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한글목차
주요 하이라이트
정주 면역글로불린은 풀 항체이며 다양한 면역 결핍 및 자가 면역 질환, 감염, 염증 상태를 포함한 많은 질병의 치료에 사용되는 생물학적 제제입니다. 이 치료의 궁극적인 목표는 기능이 저하 된 면역계를 정상화하는 것입니다.
IVIg 요법은 면역성 혈소판 감소증(ITP), 길란 밸리 증후군(GBS), 가와사키병, 만성 염증성 탈수성 다발신경염(CIDP), 다소성 운동 신경병증 등의 치료제로 승인되었습니다. 또한, IVIg는 면역 매개 질환, 신경 질환, 혈액 질환, 피부 질환의 치료에 적응 밖에서 널리 사용됩니다.
Grifols Therapeutics, ADMA Biologics, Takeda, LFB Biopharmaceuticals, OCTAPHARMA, Pfizer, CSL Behring, Biotest AG, GC Biopharma 등 여러 기업들이 정주 면역글로불린(IVIG) 요법의 개발과 상업화에 승인을 받고 있습니다.
PRIVIGEN은 주요 7개 시장(미국, 유럽 5개국, 일본)의 모든 시장에서 승인된 몇 안 되는 IVIG 요법 중 하나로 눈에 띄고 있으며, 면역 결핍 및 자가면역 질환 치료제로 널리 임상적으로 받아들여지고 규제 당국에서도 인정받고 있습니다.
2024년 9월, GC Biopharma USA, Inc.는 17세 이상의 성인 PI 환자를 대상으로 한 회사 최초의 10% IVIG 치료제인 IG 제제 ALYGLO(IVIG)의 상시와 판매를 발표했습니다.
2024년 연간 BIVIGAM은 미국에서 약 5,000만 달러의 수익을 기록했습니다.
IVIG는 널리 사용되고 있음에도 불구하고, 인간 혈장에 의존하는 공급 제한, 복잡한 제조 공정에 따른 높은 생산 비용, 고액의 생물학적 제제(특히 허가되지 않은 적응증)에 대한 보험 기업의 저항 등 여러 과제에 직면하고 있습니다.
향후 제조의 지속적인 혁신, 기증자 모집 전략의 개선, 새로운 적응증에 대한 임상 증거의 확대는 이러한 장애물을 극복하고 세계의 정맥주사용 면역글로불린(IVIG) 시장 성장을 지속하는 데 필수적입니다.
정맥주사용 면역글로불린(IVIG) 시장 전망
미국에서는 여러 개의 정주 면역글로불린 제형(IVIG)이 승인되었으며 각각 다른 임상 요건을 충족하도록 설계되었습니다. 여기에는 BIVIGAM, CARIMUNE, FLEBOGAMMA, GAMMAGARD S/D(저 IgA 제제), GAMMAGARD Liquid, GAMMAKED, GAMMAPLEX, GAMUNEX, OCTAGAM, PRIVIGEN 등이 포함됩니다.
최근, 세계적인 면역글로불린 부족이 심각한 문제가 되고 있으며, 특히 2019년 이후에는 일본도 같은 과제에 직면하고 있습니다. 면역글로불린 수요의 급증으로 긴급수입이 불가피해지고 있습니다. 분석에 따르면, 이러한 급증의 배경에는 만성 염증성 탈수성 다발신경염(CIDP)의 진행 예방에 대한 면역글로불린의 승인과 농축 제형의 도입이라는 두 가지 요인이 있습니다.
IVIg 요법은 유망한 치료법임에도 불구하고, 보급에는 두 가지 과제가 있습니다. 첫째, 혈장 기증자의 안정적인 공급이 어려웠고, 유행시에는 채혈 센터가 광범위하게 폐쇄되었기 때문에 이 문제는 더욱 심각해졌습니다. 둘째, IVIg의 투여는 병원이나 외래를 방문해야 하며, 훈련받은 의료 종사자에 의해 투여되어야 하기 때문에 환자의 부담과 의료 시스템의 제약이 증가합니다.
이 보고서는 IVIG의 주요 7개 시장(미국, 독일, 프랑스, 이탈리아, 스페인, 영국, 일본)에 대한 조사 분석을 통해 각 지역 시장 규모, 현재 치료법, 미충족 수요(Unmet Needs), 신약 등의 정보를 제공합니다.
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.
Table of Contents
1. Key Insights
2. Report Introduction
3. IVIG Market Overview at a Glance in the 7MM
3.1. Market Share (%) Distribution by Therapies in 2024
3.2. Market Share (%) Distribution by Therapies in 2034
