The global biologics market is projected to grow at a CAGR of 8.68% to reach US$483.393 billion by 2026, from US$269.931 billion in 2019. Biologics are medicines that are made up of genetically modified proteins obtained from human DNA. Biologics can be made up of carbohydrates, proteins, nucleic acids, or complex mixtures of these chemicals, or living things like cells and tissues, according to the US FDA. The majority of biologics are complex mixes that are difficult to describe or identify, are heat sensitive, and are prone to microbial contamination. Biologic products come from a wide range of natural sources, including animals, people, and microbes. Biologics are made using modern biotechnology techniques and complicated procedures. During the COVID-19 pandemic, there had been a large need for biologics because of the rising COVID-19 load, which may fuel market expansion. For example, the National Research Council of Canada and CanSino Biologics, located in China, partnered in May 2020 on the clinical development of a COVID-19 vaccine in Canada. Ad5-nCoV is an adenovirus Type 5 vector-based vaccination that is now in Phase II development in Wuhan, China. As a result, the biologics market is projected to increase in the near future due to substantial research and development activity on biologics for the treatment of COVID-19.
Growing financial investment from important market participants, an increase in the burden of chronic illnesses, the loss of patent exclusivity for top biologic medicines, and rising demand and acceptability for novel therapies are all driving the industry. Vaccines, blood and blood components, allergenic, somatic cells, gene therapy, tissues, and recombinant therapeutic proteins are examples of biologics. The majority of biologics are complex mixes that are difficult to identify or describe, are heat sensitive, and are prone to microbial contamination. In the year 2018, due to increased demand for Merck's medicines and vaccines, the firm recently announced the construction of a second production unit for vaccines and biologics in Ireland. Chronic illnesses kill more than 41 million people each year, according to World Health Organization figures from 2018. The most common chronic disease, cardiovascular disease, kills 17.9 million people per year, followed by cancer (9.3 million), respiratory disorders (4.1 million), and diabetes (1.5 million). Eighty percent of all chronic disease fatalities are caused by these four categories. Non-communicable illnesses are caused by tobacco use, physical inactivity, alcohol use, and poor diets. Furthermore, the growing elderly population is more vulnerable to chronic illnesses, which contributes to an increase in biologics demand.
One of the major reasons for the growth of the global biologics market is the increasing technological advancements and robust research and development. These research and development efforts have resulted in higher success rates in biologics clinical trials. Market leaders in the biologics market do research and development as they try to achieve breakthroughs in the market in the form of new and effective biologics. Biocon Limited, for example, is working on tregopil, oral prandial insulin for the treatment of type 2 diabetes that is now in phase II/III clinical studies. Insulin tregopil is now being studied in Phase II/III clinical trials for Type 2 diabetic patients. Oramed Pharmaceuticals, located in Jerusalem, developed ORMD-0801, an oral insulin medication now in phase 2 studies to treat type 2 diabetes. The US Food and Medication Administration gave Novo Nordisk, a Danish multinational pharmaceutical firm, clearance to market its Rybelsus oral diabetic drug in September 2019. Rybelsus is an oral version of semaglutide that is used to treat type 2 diabetic patients. These advancements in technology have boosted the market growth of the global biologics market during the forecast period.
A major restraint in the growth of the global biologics market is the stringent regulatory requirements for biologics approval. In the projected term, the biologics market is expected to be hampered by strict rules placed on biologics approvals. The manufacture and use of biologics are governed by various regulations in different areas. Furthermore, difficulties such as patent infringement or contract concerns prevent biologics producers from commercializing government-approved biosimilars. These factors continue to hamper the growth of the global biologics market during the forecast period.
The COVID-19 impact on the global biologics market has been positive owing to the rise in the demand for biologics during the COVID-19 pandemic. The rising technological advancements and the growing research and development to develop vaccines for the virus have been extensive resulting in the increasing demand for biologics. With the increasing COVID-19 pandemic, businesses in the United States are rushing to produce COVID-19 vaccinations. For example, in March 2020, Kaiser Permanente Washington Health Research Institute (KPWHRI) in Seattle launched a Phase 1 clinical trial to investigate an experimental vaccination designed to protect against COVID-19. Scientists from the National Institute of Allergy and Infectious Diseases and its partners at the biotechnology firm Moderna Inc. are working on the vaccine. Also, the National Research Council of Canada and CanSino Biologics, located in China, partnered in May 2020 to develop a COVID-19 vaccine in Canada. Ad5-nCoV is an adenovirus Type 5 vector-based vaccination that is now in Phase II development in Wuhan, China. The surging demand for biologics during the course of the pandemic has fueled the market growth of the global biologics market.
The market leaders in the pretreatment coating market are F. Hoffmann-La Roche AG, Amgen Inc., AbbVie Inc., Novo Nordisk A/S, Johnson & Johnson, Takeda Pharmaceutical Company, Alexion Pharmaceuticals, Samsung Biologics, UCB S.A., Merck & Co. Inc, Eli Lilly, and Company, Sanofi SA
Growing financial investment from important market participants, an increase in the burden of chronic illnesses, the loss of patent exclusivity for top biologic medicines, and rising demand and acceptability for novel therapies are all driving the industry. Vaccines, blood and blood components, allergenic, somatic cells, gene therapy, tissues, and recombinant therapeutic proteins are examples of biologics. The majority of biologics are complex mixes that are difficult to identify or describe, are heat sensitive, and are prone to microbial contamination. In the year 2018, due to increased demand for Merck's medicines and vaccines, the firm recently announced the construction of a second production unit for vaccines and biologics in Ireland. Chronic illnesses kill more than 41 million people each year, according to World Health Organization figures from 2018. The most common chronic disease, cardiovascular disease, kills 17.9 million people per year, followed by cancer (9.3 million), respiratory disorders (4.1 million), and diabetes (1.5 million). Eighty percent of all chronic disease fatalities are caused by these four categories. Non-communicable illnesses are caused by tobacco use, physical inactivity, alcohol use, and poor diets. Furthermore, the growing elderly population is more vulnerable to chronic illnesses, which contributes to an increase in biologics demand.
Growth Factors
Technological advancements and robust research and development will lead to market growth
One of the major reasons for the growth of the global biologics market is the increasing technological advancements and robust research and development. These research and development efforts have resulted in higher success rates in biologics clinical trials. Market leaders in the biologics market do research and development as they try to achieve breakthroughs in the market in the form of new and effective biologics. Biocon Limited, for example, is working on tregopil, oral prandial insulin for the treatment of type 2 diabetes that is now in phase II/III clinical studies. Insulin tregopil is now being studied in Phase II/III clinical trials for Type 2 diabetic patients. Oramed Pharmaceuticals, located in Jerusalem, developed ORMD-0801, an oral insulin medication now in phase 2 studies to treat type 2 diabetes. The US Food and Medication Administration gave Novo Nordisk, a Danish multinational pharmaceutical firm, clearance to market its Rybelsus oral diabetic drug in September 2019. Rybelsus is an oral version of semaglutide that is used to treat type 2 diabetic patients. These advancements in technology have boosted the market growth of the global biologics market during the forecast period.
Restraints
Market restraints might be imposed by strict regulatory criteria for biologics approval
A major restraint in the growth of the global biologics market is the stringent regulatory requirements for biologics approval. In the projected term, the biologics market is expected to be hampered by strict rules placed on biologics approvals. The manufacture and use of biologics are governed by various regulations in different areas. Furthermore, difficulties such as patent infringement or contract concerns prevent biologics producers from commercializing government-approved biosimilars. These factors continue to hamper the growth of the global biologics market during the forecast period.
Impact of COVID-19 on the Biologics Market
The COVID-19 impact on the global biologics market has been positive owing to the rise in the demand for biologics during the COVID-19 pandemic. The rising technological advancements and the growing research and development to develop vaccines for the virus have been extensive resulting in the increasing demand for biologics. With the increasing COVID-19 pandemic, businesses in the United States are rushing to produce COVID-19 vaccinations. For example, in March 2020, Kaiser Permanente Washington Health Research Institute (KPWHRI) in Seattle launched a Phase 1 clinical trial to investigate an experimental vaccination designed to protect against COVID-19. Scientists from the National Institute of Allergy and Infectious Diseases and its partners at the biotechnology firm Moderna Inc. are working on the vaccine. Also, the National Research Council of Canada and CanSino Biologics, located in China, partnered in May 2020 to develop a COVID-19 vaccine in Canada. Ad5-nCoV is an adenovirus Type 5 vector-based vaccination that is now in Phase II development in Wuhan, China. The surging demand for biologics during the course of the pandemic has fueled the market growth of the global biologics market.
Competitive Insights
The market leaders in the pretreatment coating market are F. Hoffmann-La Roche AG, Amgen Inc., AbbVie Inc., Novo Nordisk A/S, Johnson & Johnson, Takeda Pharmaceutical Company, Alexion Pharmaceuticals, Samsung Biologics, UCB S.A., Merck & Co. Inc, Eli Lilly, and Company, Sanofi SA
Segmentation:
By Type
- Monoclonal Antibodies
- Vaccines
- Recombinant Proteins
- Gene Therapy
- Others
By Application
- Oncology
- Neurology
- Orphan Indications
- Infectious Diseases
- Others
By Geography
- North America
- USA
- Canada
- Mexico
- South America
- Brazil
- Argentina
- Others
- Europe
- UK
- Germany
- France
- Spain
- Others
- Middle East and Africa
- Saudi Arabia
- Israel
- Others
- Asia Pacific
- Japan
- China
- India
- Indonesia
- Taiwan
- Thailand
- Others
Table of Contents
1. Introduction
2. Research Methodology
3. Executive Summary
4. Market Dynamics
5. Global Biologics Market Analysis, by Product Type
6. Global Biologics Market Analysis, by Application
7. Global Biologics Market Analysis, by Geography
8. Competitive Environment and Analysis
9. Company Profiles
Companies Mentioned
- F. Hoffmann-La Roche AG
- Amgen Inc.
- AbbVie Inc.
- Novo Nordisk A/S
- Johnson & Johnson
- Takeda Pharmaceutical Company
- Alexion Pharmaceuticals
- Samsung Biologics
- UCB S.A.
- Merck & Co. Inc
- Eli Lilly and Company
- Sanofi SA
Methodology
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Table Information
| Report Attribute | Details |
|---|---|
| No. of Pages | 121 |
| Published | December 2021 |
| Forecast Period | 2019 - 2026 |
| Estimated Market Value ( USD | $ 269.93 Billion |
| Forecasted Market Value ( USD | $ 483.39 Billion |
| Compound Annual Growth Rate | 8.7% |
| Regions Covered | Global |
| No. of Companies Mentioned | 12 |
