Biopharmaceutical contract manufacturing is an integral to producing biologics and biosimilars and moving those drugs from discovery to market. In 2019, the biopharmaceuticals contract manufacturing market was valued at $13.7 billion and is expected to reach $25.5 billion by 2027 according to Research and Markets. This massive increase is largely being driven by the increasing trend of pharmaceutical companies outsourcing development and manufacturing services, the increasing demand of biologics, and the diversification of the biopharmaceutical pipeline. To keep up with demand, contract manufacturing organizations (CMOs) need to be innovative and agile.
Key Trends in Biopharmaceutical Contract Manufacturing
More Facilities: Several CMOs/CDMOs are expanding their facilities or constructing new development and manufacturing sites to accommodate increasing biopharmaceutical demand and facilitate long-term partnerships that may require multi-scale manufacturing for several products.
Increase in newer drug technologies and biosimilars: Cellular and gene therapies, antibody-drug conjugates, live microbes as therapeutics, and RNAi therapies. In 2019, The FDA approved 35 biopharmaceuticals with 28 products having recombinantly manufactured active agents and recombinant monoclonal antibodies accounting for 15 of all biopharmaceutical approvals. One gene therapy (Zolgensma) received approval and a total of 22 follow-on-type products (biosimilars or generic biologics), received FDA approval in 2019.
More Single-use Equipment: CMOs are shifting away from massive stainless steel equipment towards single-use equipment in biopharmaceutical facilities, particularly at preclinical and clinical scales for upstream bioprocessing. BioPlan estimates that 85% or more of pre-commercial product manufacturing now involves substantial single-use systems.
More Collaboration and Partnerships: As medicines become more complex, drug development and manufacturing requires multidisciplinary expertise and more funding. More collaborations and communication among bioprocessing organizations and facilities at all levels are increasing, which is particularly apparent in the response to COVID-19 to develop vaccines, treatment, and diagnostic tools. Additionally, suppliers are becoming more transparent and are ramping up communications and knowledge sharing with fellow suppliers.
Better Continuous Bioprocessing: To reduce bottlenecks throughout bioprocessing, continuous systems continue to be adopted for both upstream and downstream manufacturing activities. Continuous systems can streamline workflow and reduce tedious, error-prone manual tasks, allowing manufacturing professionals to devote more time to complex issues, innovation, and quality assurance.
More Automation: To address staffing shortages and process intensification, CMOs will be investing in automation that will generate process improvements, reduce manual errors, and decrease cost. Automation technology can also provide more process control to better optimize conditions and also generate more robust and reliable data for regulatory agencies.
New Business Models: Modern CMOs are moving away from purely transactional niche services and are adopting business models where they offer comprehensive services from early-stage drug development through commercial-scale manufacturing. This facilitates long-term partnerships and allows the CMO to gain a deep understanding of the technical and regulatory requirements to efficiently transition between stages and avoid delays associated with technology transfer when multiple vendors are involved.
Notable Biopharmaceutical contract manufacturing organizations
Founded in 2013 with approximately 47,000 global employees and expertise in research, development, and manufacturing. They have five primary therapeutic areas including immunology, virology, oncology, neuroscience, and eye care, but also take on specialized projects in women’s health, cystic fibrosis, and diabetic nephropathy.
Lonza Group AG
Recognized for reliable, high-quality service; global capacity; innovative technology platforms; and extensive experience. In 2019 they provided manufacturing services for over 300 commercial molecules, supported the development of over 700 pre-clinical and clinical molecules,and supported the launch of pioneering autologous cell therapies.
A Hong Kong-based CMO offering end-to-end solutions to help companies discover, develop and manufacture biologics from concept to commercial manufacturing.As of June 2020, they had a total of 286 integrated projects, with 141 projects in pre-clinical development stage, 125 projects in early-phase clinical development, 19 projects in late-phase development and one project in commercial manufacturing.
Pantheon by Thermo Fisher Scientific
Pantheon is a CDMO with over 55 locations worldwide and offers integrated, end-to-end capabilities through all phases of development, including API, biologics, viral vector services, formulation, clinical trial solutions, logistics services and commercial manufacturing.
Ajinomoto Co. Inc.
This is a japanese company known for food science and pharmaceutical custom manufacturing. To expand into biopharmaceuticals, they acquired Althea Technologies, Inc., a U.S.-based biopharmaceuticals CDMO and anticipate growing capabilities for oligonucleotide drugs and antibody-drug conjugates.
Formerly part of GE Healthcare Life Sciences, it is a global provider of technologies and services for fundamental biological research to developing innovative vaccines, biologic drugs, and novel cell and gene therapies. They operate in 40 countries and are dedicated to advancing and accelerating the development and manufacture of therapeutics.
Samsung’s biomanufacturing arm offers CDMO services with the largest single site capacity, and the fastest throughput. Samsung Biologics is an award-winning partner of choice and is a one-stop shop for development, manufacturing, and laboratory testing services at every stage for biopharmaceutical products while offering comprehensive regulatory support and contract research services.
A global pharmaceutical and biopharmaceutical contract manufacturing organization offering end-to-end solutions for clinical drug development, scaling processes and implementing local production facilities. They have a full manufacturing process, including designing and implementing at the customer’s facility or at their GMP site. They are recognized for supporting customers move cutting-edge therapies to market with world-class process development and manufacturing capabilities for virus-based therapeutics.
The Bottom Line
Partnering with a CMO can be highly beneficial. It can eliminate the need to invest in facilities and expensive equipment, reducing drug development costs and can bridge complementary capabilities, streamlining the manufacturing process. Biopharmaceutical manufacturing is complex and time consuming. Outsourcing allows pharmaceutical and biotechnology companies to reallocate resources to other priorities, reduce costs, and increase speed to market resulting in a higher return on investment and, ultimately, getting life-changing medicines to patients faster.