세계의 정맥주사용 동결건조 인간 면역글로불린(pH4) 시장(2024-2031년)

Global Lyophilized Human Immunoglobulin (PH4) for Intravenous Injection Market - 2024-2031

US $ 4,350 ￦ 6,311,000

PDF & Excel (Single User License)

PDF 보고서를 1명만 이용할 수 있는 라이선스입니다. 인쇄 가능하며 인쇄물의 이용 범위는 PDF 이용 범위와 동일합니다.

US $ 4,850 ￦ 7,036,000

PDF & Excel (Multiple User License)

PDF 보고서를 동일 사업장에서 7명까지 이용할 수 있는 라이선스입니다. 인쇄 가능하며 인쇄물의 이용 범위는 PDF 이용 범위와 동일합니다.

US $ 7,850 ￦ 11,389,000

PDF & Excel (Enterprise License)

PDF 보고서를 동일 기업의 모든 분이 이용할 수 있는 라이선스입니다. 인쇄 가능하며 인쇄물의 이용 범위는 PDF 이용 범위와 동일합니다.

한글목차

세계 정맥주사용 동결건조 인간 면역글로불린(pH4) 시장 규모는 2023년에 557억 달러에 달했습니다. 2031년에는 1,409억 달러에 달할 것으로 예상되며, 2024년부터 2031년까지 12.3%의 연평균 복합 성장률(CAGR)을 나타낼 전망입니다.

정맥주사용 동결건조 인간 면역글로불린(pH4)은 정제된 혈액 유래 제품으로 즉각적이고 장기적인 면역 지원을 제공합니다. 감염 예방, 면역 결핍 관리, 자가 면역 질환 및 염증성 질환 치료에 중요한 항체 성분인 면역글로불린 G의 농축 용액을 함유하고 있습니다. 산성 pH로 조절되어 안정성을 높이고 응집을 감소시켜 병원, 진료소, 재택의료에서 면역치료의 핵심이 되고 있습니다.

시장 역학:

성장 촉진요인과 억제요인

면역결핍과 자가면역질환의 유병률 상승

면역결핍 및 자가면역질환의 유병률 증가로 동결건조 인간 면역글로불린 시장이 성장하고 있습니다. 앞서 언급한 질병은 유전적 또는 환경적으로 유발될 수 있습니다. 의료 기술의 발전과 인식 개선으로 질병을 조기에 진단할 수 있게 됨에 따라 면역글로불린 치료의 대상이 되는 환자층이 확대되고 있습니다. 전 세계 고령화 사회에서는 노년기에 면역력이 저하되는 경향이 있어 만성 질환을 관리하기 위해 더 많은 치료가 필요합니다. 또한, 효과적인 면역 조절 요법을 위해서는 기술 혁신과 생산 능력의 향상이 필요합니다. 제형, 전달 경로 및 적응증을 개선하기 위한 연구개발 투자는 필수적이며, 동결건조 인간 면역글로불린은 이 분야에서 가장 중요한 성장 수단 중 하나가 되고 있습니다.

예를 들어, NCBI에 따르면, 역학 조사에 따르면, 대부분의 자가면역질환의 빈도가 전 세계적으로 각각 연간 19.1%와 12.5%씩 증가하고 있는 것으로 추정되며, 이는 의사의 인식 향상만이 명백한 증가를 유발한다는 생각과 모순됩니다.

혈장 유래 제품의 높은 비용과 한정된 가용성

정맥주사용 인간면역글로불린(pH4)의 가격이 비싸게 책정되는 주요 요인은 여러 가지가 있습니다. 여기에는 혈장 채취, 분획, 정제에 필요한 전문 시설과 숙련된 인력, 제조 및 규제 관리의 어려움, 공급과 수요의 부족, 의료 시스템에 따른 요인, 시장 원리에 따른 집중화, 부작용 및 합병증 등이 있습니다.

가장 큰 요인으로는 공정 처리와 혈장 채취를 들 수 있으며, 이 역시 전문적인 시설과 인력이 필요합니다. 살세포 정제나 살바이러스 치료 방법론과 같은 제조 공정은 복잡하고 전문적인 시설과 인력이 필요하며, 이들 작업의 규제 준수를 위해 더 많은 비용이 소요됩니다. 특히 자원이 부족한 환경이나 의료보험이 잘 적용되지 않는 지역에서는 수요 및 공급의 역학이 제한적이기 때문에 가격 비용이 더 많이 듭니다.

목차

제1장 조사 방법과 조사 범위

제2장 정의와 개요

제3장 주요 요약

제4장 시장 역학

• 영향요인
  • 성장 촉진요인
• 성장 억제요인
• 기회
  • 영향 분석

제5장 산업 분석

• Porter의 Five Forces 분석
• 공급망 분석
• 가격 분석
• 규제 분석

제6장 유형별

• IgG
• 면역글로불린 A
• IgM

제7장 적응증별

• 원발성 면역 결핍증
• 2차성 면역글로불린 결핍증
• 면역 개재성 혈소판 감소증
• 기타

제8장 유통 채널별

• 원내 약국
• 소매 약국
• 온라인 약국

제9장 지역별

• 북미
  • 미국
  • 캐나다
  • 멕시코
• 유럽
  • 독일
  • 영국
  • 프랑스
  • 스페인
  • 이탈리아
  • 기타 유럽
• 남미
  • 브라질
  • 아르헨티나
  • 기타 남미
• 아시아태평양
  • 중국
  • 인도
  • 일본
  • 한국
  • 기타 아시아태평양
• 중동 및 아프리카

제10장 경쟁 구도

• 경쟁 시나리오
• 시장 현황 및 점유율 분석
• 인수합병(M&A) 분석

제11장 기업 개요

• Takeda Pharmaceutical Company Limited
  • 기업 개요
  • 제품 포트폴리오와 개요
  • 재무 개요
  • 주요 발전
• CSL Behring
• Grifols, S.A
• Kedrion Biopharma
• Octapharma AG
• Biotest AG
• Hualan Biological Engineering Inc
• Shanghai RAAS Blood Products Co., Ltd
• Beijing Tiantan Biological Products Co., Ltd
• Sinopharm Group Co., Ltd

제12장 부록

LSH

영문 목차

영문목차

The global lyophilized human immunoglobulin (ph4) for intravenous injection market reached US$ 55.7 billion in 2023 and is expected to reach US$ 140.9 billion by 2031, growing at a CAGR of 12.3% during the forecast period 2024-2031.

Lyophilized Human Immunoglobulin (pH 4) for Intravenous Injection is a purified blood-derived product that provides immediate and long-term immune support. It contains a concentrated solution of immunoglobulin G, a key antibody component for combating infections, managing immune deficiencies, and treating autoimmune and inflammatory conditions. Formulated at an acidic pH, it enhances stability and reduces aggregation, making it a cornerstone in immunotherapy across hospitals, clinics, and homecare settings.

Market Dynamics: Drivers & Restraints

Rising Prevalence of Immunodeficiency and Autoimmune Disorders

The increasing prevalence of immunodeficiency and autoimmune diseases has pushed the lyophilized human immunoglobulin market forward. The aforementioned disorders are also genetically or environmentally induced. Advancements in medical technology and awareness campaigning allow the disease to be diagnosed at a much earlier stage, expanding the patient pool that is eligible for immunoglobulin therapy. The global aging population, who tends to display immune deficiencies during old age, will need more therapy to manage chronic illnesses. Additionally, effective immune modulation therapies need innovation and increased production capacity. Research and development investment is also critical for improving formulations, delivery routes, and therapeutic indications, thus making lyophilized human immunoglobulin one of the most significant avenues of growth in this field.

For instance, according to NCBI, Epidemiologic studies show similar increases in the frequency of most autoimmune diseases, with estimates of yearly increases of 19.1% and 12.5% worldwide, respectively, contradicting the idea that increased physician recognition alone may cause their apparent rises.

High Cost and Limited Availability of Plasma-Derived Products

The market is hindered by several factors mainly contribute to making human immunoglobulin (pH4) for intravenous injection prohibitively expensive. Some of these include specialized facilities and trained personnel required for the processes involved in the plasma collection, fractionation, or purification, difficulty in manufacturing and regulatory controls, deficiency in supply and demand forces, factors from the healthcare system, market-based concentration, and adverse effects and complications.

The most significant contributors include process processing and plasma collection, which again demands specialized facilities as well as personnel. Manufacturing processes such as methodologies for cytolethal purification and virucidal therapy would be complex, need specialized facilities, human resources, and even more cost upon regulatory compliance in operations given those. Price costs involved even more from restricted dynamics of supply and demand, particularly in resource-poor settings or geographical areas with insufficient health insurance coverage.

Segment Analysis

The global lyophilized human immunoglobulin (ph4) for intravenous injection market is segmented based on type, indication, distribution channel and region.

Type:

IgG segment is expected to dominate the lyophilized human immunoglobulin (PH4) for intravenous injection market share

The IgG segment holds a major portion of the lyophilized human immunoglobulin (PH4) for intravenous injection market share and is expected to continue to hold a significant portion of the lyophilized human immunoglobulin (PH4) for intravenous injection market share during the forecast period.

Immunoglobulin G (IgG) plays a crucial role in the Global Lyophilized Human Immunoglobulin (pH4) for Intravenous Injection market, as it is a therapeutic agent for treating immunodeficiencies, autoimmune disorders, and infectious diseases.

IgG's plays an crucial role in global lyophilized human immunoglobulin (PH 4) for intravenous injection market which help the market to grow further during the forecast period due to

• IgG is the most abundant antibody in the human immune system, recognized and neutralized by bacteria, viruses, and toxins.
• Lyophilized intravenous immunoglobulin (IVIg) formulations purify and concentrate IgG for good passive immunity.
• IgG is crucial in conditions like immune deficiencies, autoimmune disorders, and infectious diseases when the immune system is weak or overactive.
• IgG's stability and long-term storage make it available for immediate reconstitution by healthcare providers.

Indication:

Primary immunodeficieny diseases segment is the fastest-growing segment in lyophilized human immunoglobulin (PH4) for intravenous injection market share

The primary immunodeficieny diseases segment is the fastest-growing segment in the lyophilized human immunoglobulin (PH4) for Intravenous Injection market share and is expected to hold the market share over the forecast period.

• PIDs are rare, genetically inherited disorders causing recurrent infections, autoimmune complications, and increased cancer risk.
• IVIg is crucial for lifelong treatment, with advantages like enhanced stability, ease of storage, and extended shelf life.
• Global awareness and improved diagnostic capabilities have increased PID cases, leading to reliance on effective treatments like pH 4 IVIg.

Moreover, in December 2023, GC Biopharma Corp has received FDA approval for ALYGLO 10% Liquid, formerly known as "GC5107," for treating adult patients with primary humoral immunodeficiency (PI) aged 17 and older. The FDA-approved clinical trial, NCT02783482, was a prospective, open-label, single-arm, historically controlled, multicenter phase 3 study to assess the efficacy and safety of GC5107B in patients with a confirmed PI diagnosis.

Geographical Analysis

North America is expected to hold a significant position in the lyophilized human immunoglobulin (PH4) for intravenous injection market share

North America holds a substantial position in the lyophilized human immunoglobulin (PH4) for intravenous injection market and is expected to hold most of the market share due to

Key Driving Factors:

• Increased Incidence of Autoimmune Disorders and Immunodeficiencies, New diagnostic tests have enabled the identification of several cases of primary immunodeficiency diseases. Such diseases cause an increased demand for lyophilized human immunoglobulin among patients.
• Advances in Manufacturing Technology, Advances in production technology enhance significantly the product's safety and efficacy. Enhanced quality and treatment options will in turn improve their sales.
• Strong Regulatory Environment, for example, the U.S. Federal Drug Administration is essential in providing new therapies approval for entering the potential market from this aspect.
• Health-care System- and Reimbursement-Related Issues, a strong healthcare system and permissive reimbursement policies help improve access to immunoglobulin therapies.

Europe is growing at the fastest pace in the lyophilized human immunoglobulin (PH4) for intravenous injection market

Europe holds the fastest pace in the lyophilized human immunoglobulin (PH4) for intravenous injection market due to:

• Rapid growth driven by technological advancements and evolving consumer preferences.
• Key trends include increased adoption of innovative solutions, focus on efficiency, and integration of specialized applications.
• Supported by substantial investments and a favorable business environment.
• Diverse range of players, from established companies to emerging startups.
• Competition driven by need for innovation and specialized solutions.
• Leading manufacturers use cutting-edge technologies and innovative solutions.
• Invest in research and development, extensive product portfolios, and strategic global partnerships.

Competitive Landscape

The major global players in the lyophilized human immunoglobulin (PH4) for intravenous injection market include Takeda Pharmaceutical Company Limited, CSL Behring, Grifols, S.A, Kedrion Biopharma, Octapharma AG, Biotest AG, Hualan Biological Engineering Inc, Shanghai RAAS Blood Products Co., Ltd, Beijing Tiantan Biological Products Co., Ltd, Sinopharm Group Co., Ltd among others.

Emerging Players

The emerging players in the lyophilized human immunoglobulin (PH4) for intravenous injection market include sanquin blood supply foundation, lfb group and among others.

Key Developments

• In January 2024, The FDA has approved GAMMAGARD LIQUID as an intravenous immunoglobulin therapy to improve neuromuscular disability and impairment in adults with chronic inflammatory demyelinating polyneuropathy (CIDP). The therapy can be used as an induction dose followed by maintenance doses. However, GAMMAGARD LIQUID has not been studied in immunoglobulin-naive patients or as maintenance therapy for longer periods.

Why Purchase the Report?

• Pipeline & Innovations: Reviews ongoing clinical trials, product pipelines, and forecasts upcoming advancements in medical devices and pharmaceuticals.
• Product Performance & Market Positioning: Analyzes product performance, market positioning, and growth potential to optimize strategies.
• Real-World Evidence: Integrates patient feedback and data into product development for improved outcomes.
• Physician Preferences & Health System Impact: Examines healthcare provider behaviors and the impact of health system mergers on adoption strategies.
• Market Updates & Industry Changes: Covers recent regulatory changes, new policies, and emerging technologies.
• Competitive Strategies: Analyzes competitor strategies, market share, and emerging players.
• Pricing & Market Access: Reviews pricing models, reimbursement trends, and market access strategies.
• Market Entry & Expansion: Identifies optimal strategies for entering new markets and partnerships.
• Regional Growth & Investment: Highlights high-growth regions and investment opportunities.
• Supply Chain Optimization: Assesses supply chain risks and distribution strategies for efficient product delivery.
• Sustainability & Regulatory Impact: Focuses on eco-friendly practices and evolving regulations in healthcare.
• Post-market Surveillance: Uses post-market data to enhance product safety and access.
• Pharmacoeconomics & Value-Based Pricing: Analyzes the shift to value-based pricing and data-driven decision-making in R&D.

The global lyophilized human immunoglobulin (PH4) for intravenous injection market report delivers a detailed analysis with 60+ key tables, more than 50 visually impactful figures, and 176 pages of expert insights, providing a complete view of the market landscape.

Target Audience 2023

• Manufacturers: Pharmaceutical, Medical Device, Biotech Companies, Contract Manufacturers, Distributors, Hospitals.
• Regulatory & Policy: Compliance Officers, Government, Health Economists, Market Access Specialists.
• Component & Innovation: AI/Robotics Providers, R&D Professionals, Clinical Trial Managers, Pharmacovigilance Experts.
• Investors: Healthcare Investors, Venture Fund Investors, Pharma Marketing & Sales.
• Consulting & Advisory: Healthcare Consultants, Industry Associations, Analysts.
• Supply Chain: Distribution and Supply Chain Managers.
• Consumers & Advocacy: Patients, Advocacy Groups, Insurance Companies.
• Academic & Research: Academic Institutions.

Table of Contents

1. Methodology and Scope

• 1.1. Research Methodology
• 1.2. Research Objective and Scope of the Report

2. Definition and Overview

3. Executive Summary

• 3.1. Snippet by Type
• 3.2. Snippet by Indication
• 3.3. Snippet by Distribution Channel
• 3.4. Snippet by Region

4. Dynamics

• 4.1. Impacting Factors
  • 4.1.1. Drivers
    • 4.1.1.1. Rising Prevalence of Immunodeficiency and Autoimmune Disorders
• 4.2. Restraints
  • 4.2.1.1. High Cost and Limited Availability of Plasma-Derived Products
• 4.3. Opportunity
  • 4.3.1. Impact Analysis

5. Industry Analysis

• 5.1. Porter's Five Force Analysis
• 5.2. Supply Chain Analysis
• 5.3. Pricing Analysis
• 5.4. Regulatory Analysis

6. By Type

• 6.1. Introduction
  • 6.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Type
  • 6.1.2. Market Attractiveness Index, By Type
• 6.2. IgG*
  • 6.2.1. Introduction
  • 6.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
• 6.3. IgA
• 6.4. IgM

7. By Indication

• 7.1. Introduction
  • 7.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Indication
  • 7.1.2. Market Attractiveness Index, By Indication
• 7.2. Primary Immunodeficiency Diseases*
  • 7.2.1. Introduction
  • 7.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
• 7.3. Secondary Immunoglobulin Deficiency Diseases
• 7.4. Immune Mediated Thrombocytopenia
• 7.5. Others

8. By Distribution Channel

• 8.1. Introduction
  • 8.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Distribution Channel
  • 8.1.2. Market Attractiveness Index, By Distribution Channel
• 8.2. Hospital Pharmacies*
  • 8.2.1. Introduction
  • 8.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
• 8.3. Retail Pharmacies
• 8.4. Online Pharmacies

9. By Region

• 9.1. Introduction
  • 9.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Region
  • 9.1.2. Market Attractiveness Index, By Region
• 9.2. North America
  • 9.2.1. Introduction
  • 9.2.2. Key Region-Specific Dynamics
  • 9.2.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Type
  • 9.2.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Indication
  • 9.2.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Distribution Channel
  • 9.2.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
    • 9.2.6.1. U.S.
    • 9.2.6.2. Canada
    • 9.2.6.3. Mexico
• 9.3. Europe
  • 9.3.1. Introduction
  • 9.3.2. Key Region-Specific Dynamics
  • 9.3.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Type
  • 9.3.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Indication
  • 9.3.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Distribution Channel
  • 9.3.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
    • 9.3.6.1. Germany
    • 9.3.6.2. U.K.
    • 9.3.6.3. France
    • 9.3.6.4. Spain
    • 9.3.6.5. Italy
    • 9.3.6.6. Rest of Europe
• 9.4. South America
  • 9.4.1. Introduction
  • 9.4.2. Key Region-Specific Dynamics
  • 9.4.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Type
  • 9.4.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Indication
  • 9.4.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Distribution Channel
  • 9.4.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
    • 9.4.6.1. Brazil
    • 9.4.6.2. Argentina
    • 9.4.6.3. Rest of South America
• 9.5. Asia-Pacific
  • 9.5.1. Introduction
  • 9.5.2. Key Region-Specific Dynamics
  • 9.5.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Type
  • 9.5.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Indication
  • 9.5.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Distribution Channel
  • 9.5.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
    • 9.5.6.1. China
    • 9.5.6.2. India
    • 9.5.6.3. Japan
    • 9.5.6.4. South Korea
    • 9.5.6.5. Rest of Asia-Pacific
• 9.6. Middle East and Africa
  • 9.6.1. Introduction
  • 9.6.2. Key Region-Specific Dynamics
  • 9.6.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Type
  • 9.6.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Indication
  • 9.6.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Distribution Channel

10. Competitive Landscape

• 10.1. Competitive Scenario
• 10.2. Market Positioning/Share Analysis
• 10.3. Mergers and Acquisitions Analysis

11. Company Profiles

• 11.1. Takeda Pharmaceutical Company Limited*
  • 11.1.1. Company Overview
  • 11.1.2. Product Portfolio and Description
  • 11.1.3. Financial Overview
  • 11.1.4. Key Developments
• 11.2. CSL Behring
• 11.3. Grifols, S.A
• 11.4. Kedrion Biopharma
• 11.5. Octapharma AG
• 11.6. Biotest AG
• 11.7. Hualan Biological Engineering Inc
• 11.8. Shanghai RAAS Blood Products Co., Ltd
• 11.9. Beijing Tiantan Biological Products Co., Ltd
• 11.10. Sinopharm Group Co., Ltd

LIST NOT EXHAUSTIVE

12. Appendix

• 12.1 About Us and Services
• 12.2 Contact Us

관련자료