DelveInsight Publishes Comprehensive Look at US and European CDMO 

Scope & Objective

A leading pharmaceutical company collaborated with DelveInsight to gain an in-depth understanding of the Contract Development and Manufacturing Organization (CDMO) landscape across the USA and Europe. The primary objective was to identify, evaluate, and benchmark key CDMO players to support the client's outsourcing strategy for drug development, formulation, and large-scale manufacturing.

The client sought a strategic assessment that would help them:

• Identify reliable CDMO partners with strong technical expertise and capacity.

• Understand the competitive positioning and service offerings across regions.

• Benchmark quality, compliance, and operational excellence standards.

• Support future partnerships and investment decisions in biologics, small molecules, and advanced therapies.

Approach & Methodology

DelveInsight applied a multi-layered research approach combining secondary intelligence, primary validation, and proprietary analytical frameworks to deliver a 360-degree view of the CDMO landscape.

1. Market Mapping and Segmentation

• Identified and categorized CDMOs based on service offerings — including drug substance manufacturing, formulation development, analytical services, packaging, and fill-finish capabilities.

• Segmented players by therapeutic area focus (biologics, cell and gene therapies, small molecules, sterile injectables, and oral solids) and scale of operations (clinical, commercial, or both).

2. Capability and Infrastructure Assessment

• Evaluated technological strengths, capacity utilization, and flexibility to handle diverse molecule types.

• Assessed manufacturing capabilities such as single-use systems, continuous manufacturing technologies, and containment infrastructure.

• Analyzed regulatory track records with authorities such as FDA, EMA, and MHRA to determine compliance reliability.

3. Competitive Benchmarking

• Conducted side-by-side benchmarking of CDMOs across key parameters such as R&D investment, operational capacity, cost-effectiveness, quality certifications, and turnaround times.

• Evaluated differentiation factors including innovation in manufacturing technologies, customer service excellence, and end-to-end service integration.

4. Partnership and Collaboration Potential

• Analyzed CDMOs' experience with technology transfers, partnership flexibility, and long-term engagement models.

• Assessed historical alliances, acquisition activity, and client satisfaction levels to gauge strategic alignment potential.

5. Pricing and Business Model Analysis

• Reviewed pricing structures, contractual models (fee-for-service, FTE, milestone-based), and cost efficiency metrics.

• Identified CDMOs offering competitive pricing without compromising quality and compliance standards.

6. Regulatory and Market Environment Assessment

• Examined evolving manufacturing trends and regulatory landscapes in the USA and Europe.

• Evaluated regional incentives, labor costs, and capacity expansion trends to identify favorable locations for outsourcing partnerships.

Explore Our CDMO Competitive Assessment Services:  https://www.delveinsight.com/case-study/cdmo-competitive-assessment?utm_source=casestudy&utm_medium=promotion&utm_campaign=kkpr

Outcomes

The assessment resulted in a comprehensive competitive landscape and a prioritized shortlist of CDMOs that best fit the client's strategic, technical, and financial criteria.

• Detailed Market Intelligence:  Provided granular insights into over 50 CDMOs operating across both regions, with detailed profiles covering capabilities, infrastructure, and ongoing investments.

• Strategic Benchmarking:  Highlighted strengths and gaps in technology adoption, regulatory reliability, and innovation leadership.

• Partner Identification:  Shortlisted high-potential CDMOs suited for biologics and small-molecule programs, aligning with the client's quality and scale needs.

• Operational Insights:  Delivered data-driven perspectives on cost structures, capacity availability, and lead times to inform outsourcing strategies.

• Informed Decision-Making:  Empowered internal teams with a structured framework to evaluate partnership opportunities and plan long-term collaborations.

Strategic Impact

Through DelveInsight's comprehensive CDMO competitive assessment, the client gained a clear and actionable understanding of the manufacturing ecosystem in two key pharmaceutical hubs — the USA and Europe. The study enabled the client to:

• Align outsourcing strategies with organizational growth goals.

• Select CDMO partners with proven expertise and scalability to support diverse programs.

• Optimize resource allocation by focusing on high-value collaboration opportunities.

• Strengthen risk management through awareness of operational and compliance variations across regions.

DelveInsight's data-driven insights and strategic recommendations empowered the client to establish a well-informed, forward-looking outsourcing roadmap. The findings served as a critical foundation for partnership negotiations, investment decisions, and long-term capacity planning — ensuring that the client's manufacturing and development strategies remained competitive, compliant, and future-ready in an evolving global market.

Ready to Optimize Your CDMO Partnerships?  https://www.delveinsight.com/case-study/cdmo-competitive-assessment?utm_source=casestudy&utm_medium=promotion&utm_campaign=kkpr

Contact Us

Kanishk
kkumar@delveinsight.com