMO market is seeing a new wave of manufacturing investment. Demand for sterile injectables, biologics, antibody-drug conjugates (ADCs), prefilled syringes, and other complex medicines is pushing CDMOs to expand manufacturing capacity across the U.S. and Europe.

The need for additional capacity is also linked to continuing supply-chain pressure. According to the U.S. Government Accountability Office (GAO), 71 of the 102 drugs in active shortage as of July 31, 2024, were sterile injectable drugs. GAO also noted that sterile injectables are particularly vulnerable because of manufacturing complexity, limited production capacity, and a relatively small number of suppliers.

At the same time, the U.S. FDA reported that during 2025 it worked with manufacturers to prevent 330 potential drug shortages, while four new drug shortages were identified during the year.

These conditions are creating a strong case for CDMOs to add capacity, modernize facilities, and provide pharmaceutical companies with more flexible manufacturing options.

1. Lonza: Large-Scale Investment in Biologics and Complex Therapies

Lonza is continuing to expand its global CDMO network, with major investments targeting biologics, drug-product manufacturing, ADCs, and highly potent materials.

One of its major projects is a CHF 500 million expansion in Stein, Switzerland, involving a facility of approximately 20,000 square meters. The facility is designed for vial filling, prefilled syringe and cartridge filling, and vial lyophilization, with operations scheduled to begin in 2027.

Lonza has also expanded biologics manufacturing capacity in Visp and Portsmouth. Its 2025 annual report highlights a 20,000-liter expansion in Visp and additional 2,000-liter bioreactor capacity in Portsmouth, U.S.

In 2026, Lonza announced another expansion focused on payload-linker manufacturing for ADCs, with the new capacity expected to become operational in 2028.

What stands out?

Lonza’s strategy is heavily focused on large-scale biologics, ADCs, highly potent manufacturing and integrated drug-product capabilities.

2. Vetter: $285 Million Investment in Illinois

Vetter is expanding its U.S. manufacturing footprint with a new clinical manufacturing facility in Des Plaines, Illinois.

The company announced an investment of approximately $285 million for the project. The planned facility will cover approximately 160,000 square feet and focus on aseptic manufacturing for early clinical development.

The facility is expected to be ready for media fill by the end of 2029.

The project is particularly important for pharmaceutical and biotech companies looking for additional early-stage clinical filling capacity.

What stands out?

Vetter is positioning this investment around clinical manufacturing and aseptic filling, rather than only large-scale commercial production.

3. Piramal Pharma Solutions: Capacity Expected to More Than Double

Piramal Pharma Solutions announced an $80 million expansion of its sterile injectables facility in Lexington, Kentucky.

The expansion includes:

• 24,000 sq. ft. of additional manufacturing space
• A new laboratory
• A new filling line
• Two commercial-size lyophilizers
• A new capping machine
• An external vial washer

One of the clearest capacity indicators is the site’s expected production increase.

The Lexington facility currently has the ability to manufacture approximately 104 batches per year at peak utilization. Following completion of the expansion, capacity is expected to exceed 240 batches annually by Q1 2027.

That represents an increase of more than 130% in annual batch capacity based on the company’s disclosed figures.

Piramal Pharma has also reported broader CDMO investment, including approximately $85 million of planned capital expenditure during the relevant fiscal year for capacity expansion, maintenance and debottlenecking.

What stands out?

Piramal’s expansion is particularly focused on sterile injectables, commercial manufacturing and ADC-related capabilities.

4. Simtra BioPharma Solutions: Major U.S. Sterile Injectable Expansion

Simtra is taking a major position in the sterile injectable manufacturing market.

The company reported a commitment of approximately $300 million to expand U.S. manufacturing capacity, including construction of a 150,000-square-foot building designed for advanced isolator filling lines.

At its Bloomington, Indiana campus, Simtra has added a clinical line for prefilled syringes and liquid and lyophilized vials. The company is also building a new production facility with three commercial-scale sterile filling lines.

Simtra has acquired an additional 65-acre property with more than 300,000 square feet of available space for future development. Its plans include at least six additional isolator filling lines. The first new high-speed isolator vial filling line, with three lyophilizers, is scheduled to become operational in 2027.

Simtra’s existing scale is also notable. The company reports producing more than 150 million units annually and partnering with more than half of the top 20 pharmaceutical companies.

What stands out?

Simtra is concentrating strongly on sterile injectables, prefilled syringes, lyophilized products and highly potent therapies such as ADCs.

5. Sharp Services: $100 Million Global Expansion

Sharp Services announced a $100 million investment across its U.S. and European facilities to increase clinical and commercial capacity. The investment includes sterile filling, injectable assembly and packaging, cold-chain capacity, and oral solid-dose capabilities.

Sharp is also investing another $28 million in its Lee, Massachusetts sterile manufacturing facility.

The new automated filling line is expected to more than double the facility’s filling capacity and can support batches of up to 100,000 units.

In Europe, Sharp has committed more than €20 million to expand injectable packaging capacity. The Belgian facility’s cold-chain warehouse capacity is expected to quadruple, while ambient storage capacity will double.

What stands out?

Sharp’s strategy is broader than manufacturing alone, combining sterile filling, packaging, cold-chain storage, clinical services and commercial supply.

6. Thermo Fisher Scientific: Expanding U.S. Sterile Manufacturing

Thermo Fisher Scientific expanded its U.S. manufacturing network through the acquisition of Sanofi’s Ridgefield, New Jersey sterile manufacturing site.

The facility provides sterile fill-finish and packaging capabilities, and more than 200 experienced employees joined Thermo Fisher as part of the transaction.

Thermo Fisher said the facility would continue manufacturing products for Sanofi while also being expanded to serve growing demand from pharmaceutical and biotechnology customers for U.S.-based manufacturing capacity.

What stands out?

Thermo Fisher is strengthening its position through additional U.S. sterile manufacturing capacity combined with its broader CDMO and CRO network.

CDMO Expansion Comparison

Looking at the publicly disclosed projects, different CDMOs are taking different approaches.

Lonza

Primary focus: Biologics, ADCs, drug product and large-scale manufacturing
Major disclosed investment: CHF 500 million
Key strength: Large-scale integrated manufacturing

Vetter

Primary focus: Clinical aseptic manufacturing
Major disclosed investment: ~$285 million
Key strength: Early clinical-stage manufacturing capacity

Piramal Pharma Solutions

Primary focus: Sterile injectables and ADC manufacturing
Major disclosed investment: $80 million at Lexington
Key strength: Significant increase in annual batch capacity

Simtra BioPharma Solutions

Primary focus: Sterile injectables and complex drug products
Major disclosed investment: ~$300 million U.S. expansion
Key strength: Multiple future isolator filling lines

Sharp Services

Primary focus: Sterile manufacturing, packaging and cold chain
Major disclosed investment: $100 million global program
Key strength: Integrated manufacturing-to-packaging services

Thermo Fisher Scientific

Primary focus: Sterile fill-finish and broader CDMO services
Expansion: Sanofi Ridgefield acquisition
Key strength: Large global pharmaceutical services network

Why Are CDMOs Investing So Heavily?

The expansion trend is closely connected to the changing pharmaceutical pipeline.

1. Sterile Injectable Capacity Remains a Major Need

GAO’s analysis found that 71 of 102 active drug shortages in July 2024 involved sterile injectable drugs.

FDA has also noted that older sterile injectable medicines can be particularly vulnerable because relatively few manufacturers may operate the necessary production lines, while the manufacturing process can involve long lead times and complex requirements.

This makes additional manufacturing capacity strategically important.

2. Biologics and Complex Therapies Require Specialized Facilities

Modern drug pipelines increasingly include biologics, ADCs, highly potent compounds, cell therapies and other complex products.

These products cannot always be manufactured using conventional pharmaceutical infrastructure.

As a result, pharmaceutical companies increasingly need CDMOs with specialized facilities, containment systems, aseptic processing, lyophilization and advanced analytical capabilities.

3. Pharmaceutical Companies Want More Manufacturing Flexibility

Building a new pharmaceutical manufacturing facility internally can require substantial capital, time and specialized expertise.

CDMOs allow pharmaceutical companies to access existing infrastructure while scaling production as their products move from clinical development to commercial launch.

4. U.S. Manufacturing Capacity Is Receiving More Attention

The FDA’s PreCheck pilot program specifically gives consideration to manufacturing facilities that strengthen the U.S. pharmaceutical supply chain, including facilities producing APIs, finished dosage forms, sterile injectables and other specialized products.

This reinforces the importance of domestic manufacturing capacity and supply-chain resilience.

What Does This Mean for the CDMO Market?

The current expansion cycle shows that CDMOs are not simply adding more manufacturing space.

They are investing in specific capabilities where pharmaceutical demand is strongest:

• Sterile injectables
• Biologics
• ADC manufacturing
• Fill-finish
• Lyophilization
• Prefilled syringes
• Highly potent compounds
• Clinical-scale manufacturing
• Commercial-scale production
• Cold-chain packaging
• Integrated development and manufacturing

The competitive landscape is therefore becoming more specialized.

A CDMO with a large facility is not automatically the strongest option. Pharmaceutical companies are increasingly likely to evaluate capacity, regulatory track record, technology, speed of scale-up, geographic footprint and experience with specific modalities.

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Which CDMO Has the Strongest Expansion Strategy?

Based on publicly disclosed expansion figures, there is no single winner across every category.

Lonza stands out for large-scale biologics and integrated capabilities.

Vetter is making a significant bet on early clinical aseptic manufacturing.

Piramal Pharma Solutions has one of the clearest disclosed increases in production capacity, with Lexington expected to move from 104 to more than 240 batches annually.

Simtra is making a large investment specifically around sterile injectable capacity and future isolator filling lines.

Sharp Services is combining manufacturing expansion with packaging and cold-chain capabilities.

Thermo Fisher Scientific is strengthening its U.S. network through additional sterile manufacturing capacity while leveraging its broader pharmaceutical services platform.

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