Accelerating innovation beyond manufacturing

Next-Gen CDMOs

The next generation of CDMOs are redefining the industry by integrating advanced technologies, end-to-end solutions, and sustainable practices to go beyond traditional manufacturing. From AI-driven drug development to flexible, scalable production models, CDMOs are accelerating innovation, ensuring faster time-to-market, and supporting the entire lifecycle of pharmaceutical and biologic products.

Challenges transforming CDMOs in the Life Sciences industry

We understand the challenges that every type of CDMO is facing right now.

Development

CDMOs are under pressure to modernize and integrate digital tools in their workflows due to the rapid pace of innovation. This requires AI-driven formulation, real-time analytics and smarter process design, as well as meeting increasing regulatory expectations for data integrity and early compliance. Building a digitally fluent, cross-functional workforce is essential.

API manufacturing

Transitioning from legacy batch processes to modular, multi-product capabilities is vital to support both small molecules and biologics manufacturing. Capital investment is often high, and robust, diversified sourcing and integrated planning are essential to deal with risks from shortages and geopolitics.

Drug product intermediates

Intermediate manufacturing requires coordination between the upstream API and final dosage production. Challenges here are consistency, GMP compliance and visibility across stages. Integrating MES, skilled teams and harmonized controls minimizes bottlenecks and ensures outputs are high quality.

FDF manufacturing

The complexity of finished dose manufacturing increases from traditional oral solids to sterile injectables and lyophilized biologics. CDMOs often need to adapt to client needs with flexible solutions across different formats. Innovation demands in process control, continuous manufacturing and robotics increase, while regulations and serialization requirements challenge compliance.

Commercial services

The commercial phase demands speed, precision, and trust. CDMOs must manage diverse client expectations while meeting regulatory requirements. Ensuring cold chain integrity, integrating digital logistics systems, and offering transparent client engagement models are key. This final leg of the value chain must be smart and scalable.

Why is consolidation essential for next-gen CDMOs?

Consolidation is driven by the need for scale, efficiency, and competitive differentiation.

As pharmaceutical companies seek end-to-end solutions, CDMOs must expand capabilities across small molecules, biologics, and APIs to remain relevant.

Larger, integrated CDMOs benefit from enhanced capacity, global reach, and diversified service offerings, making them preferred partners for drug developers. Consolidation also helps mitigate rising costs, improve supply chain resilience, and address regulatory complexities by streamlining operations across multiple sites.

Additionally, as advanced technologies such as AI-driven quality control, automation, and digital manufacturing reshape the industry, consolidation enables CDMOs to invest in innovation and maintain a competitive edge.

Ultimately, scale and integration provide pharmaceutical clients with greater reliability, speed to market, and strategic partnerships, making consolidation a necessity for long-term growth.

Tech-driven evolution of CDMOs

Technology is transforming CDMOs from traditional manufacturers into strategic, tech-enabled partners in drug development and commercialization. Machine learning in drug development, digital manufacturing, AI-driven quality control, and sustainability are transforming CDMOs by accelerating innovation, optimizing production, ensuring real-time quality assurance and reducing environmental impact.

With our industry, process and IT expertise, we help CDMOs with digital manufacturing, AI-driven quality control, integration of machine learning into drug development, and sustainable practices to drive innovation, optimize production, and improve real-time decision-making.

These advances help CDMOs evolve from traditional manufacturers to strategic partners in drug development and commercialization.

Want to learn more? Read our blog

Why SAP transformations are so important for CDMOs

Building the foundation for next-gen CDMOs with SAP S/4HANA.

In CDMO transformation projects, challenges extend beyond technology. Key hurdles include organizational change management, process design, and data management. Given the complexity of the Life Sciences sector, overcoming these hurdles is critical to success.

SAP transformations are essential for CDMOs to streamline operations, enhance process efficiency, and ensure regulatory compliance. Tenthpin leverages its deep expertise to guide CDMOs through these challenges.

Our industry-specific templates and best practices support successful process design, solution implementation, and SAP program management, enabling CDMOs to stay ahead in a rapidly evolving marketplace..