Botulism immune globulin intravenous (human) - Biologic Drug Details

Summary for botulism immune globulin intravenous (human)

Tradenames:	1
High Confidence Patents:	0
Applicants:	1
BLAs:	1
Suppliers: see list	1

Pharmacology for botulism immune globulin intravenous (human)

Mechanism of Action	Bacterial Neurotoxin Neutralization
Physiological Effect	Passively Acquired Immunity
Established Pharmacologic Class	Human Immunoglobulin G
Chemical Structure	Antitoxins

Note on Biologic Patents

Matching patents to biologic drugs is far more complicated than for small-molecule drugs.

DrugPatentWatch employs three methods to identify biologic patents:

1. Brand-side disclosures in response to biosimilar applications

These patents were identified from disclosures by the brand-side company, in response to a potential biosimilar seeking to launch. They have a high certainty of blocking biosimilar entry. The expiration dates listed are not estimates — they're expiration dates as indicated by the brand-side company.

2. General brand-side disclosures

These patents were identified from searching drug labels and other general disclosures from the brand-side company. This list may exclude some of the patents which block biosimilar launch, and some of these patents listed may not actually block biosimilar launch. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

3. Patents from broad patent text search

For completeness, these patents were identified by searching the patent literature for mentions of the branded or ingredient name of the drug. Some of these patents protect the original drug, whereas others may protect follow-on inventions or even inventions casually mentioning the drug. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

1) High Certainty: US Patents for botulism immune globulin intravenous (human) Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for botulism immune globulin intravenous (human) Derived from Company Disclosures

No patents found based on company disclosures

3) Low Certainty: US Patents for botulism immune globulin intravenous (human) Derived from Patent Text Search

No patents found based on company disclosures

Market Dynamics and Financial Trajectory for Botulism Immune Globulin Intravenous (Human)

Introduction

Botulism Immune Globulin Intravenous (BIG-IV), also known as BabyBIG, is a crucial biologic drug used in the treatment of infant botulism. This article delves into the market dynamics and financial trajectory of BIG-IV, highlighting its efficacy, cost-effectiveness, and the broader context of the immunoglobulin market.

Development and Licensure of BIG-IV

The development of BIG-IV was a lengthy and costly process, spanning approximately 15 years and requiring an investment of around $10.6 million in 2005 dollars. This effort was facilitated by the federal Orphan Drug Act, which provided the necessary funding for pivotal clinical trials[5].

Efficacy and Safety

BIG-IV has proven to be highly effective in treating infant botulism. Clinical trials demonstrated that BIG-IV significantly reduces the mean length of hospital stay from 5.7 weeks to 2.2 weeks, and the mean duration of intensive care, mechanical ventilation, and tube or intravenous feeding. These reductions were accompanied by a decrease in mean hospital charges by $88,900 per patient[2][4].

Cost-Effectiveness

The cost-effectiveness of BIG-IV is a key aspect of its market dynamics. Since its licensure in 2003, BIG-IV has treated approximately 93% of US patients with laboratory-confirmed infant botulism, preventing over 65 years of hospital stay and more than $85 million in hospital charges. The total decreases in length of stay (LOS) and hospital charges from 2003 to 2015 were 66.9 years and $86.2 million, respectively[4].

Market Impact

BIG-IV's success is part of a larger trend in the immunoglobulin market. The global immunoglobulin market, which includes BIG-IV, is expected to grow significantly. In 2023, the global immunoglobulin market size was evaluated at $13.36 billion and is projected to reach around $28.70 billion by 2034, growing at a CAGR of 7.2% from 2024 to 2034[3].

Segment Growth

• Immunodeficiency Diseases: The segment treating immunodeficiency conditions is growing at a CAGR of 9.1% from 2024 to 2034, driven by the use of intravenous immunoglobulin (IVIG) and other biologics[3].
• Intravenous vs. Subcutaneous: The intravenous segment holds the highest market share due to its widespread use, but the subcutaneous segment is anticipated to expand at the fastest rate due to its advantages in reducing adverse events[3].

Regional Market Dynamics

The immunoglobulin market, including BIG-IV, varies by region:

• North America: This region has the largest market share, driven by high per capita consumption of immunoglobulins, particularly in the United States and Canada[3].
• Asia-Pacific: This region is expected to see the fastest expansion due to increasing health spending, growth in the pharmaceutical sector, and a rising prevalence of autoimmune diseases[3].

Financial Trajectory

The financial impact of BIG-IV is substantial:

• Hospital Charges: The use of BIG-IV has resulted in significant reductions in hospital charges. For example, in the first 12 years post-licensure, the total decrease in hospital charges was $86.2 million[4].
• Market Size: While BIG-IV is a niche product, it contributes to the broader immunoglobulin market, which is expected to nearly double by 2034[3].

Key Players and Recent Developments

• California Department of Public Health (CDPH): CDPH has been instrumental in the development and distribution of BIG-IV, ensuring its availability nationwide as a public service orphan drug[1][5].
• Industry Trends: Recent approvals and agreements, such as Biotest AG's immunosuppressive drug Yimmugo, indicate ongoing innovation and expansion in the immunoglobulin market[3].

Challenges and Opportunities

Despite its success, the market for BIG-IV faces challenges:

• Regulatory Environment: The development and licensure of orphan drugs like BIG-IV depend heavily on favorable regulatory environments and funding mechanisms[5].
• Market Expansion: The growing demand for immunoglobulins, driven by increasing prevalence of autoimmune and immunodeficiency diseases, presents opportunities for market expansion and innovation[3].

Conclusion

BIG-IV has transformed the treatment of infant botulism, offering significant reductions in hospital stay and costs. Its success is part of a broader trend in the immunoglobulin market, which is expected to continue growing driven by increasing demand and innovation.

Key Takeaways

• Efficacy: BIG-IV significantly reduces the length of hospital stay and hospital charges for infant botulism patients.
• Cost-Effectiveness: The use of BIG-IV has prevented over 65 years of hospital stay and more than $85 million in hospital charges since its licensure.
• Market Growth: The global immunoglobulin market is projected to grow to $28.70 billion by 2034.
• Regional Dynamics: North America and Asia-Pacific are key regions driving the growth of the immunoglobulin market.
• Innovation: Ongoing innovation and regulatory approvals are expected to further expand the market.

FAQs

1. What is BIG-IV and how does it work? BIG-IV, or Human Botulism Immune Globulin Intravenous, is a biologic drug that neutralizes botulinum toxin, effectively treating infant botulism by reducing the severity and duration of the illness.

2. How effective is BIG-IV in reducing hospital stay and costs? BIG-IV reduces the mean length of hospital stay from 5.7 weeks to 2.2 weeks and decreases hospital charges by $88,900 per patient, resulting in significant cost savings[2][4].

3. What is the current market size and growth projection for the immunoglobulin market? The global immunoglobulin market was valued at $13.36 billion in 2023 and is expected to reach around $28.70 billion by 2034, growing at a CAGR of 7.2% from 2024 to 2034[3].

4. Which regions are driving the growth of the immunoglobulin market? North America currently holds the largest market share, while the Asia-Pacific region is expected to see the fastest expansion due to increasing health spending and a growing prevalence of autoimmune diseases[3].

5. What are the key challenges and opportunities in the market for BIG-IV and similar immunoglobulins? Challenges include regulatory environments and funding mechanisms, while opportunities arise from increasing demand driven by autoimmune and immunodeficiency diseases, as well as ongoing innovation in the field[3][5].

Sources

1. Payne, J. R., Khouri, J. M., Jewell, N. P., & Arnon, S. S. (2018). Efficacy of Human Botulism Immune Globulin for the Treatment of Infant Botulism: The First 12 Years Post Licensure.
2. Arnon, S. S., Schechter, R., Maslanka, S. E., Jewell, N. P., & Hatheway, C. L. (2006). Human botulism immune globulin for the treatment of infant botulism. New England Journal of Medicine, 354(5), 462-471.
3. Biospace. (2024). Immunoglobulin Market Size to Worth around USD 28.70 Bn by 2034.
4. Payne, J. R., Khouri, J. M., Jewell, N. P., & Arnon, S. S. (2017). Efficacy of Human Botulism Immune Globulin for the Treatment of Infant Botulism. Clinical Infectious Diseases, 65(12), 2121-2128.
5. Arnon, S. S., Schechter, R., Inglesby, T. V., Henderson, D. A., Bartlett, J. G., Ascher, M. S., ... & Danila, R. (2006). Creation and development of the public service orphan drug Human Botulism Immune Globulin. Clinical Infectious Diseases, 42(10), 1381-1388.