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Analysis of the Global Fibrinogen Market and Product Pipeline

  • December 2015
  • -
  • Frost & Sullivan
  • -
  • 54 pages

The increased demand for fibrinogen and the development of innovative delivery systems such as sprays and patches are fuelling the growth of the fibrinogen market. This research service provides a detailed assessment of the global fibrinogen market, covering the current market scenario and growth prospects for the period 2015–2020. Both marketed and pipeline products are segmented based on their therapeutic uses, namely, deficiency therapy and operative care. An elaborate discussion on clinical trial timelines and results, along with historical and projected launch timelines, has been provided. The study also discusses key companies such as CSL Behring, LFB, Baxter Healthcare, Takeda, Grifols, and Octapharma.

Executive Summary—Key Findings
• Fibrinogen and fibrin products combined account for % of the total blood plasma market, equal to
$ billion in 2015. This is expected to grow at a modest rate of % to reach $ billion in 2020.
• The growth rate is driven by the increase in innovation and the development of spray-type fibrinogen and fibrin concentrate, powdered fibrin concentrate, transparent fibrinogen concentrate/fibrin adhesives in the area of operative care as a surgical adjunct to control blood loss associated with bleeding.
• Anticoagulants and other artificial coagulation products pose a threat to market growth. Further, pricing pressure for blood plasma product providers are mitigating the entry of new participants, although the commercial potential of these products is promising.
• The market is dominated by the top blood plasma product providers CSL Behring and LFB Group, while Biotest, Octapharma, and Grifols are venturing to make their footprint in the market.
• Others include key stakeholders supplying these products to pharmaceutical companies (e.g., Takeda, The Medicines Company), and medical technologies and consumable manufacturers (e.g., Ethicon, Healthpoint) engaged in providing surgical wound adhesives coated with fibrinogen/fibrin.
• There are at least approved fibrinogen concentrates for fibrinogen deficiency, and 10 fibrin/fibrinogen products for controlling bleeding during surgeries. Key products include Haemocomplettan (CSL Behring), Clottafact (LFB), Artiss (Baxter Healthcare), EVARREST (Ethicon), Tisseel (Baxter Healthcare), and Beriplast P (CSL Behring).
• 15 more clinical trials are being conducted across the globe to treat deficiency diseases/disorders and for operative/surgical care. Most of these clinical trials are conducted for approved products to expand their application for different operative care (e.g., cardiac surgery, venous ulcers).
• The key promising candidates in the clinical development include the following:
o Haemocomplettan is a fibrinogen concentrate available as a powder for solution or as an
infusion for intravenous administration. It is approved for fibrinogen deficiency. It is also being
evaluated for cardiac surgery, in Phase 2/3, to address bleeding associated with coagulopathy
bleeding.
o Fibrin Sealant (FS) Grifols is a fibrinogen and thrombin concentrate assembled on a syringe
holder and applied topically on the bleeding site. It is in Phase 3 clinical trials as an adjunct to
haemostasis during soft-tissue open surgeries and parenchymous-tissue open surgeries.
o Octafibrin is being developed by Octapharma. It is a plasma-derived, highly purified,
lyophilized fibrinogen concentrate that has been double-virus safeguarded using two dedicated
virus inactivation/removal steps. Octafibrin is evaluated for both congenital fibrinogen
deficiency and as a surgical adjunct in operative care.
• Other key pivotal products in development include FCH (CSL Behring) and HP802-247
(Healthpoint). In April 2015, the FDA approved Raplixa (Fibrocaps) developed by Profibrix (acquired
by The Medicines Company) to control bleeding during surgery.
• The forecast period is expected to witness the launch of key products such as FCH (CSL Behring),
FS Grifols (Grifols), FIB (Grifols), Octafibrin (Octapharma), HP802-247 (Healthpoint), and BT-524
(Biotest).

Methodology and Scope
• This research service focuses on the global fibrinogen market and offers an overview of therapeutics for deficiency therapies and operative care. The market includes fibrinogen and fibrin products. A product and pipeline assessment is provided for marketed and investigational fibrinogen and fibrin products. The study covers the application of fibrinogen for deficiency therapies and operative care (surgical adjuncts).
• Products that have failed, been terminated/suspended/recalled have not been covered. No fibrin or fibrinogen stimulants, fibrinolytics and clotting factors involved in fibrinolysis are covered.
• The information contained in this research service was derived from published sources, including the following:
o Disease organization Web sites
o Clinical Trials.gov
o Company publications, including annual reports
o Securities and Exchange Commission (SEC) filings
o Press releases
o US government public sources
o Published articles in scientific journals
• Fibrinogen is a plasma glycoprotein with a molecular weight of kDa and is synthesized by the liver.
It is associated with the clotting of blood during haemorrhages or vascular injuries forming fibrin strands through proteolysis by the enzyme thrombin.
• Fibrinogen and fibrin together form part of the blood plasma market—which includes immunoglobulin, fibrinogen, alpha trypsin, Factor VIII, and thrombin—and finds application in the treatment of fibrinogen deficiencies and control of bleeding during surgeries, i.e., as a surgical adjunct.
• It is estimated that one in a million population are affected by fibrinogen deficiency. It has been
classified as a rare deficiency disease/orphan disease.
• Native fibrinogen is derived from the blood by fractionation and by recombinant methods. Large blood plasma product providers (CSL Behring), biopharmaceutical companies (Baxter Healthcare), contract manufacturers, and medical technologies and consumable manufacturers engage in providing fibrinogen and fibrin products.
• There has been an increase in innovative technologies. Spray-based fibrin bandages and transparent bandage adhesives are in clinical development.
• At present, there are only approved products for fibrinogen deficiency and 10 products for controlling bleeding during surgeries. Key products include Haemocomplettan (CSL Behring), Clottafact (LFB), Artiss (Baxter Healthcare), Evarrest (Ethicon), Tisseel (Baxter Healthcare), and Beriplast P(CSL Behring).
• Many of these approved products are also being evaluated for other surgical indications to expand their scope of application in operative care. The market is expected to grow at a modest CAGR rate of % to reach $ billion in 2020.

Table Of Contents

Analysis of the Global Fibrinogen Market and Product Pipeline
Executive Summary 5
• Executive Summary—Key Findings 6
• Key Trends 8
• Companies to Watch 9
Methodology and Scope 10
Market Background 12
• Market Overview—Introduction 13
• Market Overview—Blood Plasma Production 14
• Market Segmentation 15
• Blood Plasma Market Share 16
• Fibrinogen Production 17
• Revenue Forecast 18
• Revenue Forecast Discussion 19
• Supply Chain and Distribution Network 20
Competitive Landscape—Human Fibrinogen (Marketed and Pipeline Products) 22
• Competitive Landscape—Marketed and Pipeline Products 23
• Competitive Landscape Overview 24
• Marketed Products—Deficiency and Other Therapies 25
• Pipeline Products—Deficiency and Other Therapies 26
• Marketed Products—Operative Care 27
• Pipeline Products—Operative Care 29
Pivotal Phase 3 Trials 30
• Fibrinogen Market—Major On-going/Recently Completed Clinical Trials 31
• Summary of Key Products to Watch 34
• Timeline of Key Events—Launch of Products 36
Product Dashboard (Key Marketed and Phase 3 Products) 37
• Product Dashboard—Haemocomplettan/RiaSTAP (CSL Behring) 38
• Product Dashboard—Clottafact (LFB) 39
• Product Dashboard—Octafibrin (Octapharma) 40
• Product Dashboard—Artiss (Baxter Healthcare) 41
• Product Dashboard—Evarrest (Ethicon) 42
• Product Dashboard—Raplixa (The Medicines Company) 43
• Product Dashboard—FS Grifols (Grifols) 44
Conclusions 45

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