Category | CDMO Services
Developing and manufacturing a new drug is an intense undertaking with many moving parts. From discovery and development to preclinical research, clinical research, review and approval, and commercialization, the list of to-dos is seemingly endless. What’s more, biotechnology and pharmaceutical companies must abide by current good manufacturing practice (cGMP) regulations enforced by the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and other international counterparts, which outline minimum requirements for the methods, facilities, and controls used in manufacturing, processing, and packing of a drug product.1
To navigate industry complexities and bridge resource gaps, biotechnology and pharmaceutical companies often look to third-party vendors for development and manufacturing support — most often to CROs, CMOs, or CDMOs, specifically. But what’s the difference between the three? Contract research organizations (CROs), contract manufacturing organizations (CMOs), and contract development and manufacturing organizations (CDMOs) all provide specialized capabilities and operational infrastructure when it comes to drug development and manufacturing. Although their services and solutions often overlap, there are some key differences to keep in mind. Read on to discover the key differences between CROs, CMOs, and CDMOs, and explore which one’s right for you.
A contract research organization, or CRO, supports biotechnology and pharmaceutical companies by providing a wide range of early-stage research and development (R&D) offerings. Specifically, CROs help with clinical trial services including clinical research, regulatory affairs, clinical trial planning, site selection and initiation, recruitment support, clinical monitoring, data management, trial logistics, biostatistics, medical writing, and project management.2 CROs typically have the industry know-how needed to help coordinate and manage a clinical trial and its progress, which is why companies choose to partner with them. And the global CRO market is growing, with projections to reach $188.42 billion by 2030.3 Developing and manufacturing a new drug is complicated endeavor that ultimately depends on a clinical trial’s progress from beginning to end. By outsourcing a comprehensive range of clinical trial services to a quality CRO, pharmaceutical, biotechnology and medical device companies can leverage their knowledge, capabilities, infrastructure, and resources while simultaneously working on other important tasks.
A contract manufacturing organization, or CMO, helps pharmaceutical and biotechnology companies manufacture their innovative drug substances. Their offerings can include commercial production, drug development, formal stability, formulation development, method development, pre-formulation, and registration batches.4 CMOs can help save pharmaceutical and biotechnology companies money, since they provide the cutting-edge equipment and highly trained employees that are essential when it comes to manufacturing new drugs, whether from small or large molecules. Additionally, quality CMOs help pharmaceutical and biotechnology companies stay compliant with quality standards and regulatory requirements, helping to avoid any roadblocks on the drug development and manufacturing journey. The global CMO market size was valued at $92.42 billion in 2018 and is projected to reach $188.07 billion by 2026.5 By partnering with a CMO, pharmaceutical and biotechnology companies can effectively scale up their operations and limit financial risks while focusing on other tasks, including drug discovery and drug marketing.
A contract development and manufacturing organization, or CDMO, provides end-to-end, fully integrated drug development and manufacturing solutions and services to biotechnology and pharmaceutical companies, and its market size is projected to reach $278.98 billion by 2026.6 Specifically, the wide range of CDMO offerings include formulation development, regulatory support, clinical trial services, product packaging, supply chain management, quality assurance, and technology transfer solutions. In recent years, certain CDMOs are also offering clinical research services — either through mergers and acquisitions or by expanding their in-house capabilities. Although this trend is up-and-coming, it’s definitely one to watch. By outsourcing certain aspects of drug development and manufacturing to CDMOs, biotechnology and pharmaceutical companies can reduce costs, accelerate time to market, and ensure compliance with regulatory standards. Every year, the FDA’s Center for Drug Evaluation and Research (CDER) approves a wide range of new drugs for patients in need, and the race to market is more competitive than ever. That’s where CDMOs can step in — by serving as strategic partners and providing comprehensive drug development and manufacturing services, they can help pharmaceutical and biotechnology companies on the journey from discovery to commercialization and beyond.
There’s no “right” or “wrong” choice when it comes to picking a CRO vs a CMO vs a CDMO; it all comes down to the biotechnology or pharmaceutical company’s specific set of needs. If they only require clinical research support, a CRO may be the way to go; likewise, if they just want manufacturing solutions, a CMO may be best. A full-service CDMO, on the other hand, provides comprehensive, integrated development and manufacturing services under one roof; more and more, they’re also offering clinical research solutions, as well — all of which can help to simplify production workflows, eliminate technology transfer risks, and expedite time to market timelines. That’s why it’s important to know the difference between CROs, CMOs, and CDMOs — so you can confidently navigate the market and identify which entity is right for your project’s unique needs.
Explore what makes a quality CDMO partner in our whitepaper below.