Biologics CDMOs - A Trusted End-to-End CDMO Partner For Every Biopharmaceutical Development Journey

The Global Biologics CDMO Market pegged at US$ 18 billion (2020) is expected to witness a precipitous growth rate of ~15% from 2021 to 2031.

The advent of newer technologies such as viral vector, mRNA, cell & gene therapy where demand exceeds supply, limited capabilities of biopharmaceutical companies for these newer technologies, foray of several small & mid-sized companies with limited/no manufacturing & development capabilities, growing demand for biologics, strong product pipeline of different types of biologics, adoption of new technologies, rising investments & VC funding, increasing digitalization and rising collaborations among CDMOs & biotechnology companies are some of the pivotal factors propelling the growth of the Biologics CDMO market. However, capacity constraints and tech transfer complexities are likely to hinder the growth of the market to a certain extent.

Clairvoyance Research conducted an in-depth market analysis study of the Global Biologics CDMO Market. The study comprehensively analyzes the market from different perspectives and provides granular insights on hot revenue pockets, headwinds & tailwinds impacting the market, quantitative (market size & forecasts) and qualitative analysis on different segments, value chain analysis, technological advancements, Covid-19 impact assessment, key strategies, and competitive landscape.

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Single-Use Bioreactors – A Catalyst in Transformational Journey of Biologics CDMO

While the entire world is grappling with the ongoing COVID-19 pandemic and shortage of drugs & vaccines; CDMOs are becoming more & more efficient than ever in terms of biologics development. Many biopharmaceutical companies are turning to CDMOs to leverage the benefits of outsourced services. This paradigm shift and intense demand for biologics have brought about a significant change in the overall manufacturing requirements and forced CDMOs to look for flexible production capacity that will eventually drive the overall process efficiency. To fulfill these demands, CDMOs are exploring new advanced technologies such as single-use/disposable bioprocessing technologies that are easy-to-use and applicable from development to scale-up levels. Single-use technologies are well known for their role in reducing the risk of cross-contamination, labor requirement, and validation steps; thereby reducing the overall cost. It also reduces the overall timeline and benefits the biologics companies to maintain a competitive edge in the market.

“Single-use technologies allow us to offer our prospective clients faster process development with vendor-provided scale-down models, reduced risk of product cross-contamination, and simplified and often shorter investigations as a result of inherently less complex systems.”

                 - Business Development Director, Tier I CDMO, United States

Various CDMOs are also adopting hybrid arrangements i.e., using the combination of single-use and reusable bioreactors in the production line to enjoy advantages of both technologies, to make the process more efficient, and to pivot faster as per the clients’ needs.

Industry 4.0 Embraced by CDMOs to Fulfill & Satisfy Customer Demand

CDMOs adopting digitalization is at a competitive advantage when it comes to fulfilling the growing demands for biologics. Industry 4.0 allows CDMOs to deliver high-quality products more quickly, even with more complex biological systems. Industry 4.0 mainly involves the use of “smart” and autonomous systems to enhance the computer control of manufacturing. Many companies are using capabilities such as Big Data, AI, Advanced Analytics, IoT (Internet of Things), and Process Analytical Technologies (PAT) to differentiate themselves. Demand for high-quality products and information is leading to data-driven manufacturing, collection, and processing of real-time data at each step to increase the efficiency of the overall manufacturing process.

“For CDMOs, there is a push towards digitization, and exploring the potential value of technologies such as artificial intelligence and machine learning in a way that can improve manufacturing by reducing project timelines, while at the same time enhancing process efficiency and minimizing costs, as well as ensuring product quality.”

                  - Chief Commercial Officer, Leading CDMO, Germany

Moreover, apart from the adoption of technologies, the mergers and acquisitions (M&A) model is the latest trend that is being adopted to build platform services and end-to-end capabilities, which in turn is expected to fuel the growth of the market. M&A allows prominent players to expand their capabilities, capacities, service offerings, and deliver scale. It also allows companies to implement more effective supply chain strategies.

Tech Transfer Complexities – A Bottleneck for The Market

The key barrier faced while biopharmaceutical outsourcing is the molecules’ high transfer complexity. The main aim of technology transfer activities is to transfer product/process knowledge between development & manufacturing within or between manufacturing sites to achieve project realization. Owing to their complex structure, biopharmaceuticals require extremely sensitive production conditions. Pitfalls exist at every step when attempting to transfer biopharmaceuticals to a new production environment, may it be R&D to manufacturing, or from the originator company to a CDMO, it can be a high-risk task.

Snapshot - Competitive Landscape

The Biologics CDMO Market is marked by the presence of prominent players such as Catalent, Inc, Lonza, Thermo Fisher Scientific, Boehringer Ingelheim, Samsung Biologics, WuXi Biologics, Charles River, Oxford Biomedica, ABL, IDT Biologika, Emergent BioSolutions, Merck KGaA, AGC Biologics, Celltrion, Biovian, Avid Bioservices, BIOCENTRIQ, Novasep, SK bioscience, Minaris Regenerative Medicine, FUJIFILM Diosynth Biotechnologies., AbbVie Inc, among others.

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