重症複合免疫不全症（SCID）診断の世界市場-2023年～2030年

市場概要

重症複合免疫不全症（SCID）診断の世界市場は、2022年に1億9,650万米ドルに達し、2030年には4億2,350万米ドルに達するなど、有利な成長が予測されています。世界の重症複合免疫不全症（SCID）診断市場は、予測期間中（2023～2030年）に10.4％のCAGRを示すと予測されています。技術進歩の増加と新規製品への投資の増加が、重症複合免疫不全症（SCID）診断市場動向の需要を押し上げています。

重症複合免疫不全症（SCID）を特定するためには、通常、徹底的な病歴聴取と子どもの身体診察が必要です。診断を確認するために、総血球数などの追加の血液検査が要求されることもあります。新製品の発売と免疫不全患者の増加が、重症複合免疫不全症（SCID）診断の世界市場を推進している主な要因です。

重症複合免疫不全症（SCID）診断の市場範囲は、TREC、全血球算定（CBC）、遺伝子検査、生化学検査、その他の検査タイプで構成され、重症複合免疫不全症（SCID）診断の市場シェアを拡大しています。重度複合免疫不全症（SCID）診断の世界市場は、研究開発の増加や各国における今後の新製品承認などの要因の結果として拡大しており、重度複合免疫不全症（SCID）診断市場の成長にも明るい見通しとなっています。

市場力学

診断手順に対する意識の高まりが重症複合免疫不全症（SCID）診断市場の成長を牽引

SCIDは通常、赤ちゃんが生まれてすぐに臨床症状が現れることはないです。これは、SCIDを発症した新生児は、最初の数週間は相手の抗体から免疫を獲得して生きているという事実によるものです。しかし、時間が経つにつれて、ポリオ、水痘、ロタウイルス、BCGなどのワクチンに含まれる弱毒化された微生物の影響を受けるようになります。

新生児が最初に症状が出てから4ヶ月から6ヶ月の間に達すると、SCIDと診断されるのが一般的です。家系に免疫不全の病歴がありリスクがある場合は、胎児のDNA塩基配列を決定し、関連する遺伝子の変化を調べるなど、早期介入を行うこともあります。

妊娠中にSCIDを早期発見すれば、出産後の治療に十分な時間をかけることができます。次善の選択肢は、新生児スクリーニングです。出生時に採血してB細胞とT細胞を同定し、それぞれの役割を決定することができます。出生後のDNA検査を利用すれば、より包括的な診断が可能です。

重症複合免疫不全症（SCID）の増加により、メーカーに有利な機会が生まれる

アデノシンデアミナーゼ欠損症は非常にまれな疾患であり、世界で20万人から100万人に1人の割合でしか発症しないです。SCIDの約15％がこの疾患によるものです。SCID（重症複合免疫不全症）と呼ばれる珍しい遺伝子疾患は、生命を脅かす自己免疫異常をもたらします。何らかの形で免疫学的な症状を主症状とします。

米国では、毎年58,000人に1人の割合でSCIDの新生児が誕生しています。重症複合型免疫不全症（SCID）と呼ばれる遺伝性の原発性免疫不全症（PIDD）は、小児にしばしば現れ、重度の免疫不全を引き起こし、小さな感染症さえも撃退できなくなります。最も重症のPIDDと考えられています。

SCIDの他の型は、アデノシンデアミナーゼという酵素の欠乏だけでなく、様々な遺伝的疾患によって引き起こされます。SCIDの乳児は、健康な新生児がかかる典型的な病気にかかりやすいです。それにもかかわらず、微生物や生ワクチンによって引き起こされる病気にかかりやすいです。

診断の遅れと不適切さが市場の成長を妨げます

しかし、感染症は、既知の家族歴がないこと、鑑別可能な身体的特徴がないこと、その他の要因のために、一般的な小児集団で頻繁に発生しています。残念なことに、患者が一連の病気を経験し、そのほとんどが重篤である場合、医療関係者は宿主の防御力が弱い可能性しか考慮しないです。

悲しいことに、病気の姉や他の既知の罹患家族がいないSCIDの乳児は、通常、多くの感染症が起こってからでないと発見されないです。これらの感染症は、緊急医療、家族の苦痛、長期罹患に常に大きな影響を及ぼし、時には死に至ることもあります。

COVID-19影響分析

COVID-19のパンデミックと世界各国でのロックダウンにより、あらゆる業種の企業の財務の健全性が影響を受けた。そのため米国食品医薬品局（FDA）は、COVID-19の健康上の緊急事態が発生するまでの間、スポンサーと研究者を支援し、試験参加者の安全を確保し、適正臨床実施基準（GCP）を遵守し、試験の完全性に対するリスクを最小限に抑えるための一般的な考慮事項を含むガイドラインを発表しました。

ロシア・ウクライナ紛争の影響分析

ロシアとウクライナの紛争は、この地域の主要な市場プレイヤーの数が少ないことから、世界の重症複合免疫不全症（SCID）診断市場への影響は低いと推定されます。しかし、原材料の輸出入の影響は、予測期間中、世界の重症複合免疫不全診断市場の成長にほとんど影響を与えないと予想されます。

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
    • 診断手順に対する意識の高まり
    • 重症複合免疫不全（SCID）疾患の発生率の増加
  • 抑制要因
    • 診断の遅れと不適切さ
  • 機会
    • 研究開発と新製品上市の増加
  • 影響分析

第5章 産業分析

• ポーターの5フォース分析
• サプライチェーン分析
• 価格分析
• 規制分析

第6章 COVID-19分析

第7章 疾患タイプ別

• X連鎖性SCID
• ADA-SCID型
• その他

第8章 検査タイプ別

• トレック
• 全血球計算（CBC）
• 遺伝子検査
• 生化学検査
• その他

第9章 エンドユーザー別

• 病院
• 診断・研究機関
• その他

第10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
  • スペイン
  • イタリア
  • 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
  • オーストラリア
  • その他アジア太平洋地域
• 中東・アフリカ

第11章 競合情勢

• 競合シナリオ
• 市況/シェア分析
• M&A分析

第12章 企業プロファイル

• ARCHIMED Life Science GmbH
  • 会社概要
  • 製品ポートフォリオと説明
  • 財務概要
  • 主な発展
• Revvity（PerkinElmer）
• Labsystems Diagnostics Oy
• Revcovi
• LaCAR MDx
• Leadiant Biosciences, Inc.
• Winfertility
• GSK Plc
• CSL Behring
• Devyser Diagnostics

第13章 付録

Market Overview

The Global Severe Combined Immunodeficiency (SCID) Diagnosis Market reached US$ 196.5 million in 2022 and is projected to witness lucrative growth by reaching up to US$ 423.5 million by 2030. The global severe combined immunodeficiency (SCID) diagnosis market is expected to exhibit a CAGR of 10.4% during the forecast period (2023-2030). The increasing technological advancements and the growing investments for novel products are driving up demand for severe combined immunodeficiency (SCID) diagnosis market trends.

To identify severe combined immunodeficiency (SCID), a thorough medical history plus physical examination of the child are typically required. Additional blood tests, such as a total blood cell count, could be requested in order to verify the diagnosis. The launch of new products, and an increase in patients with immunodeficiency are the main factors propelling the global market for severe combined immunodeficiency (SCID) diagnosis.

The severe combined immunodeficiency (SCID) diagnosis market scope comprises test type as TREC, complete blood count (CBC), genetic test, biochemical test, others, which has increased the severe combined immunodeficiency (SCID) diagnosis market share. The global market for severe combined immunodeficiency (SCID) diagnosis is expanding as a result of factors including the increasing research and development and their upcoming novel product approvals across countries are also creating a positive outlook for the severe combined immunodeficiency (SCID) diagnosis market growth.

Market Dynamics

Increased Awareness of Diagnosis Procedures Drives the Growth of the Severe Combined Immunodeficiency (SCID) Diagnosis Market

SCID typically does not manifest clinically right away when a baby is born. This is due to the fact that preferably for the first few weeks, newborns with SCID live on developing immunity from mthe other's antibodies. But over time, babies are nonetheless affected by weakened microorganisms in vaccines like those for polio, chickenpox, rotavirus, BCG, and others because they lack an immune response.

When neonates reach an age between four and six months following the symptoms first appearing, SCID is typically diagnosed. Early intervention, when there is a risk owing to a family record of immunodeficiency might involve DNA sequencing of the fetus to check for any relevant gene changes.

Early detection of SCID during pregnancy allows for plenty of time for postpartum treatment. The next-best choice is newborn screening. Blood can be drawn at birth to identify B cells and T cells and determine their roles. Postnatal testing for DNA can be utilized for a more comprehensive diagnosis.

Increasing Incidence of Severe Combined Immunodeficiency (SCID) Disorder Creates Lucrative Opportunities for Manufacturers

Adenosine deaminase insufficiency is a very uncommon condition that affects only 1 in 200,000 to 1,000,000 babies globally. Around 15% of SCID instances are due to this disorder. An uncommon genetic disorder called SCID (severe combined immunodeficiency) results in life-threatening autoimmune abnormalities. It is a primary immunological symptom in some way.

In the United States, 1 in 58,000 neonates is born having SCID each year. A hereditary primary immunodeficiency disorder (PIDD) called severe combined immunodeficiency (SCID) frequently shows up in children and results in severe immunological insufficiency, leaving the body unable to fight off even small infections. It is considered to be the most severe PIDD.

Other varieties of SCID are caused by a variety of genetic disorders as well as a deficiency in the enzyme adenosine deaminase. Infants having SCID are prone to typical illnesses that affect healthy newborns. They are nonetheless more susceptible to illnesses brought on by microbes or live vaccines, which are typically safe for kids with healthy immune systems.

Delayed and Improper Diagnosis will Hamper the Growth of the Market.

However, infections are frequent in the general population of children due to the absence of a known family history, an absence of differentiating physical characteristics, and other factors. Unfortunately, when a patient has gone through a string of illnesses, most of which are serious, medical professionals only take the possibility of weakness in host defenses into account.

Sadly, infants with SCID who lack an older sister who is sick or another known affected family member are typically not detected until after numerous infections have taken place. These infections always have a significant influence on urgent medical care, family suffering, and long-term morbidity, while they occasionally result in death.

COVID-19 Impact Analysis

The financial health of companies across all industries was impacted by the COVID-19 pandemic and lockdown in numerous nations throughout the world. Therefore, for the interval of the COVID-19 health emergency, the U.S. Food and Drug Administration (FDA) issued guidelines that include general considerations to aid sponsors and researchers, ensuring the safety of trial participants, adhering to good clinical practice (GCP), and minimizing risks to trial integrity.

Russia-Ukraine War Impact Analysis

The Russia-Ukraine conflict is estimated to have a low impact on the global severe combined immunodeficiency (SCID) diagnosis market, owing to the low number of key market players in this region. However, the impact of the import and export of raw materials is expected to have little influence over the global severe combined immunodeficiency diagnosis market growth over the forecast period.

Segment Analysis

The global severe combined immunodeficiency (SCID) diagnosis market is segmented based on disease type, test type, end user and region.

TREC from Test Type Segment Accounts for 32.8% of Market Share Owing to Rising Advantages

In Guthrie card dried blood spots (DBS), T-cell receptor excision circles (TRECs) can be quantified using real-time quantitative polymerase chain reaction (RT-qPCR), which enables early SCID detection. Low TRECs represent TCL since they are a DNA consequence of T cell receptor recombination.

Thus, SCID can be screened for using neonatal TREC levels to identify defective T cell development. After receiving a positive screen, diagnostic testing is necessary to confirm a precise genetic diagnosis and to ascertain whether the patient has typical SCID or another type of TCL.

The severity of the symptoms associated with SCID, the improved prognosis following a timely diagnosis, the accessibility of a screening test, along with proof that newborn screening (NBS) for SCID is financially viable, all serve to show that SCID satisfies the Wilson-Jungner criteria for screening and designate SCID as a suitable candidate for NBS.

Geographical Analysis

North America Accounted for Approximately 43.5% of the Market Share Owing to the Strong Presence of Major Players and the Advancements in Severe Combined Immunodeficiency (SCID) Diagnosis

Manufacturers have chances to expand their operations in this region because of the rising demand for severe combined immunodeficiency (SCID) diagnosis for advancements in North America. The area has many producers and suppliers, and its rapid economic development has raised industrial production of severe combined immunodeficiency diagnosis, which has increased the demand.

There are many manufacturers and suppliers in North America, and as a result of the region's rapid economic growth, industrial production has expanded, feeding the desire for research and development of novel products.

The market will grow as new technology for research and development emerge. Rising technological developments, governmental approvals, and the introduction of new products all contribute to growth. People are becoming more aware of novel instruments and technologies, leading to the expansion of the market in this region. These factors are responsible for the dominance of North America.

Competitive Landscape

The major global players in the severe combined immunodeficiency (SCID) diagnosis market include: ARCHIMED Life Science GmbH, Revvity (PerkinElmer), Labsystems Diagnostics Oy, Revcovi, LaCAR MDx, Leadiant Biosciences, Inc., Winfertility, GSK Plc, CSL Behring and Devyser Diagnostics among others.

Why Purchase the Report?

• To visualize the global severe combined immunodeficiency (SCID) diagnosis market segmentation based on disease type, test type, 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 severe combined immunodeficiency (SCID) diagnosis market-level with all segments.
• PDF report consists of a comprehensive analysis after exhaustive qualitative interviews and an in-depth study.
• Product mapping available as Excel consisting of key products of all the major players.

The global severe combined immunodeficiency (SCID) diagnosis market report would provide approximately 53 tables, 54 figures and 195 Pages.

Target Audience 2023

• 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 Test Type
• 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. Increased Awareness of Diagnosis Procedures
    • 4.1.1.2. Increasing Incidence of Severe Combined Immunodeficiency (SCID) Disorder
  • 4.1.2. Restraints
    • 4.1.2.1. Delayed and Improper Diagnosis
  • 4.1.3. Opportunity
    • 4.1.3.1. Rising Research and Development and Novel Product Launches
  • 4.1.4. Impact Analysis

5. Industry Analysis

• 5.1. Porter's 5 Forces Analysis
• 5.2. Supply Chain Analysis
• 5.3. Pricing Analysis
• 5.4. Regulatory Analysis

6. COVID-19 Analysis

• 6.1. Analysis of COVID-19
  • 6.1.1. Scenario Before COVID-19
  • 6.1.2. Scenario During COVID-19
  • 6.1.3. Scenario Post COVID-19
• 6.2. Pricing Dynamics Amid COVID-19
• 6.3. Demand-Supply Spectrum
• 6.4. Government Initiatives Related to the Market During Pandemic
• 6.5. Manufacturers Strategic Initiatives
• 6.6. Conclusion

7. By Disease Type

• 7.1. Introduction
  • 7.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Disease Type
  • 7.1.2. Market Attractiveness Index, By Disease Type
• 7.2. X-linked SCID *
  • 7.2.1. Introduction
  • 7.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
• 7.3. ADA-SCID
• 7.4. Others

8. By Test Type

• 8.1. Introduction
  • 8.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Test Type
  • 8.1.2. Market Attractiveness Index, By Test Type
• 8.2. TREC *
  • 8.2.1. Introduction
  • 8.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
• 8.3. Complete blood count (CBC)
• 8.4. Genetic Test
• 8.5. Biochemical Test
• 8.6. Others

9. By End User

• 9.1. Introduction
  • 9.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By End User
  • 9.1.2. Market Attractiveness Index, By End User
• 9.2. Hospitals *
  • 9.2.1. Introduction
  • 9.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
• 9.3. Diagnostic and Research Laboratories
• 9.4. Others

10. By Region

• 10.1. Introduction
  • 10.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Region
  • 10.1.2. Market Attractiveness Index, By Region
• 10.2. North America
  • 10.2.1. Introduction
  • 10.2.2. Key Region-Specific Dynamics
  • 10.2.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Disease Type
  • 10.2.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Test Type
  • 10.2.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By End User
  • 10.2.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
    • 10.2.6.1. The U.S.
    • 10.2.6.2. Canada
    • 10.2.6.3. Mexico
• 10.3. Europe
  • 10.3.1. Introduction
  • 10.3.2. Key Region-Specific Dynamics
  • 10.3.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Disease Type
  • 10.3.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Test Type
  • 10.3.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By End User
  • 10.3.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
    • 10.3.6.1. Germany
    • 10.3.6.2. The U.K.
    • 10.3.6.3. France
    • 10.3.6.4. Spain
    • 10.3.6.5. Italy
    • 10.3.6.6. Rest of Europe
• 10.4. South America
  • 10.4.1. Introduction
  • 10.4.2. Key Region-Specific Dynamics
  • 10.4.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Disease Type
  • 10.4.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Test Type
  • 10.4.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By End User
  • 10.4.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
    • 10.4.6.1. Brazil
    • 10.4.6.2. Argentina
    • 10.4.6.3. Rest of South America
• 10.5. Asia-Pacific
  • 10.5.1. Introduction
  • 10.5.2. Key Region-Specific Dynamics
  • 10.5.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Disease Type
  • 10.5.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Test Type
  • 10.5.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By End User
  • 10.5.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
    • 10.5.6.1. China
    • 10.5.6.2. India
    • 10.5.6.3. Japan
    • 10.5.6.4. Australia
    • 10.5.6.5. Rest of Asia-Pacific
• 10.6. Middle East and Africa
  • 10.6.1. Introduction
  • 10.6.2. Key Region-Specific Dynamics
  • 10.6.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Disease Type
  • 10.6.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Test Type
  • 10.6.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By End User

11. Competitive Landscape

• 11.1. Competitive Scenario
• 11.2. Market Positioning/Share Analysis
• 11.3. Mergers and Acquisitions Analysis

12. Company Profiles

• 12.1. ARCHIMED Life Science GmbH *
  • 12.1.1. Company Overview
  • 12.1.2. Product Portfolio and Description
  • 12.1.3. Financial Overview
  • 12.1.4. Key Developments
• 12.2. Revvity (PerkinElmer)
• 12.3. Labsystems Diagnostics Oy
• 12.4. Revcovi
• 12.5. LaCAR MDx
• 12.6. Leadiant Biosciences, Inc.
• 12.7. Winfertility
• 12.8. GSK Plc
• 12.9. CSL Behring
• 12.10. Devyser Diagnostics

LIST NOT EXHAUSTIVE

13. Appendix

• 13.1. About Us and Services
• 13.2. Contact Us