Hypothyroidism Market

Key Highlights

• Iodine deficiency is the leading global cause of hypothyroidism because iodine is essential for the production of thyroid hormones. Hypothyroidism is mainly classified into primary and secondary (central) types. Central hypothyroidism is rare.
• In the United States, autoimmune thyroid disease (i.e., Hashimoto thyroiditis) is the most common cause of hypothyroidism, but globally, lack of iodine in the diet is the most common cause.
• Treatment typically involves lifelong hormone replacement therapy with synthetic thyroid hormone replacement medication, such as levothyroxine, to help regulate hormone levels in the body.
• Levothyroxine monotherapy is the standard treatment for hypothyroidism; it is safe and inexpensive, restores thyroid function tests to within the reference range, and improves symptoms in the majority of patients. Untreated hypothyroidism increases morbidity and mortality.
• Ongoing symptoms despite levothyroxine treatment has led to some patients using liothyronine or desiccated thyroid extract. Taken together, these factors have led to intense debate around the treatment thresholds and treatment strategies for hypothyroidism.
• In July 2025, Oliva Therapeutics announced the relaunch and immediate availability of THYQUIDITY (levothyroxine sodium oral solution). In partnership with Jerome Stevens Pharmaceuticals, a US-based prescription pharmaceutical manufacturer and packager, the launch of THYQUIDITY represents the first branded product launch for Oliva Therapeutics and expands upon a joint endocrine-focused portfolio and pipeline.
• In April 2025, Jerome Stevens Pharmaceuticals completed the acquisition of THYQUIDITY from Azurity Pharmaceuticals.
• Xeris Pharmaceuticals is preparing to initiate Phase III trials for XP-8121, a once-weekly subcutaneous injection for hypothyroidism that leads its current pipeline of investigational therapies.

DelveInsight’s "Hypothyroidism – Market Insight, Epidemiology, and Market Forecast – 2034" report delivers an in-depth understanding of hypothyroidism, historical and forecasted epidemiology, as well as the hypothyroidism market trends in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.

The hypothyroidism market report provides current treatment practices, emerging drugs, hypothyroidism share of individual therapies, and current and forecasted hypothyroidism market size from 2020 to 2034, segmented by seven major markets. The report also covers current hypothyroidism treatment practices/algorithms and unmet medical needs to curate the best of the opportunities and assess the underlying potential of the market.

Geography Covered

• The United States
• EU4 (Germany, France, Italy, and Spain) and the United Kingdom
• Japan

Hypothyroidism Disease Understanding and Treatment Algorithm

Hypothyroidism Overview

Hypothyroidism is a common endocrine disorder caused by insufficient production of thyroid hormones (thyroxine [T₄] and triiodothyronine [T₃]) by the thyroid gland, leading to a generalized slowing of metabolic processes. Hypothyroidism is primarily categorized as primary and secondary (i.e., central) hypothyroidism. In primary hypothyroidism, the thyroid gland cannot produce adequate amounts of thyroid hormone. The less commonly seen secondary or central hypothyroidism occurs when the thyroid gland functions normally. Symptoms vary from fatigue, weight gain, cold intolerance, and constipation to cognitive impairment, with severe cases potentially progressing to myxedema coma. The condition affects all age groups but is more common in women and older adults, with higher prevalence in iodine-deficient regions.

Hypothyroidism Diagnosis

The diagnosis of hypothyroidism is primarily based on laboratory evaluation of thyroid function, supported by clinical assessment. The most sensitive and widely used test is the measurement of thyroid-stimulating hormone (TSH) levels. In primary hypothyroidism, TSH is elevated due to reduced negative feedback from low circulating thyroxine (free T₄). In secondary hypothyroidism, caused by pituitary or hypothalamic dysfunction, TSH may be low or inappropriately normal, accompanied by low free T₄ levels. Additional tests, such as free T₃, thyroid peroxidase (TPO) antibodies, and thyroglobulin antibodies, help identify autoimmune thyroiditis as the underlying cause. Imaging studies like thyroid ultrasound are reserved for structural abnormalities or goiter evaluation.

Further details related to diagnosis will be provided in the report…

Hypothyroidism Treatment

The treatment of hypothyroidism focuses on restoring normal thyroid hormone levels and alleviating symptoms by replacing the deficient hormone. Levothyroxine (synthetic thyroxine, T₄) is the standard therapy, given orally in individualized doses based on age, weight, severity, and comorbidities. The goal is to normalize TSH and free T₄ levels, with regular monitoring to adjust dosage. In selected cases, such as patients with persistent symptoms despite adequate T₄ replacement, liothyronine (synthetic T₃) or combination T₄/T₃ therapy may be considered. Switching to the intravenous (IV) form of thyroid hormone in the hospital is indicated when a patient is unable to take thyroid replacement orally or when myxedema coma is suspected.  Off-label options like ARMOUR THYROID (desiccated thyroid extract) are used in some patients but require caution due to variable hormone content. Lifelong therapy is typically required.

Further details related to treatment will be provided in the report…

Hypothyroidism Epidemiology

The hypothyroidism epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by the total prevalent cases of hypothyroidism, diagnosed prevalent cases of hypothyroidism, age-specific cases of hypothyroidism, gender-specific cases of hypothyroidism, and severity-specific cases of hypothyroidism in the 7MM market covering the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan from 2020 to 2034.

• Based on NHANES data, the authors estimated that nearly 10% of the US population was affected by hypothyroidism between 2009 and 2012. Similarly, analysis of Optum data indicates a rising prevalence of hypothyroidism in the US, with rates increasing from 9.5% in 2012 to 11.7% in 2019.
• The rate of hypothyroidism was highest among females and among those older than 60 years of age.
• Among patients enrolled in the NHANES 2009–2010 and 2011–2012 cycles, approximately 29.6% of patients were aged 12–29 years, 32.2% were aged 30–49 years, and 34.3% were aged 50–79 years, while only 3.9% were aged 80 years or older.
• Hypothyroidism prevalence in the US based on NHANES data from 1988–1994 (published in 2002), was estimated at 0.3% for overt hypothyroidism and 4.3% for subclinical hypothyroidism.
• A 2019 meta-analysis of 20 studies reported a 4.7% prevalence of undiagnosed hypothyroidism in Europe, including 0.65% clinical and 4.11% subclinical cases.

Recent Developments in the Hypothyroidism Treatment Market:

• In March 2025, Sernova Biotherapeutics received FDA clearance for its Investigational New Drug application to test the Cell Pouch bio-hybrid organ with auto-transplanted thyroid cells in thyroid surgery patients. This marks a key step in Sernova's goal to offer a long-term solution for hypothyroidism, eliminating the need for hormone replacement or immune suppression.

Hypothyroidism Drug Chapters

Marketed Drugs

THYQUIDITY (levothyroxine sodium): Jerome Stevens Pharmaceuticals/Oliva Therapeutics

THYQUIDITY is indicated for hypothyroidism, as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. In collaboration with Oliva Therapeutics THYQUIDITY will remain available without interruption, providing current patients consistency as well as offering new patients an alternative high-quality levothyroxine sodium therapy. In November 2020, THYQUIDITY got approval from the US FDA for the treatment of hypothyroidism.

In July 2025, Oliva Therapeutics announced the relaunch and immediate availability of THYQUIDITY.

In April 2025, Jerome Stevens Pharmaceuticals completed the acquisition of THYQUIDITY from Azurity Pharmaceuticals.

NOTE: Levothyroxine is available in different generic versions marketed under various brand names like EUTHYROX, ELTROXIN, LEVOXYL, THYRONORM, SYNTHROID, and others, with the active ingredient listed as levothyroxine sodium.

Off-labels like ARMOUR THYROID are a prescription of thyroid hormones (T3 and T4) obtained from pig thyroid to treat hypothyroidism of any cause in patients of any age (children, adults, and the elderly).

Emerging Drugs

XP-8121: Xeris Biopharma

XP-8121 employs the Company’s XeriSol formulation technology to enable a novel once-weekly SC injection of levothyroxine. This novel formulation significantly increases the bioavailability of levothyroxine, reducing overall drug exposure and enabling a dosing regimen with the potential to mitigate the many challenges associated with achieving and maintaining a normal level of TSH with daily oral formulations of levothyroxine.

In its Q2 2025 presentation, the company projected the initiation of the Phase III trial in 2026, with topline results anticipated in 2029 and potential regulatory approval in 2030.

In May 2024, Xeris Biopharma announced topline results from its completed Phase II study of XP-8121 for the treatment of adults with hypothyroidism.

Note: A Detailed therapy assessment will be provided in the final report.

Drug Class Insight

In the marketed class of drugs, the cornerstone of therapy includes thyroid hormone receptor agonists such as THYQUIDITY.

Thyroid hormone receptor agonists

Thyroid hormone receptor agonists replicate the action of triiodothyronine (T₃) by binding to nuclear THRα or THRβ receptors. This binding activates thyroid hormone response elements on DNA, triggering transcription of genes that regulate metabolism, lipid and carbohydrate processing, and thermogenesis. Natural T₃ binds both receptor subtypes, influencing multiple tissues. Newer selective THRβ agonists, such as resmetirom, are engineered to preferentially target the liver, improving lipid profiles and reducing hepatic fat, while minimizing adverse effects on the heart and bones that are primarily associated with THRα activation. These agents offer a more targeted approach to thyroid hormone-based therapies.

Hypothyroidism Market Outlook

The therapeutic landscape for hypothyroidism is well-established, with a large and mature global market driven by the high prevalence of the condition. Levothyroxine remains the standard of care, available in multiple branded and generic formulations, with products like THYQUIDITY offering oral solution delivery for patients with swallowing difficulties. Off-label and adjunctive options, such as ARMOUR THYROID (desiccated thyroid extract) and CYTOMEL (liothyronine), are used in select cases where levothyroxine monotherapy does not provide adequate symptom control. Despite these options, there is currently limited development in the emerging pipeline with drug candidates like XP-8121, which is being investigated in the Phase III stage of clinical trial. The innovation is largely focused on optimizing formulations, delivery methods, and patient adherence rather than introducing new molecular targets.

Further details will be provided in the report….

Hypothyroidism Drugs Uptake

This section focuses on the uptake rate of potential drugs expected to be launched in the market during 2025–2034. The landscape of hypothyroidism treatment has experienced a profound transformation with the uptake of novel drugs.

Hypothyroidism Pipeline Development Activities             

The report provides insights into different therapeutic candidates in mid and early stages. It also analyzes key players involved in developing targeted therapeutics.

Pipeline Development Activities

The report covers detailed information on collaborations, acquisitions and mergers, licensing, and patent details for hypothyroidism emerging therapies.

KOL- Views

To keep up with current market trends, we take KOLs and SMEs' opinions working in the domain through primary research to fill the data gaps and validate our secondary research. Some of the leaders like MD, Professor and Vice Chair of the Department of Medicine and Director, PhD, and others. Their opinion helps to understand and validate current and emerging therapies and treatment patterns or hypothyroidism market trends. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the unmet needs.

Delveinsight’s analysts connected with 15+ KOLs to gather insights; however, interviews were conducted with 5+ KOLs in the 7MM. Centers such as the Washington University School of Medicine, University Medical Center Hamburg-Eppendorf, and University Graduate School of Medicine etc. were contacted. Their opinion helps understand and validate hypothyroidism epidemiology and market trends.

Qualitative Analysis

We perform qualitative and market intelligence analysis using various approaches, such as SWOT and Conjoint analysis. In the SWOT analysis, strengths, weaknesses, opportunities, and threats in terms of disease diagnosis, patient awareness, patient burden, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided. These pointers are based on the Analyst’s discretion and assessment of the patient burden, cost analysis, and existing and evolving treatment landscape.

Conjoint Analysis analyzes multiple approved and emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, designation, route of administration, and order of entry. Scoring is given based on these parameters to analyze the effectiveness of therapy.

The analyst analyzes multiple emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, route of administration, and order of entry.

In efficacy, the trial’s primary and secondary outcome measures are evaluated.

Further, the therapies’ safety is evaluated, wherein the acceptability, tolerability, and adverse events are majorly observed, and it sets a clear understanding of the side effects posed by the drug in the trials.

Market Access and Reimbursement

Reimbursement may be referred to as the negotiation of a price between a manufacturer and a payer that allows the manufacturer access to the market. It is provided to reduce the high costs and make the essential drugs affordable. Health technology assessment (HTA) plays an important role in reimbursement decision-making and recommending the use of a drug. These recommendations vary widely throughout the seven major markets, even for the same drug. In the US healthcare system, both Public and Private health insurance coverage are included. Also, Medicare and Medicaid are the largest government-funded programs in the US. The major healthcare programs, including Medicare, Medicaid, Health Insurance Program (CHIP), and the state and federal health insurance marketplaces, are overseen by the Centers for Medicare & Medicaid Services (CMS). Other than these, Pharmacy Benefit Managers (PBMs) and third-party organizations that provide services and educational programs to aid patients are also present.

The report further provides detailed insights on the country-wise accessibility and reimbursement scenarios, cost-effectiveness scenario of currently used therapies, programs making accessibility easier and out-of-pocket costs more affordable, insights on patients insured under federal or state government prescription drug programs, etc.

Further detailed analysis will be provided in the report….

Scope of the Report

• The report covers a descriptive overview of hypothyroidism, explaining its causes, signs and symptoms, pathogenesis, and currently available therapies.
• Comprehensive insight has been provided into hypothyroidism epidemiology and treatment.
• Additionally, an all-inclusive account of the current therapies for hypothyroidism is provided, along with the assessment of new therapies, which will have an impact on the current treatment landscape.
• A detailed review of the hypothyroidism market, historical and forecasted, is included in the report, covering the 7MM drug outreach.
• The report provides an edge while developing business strategies, by understanding trends shaping and driving the 7MM hypothyroidism market.

Hypothyroidism Report Insights

• Hypothyroidism Report Insights
• Patient Population
• Therapeutic Approaches
• Hypothyroidism Pipeline Analysis
• Hypothyroidism Market Size and Trends
• Market Opportunities
• Impact of Upcoming Therapies

Hypothyroidism Report Key Strengths

• Ten-Year Forecast
• 7MM Coverage
• Hypothyroidism Epidemiology Segmentation
• Key Cross Competition
• Highly Analyzed Market
• Drugs Uptake

Hypothyroidism Report Assessment

• Current Treatment Practices
• Unmet Needs
• Analyst Views
• Pipeline Product Profiles
• Market Attractiveness
• Qualitative Analysis (SWOT and Conjoint Analysis)

FAQs

• What was the hypothyroidism market share (%) distribution in 2020, and what would it look like in 2034?
• What would be the hypothyroidism total market size, as well as market size by therapies across the 7MM during the study period (2020–2034)?
• What are the key findings about the market across the 7MM, and which country will have the largest hypothyroidism market size during the study period (2020–2034)?
• At what CAGR, the hypothyroidism market expected to grow at the 7MM level during the study period (2020–2034)?
• What would be the hypothyroidism market growth till 2034?
• What are the disease risks, burdens, and unmet needs of hypothyroidism?
• What is the historical hypothyroidism patient pool in the United States, the EU4 (Germany, France, Italy, and Spain), and the UK, and Japan?
• What will be the growth opportunities across the 7MM concerning the patient population of hypothyroidism?
• Among the 7MM, which country would have the most prevalent cases of hypothyroidism?
• At what CAGR is the population expected to grow across the 7MM during the study period (2020–2034)?
• How many companies are developing therapies for the treatment of hypothyroidism?
• What are the key collaborations (industry–industry, industry-academia), mergers and acquisitions, and licensing activities related to hypothyroidism therapies?
• What are the recent novel therapies, targets, mechanisms of action, and technologies developed to overcome the limitations of existing therapies?
• What are the 7MM historical and forecasted market of hypothyroidism?

Reasons to buy

• The report will help in developing business strategies by understanding trends shaping and driving the hypothyroidism market.
• To understand the future market competition in the hypothyroidism market and insightful review of the SWOT analysis of hypothyroidism.
• Organize sales and marketing efforts by identifying the best opportunities for hypothyroidism in the US, EU4 (Germany, France, Italy, and Spain), and the United Kingdom, and Japan.
• Identification of strong upcoming players in the market will help in devising strategies that will help in getting ahead of competitors.
• To understand the future market competition in hypothyroidism.