Summary
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 global biologics market is expected to grow from $382.04 billion in 2022 to $416.65 billion in 2023 at a compound annual growth rate (CAGR) of 9.1%. The Russia-Ukraine war disrupted the chances of global economic recovery from the COVID-19 pandemic, at least in the short term. The war between these two countries has led to economic sanctions on multiple countries, a surge in commodity prices, and supply chain disruptions, and affecting many markets across the globe. The biologics market is expected to reach $599.62 billion in 2027 at a CAGR of 9.5%.
The biologics market consists of sales of Tumor necrosis factor inhibitors, Interleukin inhibitors, B-cells inhibitors, and T-cells inhibitors.Values in this market are ‘factory gate’ values, that is the value of goods sold by the manufacturers or creators of the goods, whether to other entities (including downstream manufacturers, wholesalers, distributors and retailers) or directly to end customers.
The value of goods in this market includes related services sold by the creators of the goods.
Biologics are medications made from organic materials that can be used to treat a wide range of illnesses, and they are frequently used to treat immune-related illnesses such Crohn’s disease, psoriasis, ankylosing spondylitis, and rheumatoid arthritis. The interesting aspect is that biologics are separated from various natural sources, whether they be carbohydrates, proteins, nucleic acids, or a complex mixture of these materials.
North America was the largest region in the biologics market in 2022.Middle East is expected to be the fastest growing region in the forecast period.
The regions covered in the biologics market report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East and Africa.
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.
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 is expected to face greater competition going forward from the entry of biosimilars into the market.Biosimilars are pharmaceuticals that are developed to have similar properties to a biological 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 the competitiveness of 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 the 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) that 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.
The countries covered in the biologics market report are Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Hong Kong, India, Indonesia, Ireland, Israel, Italy, Japan, Malaysia, Mexico, Netherlands, New Zealand, Nigeria, Norway, Peru, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, Turkey, UAE, UK, USA, Venezuela and Vietnam.
The market value is defined as the revenues that enterprises gain from the sale of goods and/or services within the specified market and geography through sales, grants, or donations in terms of the currency (in USD, unless otherwise specified).
The revenues for a specified geography are consumption values that are revenues generated by organizations in the specified geography within the market, irrespective of where they are produced. It does not include revenues from resales along the supply chain, either further along the supply chain or as part of other products.
The biologics market research report is one of a series of new reports that provides biologics market statistics, including biologics industry global market size, regional shares, competitors with a biologics market share, detailed biologics market segments, market trends, and opportunities, and any further data you may need to thrive in the biologics industry. This biologics market research report delivers a complete perspective of everything you need, with an in-depth analysis of the current and future scenarios of the industry.
