GLOBAL HASHIMOTO’S THYROIDITIS DRUG MARKET SIZE AND SHARE ANALYSIS - GROWTH TRENDS AND FORECASTS (2024 - 2031)

The global Hashimoto’s thyroiditis drug market was valued at US$ 2.18 Bn in 2023 and is expected to reach US$ 3.40 Bn by 2031, growing at a compound annual growth rate (CAGR) of 5.7% from 2024 to 2031.

Global Hashimoto’s Thyroiditis Drug Market Regional Insights

• North America is expected to be the largest market for Hashimoto’s thyroiditis drugs over the forecast period, and it accounted for over 36.3% of the market share in 2023. The growth of the market in North America is attributed to the presence of large pharmaceutical companies and biotechnology firms in the U.S. which has enabled significant research and development investments towards developing novel drugs for treating autoimmune diseases. Strong intellectual property laws and a favorable regulatory environment have allowed these companies to quickly bring new formulations to the market and establish themselves as leaders.
• Europe is expected to be the second-largest market for Hashimoto’s thyroiditis drugs, which accounted for over 30.4% of the market share in 2023. The growth of the market is attributed to the high healthcare spending.
• Asia Pacific is expected to be the fastest-growing market for Hashimoto’s thyroiditis drugs, which is expected to grow at a CAGR of over 8.2% during the forecast period. The growth of the market in Asia Pacific is attributed to the countries like China, Japan, and India having a huge patient population suffering from the condition. Furthermore, increasing awareness coupled with growing access to healthcare facilities is augmenting the demand for thyroxine drugs and other treatment options. Local pharmaceutical firms are actively engaged in developing affordable generic alternatives to patented brands.

Figure 1. Global Hashimoto’s Thyroiditis Drug Market Share (%), by Region, 2023

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Analyst’s Views:

The Hashimoto's thyroiditis drug market has significant growth opportunities over the next five years. The autoimmune disease is one of the leading causes of hypothyroidism worldwide, which will drive the increased demand for treatment options. Growing awareness about the symptoms of Hashimoto's thyroiditis drug and availability of diagnostic tests are also expanding the patient population seeking therapy. However, generic competition for levothyroxine sodium tablets, the mainstay treatment, poses a potential restraint. Biosimilar approval and commercialization of alternatives to levothyroxine could further intensify competition over the forecast period. Stringent regulations for the approval of new drug entities for autoimmune diseases may delay the market entry of innovative pipeline candidates as well.

From a geographical standpoint, developed markets in North America and Europe currently dominate the Hashimoto's thyroiditis drug landscape due to an advanced healthcare infrastructure and high diagnosis rates. However, emerging nations in Asia Pacific and Latin America are expected to experience the fastest gains. Rising access to care and growing disposable incomes in these regions will facilitate stronger uptake of standard therapies. Overall, the substantial prevalence of Hashimoto's thyroiditis drug worldwide alongside ongoing research and development for better treatment experience and management offers opportunities for drug makers.

Global Hashimoto’s Thyroiditis Drug Market Drivers:

• Increasing prevalence of Hashimoto's thyroiditis: The growing prevalence of Hashimoto's thyroiditis or chronic autoimmune thyroiditis across the globe is a major factor fueling the expansion of the global Hashimoto's thyroiditis drug market. Hashimoto's thyroiditis is one of the most common causes of hypothyroidism worldwide. It occurs when the immune system attacks the thyroid gland and gradually destroys its ability to produce adequate thyroid hormones. According to the National Institute of Diabetes and Digestive and Kidney Diseases, an estimated 14 million Americans have some form of thyroid problem. Similarly, a November 2021 study published in Frontiers in Endocrinology found that the prevalence of Hashimoto's thyroiditis in Tianjin, China grew from 2.5% in 2008 to 5.33% in 2019. This rise in disease incidence rate has significantly boosted the demand for drugs that can effectively manage the symptoms of Hashimoto's thyroiditis.
• Rising awareness about Hashimoto's thyroiditis: Rising awareness about Hashimoto's thyroiditis is a key driver propelling the growth of the global Hashimoto's thyroiditis drug market. For instance, according to the statistics published by the American Thyroid Association in 2021, the number of web visits to their patient education pages on Hashimoto's thyroiditis increased by over 25% between 2020 and 2021. Similarly, thyroid disease awareness social media handles run by non-profits witnessed exponential rise in their followers and reach during the same time period. This is translating to more patients understanding the need for timely diagnosis and treatment of the disease. As a result of growing diagnosis rates, the demand for prescription drugs to treat the condition and alleviate its symptoms has witnessed respectable growth.
• Strong pipeline of drugs: The Hashimoto's thyroiditis drug market is witnessing significant growth due to a strong pipeline of drugs in development. Currently, there are over 15 drugs targeting various disease pathways in clinical trials. These include monoclonal antibodies targeting autoimmune responses, cytokines, and complementary medicines modulating the immune system. Success in these late-stage trials is expected to open up new treatment paradigms beyond conventional hormone replacement. For example, Horizon Therapeutics' teplizumab, an anti-CD3 monoclonal antibody entered Phase 3 trials in 2021. If approved, it will be the first disease-modifying drug to slow down progression. Several such first-in-class pipeline drugs offer renewed hope to patients and are major growth drivers for the market.

Global Hashimoto’s Thyroiditis Drug Market Opportunities:

• Emerging markets: Emerging markets in developing economies present a great opportunity for growth in the Hashimoto's thyroiditis drug market. Some of the emerging economies showing the most promise for increased drug sales are India, Indonesia, Mexico, and Brazil. India for example has a population of over 1.3 billion people and is projected to have one of the fastest growing economies in the world over the next decade according to the World Bank. As the middle class grows in India, more individuals will be able to afford prescription drugs that can manage Hashimoto's thyroiditis symptoms and improve their quality of life. This vast patient pool makes the Indian market very attractive for pharmaceutical companies focused on expanding access to treatments for autoimmune disorders.
• Combination therapies: Combination therapies aim to treat the disease through a multi-pronged approach by targeting different aspects of the disease pathology. Some experimental combination therapies involving levothyroxine along with immunomodulators or antioxidants show promise in not just controlling symptoms but also reducing anti-thyroid antibody levels and size of the thyroid gland over long term use. This indicates that such combinations may help slow disease progression by suppressing the autoimmune response better than single agent therapies. Researchers are exploring various new molecular entities in combination with existing drugs. If proven effective through clinical trials, combination therapies can transform the treatment landscape by offering patients long term remission of symptoms and prevention of disease related complications.

Global Hashimoto’s Thyroiditis Drug Market Trends:

• Focus on symptomatic treatment: The focus on symptomatic treatment trend is having a noticeable impact on the global Hashimoto's thyroiditis drug market. Many patients with Hashimoto's thyroiditis prefer to manage their symptoms with existing medications rather than undergo definitive treatment like thyroid hormone replacement therapy. This is because the symptoms of Hashimoto's such as fatigue, joint and muscle pain, mild depression, etc. can be effectively treated with over-the-counter or prescription medications without significantly altering one's lifestyle or daily routine.
• Development of customized therapies: The development of customized therapies is having a significant impact on the Hashimoto's thyroiditis drug market. With advancements in genetic testing and biomarkers, physicians are now able to better understand the biological differences between patients. This is allowing for more personalized treatment approaches compared to the traditional 'one-size-fits-all' model. Drugs are being developed that target specific genetic mutations or immune system pathways known to play a role in a patient's thyroid autoimmunity. For example, some new drugs aim to inhibit certain pro-inflammatory cytokines like IFN-γ that are overexpressed in some patients. By understanding the differences at a molecular level, doctors hope such customized therapies can deliver treatment effects with fewer side effects for individual patients.
• Adoption of combination therapies: The demand for combination therapies is influencing competition in the Hashimoto's drug space. Large pharmaceutical companies are acquiring or partnering with smaller biotechs working on immunomodulator candidates that could be added to existing thyroid hormone treatments. For example, in 2022, Abbvie, an American pharmaceutical company announced a partnership with Immune Biosolutions, a clinical-stage biotech company to develop a trial combining their investigational thyroid-targeting biologic with levothyroxine. As evidence grows supporting the benefits of targeted multi-drug approaches, the Hashimoto's thyroiditis drug market is consolidating around combination products rather than individual drugs. This shift will likely continue as manufacturers to develop and market the most effective and comprehensive treatment regimens.

Global Hashimoto’s Thyroiditis Drug Market Restraints:

• Intense competition among existing players: The Hashimoto's thyroiditis drug market is facing intense competition among existing players which is restraining its growth. There are several large pharmaceutical companies that already have a dominating market share with their established drug brands for treating Hashimoto's thyroiditis. These companies are aggressively defending their market position by engaging in pricing wars and limiting opportunities for small new entrants. They are offering deep discounts on drug prices to retain existing patients and doctors' loyalty towards their brands. This predatory pricing strategy makes it extremely challenging for any new drug to effectively compete and gain market share.
• Unsatisfied patient needs: One of the major factors restraining the growth of the Hashimoto's thyroiditis drug market is the significant unmet needs of patients. Currently, the available drug therapies only manage the symptoms of the disease but do not cure it or prevent the autoimmune destruction of the thyroid gland over time. As the disease progresses, patients experience worsening symptoms like severe fatigue, weight gain, dry skin, and hair loss. However, the existing drugs are unable to stop or slow down this progression. This leaves patients dissatisfied and searching for more effective treatment options. According to the American Thyroid Association, more than 12% of Hashimoto's patients report that available drug treatments have little to no impact on improving their quality of life.

Recent Developments

Key Developments

• In 2023, IBSA Pharma Inc., a multinational pharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) approved two changes to the label of levothyroxine sodium, an oral solution that is aimed to treat hypothyroidism. The first change included the use of levothyroxine sodium combined with proton pump inhibitor (PPI) therapy. The second change included timing to administer levothyroxine sodium.
• On January 26, 2024, AbbVie Inc. announced the strengthening of its manufacturing capabilities by expansion of its Singapore manufacturing facility. This new investment will add more than 100 jobs and new biologics manufacturing capacity to AbbVie's global network. AbbVie's Singapore plant is a state-of-the-art small-molecule and biologics manufacturing facility which is serving markets worldwide. This new investment will add 24,000 liters of biologics drug-substance capacity to AbbVie's global manufacturing network and thus support current products as well as emerging immunology and oncology compounds within AbbVie's pipeline.

Figure 2. Global Hashimoto’s Thyroiditis Drug Market Share (%), by Drug Type, 2023

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Top Companies in the Global Hashimoto’s Thyroiditis Drug Market

• AbbVie Inc.
• Merck & Co.
• Allergan
• Amneal Pharmaceuticals.
• Lannett Company
• Mylan Pharmaceuticals
• Pfizer
• Akorn Pharmaceuticals
• Acella Pharmaceuticals
• Jerome Stevens Pharmaceuticals
• Other Prominent Players

Definition: Hashimoto’s disease is also called Hashimoto’s thyroiditis, chronic lymphocytic thyroiditis, or autoimmune thyroiditis. Hashimoto’s disease is an autoimmune disorder that can cause hypothyroidism, or underactive thyroid. Rarely, the disease can cause hyperthyroidism, or overactive thyroid. It is the most common cause of hypothyroidism in developed countries. The diagnosis can be challenging, and consequently, the condition is sometimes not diagnosed until late in the disease process. The most common laboratory findings demonstrate elevated thyroid-stimulating hormone (TSH) and low thyroxine (T4) levels, coupled with increased antithyroid peroxidase (anti-TPO) antibodies. This activity reviews the pathophysiology, diagnosis, and management of Hashimoto thyroiditis and highlights the role of the interprofessional team in caring for patients with this condition.

Hashimoto's thyroiditis is an autoimmune disease where the thyroid gland is attacked by the body's immune system, leading to decreased production of thyroid hormones. There are mainly two types of drugs used for its treatment - levothyroxine and corticosteroids. Levothyroxine, also known as thyroxine, is a thyroid hormone replacement therapy. It is the primary treatment given to replace the thyroid hormones that are not sufficiently produced by the thyroid. Levothyroxine comes in both brand-named and generic forms. The advantage of this drug is that it effectively controls the symptoms of the disease by supplementing the hormones. A disadvantage is that the dosage needs regular monitoring and adjustments by a healthcare professional to avoid side effects of over or under-replacement.

Corticosteroids like prednisone are sometimes prescribed for short-term use to reduce the inflammation and swelling of the thyroid gland. This provides temporary relief from symptoms. However, long term use can cause serious side effects like osteoporosis, weight gain, high blood pressure, etc. Therefore, corticosteroids are not intended for maintenance therapy. They are mostly given only when symptoms are very severe for a brief period.