Optimizing Outsourcing: A Case Study on Evaluating CDMO Capabilities for API and FD Development

A large pharmaceutical company collaborated with DelveInsight to evaluate CDMO companies for API and FD development. DelveInsight provided a comprehensive one-time report benchmarking top contract development and manufacturing organizations based on their R&D, API CDMO manufacturing, and commercialization capabilities. This analysis, leveraging both secondary and primary CI inputs, enabled the client to identify the ideal partner for outsourcing their project.

LAS VEGAS, Jan. 2, 2025 /PRNewswire/ -- DelveInsight, a leading provider of healthcare competitive intelligence, partnered with a large pharmaceutical company seeking to advance their API and FD development and assessed various CDMO companies for outsourcing capabilities. The client aimed to benchmark contract development and manufacturing organizations (CDMOs) to identify the most suitable partner for outsourcing their project. DelveInsight delivered a one-time, in-depth report analyzing the R&D, manufacturing, and commercialization capabilities of key CDMOs, utilizing both secondary and primary competitive intelligence inputs. This strategic evaluation enabled the client to make informed decisions, ensuring alignment with their development goals and achieving optimal outsourcing efficiency.

The global Contract Development and Manufacturing Organization market is set to experience significant growth, driven by its essential role in outsourcing drug development and manufacturing for pharmaceutical companies. According to the latest report by DelveInsight's recent Contract Development Manufacturing Organization (CDMO) forecast report, the CDMO market was valued at USD 100.02 billion in 2021 and is projected to grow at a CAGR of 6.25%, reaching USD 143.87 billion by 2030. 

This growth is fueled by the increasing prevalence of cancer, genetic disorders and rare conditions, which have spurred demand for innovative therapies and orphan drugs. For example, the GLOBOCAN 2022 study reported approximately 20 million new cancer cases and 9.7 million cancer deaths globally, while nearly 475 million people worldwide are affected by rare diseases. These trends underscore the critical role of CDMOs in providing scalable solutions for pharmaceutical companies addressing unmet medical needs. 

The United States remains a key hub for pharmaceutical development outsourcing; however, the APAC region is increasingly becoming the preferred market for CDMO growth. This is mainly due to the region's more cost-effective manufacturing than North America and Europe. Furthermore, significant funding investments and the proximity of pharmaceutical research centers to universities contribute to this shift.

Strategic partnerships and acquisitions, coupled with the impact of the COVID-19 pandemic, have further propelled the CDMO market growth. Leading pharmaceutical companies like Moderna and Pfizer collaborated with CDMOs such as Catalent and Lonza to meet the surge in vaccine demand during the pandemic. Additionally, industry consolidation has strengthened capabilities, with acquisitions like Thermo Fisher's purchase of Brammer Bio for USD 1.7 billion and Merck's acquisition of AmpTec to bolster mRNA manufacturing. Such initiatives have highlighted the importance of CDMOs in accelerating drug development and commercialization, especially during global health crises.

The CDMO market is dominated by key players offering a range of expertise, including Patheon (Thermo Fisher Scientific), Catalent, Inc., Laboratoire Elaiapharm, The Lubrizol Corporation, Cambrex Corporation, Recipharm (EQT), Merck & Co., Inc., AGC Biologics, Nerpharma S.r.l, Pfizer CenterOne (Pfizer Inc), EMERGENT, Onyx Scientific Limited, Lonza, Siegfried Holding AG, CordenPharma International, FUJIFILM Diosynth Biotechnologies, Samsung Biologics, Delpharm, Center for Breakthrough Medicines, and WuXi Biologics. The CDMO Market report analyzed the companies working in this domain in detail. 

Download the Sample Report to Explore Future Trends in the Contract Development and Manufacturing Organization (CDMO) market.

DelveInsight's Comprehensive Methodology for Evaluating CDMO Capabilities

DelveInsight employed a comprehensive methodology to assist clients in identifying and evaluating potential Contract Development and Manufacturing Organizations (CDMOs) that aligned with their project requirements and strategic goals. The process begins with a thorough search and identification of CDMOs in geographies of interest, ensuring the client has access to the most suitable partners. Competitive Intelligence (CI) is gathered through secondary sources and enriched with primary research conducted via interviews and surveys tailored to the client's needs. Additionally, the project's current status is meticulously analyzed to estimate potential timelines for completion, providing clarity on project progression.

Key logistical aspects such as equipment ordering, delivery schedules, and the installation and validation of machinery are carefully planned and managed. Active Pharmaceutical Ingredients (APIs) availability is assessed to ensure seamless project execution while potential partnerships with other API suppliers are explored and evaluated. Furthermore, detailed reviews of sterilization processes are conducted to maintain high-quality standards and compliance.

DelveInsight also identified and analyzed potential challenges and barriers to the project, offering strategic solutions to mitigate risks. Manufacturing plants were evaluated based on location, providing insights into logistical and strategic advantages. Finally, the manufacturing status and capabilities of identified CMOs was thoroughly assessed, ensuring the client has a clear understanding of their operational readiness and capacity to meet project demands. This structured approach empowered DelveInsight to deliver impactful insights and drive successful outcomes for their clients.

Comprehensive Results and Strategic Insights for CDMO Selection:

DelveInsight meticulously crafted a robust framework to address the client's research needs, delivering detailed CDMO profiles that streamlined the evaluation process. This framework offered the client a comprehensive understanding of potential CDMO partners, shedding light on their strengths, weaknesses, and core capabilities facilitating informed decisions regarding project outsourcing.

An in-depth analysis was conducted to assess the research and development technologies, manufacturing capabilities, and commercial potential of prospective CDMOs. This evaluation offered critical insights into each partner's technological expertise, production capacity, and long-term business viability, ensuring alignment with the client's strategic objectives and market aspirations.

Additionally, a comprehensive competitive assessment was performed to analyze the market positioning and performance of various CDMOs. This analysis provided a benchmark against industry standards, enabling the client to identify the most capable and competitive partner for outsourcing Active Pharmaceutical Ingredient (API) and Finished Dosage (FD) development. The delivery of evidence-based insights equipped the client with a robust strategic foundation to navigate regulatory and market complexities, facilitating seamless market entry and ensuring long-term success.

Why Choose DelveInsight?

DelveInsight is an expert in providing comprehensive frameworks that help pharmaceutical companies streamline their research processes and make informed decisions regarding CDMO services. With in-depth knowledge of R&D technologies, manufacturing capabilities, and commercial potential, DelveInsight offers valuable insights into the strengths and weaknesses of potential partners. The firm's expertise in conducting competitive assessments allows clients to benchmark companies of interest against industry standards, ensuring they select the most capable and competitive partners for their strategic interests. Additionally, DelveInsight's evidence-based approach provides strategic support, helping clients align their strategies with market realities and regulatory requirements for long-term success.

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About DelveInsight

DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform, PharmDelve.

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SOURCE DelveInsight Business Research, LLP