Critical Care Market Requires Improved Clinical Studies to Drive Progress

Thursday 13 June 2013, Amsterdam

Clinical studies are desperately required to prove the safety, efficacy and cost-effectiveness of blood proteins used in critical care, according to new analysis.

Alongside individuals with rare hematological conditions, the new report states that patients suffering from burns or trauma, or undergoing surgery or pregnancy, can benefit from blood protein treatment. However, prothrombin complex concentrates (PCCs), albumin, antithrombin (AT) concentrates, and factor concentrates remain controversial treatments due to a lack of clinical data and consensus among specialists.

Fibrinogen deficiency, FXIII deficiency, and AT deficiency can all be congenital, or acquired from disease, trauma, medication or surgical interventions. The natural anti-coagulants can be used for the management of bleeding, but low deficiency prevalence rates remake clinical trials difficult to conduct, and the exact role of these proteins remain relatively unknown, with no clear guidelines available on use, dosing and duration of therapy.

Albumin is the most abundant protein in human blood plasma, and it is often used to replace lost fluid and help restore blood volume in patients with liver disease or kidney damage, as well as in trauma, burns and surgery patients. Albumin accounted for the biggest share of the critical care therapeutics market in 2012, and expanded indications for albumin as a medium and protective agent in vaccine production is expected to amplify future demand. The albumin market is consequently expected to grow from $1.7 billion in 2012 to $2.4 billion in 2019 at a Compound Annual Growth Rate (CAGR) of 5%.

The AT concentrates market is competitive, containing at least eight different AT III products, including Talecris’ anti-thrombin product, Thrombate, and rEVO Biologics’ Atryn (recombinant AT). Atryn is genetically bioengineered, removing dependence on plasma donors, minimizing risk of viral transmission, and allowing speedier production. The cost of therapy with AT concentrates is high compared to other anticoagulant and plasma products, but its impressive safety and efficacy outweigh this concern. The AT concentrates market is expected to increase at a CAGR of 6.1%, from an estimated $79m in 2012 to $120m by 2019.

The value of the fibrinogen concentrate market amounted to an estimated $112.6m in 2012, and is expected to reach $154m in 2019, growing at a CAGR of 4.6%. CSL dominates the market with Haemocomplettan, also marketed under the brand name Riastap since receiving FDA approval in 2011.

We expect the global critical care therapeutics market to grow from an estimated $2.3 billion in 2012 to 3.2 billion in 2019, growing at a CAGR of 5% during the forecast period. The 5EU accounted for a 40% share of the global critical care market in 2012, followed by the US with a 37% share, and Japan with 23%.