Oral Biologics Market – Global Industry Insights, and Opportunity Analysis, 2025

Oral biologics represent a novel category of drugs, which is gaining traction in the last few decades. Biologic therapeutics has proven to be a highly effective treatment for various chronic ailments, such as diabetes, plaque psoriasis, arthritis, plaque psoriasis, Crohn’s disease, and ulcerative colitis. The major concern regarding oral biologics is to protect the protein from degradation and digestion in the gastrointestinal tract. The first products were mostly insulin-related, novel peptides and protein are appearing in the market currently. For instance, antibodies and their derivatives, particularly human monoclonal antibodies are the most rapidly growing category. Moreover, small interfering RNA, enzymes, cytokines, and various type of peptide drugs are the most studied biological therapeutics. Rapid discoveries of new drug targets, effective engineering processes, and knowledge of the fate of biologics in the human body is resulting in increased number of biologics in the market. Among the therapies, proteins and monoclonal antibodies are expected to fuel the growth of oral biologics market in near future, due to their high selective and potent therapeutic efficacy with limited side effects.

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Advance drug formulation and increase compliance of oral biologics is expected to accelerate the growth of oral biologics market in near future

Oral delivery of drugs is the most preferred route of administration by both patients and the manufacturers. Convenience and ease are the major requirements for patients leading to higher medicine adherence. The production cost for the oral dosage is low from other options and offer the greatest adaptability with respect to optimization of drug delivery. The greatest challenge of oral administration of biologic APIs is absorption across the gastrointestinal (GI) tract specifically in the small intestine, which has the highest permeability for the drugs as compared to the large intestine. Large size and polar surface of biomolecules are difficult to diffuse across the epithelial layer. Drug formulations are focusing on the overcoming of various physiochemical challenges by permeation enhancer, enzyme inhibitors, and encapsulation. Encapsulation is a protective covering that helps to prevent chemicals and enzymatic degradation. For instance, Rani Auto Pill, 2012, is an ordinary robotic capsule delivered in the intestine without exposing the drug to the digestive enzymes. It is incorporated with number of innovations enabling it to navigate through the stomach, which enters small intestine and undergoes transformation to deliver the drug into the intestine, such innovative products are expected to boost growth of market in near future. Currently, insulin buccal sprays, inhaled insulin, nanotechnological systems, phytobiochemicals, and oral insulin are under clinical trials. For instance, Nova Nordisk is bringing its latest oral version GLP-1, type-2 diabetes medication in early 2018 in partnership with Emisphere technologies.

Geographically, North America is expected to be the major consumer of innovative products, followed by Europe. These are the primary launch targets for manufacturers as they generate maximum revenues for the company. Therefore, this regions are the fastest growing markets and are expected to retain their position in near future. In 2016, around 50% of the Food and Drug Administration (FDA) approvals were for biologics. Asia Pacific region is expected to show slow growth in oral biologics market, due to higher cost of the biologics.

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Collaboration and innovation are expected to be the major strategies of the oral biologics market players

The major key players operating the oral biologics market include AstraZeneca plc, Eli Lilly and Co., GlaxoSmithKline plc, Novartis AG, Novo Nordisk, and Rani Therapeutics, LLC. Innovation and collaboration are expected to be the major strategies to combat the oral biologics market. For instance, Rani Therapeutics announced collaboration with Medimmune in 2016, research and development arm of AstraZeneca globally to evaluate Rani’s novel oral drug delivering platform. This collaboration is expected to conduct feasibility studies of the drug and test biologic molecules in the area of metabolic disease to evaluate the oral delivery of the molecules. The objective of this collaboration is to deliver biologics orally, which is expected to increase the compliance and improve the patient lives globally.

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