ORAL BIOLOGICS MARKET ANALYSIS

The global oral biologics market is estimated to be valued at US$ 2.62 Bn in 2023 and is expected to exhibit a CAGR of 35.4% during the forecast period (2023-2030).

Analysts’ Views on Global Oral Biologics Market:

The rising number of patients with diabetes, hyperoxaluria, acromegaly, irritable bowel syndrome (IBS), and chronic idiopathic constipation for whom oral biologics are used for treatment. Thus, it offers the opportunity for various manufacturers to offer various oral biologics to treat these diseases.

Figure 1. Global Oral Biologics Market Share (%), By Drug Type, 2023

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Global Oral Biologics Market– Drivers

• Increasing prevalence of diabetes: The increasing prevalence of diabetes worldwide is expected to drive the market growth over the forecast period. For instance, according to an article published by the WHO (World Health Organization) in April 2023, diabetes cases increased from 108 million in 1980 to 422 million in 2014. Prevalence has risen faster in low- and middle-income countries than in high-income countries. Furthermore, according to the same source, diabetes caused a 3% increase in age-standardized death rates between 2000 and 2019. Diabetes-related mortality increased by 13% in lower-middle-income countries.
• Increasing research and development activities: Increasing research and development activities regarding oral biologics by market players is also expected to boost the global oral biologics market over the forecast period. For instance, in February 2023, Intralytix, Inc., a biotechnology company, initiated study on the safety and efficacy of oral biologic VRELysin in the treatment of Vancomycin-resistant enterococcal colonization. The study is in phase 2 of clinical trila and is expected to be completed in March 2025.

Figure 2. Global Oral Biologics Market Share(%), By Region, 2023

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Global Oral Biologics Market- Regional Analysis

Among regions, North America is estimated to hold a dominant position in the global oral biologics market over the forecast period. North America is estimated to hold 40.0% of the market share in 2023. The global oral biologics market is expected to witness significant growth in the coming years, driven by the high prevalence of Irritable Bowel Syndrome, favorable health reimbursement, and increased awareness. The increasing prevalence of irritable bowel syndrome (IBS) is contributing to the growth of the surgical equipment market in the North America region. For instance, according to the American College of Gastroenterology, 2020, about 10% to 15% of people in the U.S. suffer from IBS symptoms annually.

Global Oral Biologics Market– Impact of Coronavirus (COVID-19) Pandemic

Since the COVID-19 virus outbreak in December 2019, the disease has spread to over 100 countries across the globe, and the World Health Organization declared it a public health emergency on January 30, 2020.

COVID-19 affected the economy in three main ways: by directly affecting the production and demand of drugs, by creating disruptions in distribution channels, and through its financial impact on firms and financial markets. Due to nationwide lockdowns, several countries, such as China, India, Saudi Arabia, the U.A.E., Egypt, and others, are facing problems with the transportation of things from one place to another.

However, the COVID-19 pandemic impacted positively on the global oral biologics market as different types of biologics, such as monoclonal antibodies, were used to treat COVID-19. For instance, sotrovimab, a monoclonal antibody medication, has been conditionally recommended by the WHO for the treatment of mild or moderate COVID-19 in patients who are at high risk of hospitalization. This includes older individuals, immunocompromised people, patients with underlying illnesses like diabetes, hypertension, and obesity, as well as unvaccinated patients.

Global Oral Biologics Market Segmentation:

The global oral biologics market report is segmented by drug class, by disease indication, by distribution channel, and by region.

• By Drug Class , the market is segmented into glucagon-like peptide 1 (GLP-1) receptor agonist, hormone, recombinant enzyme, guanylate cyclase-C agonist, somatostatin analogue, and others. Out of which, the hormone is expected to hold a dominant position in the global oral biologics market during the forecast period, and this is attributed to the increasing product launches.
• By Disease Indication, the market is segmented into diabetes, hyperoxaluria, acromegaly, irritable bowel syndrome (IBS) & chronic idiopathic constipation (CIC), and others (inflammatory bowel disease (IBD), hypoparathyroidism, and others. Out of which, diabetes is expected to dominate the market over the forecast period, and this is attributed to the increasing prevalence of diabetes.
• By Distribution Channel, the market is segmented into hospital pharmacies, retail pharmacies, and online pharmacies. Out of which, retail pharmacies is expected to dominate the market over the forecast period, and this is attributed to the launch of new retail pharmacies.

Among all the segmentation, the disease indication segment is expected to dominate the market over the forecast period, and this is attributed to the increasing prevalence of different diseases.

Global Oral Biologics Market- Cross Sectional Analysis:

In drug class, hormone segment is expected to dominate the market in the North America region, and this is attributable to the increasing product approvals from regulatory authorities. For instance, in December 2020, Myovant Sciences, a biopharmaceutical company, announced that the U.S. FDA approved Orgovyx (relugolix), the first oral hormone therapy for treating advanced prostate cancer.

Global Oral Biologics Market: Key Developments

In January 2020, the European Medicines Agency recommended granting a marketing authorization in the European Union (EU) for oral Rybelsus (semaglutide) for the treatment of adults with insufficiently controlled type 2 diabetes to improve glycaemic control as an adjunct to diet and exercise. Rybelsus is the first glucagon-like peptide (GLP-1) receptor agonist treatment, a class of non-insulin medicines for people with type 2 diabetes.

In June 2020, the U.S. FDA approved MYCAPSSA, the first and only oral somatostatin analogue (SSA), for the long-term maintenance treatment of acromegaly patients who had responded to and tolerated treatment with octreotide or lanreotide. The Mycapssa is manufactured by Chiasma, Inc., a commercial-stage biopharmaceutical company.

In February 2022, Rani Therapeutics Holdings, Inc., a clinical-stage biotherapeutics company, announced the development of RaniPill HC, a high-capacity oral biologics device. The newly launched RaniPill HC is capable of delivering up to a 500%-plus higher drug payload than Rani’s existing oral biologic capsule.

Global Oral Biologics Market: Key Trends

Increasing number of partnerships between the key market players

An increasing number of partnerships between the key market players is expected to boost market growth over the forecast period. For instance, in June 2023, Rani Therapeutics Holdings, Inc. announced that the company had extended its existing partnership with Celltrion, a biopharmaceutical company, by entering into an agreement for the development of RT-105, an orally administered adalimumab biosimilar.

Global Oral Biologics Market: Restraint

Product recalls by the manufacturers

Voluntary recalls of oral biologics such as hormones are expected to hinder market growth over the forecast period. For instance, in May 2020, Pfizer, a U.S.-based biotechnology company, announced a voluntary recall of Duavee, an estrogen-based menopause hormone therapy, to ensure product stability throughout its shelf life.

The manufacturing companies are expected to standardize the manufacturing and production processes of the drugs to ensure product quality and stability throughout  their shelf life.

Global Oral Biologics Market - Key Players

Major players operating in the global oral biologics market Novo Nordisk A/S, Biocon Limited, Oramed Pharmaceuticals, Inc., Rani Therapeutics, Entera Bio Ltd., AbbVie Inc., Enteris BioPharma, Inc., Chiasma, Inc. and Allena Pharmaceuticals, Inc.

*Definition: Biologics drugs can be defined as molecules derived from living cells such as microorganism, plant, or animals and used for the treatment, diagnosis, or prevention of various diseases. Biologic therapeutics has proven to be a highly effective treatment for various chronic ailments, such as diabetes, plaque psoriasis, arthritis, Crohn’s disease, and ulcerative colitis.