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組換え血漿タンパク質治療薬の世界市場：2024～2031年

Global Recombinant Plasma Protein Therapeutics Market - 2024-2031

出版日
ページ情報
英文 187 Pages
納期
即日から翌営業日
カスタマイズ可能
適宜更新あり
価格
価格表記: USDを日本円(税抜)に換算
本日の銀行送金レート: 1USD=144.06円
組換え血漿タンパク質治療薬の世界市場：2024～2031年
出版日: 2024年06月18日
発行: DataM Intelligence
ページ情報: 英文 187 Pages
納期: 即日から翌営業日
GIIご利用のメリット
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  • 概要
  • 目次
概要

概要

組換え血漿タンパク質治療薬の世界市場は、2023年に347億7,478万米ドルに達し、2031年には562億6,788万米ドルに達すると予測され、予測期間2024-2031年のCAGRは6.2%で成長する見込みです。

クロマトグラフィーやそ他分画プロセスを用いてヒト血漿から作られる製品は、血漿誘導体として知られています。凝固因子、抗凝固剤、免疫グロブリン、アルブミンなど、重度先天性・後天性出血性疾患や免疫疾患治療に不可欠な多く治療用タンパク質は、これまでヒト血漿からしか得ることができなかっています。技術出現と組換え技術イントロダクションより、血漿タンパク質さまざまな改良版が生成されるようになっています。それ以来、組換え血漿タンパク質市場は急成長し、複数適応症について幅広く研究されています。

研究開発活動活発化、血液疾患有病率上昇といった要因が、予測期間中市場成長を牽引すると予想されます。

市場力学

促進要因

研究開発と製品認可の増加

組換え血漿タンパク質治療薬市場の成長は、研究開発活動の活発化と規制当局による製品承認が大きな原動力となっています。大手製薬会社は、血液疾患などの希少疾患の治療オプションを強化するため、組換え血漿タンパク質治療薬の研究開発活動に絶えず投資しています。これらの承認は、患者に複数の治療選択肢を提供するだけでなく、その採用拡大に寄与すると期待されています。このような技術革新と規制の承認というダイナミックな状況が、市場を積極的に後押ししています。

例えば、2023年11月9日、米国FDAは武田薬品工業が開発したADZYNMAを承認しました。ADZYNMAは、先天性血小板減少性紫斑病（cTTP）の成人および小児患者における予防的またはオンデマンド酵素補充療法（ERT）の適応を持つ、トロンボスポンジンモチーフ13 ADAMTS13（rADAMTS13）を有するヒト組換え型Aジスインテグリン・メタロプロテアーゼです。2024年5月30日、欧州医薬品評価委員会（CHMP）は、ADZYNMAの販売承認を推奨しました。

2023年2月23日、米国FDAは、サノフィが開発した遺伝子組換え型抗血友病因子製剤ALTUVIIIOを、出血エピソードの抑制および術後管理のための血友病患者の治療薬として承認しました。ALTUVIIIOは週1回投与で、出血エピソードを大幅に減少させることができます。

同様に、複数のイノベーターが治療法の開発に積極的に投資しており、予測期間中に市場に投入される見込みです。

抑制要因

組換え血漿タンパク質治療薬の高価格は、市場成長の阻害要因の一つです。特に長期的な治療が必要な患者にとっては、手頃な価格が重要な役割を果たします。さらに、中低所得国ではこうした先進的なドラッグデリバリー・デバイスを利用できない可能性があります。さらに、患者のコンプライアンスとアドヒアランスの問題は、血漿タンパク質治療薬への採用率を低下させる可能性があり、市場成長にとって大きな課題となる可能性があります。

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
      • 研究開発と製品認可の増加
      • 血液疾患の有病率の上昇
    • 抑制要因
      • 組換え血漿タンパク質治療薬の高コスト
    • 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 COVID-19分析

第7章 タイプ別

  • 凝固因子
  • 抗凝固剤
  • 免疫グロブリン
  • アルブミン
  • コロニー刺激因子
  • その他

第8章 発現系別

  • 哺乳類細胞
  • 微生物

第9章 用途別

  • 血友病
  • 貧血
  • 低髄液圧血症
  • 遺伝性血管性浮腫
  • その他

第10章 投与経路別

  • 皮下
  • 筋肉内

第11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12章 競合情勢

  • 競合シナリオ
  • 市況/シェア分析
  • M&A分析

第13章 企業プロファイル

  • Takeda Pharmaceuticals
    • 会社概要
    • 製品ポートフォリオと説明
    • 財務概要
    • 主な発展
  • CSL
  • Pfizer Inc.
  • Novo Nordisk A/S.
  • Pharming Healthcare, Inc.
  • Amgen Inc.
  • Sanofi
  • Bayer AG
  • Octapharma USA Inc.
  • Janssen Global Services, LLC

第14章 付録

目次
Product Code: PH1275

Overview

The global recombinant plasma protein therapeutics market reached US$ 34,774.78 million in 2023 and is expected to reach US$ 56,267.88 million by 2031, growing at a CAGR of 6.2% during the forecast period 2024-2031.

Products made from human plasma using chromatographic and other fractionation processes are known as plasma derivatives. Many therapeutic proteins, including coagulation factors, anticoagulants, immunoglobulins, and albumin, which are vital for treating severe congenital or acquired bleeding or immunological disorders, have only been conceivably obtained from human plasma. With the advent of technology and the introduction of recombinant technologies, a variety of modified versions of plasma proteins are generated, whereby the gene is inserted into an expression system to make the required plasma protein. Since then the market for recombinant plasma proteins has paced up and has been extensively studied for multiple indications.

Factors such as rising research and development activities, and rising prevalence of hematological conditions are expected to drive the market growth in the forecast period.

Market Dynamics

Drivers

Rising research and development activities and product approvals

The recombinant plasma protein therapeutics market growth is largely driven by rising research and development activities and product approvals by regulatory authorities. Major pharmaceutical companies have been constantly investing in R&D activites in recombinant plasma proteins therapeutics to enhance treatment options for rare diseases such as hematological conditions. These approvals are not only expected to provide multiple treatment options to the patients, and contributing to their growing adoption. This dynamic landscape of innovation and regulatory endorsement is propelling the market positively.

For instance, on November 9, 2023, the U.S. FDA has approved ADZYNMA developed by Takeda Pharmaceutical Company Limited. ADZYNMA is a human recombinant A disintegrin and metalloproteinase with thrombospondin motifs 13 ADAMTS13 (rADAMTS13) indicated for prophylactic or on-demand enzyme replacement therapy (ERT) in adult and pediatric patients with congenital thrombotic thrombocytopenic purpura (cTTP). On May 30, 2024, the Committee for Medicinal Products for Human Use (CHMP) in the EU, has recommended the grant of of a marketing authorisation for ADZYNMA.

On February 23, 2023, the U.S. FDA has approved ALTUVIIIO a recombinant antihemophilic factor developed by Sanofi for the treatment of hemophilia patients to control bleeding episodes and also post-operative management. ALTUVIIIO is given as once-weekly dose and has the capability significantly reduce bleeding episodes.

Likewise several innovators have been actively investing to develop therapies, which are anticipated to get launched in the market in the forecast period.

Restraints

The high cost of recombinant plasma protein therapeutics is one of the restraining factors that may hinder market growth. Affordability plays a crucial role, especially for patients who need long-term treatment. Moreover, low-middle-income nations may not have access to these advanced drug-delivery devices. In addition, patient compliance and adherence issues may pose a significant challenge to the market growth which may cause lower adoption to plasma protein therapeutics.

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Segment Analysis

The global recombinant plasma protein therapeutics market is segmented based on type, expression system, application, route of administration and region.

Hemophilia in the application segment accounted for approximately 73.2% of the global recombinant plasma protein therapeutics market share

Hemophilia is a bleeding disorder in which the blood clot formation does not happen, as a result, the patient may experience excessive blood loss during any injury. This occurs as a result of mutations of the genes that replicate the proteins involved in the clotting cascade. There are several types of hemophilia such as Hemophilia A, B,, and C. Hemophilia A is the most common type in which factor VIII is missing. Hemophilia B is associated with Factor IX deficiency and Hemophilia C is associated with Factor X deficiency.

Hemophila is one of the most prevalent bleeding disorder, accounting for majority of cases. For instance, As per the World Federation of Hemophilia Report published in October 2023, there are approximately 454,690 patients suffering from bleeding disorders in the world, of which the hemophilia cases accounted for almost 60% of the cases.

Fig 1: Bleeding Disorder Total Cases (1992-2022)

Source: World Federation of Hemophilia Annual Global Survey Report 2022 (Published in October 2023)

Moreover, the majority of the recombinant plasma protein manufacturers focus on hemophilia treatment, considering the severity of the condition and disease burden.

For instance, below is the list of top-selling recombinant plasma proteins are their indications.

Recombinant Plasma Protein Manufacturer Product Indication

Takeda Pharmaceuticals RIXUBIS Hemophilia B

ADVATE Hemophilia A

Pfizer Inc. BeneFix Hemophilia B

Novo Nordisk A/S. NovoSeven(R) RT Hemophilia A & B

Rebinyn Hemophilia B

Sanofi ELOCTATE Hemophilia A

ALPROLIX Hemophilia B

Bayer AG Kogenate Hemophilia A

Geographical Analysis

North America is expected to dominate the market with a 47.6% share in the global recombinant plasma protein therapeutics market

North America is well known for its advancements in the healthcare industry. The major countries in the region such as the U.S. and Canada are well known for their investments in healthcare. The favorable yet stringent regulatory policies, favorable environment for research and development activities, higher demand for advanced therapeutics, and high investments in the industry are the factors that are contributing to the region's dominance. Moreover, the market leaders have stronghold position in the region, and are generating majority of their revenues from here, especially from U.S.

For instance, below is the top manufacturers of recombinant plasma protein therapeutic products are their geographic revenue share.

Manufacturer Product Total Revenue in 2023 (USD Million) NA Share

Sanofi ELOCTATE 519 72.45%

ALPROLIX 595 81.51%

ALTUVIIIO 175 97.71%

Novo Nordisk A/S. NovoSeven(R) RT 1178 52.38%

Total Rare Blood Disorders Portfolio 1743 45.38%

Market Segmentation

By Type

  • Coagulation Factors
  • Anticoagulants
  • Immunoglobulins
  • Albumin
  • Colony Stimulating Factors
  • Others

By Expression System

  • Mammalian Cells
  • Microorganisms

By Application

  • Hemophilia
  • Anemia
  • Hypovolemia
  • Hereditary Angioedema
  • Others

By Route of Administration

  • Subcutaneous
  • Intra-Muscular

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

Competitive Landscape

The major players in the recombinant plasma protein therapeutics market include Takeda Pharmaceuticals, CSL, Pfizer Inc., Novo Nordisk A/S., Pharming Healthcare, Inc., Amgen Inc., Sanofi, Bayer AG, Octapharma USA Inc., and Janssen Global Services, LLC among others.

Why Purchase the Report?

  • To visualize the global recombinant plasma protein therapeutics market segmentation based on type, expression system, application, route of administration 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 recombinant plasma protein therapeutics 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 recombinant plasma protein therapeutics market report would provide approximately 62 tables, 54 figures, and 187 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 Type
  • 3.2. Snippet by Expression System
  • 3.3. Snippet by Application
  • 3.4. Snippet by Route of Administration

4. Dynamics

  • 4.1. Impacting Factors
    • 4.1.1. Drivers
      • 4.1.1.1. Rising research and development activities and product approvals
      • 4.1.1.2. Rising prevalence of hematological conditions
    • 4.1.2. Restraints
      • 4.1.2.1. High cost of recombinant plasma protein therapeutics
    • 4.1.3. Opportunity
    • 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. COVID-19 Analysis

  • 6.1. Analysis of COVID-19
    • 6.1.1. Scenario Before COVID
    • 6.1.2. Scenario During COVID
    • 6.1.3. Scenario Post COVID
  • 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 Type

  • 7.1. Introduction
    • 7.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Type
    • 7.1.2. Market Attractiveness Index, By Type
  • 7.2. Coagulation Factors*
    • 7.2.1. Introduction
    • 7.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
  • 7.3. Anticoagulants
  • 7.4. Immunoglobulins
  • 7.5. Albumin
  • 7.6. Colony Stimulating Factors
  • 7.7. Others

8. By Expression System

  • 8.1. Introduction
    • 8.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Expression System
    • 8.1.2. Market Attractiveness Index, By Expression System
  • 8.2. Mammalian Cells*
    • 8.2.1. Introduction
    • 8.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
  • 8.3. Microorganisms

9. By Application

  • 9.1. Introduction
    • 9.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
    • 9.1.2. Market Attractiveness Index, By Application
  • 9.2. Hemophilia*
    • 9.2.1. Introduction
    • 9.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
  • 9.3. Anemia
  • 9.4. Hypovolemia
  • 9.5. Hereditary Angioedema
  • 9.6. Others

10. By Route of Administration

  • 10.1. Introduction
    • 10.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
    • 10.1.2. Market Attractiveness Index, By Application
  • 10.2. Subcutaneous*
    • 10.2.1. Introduction
    • 10.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
  • 10.3. Intra-Muscular

11. By Region

  • 11.1. Introduction
    • 11.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Region
    • 11.1.2. Market Attractiveness Index, By Region
  • 11.2. North America
    • 11.2.1. Introduction
    • 11.2.2. Key Region-Specific Dynamics
    • 11.2.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Type
    • 11.2.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Expression System
    • 11.2.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
    • 11.2.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Route of Administration
    • 11.2.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
      • 11.2.7.1. The U.S.
      • 11.2.7.2. Canada
      • 11.2.7.3. Mexico
  • 11.3. Europe
    • 11.3.1. Introduction
    • 11.3.2. Key Region-Specific Dynamics
    • 11.3.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Type
    • 11.3.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Expression System
    • 11.3.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
    • 11.3.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Route of Administration
      • 11.3.6.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
      • 11.3.6.2. Germany
      • 11.3.6.3. UK
      • 11.3.6.4. France
      • 11.3.6.5. Italy
      • 11.3.6.6. Spain
      • 11.3.6.7. Rest of Europe
  • 11.4. South America
    • 11.4.1. Introduction
    • 11.4.2. Key Region-Specific Dynamics
    • 11.4.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Type
    • 11.4.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Expression System
    • 11.4.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
    • 11.4.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Route of Administration
      • 11.4.6.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
      • 11.4.6.2. Brazil
      • 11.4.6.3. Argentina
      • 11.4.6.4. Rest of South America
  • 11.5. Asia-Pacific
    • 11.5.1. Introduction
    • 11.5.2. Key Region-Specific Dynamics
    • 11.5.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Type
    • 11.5.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Expression System
    • 11.5.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
    • 11.5.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Route of Administration
      • 11.5.6.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
      • 11.5.6.2. China
      • 11.5.6.3. India
      • 11.5.6.4. Japan
      • 11.5.6.5. South Korea
      • 11.5.6.6. Rest of Asia-Pacific
  • 11.6. Middle East and Africa
    • 11.6.1. Introduction
    • 11.6.2. Key Region-Specific Dynamics
    • 11.6.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Type
    • 11.6.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Expression System
    • 11.6.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
    • 11.6.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Route of Administration

12. Competitive Landscape

  • 12.1. Competitive Scenario
  • 12.2. Market Positioning/Share Analysis
  • 12.3. Mergers and Acquisitions Analysis

13. Company Profiles

  • 13.1. Takeda Pharmaceuticals
    • 13.1.1. Company Overview
    • 13.1.2. Product Portfolio and Description
    • 13.1.3. Financial Overview
    • 13.1.4. Key Developments
  • 13.2. CSL
  • 13.3. Pfizer Inc.
  • 13.4. Novo Nordisk A/S.
  • 13.5. Pharming Healthcare, Inc.
  • 13.6. Amgen Inc.
  • 13.7. Sanofi
  • 13.8. Bayer AG
  • 13.9. Octapharma USA Inc.
  • 13.10. Janssen Global Services, LLC

LIST NOT EXHAUSTIVE

14. Appendix

  • 14.1. About Us and Services
  • 14.2. Contact Us