Biobetters Market Report 2025

This Biobetters market report provides a comprehensive analysis of the market’s characteristics, size, and growth, including segmentation, regional and country-level breakdowns, competitive landscape, market shares, trends, and strategies. It also tracks historical and forecasted market growth across various geographies.

The biobetters market size has grown rapidly in recent years. It will grow from $67.81 billion in 2024 to $75.98 billion in 2025 at a compound annual growth rate (CAGR) of 12%. The growth in the historic period can be attributed to increased understanding of disease mechanisms, growing healthcare expenditure, enhanced manufacturing technologies, technological innovations in drug delivery, advancements in protein engineering, increased demand for improved therapeutic efficacy.

The biobetters market size is expected to see rapid growth in the next few years. It will grow to $118.2 billion in 2029 at a compound annual growth rate (CAGR) of 11.7%. The growth in the forecast period can be attributed to advancements in biotechnology, growing emphasis on personalized medicine, expanding pipelines of biopharmaceutical companies, rising prevalence of chronic diseases, favorable regulatory landscapes, heightened investments in research and development, advance healthcare infrastructure. Major trends in the forecast period include development of novel biobetters, protein engineering and rational design, focus on therapeutic areas, advanced healthcare infrastructure, development of next-generation sequencing (NGS) technologies,advances in high-throughput screening (HTS) technologies.

The increasing prevalence of chronic kidney disease (CKD) is expected to drive the growth of the biobetters market. CKD is a long-term condition that leads to kidney dysfunction, ultimately causing kidney failure. The rise in CKD cases can be attributed to aging populations, higher rates of diabetes and hypertension, poor diet, sedentary lifestyles, environmental pollution, and improved diagnostic technologies. Biobetters offer enhanced efficacy, fewer side effects, better dosing regimens, and improved stability compared to original biologic treatments, making them an effective option for managing CKD and improving patient outcomes. For example, in June 2023, Oxford Academic, a research platform of Oxford University Press, projected a 4% increase in CKD prevalence in the UK, from 8.27 million to 8.61 million people between 2022 and 2032. The distribution across stages in 2032 is expected to be 30.36% for stage 1, 21.07% for stage 2, 29.78% for stage 3a, 11.86% for stage 3b, 4.15% for stage 4, and 2.78% for stage 5. As a result, the rising incidence of chronic kidney diseases is driving the growth of the biobetters market.

The rising prevalence of autoimmune diseases is anticipated to drive the growth of the biobetters market. Autoimmune diseases occur when the immune system mistakenly attacks healthy cells. The increasing incidence of these conditions can be attributed to factors such as genetic predisposition, environmental influences, and lifestyle changes. Biobetters offer improved efficacy, fewer side effects, better dosing regimens, and enhanced stability compared to original biologic treatments, making them more effective and better tolerated for managing autoimmune disorders. For example, in December 2023, the Australian Institute of Health and Welfare (AIHW), a government agency focused on public health, reported that rheumatoid arthritis accounted for 2% of the total disease burden in 2023. In 2021, the condition caused 1,145 deaths, equivalent to 3.2 deaths per 100,000 people, representing 0.7% of all fatalities. Additionally, in September 2023, the Impact of IBD Report 2023 from the IBD Clinical and Research Centre in Canada highlighted that over 320,000 people in Canada suffer from inflammatory bowel disease (IBD), with a prevalence of 825 per 100,000 people in 2023. The prevalence is projected to increase by 2.44% annually, meaning that by 2035, 1.1% of the Canadian population, or around 470,000 people, will be living with IBD. As a result, the growing prevalence of autoimmune diseases is driving the expansion of the biobetters market.

Major companies in the biobetters market are developing biobetters for subcutaneous administration to improve patient convenience, enhance therapeutic outcomes, and reduce healthcare costs. Subcutaneous administration of biobetters offers a more convenient alternative to intravenous infusion, potentially improving patient compliance and healthcare delivery efficiency. For instance, in May 2023, Celltrion, a South Korean-based biopharmaceutical company, obtained approval from the Brazilian Health Regulatory Agency for their Remsima SC biobetters. This innovative biobetter version of their infliximab biosimilar, Remsima, is the world's only infliximab offering subcutaneous administration. Remsima SC improves upon a biosimilar by enhancing its accessibility and effectiveness, specifically indicated for inflammatory bowel diseases, including Crohn's disease and ulcerative colitis. Remsima SC offers patients a more convenient and potentially more effective treatment option.

Major companies operating in the biobetters market are Pfizer Inc., Johnson & Johnson, Merck & Co Inc., AbbVie Inc., Bayer AG, Sanofi Aventis LLC, Bristol-Myers Squibb Company, Novartis AG, GlaxoSmithKline plc, F Hoffmann La Roche Ltd., Eli Lilly and Co Ltd., Gilead Sciences Inc., Amgen Inc., Teva Pharmaceutical Industries Ltd., Regeneron Pharmaceuticals Inc, CSL Behring GmbH, Biogen Inc., GRIFOLS USA LLC, Celltrion Inc., Lonza Group AG, Ionis Pharmaceuticals Inc., Incyte Corporation, Amicus Therapeutics Inc., Genentech Inc., Sun Pharmaceutical Industries.

North America was the largest region in the biobetters market in 2024. Asia-Pacific is expected to be the fastest-growing region in the forecast period. The regions covered in the biobetters market report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East, Africa. The countries covered in the biobetters market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA, Canada, Italy, Spain.

Biobetters are biologic drugs that are similar to existing biologics but have been enhanced to offer improved efficacy, safety, or other clinical benefits. These enhancements may include better dosing regimens, reduced side effects, increased stability, or more convenient administration methods, providing a competitive edge over the original biologics.

The main drug classes of biobetters include erythropoietin biobetters, granulocyte-colony stimulating factor (G-CSF) biobetters, interferon biobetters, insulin biobetters, monoclonal antibody biobetters, antihemophilic factors, and others. Erythropoietin biobetters are enhanced versions of erythropoietin, a hormone that increases red blood cell production. Various routes of administration for biobetters include oral, subcutaneous, inhaled, and intravenous. These drugs address a range of disease indications such as diabetes, cancer, renal disease, neurodegenerative diseases, genetic disorders, and hemophilia. They are distributed through various channels, including hospital pharmacies, retail pharmacies, and online pharmacies.

The biobetters market research report is one of a series of new reports that provides biobetters market statistics, including biobetters industry global market size, regional shares, competitors with a biobetters market share, detailed biobetters market segments, market trends and opportunities, and any further data you may need to thrive in the biobetters industry. This biobetters market research report delivers a complete perspective of everything you need, with an in-depth analysis of the current and future scenario of the industry.

The biobetters market consists of sales of next-generation biologics, improved formulation products, and biosimilar drugs. 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.

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.

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