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Oral Biologics & Biosimilars Global Market Report 2022

Oral Biologics & Biosimilars Global Market Report 2022

  • September 2022
  • 175 pages
  • ID: 6320343
  • Format: PDF
  • The Business Research Company


Table of Contents

Major players in the oral biologics & biosimilar drugs market are Novartis, Rani Therapeutics, Eli Lilly and Co., AstraZeneca plc, Novo Nordisk A/S, Biocon Limited, Oramed Pharmaceuticals, BiosanaPharma, Entera Bio Ltd., Allergan plc, and Emisphere Technologies.

The global oral biologics & biosimilars market is expected to grow from $4.24 billion in 2021 to $5.24 billion in 2022 at a compound annual growth rate (CAGR) of 23.4%. The oral biologics & biosimilars market is expected to grow to $9.44 billion in 2026 at a compound annual growth rate (CAGR) of 15.9%.

The oral biologics and biosimilar market consist of sales of oral biologics and biosimilar products and related services by entities (organizations, sole traders, partnership) used to treat chronic diseases such as diabetes, arthritis, and cancer.Biologics are drugs made from living cells using highly complex technology while biosimilars are created to function similarly to biologics but are not identical to biologics.

Biosimilars offer active properties as any licensed biological drug. The oral biologics and biosimilar market comprise biologics and biosimilar drugs taken orally for the targeted treatment of Alzheimer’s, multiple sclerosis, HIV/AIDS, and other serious conditions.

The main therapy types of oral biologics and biosimilar lymphocytes are modulators, interleukin inhibitors, and tumor necrosis factor-alpha inhibitors.Interleukin inhibitors are immunosuppressive drugs that stop interleukins from working.

The various diseases include asthma, Crohn’s disease, carcinoma, arthritis, diabetes, multiple myeloma, enterocolitis, multiple sclerosis, sarcoma, psoriasis, and others that are treated by molecular types such as vaccines, proteins and peptides, monoclonal antibodies, and other diseases. These are distributed through hospital pharmacies, retail pharmacies, and online pharmacies.

North America was the largest region in the oral biologics and biosimilar drugs market in 2021.The 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, the Middle East, and Africa.

The rising prevalence of chronic diseases such as arthritis, asthma, and cancer is expected to propel the growth of the oral biologics and biosimilar market.Long working hours, limited physical activity, and unhealthy eating and drinking habits contribute to the prevalence of chronic diseases, and biologics are increasingly used to treat these chronic diseases.

Biologics stimulate the immune system’s attack on cancer cells, aiding the body’s natural defenses in getting rid of the disease-causing cells.According to a United Nations article, a US-based intergovernmental organization, by 2030, chronic diseases are predicted to account for 70% of all fatalities worldwide.

It is anticipated that chronic disease will account for nearly 60% of all deaths worldwide. Therefore, the rise in the prevalence of chronic diseases is driving the growth of the biologics and biosimilar market.

Stringent regulations imposed on the approval of biosimilar are anticipated to hinder the growth of oral biologics and the biosimilar market in the forecast period.The governments of different regions impose different rules regarding the production and use of biologics and biosimilars.

Further, issues such as patent infringement or agreement issues restrict the manufacturers of biologics and biosimilars from commercializing the government-approved biosimilars.The US Food and Drug Administration requires a double regulatory approval for biosimilars, restricting the use of biosimilars as interchangeable drugs for biologics whereas, in Europe, the European Medicines Agency (EMA) approves biosimilars as interchangeable products for biologics.

In February 2019, out of the total 17 approved biosimilars only 7 biosimilars including 4 originating biologics could enter the US commercial market. The robust government policies for approval of these drugs impact the manufacturers in oral biologics and biosimilar markets.

The creation of new insulin biosimilar is a key trend gaining popularity in the oral biologics and biosimilar market.The key players operating in the oral biologics and biosimilar market are investing in creating a biosimilar copy of insulin to capture the market share.

For instance, in 2019, Mylan, a US-based pharmaceuticals company, in partnership with Biocon launched a biosimilar insulin glargine named Semglee in Australia.Biocon is an Indian-based biopharmaceutical company.

Also, in 2019, Oramed Pharmaceuticals, a Jerusalem-based pharmaceutical company developed an oral insulin drug named ORMD-0801 to treat type 2 diabetes. Thus, companies in the oral biologics and biosimilar market are investing in the trend of developing biosimilar of insulin to gain profit.

The countries covered in the oral biologics & biosimilar drugs market are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, the UK, and the USA.

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