IVIG - Target Population, Competitive Landscape, and Market Forecast - 2034

Key Highlights:

• Intravenous immunoglobulin is a pooled antibody, and a biological agent used to manage various immunodeficiency states and a plethora of other conditions, including autoimmune, infectious, and inflammatory states. The ultimate goal of this therapy is to normalize a compromised immune system.
• IVIg therapy has been approved for the treatment of Immune Thrombocytopenia (ITP), Guillain-Barre Syndrome (GBS), Kawasaki's disease, Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) and Multifocal motor neuropathy (MMN) and many others. Furthermore, IVIg is widely used off-label for treating immune-mediated, neurological, hematological, and dermatological diseases.
• Several companies-such as Grifols Therapeutics, ADMA Biologics, Takeda, LFB Biopharmaceuticals, OCTAPHARMA, Pfizer, CSL Behring, Biotest AG, and GC Biopharma-are actively involved in the development and commercialization of intravenous immunoglobulin (IVIG) therapies, with many already having approved products established in the market.
• PRIVIGEN stands out as one of the few IVIG therapies approved across all 7MM (US, EU5, and Japan) markets, reflecting its broad clinical acceptance and regulatory recognition for treating immune deficiencies and autoimmune conditions.
• In September 2024, GC Biopharma USA, Inc. announced the launch and distribution of its IG product ALYGLO (IVIG), the company's first 10% IVIG therapy for the treatment of adult patients aged 17 years and older with PI.
• In full year 2024,BIVIGAM generated a revenue of approximately USD 50 million in the United States.
• Despite its widespread use, the IVIG market faces several challenges, including supply limitations due to reliance on human plasma, high production costs associated with complex manufacturing processes, and payer resistance to high-priced biologics-particularly for off-label indications-which collectively hinder consistent access, pricing flexibility, and broader market penetration.
• Looking ahead, continued innovation in manufacturing, improved donor recruitment strategies, and expanding clinical evidence for new indications will be critical to overcoming these hurdles and sustaining growth in the global IVIG market.

DelveInsight's "IVIG - Target Population, Competitive Landscape, and Market Forecast - 2034" report delivers an in-depth understanding of the IVIG, historical and Competitive Landscape as well as the IVIG' market trends in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.

The IVIG market report provides current treatment practices, emerging drugs, market share of individual therapies, and current and forecasted 7MM IVIG market size from 2020 to 2034. The report also covers current IVIG treatment practices/algorithms and unmet medical needs to curate the best opportunities and assess the market's potential.

Geography Covered:

• The United States
• EU4 (Germany, France, Italy, and Spain) and the United Kingdom
• Japan

Study Period: 2020-2034

IVIG Understanding and Treatment Algorithm

IVIG Overview

Immunoglobulins (Ig)-commonly referred to as antibodies-are glycoproteins produced by plasma cells in response to antigenic stimulation. They play a pivotal role in both physiological and pathological immune responses. As essential components of the adaptive immune system, immunoglobulins are classified based on the structure of their heavy chains into five major types: IgG, IgA, IgM, IgE, and IgD, each with distinct immunological roles. Among these, IgG is the most prevalent, comprising approximately 75-80% of total plasma antibodies (700-1600 mg/dL). It is further categorized into four subclasses-IgG1, IgG2, IgG3, and IgG4-each differing in function and distribution. IgA, which makes up around 15% of circulating immunoglobulins (70-400 mg/dL), plays a key role in mucosal immunity and exists in two subtypes: IgA1 and IgA2. IgM, though present at lower concentrations (40-230 mg/dL), is the first antibody produced during an immune response and is crucial in the initial defense against pathogens.

Intravenous Immunoglobulin (IVIG): From Replacement Therapy to Immunomodulatory Agent

IVIG products are composed of pooled IgG antibodies sourced from thousands of healthy donors. Initially introduced as a replacement therapy for patients with primary and secondary immunodeficiency disorders, IVIG has since demonstrated significant immunomodulatory properties. This expanded its therapeutic utility into a broad range of conditions, including neurological, hematological, infectious, and autoimmune diseases-solidifying its role as a versatile and indispensable treatment modality.

IVIG Market Overview

IVIG preparations consist of pooled IgG antibodies derived from thousands of donors, initially developed as a replacement therapy for primary and secondary immunodeficiency disorders. However, subsequent research revealed its profound immunomodulatory effects, making IVIG a cornerstone therapy in neurological, hematological, infectious, and autoimmune diseases. This paradoxical role of IgG-as both a driver of autoimmune pathology and a therapeutic agent-is particularly evident in conditions such as rheumatoid arthritis, systemic lupus erythematosus , immune thrombocytopenia , autoimmune hemolytic anemia , and chronic inflammatory demyelinating polyneuropathy and others. Despite its efficacy, the precise immunoregulatory mechanisms of IVIG remain incompletely understood.

IVIG Epidemiology

The IVIG epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented as total cases of selected indications for IVIG, total eligible patient pool of selected indication for IVIG, total treated cases in selected indications for IVIG in the 7MM covering the United States, EU4 (Germany, France, Italy, and Spain), and the United Kingdom, and Japan from 2020 to 2034.

• In 2024, chronic inflammatory demyelinating polyneuropathy affected approximately 21,000 patients in the United States.
• Primary Immunodeficiency Diseases had an estimated prevalence of around 38,000 cases across the EU4 and the UK in 2023.

IVIG Drug Chapters

The drug chapter segment of the IVIG reports encloses a detailed analysis of approved IVIG late-stage (Phase III and Phase II) IVIG. It also helps understand the IVIG's clinical trial details, expressive pharmacological action, agreements and collaborations, approval and patent details, advantages and disadvantages of each included drug and the latest news and press releases.

Marketed Drugs

YIMMUGO (immune globulin intravenous, human - dira): Biotest AG

YIMMUGO is an immune globulin intravenous (IVIG), human - dira, 10% liquid indicated for the treatment of primary humoral immunodeficiency (PI) in patients 2 years of age or older. It is manufactured by Biotest AG using pooled plasma from healthy donors and provides a broad spectrum of Immunoglobulin G (IgG) antibodies. In July 2024, Biotest AG announced that its IVIG, YIMMUGO, had been approved in the United States for the treatment of patients with primary immunodeficiencies.

ALYGLO (IVIG, human-stwk): GC Biopharma

ALYGLO is indicated for the treatment of PI in adults aged 17 years and older. This includes, but is not limited to, congenital agammaglobulinemia, common variable immunodeficiency (CVID), Wiskott-Aldrich syndrome, and severe combined immunodeficiencies. It contains a high concentration of IgG antibodies derived from pooled human plasma, which helps bolster the immune system against infections. Administered every 21 to 28 days, ALYGLO is crucial for patients with conditions like common variable immunodeficiency and severe combined immunodeficiencies. While it effectively reduces infection rates, patients should be monitored for potential side effects, including thrombosis and renal complications. In December 2023, GC Biopharma USA announced that the US FDA had approved ALYGLO 10% Liquid, formerly referred to as "G5107B," for the treatment of adult patients aged 17 years and older with PI.

Emerging Drugs

TAK-880: Takeda

TAK-880, developed by Takeda, is a low IgA-IgG intravenous immunoglobulin formulation being investigated for the treatment of primary immunodeficiency diseases, particularly in individuals hypersensitive to IgA TAK-880 is currently being filed with the FDA and EU for the approval in treatment of primary immunodeficiency diseases.

IVIG Market Outlook

Several intravenous immunoglobulin (IVIG) formulations have received regulatory approval in the United States, each designed to meet distinct clinical requirements. These include: BIVIGAM, CARIMUNE, FLEBOGAMMA, GAMMAGARD S/D (low IgA formulation), GAMMAGARD Liquid, GAMMAKED, GAMMAPLEX, GAMUNEX, OCTAGAM, and PRIVIGEN.

In recent years, the global immunoglobulin shortage has become a critical issue, with Japan facing similar challenges, particularly since 2019. The sharp rise in immunoglobulin demand has made urgent imports unavoidable. Analysis suggests two key factors behind this surge: the approval of immunoglobulin for preventing chronic inflammatory demyelinating polyneuropathy (CIDP) progression and the introduction of concentrated formulations.

Despite its promising potential, the widespread production and adoption of IVIg therapy remain challenging due to two primary factors. First, securing a stable supply of plasma donors is difficult-an issue exacerbated during the pandemic when blood collection centers faced widespread closures. Second, IVIg administration requires hospital or ambulatory center visits, as it must be delivered by trained medical professionals, adding to patient burden and healthcare system constraints.

IVIG Drugs Uptake

This section focuses on the uptake rate of potential approved and emerging IVIG expected to be launched in the market during 2020-2034.

IVIG Pipeline Development Activities

The report provides insights into different therapeutic candidates in Phase III, Phase II, and Phase I. It also analyzes key players involved in developing targeted therapeutics.

Pipeline Development Activities

The report covers information on collaborations, acquisitions and mergers, licensing, and patent details for IVIG therapies.

KOL Views

To keep up with current and future market trends, we take Industry Experts' opinions working in the domain through primary research to fill the data gaps and validate our secondary research. Industry experts were contacted for insights on IVIG treatment landscape, patient reliance, patient therapy switching acceptability, drug uptake, along challenges related to accessibility.

DelveInsight's analysts connected with 20+ KOLs to gather insights; however, interviews were conducted with 10+ KOLs in the 7MM.

Their opinion helps understand and validate current and emerging therapy treatment patterns IVIG market trends. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the unmet needs.

Qualitative Analysis

We perform Qualitative and market Intelligence analysis using various approaches, such as SWOT analysis. In the SWOT analysis, strengths, weaknesses, opportunities, and threats in terms of disease diagnosis, patient awareness, patient burden, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided. These pointers are based on the analyst's discretion and assessment of the patient burden, cost analysis, and existing and evolving treatment landscape.

Market Access and Reimbursement

Reimbursement may be referred to as the negotiation of a price between a manufacturer and payer that allows the manufacturer access to the market. It is provided to reduce the high costs and make the essential drugs affordable. Health technology assessment (HTA) plays an important role in reimbursement decision-making and recommending the use of a drug. These recommendations vary widely throughout the seven major markets, even for the same drug.

In the US healthcare system, both Public and Private health insurance coverage are included. Also, Medicare and Medicaid are the largest government-funded programs in the US. The major healthcare programs including Medicare, Continuing Medical Education (CME) program, the Children's Health Insurance Program (CHIP), and the state and federal health insurance marketplaces are overseen by the Centers for Medicare & Medicaid Services (CMS). Other than these, Pharmacy Benefit Managers (PBMs), and third-party organizations that provide services, and educational programs to aid patients are also present.

The report further provides detailed insights on the country-wise accessibility and reimbursement scenarios, cost-effectiveness scenario of approved therapies, programs making accessibility easier and out-of-pocket costs more affordable, insights on patients insured under federal or state government prescription drug programs, etc.

Scope of the Report:

• The report covers a segment of key events, an executive summary, and a descriptive overview of the IVIG, explaining its mechanism, and therapies (current and emerging).
• Comprehensive insight into the competitive landscape, and forecasts, the future growth potential of treatment rate, drug uptake, and drug information have been provided.
• Additionally, an all-inclusive account of the current and emerging therapies and the elaborative profiles of late-stage and prominent therapies will impact the current landscape.
• A detailed review of the IVIG market, historical and forecasted market size, market share by therapies, detailed assumptions, and rationale behind our approach is included in the report, covering the 7MM drug outreach.
• The report provides an edge while developing business strategies, by understanding trends, through SWOT analysis, expert insights/KOL views, and treatment preferences that help shape and drive the 7MM IVIG market.

IVIG Report Insights

• IVIG Targeted Patient Pool
• Therapeutic Approaches
• IVIG Pipeline Analysis
• IVIG Market Size and Trends
• Existing and future Market Opportunity

IVIG Report Key Strengths

• Ten years Forecast
• The 7MM Coverage
• Key Cross Competition
• Drugs Uptake and Key Market Forecast Assumptions

IVIG Report Assessment

• Current Treatment Practices
• Unmet Needs
• Pipeline Product Profiles
• Market Attractiveness
• Qualitative Analysis (SWOT)

Key Questions:

• What was the IVIG total market size, the market size by therapies, market share (%) distribution, and what would it look like in 2034? What are the contributing factors for this growth?
• Which drug is going to be the largest contributor in 2034?
• Which is the most lucrative market for IVIG?
• What are the pricing variations among different geographies for approved therapies?
• How the reimbursement landscape has for IVIG evolved since the first one was approved? Do patients have any access issues that are driven by reimbursement decisions?
• What are the risks, burdens, and unmet needs of treatment with IVIG? What will be the growth opportunities across the 7MM for the patient population of IVIG?
• What are the key factors hampering the growth of the IVIG market?
• What are the indications for which recent novel therapies and technologies have been developed to overcome the limitations of existing treatments?
• What key designations have been granted to the IVIG therapies?
• What is the cost burden of approved therapies on the patient?
• Patient acceptability in terms of preferred therapy options as per real-world scenarios?
• What are the country-specific accessibility issues of expensive, recently approved therapies?

Reasons to buy:

• The report will help develop business strategies by understanding the latest trends and changing dynamics driving the IVIG market.
• Understand the existing market opportunities in varying geographies and the growth potential over the coming years.
• Distribution of historical and current patient share based on real-world prescription data along with reported sales of approved products in the US, EU4 (Germany, France, Italy, and Spain) the United Kingdom, and Japan.
• Identifying strong upcoming players in the market will help devise strategies to help get ahead of competitors.
• Detailed analysis and ranking of indication-wise current and emerging therapies under the conjoint analysis section to provide visibility around leading indications.
• Highlights of Access and Reimbursement policies of approved therapies, barriers to accessibility of expensive off-label therapies, and patient assistance programs.
• To understand Key Opinion Leaders' perspectives around the accessibility, acceptability, and compliance-related challenges of existing treatment to overcome barriers in the future.
• Detailed insights on the unmet needs of the existing market so that the upcoming players can strengthen their development and launch strategy.