Shanghai, China--(Newsfile Corp. - May 29, 2024) - Frost & Sullivan released a report, titled "The Fourth Revolutionary Wave of Biologics Manufacturing: CDMOs Empower Large-Scale Production of Biologics". The report explores the role and importance of CDMOs, as well as the market growth, industrial trends, and the pioneer CDMO with ultra-large capacities.
I. CDMOs are advancing the biopharmaceutical industry with superior biomanufacturing capabilities
Production expansion for a more complex category of biologics is facilitated by a flourishing industry, accelerated drug approvals, and booming global demand for biosimilars. The global market size of biologics CDMOs has grown significantly from US$13.3 billion in 2018 to US$29.3 billion in 2022.
II. CDMOs are shifting towards scale production, flexible capacity, diverse product offerings, and customized services
With highly flexible biomanufacturing capabilities, CDMOs are expanding businesses to cover more client groups, drug types, and regions.
CDMOs serve clients of various scales including biopharmas and biotechs
As biopharmas encompass R&D, production, and commercialization, many favor an asset-light strategy that divests production activities and relies on outsourcing services to reduce costs. Small and medium-sized biotechs excel in innovation and primarily focus on the R&D stage. They depend on CDMO services to circumvent the time-consuming, costly, and risky nature of building their own production capacities.
Diversity is crucial as biologics have diversified production demands
Biopharmaceutical companies choose cost-effective production processes by considering factors such as yield, purity, and separation. Given the challenges in process development and production for different biologics types, specialized CDMO services for each type have emerged. Driven by diversified demands, more versatile CDMOs have also entered the industry. Their platforms encompass mammals, microorganisms, and gene therapies to meet R&D and production needs for clinical use of cellular and gene therapies (CGT), antibody-drug conjugates (ADC), and glucagon-like peptide-1 (GLP-1).
Regions vary in demands for biologics, and manufacturing capacities are shifting towards the Asia-Pacific region
According to Bioplan, global biologics manufacturing capacity expanded from 16.5 million liters in 2018 to 17.4 million liters in 2021. However, capacities are unevenly distributed. In 2021, 10.96 million liters were located in developed regions, including the United States, Canada, and Western Europe. CDMO services rise in the Asia-Pacific region. Global biopharmaceutical production capacity and consequently CDMOs are shifting towards this region as a result of continued efforts in improving infrastructure, industry chain supply, project management, quality management systems, and intellectual property protection.
III. Bioreactors offer various types suitable for both large-scale commercial production or small-and-medium-scale production
Facilities include bioreactors, solution conditioning systems, chromatography systems, membrane filtration systems, bulk fill systems, and packaging equipment. Among them, the critical bioreactors can be categorized into stainless steel bioreactors and single-use bioreactors based on materials.
Stainless steel and single-use bioreactors play differentiated roles in pharmaceutical manufacturing. Single-use bioreactors are predominantly utilized in the clinical stage, supporting small-batch productions from research to pilot scale. In contrast, during the commercialization stage, pharmaceutical companies prioritize process stability and cost efficiency.
IV. In the fourth revolutionary wave of biologics manufacturing, leading companies invest heavily in production capacity to remain competitive
The world's leading CDMOs are ramping up capacities for the large-scale commercial production of biologics. The construction of stainless steel bioreactors is an integral part of this effort. According to Bioprocess, the proportion of biologics manufacturing capacity utilizing mammalian cells supplied by outsourced contractors or hybrid manufacturers has grown from 27% in 2002 to 33% in 2022.
In 2023, BiBo Pharma, founded in Boston, USA, became the first in the world to deliver a new generation of ultra-large production platforms. The working volume of the main stainless steel reactor reached 30,000 liters and a total working volume exceeded 40,000 liters. This marked a new chapter in the biologics manufacturing industry. The global capacity gap and the need for cost reduction ignite the fourth wave for technological revolution, where production sites expand towards million-liter level.
V. BiBo Pharma pioneers the fourth revolutionary wave of biomanufacturing revolution with the world's first 30,000-liter ultra-large production platform
Sailing from Boston in 2014, BiBo Pharma has been committed to the commercial production of biologics, achieved through independent design and large-scale manufacturing via stainless steel bioreactors. The past decade has demonstrated that this strategy is well-aligned with the growing demand for commercial production in the biomanufacturing industry. Currently, BiBo Pharma is the first and only CDMO in the world to launch a new generation of ultra-large stainless steel bioreactors. This is a successful scale-up of the 15,000 liters commonly used in the commercial production of biologics, representing a more than two-fold increase in engineering scale.
BiBo Pharma has established a comprehensive quality and operation management system that meets international standards. This allows the company to provide efficient services to customers around the world. Since its founding, BiBo Pharma has offered CDMO services for more than 130 large molecule projects and is currently developing more than 20 projects at the commercial stage.
Source: Public Information
To read the full content, go here: https://www.frost.com/uncategorized/the-fourth-revolutionary-wave-of-biologics-manufacturing-cdmos-empower-large-scale-production-of-biologics/
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Contact: Qian Li
Company Name: Frost & Sullivan
Website: http://www.frostchina.com
Email: qian.li@frostchina.com
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