Frost & Sullivan Reported The Fourth Revolutionary Wave of Biologics Manufacturing: CDMOs Empower Large-scale Production of Biologics

Frost & Sullivan

2024-05-29 14:08 1771

SHANGHAI, May 29, 2024 /PRNewswire/ -- Recently, Frost & Sullivan released the report "The Fourth Revolutionary Wave of Biologics Manufacturing: CDMOs Empower Large-scale Production of Biologics".

I. CDMOs are advancing the biopharmaceutical industry with superior biomanufacturing capabilities

According to Frost & Sullivan analysis, production expansion for a more complex category of biologics, is facilitated by the flourishing industry, accelerated drug approvals, and booming global demand for biosimilars. This is an opportunity for biologics CDMOs who can address the high costs of self-built production lines, limited experiences in R&D and production, and other challenges faced by traditional pharmaceutical companies. The global market size of biologics CDMOs has grown significantly from US$13.3 billion in 2018 to US$29.3 billion in 2022 and is projected to reach US$58.1 billion by 2026 and US$100.4 billion by 2030.

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 rely 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.

Order-driven CDMOs should deepen cooperation with biopharmas and accelerating efforts to serve more small and medium-sized biotechs. These pose challenges to the scale production and flexibility of CDMOs.

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. Establishing international production facilities and R&D centers are essential strategies for CDMOs in the Asia-Pacific region to enter the global market.

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. Stainless steel bioreactors offer superior efficiency and economic benefits when it comes to large-scale commercial production.

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. Top CDMOs such as Lonza, Samsung Biologics, Boehringer Ingelheim, and Fujifilm Diosynth, each with stainless steel bioreactors exceeding 10,000 liters, have announced their ambitious expansion plans since 2021, with an estimated total investment of $12.6 billion and total added capacities of more than 1.7 million liters. This demonstrated their strong momentum in the biologics market. In this context, CDMOs have become a dominant force in scale production. 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 and is expected to reach 44% by 2025.

Breakthroughs in innovative production platforms, operation models, and capacity planning have been indispensable throughout its history. Between 1980 and 2000, manufacturing capacity relied on the self-built systems consisting of hundred-liter bioreactors, resulting in a highly fragmented market. As some companies began to outsource their excess capacity, CDMOs emerged as a new force in the industry.

Subsequently, the industry experienced the first wave of significant growth, with the second wave of development occurring between 2000 and 2010 and the third leap from 2010 to the present. During this period, bioreactor capacities increased from hundred-liter to thousand-liter and ten-thousand-liter. The capacity of a single production site now exceeds 100,000 liters.

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. This breakthrough not only surpasses industry standards but also offers a potential solution to reduce costs.

BiBo Pharma adopted the distinctive PanFlex^®-Engineering technology system. This system balances efficiency improvement and cost control on the basis of ensuring independently designed core equipment and a controllable supply chain. Remarkably, it took only half the time and half the cost of similar projects worldwide. During the transition from engineering project to GMP production, BiBo Pharma leveraged the PanFlex^®-Operation system to achieve successful production in March 2024 when the platform was put into operation for the first time. Subsequent productions maintained a success rate of 100%, marking an engineering and production milestone.

BiBo Pharma has established a comprehensive quality and operation management system that meets the 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.

With the world's first and only 30,000-liter production platform as its core strength, combined with tiered production capacities and diversified technology platforms, BiBo Pharma will empower more global biopharmaceutical companies to succeed in both clinical and commercial endeavors through high-quality, efficient, and cost-effective CDMO services.