The tyrosinemia type 1 treatment market was valued at USD 67.20 Million in 2025 and is expected to grow at a CAGR of 6.50%, reaching USD 126.14 Million by 2035. Growth is fueled by rising diagnosis rates and adoption of enzyme replacement therapies.
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Historical Period
Forecast Period
Increasing awareness and advancements in diagnostic technologies are enabling earlier detection of tyrosinemia type 1, driving demand for effective treatments and boosting market growth.
In June 2022, Nitisinone tablets received regulatory approval, reflecting a supportive environment for drug development. This approval enhances treatment accessibility, positively influencing the treatment market landscape positively.
The United States will likely dominate the market in the forecast period. This can be attributed to key players seeking regulatory approvals and robust healthcare infrastructure in the region.
Compound Annual Growth Rate
6.5%
Value in USD Million
2026-2035
*this image is indicative*
Tyrosinemia type 1 is a rare genetic disorder caused by the inability to break down tyrosine, leading to severe liver and kidney complications. The market is driven by advancements in diagnostic technologies and increased awareness. Several market trends such as regulatory approvals and rising demand for innovative therapies impact the market significantly, leading to global market expansion.
Efforts to Enhance Early Diagnosis to Drive the Market Growth
Tyrosinemia type 1, a rare genetic disorder affecting males and females equally, has a global prevalence of approximately 1 in 100,000 to 120,000 births. Increasing awareness and advancements in diagnostic technologies are enabling earlier detection, while the growing demand for innovative treatment options supports market expansion. These factors, combined with improving healthcare infrastructure, are creating significant opportunities for the development and boosting the market value for innovative treatment alternatives.
Several trends and developments are being observed in the market to enhance the current situation. Some of the noteworthy trends are as follows.
The market report offers a detailed analysis of the market based on the following segments:
Market Breakup by Drug
Market Breakup by Dosage Form
Market Breakup by Distribution Channel
Market Breakup by Region
Market Share Based on Dosage Form to Witness Substantial Growth
Based on dosage form, the market is divided into tablets, capsules, and others. Among these, the capsule segment is expected to dominate the market share, due to its several advantages such as the ease of swallowing and masking the unpleasant taste and odor of the medications. For instance, in February 2024, Eton Pharmaceuticals officially introduced Nitisinone capsules for the management of tyrosinemia type 1. This medication is distributed through specialized pharmacies and is intended to be used alongside a stringent diet that restricts tyrosine and phenylalanine intake.
Based on region, the market report covers the United States, United Kingdom, Germany, France, Italy, Spain, Japan, and India. Among these, the United States is expected to account for a substantial market share due to the key market players seeking expedited regulatory approvals to manage the disease effectively. In addition, favorable reimbursement policies and robust healthcare infrastructure further support market growth in the region.
The key features of the market report include patent analysis, clinical trials analysis, grants analysis, funding and investment analysis, and strategic initiatives by the leading players. The major companies are:
Established in 2017 and headquartered in Deer Park, Illinois, Eton Pharmaceuticals focuses on developing treatments for rare diseases. The company offers ALKINDI SPRINKLE and Betaine Anhydrous, targeting metabolic disorders, including tyrosinemia type 1. Eton is dedicated to improving treatment accessibility for patients with unique therapeutic needs.
Founded in 2001, Sobi is headquartered in Stockholm, Sweden. The company specializes in rare disease therapies and has a focus on innovative solutions for addressing the unmet needs of patients with rare metabolic disorders. Their products include Nitisinone, a key treatment for Tyrosinemia type 1.
Rare Disease Therapeutics, established in 1991 and headquartered in Franklin, Tennessee, focuses on orphan drug development. The company provides Orfadin (Nitisinone) for treating tyrosinemia type 1, ensuring effective care for patients. RDT is committed to advancing treatments for rare and ultra-rare diseases.
Founded in 1926 and headquartered in Milan, Italy, Recordati Rare Diseases develops therapies for rare conditions. The company offers Nitisinone, addressing tyrosinemia type 1. With a strong commitment to innovation, Recordati continues to enhance its portfolio for rare metabolic disorder treatments.
*Please note that this is only a partial list; the complete list of key players is available in the full report. Additionally, the list of key players can be customized to better suit your needs.*
Other companies include WEP Clinical, Torrent Pharma Inc., and Nobelpharma Co., Ltd., among others.
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*While we strive to always give you current and accurate information, the numbers depicted on the website are indicative and may differ from the actual numbers in the main report. At Expert Market Research, we aim to bring you the latest insights and trends in the market. Using our analyses and forecasts, stakeholders can understand the market dynamics, navigate challenges, and capitalize on opportunities to make data-driven strategic decisions.*
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| REPORT FEATURES | DETAILS |
| Base Year | 2025 |
| Historical Period | 2019-2025 |
| Forecast Period | 2026-2035 |
| Scope of the Report |
Historical and Forecast Trends, Industry Drivers and Constraints, Historical and Forecast Market Analysis by Segment:
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| Breakup by Drug |
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| Breakup by Dosage Form |
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| Breakup by Distribution Channel |
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| Breakup by Region |
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| Market Dynamics |
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| Supplier Landscape |
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| Companies Covered |
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