From Outsourcing to Integration: How CDMOs Have Evolved Over Time

In the fast-moving world of biotechnology, the decision to outsource development is more important than ever. The Contract Development and Manufacturing Organization (CDMO) model has evolved to offer a broader range of capabilities and integrations.

Understanding that evolution helps you choose a partner who’s not only fit for today’s needs, but also for what’s coming next. Discover how CDMOs grew from basic manufacturers into critical partners for biologics and advanced therapies—and understand the trends set to reshape them again.

Article Summary: How have CDMOs evolved?

• CDMOs have transformed from basic CMOs into strategic partners supporting development, scale-up, and commercialization.
• The biologics and advanced modality boom (cell & gene, mRNA, CAR-T) reshaped CDMO capabilities, requiring deeper technical and regulatory expertise.
• Integrated CDMO + CRO models reduce handoffs, data silos, and costs—and help deliver significant savings.
• Emerging trends include AI and digital twins, modular manufacturing, supply chain resilience, sustainability, and personalized therapies.
• Biotech leaders choosing a CDMO should evaluate digital maturity, modality specialization, regulatory history, global reach, and scalability.

Blog Table of Contents

1. What has changed in the CRO and CDMO landscape?
2. How have the advancements in biologics changed CDMOs?
3. Integration & Convergence: The Rise of CDMO + CRO Models
4. Trends Shaping the Future of CDMOs
5. What Biotech Leaders Should Do: How to Choose a Future-Proof CDMO?
6. Frequently Asked Questions

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What has changed in the CRO and CDMO landscape?

Traditionally, companies outsourced manufacturing functions (e.g. API synthesis, formulation, scale-up) to Contract Manufacturing Organizations (CMOs).

Over time, the need for “development support” including formulation, method development, and analytical testing led to the hybrid concept: a CDMO, which helps support manufacturing processes and scale-up processes.

• Drivers of the shift
  • Increasing molecule complexity beyond small molecule biologics, such as gene therapies, and more
  • Constantly evolving demands, including regulatory demands requiring development integration, such as the 2025 changes to new animal methodologies (NAMs)
  • Need for speed, flexibility, and risk sharing
  • Cost and capital constraints in biotech / pharma
• Early limitations
  Earlier-generation CDMOs had limitations that have since been met. Some lacked specializations, global reach, or the ability to integrate with clinical services. Or many worked with CROs and supply chain partners instead of creating an integrated environment.

How have the advancements in biologics changed CDMOs?

As biologics, cell and gene therapies, oligonucleotides, mRNA, CAR-T, and advanced mABs entered the pipeline, the needs in a partner changed.

• Technical complexity
  Biologics and advanced therapies require cell culture, viral vector work, aseptic processing, advanced analytics, and GMP infrastructure — areas that were not needed at the start of CDMOs
• Regulatory / compliance demands
  Global regulation (e.g. regional regulatory authorities, inspections) became more stringent, raising the need for process validation, regulatory liaison capability, comparability studies, and global registration support
• Scale-up challenges
  Scaling up and planning ahead for scale-up is pivotal. Early on, many CDMOs had to invest heavily in scale-up platforms, risk mitigation, and platform technologies and now have experience and dedicated processes to bring to the table.
• Fragmentation and specialization
  Some CDMOs began specializing by modality (viral vector, gene therapy, biologics, cell therapy) to build key expertise rather than remaining more general.

Integration & Convergence: The Rise of “CDMO + CRO” Models

One of the biggest shifts in recent years isthe integration of CDMO and CRO models which blend development, process, clinical services, and manufacturing.

There are proven results showing that using integrated services can help provide time and cost savings.

• Why the shift matters
  • Fewer handoffs and communication silos
  • Centralized governance and program oversight
  • Shared data platforms (single source of truth)
  • Risk mitigation across development and manufacturing
• Challenges / constraints
  Not all CDMOs can or want to become full-service — building clinical trial capability, regulatory depth, and data infrastructure is capital-intensive. Some sponsors prefer modular outsourcing or best-of-breed models.

Trends Shaping the Future of CDMOs

Evolving dynamics in the biotechnology industry is accelerating new changes for CDMOS, CROs, and integrated CDMO/CRO models, including:

• Digitalization, AI / ML, and predictive analytics
  CDMOs are increasingly investing in digital twins, process modeling, AI-driven optimization, and predictive maintenance. We’re leveraging AI in solubility, bioavailability, and clinical analytics across its CRO/CDMO network.
• Flexibility, modular manufacturing, and single-use systems
  To support rapid change, many CDMOs are shifting to modular, flexible manufacturing (e.g. single-use bioreactors, plug-and-play modules).
• Global supply chain resilience / regional footprints
  With changes in the landscape and supply risk rising, CDMOs are expanding regional capacity to mitigate logistics and regulatory risks.
• Sustainability
  Biotech support is increasingly scrutinizing sustainability factors such as total carbon footprint, waste, energy usage, and more. To remain competitive, CDMOs will need greener operations, more efficient utilities, and sustainable materials.
• Personalized / small-batch / cell & gene therapies
  The increasing shift toward niche and patient-specific therapies (e.g. autologous cell therapy) demands CDMOs capable of ultra-small-scale, high-mix, rapid turnaround operations.
• Platform-driven standardization
  CDMOs are building custom “platforms” to reduce custom work and shorten timelines.

What Biotech Leaders Should Do: How to Choose a Future-Ready CDMO?

• Evaluate a CDMO’s digital maturity (data systems, AI, analytics)
• Ask whether they support modular / flexible manufacturing
• Understand their geographic footprint and ability to localize supply
• Probe their next-gen modality competence (gene therapy, cell therapy)
• See whether they can provide end-to-end / integrated services or modular ones as needed
• Look at their track record in regulatory inspections, risk mitigation, and scale-up transitions
• Consider whether their business model (full integration vs niche) aligns with your pipeline and strategy

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Frequently Asked Questions

What is a CDMO?
A CDMO (Contract Development and Manufacturing Organization) is a company that provides outsourced services across the full drug development journey. A CDMO extends beyond the CMO model by adding more to the development phase.

What services do CDMOs provide?
Typical services include pre-formulation, formulation development, method development / validation, stability studies, small-scale manufacturing, scale-up, GMP clinical manufacturing, commercial production, analytical testing, process validation, regulatory support, tech transfer, and more.

How do you choose a CDMO? / What should you ask when selecting a CDMO?
Some important criteria and questions include:

• Do they have experience in your modality?
• What is their regulatory track record?
• How do they handle quality assurance and compliance?
• What scale-up capabilities can they provide?
• Do they support integrated services across the full drug development journey?
• What is their digital / data maturity?
• What region(s) do they operate in and/or have partnerships in?
• What is their risk management and communication framework?
• Do they support collaboration and transparency (open labs, joint reports)?

Read more about seven things to look for in a qualified CDMO.

Is Thermo Fisher Scientific a CDMO?
Yes, Thermo Fisher provides exceptional pharma services for drug development, clinical trial logistics, and commercial manufacturing through our Patheon™ brand. In addition, with the acquisition of PPD (a clinical research organization), Thermo Fisher now provides an integrated offering through Accelerator™ Drug Development, our 360° CDMO and CRO solutions.

Why are companies shifting to integrated CDMO + CRO models?
Companies are shifting to integrated CDMO and CRO models because of the benefits they provide in the modern landscape. Integration helps reduce communication gaps, handoffs, data fragmentation, and delays.

The CDMO model has matured dramatically. What once was an outsourcing endpoint has evolved into an ecosystem of integration, digital innovation, and specialization.

The goal is to work with a collaborator that can help accelerate your current development pipeline and grow with you.

Ready to learn more? Reach out today to learn more about how we can help accelerate your drug development.