U.S. Intravenous Immunoglobulin Market Size, Share & Trends Analysis Report By Application (CIDP, Congenital AIDS), By Route of Administration (IV, Subcutaneous), By Distribution Channel, And Segment Forecasts, 2018 - 2025

Industry Insights

The U.S. intravenous immunoglobulin (IVIG) market size was valued at USD 3.13 billion in 2017. It is expected to register a CAGR of 6.1% during the forecast period. A rise in demand for immunoglobulin replacement therapies for the treatment of primary immunodeficiency diseases is a high impact-rendering driver for the market.According to the American Board of Internal Medicine (AIBM) Foundation, at least 1 in 1,200 persons in the U.S. had PID in 2017. Moreover, according to the Immune Deficiency Foundation (IDF), there are more than 350 rare immune disorders representing primary immunodeficiency disorders.

Growing incidences of primary and acquired immunodeficiency diseases, such as AIDS and X-linked hypogammaglobulinemia, are expected to boost the demand for immunoglobulin therapies in the coming years. In addition to the rising prevalence of immunodeficiency disorders, shifting preference from steroids to intravenous immunoglobulins owing to lesser adverse effects and greater efficacy is expected to increase the demand for IVIGs.

According to the United States Census Bureau, the number of people aged 65 and older in U.S. was approximately 46.2 million in 2014, which is expected to reach over 98 million by 2060. Thus, rising geriatric population, which is prone to antibody deficiency disorders due to a weakened immune system, is another factor anticipated to propel the demand for immunoglobulin therapies in the near future.

Application Insights

Among application segments, hypogammaglobulinemia segment held the substantial share of the market in 2017. This was mainly due to rising adoption of intravenous and subcutaneous immunoglobulin replacement therapies. Key benefits including high patient response rates and fewer adverse effects are further driving the demand for immunoglobulin therapy. According to estimates published by CDC in 2012, the global incidence rate of hypogammaglobulinemia was approximately 2 per 100,000 populations every year and was forecasted to increase in coming years.

Kawasaki disease segment is expected to witness a lucrative growth over the forecast period owing to increasing prevalence of the disease in children. According to the Kawasaki Disease Foundation, over 4,200 children are affected in U.S. every year. About 80% of the patients are under five years of age. Alternative treatment includes the use of steroids, which cause more adverse effects than IVIG replacement therapy. This is also estimated to drive the segment. Furthermore, rising prevalence of immunodeficiency diseases and increasing patient awareness levels are also expected to contribute towards the segment growth.

Route of Administration Insights

Intravenous immunoglobulin accounted for the largest share of the U.S. immunoglobulin market in 2017 based on the route of administration. This can be attributed to the high adoption of IVIGs for treatment of a wide range of immune deficiency diseases as it is the first line of treatment for patients suffering from primary immunodeficiency disorders. Increasing adoption of IVIG therapy for off-label indications, such as myasthenia gravis, and rising awareness levels among people is another factor contributing to its largest share. Moreover, extensive R&D for the development of novel products would also drive the market demand over the next few years.

Subcutaneous immunoglobulin is also likely to witness a significant growth over the forecast period. This is attributable to its benefits such as easy and shorter administration duration, fewer needle punctures, lower systemic adverse effects, and longer infusion intervals. According to a study published by National Institutes of Health in 2015, subcutaneous administration facilitates larger volumes of IgG delivery, as required in replacements therapies. In addition, ongoing R&D pertaining to the development of subcutaneous immunoglobulin for treatment of diseases is expected to boost the market in coming years.

Distribution Channel Insights

Hospital pharmacy held the largest of U.S. IVIG market in 2017 owing to the presence of a large number of hospital pharmacies and easy availability of products in the hospitals. Increasing prevalence of primary immune deficiencies, hepatitis C, and other diseases has led to an increase in the total number of hospitalizations worldwide, which has further resulted in a rise in customers for hospital pharmacies. Moreover, hospitals provide treatment and care to a high number of patients. It also offers quick reimbursement policies, owing to which patients opt for hospital pharmacies.

On the other hand, the specialty pharmacy segment is expected to witness lucrative growth over the forecast period. The number of approved specialty drugs is increasing rapidly, owing to which the total spending on specialty drugs is increasing dramatically. This trend is expected to continue in future, thereby driving the segment growth. According to a white paper published by Mckesson Corporation in 2015, specialty drugs account for 30% of the total drug spending, which is projected to increase by 8% to 10% per year, reaching 50% of drug spending by 2018.

U.S. Intravenous Immunoglobulin (IVIG) Market Share Insights

The major companies in the industry are Biotest AG; Octapharma AG; LFB Biotechnologies; China Biologics Products; Holdings, Inc.; Grifols S.A.; Kedrion Biopharma, Inc.; CSL Behring; BDI Pharma, Inc.; Shire plc; and Bio Products Laboratory Ltd. Grifols, S.A., Shire, and CSL Behring hold a major share of the market as these companies have significantly greater financial, clinical, manufacturing, marketing, distribution, and technical resources and experience.

Most of the market leaders are involved in the development of new plasma collection centers and other collaborative strategies to expand their geographical reach and widen their product portfolio. For instance, In March 2018, Grifols entered into an agreement with Haema to acquire the latter including 35 donation centers in Germany, thereby strengthening the company's position in plasma collection.

Report Scope

Segments Covered in the Report

This report forecasts revenue growth at country level and provides an analysis of the industry trends in each of the sub-segments from 2014 to 2025. For the purpose of this study, Grand View Research has segmented the U.S. intravenous immunoglobulin (IVIG) market report on the basis of application, route of administration, and distribution channel:

• U.S. IVIG Application Outlook (Revenue, USD Million, 2014 - 2025)

  • Hypogammaglobulinemia

  • CIDP

  • Immunodeficiency Diseases

  • Congenital AIDS

  • Chronic Lymphocytic Leukemia

  • Myasthenia Gravis

  • Multifocal Motor Neuropathy

  • ITP

  • Kawasaki Disease

  • Guillain-Barre Syndrome

  • Others

• U.S. IG Route of Administration Outlook (Revenue, USD Million, 2014 - 2025)

  • Intravenous

  • Subcutaneous

• U.S. IVIG Distribution Channel Outlook (Revenue, USD Million, 2014 - 2025)

  • Hospital Pharmacy

  • Specialty Pharmacy