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表紙：モノクローナル抗体治療薬の世界市場-2023-2030
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1290357

モノクローナル抗体治療薬の世界市場-2023-2030

Global Monoclonal Antibody Therapeutics Market - 2023-2030
出版日: | 発行: DataM Intelligence | ページ情報: 英文 195 Pages | 納期: 約2営業日

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モノクローナル抗体治療薬の世界市場-2023-2030
出版日: 2023年06月12日
発行: DataM Intelligence
ページ情報: 英文 195 Pages
納期: 約2営業日
ご注意事項 :
本レポートは最新情報反映のため適宜更新し、内容構成変更を行う場合があります。ご検討の際はお問い合わせください。
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  • 概要
  • 目次
概要

市場概要

モノクローナル抗体治療薬の世界市場は、2022年に1,906億9,830万米ドルに達し、2030年には5,313億1,460万米ドルに達することで有利な成長を示すと予測されます。世界のモノクローナル抗体治療薬市場は、予測期間中（2023-2030年）に14.1%のCAGRを示すと予測されています。

モノクローナル抗体治療薬（mAb）は、同一の抗体（または単に抗体断片）から均質な方法で生成されます。製品に含まれるすべての抗体分子の抗原認識部位、生物学的相互作用、親和性、下流の生物学的結果は同一です。このことが、多様なタンパク質配列とエピトープ認識を持つポリクローナル抗体とmAbの違いです。

モノクローナル抗体治療薬の世界市場は、自己免疫疾患の有病率の増加、治療パイプラインの規模の拡大、バイオ医薬品企業による投資、各国での今後の医療承認などの要因により拡大しており、モノクローナル抗体治療薬の市場成長にも明るい見通しを示しています。

市場力学

規制当局の承認と治療薬の上市の増加がモノクローナル抗体治療薬市場の成長を促進する

がんや自己免疫疾患に使用されるさまざまなモノクローナル抗体治療薬の規制当局による承認数の増加、大手バイオ医薬品企業による臨床試験の増加、がん患者の増加、革新的で技術的に洗練された新しい治療法が、モノクローナル抗体治療薬の世界市場の成長に寄与しています。

さらに、2023年1月5日、ニルセビマブの生物製剤承認申請（BLA）が米国FDA医薬品評価研究センターにより、RSV第2シーズン中も重症呼吸器合胞体ウイルス（RSV）疾患を発症しやすい生後24カ月までの子ども、およびRSV第1シーズンを迎えるかすでに経験している乳児と新生児の治療のために承認されています。したがって、バイオ医薬品企業が発売する新規治療薬の数が増加していることが、モノクローナル抗体治療薬市場を牽引しています。

バイオテクノロジー企業別研究開発への投資拡大が、メーカーに有利な機会をもたらす

主要企業やバイオテクノロジー企業が独自の技術的ブレークスルーを目指して研究開発能力への支出や投資を増やしているため、モノクローナル抗体医薬品の市場機会は拡大しています。また、モノクローナル抗体治療薬市場を牽引するトレンドとして、呼吸器疾患の発生が増加していることが挙げられます。

さらに、2023年4月には、Janssen Biotech, Inc.とNYU Grossman School of Medicineの研究者が行った初期の実験により、生物工学に基づく投薬候補が細菌種Staphylococcus aureusの感染を防止できることが実証されました。

これは、黄色ブドウ球菌に付着して識別し、免疫細胞に取り込ませて駆除するタンパク質の一種であるヒトモノクローナル抗体（mAb）を操作して得られた組み合わせ分子であるmAbtyrinsの予備評価について詳述しています。また、MAbに結合した小さなタンパク質であるセンチリンは、黄色ブドウ球菌がヒトの免疫細胞に穴を開けるのを阻止します。

高いコストと厳しい規制措置が市場の成長を妨げます

しかし、モノクローナル抗体や遺伝子組換えタンパク質を含むバイオ医薬品は、現代医学の基盤として成長してきましたが、標準治療よりも臨床的な効果が得られることが多いにもかかわらず、コストが高いため、中低所得国の人々にはまだほとんど手が届かないのが、モノクローナル抗体治療薬市場の抑制要因になっています。

モノクローナル抗体の年間平均コストは96,731ドルであり、34種類のモノクローナル抗体と適応症の組み合わせでは、10万米ドルを超えています。また、承認された適応症の組み合わせの40％を占めているにもかかわらず、10万米ドル以上の価格帯を持つもの85％以上を血液・腫瘍領域のmAbが占めています。したがって、これらの上記の要因は、モノクローナル抗体治療薬市場の成長を制限しています。

COVID-19の影響分析

COVID-19のパンデミックと世界各国での封鎖により、あらゆる業種の企業の財務状況が影響を受けています。そのため、COVID-19の公衆衛生上の緊急事態の期間中、米国食品医薬品局（FDA）は、スポンサーや研究者を支援し、試験参加者の安全を確保し、優良臨床試験（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。

これらの治療用モノクローナル抗体は、COVID-19をコントロールするためにも使用されました。例えば、2022年2月11日、イーライリリー・アンド・カンパニーは、オミクロン変異体に対する中和作用を示す抗体であるベブテロビマブが米国食品医薬品局（FDA）から緊急使用承認（EUA）を取得したと発表しました。

ロシア・ウクライナ紛争影響分析

ロシア・ウクライナ紛争は、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、世界のモノクローナル抗体治療薬市場に与える影響は少ないと推定されます。しかし、原材料の輸出入の影響は、予測期間中、世界のモノクローナル抗体治療薬市場の成長にほとんど影響を及ぼさないと予想されます。

目次

第1章 調査手法とスコープ

  • 調査手法
  • 調査目的および調査範囲

第2章 定義と概要

第3章 エグゼクティブサマリー

  • 製品タイプ別スニペット
  • スニペット：アプリケーション別
  • スニペット：エンドユーザー別
  • 地域別スニペット

第4章 市場力学

  • 影響要因
    • 促進要因
      • 規制当局の承認と治療薬の上市の増加
      • がんやその他の慢性疾患の発生率の増加
    • 抑制要因
      • コスト高と厳しい規制
    • 機会
      • バイオテクノロジー企業別研究開発への投資拡大
    • 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
  • 法規制の分析

第6章 COVID-19の分析

  • COVID-19の分析
    • COVID-19の前のシナリオ
    • COVID-19実施中のシナリオ
    • COVID-19後のシナリオ
  • COVID-19の中での価格・ダイナミクス
  • 需給スペクトル
  • パンデミック時の市場に関連する政府の取り組み
  • メーカーの戦略的な取り組み
  • サマリー

第7章 製品タイプ別

  • ネイキッド
  • 融合タンパク質
  • フラグメント抗体
  • 複合体
  • 多重特異性薬

第8章 アプリケーション別

  • がん
  • 自己免疫疾患
  • 感染症
  • その他

第9章 生産源別

  • ヒト
  • ヒト化
  • キメラ
  • その他

第10章 エンドユーザー別

  • 病院
  • 専門施設
  • 研究機関

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
    • その他南米地域
  • アジア太平洋地域
    • 中国
    • インド
    • 日本
      • その他アジア太平洋地域
  • 中東・アフリカ地域
    • 地域別の主なダイナミクス

第12章 競合情勢

  • 競合シナリオ
  • 市況ポジショニング/シェア分析
  • M&A（合併・買収）分析

第13章 企業プロファイル

  • F. Hoffmann-La Roche
    • 会社概要
    • 製品ポートフォリオと説明
    • 財務概要
    • 主な発展状況
  • Novartis AG
  • Merck & Co. Inc.
  • Pfizer Inc.
  • Eli Lilly and Co.（Lilly）
  • Sanofi
  • AstraZeneca
  • Bayer AG
  • Regeneron Pharmaceuticals Inc.
  • GSK Plc

第14章 付録

目次
Product Code: BT12

Market Overview

The Global Monoclonal Antibody Therapeutics Market reached US$ 190,698.3 million in 2022 and is projected to witness lucrative growth by reaching up to US$ 531,314.6 million by 2030. The global monoclonal antibody therapeutics market is expected to exhibit a CAGR of 14.1% during the forecast period (2023-2030).

Monoclonal antibody therapeutics (mAbs) are generated from identical antibodies (or simply antibody fragments) in a homogeneous manner. The antigen recognition site, biological interactions, affinity and downstream biologic consequences of every antibody molecule in the product are identical. This sets mAbs apart from polyclonal antibodies, which have a diverse range of protein sequences and epitope recognition

The global market for monoclonal antibody therapeutics is expanding as a result of factors including the increasing prevalence of autoimmune disorders, the growing size of the therapeutic pipeline, investment by biopharmaceutical companies and their upcoming medical approvals across countries are also creating a positive outlook for the monoclonal antibody therapeutics market growth.

Market Dynamics

Increasing Regulatory Approvals and Launch of Therapies Drive the Growth of the Monoclonal Antibody Therapeutics Market

The growing number of regulatory approvals by various regulatory bodies for different monoclonal antibodies therapeutics utilized for cancer or autoimmune diseases, the growing clinical trials by major biopharmaceutical companies, an increase in the population with cancer, and new, innovative, technologically sophisticated therapies are all contributing to the growth of the global market for monoclonal antibody therapeutics.

Furthermore, on January 5, 2023, Nirsevimab's Biologics License Application (BLA) was approved by the U.S. FDA, Center for Drug Evaluation and Research for the treatment of children up to 24 months old who are still susceptible to developing severe respiratory syncytial virus (RSV) disease throughout the second RSV season as well as for infants and newborns entering or already experiencing their first RSV season. Hence, the growing number of novel therapies launched by biopharmaceutical companies is driving the monoclonal antibody therapeutics market.

The Growing Investments in Research and Development by Biotechnology Companies Create Lucrative Opportunities for Manufacturers

Due to increasing spending or investments in research and development capabilities by key players or biotechnology businesses for unique technological breakthroughs, there is a growing market opportunity for monoclonal antibody therapeutics. Another trend driving the monoclonal antibody therapies market is the increasing occurrence of respiratory diseases.

Furthermore, in April 2023, early experiments conducted by researchers at Janssen Biotech, Inc. and NYU Grossman School of Medicine demonstrated that a bioengineered medication candidate can prevent infection with the bacterium species Staphylococcus aureus.

It details the preliminary evaluation of mAbtyrins, a combination molecule derived from an engineered human monoclonal antibody (mAb), a kind of protein that adheres to and identifies S. aureus for uptake and eradication by immune cells. Centyrins, tiny proteins that are attached to the mAb, stop these germs from drilling holes in the human immune cells where they hide.

Higher Costs and Strict Regulatory Measures will Hamper the Growth of the Market.

However, biotherapeutics, including monoclonal antibodies and recombinant proteins, which have grown into the foundation of contemporary medicine, are still largely beyond reach for populations in middle- and low-income countries, in part due to their high costs, despite often providing clinical benefits over the standard of care is a restraint for monoclonal antibody therapeutics market.

The average yearly cost of a mAb was $96,731, and for 34 mAb-indication combos, it exceeded $100,000. Despite making up 40% of the approved mAb-indication combinations, hematology and oncology mAbs accounted for over 85 percent of those with a price tag of $100,000 or higher. Hence these above mentioned factors are limiting the monoclonal antibody therapeutics market's growth.

COVID-19 Impact Analysis

The financial health of companies across all industries has been impacted by the COVID-19 pandemic and lockdown in numerous nations throughout the world. Therefore, for the period of the COVID-19 public 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.

These therapeutic monoclonal antibodies were also used to control COVID-19. For instance, on February 11, 2022, Eli Lilly and Company announced that Bebtelovimab, an antibody that exhibits neutralization against the Omicron variant, received an Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA).

Russia-Ukraine War Impact Analysis

The Russia-Ukraine conflict is estimated to have a low impact on the global monoclonal antibody therapeutics 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 monoclonal antibody therapeutics market growth over the forecast period.

Segment Analysis

The global monoclonal antibody therapeutics market is segmented based on product type, application, production source, distribution channel and region.

Humanoid from the Production Source Segment Accounts for 45.79% of the Market Share Owing to Rising Novel Product Launches.

A humanized antibody possesses three advantages over a native mouse mAb: it is less immunogenic (since the immune response is primarily directed against the mouse Ig constant region); it can perform human effector functions; and its serum half-life in humans is significantly longer. Researchers have extracted the mouse CDRs targeted against a relevant human antigen and assembled them in a human antibody framework to further humanize these antibodies.

A humanized IgG4 anti-PD-1 monoclonal antibody called tislelizumab is being researched as a monotherapy and in conjunction with other treatments. Treatment of inoperable recurrent metastatic or locally progressed esophageal squamous cell carcinoma (ESCC) is possible in patients who had previously received systemic therapy with the anti-PD-1 immune checkpoint inhibitor tislelizumab.

Geographical Analysis

North America Accounted for Approximately 40.2% of the Market Share in 2022, Owing to the Strong Presence of Major Players and Increasing Healthcare Infrastructure Investment

Manufacturers have chances to expand their operations in this region because of the rising demand for monoclonal antibody therapeutics for advancements in North America. The area has many producers and suppliers, and its rapid economic development has raised industrial production of monoclonal antibody therapeutics, which has increased the demand.

North America has a large number of producers and suppliers, and as a result of the swift economic development of the area, industrial production has increased, fueling the demand for monoclonal antibody therapeutics.

Rising new product types or applications will drive market growth. Growth is also fueled by rising technological advancements, regulatory approvals, and novel product launches. Researchers are becoming more aware of various kinds of treatment approaches for cancer or various other disorders, leading to the expansion of the market in this region.

Competitive Landscape

The major global players in the monoclonal antibody therapeutics market include: F. Hoffmann-La Roche, Sanofi, Merck & Co. Inc., Pfizer Inc., GSK Plc, Eli Lily and Co., Regeneron Pharmaceuticals Inc., AstraZeneca, and Bayers AG among others.

Why Purchase the Report?

  • To visualize the global monoclonal antibody therapeutics market segmentation based on product type, application, production source, 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 monoclonal antibody 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 monoclonal antibody therapeutics 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 Product Type
  • 3.2. Snippet by Application
  • 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 Regulatory Approvals and Launch of Therapies
      • 4.1.1.2. Rising Incidence of Cancer and Other Chronic Diseases
    • 4.1.2. Restraints
      • 4.1.2.1. Higher Costs and Strict Regulatory Measures
    • 4.1.3. Opportunity
      • 4.1.3.1. The Growing Investments in Research and Development by Biotechnology Companies
    • 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 Product Type

  • 7.1. Introduction
    • 7.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product Type
    • 7.1.2. Market Attractiveness Index, By Product Type
  • 7.2. Naked *
    • 7.2.1. Introduction
    • 7.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
  • 7.3. Fusion Protein
  • 7.4. Antibody Fragment
  • 7.5. Conjugate
  • 7.6. Multi-specific

8. By Application

  • 8.1. Introduction
    • 8.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
    • 8.1.2. Market Attractiveness Index, By Application
  • 8.2. Cancer *
    • 8.2.1. Introduction
    • 8.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
  • 8.3. Autoimmune Diseases
  • 8.4. Infectious Diseases
  • 8.5. Others

9. By Production Source

  • 9.1. Introduction
    • 9.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Production Source
    • 9.1.2. Market Attractiveness Index, By Production Source
  • 9.2. Human *
    • 9.2.1. Introduction
    • 9.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
  • 9.3. Humanized
  • 9.4. Chimeric
  • 9.5. Others

10. By End User

  • 10.1. Introduction
    • 10.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By End User
    • 10.1.2. Market Attractiveness Index, By End User
  • 10.2. Hospital *
    • 10.2.1. Introduction
    • 10.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
  • 10.3. Specialty Centers
  • 10.4. Research Institutes

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 Product Type
    • 11.2.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
    • 11.2.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Production Source
    • 11.2.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By End User
    • 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 Product Type
    • 11.3.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
    • 11.3.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Production Source
    • 11.3.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By End User
    • 11.3.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
      • 11.3.7.1. Germany
      • 11.3.7.2. The U.K.
      • 11.3.7.3. France
      • 11.3.7.4. Italy
      • 11.3.7.5. Spain
      • 11.3.7.6. 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 Product Type
    • 11.4.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
    • 11.4.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Production Source
    • 11.4.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By End User
    • 11.4.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
      • 11.4.7.1. Brazil
      • 11.4.7.2. Argentina
      • 11.4.7.3. 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 Product Type
    • 11.5.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
    • 11.5.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Production Source
    • 11.5.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By End User
    • 11.5.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
      • 11.5.7.1. China
      • 11.5.7.2. India
      • 11.5.7.3. Japan

Australia

      • 11.5.7.4. 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 Product Type
    • 11.6.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
    • 11.6.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Production Source
    • 11.6.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By End User

12. Competitive Landscape

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

13. Company Profiles

  • 13.1. F. Hoffmann-La Roche *
    • 13.1.1. Company Overview
    • 13.1.2. Product Portfolio and Description
    • 13.1.3. Financial Overview
    • 13.1.4. Key Developments
  • 13.2. Novartis AG
  • 13.3. Merck & Co. Inc.
  • 13.4. Pfizer Inc.
  • 13.5. Eli Lilly and Co. (Lilly)
  • 13.6. Sanofi
  • 13.7. AstraZeneca
  • 13.8. Bayer AG
  • 13.9. Regeneron Pharmaceuticals Inc.
  • 13.10. GSK Plc

LIST NOT EXHAUSTIVE

14. Appendix

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