Lewes, DE -- (SBWIRE) -- 07/22/2014 -- The critical care market in the eight major developed markets (the US, UK, France, Germany, Italy, Spain, Japan and Canada) was worth an estimated $1.8 billion in 2013 and is expected to grow to $2.5 billion by 2020 at a Compound Annual Growth Rate (CAGR) of 4.7%. The majority of this revenue was due to albumin sales which amounted to $1.1 billion in 2013 and are expected to grow to $1.6 billion by 2020. In terms of markets, the US held the largest share with 41% of the total critical care market in 2013 and is projected to grow at the highest rate of any market at 7.5% during the 2013–2020 period.
Albumin was used to treat the highest share of the critical care treatment population across all eight markets with 2.2 million patients of a total of 2.4 million in 2013. Expectedly, the highest share of these patients was in the US, a total of 46% in 2013. A further 39.3% of the 2013 treatment population were located in the top five countries of Europe, followed by Japan with 9.5% and rest from Canada. The treatment population in the US is estimated to grow at a CAGR of 0.9% until 2020 with highest growth expected in the number of patients treated with Prothrombin Complex Concentrate (PCC) which is expected to grow at a CAGR of 2%. Globally, the treatment population receiving Anti-Thrombin (AT) concentrates and PCCs is expected to be larger than any other category and will grow at a CAGR of 1.5% during the 2013–2020 period.
The projected high growth rate of revenues in the US market of 7.5% is mainly due the increased uptake of factor concentrates over older alternatives (such as Fresh-Frozen Plasma (FFP)), higher price inflation and the launch of new drugs such as Kcentra (PPC, human) and Tretten (Factor XIII concentrate, recombinant) in 2013. Kcentra is the first four-factor PCC in the US and Tretten is the first recombinant factor XIII concentrate. In the top five European critical care markets there have been no recent significant product launches and none are expected during the forecast period. These markets are therefore anticipated to grow slowly during the forecast period, the UK market will grow at a CAGR of 3.0%, followed by France at 2.5%, Germany and Spain will each grow at 2.3% and Italy at 2.0%.
Increased Uptake of Four-Factor Prothombin Complex Concentrates in the US will Boost Growth
Although four-factor PCCs have been available in the European Union (EU) since 1996 , Kcentra became the first four-factor PCC to be approved in the US in 2013. Kcentra is a non-activated four-factor PCC which contains the vitamin K-dependent coagulation factors II, VII, IX, and X and antithrombotic proteins C and S. It is indicated for the urgent reversal of acquired coagulation factor deficiency induced by vitamin K antagonist (e.g. warfarin) therapy. In the US 35–40 million prescriptions of warfarin are dispensed each year and the incidence of fatal bleeding in patients on this treatment is 1–3%. Kcentra is already available in other markets such as Europe and Australia under the brand names Beriplex and/or Confidex and was first approved in Europe in 2008. Kcentra has been awarded new technology add-on payment status by the Centers for Medicare and Medicaid Services which grants additional reimbursement for inpatient costs under Medicare. Another four-factor PCC from Octapharma is in late-stage development in the US and is expected to be launched in late 2014 which will present another four-factor PCC option for clinicians. As the US has a large patient pool and a higher cost of therapy than other markets, the launch of these new four-factor PCCs is expected to give a tremendous boost to the PCC market during the forecast period.
Recombinant Factor Concentrates to Witness Strong Uptake
The use of factor concentrates is relatively recent in the US where vitamin K, FFP or cryoprecipitate were the traditionally preferred options in most critical care settings covered in this report. For example, although off-label use of three-factor PCCs and recombinant Factor (F) VII is prevalent, vitamin K and plasma were the recommended options for vitamin K antagonist reversal in the US. With the recent approval of several new factor concentrates in the US, the critical care market landscape is expected to change drastically. For congenital factor deficiencies, availability of more concentrated forms of the required factors in factor concentrates is much more efficacious and less risky than FFP treatment as factor concentrates are subjected to a viral inactivation process. However, recent recombinant products present a much better safety profile as they are not blood- or plasma-derived products and therefore completely avoid any related risks. While factor concentrates are established treatments in the EU, recombinant products are relatively new. Atryn (AT concentrate, recombinant) and NovoThirteen (or Tretten) are two recombinant products that expected to gain a good share of their respective markets in both the US and EU. Atryn, a recombinant AT concentrate, was approved in the US in 2009 and Tretten, a recombinant FXIII concentrate, in 2013.
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