The biopharmaceutical industry continues to experience dynamic growth as new medicines are developed to treat diseases. With increased opportunities also comes greater complexities that require specialized expertise. This has led to rising demand for contract manufacturing organizations (CMOs) and contract research organizations (CROs) that provide outsourced services to drug developers.
The Rise of Biologic Therapies
Development of biologics has accelerated due to their targeted mechanisms that can revolutionize treatment. However, biologics are extremely complex to manufacture compared to traditional small molecule drugs. Their development requires specialized multi-step production processes and infrastructure that is challenging for many drug companies to establish independently. This has fueled expansion of CMOs that can handle biologics manufacturing on a contract basis.
Barriers to Internal Manufacturing
The high financial barriers of building end-to-end biomanufacturing facilities, obtaining regulatory approvals, and maintaining compliance are prohibitive for many smaller biopharma companies and virtual startups focused on R&D. Outsourcing to CMOs eliminates these hurdles and allows development resources to concentrate on innovation. Even large pharmaceutical firms increasingly see value in leveraging CMOs’ expertise rather than owning all infrastructure internally.
Growth of Specialized CMOs
To meet rising demand for biologics manufacturing services, CMOs have substantially upgraded and expanded their capabilities. Leading CMOs now offer multi-product facilities that can handle mammalian, microbial, and viral vector production. They provide process development, technical transfer, regulatory support, and commercial drug substance and drug product services from early to late stages. Some CMOs have evolved into fully integrated partners managing entire projects.
Reliance on CRO Expertise
While manufacturing is predominantly outsourced to CMOs, CROs play a critical role supporting the non-clinical and clinical portions of drug development. Biopharma companies rely on CROs’ therapeutics expertise and global networks for vital functions such as preclinical research, clinical trial design/management, data management/biostatistics, regulatory submissions, and pharmacovigilance.
Increasing Specialization of CRO Services
To meet rising demand from biotechs, CROs have enhanced specialized capabilities for services such as biomarker discovery, bioanalytical testing, translational medicine, lab services and more. They provide expertise across diverse therapeutic areas. Some CROs have evolved into fully integrated partners guiding biotechs through the entire development cycle from target identification to commercialization. This allows researchers to focus fully on science.
Growth through Strategic Partnerships
To ensure comprehensive service offerings, many CMOs and CROs form strategic partnerships leveraging each other’s complementary capabilities. For example, CMOs strategically partner with CROs to offer integrated development and manufacturing packages to streamline clients’ projects. Large CROs also acquire specialized boutique firms to diversify their therapeutic expertise.
Promising Future Outlook
The Global Biopharmaceutical CMO And CRO contract services market size continues growing significantly annually in response to increasing drug development complexities and industry trends favoring outsourcing. Market analysts project this trend will remain robust driven by substantial investments in biologics and cell & gene therapies. Both CMOs and CROs are expected to strategically expand through partnerships and capabilities to sustain their value proposition for biopharma innovators. Ultimately, continuous evolution of the CMO and CRO industry serves to accelerate development of new life-enhancing medicines for patients worldwide.
1. Source: Coherent Market Insights, Public sources, Desk research
2. We have leveraged AI tools to mine information and compile it