The global biologics CDMO market (henceforth, referred to as the market studied) was valued at USD 9.93 billion in 2020, and it is expected to reach USD 18.90 billion by 2026, registering a CAGR of 11.2% during 2021-2026 (henceforth, referred to as the forecast period).?
- 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.?
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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1.1 Study Assumptions and Market Definition
1.2 Scope of the Study
2 RESEARCH METHODOLOGY
3 EXECUTIVE SUMMARY
4 MARKET DYNAMICS
4.1 Market Overview
4.2 Market Drivers
4.2.1 Access to New Technologies and Higher Speed of Execution Realized by CDMOs
4.2.2 Need for High Capital Investments to Develop Capabilities Has Led to Firms Choosing the Outsourcing Model
4.2.3 Lack of In-house Capacity among the Emerging Drug Development Companies
4.3 Market Challenges
4.3.1 Transfer Complexities and Concerns over the Breach of IP and Patents
4.3.2 Capacity Issues Related to Large-molecule Drugs
4.4 Market Opportunities
4.4.1 Emergence of the Concept of Biosimilars Co-development and Designer Cell Lines
4.5 Key Considerations Involved in the Selection of a Biologics CDMO Vendor
4.6 Business Model Analysis - Value Added, Flexible Capacity Risk Sharing, and In-time Manufacturing
4.7 Detailed Assessment of the Impact of COVID-19 on Biologics CDMO (The Race for the Development of a New Vaccine and Impact on the Current Capacities)
4.8 Key Trends in Biopharmaceutical Industry
4.9 Coverage on the Current Use of Biologics for Different Types of Disease Treatment - Oncology, Infectious, Cardiovascular, Etc.
5 MARKET SEGMENTATION
5.1.2 Non-mammalian (Microbial)
5.2 Product Type
22.214.171.124 Monoclonal (Diagnostic, Therapeutic, and Protein-based)
126.96.36.199 Recombinant Proteins
188.8.131.52 Antisense and Molecular Therapy
184.108.40.206 Other Biologics
5.3.1 North America
5.3.4 Latin America
5.3.5 Middle East and Africa
6 COMPETITIVE LANDSCAPE
6.1 Company Profiles
6.1.1 Boehringer Ingelheim Group
6.1.2 Wuxi Biologics
6.1.3 Samsung Biologics
6.1.4 Lonza Group
6.1.5 Fujifilm Diosynth Biotechnologies USA Inc.
6.1.6 Toyobo Co. Limited
6.1.7 Parexel International Corporation
6.1.8 PRA Health Sciences
6.1.9 Binex Co. Limited
6.1.10 JRS Pharma
6.1.11 Rentschler Biotechnologies
6.1.12 AGC Biologics
6.1.13 Sandoz Biopharmaceuticals
6.1.14 Catalent Inc.
6.1.15 AbbVie Contract Manufacturing
7 VENDOR MARKET SHARE
8 INVESTMENT ANALYSIS
9 MARKET OPPORTUNITIES AND FUTURE TRENDS
Secondary Research Information is collected from a number of publicly available as well as paid databases. Public sources involve publications by different associations and governments, annual reports and statements of companies, white papers and research publications by recognized industry experts and renowned academia etc. Paid data sources include third party authentic industry databases.
Once data collection is done through secondary research, primary interviews are conducted with different stakeholders across the value chain like manufacturers, distributors, ingredient/input suppliers, end customers and other key opinion leaders of the industry. Primary research is used both to validate the data points obtained from secondary research and to fill in the data gaps after secondary research.
The market engineering phase involves analyzing the data collected, market breakdown and forecasting. Macroeconomic indicators and bottom-up and top-down approaches are used to arrive at a complete set of data points that give way to valuable qualitative and quantitative insights. Each data point is verified by the process of data triangulation to validate the numbers and arrive at close estimates.
The market engineered data is verified and validated by a number of experts, both in-house and external.
REPORT WRITING/ PRESENTATION
After the data is curated by the mentioned highly sophisticated process, the analysts begin to write the report. Garnering insights from data and forecasts, insights are drawn to visualize the entire ecosystem in a single report.