Human Coagulation Factor VII Market Companies and Developments

The global human coagulation factor VII market size was estimated at US$ 1.21 billion in 2023 and is projected to grow to US$ 1.82 billion by 2034, rising at a compound annual growth rate (CAGR) of 3.74% from 2024 to 2034. Human coagulation factor VII is used to prevent bleeding, and growing cases of accidents and trauma are increasing the demand for coagulation factor VII.

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Human Coagulation Factor VII Market Overview

Human coagulation factor VII is a critical clotting agent used to prevent excessive bleeding, particularly in individuals with hemophilia. This condition can lead to life-threatening bleeding during surgeries or following trauma and accidents. In such cases, external doses of coagulation factors like factor VII are needed to manage bleeding. As the incidence of hemophilia increases and more surgeries are performed globally, the demand for human coagulation factor VII is expected to rise.

Market Trends

In August 2024, the U.S. Food and Drug Administration (FDA) resolved a shortage of the 8-milligram vial of Novo Nordisk’s NovoSeven RT coagulation factor VIIa (recombinant), which had been ongoing since February 2024.

Additionally, in March 2024, TiumBio Co., Ltd. filed a Clinical Trial Application (CTA) with the Spanish and Italian Medicines Agencies to begin a Phase 1b study for TU7710, a novel recombinant activated factor VII (rFVIIa) aimed at treating hemophilia patients with inhibitors.

Market Opportunity: Growing Geriatric Population

The increasing elderly population is another key factor driving the growth of the human coagulation factor VII market. Older individuals are more likely to undergo surgeries due to age-related health issues. As factor VII plays a crucial role in preventing excessive bleeding during surgeries, the growing number of older patients will contribute to the rising demand for this product.

Challenges Facing the Human Coagulation Factor VII Market

Despite its importance, factor VII treatments are often expensive, which may limit access for patients, particularly in low-income countries. The complex regulatory process and long approval times for new treatments can also delay the availability of new products. Additionally, the potential side effects of factor VII therapies may discourage some patients and healthcare providers from choosing this treatment.

Regional Insights

North America led the human coagulation factor VII market in 2023. This is largely due to the region’s high number of surgeries, strong government support, a growing healthcare and pharmaceutical industry, and active blood donation initiatives that ensure a steady supply of coagulation factors. The U.S. and Canada are major contributors to market growth, with the U.S. holding the largest share.

For instance:

• In the U.S., approximately 33,000 men have hemophilia, and around 3,442 Canadians were diagnosed with Hemophilia A in 2022.
• Surgical expenses account for over 25% of healthcare-related costs in the U.S. With around 40 to 50 million major surgeries performed annually in the U.S. and 20 million in Europe, the demand for coagulation factor VII remains high.

Asia Pacific is expected to experience the fastest market growth during the forecast period, driven by an expanding population and an increasing number of surgeries. Coagulation factor VII is crucial for preventing excessive bleeding during surgeries, further boosting its demand in the region.

For example:

• By 2050, the elderly population in India is projected to grow significantly, reaching over 20% of the total population.
• In 2023, China had over 297 million people aged 60 or older, and this number is expected to surpass 500 million by 2050.
• In 2022, Chinese hospitals conducted approximately 82.7 million inpatient surgeries, with significant regional differences in surgical volume.
• India, with an estimated 30 million surgeries annually, will also see an increased demand for coagulation factors, especially given the country’s large population and high surgical procedure rates.

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