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.
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.
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.
Global
Oral Biologics Market Taxonomy -
By
Therapy Type:
-
Tumor necrosis factor-alpha inhibitors
-
Lymphocyte modulators
-
Interleukin inhibitors
By
Indications:
-
Arthritis
-
Asthma
-
Carcinoma
-
Crohn’s Disease
-
Diabetes
-
Enterocolitis
-
Multiple myeloma
-
Multiple sclerosis
-
Psoriasis
-
Sarcoma
-
Others
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