Large Molecule Drug Substance CDMO Market Size, Share, Growth Analysis, By Service(Contract manufacturing and contract development), By Source(Microbial, mammalian) - Industry Forecast 2024-2031

Large Molecule Drug Substance CDMO Market size was valued at USD 10 billion in 2019 and is poised to grow from USD 10.86 billion in 2023 to USD 21 billion by 2031, growing at a CAGR of 8.6% in the forecast period (2024-2031).

The large molecule drug substance CDMO market is fragmented and highly competitive. Key industry players are focused on product developments, new product launches, and geographical expansions to gain a significant amount of market share. 'Lonza', 'Catalent', 'Samsung Biologics', 'WuXi Biologics', 'Boehringer Ingelheim', 'Cytiva (formerly GE Healthcare Life Sciences)', 'Thermo Fisher Scientific', 'AbbVie Contract Manufacturing', 'Fujifilm Diosynth Biotechnologies', 'AGC Biologics', 'Merck KGaA', 'Biogen', 'GSK Contract Manufacturing', 'Ajinomoto Bio-Pharma Services', 'Novartis Contract Manufacturing', 'Rentschler Biopharma', 'Syngene International', 'KBI Biopharma', 'JHL Biotech', 'Emergent BioSolutions'

Numerous companies have made large expenditures in the development of biologics and biosimilar substances since the epidemic. Currently, about half of the potential therapeutic candidates are biologics at the discovery stage, such as peptides, proteins, and monoclonal antibodies. Numerous innovative biologics are either being developed or are in the pipeline as a result of the increased investment in research and development by biopharmaceutical companies. Therefore, each of these reasons contributes to the expansion of the market for CDMOs for large molecular drugs.

The development of large molecule biopharmaceuticals and their expansion are hastening the evolution of commercial-scale manufacturing. Many high-value biologics don't have the same quantities or batch sizes as small-molecule medications, which is one difference. The emergence of small molecule inhibitors and antibody-drug conjugates (ADCs), which are fostering a more focused approach to cancer therapy, could be compared to this. Innovative start-ups and smaller businesses that lack the resources to invest in manufacturing capabilities or access to the knowledge necessary to guide their product from development through to commercialization are also heavily represented in the biologics market. For some businesses, trial supply, tech transfer, and scale-up may be completely uncharted territory. Businesses need to reevaluate their capabilities and make investments in new machinery, lines, procedures, and operational strategies in order to keep up with the trend towards more tailored therapies. There is a substantial danger for solitary CDMOs here. Even while they will need to concentrate their efforts on achieving the same efficiencies, saving APIs, reducing loss, and increasing yield, they will need to adapt to more adaptable and dynamic working methods to suit the demands of small-scale production. For contract producers, the market for high-potency APIs presents additional difficulties. Oncology medications, hormone products, and substances to treat organ rejection are driving significant expansion, which is being accompanied by heightened regulatory scrutiny. Effective containment techniques are needed in high-potency manufacturing to safeguard both the health of employees and patients.

In 2021, Asia Pacific accounted for approximately 35.0% of revenue, and it is expected to grow at the fastest rate (CAGR) during the projection period. The primary drivers of the regional market growth are a big patient base, lower total costs, a competent workforce, and changes in the regulatory environment. The region is thought to be the most desirable for contract manufacturing. Large patient populations and the opportunity for highly qualified medical personnel exist in the Asia Pacific region. When compared to western nations, the cost of producing and conducting a clinical trial is remarkably inexpensive. Additionally, organizations like Wuxi Biologics and Boehringer Ingelheim are always looking for ways to expand their services in this region. For instance, Wuxi Biologics established a biologics-integrated innovation hub in Hangzhou, China's Zhejiang province, in November 2020. This center will offer a variety of services, including manufacturing and process development.