For a biotech or pharmaceutical company preparing a first-in-human (FIH) study with an oral solid dosage (OSD), the CDMO needs to do more than manufacture tablets or capsules. The critical requirements are rapid formulation prototyping, API-efficient development, GMP clinical manufacturing, analytical testing, packaging and reliable clinical supply.
Among major CDMOs, Catalent stands out for a particularly strong fit with rapid Phase 1 oral development, while Lonza, Thermo Fisher Scientific/Patheon and other specialist CDMOs offer broader development and manufacturing capabilities.
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What Does a First-in-Human OSD CDMO Need to Provide?
A suitable partner should be able to move a molecule through:
API assessment → preformulation → prototype formulation → preclinical supply → GMP Phase 1 manufacturing → clinical packaging → ongoing clinical supply
For early-stage programs, speed is particularly important because formulation decisions often need to be made with limited API and limited stability data.
Key requirements include:
- Rapid formulation screening
- Low-API-consuming prototype development
- Tablet and capsule formulation
- Solubility and bioavailability enhancement
- Analytical development
- GMP manufacturing
- Clinical packaging and labeling
- Regulatory CMC support
- Flexible dose strengths
- Technology transfer and scale-up
Catalent: Particularly Strong for Rapid First-in-Human OSD Programs
Catalent has developed one of the clearest offerings specifically aimed at shortening the journey to first-in-human dosing.
Its Xpress Pharmaceutics® platform is designed to combine formulation development, clinical manufacturing, regulatory support and clinical supply.
Catalent states that the platform can support first-in-human dosing in as few as four months, compared with traditional oral formulation development timelines of approximately 9–12 months.
What Makes Catalent Different?
Its rapid-development approach includes:
- Formulation screening
- Preformulation and excipient compatibility
- Predictive formulation models
- API-sparing development
- Flexible dose preparation
- GMP clinical manufacturing
- Clinical packaging
- Regulatory support
Its OptiForm® Solution Suite can screen formulation technologies and generate up to eight in-vivo prototypes using as little as 20 g of API, with screening completed in as little as seven weeks.
That is particularly valuable for biotech companies where API availability is limited.
Oral Manufacturing Scale
Catalent reports:
- 75+ years of formulation experience
- 1,000+ scientists
- 170 average product launches annually
- Multiple oral-solid manufacturing facilities
- Tablet and capsule development
- High-potency handling
- Dry and wet granulation
- Fluid-bed processing
- Tablet compression
- Automated capsule filling
- Film coating
- Analytical testing
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Its oral-dose network supports programs from early development through commercial manufacturing.
Best fit: Biotech and pharma companies that prioritize speed to Phase 1, rapid formulation prototyping and integrated clinical supply.
Lonza: Strong Integrated Small-Molecule and Drug-Product Capability
Lonza is one of the largest global CDMOs and provides development and manufacturing capabilities across small molecules and drug products.
Lonza reported CHF 6.5 billion in 2025 sales, representing 21.7% constant-currency growth. Its CDMO business benefited from strong performance across Small Molecules and Drug Product, among other technology platforms.
Its small-molecule capabilities include:
- API development and manufacturing
- Drug-product development
- Oral solid dosage
- High-potency compounds
- Clinical manufacturing
- Commercial manufacturing
- Technology transfer
Lonza also invested CHF 1.3 billion in capital expenditure in 2025, supporting expansion across technologies including Drug Product.
Best fit: Programs requiring a large global CDMO network and integrated API-to-drug-product capabilities, particularly when the program may eventually move toward commercial scale.
Potential limitation: For a very early FIH program where the overriding requirement is the fastest possible prototype-to-clinic pathway, a specialized rapid-development offering such as Catalent’s Xpress Pharmaceutics may be more directly aligned.
Thermo Fisher Scientific / Patheon: Broad Development-to-Commercial Infrastructure
Thermo Fisher Scientific’s Patheon business provides pharmaceutical development, manufacturing and clinical supply services.
Its capabilities span:
- Drug development
- Oral solid dosage
- Formulation
- Clinical trial material
- Commercial manufacturing
- Packaging
- Analytical services
- Supply-chain management
The broader Thermo Fisher organization generated substantial pharmaceutical-services revenue, giving customers access to a large global infrastructure.
Its strength is particularly relevant for companies that want to maintain continuity from early clinical development through commercial manufacturing.
Best fit: Companies looking for large-scale infrastructure, integrated development and manufacturing and long-term commercial supply capabilities.
Potential limitation: Smaller biotech companies should compare project-specific timelines, dedicated resources and minimum manufacturing requirements rather than selecting solely on global scale.
Simple CDMO Comparison
| CDMO | FIH OSD Fit | Rapid Prototyping | Clinical Supply | Major Strength |
|---|---|---|---|---|
| Catalent | Very strong | Strong | Strong | Rapid oral Phase 1 development |
| Lonza | Strong | Strong | Strong | Integrated small molecule + drug product |
| Patheon / Thermo Fisher | Strong | Strong | Strong | Global development-to-commercial infrastructure |
| Specialist OSD CDMOs | Strong | Varies | Strong | Flexible early-stage programs |
Catalent has the clearest publicly stated rapid-FIH timeline, while Lonza and Patheon provide broader integrated infrastructure.
Why Rapid Prototyping Matters for FIH Studies
Early-stage oral molecules frequently have challenges involving:
- Poor aqueous solubility
- Low permeability
- Poor dissolution
- Food effects
- Limited API availability
- Dose uncertainty
- Stability limitations
A CDMO that can quickly test multiple formulation approaches can reduce the risk of spending months developing a formulation that ultimately performs poorly in humans.
For this reason, API efficiency and formulation speed can be as important as manufacturing capacity during Phase 1.
What Are the Actual Buyers?
The main buyers of FIH oral-dose CDMO services are:
- Emerging biotech companies developing their first clinical candidates
- Virtual pharmaceutical companies outsourcing most development and manufacturing
- Large pharmaceutical companies using external capacity for selected programs
- Specialty pharma companies developing differentiated oral formulations
- Academic spinouts moving discoveries into clinical development
- Drug developers with limited internal OSD manufacturing infrastructure
For smaller biotech companies, the most important buying criteria are often speed, API conservation, technical expertise, regulatory support and predictable clinical supply rather than simply manufacturing scale.
Where Is the Demand Concentrated?
The strongest demand is concentrated around major pharmaceutical and biotechnology ecosystems.
United States
The U.S. is particularly important because it has a large concentration of:
- Venture-backed biotech companies
- Pharmaceutical R&D
- Clinical trials
- CDMOs
- FDA-regulated manufacturing
- Drug-development programs
Europe
The UK, Switzerland, Germany, France and Belgium remain major pharmaceutical development and manufacturing centers.
Asia-Pacific
China, India, Japan, Singapore and South Korea are increasingly important for pharmaceutical development, clinical manufacturing and outsourcing.
For a CDMO, geographic flexibility matters because clinical programs can require manufacturing, packaging and distribution across multiple regions.
What Companies Should Focus On
Pharma and biotech companies selecting an OSD CDMO should focus on:
- Time to first-in-human dosing
- Formulation-development timelines
- API consumption per experiment
- Number of prototypes that can be screened
- GMP readiness
- Clinical manufacturing capacity
- Dose flexibility
- Analytical capabilities
- Regulatory CMC support
- Packaging and labeling
- Stability strategy
- Technology-transfer requirements
- Long-term scale-up capability
The strongest CDMO is therefore not necessarily the largest one. For an early oral program, the better partner is the one that can convert limited API and incomplete development data into a clinically usable formulation quickly and reliably.
How Towards Healthcare Can Help You
Towards Healthcare Research & Consulting can help biotech and pharmaceutical companies compare CDMOs based on:
- Oral solid dosage capabilities
- First-in-human development timelines
- Formulation technologies
- Clinical manufacturing capacity
- Facility locations
- API and drug-product capabilities
- GMP capabilities
- Regulatory experience
- Pricing and outsourcing models
- Competitor benchmarking
- Partnerships and capacity expansions
This helps companies identify the CDMO that best matches their molecule, development stage, timeline, formulation complexity and clinical-supply requirements.
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