Creating Solutions for CDMOs: An EPCMV Firm's Perspective

Posted May 15, 2024

A look at the critical services EPCMV firms provide to CDMO partners.

In the biopharma industry, the role of contract development and manufacturing organizations (CDMOs) has grown significantly over the past few decades. According to the latest research, the global CDMO market was valued at approximately $160 billion in 2023 and is expected to expand at a CAGR of 7.2%, reaching roughly $332 billion by 2033. These specialized organizations play a crucial role in developing and manufacturing biological and pharmaceutical products, providing time-saving, cost-effective, and creative solutions to innovative companies.

However, the seamless operation and growth of CDMOs are not possible without the support and collaboration of various stakeholders. Among those stakeholders, Engineering, Procurement, Construction Management, and Validation (EPCMV) firms engage CDMOs as key partners to provide optimized manufacturing solutions and enable the growth of CDMO facilities and operations.

This article explores the critical services EPCMV firms provide when partnering with CDMOs and how this collaboration benefits the biopharma sector. These innovative services empower CDMOs to deliver high-quality products to the market and, ultimately, the patients.

Importance of CDMOs in the Biopharma Industry

Before discussing how EPCMV firms support CDMOs, it is essential to understand the significance of CDMOs in the biopharma sector. CDMOs are specialized service providers offering various services, including product development, formulation, analytical testing, and manufacturing.

CDMOs are vital for several reasons:

CDMOs provide scalability and agility to biopharma companies. CDMOs can quickly adjust production capacities to meet the ever-changing market demands. This is particularly crucial in the biopharma industry, where clinical trial materials, small-batch manufacturing, and large-scale production requirements can vary significantly.

CDMOs provide a strategic advantage in commercial products. In early February 2024, the acquisition of CDMO Catalent positioned Novo Nordisk to match supply with demand of the $25-30 billion/year GLP-1 market. For startup companies, an innovator may have a small or no cGMP manufacturing space. Innovator companies partner with CDMOs to scale up and manufacture their new product for cGMP clinical studies.

CDMOs bring expertise and specialized capabilities that innovator companies may lack. CDMOs often invest in cutting-edge technology, equipment, and highly skilled personnel, enabling them to tackle complex development and manufacturing challenges for innovators. This expertise is critical in accelerating the product development process and ensuring regulatory compliance.

CDMOs help biopharma companies reduce costs and risks. By outsourcing certain product development and manufacturing aspects to CDMOs, innovator companies can focus on their core competencies: research and development. This allows them to operate more efficiently and allocate resources more effectively.

CDMOs are integral to the biopharma industry’s success. They enable companies to bring new products to market faster, with high quality and cost-effectiveness. However, to perform these functions optimally, CDMOs rely on the support of various partners. EPCMV firms are a crucial ally in this journey.

EPCMV Firms Create Solutions for CDMOs

EPCMV firms create solutions and bring expertise to the table. They are responsible for the design, construction, and validation of biopharma facilities, ensuring that these facilities meet the stringent regulatory requirements of the industry. CDMOs usually do not have large engineering organizations experienced in designing and delivering new facilities or making significant modifications to existing facilities. Also, many CDMOs are young, budding start-up companies with lean staff focused on creating the organization, not building, and designing a facility.

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