February 25, 2024
Biologics Outsourcing

Biologics Outsourcing: The Future of Biological Therapeutics Development

The biologics industry has seen tremendous growth over the past decade with the development and approval of new biological therapies to treat various diseases. However, developing biologics drugs is an extremely complex, costly and time-consuming process for pharmaceutical companies to undertake on their own. This has led to a rise in outsourcing certain stages of biologics development to contract development and manufacturing organizations (CDMOs). By outsourcing non-core functions like process development, manufacturing and packaging, biotech and pharma companies can focus their internal resources on drug discovery and clinical research while leveraging the specialized expertise of CDMOs.

Growing Demand for CDMO Capabilities
With the biologics projected to reach over $400 billion by 2027, the demand for CDMO services is stronger than ever. Most pharmaceutical companies lack the facilities and expertise required for developing biologics in-house. CDMOs have made significant investments in recent years to expand their capabilities for cell line development, process optimization, analytics, fill/finish and lyophilization to support a wide range of biologics modalities like monoclonal antibodies, gene therapies and vaccine candidates. They can customize services and timelines to meet project needs. Outsourcing non-core activities to CDMOs enables drug makers to access these specialized end-to-end bioprocessing solutions and technologies in a capital efficient manner.

Expanding into Early Stage Work
While large pharma traditionally outsourced later stage manufacturing, CDMOs are increasingly taking on more early stage work like analytics, cell banking, assay development and clinical trial material production. For example, many offer modular lab space and small-scale manufacturing capabilities tailor-made for biotechs advancing early phase projects. Some CDMOs now provide integrated discovery to commercialization services to streamline biologics development. By outsourcing even preclinical activities, small biotechs can maximize their funding and resources for core drug development functions. Several CDMOs have advanced technology platforms that speed up early stage research and manufacturing process characterization activities.

Globalization of Outsourcing Networks
Biologics Outsourcing
networks have expanded globally to maximize cost efficiencies and proximity to key talent. Many CDMOs have established manufacturing sites and R&D centers across regions like Europe, Asia and Latin America to diversify risks and better serve multinational clients. For example, international CDMOs support regional clinical trials by providing local drug product supply. Several have built large multi-product facilities in low cost regions like China and India that comply with international regulatory standards. Emerging biologics hubs in these locations also attract specialized technical talent, encouraging further CDMO investments abroad. The globalization of outsourcing fosters around the clock project management and faster development timelines.

Partnerships for Novel Modalities
Developing complex new modalities like gene therapies, cell therapies and vaccines pose unique technical challenges that require significant investments and cross-industry collaborations. Several leading CDMOs have partnered with academic institutes and biotechs to advance capabilities in emerging areas like viral vector manufacturing, stem cell biology, mRNA production. Areas like CRISPR, nanotechnology and immunotherapies also see joint development agreements between innovators and experienced CDMOs. These partnerships allow early access to cutting edge science while the CDMOs gain expertise to commercially translate next generation modalities. As novel therapies progress, specialized CDMO networks and partnerships will play a crucial role in scaling up production to cater to global patient populations.

Regulatory Considerations
As biologics outsourcing grows, regulatory agencies are also evolving guidance to enhance quality oversight of outsourced activities and third party providers. For example, the FDA has issued revised regulatory requirements for gene therapy developers to better address cell and vector characterization, manufacturing controls and supply chain complexities that often involve multiple external partners. The European Medicines Agency also released new guidelines for oversight of CDMO qualification and changes to outsourced activities. Compliance with these evolving standards requires close coordination between innovator companies and qualified CDMOs that maintain global regulatory compliance. Outsourcing to CDMOs with proven compliance histories and advanced quality systems helps smoothly navigate regulatory reviews and inspections critical for biologics approvals.

With continued growth projected across biological therapeutics, strategic outsourcing will remain an essential part of the biopharma business model. Top pharmaceutical companies are establishing new partnerships and alliances that combine internal innovation with access to specialized solutions across the full development lifecycle from CDMOs. As outsourcing networks expand globally and capabilities mature for novel modalities, CDMOs are transforming into end-to-end biologics development collaborators.Their investments in regulatory compliance and emerging technologies will play a key role in advancing the next wave of biological therapies to patients worldwide. Outsourcing to reputed CDMOs with integrated expertise will remain pivotal for efficient and scalable biologics development programs in the years ahead.

1. Source: Coherent Market Insights, Public sources, Desk research
2. We have leveraged AI tools to mine information and compile it