Clinical Advancements in Immunoglobulin Therapy
U.S. Immunoglobulin Market Overview
Impact of Trough IgG on Pneumonia Incidence in Primary Immunodeficiency:
A Meta-analysis of Clinical Studies
In 2009, approximately 38,507 million grams of IVIg were administered to some 85,100 patients in the U.S., or 453 grams per patient on average.
The breakdown of this volume by therapeutic area shows that the most popular indications represented 60.5 percent of the total number of patients, and 66.8 percent of the totals grams.
- Primary Immune Deficiency
- Guillain-Barré Syndrome
- Chronic Inflammatory Demyelinating Polyneuropathy
- Bone Marrow Transplant
- Immune Thrombocytopenic Purpura
- Chronic Lymphocytic Leukemia
- Kawasaki Disease
Primary immune deficiency represented 36 percent of the total quantity of IVIg used, (including the subcutaneous formulation), neurological diseases represented 25 percent of the total, and hematology/oncology represented 26 percent.
In 2009, some 55 percent of the IVIgG was prescribed for non FDA-approved indications. Since most of these indications are included in the drug formularies of the insurance companies, and covered by Medicare, IVIg is generally reimbursed when prescribed for such an off-label indication.
Table 2: IVIg Usage by Medical Specialty in 2009
| Medical Specialty | Patients | Percent | Kilograms | Percent | Avg. Grams |
| Allergy/Immunology | 27,573 | 32.4% | 13,875 | 36.0% | 503 |
| - Primary Immune Deficiencies | 23,997 | 28.2% | 12,598 | 32.7% | 525 |
| Neurology | 24,266 | 28.5% | 9,649 | 25.1% | 398 |
| - Guillain Barre Syndrome | 5,921 | 7.0% | 3,316 | 8.6% | 560 |
| - CIDP | 2,460 | 2.9% | 2,067 | 5.4% | 840 |
| - Alzheimer's Disease | 1,468 | 1.7% | 801 | 2.1% | 546 |
| Hematology/Oncology | 14,236 | 16.7% | 9,900 | 25.7% | 695 |
| - Bone Marrow Transplant | 6,133 | 7.2% | 5,152 | 13.4% | 840 |
| - Idiopathic Thrombocytopenic Purpura | 2,953 | 3.5% | 977 | 2.5% | 331 |
| - Chronic Lymphocytic Leukemia | 3,212 | 3.8% | 1,349 | 3.5% | 420 |
| Cardiology | 7,139 | 8.4% | 570 | 1.5% | 80 |
| - Kawasaki Disease | 6,783 | 8.0% | 271 | 0.7% | 40 |
| Dermatology | 5,052 | 5.9% | 1,145 | 3.0% | 227 |
| Rheumatology/Nephrology | 2,978 | 3.5% | 2,078 | 5.4% | 698 |
| Infectious Disease | 1,716 | 2.0% | 674 | 1.8% | 393 |
| Ophthalmology | 1,168 | 1.4% | 394 | 1.0% | 338 |
| Obstetrics/Gynecology | 948 | 1.1% | 222 | 0.6% | 234 |
| Total | 85,074 | 100.0% | 38,507 | 100.0% | 453 |
| Source: MRB IVIg Industry Report 2009 | |||||
