CLINICAL TRIALS PROFILE FOR IMMUNE GLOBULIN INFUSION (HUMAN)

All Clinical Trials for immune globulin infusion (human)

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00003913 ↗	Umbilical Cord Blood Transplantation in Treating Patients With Hematologic Cancer or Nonmalignant Hematologic Disease	Completed	National Cancer Institute (NCI)	Phase 2	1998-12-01	RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Umbilical cord blood transplantation may be able to replace immune cells that were destroyed by the chemotherapy or radiation therapy that was used to kill cancer cells. PURPOSE: Phase II trial to study the effectiveness of umbilical cord blood transplantation plus combination chemotherapy in treating patients who have hematologic cancer or nonmalignant hematologic disease.
NCT00003913 ↗	Umbilical Cord Blood Transplantation in Treating Patients With Hematologic Cancer or Nonmalignant Hematologic Disease	Completed	National Heart, Lung, and Blood Institute (NHLBI)	Phase 2	1998-12-01	RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Umbilical cord blood transplantation may be able to replace immune cells that were destroyed by the chemotherapy or radiation therapy that was used to kill cancer cells. PURPOSE: Phase II trial to study the effectiveness of umbilical cord blood transplantation plus combination chemotherapy in treating patients who have hematologic cancer or nonmalignant hematologic disease.
NCT00003913 ↗	Umbilical Cord Blood Transplantation in Treating Patients With Hematologic Cancer or Nonmalignant Hematologic Disease	Completed	Fred Hutchinson Cancer Research Center	Phase 2	1998-12-01	RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Umbilical cord blood transplantation may be able to replace immune cells that were destroyed by the chemotherapy or radiation therapy that was used to kill cancer cells. PURPOSE: Phase II trial to study the effectiveness of umbilical cord blood transplantation plus combination chemotherapy in treating patients who have hematologic cancer or nonmalignant hematologic disease.
NCT00003661 ↗	Chemotherapy, Radiation Therapy, and Umbilical Cord Blood Transplantation in Treating Patients With Hematologic Cancer	Completed	Roswell Park Cancer Institute	Phase 2	1998-06-01	RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage cancer cells. Umbilical cord blood transplantation may be able to replace cells destroyed by chemotherapy or radiation therapy. PURPOSE: Phase II trial to study the effectiveness of chemotherapy, radiation therapy, and umbilical cord blood transplantation in treating patients who have hematologic cancer.
NCT00003335 ↗	Umbilical Cord Blood Transplantation in Treating Patients With High-Risk Hematologic Cancer	Completed	National Cancer Institute (NCI)	Phase 2	1998-01-01	RATIONALE: Umbilical cord blood transplantation may allow doctors to give higher doses of chemotherapy or radiation therapy and kill more cancer cells. PURPOSE: This phase II trial is studying allogeneic umbilical cord blood transplantation to see how well it works when given with chemotherapy or radiation therapy in treating patients with high-risk hematologic cancer.
NCT00003335 ↗	Umbilical Cord Blood Transplantation in Treating Patients With High-Risk Hematologic Cancer	Completed	Case Comprehensive Cancer Center	Phase 2	1998-01-01	RATIONALE: Umbilical cord blood transplantation may allow doctors to give higher doses of chemotherapy or radiation therapy and kill more cancer cells. PURPOSE: This phase II trial is studying allogeneic umbilical cord blood transplantation to see how well it works when given with chemotherapy or radiation therapy in treating patients with high-risk hematologic cancer.
NCT00004286 ↗	Phase III Multicenter Double Blind Controlled Trial of Human Immune Globulin Therapy in Previously Untreated Patients With Chronic Inflammatory Demyelinating Neuropathy	Completed	University of Vermont	Phase 3	1996-02-01	OBJECTIVES: I. Compare and evaluate the response to treatment with intravenous human immune globulin (IVIG) or placebo in previously untreated patients with chronic inflammatory demyelinating polyneuropathy.

Clinical Trial Conditions for immune globulin infusion (human)

Condition Name

Condition Name for immune globulin infusion (human)
Intervention	Trials
Leukemia	19
Lymphoma	13
Myelodysplastic Syndromes	11
Myelodysplastic Syndrome	7

Condition MeSH

Condition MeSH for immune globulin infusion (human)
Intervention	Trials
Leukemia	25
Myelodysplastic Syndromes	19
Preleukemia	19
Lymphoma	16

Clinical Trial Locations for immune globulin infusion (human)

Trials by Country

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Trials by Country for immune globulin infusion (human)
Location	Trials
United States	108
Canada	7
Nepal	2
Korea, Republic of	1

Trials by US State

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−

Trials by US State for immune globulin infusion (human)
Location	Trials
Texas	14
California	10
Ohio	9
Florida	8
New York	7

Clinical Trial Progress for immune globulin infusion (human)

Clinical Trial Phase

Clinical Trial Phase for immune globulin infusion (human)
Clinical Trial Phase	Trials
Phase 4	1
Phase 3	5
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for immune globulin infusion (human)
Clinical Trial Phase	Trials
Completed	34
Terminated	7
Withdrawn	4

Clinical Trial Sponsors for immune globulin infusion (human)

Sponsor Name

Sponsor Name for immune globulin infusion (human)
Sponsor	Trials
National Cancer Institute (NCI)	16
M.D. Anderson Cancer Center	11
Case Comprehensive Cancer Center	4

Sponsor Type

Sponsor Type for immune globulin infusion (human)
Sponsor	Trials
Other	54
NIH	23
Industry	12

Immune Globulin Infusion (Human): Clinical Trials, Market Analysis, and Projections

Introduction to Immune Globulin Infusion (Human)

Immune globulin infusion, also known as intravenous immunoglobulin (IVIG), is a therapy derived from the pooled plasma of thousands of donors. It contains a broad spectrum of antibodies that can help replace or supplement the immune system's natural defenses. Here, we will delve into recent clinical trials, market analysis, and future projections for this vital therapeutic agent.

Recent Clinical Trials

Gammagard Liquid for CIDP

In January 2024, the FDA approved Gammagard Liquid (Immune Globulin Infusion [human] 10% solution) for the treatment of neuromuscular disability and impairment in adults with chronic inflammatory demyelinating polyneuropathy (CIDP). This approval was based on data from the phase 3 ADVANCE-CIDP 2 clinical trial, which demonstrated the safety, tolerability, and efficacy of Gammagard Liquid in improving functional disability in patients with CIDP[1].

YIMMUGO for Primary Humoral Immunodeficiency

YIMMUGO, a next-generation IVIG product, was approved by the FDA following a phase 3 clinical trial (Study 991) that evaluated its safety and efficacy in patients with primary humoral immunodeficiency (PI). The study showed that YIMMUGO effectively restored IgG levels and reduced the annualized rate of serious bacterial infections (SBIs) in these patients[4].

XEMBIFY for Primary Immunodeficiencies

Grifols' XEMBIFY (immune globulin subcutaneous human-klhw) has also shown promising results in a phase 4 study, demonstrating comparable total immunoglobulin levels when administered biweekly versus weekly in patients with primary immunodeficiencies. This study aims to support extending the FDA labeling of XEMBIFY to include biweekly dosing, offering greater flexibility and convenience for patients[3].

Market Analysis

Current Market Size

The global immunoglobulin market was valued at USD 16.24 billion in 2023 and is projected to grow significantly in the coming years. The intravenous immunoglobulin market alone reached USD 12.7 billion in 2023 and is expected to reach USD 23.5 billion by 2034, with a compound annual growth rate (CAGR) of 5.76% during 2024-2034[2][5].

Driving Factors

Several factors are driving the growth of the immunoglobulin market:

• Increasing Prevalence of Autoimmune and Inflammatory Diseases: Conditions such as Guillain-Barré Syndrome, CIDP, and primary humoral immunodeficiency are becoming more prevalent, leading to a higher demand for IVIG therapies[2][5].
• Advancements in Production Technologies: Improvements in plasma fractionation and purification processes have enhanced the quality and consistency of IVIG products, addressing previous supply constraints[2].
• Heightened Awareness and Technological Advancements: Greater awareness about IVIG therapies and advancements in treatment options are contributing to the market's growth[2][5].

Regional Markets

The United States has the largest patient pool and market for IVIG treatments, driven by the prevalence of autoimmune and chronic diseases, an aging population, and technological advancements in plasma fractionation. Other significant markets include Germany, France, the United Kingdom, Italy, Spain, and Japan. The Asia Pacific region is expected to grow with the highest CAGR due to rising healthcare reforms and increasing healthcare expenditure[2][5].

Market Projections

Global Growth

The global immunoglobulin market is projected to grow from USD 17.58 billion in 2024 to USD 35.85 billion by 2032. This growth is fueled by the increasing demand for IVIG therapies, advancements in treatment options, and rising healthcare expenditure in various regions[5].

Regional Growth

• Asia Pacific: Expected to grow with the highest CAGR due to healthcare reforms, government initiatives, and increasing healthcare expenditure.
• Latin America and Middle East & Africa: Anticipated to grow with a moderate CAGR driven by increasing product awareness, rising numbers of healthcare professionals, and improved product availability[5].

Key Players

The global market is consolidated with major players such as Grifols, S.A., CSL Limited, and Takeda Pharmaceutical Company Limited holding a significant share of the market. These companies are continuously investing in research and development to enhance their immunoglobulin products and expand their market presence[5].

Challenges and Opportunities

Supply Chain and Accessibility

Despite advancements, the COVID-19 pandemic highlighted the vulnerability of the plasma collection and fractionation process. Ensuring a stable supply chain and improving accessibility to IVIG treatments remain critical challenges. However, efforts to enhance supply chain logistics and increase plasma collection are ongoing, offering opportunities for market growth[5].

Technological Advancements

Continuous improvements in production technologies, such as advanced plasma fractionation and purification processes, are expected to drive the market forward. These advancements not only improve product quality but also address previous supply constraints, making IVIG therapies more accessible and affordable[2].

Key Takeaways

• Clinical Trials: Recent approvals for Gammagard Liquid, YIMMUGO, and positive results for XEMBIFY highlight the ongoing research and development in IVIG therapies.
• Market Growth: The global immunoglobulin market is expected to grow significantly, driven by increasing demand, technological advancements, and rising healthcare expenditure.
• Regional Focus: The United States and Asia Pacific region are key markets, with the latter expected to grow at the highest CAGR.
• Challenges and Opportunities: Ensuring a stable supply chain and improving accessibility are crucial, while technological advancements offer significant opportunities for market growth.

FAQs

1. What is the current market size of the intravenous immunoglobulin market?

   • The intravenous immunoglobulin market size reached USD 12.7 billion in 2023[2].

2. Which regions are expected to drive the growth of the immunoglobulin market?

   • The Asia Pacific region is expected to grow with the highest CAGR, followed by moderate growth in Latin America and the Middle East & Africa[5].

3. What are the key factors driving the growth of the immunoglobulin market?

   • Increasing prevalence of autoimmune and inflammatory diseases, advancements in production technologies, and heightened awareness about IVIG therapies are key drivers[2][5].

4. Which companies are major players in the immunoglobulin market?

   • Grifols, S.A., CSL Limited, and Takeda Pharmaceutical Company Limited are among the major players[5].

5. What are the recent clinical trial updates for immune globulin infusion?

   • Recent approvals include Gammagard Liquid for CIDP, YIMMUGO for primary humoral immunodeficiency, and positive results for XEMBIFY in a phase 4 study[1][3][4].

Sources

1. Practical Neurology: "Gammagard Liquid Receives FDA Approval to Treat Disability and Impairment Associated with Chronic Inflammatory Demyelinating Polyneuropathy"[1].
2. BioSpace: "Intravenous Immunoglobulin Market Size to Reach USD 23.5 Billion by 2034, Impelled by Advancements in Production Technologies"[2].
3. Grifols: "Grifols achieves positive topline results from phase 4 study of XEMBIFY® (immune globulin subcutaneous human-klhw) evaluating biweekly dosing option for patients"[3].
4. FDA: "Summary Basis for Regulatory Action - YIMMUGO (IgG Next Generation; BT595)"[4].
5. Fortune Business Insights: "Immunoglobulin Market Size, Share & Global Report [2032]"[5].