原発性免疫不全症の世界市場：2024年～2031年

レポート概要

原発性免疫不全症市場は2023年に73億米ドルに達し、2031年には130億米ドルに達し、予測期間2024年～2031年のCAGRは7.6%で成長すると予測されます。

原発性免疫不全症（PIDD）は、免疫系を障害するまれな遺伝性疾患です。機能的な免疫応答がなければ、PIDD患者は慢性的で衰弱性の感染症にかかる可能性があり、様々な種類の疾病を発症するリスクが高まる。ほとんどの原発性免疫不全症は遺伝性で、両親のどちらか一方から受け継がれます。原発性免疫不全症の種類は300以上あり、現在も調査中です。

原発性免疫不全症は遺伝子の変異によって引き起こされ、年齢、性別、民族に関係なく誰にでも発症する可能性があります。乳幼児期や小児期早期に症状が現れる原発性免疫不全症もあるが、成人期半ば、あるいはそれ以上になってから症状が現れるものもあります。原発性免疫不全症は時に発見が困難です。原発性免疫不全症の診断には、専門的な知識と経験を有する医師の専門知識が必要です。

市場力学：

促進要因

原発性免疫不全症の有病率の増加

原発性免疫不全症市場の需要は、複数の要因によって牽引されています。原発性免疫不全症の有病率の上昇と、免疫学および診断学の分野における進歩が、市場の成長を後押ししています。

ncbi.nih.govによると、世界の全人口において、1万人に1人が原発性免疫不全症に罹患しています。世界の全人口において、約600万人が原発性免疫不全症に罹患していると推定され、そのうち70％は未診断のままです。未診断のままPPIDに罹患している人々は、通常の人々よりも感染症、重篤な自己炎症、自己免疫、アレルギー、悪性腫瘍に罹患しやすいです。

原発性免疫不全症では、IgGを投与された患者は全体で19％増加しました。PI欠損症と診断された全患者のうち、24.3％が免疫グロブリン補充療法を受けています。病院または診療所でIVIGを受けている患者数が27％増加したことは注目に値します。nih.govに掲載された論文によると、実施された調査により、原発性免疫不全症は最近86.1％増加しています。原発性免疫不全症の分野は、シーケンシング、遺伝子編集ツール、免疫と炎症に関連する特定のチェックポイントを標的とする新しい生物学的薬剤や低分子のイントロダクションの最近の進歩により、急速に拡大しています。

抑制要因

治療に伴う高額な費用、人々の認識不足、熟練した専門家の不足などの要因が市場の妨げになると予想されます。

市場セグメンテーション

原発性免疫不全症市場は、疾患タイプ、治療、エンドユーザー、地域によって区分されます。

免疫グロブリン補充療法は原発性免疫不全症市場シェアの約56.6%を占める

予測期間中、免疫グロブリン補充療法が最大の市場シェアを占めると予想されます。この分野では、最近の技術的進歩がこの市場を牽引すると思われます。

免疫グロブリン補充療法は、免疫グロブリンとして知られる抗体を欠く抗体欠乏症患者の治療法です。抗体は、細菌やウイルスを中和し、他の免疫系細胞による微生物の破壊を開始する免疫系において重要な役割を担っているため、抗体欠乏症は感染症のリスクが高まるという特徴があります。Ig補充療法は、体が感染症を撃退できるようにする機能的な抗体を個人に提供することによって、抗体欠乏症を治療します。

Ig療法で使用される免疫グロブリンは、抗体を含む血液の液体成分である提供されたヒト血漿から作られます。Ig補充療法は、静脈内投与（IVIG）または皮下投与（SCIG）のいずれかで行われます。Ig補充療法は、感染症への感受性を低下させ、健康を最適化し、抗体欠乏症患者の生活の質を向上させる。ただし、他の治療と同様、個々のリスクとベネフィットについてはヘルスケアプロバイダーと相談する必要があります。

地域別市場分析

北米が原発性免疫不全症市場シェアの約43.3%を占める

予測期間中、北米地域が最大の市場シェアを占めると予想されます。同地域では、原発性免疫不全症の罹患率が上昇しており、免疫学と診断学の分野における技術進歩が市場の推進力となっています。

国際免疫学会連合（International Union of Immunological Society）が最近実施した調査によると、選択的IgA欠損症は米国で最も多く、その割合は16.4％でした。抗体欠乏症患者の約63.4%は北米出身者です。米国では、原発性免疫不全症患者の55.7％が男性で、44.3％が女性です。

この北米地域に大手企業が存在することが、市場シェア最大の理由のひとつです。造血幹細胞移植技術は日に日に勢いを増しています。造血幹細胞移植は骨髄移植とも呼ばれ、機能不全や骨髄が枯渇した患者に健康な造血幹細胞を投与します。標的療法は原発性免疫不全症を治療する方法の一つです。標的療法には、特定の遺伝子やタンパク質、あるいは免疫系の構成要素を標的とする生物学的薬剤や低分子薬剤が含まれます。これらの治療薬は、しばしばモノクローナル抗体と呼ばれる改変抗体やサイトカインなどの化学物質です。

目次

第1章 調査手法と調査範囲

第2章 定義と概要

第3章 エグゼクティブサマリー

第4章 市場力学

• 影響要因
  • 促進要因
    • 原発性免疫不全症の有病率の増加
    • 免疫学・診断学の進歩
  • 抑制要因
  • 機会
  • 影響分析

第5章 産業分析

• ポーターのファイブフォース分析
• サプライチェーン分析
• 価格分析
• 規制分析
• アンメットニーズ
• PESTEL分析
• 特許分析
• SWOT分析

第6章 疾患タイプ別

• 抗体欠損症
• 細胞性免疫不全
• 自然免疫疾患

第7章 治療法別

• 免疫グロブリン（Ig）補充療法
• 造血幹細胞療法
• 遺伝子治療
• その他

第8章 エンドユーザー別

• 病院
• 専門クリニック
• 学術研究センター
• その他

第9章 地域別

• 北米
  • 米国
  • カナダ
  • メキシコ
• 欧州
  • ドイツ
  • 英国
  • フランス
  • イタリア
  • スペイン
  • その他欧州
• 南米
  • ブラジル
  • アルゼンチン
  • その他南米
• アジア太平洋
  • 中国
  • インド
  • 日本
  • 韓国
  • その他アジア太平洋地域
• 中東・アフリカ

第10章 競合情勢

• 競合シナリオ
• 市況/シェア分析
• M&A分析

第11章 企業プロファイル

• Abbott Laboratories
  • 会社概要
  • 製品ポートフォリオと説明
  • 財務概要
  • 主な発展
• AstraZeneca
• Pfizer
• Baxter International Inc.
• Bayer
• Bristol Myers Squibb
• Eli Lilly
• Biotest AG
• Grifols
• CSL Behring（*LIST NOT EXHAUSTIVE）

第12章 付録

Report Overview

The Primary Immunodeficiency Diseases Market reached US$ 7.3 billion in 2023 and is expected to reach US$ 13.0 billion by 2031, growing at a CAGR of 7.6% during the forecast period 2024-2031.

Primary immunodeficiency diseases (PIDDs) are rare, genetic disorders that impair the immune system. Without a functional immune response, people with PIDDs may be subject to chronic, debilitating infections which can increase the risk of developing various types of diseases. Most of the primary immunodeficiency diseases are inherited that is, the disease is passed down from one or two of the parents. There are more than 300 types of primary immunodeficiency disorders, and researchers continue to identify more.

Primary immunodeficiency diseases are caused by genetic variants and can affect anyone, regardless of age, gender, or ethnicity. Some primary immunodeficiency diseases cause symptoms in infancy or early childhood, but others may not present until mid- or even older adulthood. The primary immunodeficiency disorders are sometimes difficult to detect. The diagnosis of primary immunodeficiency disorders requires the expertise of a physician with specialized knowledge and experience.

Market Dynamics: Drivers

Increasing prevalence of primary immunodeficiency diseases

The demand for the primary immunodeficiency diseases market is driven by multiple factors. The rising prevalence of primary immunodeficiency diseases and advancements in the fields of immunology and diagnostics propels the market growth.

According to ncbi.nih.gov, in the entire global population, 1 in every 10,000 human beings are being affected by primary immunodeficiency diseases. In the entire global population, it is estimated that around 6 million people are affected by primary immunodeficiency disorders, out of which 70% of the cases remain undiagnosed. People living with PPID undiagnosed, are more prone to infections, severe autoinflammation, autoimmunity, allergy, and malignancy than normal people.

For primary immunodeficiency diseases, there was a 19% overall increase in patients receiving IgG. Out of all patients diagnosed with a PI defect, 24.3% are on immunoglobulin replacement therapy. It is noteworthy that there was a 27% increase in the number of patients receiving IVIG in the hospital or clinic. According to an article published in nih.gov, as per the survey conducted, there has been an increase of 86.1% in primary immunodeficiency diseases in recent times. The field of primary immunodeficiency is expanding rapidly due to recent advances in sequencing, gene editing tools, and the introduction of new biological drugs and small molecules that target specific checkpoints relevant to immunity and inflammation.

Restraints

Factors such as high cost associated with the treatment, lack of awareness among people, and shortage of skilled professionals are expected to hamper the market.

Market Segment Analysis

The primary immune deficiency disorders market is segmented based on disease type, treatment, end-user, and region.

The immunoglobulin replacement therapy accounted for approximately 56.6% of the primary immunodeficiency diseases market share

The immunoglobulin replacement therapy is expected to hold the largest market share over the forecast period. In this segment, the technological advancements in recent times would drive this market.

Immunoglobulin replacement therapy is a treatment for patients with antibody deficiency that is people who lack antibodies which are known as immunoglobulins. Since antibodies have a vital role in the immune system neutralizing bacteria and viruses and initiating the destruction of microbes by other immune system cells, antibody deficiencies are characterized by an increased risk of infections. Ig replacement therapy treats antibody deficiencies by providing individuals with functional antibodies that allow their bodies to fight off infections.

The immunoglobulin utilized in Ig therapy is made from donated human plasma, the liquid component of blood that contains antibodies. Ig replacement therapy can be given either intravenously (IVIG) or subcutaneously (SCIG). Ig replacement therapy reduces susceptibility to infections, can optimize health, and improves the quality of life for those with antibody deficiencies. As with any treatment, however, individual risks and benefits should be discussed with a healthcare provider.

Market Geographical Analysis

North America accounted for approximately 43.3% of the primary immunodeficiency diseases market share

North America region is expected to hold the largest market share over the forecast period. The rising incidence of primary immunodeficiency diseases, and technological advancements in the field of immunology and diagnostics, in this region, help to propel the market.

According to a recent survey conducted by the International Union of Immunological Society, selective IgA deficiency is most prevalent in the US with a percentage of 16.4%. Around 63.4% of the total people having antibody deficiency are from North America. In the US, 55.7% of the patients who are suffering from primary immunodeficiency diseases are male and 44.3% of patients are female.

The presence of major players in this region of North America is one of the reasons for the largest market share. The hematopoietic stem cell transplantation technology is gaining momentum day by day. Hematopoietic stem cell transplantation sometimes referred to as bone marrow transplantation involves administering healthy hematopoietic stem cells to patients with dysfunctional or depleted bone marrow. Targeted therapies are one of the ways to treat the primary immunodeficiency diseases. Targeted therapies include biological agents and small molecule drugs that target specific genes or proteins or components of the immune system. These therapies could be modified antibodies, often referred to as monoclonal antibodies, or chemicals such as cytokines.

Market Segmentation

By Disease Type

• Antibody deficiency
• Agammaglobulinaemia
• IgG Subclass deficiency
• Selective IgA Deficiency
• Others
• Cellular immunodeficiency
• Hyder IgM Syndromes
• Ataxia Telangiectasia
• Wiskott Aldrich syndrome
• Others
• Innate Immune Disorders
• TLR 3 Deficiencies
• Natural killer cell deficiency
• NF Kappa B Essential Modulator Deficiency
• Others

By Treatment

• Immunoglobulin (Ig) Replacement Therapy
• Haemopoietic Stem Cell Transplantation
• Gene Therapy
• Others

By End-User

• Hospitals
• Specialty Clinics
• Academic and Research Centers
• Others

By Region

• North America
• U.S.
• Canada
• Mexico
• Europe
• Germany
• U.K.
• France
• Spain
• Italy
• Rest of Europe
• South America
• Brazil
• Argentina
• Rest of South America
• Asia-Pacific
• China
• India
• Japan
• South Korea
• Rest of Asia-Pacific
• Middle East and Africa

Market Competitive Landscape

The major global players in the primary immunodeficiency diseases market include Abbott Laboratories, AstraZeneca, Pfizer, Baxter International, Inc., Bayer, Bristol Myers Squibb, Eli Lilly, Biotest AG, Grifols, CSL Behring among others.

Key Developments

• Pfizer is always a leading company when it comes to the manufacture of drugs related to immunology. In 2022, Pfizer FDA approval for Panzgya which is a drug that is used for immunotherapy.
• On September 12, 2023, Abbott acquired a company known as Bigfoot Biomedical. Through acquisition, Abbott can prosper in the fields of diabetes care and insulin management systems.
• On August 9, 2022, CSL Behring acquired a company called Vifor Pharmaceuticals. Through this acquisition, CSL Behring has prospered well in the field of therapeutics.

Why Purchase the Report?

• To visualize the primary immunodeficiency diseases segmentation based on disease type, treatment, end-user, and region, as well as understand key commercial assets and players.
• Identify commercial opportunities by analyzing trends and co-development
• Excel data sheet with numerous data points of primary immunodeficiency diseases market level with all segments.
• PDF report consists of a comprehensive analysis after exhaustive qualitative interviews and an in-depth study.
• Product mapping is available in Excel consisting of key products of all the major players.

The primary immunodeficiency diseases market report would provide approximately 51 tables, 54 figures, and 181 Pages.

Target Audience 2024

• Manufacturers/ Buyers
• Industry Investors/Investment Bankers
• Research Professionals
• Emerging Companies

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 Disease Type
• 3.2. Snippet by Treatment
• 3.3. Snippet by End-User
• 3.4. Snippet by Region

4. Dynamics

• 4.1. Impacting Factors
  • 4.1.1. Drivers
    • 4.1.1.1. Increasing Prevalence of Primary Immunodeficiency Diseases
    • 4.1.1.2. Advancements in the fields of Immunology and Diagnostics
  • 4.1.2. 4.1.2 Restraints
  • 4.1.3. 4.1.2.1 High Cost Associated with the Treatment
  • 4.1.4. 4.1.2.2. Lack of awareness among people
  • 4.1.5. 4.1.3 Opportunity
  • 4.1.6. 4.1.4 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
• 5.5. Unmet Needs
• 5.6. PESTEL Analysis
• 5.7. Patent Analysis
• 5.8. SWOT Analysis

6. By Disease Type

• 6.1. Introduction
  • 6.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Disease Type
  • 6.1.2. Market Attractiveness Index, By Disease Type
• 6.2. Antibody Deficiency *
  • 6.2.1. Introduction
  • 6.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
• 6.3. Cellular Immunodeficiency
• 6.4. Innate Immune Disorders

7. By Treatment

• 7.1. Introduction
  • 7.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Treatment
  • 7.1.2. Market Attractiveness Index, By Application
• 7.2. Immunoglobulin (Ig) Replacement Therapy*
  • 7.2.1. Introduction
  • 7.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
• 7.3. Hematopoietic Stem Cell Therapy
• 7.4. Gene Therapy
• 7.5. Others

8. By End-User

• 8.1. Introduction
  • 8.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
  • 8.1.2. Market Attractiveness Index, By End-User
• 8.2. Hospitals*
  • 8.2.1. Introduction
  • 8.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
• 8.3. Specialty Clinics
• 8.4. Academic and research centers
• 8.5. Others

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 Disease Type
  • 9.2.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Treatment
  • 9.2.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
  • 9.2.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
    • 9.2.6.1. The 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 Disease Type
  • 9.3.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Treatment
  • 9.3.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
  • 9.3.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
    • 9.3.6.1. Germany
    • 9.3.6.2. UK
    • 9.3.6.3. France
    • 9.3.6.4. Italy
    • 9.3.6.5. Spain
    • 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 Disease Type
  • 9.4.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Treatment
  • 9.4.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
  • 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 Disease Type
  • 9.5.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Treatment
  • 9.5.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
  • 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 Disease Type
  • 9.6.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Treatment
  • 9.6.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User

10. Competitive Landscape

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

11. Company Profiles

• 11.1. Abbott Laboratories *
  • 11.1.1. Company Overview
  • 11.1.2. Product Portfolio and Description
  • 11.1.3. Financial Overview
  • 11.1.4. Key Developments
• 11.2. AstraZeneca
• 11.3. Pfizer
• 11.4. Baxter International Inc.
• 11.5. Bayer
• 11.6. Bristol Myers Squibb
• 11.7. Eli Lilly
• 11.8. Biotest AG
• 11.9. Grifols
• 11.10. CSL Behring (*LIST NOT EXHAUSTIVE)

12. Appendix

• 12.1. About Us and Services
• 12.2. Contact Us