The global biologics CDMO market (henceforth, referred to as the market studied) was valued at USD 8.89 billion in 2019, and it is expected to reach USD 16.9 billion by 2025, registering a CAGR of 11.2% during 2020-2025
NEW YORK, Nov. 17, 2020 /PRNewswire/ -- The global biologics CDMO market (henceforth, referred to as the market studied) was valued at USD 8.89 billion in 2019, and it is expected to reach USD 16.9 billion by 2025, registering a CAGR of 11.2% during 2020-2025 (henceforth, referred to as the forecast period).?
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- The global pharmaceutical industry is growing at an exponential rate and is expected to reach USD 1.52 trillion in annual sales by 2023, 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. ?
- Even though volumes in large molecules tend to be smaller, the segment is growing at a faster pace. Absolute growth in the large molecules market, including both originator biologics, biosimilars, and cell and gene therapies, is projected at USD 133 billion by 2023. The market size for originator biologics is expected to reach USD 371 billion by 2023, according to Results Healthcare. ?
- 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 2018, the FDA approved 42 new small molecule products, whereas biologics approval amounted to just 17. However, the number of biologic approvals has been increasing steadily over the past few years.?
- 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. However, the drug shortages due to COVID-19 are limited, and they are expected to remain so for 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.?
- Since lockdowns were imposed, supply from Chinese manufacturing facilities were significantly reduced. The major extent has been a number of typical workforce who were unable to return to work, which led to underutilized efficiency across multiple levels in the industry. Furthermore, short-term scarcities were announced by the US Food and Drug Administration (FDA) back in February 2020, due to API manufacturing delays. ?
Key Market Trends
Biologics to Drive the Market
- Monoclonal antibodies or synthetic versions of the antibody have been representative of most successful therapeutic drug classes and attract 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 sue 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 the development of monoclonal antibody vectors free of any viral transforming functions or contamination from parental lines.?
- Recombinant biologics are being developed by a process 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.?
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 R&D expenditure of the total US pharmaceutical industry in 2018 was around USD 79.6 billion, 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.?
- 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.?
Competitive Landscape
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.
- Aug 2020 - The Lonza Group AG announced to collaborate with IsoPlexis to Enable the Next Generation of Precision Cell Therapy Manufacturing. The company plan utilize IsoPlexis IsoLight automated proteomics platform, to scale the manufacturing of cell therapies
- July 2020 - Boehringer Ingelheim, has acquired Global Stem cell Technology (GST), a Belgian veterinary biotech company. GST is dedicated to the research, development, and production of evidence-based, regenerative medicines (stem cell therapies) used to treat orthopedic and metabolic diseases in animals.
- May 2020 - WuXi Biologics and the Worcester Business Development Corporation (WBDC) announced the successful signing of a land deal for WuXi Biologics' clinical and commercial manufacturing facility (MFG11) in Worcester at The Reactory, a 46-acre master-planned biomanufacturing campus.
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