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市場調查報告書

商品編碼

1624428

全球生物製劑安全測試市場規模（按測試類型、產品/服務、應用、地區、範圍和預測）

Global Biologics Safety Testing Market Size By Test Type, By Products and Services, By Application, By Geographic Scope And Forecast

出版日期: 2024年10月02日 | 出版商:

Verified Market Research | 英文 202 Pages | 商品交期: 2-3個工作天內

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簡介目錄

生物製劑安全性測試的市場規模及預測

2024 年生物製劑安全測試市場規模價值為 42.6 億美元，預計到 2031 年將達到 98 億美元，2024 年至 2031 年的複合年增長率為 12.13%。生物製品安全測試對於確保疫苗、基因療法和單株抗體等生物製品的安全性、純度和有效性至關重要。我們進行各種測試，包括無菌測試、支原體鑑定測試和偶然藥物測試，以確保生物製劑符合監管標準並可安全用於人類使用和臨床試驗。它們用於確保疫苗、基因療法和單株抗體等生物製品的安全性、純度和有效性。檢測生產過程中可能產生的細菌、病毒、支原體和內毒素等污染物。此項測試確保生物製劑符合監管標準並且可供人類安全使用。

生物製劑安全性測試的未來將圍繞確保基因療法、細胞療法和個人化醫療等尖端療法的安全性和有效性。隨著生物製劑變得越來越複雜，檢測方法可能會發生變化，包括更靈敏、自動化和高通量的技術。預計監管機構將實施更嚴格的要求，增加對先進測試方法來檢測污染物和雜質並確保產品的一致性的需求。

生物製劑安全測試的全球市場動態

主要市場推動因素：

對生物製劑和先進療法的需求不斷增加：

慢性病、癌症和自體免疫疾病的發生率不斷上升，推動了對單株抗體、基因療法和細胞療法等生物製劑的需求。隨著生物製劑變得越來越複雜和個人化，對嚴格的安全測試的需求也隨之增加。生物製劑被認為對於治療標準藥物無法充分解決的疾病至關重要，其開發和商業化正在加速。

嚴格的法規要求和安全標準：

美國 FDA、歐洲藥品管理局（EMA）和日本藥品和醫療器材管理局（PMDA）等監管機構正在對生物製劑實施更嚴格的安全標準。公司必須遵守這些嚴格的監管框架，以確保生物製劑的安全性、品質和有效性，這需要在研究、製造和上市後進行廣泛的安全測試。這包括篩選內毒素、病毒和蛋白質聚集體等污染物。

測試方法的技術進步：

高通量篩選、即時 PCR、先進色譜技術以及下一代定序等檢測創新顯著提高了生物安全檢測的靈敏度和準確性。這些發展使得雜質檢測能夠更快、更一致，進而提高生物製劑的整體安全性。

主要問題

法規的複雜性與嚴格性：

生物製劑安全測試受到 FDA、EMA 和其他全球衛生當局等機構的嚴格且不斷變化的監管標準的約束。這些法規要求對生物製劑進行廣泛的測試，包括雜質、污染物和穩定性測試，這大大增加了產品開發的時間和成本。此外，不同地區沒有統一的標準，增加了生產商和檢測機構的工作複雜性。

成本高、測試時間長：

生物製劑安全性測試通常成本高且耗時。檢測生物製劑中的污染物、毒素和其他安全問題需要複雜、高品質的設備、訓練有素的人員和尖端技術。漫長的測試時間會增加營運成本，尤其是對於中小型企業而言。

測試新型生物製劑的複雜性：

基因療法、單株抗體和細胞藥物等新型生物製劑的出現為安全性評估帶來了新的障礙。這些藥物變得越來越複雜，並可能帶來明顯的安全風險，例如意外的免疫反應或基因異常。適用於傳統生物製劑的測試程序可能不適用於這些新藥，因此需要開發專門的測試。

主要趨勢：

測試技術的進步：

最重要的主題之一是開發處理日益複雜的生物產品的測試技術。傳統方法正在被更靈敏、更快速和更自動化的程序所補充，包括基於細胞的測試、PCR（聚合酶鏈反應）測試和下一代定序。這些技術能夠更準確地檢測生物製劑中的污染物、雜質和病原體，確保產品符合最高的安全性和有效性標準。

監理壓力與合規性：

隨著越來越多的生物製劑進入市場，美國FDA、EMA和WHO等監管機構正在加強安全標準。有關生物製劑的污染、效力和純度的立法已經得到加強，並且要求製造商進行更嚴格的安全測試。這一趨勢推動了對病毒清除和內毒素檢測等專門檢測服務的需求，以確保符合更嚴格的標準。

細胞與基因治療的發展：

細胞和基因療法的快速發展和商業化正在打開生物製劑安全測試市場。這些藥物高度複雜，需要嚴格的安全測試技術來識別潛在問題，例如免疫原性、致瘤性和病毒污染。 CRISPR 等基因編輯技術的日益廣泛使用需要進行專門的測試以確保這些療法的安全性，這有助於推動市場擴張。

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.

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