DUBLIN, May 18, 2022--(BUSINESS WIRE)--The "Biologics Global Market Report 2022: By Type, By Distribution, By Route, By Drug, By Mode" report has been added to ResearchAndMarkets.com's offering.
The global biologics market is expected to grow from $338.45 billion in 2021 to $382.04 billion in 2022 at a compound annual growth rate (CAGR) of 12.9%. The market is expected to reach $540.66 billion in 2026 at a CAGR of 9.1%.
Major companies in the biologics market include AbbVie, Johnson & Johnson, Amgen, Sanofi S.A, F. Hoffmann-La Roche Ltd., GlaxosmithKline, Novartis AG, Pfizer Inc., Teva Pharmaceuticals and CSL.
The biologics market consists of sales of biologics and related services by entities (organizations, sole traders and partnerships) that produce biologics to treat and prevent various microbial diseases and cancers. Biological products include a wide range of products such as vaccines, allergenics, somatic cells, tissues, and recombinant therapeutic proteins.
This industry includes establishments that produce products that are composed of sugars, proteins, nucleic acids, and combination of all these substances isolated from humans, animal and microorganisms or produced from biotechnology methods. Specifically, most biologic medicines are developed using recombinant DNA (rDNA) technology.
The main types of biologics are monoclonal antibodies (MAbS), therapeutic proteins and vaccines. Monoclonal antibodies, or mAbs, are created in a laboratory to combat a specific infection. The various route of administration includes oral, parenteral, and others that are distributed by hospital pharmacies, retail pharmacies/ drug stores and others.
North America was the largest region in the biologics market in 2021. Middle East is expected to be the fastest growing region in the forecast period. The regions covered in this report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East and Africa.
Technology is expected to be a continued driver of market growth during this period. An area of particular development is likely to be physiology simulation modeling. Markets such as this one will benefit from the greater efficiencies offered by developments in this area.
For example, Eli Lilly and Pfizer have adopted Amazon's Elastic Compute Cloud (EC2) platform to conduct simulation models in early drug discovery that have been operational within hours, whereas traditional models would have taken weeks to conduct simulations.
The Open Innovation Drug Discovery program is another initiative by Lilly to enhance the research and development of biologics. Such technological advances are likely to reduce costs and expedite the development phase of biologics, allowing companies to launch their products early.
The early generation of biologics is losing its patent protection and are expected to face greater competition going forward from the entry of biosimilars into the market. Biosimilars are the pharmaceuticals that are developed to have similar properties to a biologic drug that has already been approved.
Demand for biosimilars is being fueled by governments around the world trying to reduce healthcare costs. In India, a new biosimilar policy called the 'Guidelines on Similar Biologics' prepared by the Central Drugs Standard Control Organization (CSDCO) is expected to give a major boost to the Indian biosimilars industry.
In the EU, a pathway for approving biosimilar medicines has existed since 2003. These less expensive alternatives increase competitiveness for the biologics market putting downward pressure on pricing and market value growth.
The US Food and Drug Administration (FDA) has revised its regulations to eliminate outdated biologics requirements, thus allowing drug manufacturers to employ new manufacturing technologies and testing capabilities. Standard preparations (standard solutions containing a precisely known concentration of an element), which help to ensure safety, purity and potency of biologics can now be obtained from sources other than FDA's Center for Biologics Evaluation and Research (CBER), or can be developed internally by the biologics license applicant.
The FDA has also removed a rule (Section 610.21 of FDA code) which specifies minimal potency limits to be met for certain antibodies and antigens. In addition, FDA is also updating regulations (Section 610.53 of FDA code) regarding storage periods and storage conditions for biologics. These amendments in regulations are expected to increase regulatory flexibility by allowing the pharmaceutical industry and the FDA to incorporate current scientific technologies in the manufacture of licensed biological products.
Key Topics Covered:
1. Executive Summary
2. Report Structure
3. Biologics Market Characteristics
3.1. Market Definition
3.2. Key Segmentations
4. Biologics Market Product Analysis
4.1. Leading Products/ Services
4.2. Key Features and Differentiators
4.3. Development Products
5. Biologics Market Supply Chain
5.1. Supply Chain
5.3. End Customers
6. Biologics Market Customer Information
6.1. Customer Preferences
6.2. End Use Market Size and Growth
7. Biologics Market Trends And Strategies
8. Impact Of COVID-19 On Biologics
9. Biologics Market Size And Growth
9.1. Market Size
9.2. Historic Market Growth, Value ($ Billion)
9.2.1. Drivers Of The Market
9.2.2. Restraints On The Market
9.3. Forecast Market Growth, Value ($ Billion)
9.3.1. Drivers Of The Market
9.3.2. Restraints On The Market
10. Biologics Market Regional Analysis
10.1. Global Biologics Market, 2021, By Region, Value ($ Billion)
10.2. Global Biologics Market, 2016-2021, 2021-2026F, 2031F, Historic And Forecast, By Region
10.3. Global Biologics Market, Growth And Market Share Comparison, By Region
11. Biologics Market Segmentation
11.1. Global Biologics Market, Segmentation By Type, Historic and Forecast, 2016-2021, 2021-2026F, 2031F, $ Billion
Monoclonal Antibodies (MAbS)
11.2. Global Biologics Market, Segmentation By Distribution Channel, Historic and Forecast, 2016-2021, 2021-2026F, 2031F, $ Billion
Retail Pharmacies/ Drug Stores
11.3. Global Biologics Market, Segmentation By Route Of Administration, Historic and Forecast, 2016-2021, 2021-2026F, 2031F, $ Billion
11.4. Global Biologics Market, Segmentation By Drug Classification, Historic and Forecast, 2016-2021, 2021-2026F, 2031F, $ Billion
11.5. Global Biologics Market, Segmentation By Mode Of Purchase, Historic and Forecast, 2016-2021, 2021-2026F, 2031F, $ Billion
12. Biologics Market Segments
12.1. Global Monoclonal Antibodies (MAbS) Market, Segmentation By Type, 2016-2021, 2021-2026F, 2031F, Value ($ Billion) - Anti-Cancer MAbS; Immunological MAbS; Anti-Infective Monoclonal Antibodies (MAbs); Neuropharmacological MABS; Cardiovascular And Cerebrovascular MAbS; Other Monoclonal Antibodies (MAbs)
12.2. Global Therapeutic Proteins Market, Segmentation By Type, 2016-2021, 2021-2026F, 2031F, Value ($ Billion) - Metabolic Disorders Therapeutic Proteins; Cancer Therapeutic Proteins; Cardiovascular Therapeutic Proteins; Immunological Therapeutic Proteins; Other Therapeutic Proteins
12.3. Global Vaccines Market, Segmentation By Type, 2016-2021, 2021-2026F, 2031F, Value ($ Billion) - Anti-Infective Vaccines; Autoimmunity Vaccines; Other Vaccines
13. Biologics Market Metrics
13.1. Biologics Market Size, Percentage Of GDP, 2016-2026, Global
13.2. Per Capita Average Biologics Market Expenditure, 2016-2026, Global
Johnson & Johnson
F.Hoffmann-La Roche Ltd.
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