Human Fibrinogen Concentrate Market Highlights

• Global human fibrinogen concentrate market revenue is poised to garner USD 2.8 billion by 2032 with a CAGR of 5.8% from 2024 to 2032
• North America human fibrinogen concentrate market value occupied around USD 576 million in 2022
• Asia-Pacific human fibrinogen concentrate market growth will record a CAGR of more than 6.2% from 2024 to 2032
• Among type, the 1.0 g sub-segment generated noteworthy revenue in 2022
• Based on application, the congenital fibrinogen deficiency sub-segment generated significant human fibrinogen concentrate market share in 2022
• Adoption of telemedicine and remote patient monitoring for enhanced access to therapy is a popular human fibrinogen concentrate market trend that fuels the industry demand

Fibrinogen, also known as factor I, is a protein produced by the liver that aids in blood clotting by facilitating the thickening of blood. The soluble fibrinogen in blood plasma is converted into fibrins by the enzyme thrombin, resulting in blood clot formation. Lower fibrinogen levels can lead to excessive bleeding and may cause thrombosis, which involves the formation of blood clots inside veins, leading to blocked blood flow. Thrombosis can have serious complications if blockage occurs in critical areas, potentially leading to heart attacks or strokes.

Decreased fibrinogen levels can result from chronic liver disease, extensive blood transfusions, and severe malnutrition, while elevated levels can cause inflammation, tissue damage, certain cancers, strokes, and severe infections. Therefore, the fibrinogen test finds wide application in disease diagnosis. Fibrinogen deficiency may arise due to genetic inheritance of defective DNA, including conditions such as afibrinogenemia (complete absence of fibrinogen), hypofibrinogenemia (lower than normal levels), and dysfibrinogenemia (improper functioning of the protein).

The fibrinogen molecule is a soluble, large, and complex 340 kDa plasma glycoprotein that is converted by thrombin into fibrin during blood clot formation. It has a rod-like shape with dimensions of 9 × 47.5 × 6 nm and exhibits a negative net charge at physiological pH (with an isoelectric point at pH 5.2). Fibrinogen is synthesized in the liver by hepatocytes, and its concentration in blood plasma typically ranges from 200 to 400 mg/dL, often measured using the Claus method.

Global Human Fibrinogen Concentrate Market Dynamics

Market Drivers

• Increasing prevalence of bleeding disorders
• Growing demand for fibrinogen concentrates in surgical procedures
• Advancements in biotechnology leading to improved product efficacy
• Rising awareness about the benefits of fibrinogen concentrate therapy

Market Restraints

• Stringent regulatory requirements for product approval
• High cost associated with fibrinogen concentrate therapy
• Limited availability of skilled healthcare professionals for administration

Market Opportunities

• Expansion into emerging markets with unmet medical needs
• Development of novel formulations for improved patient outcomes
• Strategic collaborations for market expansion and product development

Human Fibrinogen Concentrate Market Report Coverage

Human Fibrinogen Concentrate Market Insights

The market will be driven by increasing occurrences where fibrinogen tests are recommended; these include stroke, liver diseases, hemophilia, inflammatory diseases, and others. According to the National Hemophilia Foundation in New York, U.S., factor I deficiency, which includes afibrinogenemia, dysfibrinogenemia, or hypofibrinogenemia, has an incidence of 2 people per million in the U.S. Conversely, liver cancer also increases the risk of hemostasis, as it produces most of the clotting factors and inhibitors, as well as various proteins involved in fibrinolysis. In 2012, it was estimated that around 120,000 people were suffering from liver cancer, and this number was predicted to rise exponentially. This exponential growth of liver disease will also play a vital role in the development of the human fibrinogen concentrate market.

However, certain adverse conditions, namely dyspnea, arterial thrombosis, vomiting, chills, nausea, and pulmonary embolism, hinder market growth. Overall, the diagnostics industry is driven by a major provider and merchant network worldwide. This has facilitated significant market penetration of fibrinogen tests, particularly in both underdeveloped and developed economies where the prevalence of several diseases, such as cancer and others, is high. The fibrinogen test is projected to become more cost-efficient with the advancement of technology and the increasing number of local players in the diagnostics market.

Human Fibrinogen Concentrate Market Segmentation

The worldwide market for human fibrinogen concentrate is split based on type, application, and geography.

Human Fibrinogen Concentrate Types

• 0.5g
• 1.0g
• Others

In the human fibrinogen concentrate market, the 1.0g category is predicted to be the biggest. This can be ascribed to a number of causes, including increased demand for greater dose formulations. To begin, treating fibrinogen shortage frequently need bigger dosages in order to produce therapeutic results, especially in situations of severe bleeding or surgical operations. Patients with congenital fibrinogen deficiency, for example, may require greater doses of fibrinogen concentrate to maintain appropriate fibrinogen levels. Additionally, healthcare providers may favour larger dose formulations since they enable greater flexibility in dosing regimens and might be more cost-effective in certain instances. Using a 1.0g formulation, for example, may allow for fewer doses and shorter treatment periods than lower dosage choices, thus resulting to cost savings for healthcare institutions.

Also, innovations in medical technology and manufacturing techniques have made larger dose formulations more widely available and affordable. As healthcare providers get greater access to 1.0g formulations, their market dominance may expand. Furthermore, the 1.0g category might benefit from a larger set of indications and uses. Higher dose formulations may be appropriate for a broader range of individuals and medical problems, increasing their demand and market share.

Human Fibrinogen Concentrate Applications

• Congenital Fibrinogen Deficiency
• Surgical Procedures

According to human fibrinogen concentrate industry analysis, in terms of revenue and volume, the segment associated to congenital fibrinogen deficiency had the biggest market share among human fibrinogen concentrate applications in 2022. The frequency of afibrinogenemia is estimated to be 1 in 1,000,000. Hypofibrinogenemia and dysfibrinogenemia are more prevalent. Fibrinogen insufficiency affects both genders equally. While fibrinogen deficiency can develop at any age, afibrinogenemia usually appears early in life, especially during the neonatal period. Fibrinogen concentrates are used largely to treat haemorrhages. When fibrinogen concentrates are not available, fresh frozen plasma is used. Routine prophylaxis with fibrinogen concentrates in early pregnancy can help avoid recurring spontaneous abortions. As a result, the congenital fibrinogen deficiency category has the largest market share and is anticipated to continue that position in the human fibrinogen concentrate industry forecast period.

Human Fibrinogen Concentrate Market Regional Outlook

North America

Human Fibrinogen Concentrate Market Regional Analysis

In terms of human fibrinogen concentrate market analysis, North America dominates the human fibrinogen concentrate market for a variety of reasons. The region has modern healthcare infrastructure, significant healthcare spending, and a sizable patient population suffering from numerous bleeding problems. Furthermore, strict regulatory frameworks and favorable reimbursement policies contribute to market growth in North America. Furthermore, the presence of important market players, as well as continuous R&D initiatives, contributes to North America's dominance in the human fibrinogen concentrate market.

On the other hand, Asia-Pacific is the fastest-growing region and it will grow over the human fibrinogen concentrate market forecast period. This expansion is being driven by increased knowledge of bleeding disorders, improved healthcare infrastructure, rising healthcare costs, and a growing patient population in countries such as China, India, and Japan. Furthermore, partnerships between global and local companies, as well as favorable government measures to promote healthcare access, are propelling market expansion in Asia-Pacific. Furthermore, increased use of modern medical treatments and technologies drives market expansion in this area.

Human Fibrinogen Concentrate Market Players

Some of the top human fibrinogen concentrate companies offered in our report includes Hualan Biological Engineering, Baxter International Inc., Octapharma AG, CSL Behring, LFB S.A, ProFibrix B.V., Green Cross Corp., Shanghai Xinxing Medicine Co Ltd, Harbin Pacific Biopharmaceutical Co. Ltd., and Shanghai Raas Blood Products Co. Ltd.