Top 5 U.S. Pharmaceutical CDMO Companies Driving Innovation in 2025

Top 5 U.S. Pharmaceutical CDMO Companies in 2025

The U.S. pharmaceutical CDMO (Contract Development and Manufacturing Organization) market continues to grow rapidly in 2025, fueled by demand for biologics, cell and gene therapies, and domestic supply-chain resilience. Below are the top five CDMOs shaping the U.S. market this year, along with their offerings, strengths, challenges, and 2025 developments.

1) Thermo Fisher Scientific (Patheon)

Overview

• Thermo Fisher Scientific, through its Patheon division, is one of the largest integrated CDMOs globally. It offers end-to-end solutions for small molecules, biologics, and advanced therapies, covering every stage from R&D to commercial manufacturing.

Products / Services

• It provides API and drug-substance development, oral solid and sterile drug-product manufacturing, and advanced biologics processing.
• The company also offers clinical trial supply chain management, analytical testing, and large-scale commercial production support.

Strengths

• Thermo Fisher’s greatest strength lies in its deep vertical integration, combining scientific instruments, consumables, and CDMO services under one umbrella.
• Its global manufacturing network ensures scalability and flexibility for both emerging biotech firms and large pharmaceutical companies.
  The company’s regulatory expertise and compliance track record give it a strong competitive advantage.

Challenges

• Integrating multiple acquisitions remains a key operational challenge.
• Margin pressures continue in mature small-molecule manufacturing segments.
• Additionally, geopolitical tensions and the need for supply chain localization present ongoing risks.

Recent Developments & Innovations (2025)

• In 2025, Thermo Fisher announced the acquisition of Solventum’s purification and filtration business, expanding its biologics purification capabilities.
• The company invested heavily in bioprocessing innovation, focusing on efficiency and sustainability.
  It continues to strengthen U.S.-based capacity to support domestic supply resilience.

2) Catalent

Overview

• Catalent remains a leading U.S.-based CDMO known for its strong expertise in drug delivery, sterile fill/finish, and advanced therapy manufacturing.
• It partners extensively with biotech and pharma firms to accelerate time-to-market for new drugs and biologics.

Products / Services

• Catalent’s offerings span formulation and delivery technologies across oral, inhalation, and injectable modalities.
• The company provides sterile fill-finish operations, clinical supply services, and device assembly.
• It also has significant capabilities in cell and gene therapy process development and manufacturing.

Strengths

• Catalent’s broad platform across modalities gives it flexibility to serve diverse client needs.
• Its recognized fill/finish expertise makes it a preferred partner for biologics and vaccine production.
• The company’s infrastructure supports end-to-end solutions, from early-stage development to commercial launch.

Challenges

• Catalent faces high capital expenditure requirements for its advanced therapy and sterile manufacturing facilities.
• Dependence on major biologic product contracts introduces revenue concentration risk.
• It also operates under intense regulatory oversight, where quality lapses can have financial and reputational consequences.

Recent Developments & Innovations (2025)

• Following its acquisition by Novo Holdings in late 2024, Catalent began 2025 with renewed strategic direction and investment stability.
• The company expanded its partnerships in CAR-T and cell therapy manufacturing to meet rising demand.
• Several U.S. facility upgrades and network optimizations were initiated to enhance throughput and compliance.

3) FUJIFILM Diosynth Biotechnologies

Overview

• FUJIFILM Diosynth Biotechnologies has emerged as one of the fastest-growing biologics CDMOs in the U.S., driven by its cutting-edge facility expansions.
• The company’s North Carolina operations have positioned it as a key supplier to top biopharma clients.

Products / Services

• The company specializes in mammalian cell culture-based biologics, viral vectors, vaccines, and advanced therapies.
• It offers process development, technology transfer, scale-up, and commercial manufacturing, including fill/finish capabilities.

Strengths

• Massive capital investments in U.S. facilities have significantly boosted its production capacity.
• The company’s biologics expertise and quality record make it a top choice for large-scale commercial supply.
• Its partnerships with leading pharma companies ensure stable, long-term revenue streams.

Challenges

• Rapid scaling introduces risks in validation, workforce readiness, and regulatory compliance.
• Competition from other global CDMOs such as Lonza and Thermo Fisher is intensifying.
• The company must also manage cost pressures while maintaining premium quality standards.

Recent Developments & Innovations (2025)

• In 2025, FUJIFILM Diosynth signed a landmark 10-year, $3 billion manufacturing agreement with Regeneron to produce biologics in the U.S.
• The Holly Springs site became a focal point for the partnership, symbolizing the company’s role in reshoring U.S. biologics manufacturing.
• The company also introduced advanced automation and data-driven quality monitoring to enhance efficiency.

4) Lonza

Overview

• Lonza remains one of the world’s most comprehensive CDMOs, with a strong and growing presence in the U.S. market.
• It focuses on biologics, cell and gene therapy, and advanced synthesis for small molecules.

Products / Services

• Lonza’s service portfolio includes biologics development, commercial manufacturing, and API synthesis.
• It also provides support for gene and cell therapies, along with specialty chemical manufacturing.

Strengths

• The company’s technical expertise across multiple modalities makes it a partner of choice for complex drug programs.
• Its global network, including recent expansions in Vacaville, California, strengthens its U.S. supply capacity.
• Lonza’s scientific and regulatory leadership reinforces its credibility among big pharma clients.

Challenges

• Lonza is currently restructuring to divest non-core businesses and focus entirely on CDMO services.
• Managing cost efficiency during expansion remains a key operational challenge.
• The company must also navigate global supply-chain complexities and inflationary pressures.

Recent Developments & Innovations (2025)

• In April 2025, Lonza launched its “One Lonza” organizational model to improve efficiency and collaboration across divisions.
• The company upgraded its 2025 guidance, citing strong demand for biologics and cell therapy manufacturing.
• Lonza also strengthened partnerships to streamline cell therapy supply chains and reduce time to market.

5) Cambrex

Overview

• Cambrex stands out as a U.S.-based CDMO with deep expertise in small-molecule API development and manufacturing.
• It primarily serves mid-sized pharmaceutical companies, providing agile and reliable chemistry solutions.

Products / Services

• The company offers API synthesis, GMP manufacturing, and process development.
• It also provides peptide synthesis and scale-up support from clinical to commercial stages.

Strengths

• Cambrex’s core strength lies in its exceptional small-molecule chemistry know-how.
• Its flexible operations allow it to respond quickly to client needs and regulatory requirements.
• The company’s U.S. and European network ensures secure and compliant production capacity.

Challenges

• The firm faces pricing pressure in commoditized API markets.
• It must continue investing in high-value modalities such as peptides and oligonucleotides to remain competitive.
• Market consolidation and private equity interest pose strategic uncertainties.

Recent Developments & Innovations (2025)

• In 2025, Cambrex expanded its peptide manufacturing capacity in Waltham, Massachusetts, to meet growing demand.
• The company has reportedly attracted acquisition interest from private equity firms looking to enter the CDMO market.
• It is also modernizing production with automation and continuous-flow chemistry technologies to boost efficiency.

Become a valued research partner with us, please feel free to contact us at sales@towardshealthcare.com