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mRNAワクチンと治療薬の世界市場-2023年～2030年

Global mRNA Vaccine and 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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mRNAワクチンと治療薬の世界市場-2023年～2030年
出版日: 2023年10月18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

概要

mRNAワクチンは、ウイルスタンパク質に翻訳されるmRNAの断片を導入することで機能するもので、一般的にはウイルスの外膜に存在するタンパク質の短い断片です。このmRNAを利用することで、細胞はウイルスタンパク質を組み立てることができます。標準的な免疫反応の構成要素として、免疫システムはそのタンパク質が見慣れないものであることを識別し、抗体と呼ばれる特殊なタンパク質を作り出します。抗体は、個々のウイルスやその他の病原体を特定し、それらに結合し、病原体を消滅させるための目印をつけることによって、病気から体を守るのを助ける。

半減期がかなり短いため、コードされた抗原の発現が短く、さらに安定しています。また、mRNAはin vitro転写（IVT）により無細胞条件下で構築できるため、生産に微生物や培養細胞を利用する必要がなく、生産に関連する品質や安全性の問題を回避できます。これにより、下流での精製が容易になり、迅速でコスト効率の高い製造が可能になります。

ここ数年、メッセンジャーRNA（mRNA）の使用は、明確な慢性疾患に対する新しい治療法として重視されるようになってきています。そのため、慢性疾患患者の増加、研究の増加、市場への投資が市場を牽引しています。また、mRNAワクチンの開発・生産に役立つ技術の進歩や、市場参入企業間の合併、製品イントロダクション、事業拡大、買収、提携などの市場開拓も需要を押し上げています。

力学

慢性疾患患者の増加がmRNAワクチンと治療薬市場の成長を牽引

慢性疾患患者の増加は、予測期間中、世界のmRNAワクチンおよび治療薬市場を押し上げると予想されます。例えば、米国がん協会が発表したCancer Facts &Figures 2022データによると、2022年には米国で190万人の新鮮ながん患者が分析され、60万9,360人以上ががんで死亡しています。

さらに、NIHによれば、米国における50歳以上の高齢者数は、2020年の1億3,725万人から2050年には2億2,113万人へと61.11％増加すると予想されています。50歳以上の人のうち、少なくとも1つの慢性疾患を持つ人の数は、2020年の7,152万2,000人から2050年には1億4,266万人へと99.5％増加すると評価されています。同時に、多疾患併存者は、2020年の783万400人から2050年には1,496万8,000人へと91.16％増加すると推定されます。

mRNAワクチンと治療薬に関する調査活動の増加が、世界のmRNAワクチンと治療薬市場に成長機会をもたらす見込み

mRNAワクチンおよび治療薬に関する調査活動の活発化により、mRNAワクチンおよび治療薬の世界市場には、今後数年間、有望な成長機会がもたらされると期待されています。例えば、2021年6月、米国マサチューセッツ州ケンブリッジに本拠を置くStrand Therapeutics社は、新しいmRNAがん治療法を設計するために5,200万米ドルを獲得しました。さらに、clinicaltrials.govによると、2022年には米国でバイオ医薬品に関する約150件のmRNAワクチンの臨床試験が記録されています。

さらに2023年7月、韓国食品医薬品安全部（MFDS）はレモネックス社のmRNAワクチン候補LEM-mR203のIND申請を承認しました。同社はLEM-mR203をCOVID-19の治療薬として推定する意向で、韓国のソウル大学病院で健康な成人を対象に安全性と免疫原性を評価する第I相臨床試験を計画しています。

mRNAデリバリーシステム開拓の課題が推定・予測期間中、世界のmRNAワクチンと治療薬市場を阻む

mRNA送達システムの市場開拓における課題は、世界のmRNAワクチンおよび治療薬市場の成長を妨げると予想されます。例えば、高分子量、負電荷、リボヌクレアーゼ（RNase）に対する感受性、細胞外および細胞内障害物の存在といったmRNAの物理的特性は、mRNAが細胞内にうまく取り込まれ、標的とする抗原に復号化されることを困難にします。

これらのハードルのいくつかは、mRNAの化学的変換を利用することで部分的に取り除かれてはいるが、それでもmRNAの細胞内送達には大きな限界があります。mRNAに基づく治療薬の臨床応用には、生理的環境下でのmRNAの安定化を保証できるデリバリー技術が必要です。とはいえ、適切なキャリアは分解を回避し、免疫反応、エフェクター発現、生体適合性、生体安全性を改善することができます。

このレポートの詳細- サンプル請求

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
      • 慢性疾患の増加
      • 市場開拓
    • 抑制要因
      • mRNAデリバリーの課題
    • 機会
      • mRNAワクチン研究の増加
    • 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
  • サプライチェーン分析
  • 疫学分析
  • 特許分析
  • SWOT分析
  • PEST分析
  • パイプライン分析

第6章 COVID-19分析

第7章 製品タイプ別

  • 予防ワクチン
  • 治療用ワクチン
  • 治療薬

第8章 用途別

  • がん
  • 感染症
  • 自己免疫疾患
  • その他

第9章 エンドユーザー別

  • 学術研究センター
  • 病院
  • 専門クリニック
  • 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
    • その他の欧州
  • 南米
    • ブラジル
    • アルゼンチン
    • その他の南米
  • アジア太平洋
    • 中国
    • インド
    • 日本
      • その他のアジア太平洋
  • 中東およびアフリカ
    • 主な地域別力学

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

  • CureVac N.V.
  • BioNTech SE
  • Moderna, Inc.
  • Sangamo Therapeutics, Inc.
  • GSK plc.
  • Pfizer Inc.
  • AstraZeneca plc.
  • Arcturus Therapeutics
  • Argos Therapeutics Inc.
  • Translate Bio, Inc.
  • CRISPR Therapeutics AG
  • Merck

第13章 付録

  • 米国と製品について
目次
Product Code: BT7307

Overview

mRNA vaccines function by introducing a fragment of mRNA that translates to a viral protein, generally a short fragment of a protein encountered on the virus's external membrane. By utilizing this mRNA, cells can assemble the viral protein. As a component of a standard immune reaction, the immune system identifies that the protein is unfamiliar and creates specialized proteins called antibodies. Antibodies assist defend the body against disease by specifying individual viruses or other pathogens, conjoining to them, and marking the pathogens for annihilation.

The fairly short half-life effects in short and additionally a steady expression of the encoded antigen. Also, mRNA can be constructed in cell-free conditions by in vitro transcription (IVT), thereby circumventing utilizing microbes or cultured cells for production and evading the related quality and safety problems in the production. This allows straightforward downstream purification and quick-cost-effective manufacturing.

In the last few years, there has been growing emphasis on the usage of messenger RNA (mRNA) as a novel therapeutic modality for distinct chronic conditions. Therefore the market is driven by the growing chronic disease cases, increasing research and investments into the market. The demand is again pushed by technological advancements aiding in mRNA vaccine development and production, and market developments including mergers, product introductions, expansions, acquisitions and collaborations among market players.

Dynamics

Growing Cases of Chronic Diseases Drive the Growth of the mRNA Vaccines and Therapeutics Market

The growing cases of chronic diseases is expected to boost the global mRNA vaccines and therapeutics market during the forecast period. For instance, according to the Cancer Facts & Figures 2022 data published by the American Cancer Society, an assessed 1.9 million fresh cancer patients were analyzed, and over 609,360 cancer deaths in the United States in 2022.

Moreover, according to the NIH, the number of individuals in the United States aged 50 years and older is expected to rise by 61.11% from 137.25 million in 2020 to 221.13 million in 2050. Among people, 50 years and elder the number with at least one chronic condition is assessed to advance by 99.5% from 71.522 million in 2020 to 142.66 million by 2050. Concurrently, those with multimorbidity are estimated to grow 91.16% from 7.8304 million in 2020 to 14.968 million in 2050.

Increasing Research Activities for mRNA Vaccines and Therapeutics are Expected to Present the Global mRNA Vaccines and Therapeutics Market With Growth Opportunities

Increasing research activities for mRNA vaccines and therapeutics are expected to present the global mRNA vaccines and therapeutics market with prospective growth opportunities in the forthcoming years. For instance, in June 2021, Cambridge, Massachusetts, United States-based Strand Therapeutics obtained USD 52.0 million to design new mRNA cancer therapies. Further, as per clinicaltrials.gov, about 150 mRNA vaccine clinical trials were documented in the United States concerning biopharmaceuticals in 2022.

Moreover, in July 2023, the Korean Ministry of Food and Drug Safety (MFDS) authorized Lemonex Inc.'s IND application for its mRNA vaccine candidate LEM-mR203. The corporation intends to estimate LEM-mR203 as a possible therapy for COVID-19, with the designed phase I clinical investigation being devised to evaluate its safeness and immunogenicity in healthy adults at Seoul National University Hospital, Korea.

Challenges for the Development of mRNA Delivery Systems is Estimated to Hamper the Global mRNA Vaccines and Therapeutics Market During the Forecast Period

The challenges for the development of mRNA delivery systems are expected to hamper the global mRNA vaccine and therapeutics market growth. For instance, the challenges that hinder the successful translation of these molecules into drugs are mRNA's physical characteristics like high molecular weight, negative charge, susceptibility to ribonucleases (Rnases), and the presence of extracellular and intracellular hindrances, which make it tough for mRNA to be successfully uptaken into cells and decrypted to targeted antigens.

Although a few of these hurdles have been partly removed by utilizing a chemical transformation of the mRNA, intracellular delivery of mRNA nonetheless represents a significant limitation. The clinical translation of mRNA-based therapeutics needs delivery technologies that can guarantee the stabilization of mRNA under physiological circumstances. Nevertheless, fitting carriers can bypass degradation and improve immune reactions, effector expression, biocompatibility, and biosafety.

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Segment Analysis

The global mRNA vaccines and therapeutics market is segmented based on product type, application, end user and region.

Infectious Disease Application of mRNA Vaccines and Therapeutics is Estimated to Dominate the Global mRNA Vaccines and Therapeutics Market

The infectious disease application of mRNA vaccines and therapeutics is expected to hold around 47.8% of the global market share owing to increased cases of infectious diseases and increased research activities for development of mRNA based vaccines to fight the battel against infectious diseases. For instance, the Minority of HIV/AIDS Fund (MHAF) United States Department of Health and Human Services Statistics revised in June 2021, roughly 37.6 million individuals were living with HIV globally in 2020, out of which over 35.9 million were adults and 1.7 million were children (under the age of 15).

Further, in April 2022, the National Institute of Allergy and Infectious Diseases (NIAID), a component of the National Institutes of Health (NIH), introduced a Phase 1 clinical investigation to assess three experimental messenger RNA (mRNA) based HIV vaccines platform. The HVTN 302 investigation is funded by NIAID and executed by the NIAID-supported HIV Vaccine Trials Network (HVTN) founded at the Fred Hutchinson Cancer Research Center in Seattle.

Geographical Penetration

North America is Estimated to hold Approximately 38.3% of the Market Share by 2030, Owing to Growing Cases of Infectious Diseases in this Region

Owing to the growing cases of infectious diseases in the North American region, it is estimated to dominate the global market holding around 38.3% of the market by 2030. For instance, according to the December 2022 update by the CDC Weekly US Influenza Surveillance Report, during October 2022, over 113,482 patients were registered for influenza in clinical laboratories. Consisting of over 112,488 cases reported for influenza A and above 994 cases for influenza B.

Furthermore, the increasing mRNA vaccine and therapeutics research endeavors from US-based key market players are also contributing to regional market growth. For instance, in July 2023, Merck, and Moderna, Inc., a biotechnology corporation pioneering messenger RNA (mRNA) therapeutics and vaccines, together began the pivotal Phase 3 randomized V940-001 clinical investigation assessing V940 (mRNA-4157), an experimental individualized neoantigen therapy (INT), in mixture with KEYTRUDA, Merck's anti-PD-1 therapy, as adjuvant therapy in individuals with resected high-risk (Stage IIB-IV) melanoma.

Competitive Landscape

The major global players in the mRNA vaccines and therapeutics market include: CureVac N.V., BioNTech SE, Moderna, Inc., Sangamo Therapeutics, Inc., GSK plc., Pfizer Inc., AstraZeneca plc., Arcturus Therapeutics, Argos Therapeutics Inc., Translate Bio, Inc., and CRISPR Therapeutics AG, among others.

COVID-19 Impact Analysis:

COVID-19 has positively impacted the global mRNA vaccine and therapeutics market as with the quick hit in the design of mRNA vaccines against COVID-19 and with several mRNA-based drugs onwards in the pipelines, mRNA has catapulted to the vanguard of a drug investigation, exhibiting its significant efficacy against a wide spectrum of conditions.

Since the outburst of SARS-CoV-2, mRNA vaccine product has experienced a massive drive within the pharmaceutical domain. In current years, significant improvement has been pushed into mRNA vaccine development, particularly in individualized tumor vaccines.

Russia-Ukraine Conflict Analysis

The Russia-Ukraine conflict is assumed to have had a moderate impact on the global mRNA vaccines and therapeutics market, as this region lacks primary market players. However, during the 3 months of full-scale warfare, Russians sabotaged over 600 infirmaries and massacred at least 12 medics.

Access to health care is majorly affected because of security considerations, limited mobility, damaged supply chains, and mass population eviction. Again, the import and export of fundamental materials' significance is expected to slightly impact the global mRNA vaccines and therapeutics market growth in the forecast period.

By Product Type

  • Prophylactic Vaccines
  • Therapeutic Vaccines
  • Therapeutic Drugs

By Application

  • Cancer
  • Infectious Diseases
  • Autoimmune Diseases
  • Others

By End User

  • Academic Research Centers
  • Hospitals
  • Specialty Clinics
  • 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
    • Australia
    • Rest of Asia-Pacific
  • Middle East and Africa

Key Developments

  • In August 2023, AGC Biologics, a top multinational Biopharmaceutical Contract Development and Manufacturing Organization (CDMO) expanded its manufacturing reach at its Milan Cell & Gene Center of Excellence production location.
  • In February 2022, Eli Lilly and Company infused USD 700.0 million to establish a building at the Port of Boston to sustain its RNA-based investigation and development activities.
  • In September 2021, Sanofi became the first big pharma to acquire a mRNA therapeutics corporation, Translate Bio.

Why Purchase the Report?

  • To visualize the global mRNA vaccines and therapeutics market segmentation based on product type, application, end user and region and understand key commercial assets and players.
  • Identify commercial opportunities by analyzing trends and co-development.
  • Excel data sheet with numerous mRNA vaccines and therapeutics market-level data points with all segments.
  • PDF report consists of a comprehensive analysis after exhaustive qualitative interviews and an in-depth study.
  • Product mapping available in excel consisting of key products of all the major players.

The global mRNA vaccines and 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. Growing Chronic Diseases
      • 4.1.1.2. Market Developments
    • 4.1.2. Restraints
      • 4.1.2.1. mRNA Delivery Challenges
    • 4.1.3. Opportunity
      • 4.1.3.1. Increasing Research in mRNA Vaccines
    • 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
  • 5.5. Supply Chain Analysis
  • 5.6. Epidemiological Analysis
  • 5.7. Patent Analysis
  • 5.8. SWOT Analysis
  • 5.9. PEST Analysis
  • 5.10. Pipeline 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 the 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. Prophylactic Vaccines*
    • 7.2.1. Introduction
    • 7.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
  • 7.3. Therapeutic Vaccines
  • 7.4. Therapeutic Drugs

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. Infectious Diseases
  • 8.4. Autoimmune Disease
  • 8.5. 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. Academic Research Centers*
    • 9.2.1. Introduction
    • 9.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
  • 9.3. Hospitals
  • 9.4. Specialty Clinics
  • 9.5. 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 Product Type
    • 10.2.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
    • 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 Product Type
    • 10.3.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
    • 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 Product Type
    • 10.4.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
    • 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 Product Type
    • 10.5.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
    • 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
      • Australia
      • 10.5.6.4. 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 Product Type
    • 10.6.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
    • 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. CureVac N.V.*
    • 12.1.1. Company Overview
    • 12.1.2. Product Portfolio and Description
    • 12.1.3. Financial Overview
    • 12.1.4. Key Developments
  • 12.2. BioNTech SE
  • 12.3. Moderna, Inc.
  • 12.4. Sangamo Therapeutics, Inc.
  • 12.5. GSK plc.
  • 12.6. Pfizer Inc.
  • 12.7. AstraZeneca plc.
  • 12.8. Arcturus Therapeutics
  • 12.9. Argos Therapeutics Inc.
  • 12.10. Translate Bio, Inc.
  • 12.11. CRISPR Therapeutics AG
  • 12.12. Merck

LIST NOT EXHAUSTIVE

13. Appendix

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