Global Recombinant Human Coagulation VIIa Market 2025 by Manufacturers, Regions, Type and Application, Forecast to 2031

According to our (Global Info Research) latest study, the global Recombinant Human Coagulation VIIa market size was valued at US$ 1241 million in 2024 and is forecast to a readjusted size of USD 1593 million by 2031 with a CAGR of 3.6% during review period.

Recombinant activated factor VII (rFVIIa) binds to exposed tissue factor at the place of tissue and vascular injury. Thrombin generated by this process activates platelets and the coagulation cascade.

Coagulation Factor VIIa, recombinant is a coagulation factor indicated for:

Treatment of bleeding episodes and perioperative management in adults and children with Hemophilia or B with inhibitors, congenital Factor VII (FVII) deficiency, and Glanzmann’s thrombasthenia with refractoriness to platelet transfusions, with or without antibodies to platelets

Treatment of bleeding episodes and perioperative management in adults with acquired haemophilia.

Drivers of the Recombinant Human Coagulation Factor VIIa (rFVIIa) Market:

Rising Prevalence of Hemophilia and Bleeding Disorders: Recombinant Factor VIIa is primarily used in treating hemophilia, especially in patients with inhibitors to Factor VIII or IX. The growing global incidence of hemophilia and other bleeding disorders is a major driver of market demand.

Advancements in Recombinant Technology: Ongoing improvements in biotechnology have led to the development of safer and more effective recombinant coagulation products. These advancements reduce the risk of bloodborne pathogen transmission, increasing their adoption over plasma-derived alternatives.

Increased Use in Trauma and Surgery: Recombinant Factor VIIa is also used in managing severe bleeding during trauma and surgical procedures, further expanding its clinical applications and boosting demand, particularly in emergency care settings.

Rising Adoption in Off-Label Uses: While its primary indication is for hemophilia, rFVIIa is increasingly being used off-label to manage uncontrolled bleeding in non-hemophiliac patients, particularly in critical care and trauma settings. This broadens its potential market.

Favorable Reimbursement Policies in Developed Regions: In regions like North America and Europe, the availability of comprehensive insurance and reimbursement for advanced therapies like rFVIIa makes these treatments more accessible to patients, supporting market growth.

Challenges of the Recombinant Human Coagulation Factor VIIa (rFVIIa) Market:

High Cost of Treatment: Recombinant Factor VIIa therapy is expensive, which can limit access, especially in low-income countries and regions without robust healthcare funding or insurance coverage.

Potential for Off-Label Use Concerns: Despite its increasing use in off-label applications, concerns about the safety and efficacy of rFVIIa in non-hemophilia patients have led to caution in its broader application. Regulatory scrutiny on off-label use may impact market expansion.

Limited Awareness and Access in Developing Regions: In many developing countries, awareness of recombinant therapies for hemophilia is limited, and access to advanced treatments is constrained by inadequate healthcare infrastructure and funding.

Competition from Alternative Therapies: Emerging gene therapies, extended half-life clotting factors, and other innovative treatments for hemophilia may compete with or reduce the demand for rFVIIa in the future. These newer therapies promise more long-term efficacy or convenience.

Regulatory Challenges: The stringent regulatory approval process for biologics, along with the ongoing need for post-market surveillance, can slow down the introduction of new products or indications, impacting the pace of market growth.

The top three manufacturers of recombinant human coagulation VIIa in the world include Novo Nordisk, LFB SA HEMA Biologics, and GENERIUM, with a total market share of more than 99%. The largest manufacturer is Novo Nordisk, with a market share of more than 95%. North America is the global most important consumer market for recombinant human coagulation VIIa, with a market share of about 45%.

This report is a detailed and comprehensive analysis for global Recombinant Human Coagulation VIIa market. Both quantitative and qualitative analyses are presented by manufacturers, by region & country, by Type and by Application. As the market is constantly changing, this report explores the competition, supply and demand trends, as well as key factors that contribute to its changing demands across many markets. Company profiles and product examples of selected competitors, along with market share estimates of some of the selected leaders for the year 2025, are provided.

Key Features:

Global Recombinant Human Coagulation VIIa market size and forecasts, in consumption value ($ Million), sales quantity (K Units), and average selling prices (US$/Unit), 2020-2031

Global Recombinant Human Coagulation VIIa market size and forecasts by region and country, in consumption value ($ Million), sales quantity (K Units), and average selling prices (US$/Unit), 2020-2031

Global Recombinant Human Coagulation VIIa market size and forecasts, by Type and by Application, in consumption value ($ Million), sales quantity (K Units), and average selling prices (US$/Unit), 2020-2031

Global Recombinant Human Coagulation VIIa market shares of main players, shipments in revenue ($ Million), sales quantity (K Units), and ASP (US$/Unit), 2020-2025

The Primary Objectives in This Report Are:

To determine the size of the total market opportunity of global and key countries

To assess the growth potential for Recombinant Human Coagulation VIIa

To forecast future growth in each product and end-use market

To assess competitive factors affecting the marketplace

This report profiles key players in the global Recombinant Human Coagulation VIIa market based on the following parameters - company overview, sales quantity, revenue, price, gross margin, product portfolio, geographical presence, and key developments. Key companies covered as a part of this study include Novo Nordisk, LFB SA HEMA Biologics, AryoGen Pharmed, GENERIUM, etc.

This report also provides key insights about market drivers, restraints, opportunities, new product launches or approvals.

Market Segmentation

Recombinant Human Coagulation VIIa market is split by Type and by Application. For the period 2020-2031, the growth among segments provides accurate calculations and forecasts for consumption value by Type, and by Application in terms of volume and value. This analysis can help you expand your business by targeting qualified niche markets.

Market segment by Type
Prefilled Syringe
Vial

Market segment by Application
Congenital Hemophilia
Acquired Hemophilia
Others

Major players covered
Novo Nordisk
LFB SA HEMA Biologics
AryoGen Pharmed
GENERIUM

Market segment by region, regional analysis covers

North America (United States, Canada, and Mexico)

Europe (Germany, France, United Kingdom, Russia, Italy, and Rest of Europe)

Asia-Pacific (China, Japan, Korea, India, Southeast Asia, and Australia)

South America (Brazil, Argentina, Colombia, and Rest of South America)

Middle East & Africa (Saudi Arabia, UAE, Egypt, South Africa, and Rest of Middle East & Africa)

The content of the study subjects, includes a total of 15 chapters:

Chapter 1, to describe Recombinant Human Coagulation VIIa product scope, market overview, market estimation caveats and base year.

Chapter 2, to profile the top manufacturers of Recombinant Human Coagulation VIIa, with price, sales quantity, revenue, and global market share of Recombinant Human Coagulation VIIa from 2020 to 2025.

Chapter 3, the Recombinant Human Coagulation VIIa competitive situation, sales quantity, revenue, and global market share of top manufacturers are analyzed emphatically by landscape contrast.

Chapter 4, the Recombinant Human Coagulation VIIa breakdown data are shown at the regional level, to show the sales quantity, consumption value, and growth by regions, from 2020 to 2031.

Chapter 5 and 6, to segment the sales by Type and by Application, with sales market share and growth rate by Type, by Application, from 2020 to 2031.

Chapter 7, 8, 9, 10 and 11, to break the sales data at the country level, with sales quantity, consumption value, and market share for key countries in the world, from 2020 to 2025.and Recombinant Human Coagulation VIIa market forecast, by regions, by Type, and by Application, with sales and revenue, from 2026 to 2031.

Chapter 12, market dynamics, drivers, restraints, trends, and Porters Five Forces analysis.

Chapter 13, the key raw materials and key suppliers, and industry chain of Recombinant Human Coagulation VIIa.

Chapter 14 and 15, to describe Recombinant Human Coagulation VIIa sales channel, distributors, customers, research findings and conclusion.