Levothyroxine sodium is a narrow therapeutic range, the effect of which significantly depends on its level of potency or bioavailability. Administering a drug product of lesser potency or bioavailability to a patient who has conditions controlled by other products, could result in a suboptimal response and hypothyroidism. On the other hand, drug with higher potency could result in a noxious manifestation of hyperthyroidism, including cardiac arrhythmia, palpitations, and cardiac pain, thereby, making its significantly important to administer just the right dose of levothyroxine sodium to patients with coronary heart disease. Lowest effective dose of levothyroxine must be titrated to lower the risk of osteoporosis—a condition mostly found in woman.

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Treatment of hypothyroidism or underactive thyroid disease remains the single largest application of levothyroxine sodium—with treatment goals to correct catabolic imbalances and reverse clinical progressions. As per the American Association of Clinical Endocrinologists (AACE), of nearly 27 million people suffering from various thyroid disorders, most people suffer from hypothyroidism—autoimmune thyroiditis and odine deficiency being the most common causes. An increase in demand for levothyroxine to treat thyroid cancer, apart from decreasing the size of an enlarged thyroid gland, could drive up the sales of levothyroxine sodium products in the coming years.

Mostly used under the branded umbrella of Synthyroid, that received its FDA-Approved status only in 2002, the food and drug regulatory body also considers generic levothyroxine drugs to be as effective as the branded ones. Moreover, the American Thyroid Association (ATA) has found no better thyroid hormone replacements than levothyroxine, thereby, supplementing to the higher global adoption of levothyroxine sodium. The thyroid association, in its guidelines for treating underactive thyroid gland, confirms that levothyroxine sodium (brand or generics) would remain the most preferred treatment choice for hypothyroidism. Moreover, as per ATA’s task force on thyroid replacement, alternative preparations including levothyroxine–including liothyronine combination therapy, or thyroid extract therapy, or others were not found to have any superior finding compared to levothyroxine monotherapy, making it the most preferred hypothyroidism treatment arrangement.

Product Recalls Could Hamper Levothyroxine Sodium Sales Growth

FDA imposes tight regulations on oral levothyroxine sodium products—that have been plagued by potency and stability problems. In a recent development, the food and drug regulatory body alerted API distributor, repackagers, compounders, and finished drug manufacturers pertaining to the recall of porcine thyroid API- a product of Sichuan Friendly Pharmaceutical Co. Limited, based in China, in the wake of unreliable quality API. The FDA laboratory found inconsistent levels of active ingredients—levothyroxine and liothyronine—leading to permanent health conditions, if used. In a subsequent development, Westminster Pharmaceuticals recalled its unexpired lot of levothyroxine and liothyronine as a precautionary measure as some of its products were made manufacturers using Sichuan Friendly Pharmaceutical Co. Limited’s active ingredients.

Studies Indicate Change in Formulations Could Improve Levothyroxine Sodium Tolerance and Efficacy

Considering that the efficiency of hypothyroidism adequately depends on the dosage of levothyroxine sodium—which requires adjustments annually, arising from lack of medication persistence, dosage errors, changes in dietary habits, body mass, and medical conditions, and use of concomitant medications, studies indicate that oral absorption of levothyroxine could remain inefficient by foods including coffee beverages, certain foods, and drug. Researchers have found that hypothyroid patients treated with levothyroxine sodium gel capsules may experience less thyroid hormone fluctuations compared to levothyroxine tablets.

From the formulations standpoints, another study indicates that patients with suboptimal TSH on tablet LT4, could significantly improving the TSH levels by switching to liquid formulation of levothyroxine sodium, wherein the dosage remains unchanged. Changeover to liquid formulations have been suggested considering the reduced efficacy of levothyroxine (LT4) owing to factors such as intestinal disorders, gastric diseases, and concomitant intake of some drugs that might interfere with the absorption of levothyroxine. Apart from formulations, dosage timings of levothyroxine sodium- mornings of bed time- is studied to show a substantial improvement in the thyroid improvement level, with changes in the serum lipid level.

Levothyroxine Administered in Patients Eligible for Organ Donation Shows Promising Future Applications

Although organ transplantation remains the most preferred treatment for end-stage organ diseases, suitable organ donors often fail to meet the perquisites of organ transplantation. Hemodynamic, endocrine, and metabolic instabilities, in brain dead cases, often translate into potential organs being lost. Vasopressors are often used to battle hemodynamic instability—often a resultant of low thyroxine levels, and present cardiovascular collapse. High dosage of vasopressors are required to retrieve organs fit for transplantation. Research indicates that administering intravenous bolus of levothyroxine sodium in brain dead patients could significantly reduce vasopressor in patients. Nearly all organ procurement organizations in US are presently using levothyroxine in varying measures.

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Key Development in the Competitive Landscape

Lannett Company, Inc. and Amneal Pharmaceuticals recently entered a distribution agreement, with Amneal taking over marketing and distribution of Lannett’s Levothyroxine sodium tablets, effective from December 1, 2018 till the mid-March 2019. In another development, Amneal recently announced a 10-year license and supply agreement with Jerome Stevens Pharmaceuticals, Inc. for the former’s levothyroxine sodium tablets, beginning March 23, 2019.

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The research report on levothyroxine sodium presents a comprehensive analysis, assaying some key aspects including market dynamics, segmentation analysis, and coopetition profiling. Apart from the historical data analysis, the report on levothyroxine sodium also highlights present growth, year-on-year growth, and forecast—providing a better understanding of the levothyroxine sodium market.

Apart from an in-depth analysis of the key market dynamics shaping the growth trajectory of levothyroxine sodium market, the report also offers an elaborate segmental analysis, on the basis of Disease Indication, covering, Hypothyroidism, Thyroid Cancer, Myxedema Coma, and Goiter.