Cytomegalovirus immune globulin intravenous (human) - Biologic Drug Details

Summary for cytomegalovirus immune globulin intravenous (human)

Tradenames:	1
High Confidence Patents:	0
Applicants:	1
BLAs:	1
Suppliers: see list	1
Recent Clinical Trials:	See clinical trials for cytomegalovirus immune globulin intravenous (human)

Recent Clinical Trials for cytomegalovirus immune globulin intravenous (human)

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Joseph Kahwaji, MD, MPH	Phase 2
Novartis	Phase 2
Maastricht University Medical Center	Phase 1

See all cytomegalovirus immune globulin intravenous (human) clinical trials

Pharmacology for cytomegalovirus immune globulin intravenous (human)

Mechanism of Action	Virus Neutralization
Physiological Effect	Passively Acquired Immunity
Established Pharmacologic Class	Human Immunoglobulin G
Chemical Structure	Immunoglobulins

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

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

No patents found based on company disclosures

Cytomegalovirus immune globulin intravenous (human) Market Analysis and Financial Projection Experimental

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

Introduction

Cytomegalovirus Immune Globulin Intravenous (CMV-IGIV) is a biologic drug used to prevent cytomegalovirus (CMV) disease, particularly in patients undergoing organ transplants. This article delves into the market dynamics, financial trajectory, and key factors influencing the CMV-IGIV market.

Market Overview

The global market for immune globulin intravenous (IVIG) products, including CMV-IGIV, is experiencing significant growth driven by several factors.

Increasing Demand

Demand for IVIG products, including CMV-IGIV, has risen sharply over the last decade. This growth is largely attributed to the increasing prevalence of diseases such as immunodeficiencies, autoimmune diseases, and the need for prophylaxis in organ transplant patients[3].

Product Types

The market is segmented into liquid and powder formulations of IVIG. CMV-IGIV, specifically, is often administered in liquid form due to its convenience and ease of administration, particularly in home healthcare and clinic settings[1].

Applications and Indications

CMV-IGIV is primarily indicated for the prophylaxis of CMV disease associated with the transplantation of organs such as the kidney, lung, liver, pancreas, and heart. It is especially considered for transplants from CMV seropositive donors to seronegative recipients[2].

Off-Label Uses

While FDA-approved for specific indications, IVIG products, including CMV-IGIV, are also used for numerous off-label indications. This broader use contributes to the growing demand and market expansion[1].

Market Drivers

Several factors are driving the growth of the CMV-IGIV market:

Technological Advancements

Advancements in medical technology, particularly in plasma collection and fractionation, have improved the yield and quality of IVIG products. High-yield fractionation technologies are enhancing production capacities, although these improvements are gradual and do not immediately impact supply[1].

Investments in R&D

Increasing investments in the pharmaceutical sector, including drug discovery and development, are boosting market revenue growth. Public and private sector funding is crucial for the development of new IVIG products and the expansion of existing ones[3].

Healthcare Infrastructure

Improvements in healthcare infrastructure, especially in developed and developing countries, are facilitating the adoption of IVIG products. The growing need for early diagnosis and the increasing adoption of precision medicine are also fueling market growth[3].

Market Restraints

Despite the growth drivers, there are several restraints affecting the CMV-IGIV market:

Supply Chain Challenges

The supply of CMV-IGIV is heavily dependent on plasma availability and the capacity of fractionation facilities. Manufacturers are often operating near or at full capacity, leading to allocation systems and potential shortages[1].

Secondary Market Issues

The existence of a significant secondary market outside authorized distribution channels complicates the supply chain. This secondary market is characterized by fluctuating prices and product availability, which can disrupt the stable supply of CMV-IGIV[1].

Economic Factors

Medicare reimbursement rates, such as the average sales price (ASP) methodology, can impact the financial viability of CMV-IGIV for healthcare providers. Some providers face challenges in purchasing CMV-IGIV at or near the ASP plus 6 percent, leading to financial strain[1].

Financial Trajectory

The financial trajectory of the CMV-IGIV market is influenced by several economic factors:

Cost-Effectiveness

Studies have shown that prophylactic use of CMV-IGIV after organ transplantation can be cost-effective. For instance, a cost-effectiveness analysis indicated that CMV-IGIV can increase life expectancy at a marginal cost-effectiveness ratio comparable to other well-accepted medical therapies[5].

Pricing Dynamics

Prices in the secondary market are substantially higher than those in the authorized channel, reflecting the demand-supply imbalance. This pricing dynamic can affect the overall financial performance of manufacturers and the affordability for healthcare providers[1].

Market Size and Growth

The global IVIG market, which includes CMV-IGIV, is projected to grow significantly by 2027. The market size is expected to increase due to the growing prevalence of diseases, technological advancements, and increasing investments in the pharmaceutical sector[3].

Key Players

Several key players are active in the CMV-IGIV market, including:

• Baxter
• Octapharma
• Grifols
• Biotest
• CSL
• Hualan Bio
• LFB Group
• Kedrion
• BPL

These companies are focusing on strategies such as mergers and acquisitions, joint ventures, new product launches, and partnerships to maintain their market position and expand their product base[3].

Regional Dynamics

The global CMV-IGIV market is segmented into several major regions, each with its own market dynamics and growth prospects. Developed regions are driving the market due to advanced healthcare infrastructure and higher adoption rates, while developing regions are expected to grow rapidly due to increasing investments in healthcare[3].

Future Outlook

The future outlook for the CMV-IGIV market is positive, driven by increasing demand, technological advancements, and growing investments in the pharmaceutical sector. However, challenges such as supply chain disruptions, secondary market issues, and economic factors need to be addressed to ensure stable and sustainable growth.

"The possibility of new market entrants in the near future is uncertain as we cannot assess whether or when new IGIV products might be licensed for marketing in the United States"[1].

Key Takeaways

• Growing Demand: The demand for CMV-IGIV is increasing due to its use in organ transplantation and off-label indications.
• Technological Advancements: High-yield fractionation technologies are enhancing production capacities.
• Economic Factors: Medicare reimbursement rates and secondary market dynamics affect the financial viability of CMV-IGIV.
• Cost-Effectiveness: Prophylactic use of CMV-IGIV can be cost-effective in preventing CMV disease.
• Market Growth: The global IVIG market, including CMV-IGIV, is projected to grow significantly by 2027.

FAQs

What is the primary indication for CMV-IGIV?

CMV-IGIV is primarily indicated for the prophylaxis of cytomegalovirus disease associated with the transplantation of organs such as the kidney, lung, liver, pancreas, and heart[2].

How does the secondary market affect the CMV-IGIV supply chain?

The secondary market for CMV-IGIV is characterized by fluctuating prices and product availability, which can disrupt the stable supply of the product and lead to higher prices compared to the authorized channel[1].

What are the key drivers of the CMV-IGIV market growth?

Key drivers include increasing investments in the pharmaceutical sector, technological advancements in plasma collection and fractionation, and improvements in healthcare infrastructure[3].

Who are the major players in the CMV-IGIV market?

Major players include Baxter, Octapharma, Grifols, Biotest, CSL, Hualan Bio, LFB Group, Kedrion, and BPL, among others[3].

What is the expected market size and growth of the IVIG market by 2027?

The global IVIG market, which includes CMV-IGIV, is projected to grow significantly by 2027 due to the growing prevalence of diseases, technological advancements, and increasing investments in the pharmaceutical sector[3].

Sources

1. ANALYSIS OF SUPPLY, DISTRIBUTION, DEMAND, AND ACCESS ... - ASPE.HHS.GOV
2. Human cytomegalovirus immune globulin - DrugBank
3. Immune Globulin Intravenous Market Growth by 2027 - BioSpace
4. Global Cytomegalovirus Immune Globulin Intravenous Human (CMV ... - Market Research Intellect
5. Cytomegalovirus immune globulin after liver transplantation: a cost ... - PubMed