Levothyroxine Sodium Market Size was valued at USD 3.9 Billion in 2022. The Levothyroxine Sodium Market industry is projected to grow from USD 4.0 Billion in 2023 to USD 5.17 Billion by 2032, exhibiting a compound annual growth rate (CAGR) of 3.20% during the forecast period (2024 - 2032). The higher prevalence of bipolar disorders, technological advances, high unmet medical needs, and government initiatives are expected to be a significant market driver for the Levothyroxine Sodium Market.
Source: Secondary Research, Primary Research, MRFR Database and Analyst Review
In June 2024, the FDA announced a voluntary recall of select lots of TIROSINT-SOL because it was concerned about subpotency. For this reason, twenty-seven lots were taken back, as some samples contained less than 95% of the labeled amount of levothyroxine sodium. Such an underpotency can result in symptoms like fatigue, weight gain, and depression that are usually seen in hypothyroidism patients. No adverse events related to the recall have been reported; however, patients using these lots should consult with their healthcare provider prior to discontinuing use.Vertice Pharma launched THYQUIDITY in February 2021, which is a replacement for all stages of hypothyroidism. THYQUIDITY is an adjunct to radioiodine and surgical ablation therapy. It should be noted that levothyroxine is available in the form of liquid doses, thus enabling individualized therapy.
The US Food and Drug Administration (FDA) made two important label changes for levothyroxine sodium (Tirosint-SOL), such as its use in combination with proton pump inhibitors (PPIs) or having it administered fifteen minutes before breakfast. The drug is now the only LT4 therapy approved by the FDA without a labeled interaction with PPIs facilitating administration to patients​.
IBSA Pharma issued a voluntary recall for 27 lots of Tirosint-SOL due to concerns about subpotency in February 2023. This means that some samples have less than what was indicated on their labels, leading to under-treatment of hypothyroidism. These lots are advised to reach out to their healthcare providers for additional information.
In June 2020, Lannett Company, Inc. (NYSE: LCI) and Cediprof, Inc., part of Neolpharma Pharmaceutical Group, together with others, entered into an interim exclusive supply and distribution agreement for Cediprof's FDA-approved Levothyroxine Sodium Tablets USP. On August 3, 2020, it is expected that the product will commence being distributed in America by Lannett company. On July 31, 2022, this interim supply agreement ends when a previously announced ten-year exclusive supply and distribution agreement commences with Cediprof. IQVIA market has estimated total sales of $2.3bn over the past twelve months ending May 2020, whereas the actual generic market value should be lower.
A study presented at the Endocrine Society’s annual meeting in June 2022 showed that drinking coffee five minutes after dosing with levothyroxine sodium oral solution did not affect its absorption. This could provide more flexibility for patients who previously needed to wait up to an hour before having their coffee.
Market CAGR for Levothyroxine Sodium is driven by the increasing prevalence of thyroid disorders and the Rising incidence of obesity. The prevalence of thyroid disorders worldwide is rapidly increasing, with an estimated 2,120 deaths (970 men and 1,150 women) projected in the United States in 2023. The death rate has remained stable from 2011 to 2020, and women are three times more likely than men to develop thyroid cancer, although both genders experience similar mortality rates. This trend is largely attributed to shifting lifestyle and dietary patterns. Levothyroxine Sodium, the most commonly prescribed medication for thyroid disorders, is expected to see a rise in demand in the coming years.
Obesity has emerged as a prominent risk factor for various thyroid diseases, including hypothyroidism and hyperthyroidism. The World Obesity Atlas 2023, published by the World Obesity Federation, forecasts that the economic impact of overweight and obesity could reach $4.32 trillion annually by 2035 if preventive and treatment measures are not enhanced. This represents almost 3% of the GDP, comparable to the impact of COVID-19 in 2020. If current trends persist, over half of the population (51%, or over 4 billion people) will be living with overweight or obesity by 2035, and one in four people (almost 2 billion) will have obesity. Consequently, there has been a substantial increase in the demand for Levothyroxine Sodium drugs from obese patients in recent years. As a result, it is anticipated that throughout the projection period, demand for the Levothyroxine Sodium Market will increase due to the increasing prevalence of thyroid disorders and the Rising incidence of obesity. Thus, driving the Levothyroxine Sodium Market revenue.
The Levothyroxine Sodium Market segmentation, based on Type includes Oral and Injection. The Oral segment dominated the market, accounting for 58% of market revenue (2.2 Billion). The oral segment is poised to take the lead in the market, driven by a continual increase in diabetes cases and the introduction of new products. Within this segment, the oral type is anticipated to witness steady adoption. Not only does the oral approach come at a lower cost compared to surgery, but the growing preference for this method is expected to escalate rapidly.
Figure 1: Levothyroxine Sodium Market, by Type, 2023 & 2032 (USD Billion)
Source: Secondary Research, Primary Research, MRFR Database and Analyst Review
The Levothyroxine Sodium Market segmentation, based on Application includes Hospitals, Pharmacies, and Others. The Hospitals segment dominated the market, accounting for 58% of market revenue. Hospitals represent a substantial segment of the levothyroxine sodium tablet market, serving as essential distribution hubs for this medication. Levothyroxine is frequently prescribed for the management of thyroid disorders, and hospitals play a pivotal role in ensuring prompt access for patients undergoing treatments or surgeries associated with thyroid conditions.
By region, the study provides market insights into North America, Europe, Asia-Pacific, and Rest of the World. The anticipated expansion of the Levothyroxine Sodium market in North America can be attributed to several key factors. As reported by the American Thyroid Association, an estimated 12% of the U.S. population is expected to experience thyroid conditions at some point in their lives, with 20 million Americans currently affected. The dominant position of the North American market on a scale can be attributed to the significant prevalence of thyroid disorders, enhanced diagnostic procedures, and a lower threshold for initiating treatment. Furthermore, the market experiences growth driven by favorable reimbursements for levothyroxine drug regimens, encompassing both short- and long-term treatment plans.
Further, the major countries studied in the market report are the US, Canada, Germany, France, the UK, Italy, Spain, China, Japan, India, Australia, South Korea, and Brazil.
Figure 2: LEVOTHYROXINE SODIUM MARKET SHARE BY REGION 2023 (USD Billion)
Source: Secondary Research, Primary Research, MRFR Database and Analyst Review
Europe's Levothyroxine Sodium Market accounts for the second-largest market share as Thyroid disorders exhibit a higher prevalence among the elderly, a demographic that constitutes over one-fifth (21.1%) of the EU population in 2022. The median age of the EU population, standing at 44.4 years as of January 1, 2022, underscores the aging trend, with half of the population surpassing this age. Given the ongoing aging of Europe's population, there is a heightened probability of an upswing in individuals necessitating thyroid medication, consequently fueling the demand for Levothyroxine Sodium. This demographic shift presents a strategic consideration for businesses operating in the pharmaceutical sector. Further, the German Levothyroxine Sodium Market held the largest market share, and the UK Levothyroxine Sodium Market was the fastest-growing market in the European region
The Asia-Pacific Levothyroxine Sodium Market is expected to grow at the fastest CAGR from 2024 to 2032. The growing incidence of thyroid disorders in the region is influenced by factors such as an aging population and shifts in lifestyle. According to the UNFPA report, the demographic aged 60 years and above numbered 149 million individuals as of July 1, 2022, constituting approximately 10.5% of the country's population. Projections indicate a doubling of this population by 2050, reaching 20.8%, with an absolute number of 347 million. With the aging of populations, the probability of thyroid-related issues increases, thereby contributing to a heightened demand for Levothyroxine Sodium. Moreover, China’s Levothyroxine Sodium Market held the largest market share, and the Indian Levothyroxine Sodium Market was the fastest-growing market in the Asia-Pacific region.
Levothyroxine Sodium Market Key Market Players & Competitive Insights
Leading market players are investing heavily in research and development to expand their product lines, which will help the Levothyroxine Sodium market, grow even more. Market participants are also undertaking a variety of strategic activities to expand their footprint, with important market developments including new product launches, contractual agreements, mergers and acquisitions, higher investments, and collaboration with other organizations. To expand and survive in a more competitive and rising market climate, the Levothyroxine Sodium industry must offer cost-effective items.
Manufacturing locally to minimize operational costs is one of the key business tactics used by manufacturers in the Levothyroxine Sodium industry to benefit clients and increase the market sector. In recent years, the Levothyroxine Sodium industry has offered some of the most significant advantages to the management and treatment of thyroid disorders, enhancing patient well-being and providing effective therapeutic solutions. Major players in the Levothyroxine Sodium Market, including Abbvie (U.S.), Mylan Pharma (U.S.), Merck (U.S.), Pfizer (U.S.), Lannett Company (U.S.), Novartis (Switzerland), Fresenius Kabi (Germany), IBSA (Switzerland), Piramal Critical Care (U.S.), and Abbott (U.S.) are attempting to increase market demand by investing in research and development operations.
AbbVie is a specialized biopharmaceutical company dedicated to the discovery, development, manufacturing, and commercialization of drugs tailored for the treatment of chronic and intricate diseases. The range of its drugs encompasses metabolic and rheumatological diseases, neurological disorders, skin conditions, rheumatoid arthritis, endometriosis-related pain, pediatric Crohn's disease, cancer, and various other serious health conditions. AbbVie is actively progressing its pipeline programs targeting conditions such as Crohn's disease, Parkinson's disease, viral diseases, wet AMD, different cancers, neurological disorders, aesthetics, and autoimmune diseases. The company distributes its products directly to wholesalers, distributors, healthcare facilities, government agencies, specialty pharmacies, and independent retailers through its distribution centers and public warehouses. AbbVie's headquarters are located in North Chicago, Illinois, USA.
Pfizer is engaged in the discovery, development, manufacturing, and commercialization of biopharmaceuticals. The company's product portfolio addresses a wide range of conditions, including cardiovascular, metabolic, and pain-related issues, women’s health, cancer, inflammation, immune disorders, and rare diseases. Pfizer also offers sterile injectable pharmaceuticals, biosimilars, active pharmaceutical ingredients (APIs), and contract manufacturing services. Distribution of Pfizer's products occurs through wholesalers, retailers, hospitals, individual provider offices, clinics, government agencies, and pharmacies. The company operates major manufacturing facilities in various countries, including India, China, Japan, Ireland, Italy, Belgium, Germany, Singapore, and the US. Pfizer serves markets in North America, South America, Asia-Pacific, Australia, Europe, Africa, and the Middle East. The corporate headquarters of Pfizer is located in New York, the US.
Key companies in the Levothyroxine Sodium Market include
Levothyroxine Sodium Industry Developments
February 2021: In February 2021, Vertice Pharma introduced THYQUIDITY, a replacement therapy designed for all stages of hypothyroidism. THYQUIDITY represents an innovative approach combining radioiodine and surgery therapy. This liquid form of levothyroxine allows for personalized dosing, catering to individual patient needs.
| Report Attribute/Metric | Details |
| Market Size 2022 | USD 3.9 Billion |
| Market Size 2023 | USD 4.0 Billion |
| Market Size 2032 | USD 5.17 Billion |
| Compound Annual Growth Rate (CAGR) | 3.20% (2024-2032) |
| Base Year | 2023 |
| Market Forecast Period | 2024-2032 |
| Historical Data | 2018- 2022 |
| Market Forecast Units | Value (USD Billion) |
| Report Coverage | Revenue Forecast, Market Competitive Landscape, Growth Factors, and Trends |
| Segments Covered | Type, Application, and Region |
| Geographies Covered | North America, Europe, Asia Pacific, and the Rest of the World |
| Countries Covered | The US, Canada, Germany, France, UK, Italy, Spain, China, Japan, India, Australia, South Korea, and Brazil |
| Key Companies Profiled | Abbvie (U.S.), Mylan Pharma (U.S.), Merck (U.S.), Pfizer (U.S.), Lannett Company (U.S.), Novartis (Switzerland), Fresenius Kabi (Germany), IBSA (Switzerland), Piramal Critical Care (U.S.), and Abbott (U.S.) |
| Key Market Opportunities | ·        The expansion of pharmaceutical companies especially in emerging markets |
| Key Market Dynamics | ·        Expanding aging populations and increasing awareness |
Frequently Asked Questions (FAQ) :
The Levothyroxine Sodium Market size was valued at USD 3.9 Billion in 2022.
The Levothyroxine Sodium Market is projected to grow at a CAGR of 3.20% during the forecast period, 2024-2032.
North America had the largest share of the market
The key players in the market are Abbvie (U.S.), Mylan Pharma (U.S.), Merck (U.S.), Pfizer (U.S.), Lannett Company (U.S.), Novartis (Switzerland), Fresenius Kabi (Germany), IBSA (Switzerland), Piramal Critical Care (U.S.), and Abbott (U.S.)
The Oral segment dominated the market in 2022.
The Hospitals segment had the largest share in the
Assistant Manager He holds an experience of about 7+ years in market research and business consulting, working under the spectrum of life sciences and healthcare domains. rahul conceptualizes and implements a scalable business strategy and provides strategic leadership to the clients. his expertise lies in market estimation, competitive intelligence, pipeline analysis, customer assessment, etc. in addition to the above, his other responsibility includes strategic tracking of high growth markets & advising clients on the potential areas of focus they could direct their business initiatives
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