). The CMO/CDMO service sector is uniquely positioned to address some of the challenges that drug developers are facing amid the COVID-19 pandemic. This pandemic has impacted multiple aspects of the biopharma industry, from drug development, clinical trials, supplies, manufacturing, to supply chain logistics.
New York, July 01, 2021 (GLOBE NEWSWIRE) -- Reportlinker.com announces the release of the report "Biologics Contract Development and Manufacturing Organization (CDMO) Market - Growth, Trends, COVID-19 Impact, and Forecasts (2021 - 2026)" - https://www.reportlinker.com/p06030507/?utm_source=GNW
However, the drug shortages due to COVID-19 are limited, and they are expected to remain so for the short term, due to stockpiles of pharmaceuticals, APIs, globally. Among the issues being faced across the supply chains, China and India have been impacted the most due to being the largest global producers of active pharmaceutical ingredients (APIs) and generics.?
- The global pharmaceutical industry is growing at an exponential rate, which is driven by global economic growth, a growing and aging population, and new product launches. Even though small molecules continue to command the prominent share of the market, large molecules, such as biologics, biosimilars, and cell and gene therapies, are expected to witness the fastest growth over the forecast period.
- Cancer therapies are among the primary drivers for a large proportion of the growth in the biologics market. Even with the faster growth forecast, in terms of drug approvals, small molecules outweigh biologics. For instance, in 2020, the US Food and Drug Administration’s Center for Drug Evaluation and Research approved 53 new molecular entities (NMEs), of which 40, or 75%, were small molecules. This continues a recent trend of having approximately three-fourths of NME approvals be small molecules. In 2019, 79% of NME approvals were small molecules; in 2018, it was 71%, 74% in 2017, and 68% in 2016, when a recent low of 22 NMEs were approved.
- Top pharma companies’ propensity toward producing biologic drugs in-house is challenging the growth, as these drugs are high value, high margin products, owing to which large companies are focused on the security of supply, ensuring quality, IP protection of proprietary cell strains, and manufacturing process. For instance, unlike some of its peers in the drug industry, Pfizer has retained significant in-house manufacturing assets. It announced to make raw materials, the mRNA active, and finished doses for BNT162b2, the partnership’s vaccine, at its own plants in Andover, Massachusetts; Kalamazoo, Michigan, and St. Louis. It will also use its site in Belgium for the European market.
- However, pharma companies are more comfortable and willing to outsource the secondary manufacturing and packaging stages of their biologicsproducts even with the growing tendency to keep the biologic API production in-house. Another major factor influencing the growth in outsourcing of biologics to CDMO is the lack of available assets among CDMOs. This is expected to change over the next five years, due to the increasing investment from major CDMOs. For instance, Fujifilm Corp. is investing USD 928 million into Fujifilm Diosynth Biotechnologies, a CDMO for biologics and advanced therapies. This will double Denmark facility’s current drug substance manufacturing capacity, thus expanding its fill/finish and enhancing its assembly, labelling, packaging services.
- Further, Fujifilm Diosynth Biotechnologies also aims to build and open a mammalian cell culture facility in the United States in 2025. When the plant opens, it will boast eight 20,000 L stainless-steel bioreactor tanks for commercial drug substance manufacturing. It will also offer automated fill-finish and assembly, including packaging and labeling services.
- CDMOs are expected to form alliances and partnerships with pharma companies to expand and enhance their biologic services. For example, in August 2020, HJB, a biologics CDMO, entered a strategic partnership for CMC development and manufacturing with Ansun Biopharma on its therapeutic biologics pipeline.
- Furthermore, for technically difficult to manufacture products, such as biologics, where tech transfer can be a lengthy and expensive process, a single supplier relationship has the potential to reduce the risk of supply issues. The relationship should, in turn, create opportunities for the CDMO to sell more services to the same customer, as well as locking in products at an earlier stage in their life cycle.
Key Market Trends
Biologics to Drive the Market
- Monoclonal antibodies or synthetic versions of antibody have been representative of most successful therapeutic drug classes and attracts huge investment for the biologics industry. The use of monoclonal antibodies to treat diseases is called immunotherapy therapy because each type of monoclonal antibody will target a specifically targeted antigen in the body.
- Mammalian cells are traditionally used for monoclonal antibody production, however, plant-based expression systems have been gaining share due to significant advantages. The advancements in plant glycoengineering have allowed the production of monoclonal antibodies (mAbs) with more homogenous human-like glycans. iBio’s proprietary plant-based technology instead of CHO or other mammalian cell technologies led to the development of monoclonal antibody vectors free of any viral transforming functions or contamination from parental lines.
- Recombinant biologics are being developed by processes wherein a genetic code for a specific therapeutic protein is inserted into an expression vector’s DNA. The inserted DNA codes leads to recombinant protein being produced through replication in living host cells. Since the first recombinant therapeutic antibody (OKT3) in 1986, biologics products became a larger pharmaceutical industry percentage.
- Since biologics have been dominating the human drug development because of their long-lasting effects and ability to precisely address the molecular causes of disease, only one recombinant protein drug, an antibody, is available for veterinary use in the U.S. or EU.?
- Likewise, in February 2020, Invetx, invested USD 15 million Series A financing and undertook collaborations with WuXi Biologics and AbCellera. This is expected to drive clinical entry of a first therapeutic candidate and preclinical development of Invetx’s broader pipeline of protein-based therapeutics for Animal Biopharmaceutical Development.?
- According to the World Health Organization (WHO), as compared to the pharmaceutical market, the vaccine market is relatively small & concentrated on both supply and demand sides. Over time, the largest contract biologics manufacturers have been investing heavily in manufacturing capabilities to address unique product areas, including vaccines. And recently, the number of mergers and acquisitions and partnerships increased in light of new business models for vaccine research and development.
- In April 2020, Cytovance Biologics, a US-based CDMO and a subsidiary of the Shenzhen Hepalink Pharmaceutical Group Co., Ltd., entered into a collaboration agreement with Akshaya Bio, Inc., a Canadian development-stage biotechnology company. The latter would be provided with rapid access to clinical materials using Akshaya’s proprietary Chimigen Platform Technology for vaccine development for COVID-19 and HBV.
North America to Dominate the Market
- North America is one of the major markets for the biologics CDMO industry, owing to the presence of two major economies, such as the United States and Canada. The United States is home to one of the major pharmaceutical industries in the world and commands a significant share of the industry revenue; according to IQVIA, in 2019, the United States held about 48% of the global pharmaceutical market sales and seeing a steady growth in the last couple of years.?
- The United States is the world’s largest market for drugs and accounts for almost half of the R&D spending in pharmaceutical and biotechnology markets. Hence, biologic CDMOs play a critical role in this market and have invested in new facilities and technologies to cater to a wide range of outsourcers.?
- Moreover, the spending of the US pharmaceutical industry (PhRMA members) on R&D abroad totaled approximately USD 18.6 billion in 2019, according to PhRMA. With such a prominent presence in the market, the biologics CDMO vendors in the region are expected to scale up their presence and expand their capacities as well. For instance, AGC Biologics is looking to invest about USD 100 million into the AstraZeneca plant in Boulder; such developments are expected to increase over the coming years.
- Moreover, in August 2020, AGC Biologics, a global biopharmaceutical CDMO, partnered with Ono Pharmaceutical Co Ltd to manufacture its new biopharmaceutical at the clinical development stage. Such developments are expected to further increase over the coming years, further expanding the reach of CDMOs in biologics. Also, in December 2020, AGC Biologics announced its partnership with Laboratoire Pierre Fabre to manufacture ER-004, an intra-amniotic drug that would pioneer the treatment of a rare and debilitating genetic disorder.
- In addition to this, global biologics CDMO vendors are increasing their investments and are expanding their presence in the region. For example, in March 2020, Bora Pharmaceuticals expanded its footprint in North America. Over the coming years, CDMOs are expected to expand their presence in the region due to the growing health ailments and aging population.?
- Further, US-based KBI Biopharma announced plans to invest USD 150 million into a 140,000-square-foot commercial manufacturing facility in Research Triangle Park, North Carolina, to produce complex biologics including "therapeutic proteins" for a pharma partner. The newest facility would add 200 positions in operations and quality assurance, and is set to be operational in the first quarter of 2022. This site would complement KBI’s growing presence in clinical manufacturing after its parent company, Sunnyvale, California-based JSR Life Sciences, announced plans in October to boost its CDMO’s early-stage work in Geneva.
The Biologics Contract Development and Manufacturing Organization (CDMO) Market is highly fragmented and consists of several major players. They have adopted different strategies such as expansions, agreements, new product launches, joint ventures, acquisitions, partnerships, and others to expand their footprints in this market. Major players of the market include Boehringer Ingelheim Group, Wuxi Biologics, Samsung Biologics, Lonza Group, and Fujifilm Diosynth Biotechnologies USA Inc among others.
- March 2021 - WuXi Biologics has entered into an equity agreement with Pfizer China to acquire its state-of-the-art biologics manufacturing facilities and its labor force in Hangzhou, China. This will boost the commercial Drug Substance (DS) and Drug Product (DP) capacities for WuXi Biologics to address surging manufacturing demands.
- January 2021 - Boehringer Ingelheim entered into a strategic collaboration and licensing agreement with Enara Bio to research and develop novel targeted cancer immunotherapies, leveraging Enara Bio’s Dark Antigen discovery platform. The collaboration combines Boehringer Ingelheim’s approach to tackling cancer through pairing leading science with innovative immune-oncology platforms, such as oncolytic viruses and cancer vaccines, with Enara Bio’s expertise in cancer antigen identification.
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