How Tech Is Reshaping the CDMO Landscape

Pharmaceutical companies rely on CDMOs to meet growing demands. These include speed, flexibility, and global compliance. To meet these expectations, CDMOs must embrace digital technology at every stage, from electronic lab notebooks to real-time batch monitoring and client portals. Technology is now essential for performance, reliability and long-term value in CDMO relationships.

The technology revolution: From manufacturing to innovation

Next-Gen CDMOs must embrace the use of advanced technologies that will change their operations completely. Here are some of the key innovations taking place:

• AI-driven quality control: By applying predictive analytics to anticipate deviations and deploying machine vision systems to detect real-time defects—such as inconsistencies in tablet coatings or vial fill levels—CDMOs can take early corrective action. This minimizes out-of-spec batches, increases the proportion of batch output that meets quality standards, and ensures consistently high product quality with fewer manual interventions.
• Digital manufacturing: Smart factories equipped with sensors and integrated MES systems allow operators to track every step of production in real time—from raw material input to final packaging. This visibility enables immediate adjustments, full traceability for compliance, and data-driven process improvements that reduce downtime and boost throughput.
• Machine learning in drug development: By analyzing vast datasets from previous formulations and experiments, machine learning models can predict optimal ingredient combinations, process parameters, and scale-up conditions. This shortens development timelines, reduces trial-and-error work, and increases the likelihood of success during tech transfer to manufacturing.
• Sustainable and eco-friendly practices: CDMOs are increasingly implementing green chemistry principles to create more sustainable drug production processes, reducing the environmental footprint of the industry. This includes minimizing the use of hazardous reagents, optimizing reactions to reduce waste, and designing cleaner synthesis routes. Combined with energy-efficient infrastructure—like advanced HVAC systems and heat recovery technologies—and smarter batch planning, these efforts support both regulatory compliance and the sustainability goals of pharma sponsors.

These innovations aren’t just about efficiency—they’re redefining what's possible in terms of speed to market, regulatory compliance, and customer-centricity.
 

Understanding the CDMO landscape: A segmented market

Before exploring the key challenges across the CDMO value chain, it’s important to recognize that the CDMO market is far from uniform. It spans a broad spectrum of service scopes and manufacturing complexities—ranging from small molecule development to highly specialized biologics production, and increasingly, to advanced modalities like cell & gene therapies.

At a high level, CDMO operations can be segmented along two dimensions:

1. Service scope: From early-stage development and API manufacturing to drug product formulation, fill-finish operations, and commercial services such as packaging, tech transfer, and supply chain support.
2. Manufacturing complexity: Differentiated by the product class—Small Molecules, which involve more traditional chemical synthesis and formulation methods; Biologics, which demand advanced capabilities like cell line development, fermentation, and aseptic processing; and Cell & Gene Therapies, that require highly specialized expertise in cell line engineering, viral vector manufacturing and closed-system processing environments.

This segmentation is critical for understanding the challenges CDMOs face across the value chain—challenges that go well beyond technical execution and into areas such as data management, supply chain resilience, and regulatory alignment.

Key challenges across the CDMO value chain: From molecule to market

As CDMOs expand their roles across the development-to-commercialization continuum, the nature of their challenges becomes more interconnected, cross-functional, and strategic.

Each of these areas demands not only technology adoption but also operational excellence.

Going beyond technology: The human and process side of transformation

Technology may drive transformation—but people and processes determine its success. True transformation demands an integrated approach that aligns technology with the organizational mindset, operational workflows, and data foundations that support it. 

Focus on the following:

• Organizational change management: Introducing new systems often requires new ways of working. Without engaging teams, aligning incentives, and nurturing a culture open to innovation, even the most advanced technologies can face resistance or underuse.
• Process design & redesign: Legacy processes aren’t always ready for automation. CDMOs must take a critical look at their workflows, rethinking them for digital efficiency rather than digitizing inefficiencies.
• Data management: AI and analytics depend on accurate, structured, and accessible data. Poor data quality or fragmented data governance can undermine even the most sophisticated digital tools.

CDMO transformation projects succeed when technology, people, and processes evolve together. Failing to address these interdependencies creates friction, slows adoption, and limits the long-term value of innovation. A holistic, cross-functional approach is not just beneficial—it’s essential for sustained impact.

Partnering for transformation: Tenthpin’s approach

With deep expertise in life sciences and a thorough understanding of the CDMO ecosystem, Tenthpin helps organizations embrace the digital revolution and enhance their operations. Our approach is structured around a comprehensive framework that guides CDMOs through their digital transformation journey.
 

Laying the foundation: Strategic alignment and system fit

A successful digital transformation starts with aligning the initiative to your business strategy—and selecting the right tools to support that vision. Tenthpin helps CDMOs build this foundation through:

• Business-driven transformation planning: We ensure your digital program aligns with long-term goals, focusing on value creation and measurable outcomes from day one.
• Early ROI focus: Rather than “big bang” approaches, we prioritize fast wins that prove value early and build momentum across the organization.
• Tailored system evaluation: We can guide CDMOs in selecting the right tools for their specific needs —balancing functionality, integration, cost, and long-term scalability. This often involves helping clients navigate between overlapping or competing technologies. By making these technology decisions through a strategic lens, CDMOs can avoid future rework, reduce complexity, and accelerate the path to digital maturity.
• Future-ready architecture design: Whether it’s SAP S/4HANA or another enterprise platform, we help design systems that are simple, scalable, and standardized—avoiding fragmented or overly complex IT environments.
• Implementation with industry context: With our life sciences and CDMO-specific expertise, we help ensure selected solutions support regulatory needs, operational agility, and growth-readiness.

Scaling smartly: From model design to digital execution

To reduce transformation risk and accelerate outcomes, Tenthpin provides a tailored CDMO industry model—a ready-to-use blueprint that adapts to organizations at varying levels of complexity. Whether a CDMO focuses on R&D, clinical manufacturing, or full end-to-end commercialization, this model provides a structured, scalable foundation that covers both core operations and compliance requirements.

Building on this, we guide CDMOs through a digital transformation journey that emphasizes five key enablers:

1. Automation of enterprise processes: Implementing intelligent workflows and ERP systems to reduce manual effort and improve consistency.
2. Real-time operational transparency: Enabling better decision-making through integrated data visibility across functions and geographies.
3. Flexible collaboration models: Supporting agile ways of working that align with shifting customer and partner expectations.
4. Standardization and simplification: Reducing complexity across sites and functions while maintaining local flexibility.
5. Supply chain resilience: Designing systems and processes that adapt quickly to disruption—critical in a post-pandemic, high-volatility environment.
    

Through this end-to-end transformation, CDMOs become more responsive, compliant, and digitally mature—positioning themselves as strategic partners, not just service providers.

Tenthpin's role is to bridge strategy and execution, helping CDMOs unlock the full potential of their transformation efforts and remain competitive in a rapidly evolving industry.
 

The future of CDMOs in a tech-enabled world

As the pharmaceutical landscape evolves, CDMOs stand at a pivotal crossroads. By embracing digital transformation and rethinking their operating models, they can shift from being manufacturers to becoming innovation partners—adding value across the full drug lifecycle.

The future belongs to those who innovate boldly, act with agility, and collaborate deeply. With the right technologies and a clear transformation vision, CDMOs are not just keeping up—they’re shaping the future of healthcare.