Oral Biologics & Biosimilar Drugs Global Market Report 2024

The oral biologics & biosimilar drugs market size has grown exponentially in recent years. It will grow from $5.94 billion in 2023 to $7.19 billion in 2024 at a compound annual growth rate (CAGR) of 21.0%. The growth observed in the historical period can be attributed to several factors, including an increased prevalence of chronic diseases, heightened awareness surrounding oral biologics, the expiration of patents on existing medications, and an escalating demand for biosimilars.

The oral biologics & biosimilar drugs market size is expected to see exponentially grown in the next few years. It will grow to $13.32 billion in 2028 at a compound annual growth rate (CAGR) of 16.7%. Anticipated growth in the forecast period is driven by several factors, notably the expansion of targeted therapy, a growing emphasis on preventive medicine, increased healthcare expenditures, and an aging population. Major trends expected during this period encompass advancements in oral delivery technology, the development of orally administered biologics, innovative strides in biosimilars, and a shift towards patient-centric care models.

The prevalence of chronic conditions like arthritis, asthma, and cancer is anticipated to drive growth in the oral biologics and biosimilar market. Factors such as extended work hours, limited physical activity, and unhealthy dietary habits contribute to the rise in chronic diseases, and biologics are increasingly utilized for their treatment. These medications trigger the immune system to combat cancer cells, aiding in their elimination. The United Nations projects that by 2030, about 70% of global deaths will be attributed to chronic diseases, with the global burden of these conditions expected to reach approximately 60%. Consequently, the surge in chronic diseases is expected to fuel demand for biologics and biosimilars, spurring growth in the oral biologics and biosimilar drugs market.

The escalating demand for personalized medicine is set to propel growth in the oral biologics and biosimilar drugs market. Personalized medicine involves tailoring medical decisions and drug therapies to individual patients. This approach aligns with the development and utilization of oral biologics and biosimilars, optimizing treatment efficacy while minimizing side effects and reducing trial-and-error methods, leading to higher response rates and extended survival. Reports by STAT in October 2022 indicated over 75,000 genetic testing products and 300 personalized medicines, underscoring the increasing demand for personalized medicine driving growth in the oncology molecular diagnostics market. A noteworthy trend in the oral biologics and biosimilar market is the creation of new insulin biosimilars. Key market players are investing in developing biosimilar versions of insulin, fostering competition among different biosimilar manufacturers. For instance, in April 2023, Eli Lilly and Company introduced Rezvoglar (insulin glargine-aglr), a biosimilar of insulin glargine used for improving glycemic control in adults, children, and infants with type 1 diabetes, as well as adults with type 2 diabetes.

Major players in the oral biologics and biosimilar market are concentrating on innovative products like interchangeable biosimilars to drive market revenues. Interchangeable biosimilars meet specific regulatory requirements, allowing them to be substituted for the reference biologic product without the intervention of the prescribing healthcare provider. For example, in November 2021, Viatris Inc. And Biocon Biologics Limited launched SEMGLEE (insulin glargine-yfgn) injection and Insulin Glargine (insulin glargine-yfgn) injection. These interchangeable biosimilars aid adults with type 2 diabetes and children with type 1 diabetes in managing high blood sugar, substituting for the reference brand LANTUS (insulin glargine) and available in vial and prefilled pen formats for pharmacy counter substitution.

Major companies operating in the oral biologics & biosimilar drugs market include Novartis International AG, Rani Therapeutics Holdings Inc., Eli Lilly and Company, AstraZeneca PLC, Novo Nordisk A/S, Biocon Limited, Oramed Pharmaceuticals Inc., BiosanaPharma, Entera Bio Ltd., Allergan PLC, Emisphere Technologies Inc., Enteris BioPharma Inc., Chiasma Inc., Allena Pharmaceuticals Inc., Gelgen Corporation, Ganlee Corporation, 3SBio Inc., Innovent Biologics Inc., Retractable Technologies Inc., Changchun High & New Technology Industries (Group) Inc., Dong Bao Pharmaceutical Co. Ltd., CP Guojian Pharmaceutical Co. Ltd., GlaxoSmithKline PLC, Concord Biotech Limited, Aurobindo Pharma Limited, H. Lundbeck A/S, Sanofi S.A., F. Hoffmann-La Roche Ltd., Allergan Pharmaceuticals International Limited, Hikma Pharmaceuticals PLC, Mylan N.V., Pfizer Inc., Sandoz International GmbH, Teva Pharmaceutical Industries Ltd.

North America was the largest region in the oral biologics and biosimilar drugs market in 2023. The Middle East is expected to be the fastest growing region in the oral biologics & biosimilar drugs market report during the forecast period. The regions covered in the oral biologics & biosimilar drugs market report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East, and Africa.

The countries covered in the oral biologics & biosimilar drugs market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA, Italy, Spain, Canada. The oral biologics and biosimilar market consist of sales of therapeutic proteins, cystic fibrosis, somatic cells, and allergenics. 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.

Within therapy types, there are oral biologics and biosimilars categorized as lymphocyte modulators, interleukin inhibitors, and tumor necrosis factor-alpha inhibitors. Interleukin inhibitors are immunosuppressive drugs that hinder interleukins' functionality. Interleukins are a group of cytokines generated by lymphocytes, monocytes, macrophages, and various other cells, crucial in regulating the immune system. These drugs treat various conditions such as asthma, Crohn’s disease, carcinoma, arthritis, diabetes, multiple myeloma, enterocolitis, multiple sclerosis, sarcoma, psoriasis, and others. They are available in forms like vaccines, proteins, peptides, monoclonal antibodies, distributed through hospital pharmacies, retail pharmacies, and online pharmacies.

The oral biologics and biosimilar market research report is one of a series of new reports provides oral biologics and biosimilar market statistics, including oral biologics and biosimilar industry global market size, regional shares, competitors with an oral biologics and biosimilar market share, detailed oral biologics and biosimilar market segments, market trends and opportunities, and any further data you may need to thrive in the oral biologics and biosimilar industry. This oral biologics and biosimilar 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.

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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