Orally Disintegrating Tablet Market

Modification in Drug Specifications Pointing to Robust Growth Opportunities

Over the past decade, orally disintegrating tablets (ODTs) have gained considerable attention as a preferred alternative to conventional tablets and capsules owing to better patient compliance. United States Food and Drug Administration defines orally disintegrating tablets as “A solid dosage form containing a medicinal substance or active ingredient, which disintegrates rapidly usually within a matter of seconds when placed upon the tongue.”

European Pharmacopoeia uses the term orodispersible tablet for tablets that disperses readily and within 3 min in mouth before swallowing. Infants, young children, and geriatric population with swallowing problems find it difficult swallowing traditional drugs. To overcome such complexities, development and launch of numerous orally disintegrating tablets in the past decade with improved performance and acceptability were carried out.

These useful specifications have backed the orally disintegrating tablets market to exhibit a CAGR of 10%. The market was valued at around US$ 12 Bn in 2018.

Improved Palatability Increasing Dosage Compliance

Children are reluctant to bitter taste of tablets. Apart from that, swallowing tablet is not an innate ability and needs to be acquired. Developments to improve taste and disintegration are currently undertaken by researchers and manufacturers in a way to increase acceptance of ODTs. 

A report published in Pediatric Praziquantel Consortium, 2019, titled “Comparative palatability of orally disintegrating tablets (ODTs) of Praziquantel (L-PZQ and Rac-PZQ) versus current PZQ tablet in African children” found L-PZQ and Rac-PZQ more palatable consequently improving dosage compliance. As of April 2019, Praziquantel (PZQ) is the only recommended drug for schistosome infection and disease in North African countries.

Increasing Clinical Trials for Improvements in ODTs

The ODTs market is growing with a double digit CAGR since last decade. Increasing number of clinical trials and clinical studies is favouring more investments for improvements in orally disintegrating tablets. As of November 2019, 144 clinical trials for orally disintegrating tablets are under study, of which 16, 27, and 8 are in Phase 2, Phase 3 and Phase 4 respectively.

In December 2018, Biohaven Pharmaceutical Holding Company Ltd. announced positive top-line results from a randomized, controlled Phase 3 clinical trial evaluating the efficacy and safety of its Zydis® orally dissolving tablet (ODT) formulation of Rimegepant, an oral calcitonin gene-related peptide (CGRP) receptor antagonist for the acute treatment of migraines.

Modifications to Increase Bioavailability of Drugs

When a tablet is administered orally, the concentration of drug is reduced to a great extent before reaching the systemic circulation. The ability of ODTs to bypass first pass metabolism is useful in addressing such complexities, thus maintaining bioavailability of administered drug. Better bioavailability offered by orally disintegrating tablets for protein and peptide-based therapeutics is a promising approach for delivery of high molecular weight drugs.

In a report published in Journal of Acquired Immune Deficiency Syndromes, 2011, reported that crushing lopinavir/ritonavir mixed with food or water, was a common practice for children with HIV 1 infection, resulting in a significant reduction in drug bioavailability.

Fragmented Market with Allocative Efficiency

The orally disintegrating tablets market is highly fragmented with no single player holding a significant market share, paving way for market entrants to gain admittance. The incumbent players are focused on discovering NCEs and excipients for rare diseases along with developing novel formulations to extend the patent regime.

For instance, Kissei Pharmaceutical Co., Ltd. launched GLUBES® Combination OD Tab on 14^th June, 2019, which is the new orally disintegrating dosage form of GLUBES® Combination Tab.

Prominently, off-patent drugs are tapped by generic manufacturers to get an ANDA in different geographical regions to access new markets.

Mylan N.V. received final approval from U.S. FDA for its Abbreviated New Drug Application (ANDA) of Lansoprazole Delayed-Release (DR) orally disintegrating tablets (ODT), a generic version of Takeda's Prevacid® SoluTab DR ODT.

In May 2014, Mylan N.V launched Olanzapine orally disintegrating tablets (ODT), the generic version of Eli Lilly and Company's Zyprexa Zydis® tablets for treatment of schizophrenia and bipolar disorders that reduced the price of dosing for patients. 

Analyst’s Viewpoint

The orally disintegrating tablets market has low entry barriers with manufacturers focusing on improved patenting technology, better products, and effective formulation process. The market is presenting lucrative opportunities for players to diversify their products portfolio and increase regional presence. Product lines and extensions created for various disease indications by manufacturers coupled with increasing preference by consumers are expected to fuel the overall orally disintegrating tablets market growth.