For decades, Contract Development and Manufacturing Organizations (CDMOs) have provided process development, scale-up, and GMP manufacturing expertise.
More recently, Contract Research, Development, and Manufacturing Organizations (CRDMOs) have emerged. These providers integrate discovery and early development with manufacturing, creating a single pipeline from hit identification to clinical supply.
This shift reflects growing demand for speed, fewer handoffs, and stronger regulatory alignment in drug development.
CDMOs specialize in scale-up, process optimization, and GMP manufacturing for small and large molecules. They are often engaged once a lead candidate is defined and ready for preclinical or clinical material production.
Key advantages of CDMOs include:
Established regulatory and quality frameworks
Expertise in large-scale synthesis and formulation
Cost efficiency for well-characterized programs
However, CDMOs usually do not cover discovery or early development, requiring biotechs to coordinate multiple partners before IND submission.
CRDMOs extend beyond manufacturing by offering early-stage discovery, medicinal chemistry, biology, DMPK, analytical development, and regulatory planning. This creates an integrated model where discovery and development flow into manufacturing without external vendor transitions.
Benefits of CRDMOs include:
Continuity across R&D and manufacturing — reduced risk of data silos and rework
Streamlined IND preparation — regulatory input is integrated from early stages
Fewer handoffs — one organization oversees the entire program
Every vendor transition increases the risk of delays and miscommunication. Integrated CRDMO models reduce these inefficiencies by aligning discovery, development, and manufacturing within a single team.
With one quality system spanning the entire workflow, CRDMOs can deliver greater consistency in data management and manufacturing standards. Centralized oversight reduces variability and improves reproducibility.
Regulatory submissions such as the Common Technical Document (CTD) require cross-disciplinary data packages covering discovery, nonclinical studies, and manufacturing. CRDMOs are positioned to support these requirements because they are involved throughout the development chain.
Partnering with a CRDMO reduces the burden of managing multiple contracts, budgets, and reporting structures. This allows biotech teams to focus resources on science and strategy rather than administrative coordination.
The CDMO/CRDMO sector is expanding rapidly. According to Grand View Research, the global pharmaceutical CDMO market was valued at $146.9 billion in 2023 and is expected to grow at a 7.2% CAGR through 2030. Similar reports from BCC Research and Fortune Business Insights place the 2024 market between $136 billion and $238 billion, underscoring strong growth expectations across all analyses.
In parallel, several established CDMOs are repositioning as CRDMOs:
Thermo Fisher Scientific integrated its Patheon CDMO and PPD CRO units to deliver discovery-through-development services under one roof.
WuXi AppTec and BioDuro-Sundia also market themselves as CRDMOs, highlighting “end-to-end” capabilities that span discovery through commercial production.
This consolidation trend reflects biotech demand for shorter timelines, fewer vendor handoffs, and integrated regulatory support.
While CRDMOs offer integration benefits, CDMOs remain a strong choice in certain situations:
Straightforward or late-stage projects: When an API or biologic is well-characterized, CDMOs can deliver efficient scale-up and GMP production without requiring research integration.
Biotechs with in-house discovery: Companies that maintain medicinal chemistry or biology functions internally may not need CRDMO-level discovery services.
Cost-sensitive programs: For smaller or less complex projects, partnering with a CDMO provides an efficient and economical outsourcing path. In such cases, choosing CDMO services is the smart choice.
Whether selecting a CDMO or CRDMO, biotechs should weigh several key factors:
Technical depth: Does the partner have experience in your modality (e.g., small molecules, biologics, oligonucleotides)?
Regulatory expertise: A strong track record with FDA/EMA submissions is critical.
Data and IP security: Integrated systems should include robust safeguards for sensitive project information.
The outsourcing landscape is shifting from siloed CDMOs to fully integrated CRDMOs. For biotech startups and mid-sized companies, CRDMOs provide fewer handoffs, faster timelines, and unified oversight—advantages that reduce development risk and accelerate IND submissions.
That said, the right model depends on program complexity and stage. CDMOs remain valuable for late-stage or well-defined projects, while CRDMOs are best suited to innovative, high-risk pipelines that demand seamless integration across research, development, and manufacturing.