Koate-DVI Market Report 2025: Epidemiology, Pipeline Analysis, Market Insights & Forecasts

This Koate-DVI market report delivers an in-depth analysis of the market’s key characteristics, including size, growth potential, and segmentation. It provides a detailed breakdown of the market across major regions and leading countries, highlighting historical data and future growth projections. The report also examines the competitive landscape, market share insights, emerging trends, and strategic developments shaping the market.

The growth observed during the historic period can be attributed to the adoption of factor VIII replacement therapies, advancements in diagnostic capabilities for coagulation disorders, the strengthening of supply chain networks, increased advocacy by hemophilia patient organizations, and expanded insurance coverage.

The anticipated growth during the forecast period is driven by government initiatives supporting hemophilia care, increased research and development investments in plasma-derived products, the expansion of healthcare facilities in emerging markets, rising demand for personalized medicines, and a growing prevalence of bleeding disorders. Key trends during the forecast period include the integration of data analytics into supply chain management, expansion of clinical trials for innovative coagulation therapies, advancements in nanotechnology for drug delivery, the development of dual-action therapeutics, and the adoption of value-based pricing models.

The increasing prevalence of bleeding disorders is expected to drive the koate-DVI market in the coming years. Bleeding disorders are conditions that disrupt the blood's ability to clot effectively, leading to prolonged or excessive bleeding. The prevalence of these disorders is rising due to factors such as increased awareness and diagnosis, genetic influences, lifestyle changes, and advances in screening methods. Koate-DVI plays a critical role in managing bleeding disorders such as hemophilia A by replacing the deficient factor VIII, facilitating proper blood clotting and reducing the risk of bleeding episodes. For example, in November 2022, the United Kingdom Haemophilia Centre Doctors’ Organisation reported an increase in new registrations of Haemophilia A in the UK from 16 in 2021 to 19 in 2022. Consequently, the growing prevalence of bleeding disorders is fueling the koate-DVI market.

The rising healthcare expenditure is another factor expected to boost the koate-DVI market. Healthcare expenditure encompasses the total financial resources allocated to medical services, healthcare infrastructure, pharmaceuticals, and related activities. Factors contributing to this rise include higher operational costs in healthcare facilities, an increasing prevalence of chronic and lifestyle-related diseases, a growing incidence of genetic disorders, advancements in medical technology, and expanded access to healthcare services. Healthcare expenditure for koate-DVI is used to manage and prevent bleeding episodes in patients with hemophilia A, improving patient quality of life and reducing hospitalizations. For instance, in May 2024, the Office for National Statistics, a UK-based government agency, reported that total healthcare expenditure increased by 5.6% in nominal terms from 2022 to 2023, compared to a growth rate of 0.9% in 2022. Additionally, long-term health and social care expenditure grew by 2.8% in real terms in 2022. Thus, rising healthcare expenditure is driving the koate-DVI market.

The growing aging population is also expected to propel the koate-DVI market forward. Aging is the natural process of growing older, marked by a gradual decline in physiological functions and tissue integrity. The aging population is expanding due to factors such as increased life expectancy, lower birth rates, and advancements in healthcare that enhance longevity. Koate-DVI, a factor VIII coagulation therapy, is used to manage bleeding episodes and prevent complications in older individuals with hemophilia A, enhancing mobility and quality of life. For instance, in January 2024, the Population Reference Bureau (PRB), a US-based nonprofit organization, projected that the number of Americans aged 65 and older will rise from 58 million in 2022 to 82 million in 2050 (a 47% increase), with their share of the total population increasing from 17% to 23%. Therefore, the rising aging population is a key driver of the koate-DVI market.

The key company operating in the koate-DVI market are Grifols SA.

North America was the largest region in the koate-DVI market in 2024. Asia-Pacific is expected to be the fastest-growing region in the forecast period. The regions covered in koate-DVI report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East and Africa. The countries covered in the koate-DVI market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA, Canada, Italy, Spain.

Koate-DVI is a pharmaceutical coating polymer primarily utilized in delayed-release drug formulations. It is a divinyl adipate-based polymer designed to provide a protective coating for oral tablets and capsules, enabling controlled or delayed drug release within the digestive system. These polymers shield active pharmaceutical ingredients (APIs) from the stomach's acidic environment, allowing the drug to be released in the intestine or at a specific time for targeted and effective delivery. Koate is typically composed of methacrylic acid derivatives or similar copolymers, forming a stable, uniform film around the drug to protect it from moisture, light, and heat.

The primary indications for koate-DVI include the treatment of hemophilia A, prophylaxis for hemophilia A, and the management of bleeding episodes. Hemophilia A is a genetic bleeding disorder caused by a deficiency of factor VIII. The formulations available are injectable types, including lyophilized powder and ready-to-use solutions. Patient demographics cover pediatric, adult, and geriatric populations. Distribution channels include direct sales, wholesalers and distributors, retail pharmacies, and online pharmacies. It is used by various end users such as hospitals, hemophilia treatment centers, specialty clinics, and home healthcare providers.

The koate-DVI market research report is one of a series of new reports that provides koate-DVI market statistics, including koate-DVI industry global market size, regional shares, competitors with a koate-DVI market share, detailed koate-DVI market segments, market trends and opportunities, and any further data you may need to thrive in the koate-DVI industry. This koate-DVI 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.

The koate-DVI market consists of sales of gastrointestinal (GI) drug delivery systems, delayed-release formulations, and pharmaceutical coatings. Values in this market are ‘factory gate’ values, 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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