ウイルス不活性化の世界市場規模：方法別、製品別、用途別、エンドユーザー別、地域別、範囲および予測

ウイルス不活性化の市場規模と予測

ウイルスの不活性化市場規模は、2023年に6億8,391万米ドルと評価され、2031年には13億8,946万米ドルに達すると予測され、2024年から2031年までのCAGRは9.27%で成長します。ウイルスの不活化とは、ウイルスの構造や遺伝物質を破壊することでウイルスを非感染性にし、複製や他者への感染を防ぐことです。これには、熱処理、化学的暴露、放射線照射など、さまざまな方法が用いられます。ウイルスの不活化は、医薬品、バイオテクノロジー、ヘルスケアなど数多くの用途があります。医薬品製造におけるウイルス不活性化は、ワクチン、血液製剤、組換えタンパク質など、動物やヒトの組織に由来する生物学的製品を、ウイルス汚染の危険性を減らすことで保護します。

さらに、ヘルスケア環境では、ウイルス不活性化処置は、医療機器、表面、体液の滅菌に使用され、ウイルス病原体の感染を制限し、疾病の蔓延を防止します。

世界のウイルス不活性化市場力学

主な市場促進要因

慢性疾患の有病率の上昇：

がん、HIV、肝炎などの慢性疾患や生命を脅かす疾患の有病率が上昇しているため、より効果的なバイオ医薬品による治療が必要とされています。このニーズは、生物製剤や血漿誘導体の安全性と有効性に不可欠であるため、ウイルス不活性化市場の原動力となっています。

厳しい規制ガイドライン：

バイオ医薬品がウイルスに汚染されていないことを保証するため、FDAやEMAを含む世界中の規制機関は、その製造に関して厳しい規則を設けています。これらの規則を遵守するためには、ウイルス不活性化技術を使用する必要があり、市場の拡大に拍車をかけています。

バイオテクノロジーの進歩：

バイオテクノロジーと医薬品研究開発の急速な進歩により、ワクチン、治療用タンパク質、モノクローナル抗体などのバイオ医薬品の製造が拡大しています。これらの製品は、安全性を確保するためにウイルス不活性化を必要とするため、ウイルス不活性化技術の需要が高まっています。

成長する生物製剤とバイオシミラー市場：

生物製剤とバイオシミラーの市場は、さまざまな疾患の治療における有効性によって拡大しており、ウイルス不活性化を含む厳重な安全対策が必要とされています。製品の安全性は規制当局の承認と社会的信用に不可欠であるため、このニーズはウイルス不活性化市場の主要促進要因となっています。

主な課題

高いコストとリソースの集中：

ウイルス不活性化技術の実行には時間とコストがかかり、技術や有資格スタッフへの多大な投資が必要となります。中小の製薬会社やバイオテクノロジー企業にとって、こうした高額な投資は法外に高く、市場での競争力を制限します。

ウイルスブレイクスルーのリスク：

厳格なウイルス不活性化手順にもかかわらず、突然変異や見慣れないウイルスの存在によってウイルスが出現する可能性は常にあります。このリスクは、不活化方法の有効性を向上させるための継続的な研究開発を必要とし、バイオ医薬品製造の複雑さとコストを増大させる。

主な動向

新技術の採用：

ウイルス不活性化市場では、UV-C照射、高温短時間（HTST）処理、高度な化学的アプローチなど、新規技術の採用が進んでいます。これらの技術は効率性と安全性を高め、従来のアプローチの制約を克服して市場の成長を後押ししています。

自動化への注目の高まり：

再現性を高め、人為的ミスを排除し、スループットを向上させるために、ウイルス不活性化操作を自動化する傾向が高まっています。自動化は規制基準の遵守にも役立ち、手順をより効率的でコスト効率の高いものにします。

新興市場への進出：

ウイルス不活性化市場は、バイオ医薬品産業の拡大、ヘルスケア支出の増加、生物製剤の安全性に対する懸念の高まりなどを背景に、新興国へと拡大しています。この拡大は、従来の市場を超えた新たな市場成長の展望を開くものです。

高度分析の統合：

ウイルス不活性化プロセスへの高度分析の統合が進み、リアルタイムのモニタリングと制御が可能になりつつあります。この接続により、より正確で迅速な不活化方法が可能になり、安全性プロファイルと規制コンプライアンスが改善されるとともに、市場のイノベーションも促進されます。

目次

第1章 世界のウイルス不活性化市場のイントロダクション

• 市場概要
• 調査範囲
• 前提条件

第2章 エグゼクティブサマリー

第3章 VERIFIED MARKET RESEARCHの調査手法

• データマイニング
• バリデーション
• 一次資料
• データソース一覧

第4章 世界のウイルス不活性化市場の展望

• 概要
• 市場力学
  • 促進要因
  • 抑制要因
  • 機会
• ポーターのファイブフォースモデル
• バリューチェーン分析

第5章 世界のウイルス不活性化市場：方法別

• 概要
• 溶剤洗浄法
• 低温殺菌法
• その他

第6章 ウイルス不活性化の世界市場：製品別

• 概要
• キットと試薬
• サービス
• システムとアクセサリー

第7章 世界のウイルス不活性化市場：用途別

• 概要
• 血液・血液製剤
• 細胞・遺伝子治療製品
• 幹細胞製品
• 組織・組織製品
• ワクチンと治療薬

第8章 世界のウイルス不活性化市場：エンドユーザー別

• 概要
• 製薬会社およびバイオテクノロジー企業
• 受託研究機関
• 学術研究機関
• その他

第9章 ウイルス不活性化の世界市場：地域別

• 概要
• 北米
  • 米国
  • カナダ
  • メキシコ
• 欧州
  • ドイツ
  • 英国
  • フランス
  • その他欧州
• アジア太平洋
  • 中国
  • 日本
  • インド
  • その他アジア太平洋地域
• 世界のその他の地域
  • ラテンアメリカ
  • 中東・アフリカ

第10章 世界のウイルス不活性化市場の競合情勢

• 概要
• 各社の市場ランキング
• 主な開発戦略

第11章 企業プロファイル

• Sartorius AG
• Clean Cells
• Danaher Corporation
• Charles River Laboratories
• Merck KGaA
• Rad Source Technologies
• Parker Hannifin Corporation
• Viral Inactivated Plasma Systems SA
• SGS SA
• Texcell

第12章 付録

• 関連調査

Viral Inactivation Market Size And Forecast

Viral Inactivation Market size was valued at USD 683.91 Million in 2023 and is projected to reach USD 1389.46 Million by 2031 , growing at a CAGR of 9.27% from 2024 to 2031. Viral inactivation is the process of rendering viruses non-infectious by destroying their structure or genetic material, preventing them from replicating and infecting others. This is accomplished using a variety of ways, including heat treatment, chemical exposure, and irradiation. Viral inactivation has numerous applications, including medicines, biotechnology, and healthcare. Viral inactivation in pharmaceutical production protects biological products originating from animal or human tissues, such as vaccines, blood products, and recombinant proteins, by reducing the danger of viral contamination.

Additionally, in healthcare settings, viral inactivation procedures are used to sterilize medical equipment, surfaces, and bodily fluids, limiting viral pathogen transmission and preventing disease spread.

Global Viral Inactivation Market Dynamics

The key market dynamics that are shaping the Viral Inactivation Market include:

Key Market Drivers

Rising Prevalence of Chronic Diseases:

The rising prevalence of chronic and life-threatening diseases such as cancer, HIV, and hepatitis need more effective biopharmaceutical therapies. This need drives the Viral Inactivation Market since it is crucial to the safety and efficacy of biologics and plasma derivatives.

Stringent Regulatory Guidelines:

To ensure that biopharmaceutical products are free of viral contamination, regulatory bodies around the world, including the FDA and EMA, have established tight rules for their manufacturing. Complying with these rules involves the use of viral inactivation techniques, thereby fueling market expansion.

Advancements in Biotechnology:

Rapid advances in biotechnology and pharmaceutical R&D are resulting in greater manufacturing of biopharmaceuticals such as vaccines, therapeutic proteins, and monoclonal antibodies. These products require viral inactivation to ensure safety, which increases the demand for viral inactivation technology.

Growing Biologics and Biosimilars Market:

The rising market for biologics and biosimilars, driven by their efficacy in treating a variety of diseases, necessitates severe safety precautions, including viral inactivation. This need is a major driver of the Viral Inactivation Market, as product safety is critical for regulatory approval and public trust.

Key Challenges:

High Costs and Resource Intensity:

The execution of viral inactivation techniques is time-consuming and expensive, necessitating considerable investments in technology and qualified staff. These high expenditures are prohibitively expensive for smaller pharmaceutical and biotech companies, restricting their competitiveness in the market.

Risk of Viral Breakthrough:

Despite stringent viral inactivation procedures, there is always a possibility of viral emergence due to mutations or the presence of unfamiliar viruses. This risk needs continual research and development to improve the efficacy of inactivation methods, which increases the complexity and cost of biopharmaceutical manufacturing.

Key Trends:

Adoption of Novel Technologies:

The Viral Inactivation Market has experienced the use of novel technologies such as UV-C irradiation, high-temperature short-time (HTST) treatments, and sophisticated chemical approaches. These technologies increase efficiency and safety characteristics, overcoming the constraints of traditional approaches and boosting market growth.

Increased Focus on Automation:

There is a growing trend of automating viral inactivation operations to improve repeatability, eliminate human error, and boost throughput. Automation also helps to comply with regulatory standards, making procedures more efficient and cost-effective.

Expansion into Emerging Markets:

The Viral Inactivation Market is expanding into emerging economies, fueled by expanding biopharmaceutical industries, increased healthcare spending, and growing concern about biologics' safety. This expansion opens up new prospects for market growth beyond traditional markets.

Integration of Advanced Analytics:

Advanced analytics are increasingly being integrated into viral inactivation processes to provide real-time monitoring and control. This connection allows for more precise and fast inactivation methods, which improves safety profiles and regulatory compliance while also promoting market innovation.

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Global Viral Inactivation Market Regional Analysis

Here is a more detailed regional analysis of the Viral Inactivation Market:

North America:

According to Verified Market Research, North America is estimated to dominate the Viral Inactivation Market over the forecast period. North America, particularly the United States, has a vast and sophisticated biopharmaceutical industry that leads in the development and production of vaccines, therapeutic proteins, and monoclonal antibodies. The magnitude and growth of this sector necessitate substantial viral inactivation methods, which drive regional demand.

The presence of severe regulatory organizations in the United States, such as the FDA, requires biopharmaceutical goods to meet stringent safety criteria, which include viral inactivation. This regulatory structure promotes high levels of compliance and the use of viral inactivation technology, hence promoting market dominance.

Furthermore, North America, particularly the United States, has one of the world's highest healthcare costs, indicating a significant investment in healthcare infrastructure, including innovative therapies and biopharmaceutical products. This investment encourages the use of sophisticated viral inactivation technologies, hence driving the market.

Asia Pacific:

The Asia Pacific region is estimated to exhibit the highest growth potential in the market during the forecast period. The Asia Pacific region's biopharmaceutical industry is expanding rapidly, spurred by increased expenditures in biotechnology and healthcare infrastructure. This expansion needs sophisticated viral inactivation technologies, which drive market growth in countries such as China and India.

Governments and the corporate sector in Asia Pacific are considerably boosting healthcare spending to improve public health services and access to innovative treatments. This investment promotes the development and use of safe biopharmaceutical products, particularly those that require viral inactivation.

Furthermore, there is a growing awareness in the region about the necessity of biological safety and the dangers of virus contamination. This knowledge is increasing the demand for viral inactivation technologies to ensure the safety of vaccinations, therapeutic proteins, and other biologics.

Europe:

Europe has advanced healthcare systems with robust regulatory frameworks overseen by authorities such as the European Medicines Agency (EMA). These systems require rigorous safety criteria for biopharmaceutical goods, emphasizing the importance of successful viral inactivation to ensure patient safety and product efficacy.

Europe is home to considerable biopharmaceutical research and development efforts, which are funded by both public and private funding. This investment promotes innovation in viral inactivation technologies and procedures, hence contributing to regional market growth.

Furthermore, in Europe, biopharmaceutical businesses, research institutes, and technology providers are highly collaborative and form collaborations. These agreements promote the exchange of knowledge and technology, such as viral inactivation, which improves the region's ability to address viral safety in biopharmaceuticals.

Global Viral Inactivation Market: Segmentation Analysis

The Viral Inactivation Market is Segmented based on Method, Product, Application, End-User, and Geography.

Viral Inactivation Market, By Method

• Solvent Detergent Method
• Pasteurization
• Others

Based on Method, the market is segmented into Solvent Detergent Method, Pasteurization, and Others. The solvent detergent method segment is estimated to grow at the highest CAGR within the Viral Inactivation Market due to its ability to inactivate encapsulated viruses while retaining the product's biological activity, making it a popular choice for the treatment of blood and plasma products, as well as certain biopharmaceuticals. The method's widespread acceptance can also be attributed to its simplicity, low cost, and comprehensive validation in assuring viral safety.

Viral Inactivation Market, By Product

• Kits and Reagents
• Services
• Systems and Accessories

Based on Product, the market is segmented into Kits & Reagents, Services, and Systems & Accessories. The kits & reagents segment is estimated to dominate the Viral Inactivation Market due to their widespread application throughout all stages of pharmaceutical and biopharmaceutical production, including research and development, manufacturing, and quality control. Kits and reagents are critical for efficiently and effectively carrying out viral inactivation activities, providing a balance of usability, cost-effectiveness, and dependability. Their high demand is exacerbated by the requirement for continuous viral safety testing in the production of vaccines, medicinal proteins, and other biologics.

Viral Inactivation Market, By Application

• Blood & Blood Products
• Cellular & Gene Therapy Products
• Stem Cell Products
• Tissue & Tissue Products
• Vaccines and Therapeutics

Based on Application, the market is segmented into Blood & Blood Products, Cellular & Gene Therapy Products, Stem Cell Products, Tissue & Tissue Products, and Vaccines & Therapeutics. The vaccines and therapeutics segment is estimated to dominate the market over the forecast period due to rising demand for vaccines and therapeutic medications, which is being driven by an increase in the global prevalence of chronic diseases and infectious outbreaks. The research and manufacturing of these products necessitate severe viral inactivation techniques to ensure safety and efficacy, making this market an important user of viral inactivation technology. Furthermore, continued efforts to improve vaccine development, particularly in response to new infectious illnesses, as well as increased investment in biopharmaceutical R&D, help to drive the segment's importance.

Viral Inactivation Market, By End-User

• Pharmaceutical and Biotechnology Companies
• Contract Research Organizations
• Academic Research Institutes
• Others

Based on End-User, the market is segmented into Pharmaceutical & Biotechnology Companies, Contract Research Organizations, Academic Research Institutes, and Others. The pharmaceutical & biotechnology companies segment is estimated to dominate the market over the forecast period due to these companies' critical roles in the development, production, and commercialization of biopharmaceuticals such as vaccines, therapeutic proteins, and monoclonal antibodies, all of which require stringent viral inactivation processes to ensure safety and efficacy. The continued rise of biopharmaceutical research and development, combined with increased investments in biologic drug discovery, is driving demand for viral inactivation technologies in this market.

Key Players

• The "Global Viral Inactivation Market" study report will provide valuable insight with an emphasis on the global market. The major players in the market are
• Merck KGaA, Danaher Corporation, Sartorius AG, Charles River Laboratories, Clean Cells, Rad Source Technologies, Texcell, Viral Inactivated Plasma Systems SA, WuXi PharmaTech, Parker Hannifin Corporation, SGS SA, Thermo Fisher Scientific, Bio-Rad Laboratories, GE Healthcare, MilliporeSigma, Lonza Group, and Catalent.

Our market analysis also entails a section solely dedicated to such major players wherein our analysts provide an insight into the financial statements of all the major players, along with product benchmarking and SWOT analysis. The competitive landscape section also includes key development strategies, market share, and market ranking analysis of the above-mentioned players globally.

• Viral Inactivation Market Recent Developments
• In May 2022, Pall Corporation established a partnership with RD-Biotech to produce vast volumes of Good Manufacturing Practice (GMP)-grade plasmid DNA (pDNA). The partnership seeks to fulfill the growing demand for gene and mRNA-based therapeutics, particularly for COVID-19 vaccine development.
• In January 2021, Akron Biotechnology announced an exclusive global deal with Octapharma to manufacture virally inactivated Human AB Serum derived from Octaplas(R) for cell therapy. This alliance intends to improve the safety of human serum against viruses, particularly COVID-19, and support research and development for commercialization.

TABLE OF CONTENTS

1 INTRODUCTION OF GLOBAL VIRAL INACTIVATION MARKET

• 1.1 Overview of the Market
• 1.2 Scope of Report
• 1.3 Assumptions

2 EXECUTIVE SUMMARY

3 RESEARCH METHODOLOGY OF VERIFIED MARKET RESEARCH

• 3.1 Data Mining
• 3.2 Validation
• 3.3 Primary Interviews
• 3.4 List of Data Sources

4 GLOBAL VIRAL INACTIVATION MARKET OUTLOOK

• 4.1 Overview
• 4.2 Market Dynamics
  • 4.2.1 Drivers
  • 4.2.2 Restraints
  • 4.2.3 Opportunities
• 4.3 Porters Five Force Model
• 4.4 Value Chain Analysis

5 GLOBAL VIRAL INACTIVATION MARKET, BY METHOD

• 5.1 Overview
• 5.2 Solvent Detergent Method
• 5.3 Pasteurization
• 5.4 Others

6 GLOBAL VIRAL INACTIVATION MARKET, BY PRODUCT

• 6.1 Overview
• 6.2 Kits and Reagents
• 6.3 Services
• 6.4 Systems and Accessories

7 GLOBAL VIRAL INACTIVATION MARKET, BY APPLICATION

• 7.1 Overview
• 7.2 Blood & Blood Products
• 7.3 Cellular & Gene Therapy Products
• 7.4 Stem Cell Products
• 7.5 Tissue & Tissue Products
• 7.6 Vaccines and Therapeutics

8 GLOBAL VIRAL INACTIVATION MARKET, BY END-USER

• 8.1 Overview
• 8.2 Pharmaceutical and Biotechnology Companies
• 8.3 Contract Research Organizations
• 8.4 Academic Research Institutes
• 8.5 Others

9 GLOBAL VIRAL INACTIVATION MARKET, BY GEOGRAPHY

• 9.1 Overview
• 9.2 North America
  • 9.2.1 U.S.
  • 9.2.2 Canada
  • 9.2.3 Mexico
• 9.3 Europe
  • 9.3.1 Germany
  • 9.3.2 U.K.
  • 9.3.3 France
  • 9.3.4 Rest of Europe
• 9.4 Asia Pacific
  • 9.4.1 China
  • 9.4.2 Japan
  • 9.4.3 India
  • 9.4.4 Rest of Asia Pacific
• 9.5 Rest of the World
  • 9.5.1 Latin America
  • 9.5.2 Middle East and Africa

10 GLOBAL VIRAL INACTIVATION MARKET COMPETITIVE LANDSCAPE

• 10.1 Overview
• 10.2 Company Market Ranking
• 10.3 Key Development Strategies

11 COMPANY PROFILES

• 11.1 Sartorius AG
  • 11.1.1 Overview
  • 11.1.2 Financial Performance
  • 11.1.3 Product Outlook
  • 11.1.4 Key Developments
• 11.2 Clean Cells
  • 11.2.1 Overview
  • 11.2.2 Financial Performance
  • 11.2.3 Product Outlook
  • 11.2.4 Key Developments
• 11.3 Danaher Corporation
  • 11.3.1 Overview
  • 11.3.2 Financial Performance
  • 11.3.3 Product Outlook
  • 11.3.4 Key Developments
• 11.4 Charles River Laboratories
  • 11.4.1 Overview
  • 11.4.2 Financial Performance
  • 11.4.3 Product Outlook
  • 11.4.4 Key Developments
• 11.5 Merck KGaA
  • 11.5.1 Overview
  • 11.5.2 Financial Performance
  • 11.5.3 Product Outlook
  • 11.5.4 Key Developments
• 11.6 Rad Source Technologies
  • 11.6.1 Overview
  • 11.6.2 Financial Performance
  • 11.6.3 Product Outlook
  • 11.6.4 Key Developments
• 11.7 Parker Hannifin Corporation
  • 11.7.1 Overview
  • 11.7.2 Financial Performance
  • 11.7.3 Product Outlook
  • 11.7.4 Key Developments
• 11.8 Viral Inactivated Plasma Systems SA
  • 11.8.1 Overview
  • 11.8.2 Financial Performance
  • 11.8.3 Product Outlook
  • 11.8.4 Key Developments
• 11.9 SGS SA
  • 11.9.1 Overview
  • 11.9.2 Financial Performance
  • 11.9.3 Product Outlook
  • 11.9.4 Key Developments
• 11.10 Texcell
  • 11.10.1 Overview
  • 11.10.2 Financial Performance
  • 11.10.3 Product Outlook
  • 11.10.4 Key Developments

12 Appendix

• 12.1 Related Research