Scale vs Specialisation: Defining the Competitive Edge for CDMOs

26 November 2025.

The Strategic Crossroads for CDMOs

Contract Development and Manufacturing Organisations (CDMOs) are entering a defining phase as client pipelines broaden in complexity and volume.

The question is no longer whether to expand, but how.

For CDMO leaders, choosing the right model now will determine competitiveness, capital allocation, and the ability to win long-term pharma partnerships over the next 5–10 years.

Scaled CDMOs: Provide global reach, multimodality capacity, end-to-end services, and harmonised quality systems. They are highly attractive to large pharma seeking integrated outsourcing partners but require significant capital and risk diluting scientific depth.
Specialised CDMOs: Compete on technical excellence in viral vectors, ADCs, cell therapies, mRNA, and complex biologics. They attract high-value, high-risk programmes but face scalability limits and dependence on modality cycles.
Hybrid CDMOs: Increasingly, CDMOs are combining global capacity with centres of excellence in advanced modalities. These modular platforms blend efficiency with scientific depth and are emerging as the sector’s most resilient model.

Visiongain Insight: Hybrid operating models are becoming the new competitive benchmark. CDMOs that blend scale with deep modality expertise secure higher retention, faster onboarding, and more stable revenue streams than organisations pursuing either strategy alone.

Market Drivers Reshaping the CDMO Landscape

Several macro shifts are accelerating the need for both scale and specialisation:

Pipeline expansion across biologics, CGT, mRNA, and ADCs is intensifying global capacity constraints.
Regulatory convergence between the US, Europe, and Asia is enabling multi-site strategies but increasing documentation and validation complexity.
Talent shortages in biologics, viral vectors, formulation, and QC analytics remain one of the sector’s most severe operational bottlenecks.
Supply-chain fragmentation, geopolitical risk, and raw-material vulnerabilities are pushing CDMOs to diversify vendor networks and invest in multi-region redundancy.
Capital intensity is rising sharply: greenfield biologics plants require hundreds of millions in investment, putting pressure on mid-tier CDMOs to partner, consolidate, or specialise.
Digital Transformation: AI, automation, and data-driven manufacturing are now essential differentiators. Digitalised workflows enable real-time monitoring, predictive analytics, and faster tech transfers, supporting consistent, compliant scale-up. AI-enabled scheduling, automated QC analytics, and digital twins are increasingly becoming baseline expectations rather than differentiators.

Visiongain Insight: The interplay of these drivers reinforces why no single strategic model, scale, or specialisation is sufficient. Future competitiveness lies in dynamic capability portfolios that flex with modality demand, regulatory shifts, and capital cycles.

Scale CDMOs: Global Platforms for End-to-End Delivery

Scaled CDMOs are reshaping outsourcing by building global, multimodality manufacturing platforms. Their competitive strengths include:

Expanded capacity across biologics, CGT, mRNA, and small molecules
Geographic diversification and multi-site redundancy
Integrated development-to-commercialisation services
Harmonised quality and regulatory systems
Digitalisation and automation enabling faster tech transfers and supply-chain resilience

Examples shaping the scale landscape

Lonza: Expanded its biologics footprint through the acquisition of Genentech’s Vacaville facility, adding 330,000L of bioreactor capacity. Strengthens its global leadership in biologics manufacturing.

Samsung Biologics: Continued scaling post-COVID, expanding biologics capacity and diversifying into new modalities, reinforcing its status as one of the sector’s fastest-growing CDMOs.

Catalent: Added global mammalian cell culture and biologics capabilities to meet rising demand for mAbs, biologics, and cell therapies.

WuXi Biologics: expanded sites across Asia, Europe, and North America, operating a hybrid model combining scale with specialised expertise.

Visiongain Insight: Scale is becoming a structural advantage. Multi-site CDMOs achieve faster tech transfers, higher retention, and stronger margin resilience, especially in advanced modalities where global capacity remains constrained.

Specialised CDMOs: Competing Through Depth and Precision

Specialised CDMOs focus on the highest-complexity segments of outsourced development, where regulatory scrutiny and scientific precision are essential.

Their advantage comes from:

Centres of excellence anchored in proprietary processes
Modality-specific expertise for high-risk therapeutic areas
Targeted collaborations that accelerate innovation
Agility to pivot quickly as science evolves
The ability to command premium pricing and long-term partnerships

Specialisation leaders making headlines

ten23 health: Expanded biologics development and fill–finish capabilities in Switzerland, deepening its expertise in complex injectables.
AGC Biologics: Increased viral vector capacity across the US and Europe, reinforcing its position in CGT manufacturing.
FUJIFILM Diosynth Biotechnologies: Expanded mammalian cell culture and fermentation capabilities in Denmark to support advanced biologics.
Merck Millipore CTDMO: Integrated with Synplogen to streamline viral vector development and manufacturing for next-generation gene therapies.

Visiongain Insight: Specialisation is now a high-value strategic position, not a niche model. Modality-focused CDMOs win earlier-stage projects, secure higher-margin contracts, and become indispensable partners in next-generation therapeutic pipelines.

Hybrid CDMO Models: Integrating Scale with Scientific Depth

Hybrid CDMOs combine global reach with advanced-modality expertise, allowing them to serve diversified pipelines while maintaining scientific credibility.

Their strength lies in:

End-to-end manufacturing networks
Centres of excellence in CGT, mRNA, viral vectors, and biologics
Modular operating models that adapt quickly to scientific change
Balanced revenue from high-volume and high-margin programmes

Hybrid front-runners

WuXi Biologics: Combines large-scale infrastructure with deep viral vector and CGT expertise.
Lonza: Pairs global biologics scale with specialised innovation hubs in advanced modalities.
FUJIFILM Diosynth: Scales mammalian culture while reinforcing niche biologics and microbial fermentation capabilities.

Visiongain Insight: Hybrid CDMOs outperform single-model competitors. They secure longer contracts, faster onboarding, and greater margin stability, positioning them as the preferred partners for diversified biopharma pipelines.

Companies to Watch Across the CDMO Landscape

Scale Leaders

Samsung Biologics: Aggressively expanding multimodality capacity post-COVID.
Lonza: Vacaville acquisition (+330,000L capacity) strengthens biologics scale.
Catalent: Scaling mammalian and biologics capacity globally.
WuXi Biologics: Growing multinational footprint across three continents.

Visiongain Insight: Scale-driven CDMOs are winning the largest multi-year contracts as biologics demand outpaces supply.

Specialisation Leaders

ten23 health: Specialist in complex biologics and injectable fill–finish.
AGC Biologics: Viral vector and CGT expansion across US/EU.
FUJIFILM Diosynth: Advanced biologics capabilities in Denmark.
Merck Millipore CTDMO: Gene therapy focus, strengthened by Synplogen integration.

Visiongain Insight: Specialised CDMOs gain early-mover advantage as pipelines shift to CGT, mRNA, and ADCs.

Hybrid CDMO Leaders

Lonza: Scaling globally while retaining advanced-modality excellence.
WuXi Biologics: Combines network scale with deep CGT capability.
FUJIFILM Diosynth: Incremental scaling with sustained modality depth.

Visiongain Insight: Hybrid models represent the strongest path to long-term resilience and pipeline diversity.

Market Outlook

The CDMO sector is entering a decisive growth phase driven by expanding CGT, mRNA, biologics, and complex small-molecule pipelines. Global demand continues to outpace capacity, reinforcing the need for both scale and specialised expertise.

The next decade will be shaped by:

Scaled CDMOs building multimodality, globally redundant networks
Specialised CDMOs dominating advanced therapeutic niches
Hybrid CDMOs emerging as the sector’s dominant model, combining both

With increasing outsourcing, regulatory convergence, and consolidation, Visiongain forecasts sustained double-digit growth across biologics and advanced therapy CDMO markets.

Visiongain Insight: CDMOs balancing scale with modality expertise will outperform. Hybrid platforms achieve stronger retention, faster onboarding, and more resilient revenues than single-strategy competitors.

Strategic Questions for Executives

As CDMOs navigate rising complexity, leaders must answer four defining questions:

How will capacity for biologics, CGT, and mRNA be expanded without creating bottlenecks or unsustainable capital demands?
How can regulatory divergence across the US, EU, and emerging markets be managed as modalities grow more complex?
What strategies will mitigate shortages in specialist talent and strengthen global supply-chain resilience?
How should CDMOs balance client demand for scale and depth — and is the hybrid model now the most viable route to competitiveness?

What’s Next from Visiongain?

Visiongain continues to track these shifts with rigour, grounding our analysis in data, market intelligence, and strategic insight tailored to decision-makers across the global health ecosystem.

Explore our new strategic market reports: