Tretten or Novothirteen Market Report 2026: Epidemiology, Pipeline Analysis, Market Insights & Forecasts

The growth in the historic period can be attributed to increased diagnosis of factor xiii deficiency, advancements in recombinant protein production, expansion of specialty treatment centers, growing awareness of rare bleeding disorders, improved cold chain pharmaceutical logistics.

The growth in the forecast period can be attributed to expansion of precision medicine adoption, rising investments in orphan drug development, increasing demand for safer long-term clot stabilization therapies, advancements in recombinant biologics manufacturing, growing focus on home-based infusion therapies. Major trends in the forecast period include increasing adoption of recombinant coagulation therapies, rising focus on rare bleeding disorder treatments, growing emphasis on targeted protein replacement therapies, expansion of personalized treatment regimens, enhanced manufacturing quality and purity standards.

The increasing awareness of rare bleeding disorders is expected to drive the growth of the Tretten or NovoThirteen market in the coming years. Rare bleeding disorders are uncommon conditions that impair the blood’s ability to clot properly, including hemophilia, von Willebrand disease, and factor XIII deficiency. The rise in awareness is driven by improved diagnostic capabilities, patient advocacy, and educational campaigns, resulting in earlier detection, better treatment access, and improved patient outcomes. Tretten (also known as NovoThirteen) treats rare bleeding disorders by providing a recombinant form of activated Factor XIII, which is essential for stabilizing blood clots and reducing bleeding risk in patients with Factor XIII deficiency. For example, in March 2024, according to the National Institute for Health and Care Excellence, a UK-based non-departmental public body, 2,069 individuals in the UK were diagnosed with hemophilia B in 2022-2023, including 374 with severe disease and 351 with moderate disease. Therefore, increasing awareness of rare bleeding disorders is driving the Tretten or NovoThirteen market.

The rising demand for personalized medicine is expected to support the growth of the Tretten or NovoThirteen market. Personalized medicine tailors treatment plans to individual patients by considering their genetic makeup, lifestyle, and environmental factors to improve treatment outcomes. The growing demand is fueled by advancements in genomics and diagnostic technologies, enabling more targeted and effective therapies. Tretten or NovoThirteen functions as a personalized treatment by addressing the specific clotting factor deficiencies in patients with hemophilia B, improving bleeding control and reducing the risk of episodes. For instance, in February 2024, the Personalized Medicine Coalition, a US-based nonprofit organization, reported that the FDA approved 16 new personalized treatments for rare disease patients in 2023, up from six in 2022, including seven cancer drugs and three therapies for other conditions. Therefore, the rising demand for personalized medicine is driving growth in the Tretten or NovoThirteen market.

The growing healthcare expenditure is expected to propel the Tretten or NovoThirteen market. Healthcare expenditure includes the total financial resources spent on medical services by governments, businesses, and individuals, covering hospital care, medications, treatments, and public health initiatives. The increase in healthcare spending is driven by advances in medical technology, rising healthcare needs, and a focus on quality patient care, leading to higher investments worldwide. Greater healthcare expenditure enables more funding for research, development, and accessibility of treatments for rare and complex conditions like congenital factor XIII deficiency, which Tretten addresses. For example, in June 2025, according to the Centers for Medicare and Medicaid Services, a US-based federal agency, Medicare spending in 2023 grew 8.1% to $1.02 trillion (21% of total national health expenditure), Medicaid spending rose 7.9% to $871.7 billion (18%), and private health insurance spending increased 11.5% to $1.46 trillion (30%). Therefore, growing healthcare expenditure is driving growth in the Tretten or NovoThirteen market.

Major companies operating in the tretten or novothirteen market are Novo Nordisk A/S.

North America was the largest region in the tretten or novothirteen market in 2025. The regions covered in the tretten or novothirteen market report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East, Africa. The countries covered in the tretten or novothirteen market report are Australia, India, China, South Korea, Japan, UK, France, Germany, USA, Canada.

Tariffs are impacting the tretten or novothirteen market by increasing costs of imported bioprocessing equipment, recombinant protein inputs, sterile packaging materials, and cold-chain logistics components used in biologic drug manufacturing. Pharmaceutical production facilities in North America and Europe are most affected due to reliance on specialized imported inputs, while Asia-Pacific faces higher costs for technology transfer and formulation imports. These tariffs are raising manufacturing and distribution expenses, contributing to higher treatment costs. However, they are also encouraging localized biologics manufacturing, regional supply chain development, and long-term investment in domestic recombinant therapy production capabilities.

The tretten or novothirteen market research report is one of a series of new reports that provides tretten or novothirteen market statistics, including tretten or novothirteen industry global market size, regional shares, competitors with a tretten or novothirteen market share, detailed tretten or novothirteen market segments, market trends and opportunities, and any further data you may need to thrive in the tretten or novothirteen industry. This tretten or novothirteen market research report delivers a complete perspective of everything you need, with an in-depth analysis of the current and future scenario of the industry.

Tretten (Novothirteen) is a recombinant therapy used to treat factor XIII deficiency, a rare bleeding disorder. It works by providing recombinant factor XIII, which stabilizes blood clots through fibrin strand cross-linking. Tretten is generally administered via intravenous infusion and is part of a treatment regimen for patients with PNH or aHUS to help reduce the risk of complications such as organ damage or thrombosis.

The primary indications for Tretten or Novothirteen include hemophilia B and surgical prophylaxis. Hemophilia B is a genetic bleeding disorder caused by a deficiency of clotting factor IX, resulting in impaired clotting and prolonged bleeding. Tretten is available in formulations such as lyophilized powder and intravenous solution. It is distributed through hospital and clinic channels, retail and specialty pharmacies, and is used by end users including adult and pediatric patients.

The tretten or novothirteen market consists of sales of plasma-derived factor XIII concentrates, diagnostic kits, assays, and ancillary products. Values in this market are ‘factory gate’ values, that is the value of goods sold by the manufacturers or creators of the goods, whether to other entities (including downstream manufacturers, wholesalers, distributors and retailers) or directly to end customers. The value of goods in this market includes related services sold by the creators of the goods.

The market value is defined as the revenues that enterprises gain from the sale of goods and/or services within the specified market and geography through sales, grants, or donations in terms of the currency (in USD unless otherwise specified).

The revenues for a specified geography are consumption values that are revenues generated by organizations in the specified geography within the market, irrespective of where they are produced. It does not include revenues from resales along the supply chain, either further along the supply chain or as part of other products.

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