Immunoglobulins Market in Top Seven Markets is Estimated to Reach $5.8 Billion by 2019

Date: 20-May-2013 adds “Immunoglobulins Market to 2019 - Demand in Primary Immunodeficiency (PI) and Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Potentially Supplemented by Approvals for Alzheimer’s Disease” new report on its database


The market for immunoglobulin in the top seven markets stood at $3.6 billion in 2012, having grown at a Compound Annual Growth Rate (CAGR) of 6% from 2006. It is estimated to grow at a CAGR of 6.9% to $5.8 billion by 2019. It is dominated by two indications which account for 60% of Intravenous Immunoglobulin (IVIG) usage. In terms of regional markets, the US accounts for the largest share with 71.4%, followed by the top five countries in Europe (the UK, Germany, France, Italy and Spain) with 24.3% and Japan with 4.3%. Following a high number of product approvals between 2003 and late 2012, the US market witnessed a growth rate of 5.7% from $1.8 billion in 2006 to $2.6 billion in 2012, and is estimated to reach $4 billion by 2019.


The immunoglobulin market in the top seven markets is estimated to grow at a slightly higher growth rate in the forecast period due to continuing demand for immunoglobulin treatment for several indications, rising disease awareness, approval of existing IVIG products for new indications, the expected approval of new Subcutaneous Immunoglobulin (SCIG) and global blood product shortages.


Continuing Demand from Major Indications and Approval of Subcutaneous Immunoglobulin to Give Slight Boost to the Market


In terms of replacement therapy, Primary Immunodeficiency (PI) accounts for the highest IVIG consumption with 32%, and for long-term treatment, Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) accounts for the highest with 28%. PI is an indication for which all existing IVIG products have received approval from both the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA). The FDA has approved only one product for CIDP, namely Gamunex-C in 2008, while the EMA has approved three products since 2004. The IVIG market for PI grew at a CAGR of 10.7% from 2006 to $1.2 billion in 2012 and is estimated to grow at 11% from 2012 to $2.4 billion in 2019. Since 2006, the FDA has approved five IVIG products and two SCIG products for the treatment of PI, the latest being IVIG Bivigam by Biotest in December 2012. Only one product has been approved for CIDP since 2008 in the US market, which accounts for a large share of the global market. This is reflected in a lower growth rate of 4% from 2006 to $1.0 billion by 2012. However, this segment is expected to maintain its growth rate to reach $1.4 billion by 2019, accounting for 24% of the total immunoglobulin market.


Two SCIG products, CSL's Vivaglobin and Hizentra, received approval for PI in the US in 2006 and 2011 respectively, while Gammanorm was approved by the EMA in 2005 for PI, Immune Thrombocytopenic Purpura (ITP), Guillain-Barré Syndrome (GBS) and Chronic Lymphocyte Leukemia (CLL). Another SCIG product, Baxter's HyQvia, also received a positive opinion from the EMA for marketing authorization in Europe for PI in March 2013. The trend towards SCIG is also reflected in the product pipelines. CSL's NextGen 16% for PI and Hizentra for CIDP are two SCIG products in late-stage clinical trials, while Baxter's SCIG is under investigation for approval for PI in the US.


Possible Approval of Immunoglobulin for Alzheimer’s Disease Could Double the Growth Rate


The use of immunoglobulin as a treatment option for Alzheimer’s disease is being investigated by all major companies in this segment, and the product pipeline is dominated by R&D in Phase II and III clinical trials. The recently completed Phase III study results of Baxter’s Gammagard Liquid are anticipated in mid-2013. Similarly, Octapharma completed a Phase II study of its Octagam 10% IVIG for Alzheimer’s disease and published positive results in January 2013. With a significant number of Alzheimer’s patients awaiting better treatment options, the approval of either of these products could change the immunoglobulin market landscape.


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