Immunoglobulins Market to 2017 - Off-Label Usage and Treatment of Primary Immunodeficiency Diseases and Neurological Disorders Stimulate Market Growth

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The Global Immunoglobulins Market Will Grow Steadily With a Few Promising Products in the Pipeline

The immunoglobulins market is a steadily growing market and it is expected to grow steadily in the forecast period without any significant thrust due to a weak pipeline with few innovations. The existing promising immunoglobulins are undergoing life-cycle management, with them being approved for new indications.

CSL’s Privigen, an approved intravenous immunoglobulin (IVIG) for PID is undergoing Phase III trials for approval as an immunomodulating therapy for CIDP in Europe. Similarly, Baxter’s Gammagard Liquid, an approved IVIG for the treatment of PID may seek approval for MMN in the recent future due to its favorable results in clinical studies. Immune-mediated neurological disorders are expected to be one of the biggest drivers of IVIG to 2017, driven by anticipated approvals for the treatment of MMN and other diseases such as Alzheimer's diseases. Moreover, further research and development (R&D) in immunoglobulins therapy is focused on the subcutaneous mode of administration of immunoglobulins, an area that commands significant interest in the treatment of PID.

PID and Immune-Mediated Neurological Disorders the Biggest Driver of Immunoglobulins Products

Immunoglobulins products are used in a host of diseases and conditions such as bone marrow transplants, hematological disorders, dermatology, rheumatology, infectious diseases, ophthalmology and obstetrics; however, PID and neuroimmunologic disorders, primarily CIDP, MMN and GBS, command the major share of the revenue from immunoglobulin therapies. Together they accounted for around 89% of the revenues from the seven indications for immunoglobulins for 2010. It is in these two disease areas where a majority of the companies are focusing their products in terms of the number of approved indications and the mode of administration of the product.

Usage of Immunoglobulins Replacement Therapy in SCID to Decrease in the US in Near Future

It is expected that the use of immunoglobulins in severe combined immune deficiency (SCID), a major form of PID, may decrease in the future in the US due to the adoption of screening programs for newborn babies, which will lead to more success of hematopoietic stem cell transplantation (HSCT), a permanent treatment for SCID. In January, 2010, the Advisory Committee on Heritable Disorders in Newborns and Children voted unanimously to add screening for SCID to the core panel for universal screening of all newborns in the US. However, it is expected that several years will be needed before the screening will be implemented in all states.

The US Commands the Largest Share of Immunoglobulins Revenue due to High Usage and Favorable Reimbursement

The geographical break-up of revenue of the immunoglobulins market shows that the US accounted for 52% of the revenue, followed by the top five countries in Europe (38%) and Japan (10%) in 2010. The use of immunoglobulins, especially IVIG use, varies from country to country based on reimbursement rates and clinical practices at hospitals. The IVIG usage (grams per 1000 population) was highest in the US, followed by France, Italy, the UK, Germany and Japan. The US accounts for the largest share of the revenue for immunoglobulins and the trend is expected to continue in the future. In July 2007, Medicare in the US implemented brand-specific reimbursement codes for liquid IVIG; the system replaced the earlier single bundled code and payment rate for all liquid IVIG brands. The present individual codes and reimbursement rates on liquid IVIG on a brand-basis provides more flexibility in reimbursement for providers, allowing a better opportunity to utilize all brands of therapy with patients.

GBI Research’s report, “Immunoglobulins Market to 2017 - Off-Label Usage and Treatment of Primary Immunodeficiency Diseases and Neurological Disorders Stimulate Market Growth” provides in-depth analysis of the, drivers and barriers that affect the global immunoglobulins market. The report analyzes the markets for immunoglobulins products in the US, the top five countries in Europe (the UK, Germany, France, Italy and Spain) and Japan. Epidemiology, revenue, and annual cost of therapy are forecast until 2017 for the key geographies as well as seven key therapeutic segments. The report also provides profiles for the leading companies and analyzes the mergers, acquisitions and licensing agreements that shape the global markets.

GBI Research has found that the global immunoglobulins market is a niche market in the pharmaceutical industry. The indications covered in the study such as primary immunodeficiency (PID), Guillain-Barré syndrome (GBS), chronic inflammatory demyelinating polyneuropathy (CIDP), myasthenia gravis; multifocal motor neuropathy (MMN) and idiopathic thrombocytopenic purpura (ITP) have very low prevalence and incidence rates. Chronic lymphocytic leukemia (CLL), an indication covered in the report, has a high incidence rate compared to the other indications which are orphan diseases. The use of immunoglobulins as a mode of therapy differs from indication to indication. It has established therapeutic significance in the indications covered in the report. However, there is a significantly long list of indications where immunoglobulins are used off-label and as an alternative treatment when all the other established treatments fail to show any results. The expected growth in the overall market for immunoglobulins is due to reasons such as improved diagnosis of diseases and increasing number of patients as awareness about diseases increases; new indications where immunoglobulins are used; increased off-label uses; and the significantly high per-capita usage in the US. The market for immunoglobulins in the indications covered in the report has witnessed stable growth between 2002 and 2010. The market revenue in the forecast period is expected to grow at a steady rate as there are very few promising pipeline immunoglobulins products. Moreover, the absence of generics leads to relatively weak competition in the market, compared to other therapeutic classes of drugs.

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