バイオロジクス安全性試験の世界市場規模：試験タイプ別、製品・サービス別、用途別、地域別、範囲および予測

バイオロジクス安全性試験の市場規模と予測

バイオロジクス安全性試験の市場規模は、2024年に42億6,000万米ドルと評価され、2024年から2031年にかけて12.13%のCAGRで成長し、2031年には98億米ドルに達すると予測されています。バイオロジクス安全性試験は、予防接種、遺伝子治療、モノクローナル抗体などの生物製剤の安全性、純度、有効性を保証するために重要です。生物製剤が規制基準を満たし、ヒトへの使用や臨床試験において安全であることを保証するために、無菌性試験、マイコプラズマ同定試験、不定性薬剤試験など、さまざまな試験が行われています。ワクチン、遺伝子治療、モノクローナル抗体などの生物学的製剤の安全性、純度、有効性を確認するために使用されます。製造中に発生する可能性のある細菌、ウイルス、マイコプラズマ、エンドトキシンなどの汚染物質を検出します。この検査は、生物製剤が規制基準を遵守し、ヒトへの使用が安全であることを確認するものです。

バイオロジクス安全性試験の将来は、遺伝子治療、細胞ベース治療、個別化医薬品のような最先端の治療薬の安全性と有効性を保証することが中心になると思われます。生物製剤がより洗練されるにつれて、試験方法はより高感度で自動化されたハイスループット技術を含むものに変化していくと思われます。規制機関は、汚染物質や不純物を検出し、製品の均一性を保証するための高度な試験方法の必要性を高め、より厳しい要件を実施すると予測されます。

バイオロジクス安全性試験の世界市場力学

主な市場促進要因：

生物製剤と先進治療に対する需要の増加：

慢性疾患、がん、自己免疫疾患の有病率の増加は、モノクローナル抗体、遺伝子治療、細胞ベースの治療などの生物製剤の需要を押し上げています。生物製剤がより複雑で個別化されるにつれて、厳格な安全性試験の必要性が高まっています。生物製剤は、標準的な医薬品では十分に対処できない疾患の治療において極めて重要であると考えられており、その開発と商業化が進んでいます。

厳しい規制要件と安全基準：

米国FDA、欧州医薬品庁（EMA）、日本の医薬品医療機器総合機構（PMDA）などの規制当局は、生物学的製剤に対してより厳しい安全性基準を課しています。企業は、生物製剤の安全性、品質、有効性を保証するために、これらの厳しい規制の枠組みに従わなければならず、そのためには研究、製造、市販後の各段階で広範な安全性試験が必要となります。これには、エンドトキシン、ウイルス、タンパク質凝集などの汚染物質のスクリーニングが含まれます。

検査方法の技術的進歩：

ハイスループット・スクリーニング、リアルタイムPCR、アドバンスト・クロマトグラフィー、次世代シーケンシングなどの検査法の革新により、生物学的安全性検査の感度と精度が大幅に向上しています。これらの開発により、不純物をより迅速かつ一貫して検出できるようになり、生物学的製剤全体の安全性が向上しました。

主な課題

規制の複雑さと厳格さ：

バイオロジクス安全性試験は、FDA、EMA、その他の世界の保健当局などの機関による厳格で常に変化する規制基準の対象です。これらの規制は、不純物、汚染物質、安定性の試験を含む生物製剤の広範な試験を要求し、製品開発の時間とコストを大幅に増加させる。さらに、地域間で統一された基準がないため、生産者や試験施設の業務が複雑になっています。

高いコストと長い試験期間：

バイオロジクス安全性試験にはしばしばコストと時間がかかります。生物製剤の汚染物質、毒素、その他の安全性問題の検査には、複雑で高品質な機器、訓練を受けた作業員、最先端技術が必要です。特に中小企業にとっては、試験スケジュールが長期化することで、運営コストがかさみます。

新規生物学的製剤の試験における複雑さ：

遺伝子治療、モノクローナル抗体、細胞ベースの医薬品など、新しい生物学的製剤の出現は、安全性評価に新たなハードルを生み出しました。これらの医薬品はより洗練されており、予期せぬ免疫反応や遺伝子異常など、明確な安全性リスクをもたらす可能性があります。従来の生物学的製剤には有効であった試験手順が、これらの新規医薬品には適用されない可能性があり、特殊な試験の開発が必要となります。

主要動向：

検査技術の進歩：

最も重要なテーマの一つは、複雑化する生物学的製剤に対応するための検査技術の開発です。従来のアプローチは、細胞ベースの検査、PCR（ポリメラーゼ連鎖反応）検査、次世代シーケンシングなど、より高感度、迅速、自動化された手順で補完されつつあります。これらの技術は、生物製剤中の汚染物質、不純物、病原体をより正確に検出することを可能にし、製品が最高の安全性と有効性の基準を満たすことを保証します。

規制圧力とコンプライアンス：

市場に参入する生物製剤の増加に伴い、米国FDA、EMA、WHOなどの規制当局は安全基準を強化しています。生物製剤の汚染、力価、純度に関する法律が強化され、製造業者はより厳格な安全性試験を実施するよう求められています。この傾向は、より厳格な基準への適合を保証するウイルスクリアランス試験やエンドトキシン試験などの専門的な試験サービスへの需要を高めています。

細胞治療と遺伝子治療の成長：

細胞治療と遺伝子治療の急速な開発と商業化が、バイオロジクス安全性試験市場を開拓しています。これらの医薬品は非常に複雑であるため、免疫原性、腫瘍原性、ウイルス汚染などの可能性のある懸念事項を特定するための厳格な安全性試験技術が必要となります。CRISPRのような遺伝子編集技術の使用が増加しているため、これらの治療薬の安全性を保証するために専門的な試験が必要であり、これが市場の拡大を促進しています。

目次

第1章 世界のバイオロジクス安全性試験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 世界のバイオロジクス安全性試験市場の展望

• 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
• 規制の枠組み

第5章 世界のバイオロジクス安全性試験市場：試験タイプ別

：

• エンドトキシン検査
• 無菌試験
• 細胞株の認証と特性試験
• 生物負荷試験
• 残留宿主汚染物質検出試験
• 不純物検出試験

第6章 世界のバイオロジクス安全性試験市場：製品・サービス別

• キット・試薬
• サービス
• 機器

第7章 バイオロジクス安全性試験の世界市場：用途別

• ワクチンおよび治療薬開発
• 血液および血液関連製品試験
• 細胞・遺伝子治療
• 組織および組織関連製品試験
• 幹細胞研究

第8章 バイオロジクス安全性試験の世界市場：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
• ラテンアメリカ
  • ブラジル
  • アルゼンチン
• 世界のその他の地域

第9章 世界のバイオロジクス安全性試験市場の競合情勢

• 概要
• 企業市場シェア
• ベンダー情勢
• 主な発展戦略

第10章 企業プロファイル

• Charles River Laboratories International, Inc.
• Merck KGaA
• Lonza Group Ltd.
• SGS S.A.
• Thermo Fisher Scientific Inc.
• Wuxi Apptec
• Sartorius AG
• Cytovance Biologics, Inc.
• Pace Analytical Services Inc.
• Toxikon Corporation
• Eurofins Scientific Se
• Avance Biosciences Inc.
• Source Bioscience

第11章 付録

• 関連レポート

Biologics Safety Testing Market Size And Forecast

Biologics Safety Testing Market Size was valued at USD 4.26 Billion in 2024 and is projected to reach USD 9.8 Billion by 2031, growing at a CAGR of 12.13% from 2024 to 2031. Biologics safety testing is important for ensuring the safety, purity, and efficacy of biological products such as vaccinations, gene treatments, and monoclonal antibodies. To guarantee that biologics fulfill regulatory standards and are safe for human usage or clinical trials, various assays are used including sterility, mycoplasma identification, and adventitious agent testing. It is used to verify the safety, purity, and efficacy of biological products such as vaccines, gene treatments, and monoclonal antibodies. It entails detecting pollutants such as bacteria, viruses, mycoplasma, and endotoxins that may develop during production. This testing verifies that biologics adhere to regulatory criteria and are safe for human usage.

The future of biologics safety testing will center on guaranteeing the safety and efficacy of cutting-edge therapeutics such as gene therapies, cell-based treatments, and personalized pharmaceuticals. As biologics become more sophisticated, testing methods will change to include more sensitive, automated, and high-throughput technology. Regulatory bodies are projected to implement stricter requirements, increasing the need for advanced testing methods to detect pollutants, and impurities, and assure product uniformity.

Global Biologics Safety Testing Market Dynamics

The key market dynamics that are shaping the global biologics safety testing market include:

Key Market Drivers:

Increasing Demand for Biologics and Advanced Therapies:

The growing prevalence of chronic diseases, cancer, and autoimmune disorders is driving up demand for biologics such as monoclonal antibodies, gene therapies, and cell-based treatments. As biologics become more complicated and personalized, the necessity for rigorous safety testing has increased. Biologics are viewed as crucial in the treatment of disorders that standard pharmaceuticals cannot adequately address, increasing their development and commercialization.

Stringent Regulatory Requirements and Safety Standards:

Regulatory authorities such as the US FDA, the European Medicines Agency (EMA), and Japan's PMDA are enforcing stricter safety criteria for biologics. Companies must comply with these demanding regulatory frameworks to assure the safety, quality, and efficacy of biologics which necessitate extensive safety testing during the research, manufacturing, and post-marketing phases. This includes screening for pollutants such as endotoxins, viruses, and protein aggregation, among others.

Technological Advancements in Testing Methods:

Innovations in testing methods including high-throughput screening, real-time PCR, advanced chromatography, and next-generation sequencing have considerably improved the sensitivity and accuracy of biological safety testing. These developments allow for faster and more consistent detection of impurities which improves the overall safety of biologic goods.

Key Challenges:

Regulatory Complexity and Stringency:

Biologics safety testing is subject to stringent and ever-changing regulatory standards from agencies such as the FDA, EMA, and other worldwide health authorities. These rules require extensive testing of biologics including tests for impurities, pollutants, and stability which can greatly increase the time and cost of product development. Furthermore, the lack of harmonized standards across areas complicates operations for producers and testing facilities.

High Costs and Long Testing Timelines:

Biologics safety testing is often costly and time-consuming. Testing biologics for pollutants, toxins, and other safety problems necessitates complex and high-quality equipment, trained workers, and cutting-edge technology. The prolonged testing schedules add to high operational costs, especially for small and medium-sized businesses.

Complexity in Testing Novel Biologic Therapies:

The emergence of newer biologics such as gene therapies, monoclonal antibodies, and cell-based medicines has created new hurdles for safety assessment. These medicines are more sophisticated and may pose distinct safety risks such as unexpected immune reactions or genetic abnormalities. Testing procedures that were effective for traditional biologics may not apply to these novel medicines necessitating the development of specialized testing.

Key Trends:

Advancements in Testing Technologies:

One of the most important themes is the ongoing development of improved testing technology to address the growing complexity of biologics. Traditional approaches are being supplemented with more sensitive, quick, and automated procedures such as cell-based tests, PCR (Polymerase Chain Reaction) testing, and next-generation sequencing. These technologies allow for more accurate detection of pollutants, impurities, and pathogens in biologics guaranteeing that products satisfy the highest safety and efficacy criteria.

Regulatory Pressure and Compliance:

With an increasing number of biologics entering the market, regulatory authorities such as the US FDA, EMA, and WHO are strengthening safety standards. Stricter laws governing contamination, potency, and purity in biologics are prompting producers to implement more rigorous safety tests. This tendency has increased demand for specialized testing services such as viral clearance studies and endotoxin testing which ensure compliance with more stringent criteria.

Growth of Cell and Gene Therapies:

The fast development and commercialization of cell and gene therapies is driving the biologics safety testing market. These medicines are extremely complicated necessitating stringent safety testing techniques to identify possible concerns such as immunogenicity, tumorigenicity, and viral contamination. The increasing usage of gene editing techniques such as CRISPR, needs specialized testing to assure the safety of these therapeutics which fuels market expansion.

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Global Biologics Safety Testing Market Regional Analysis

Here is a more detailed regional analysis of the global biologics safety testing market:

North America:

North America dominates the biologics safety testing market due to its highly developed biopharmaceutical sector and superior healthcare infrastructure. The region is home to large pharmaceutical companies, research institutions, and contract research organizations (CROs) that are at the forefront of biologics development, increasing demand for extensive safety testing. The presence of strong regulatory organizations such as the United States Food and Drug Administration (FDA), maintains strict standards for biologics safety which encourages the use of cutting-edge testing technologies to meet compliance criteria.

Furthermore, North America's significant emphasis on research and development particularly in novel biologics such as gene and cell therapies strengthens its position. Significant expenditures in biotechnology, a high rate of clinical trials, and early acceptance of breakthrough technologies all help to drive the market forward. The region's leadership is also reinforced by government programs and financing aimed at encouraging biopharma innovation transforming North America into a global centre for biologics safety testing.

Asia-Pacific:

Asia Pacific is the fastest-growing region in the biologics safety testing market owing to the rapid growth of the biopharmaceutical industry in China, India, and South Korea. These countries are increasing their investments in biotechnology and pharmaceutical research owing to government assistance, rising healthcare demands, and the increased prevalence of chronic diseases. Furthermore, reduced manufacturing costs and trained labour make Asia Pacific a desirable hub for biologics production, increasing demand for safety testing to assure compliance with international quality standards.

Furthermore, as regulatory frameworks in the area tighten, particularly in China and India, businesses are focussing on enhancing biologics safety processes. This regulatory tightening is accompanied by increased collaborations between local and worldwide biopharmaceutical businesses accelerating the implementation of new safety testing technologies. The region's growing population, rising healthcare expenditure, and increased consumer awareness of biologic quality are all major drivers driving Asia Pacific's biologics safety testing market forward.

Global Biologics Safety Testing Market: Segmentation Analysis

The Global Biologics Safety Testing Market is segmented based on Test Type, Application, Products & Services, and Geography.

Biologics Safety Testing Market, By Test Type

• Endotoxin Test
• Sterility Test
• Cell Line Authentication and Characterization Test
• Bioburden Test
• Residual Host Contaminant Detection Test
• Adventitious Agent Detection Tests

Based on Test Type, the Global Biologics Safety Testing Market is bifurcated into Endotoxin Tests, Sterility Tests, Cell Line Authentication and Characterization Tests, Bioburden Tests, Residual Host Contaminant Detection Tests, Adventitious Agent Detection Tests. The endotoxin test is the most dominant in the biologic safety testing market due to its critical role in detecting harmful bacterial endotoxins in biological products which can cause severe immune reactions in patients. Given the strict regulatory requirements for ensuring product safety in industries like pharmaceuticals and biotechnology, endotoxin testing is a mandatory step.

Biologics Safety Testing Market, By Application

• Vaccine & Therapeutics Development
• Blood and Blood-Related Product Testing
• Cellular and Gene Therapy
• Tissue and Tissue-Related Product Testing
• Stem Cell Research

Based on Application, the Global Biologics Safety Testing Market is bifurcated into Vaccine and Therapeutics Development, Blood and Blood-Related Product Testing, Cellular and Gene Therapy, Tissue And Tissue-Related Product Testing, and Stem Cell Research. Vaccine and therapeutics development is the most dominant segment in the biologics safety testing market due to the global focus on developing vaccines for infectious diseases like COVID-19 and ongoing efforts for therapeutic innovations. The increasing demand for vaccines and biologics to combat emerging health threats has driven the need for stringent safety testing to ensure product efficacy and patient safety. Regulatory agencies emphasize rigorous testing protocols for vaccines making this segment a key driver in the biologics safety testing market.

Biologics Safety Testing Market, By Products & Services

• Instruments
• Services
• Kits & Reagents

Based on Products and Services, the Global Biologics Safety Testing Market is bifurcated into Instruments, Services, Kits and Reagents. Kits & reagents are the most dominant segment in the biologics safety testing market due to their essential role in a wide range of testing applications, including contamination detection, endotoxin testing, and sterility checks. These consumables are used regularly in laboratories, driving continuous demand. Unlike instruments which are typically a one-time investment, kits and reagents need to be replenished frequently, making them a recurring expense. Their crucial role in ensuring biologics' safety and compliance with regulatory standards further boosts their dominance.

Biologics Safety Testing Market, By Geography

• North America
• Europe
• Asia Pacific
• Rest of the world

Based on Geography, the Global Biologics Safety Testing Market is classified into North America, Europe, Asia Pacific, and the Rest of the world. North America is the most dominant region in the biologics safety testing market due to its advanced biotechnology sector, strong pharmaceutical industry presence, and well-established regulatory frameworks. The region is home to major biologics manufacturers and extensive research and development activities. Additionally, stringent FDA guidelines and high investment in cutting-edge technologies drive the demand for comprehensive safety testing.

Key Players

• The "Global Biologics Safety Testing Market" study report will provide valuable insight with an emphasis on the global market. The major players in the market are
• Charles River Laboratories International, Inc., Merck KGaA, Lonza Group Ltd., SGS S.A., Thermo Fisher Scientific Inc., Wuxi Apptec, Sartorius AG, Cytovance Biologics, Inc., Pace Analytical Services Inc., Toxikon Corporation, Eurofins Scientific Se, Avance Biosciences Inc., Source Bioscience.

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.

• Biologics Safety Testing Market Recent Developments:
• In January 2023, Charles River Laboratories, Inc. purchased SAMDI Tech, Inc., a high-throughput screening (HTS) solutions provider. This acquisition seeks to improve drug discovery procedures by utilizing SAMDI Tech's technologies to speed up the identification of prospective medication candidates.
• In September 2022, Thermo Fisher Scientific, Inc. will debut the Thermo Scientific 1500 Series Biological Safety Cabinet (BSC) designed to satisfy the needs of a variety of laboratories. This revolutionary device protects from biological dangers and contaminations.

TABLE OF CONTENTS

1 INTRODUCTION OF GLOBAL BIOLOGICS SAFETY TESTING 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 BIOLOGICS SAFETY TESTING 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
• 4.5 Regulatory Framework

5 GLOBAL BIOLOGICS SAFETY TESTING MARKET, BY TEST TYPE

:

• 5.1 Endotoxin Tests
• 5.2 Sterility Tests
• 5.3 Cell Line Authentication and Characterization Tests
• 5.4 Bioburden Tests
• 5.5 Residual Host Contaminant Detection Tests
• 5.6 Adventitious Agent Detection Tests

6 GLOBAL BIOLOGICS SAFETY TESTING MARKET, BY PRODUCTS AND SERVICES:

• 6.1 Kits & Reagents
• 6.2 Services
• 6.3 Instruments

7 GLOBAL BIOLOGICS SAFETY TESTING MARKET, BY APPLICATION:

• 7.1 Vaccine & Therapeutics Development
• 7.2 Blood and Blood-Related Products Testing
• 7.3 Cellular and Gene Therapy
• 7.4 Tissue and Tissue-Related Products Testing
• 7.5 Stem Cell Research

8 GLOBAL BIOLOGICS SAFETY TESTING MARKET, BY GEOGRAPHY

• 8.1 Overview
• 8.2 North America
  • 8.2.1 U.S.
  • 8.2.2 Canada
  • 8.2.3 Mexico
• 8.3 Europe
  • 8.3.1 Germany
  • 8.3.2 U.K.
  • 8.3.3 France
  • 8.3.4 Rest of Europe
• 8.4 Asia Pacific
  • 8.4.1 China
  • 8.4.2 Japan
  • 8.4.3 India
  • 8.4.4 Rest of Asia Pacific
• 8.5 Latin America
  • 8.5.1 Brazil
  • 8.5.2 Argentina
• 8.6 Rest of the World

9 GLOBAL BIOLOGICS SAFETY TESTING MARKET COMPETITIVE LANDSCAPE

• 9.1 Overview
• 9.2 Company Market Share
• 9.3 Vendor Landscape
• 9.4 Key Development Strategies

10 COMPANY PROFILES

• 10.1 Charles River Laboratories International, Inc.
  • 10.1.1 Overview
  • 10.1.2 Financial Performance
  • 10.1.3 Product Outlook
  • 10.1.4 Key Developments
• 10.2 Merck KGaA
  • 10.2.1 Overview
  • 10.2.2 Financial Performance
  • 10.2.3 Product Outlook
  • 10.2.4 Key Developments
• 10.3 Lonza Group Ltd.
  • 10.3.1 Overview
  • 10.3.2 Financial Performance
  • 10.3.3 Product Outlook
  • 10.3.4 Key Developments
• 10.4 SGS S.A.
  • 10.4.1 Overview
  • 10.4.2 Financial Performance
  • 10.4.3 Product Outlook
  • 10.4.4 Key Developments
• 10.5 Thermo Fisher Scientific Inc.
  • 10.5.1 Overview
  • 10.5.2 Financial Performance
  • 10.5.3 Product Outlook
  • 10.5.4 Key Developments
• 10.6 Wuxi Apptec
  • 10.6.1 Overview
  • 10.6.2 Financial Performance
  • 10.6.3 Product Outlook
  • 10.6.4 Key Developments
• 10.7 Sartorius AG
  • 10.7.1 Overview
  • 10.7.2 Financial Performance
  • 10.7.3 Product Outlook
  • 10.7.4 Key Developments
• 10.8 Cytovance Biologics, Inc.
  • 10.8.1 Overview
  • 10.8.2 Financial Performance
  • 10.8.3 Product Outlook
  • 10.8.4 Key Developments
• 10.9 Pace Analytical Services Inc.
  • 10.9.1 Overview
  • 10.9.2 Financial Performance
  • 10.9.3 Product Outlook
  • 10.9.4 Key Developments
• 10.10 Toxikon Corporation
  • 10.10.1 Overview
  • 10.10.2 Financial Performance
  • 10.10.3 Product Outlook
  • 10.10.4 Key Developments
• 10.11 Eurofins Scientific Se
  • 10.11.1 Overview
  • 10.11.2 Financial Performance
  • 10.11.3 Product Outlook
  • 10.11.4 Key Developments
• 10.12 Avance Biosciences Inc.
  • 10.12.1 Overview
  • 10.12.2 Financial Performance
  • 10.12.3 Product Outlook
  • 10.12.4 Key Developments
• 10.13 Source Bioscience
  • 10.13.1 Overview
  • 10.13.2 Financial Performance
  • 10.13.3 Product Outlook
  • 10.13.4 Key Developments

11 Appendix

• 11.1 Related Reports