Global Biologics Safety Testing Market

Biologics Safety Testing Market Size, Share, Growth Analysis, By Test(Endotoxin Test, Sterility Test), By Application(Blood & Blood-based Products, Vaccines & Therapeutics), By End-use(Pharmaceutical and Biotechnology Companies, Contract Development and Manufacturing Companies) - Industry Forecast 2024-2031


Report ID: SQMIG35A2786 | Region: Global | Published Date: July, 1990
Pages: 219 | Tables: 93 | Figures: 70

Biologics Safety Testing Market Insights

Global Biologics Safety Testing Market size was valued at USD 4.70 billion in 2022 and is poised to grow from USD 5.25 billion in 2023 to USD 12.72 billion by 2031, growing at a CAGR of 11.70% during the forecast period (2024-2031).

Biological safety testing comprises a comprehensive array of meticulous procedures essential for ensuring the safety of products derived from biological sources, notably biopharmaceuticals and medical devices. Its fundamental aim revolves around assessing and mitigating potential risks associated with these products, meticulously analysing aspects such as contamination and adverse biological effects. Adherence to stringent regulatory standards is pivotal, ensuring the purity, potency, and overall safety of biological materials. Techniques like sterility testing, endotoxin assessment, and cell-based assays assume critical roles in rigorously evaluating these products, affirming their compliance with exacting safety benchmarks and assuring their suitability for clinical use and public health.

Market snapshot - 2024-2031

Global Market Size

USD 4.70 billion

Largest Segment

Bioburden Tests

Growth Rate

11.70% CAGR

Global Biologics Safety Testing Market ($ Bn)
Country Share for North America Region (%)
Global Biologics Safety Testing Market By Test Type (%)

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Biologics Safety Testing Market Segmental Analysis

The global Biologics Safety Testing market is segmented on the basis of test, application, end-use, and region. Based on Test, it is divided into Endotoxin Test, Bioburden Tests, Sterility Test, Adventitious Agent Detection Test, Others. Based on Application, it is divided into Blood & Blood-based Products, Gene Therapy, Vaccines & Therapeutics, Stem Cells, Others. Based on End-use, it is divided into Pharmaceutical and Biotechnology Companies, Contract Development and Manufacturing Companies, Research and Academia, Others. Based on region, the market is segmented into North America, Europe, Asia-Pacific, Latin America, Middle East & Africa.

Analysis by Test Type

In 2022, the realm of biological safety testing products and services witnessed the ascendancy of the endotoxin tests segment, claiming a substantial 21.96% share of the market's revenue. This commanding position stems from the escalating utilisation of these tests across various sectors, notably within drug manufacturing processes aimed at mitigating risks associated with endotoxins. A noteworthy development in this domain unfolded in August 2022 when Lonza introduced the Nebula Multimode Reader, marking a significant stride in this landscape.

Concurrently, the bioburden tests segment is poised for rapid expansion throughout the forecast period, driven by its widespread adoption in assessing bioburden thresholds across diverse biologics and medical devices. In April 2023, a significant breakthrough emerged courtesy of STEMart, a U.S.-based provider, introducing specialised bioburden and sterility testing tailored explicitly for medical devices. This pioneering offering aligns meticulously with the rigorous regulatory standards outlined in the ISO 11731 technique.

Analysis by Application

In 2022, the vaccine and therapeutics segment emerged as the dominant application within the market, capturing a substantial market share of 23.58% and poised for further growth in the forecast period. This dominance is a result of stringent guidelines focused on ensuring the safety and efficacy of vaccines, prioritising therapeutic integrity while mitigating potential risks of toxicity. An important development in January 2023 was the announcement by BioNTech SE of a significant collaboration through a Memorandum of Understanding with the UK Government. This strategic partnership aims to expedite clinical trials for mRNA personalised immunotherapies, showcasing promising advancements in patient care and treatment.

The gene therapy segment is forecasted to experience significant growth during the forecast period, primarily propelled by concerns related to potential contamination risks arising from residual DNA. The management of residual DNA is critical due to its inherent infectivity risks, necessitating stringent measures to address this concern in the final product. Concurrently, monoclonal antibodies (mAbs) assume a crucial role in the biopharmaceutical landscape, especially in the identification and characterization of critical quality attributes (CQAs). These CQAs serve as essential benchmarks, delineating specific characteristics that determine a product's safety, purity, and efficacy.

Global Biologics Safety Testing Market By Test Type, 2022 (%)

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Biologics Safety Testing Market Regional Insights

North America emerges as the leader in shaping and propelling the market dynamics, poised to sustain its influential trajectory in the forecast period. This regional dominance is attributed to various key factors, notably the robust presence of a multitude of biotechnology and pharmaceutical companies. Renowned for its status as an innovation hub, North America consistently fosters the evolution of cutting-edge technologies, driving advancements and breakthroughs within the industry.

Asia-Pacific is poised for substantial growth, projected to experience a rapid CAGR from 2023 to 2030. This anticipated surge finds its foundation in the escalating investments funnelling in from both governmental initiatives and private sectors deeply entrenched within the biopharmaceutical and pharmaceutical domains across the region. Notably, within this landscape, China emerges as a dominant force, holding the largest market share in the Biologics Safety Testing sector.

Global Biologics Safety Testing Market By Region, 2024-2031
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Biologics Safety Testing Market Dynamics

Drivers

Rising Pharmaceutical and Biotechnology Sectors

  • The expansions witnessed in the pharmaceutical and biotechnology sectors, propelled by substantial investments in research and development, signify a pivotal epoch in healthcare progress. These industries stand at the forefront of creating pharmaceuticals, biologics, and vaccines, actively addressing the complexities associated with diverse healthcare challenges, especially in combating intricate diseases. This surge in innovation inevitably leads to an increased necessity for stringent safety evaluations, wherein biological safety testing plays a pivotal role in safeguarding patient well-being.

Restraints

High Cost of Biologics

  • Biologics and biosimilars represent a groundbreaking category of medications derived from living cells, offering potent treatments across a spectrum of ailments, including cancer, diabetes, rheumatoid arthritis, and various inflammatory diseases.

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Biologics Safety Testing Market Competitive Landscape

The Global Biologics Safety Testing Market showcases a competitive landscape characterised by a diverse mix of well-established brands, emerging players, and specialised producers. In this dynamic environment, innovation serves as a pivotal competitive edge. Leading brands dedicate significant resources to research and development endeavours, consistently introducing fresh flavours, innovative packaging formats, and health-focused variations in response to ever-evolving consumer preferences.

Top Player’s Company Profiles

  • Cytovance Biologics
  • Eurofins Scientific
  • Merck KGaA
  • Biomerieux SA
  • Lonza
  • Promega Corporation
  • Thermo Fisher Scientific
  • WuXi AppTec
  • Nelson Laboratories, LLC
  • Almac Group
  • GenScript
  • InvivoGen
  • Toxikon
  • Maravai LifeSciences

Recent Developments

  • In May 2022, Avance Biosciences achieved a noteworthy milestone by completing a substantial expansion, acquiring an expansive 26,000 square feet of laboratory space. This strategic move serves as a catalyst, empowering Avance to diversify its service portfolio offered to biopharmaceutical and CDMO clients. The newly established facilities are specifically tailored to augment protein and cell-based assay services, emphasising the enhancement of protein analysis capabilities. These expanded services encompass a comprehensive range, spanning ELISA assays, protein characterization, and immunoassays, strategically catering to the evolving requirements of their clientele.
  • In September 2023, Pace Analytical Services introduced a groundbreaking PFAS test method designed to revolutionise testing efficacy. Known as ASTM D8421/EPA 8327, this method leverages isotope dilution and LC/MS/MS technology to meticulously analyse up to 44 PFAS compounds in both aqueous and solid samples. This innovative approach offers several advantages, including accelerated delivery of results, reduced sample size requirements, and the assurance of precise quantification. By enabling expedited and cost-effective analyses while ensuring accuracy in identifying PFAS compounds, this method signifies a significant advancement in environmental testing methodologies, promising a notable leap forward in the landscape of environmental analysis and safety protocols.

Biologics Safety Testing Key Market Trends

  • Global regulatory bodies have embarked on a path of heightened vigilance over biopharmaceutical products, prioritising both patient safety and product quality. These stringent regulations mandate an exhaustive spectrum of safety evaluations, elevating biological safety testing to a cornerstone in the landscape of drug approvals. For pharmaceutical and biotech enterprises, strict adherence to these evolving standards isn't just a necessity but a crucial pathway to securing product approval and market entry. This escalating emphasis on compliance fuels an increased demand for testing services, firmly cementing the pivotal role of biological safety testing within this framework.

Biologics Safety Testing Market SkyQuest Analysis

SkyQuest’s ABIRAW (Advanced Business Intelligence, Research & Analysis Wing) is our Business Information Services team that Collects, Collates, Correlates, and Analyses the Data collected by means of Primary Exploratory Research backed by robust Secondary Desk research.

The rapid proliferation of biopharmaceutical firms and laboratories emerges as a pivotal driving force propelling the market's growth trajectory. This influx signifies not just an expanding landscape but also heralds a forthcoming surge in novel biologics' production. This anticipated wave of innovative biologics is poised to substantially bolster the demand within the biological safety testing market. The proliferation of these firms and laboratories acts as a catalyst, fostering an environment conducive to creating and developing new biological entities. Consequently, the projected escalation in biologic production is set to drive a corresponding increase in the demand for rigorous biological safety testing, aligning seamlessly with the escalating market need to ensure the safety and efficacy of these groundbreaking biopharmaceutical products.

Report Metric Details
Market size value in 2022 USD 4.70 billion
Market size value in 2031 USD 12.72 billion
Growth Rate 11.70%
Base year 2023
Forecast period 2024-2031
Forecast Unit (Value) USD Billion
Segments covered
  • Test
    • Endotoxin Test, Sterility Test, Adventitious Agent Detection Test, and Others
  • Application
    • Blood & Blood-based Products, Vaccines & Therapeutics, Stem Cells, and Others
  • End-use
    • Pharmaceutical and Biotechnology Companies, Contract Development and Manufacturing Companies, Research and Academia, and Others
Regions covered North America (US, Canada), Europe (Germany, France, United Kingdom, Italy, Spain, Rest of Europe), Asia Pacific (China, India, Japan, Rest of Asia-Pacific), Latin America (Brazil, Rest of Latin America), Middle East & Africa (South Africa, GCC Countries, Rest of MEA)
Companies covered
  • Cytovance Biologics
  • Eurofins Scientific
  • Merck KGaA
  • Biomerieux SA
  • Lonza
  • Promega Corporation
  • Thermo Fisher Scientific
  • WuXi AppTec
  • Nelson Laboratories, LLC
  • Almac Group
  • GenScript
  • InvivoGen
  • Toxikon
  • Maravai LifeSciences
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Table Of Content

Executive Summary

Market overview

  • Exhibit: Executive Summary – Chart on Market Overview
  • Exhibit: Executive Summary – Data Table on Market Overview
  • Exhibit: Executive Summary – Chart on Biologics Safety Testing Market Characteristics
  • Exhibit: Executive Summary – Chart on Market by Geography
  • Exhibit: Executive Summary – Chart on Market Segmentation
  • Exhibit: Executive Summary – Chart on Incremental Growth
  • Exhibit: Executive Summary – Data Table on Incremental Growth
  • Exhibit: Executive Summary – Chart on Vendor Market Positioning

Parent Market Analysis

Market overview

Market size

  • Market Dynamics
    • Exhibit: Impact analysis of DROC, 2021
      • Drivers
      • Opportunities
      • Restraints
      • Challenges
  • SWOT Analysis

KEY MARKET INSIGHTS

  • Technology Analysis
    • (Exhibit: Data Table: Name of technology and details)
  • Pricing Analysis
    • (Exhibit: Data Table: Name of technology and pricing details)
  • Supply Chain Analysis
    • (Exhibit: Detailed Supply Chain Presentation)
  • Value Chain Analysis
    • (Exhibit: Detailed Value Chain Presentation)
  • Ecosystem Of the Market
    • Exhibit: Parent Market Ecosystem Market Analysis
    • Exhibit: Market Characteristics of Parent Market
  • IP Analysis
    • (Exhibit: Data Table: Name of product/technology, patents filed, inventor/company name, acquiring firm)
  • Trade Analysis
    • (Exhibit: Data Table: Import and Export data details)
  • Startup Analysis
    • (Exhibit: Data Table: Emerging startups details)
  • Raw Material Analysis
    • (Exhibit: Data Table: Mapping of key raw materials)
  • Innovation Matrix
    • (Exhibit: Positioning Matrix: Mapping of new and existing technologies)
  • Pipeline product Analysis
    • (Exhibit: Data Table: Name of companies and pipeline products, regional mapping)
  • Macroeconomic Indicators

COVID IMPACT

  • Introduction
  • Impact On Economy—scenario Assessment
    • Exhibit: Data on GDP - Year-over-year growth 2016-2022 (%)
  • Revised Market Size
    • Exhibit: Data Table on Biologics Safety Testing Market size and forecast 2021-2027 ($ million)
  • Impact Of COVID On Key Segments
    • Exhibit: Data Table on Segment Market size and forecast 2021-2027 ($ million)
  • COVID Strategies By Company
    • Exhibit: Analysis on key strategies adopted by companies

MARKET DYNAMICS & OUTLOOK

  • Market Dynamics
    • Exhibit: Impact analysis of DROC, 2021
      • Drivers
      • Opportunities
      • Restraints
      • Challenges
  • Regulatory Landscape
    • Exhibit: Data Table on regulation from different region
  • SWOT Analysis
  • Porters Analysis
    • Competitive rivalry
      • Exhibit: Competitive rivalry Impact of key factors, 2021
    • Threat of substitute products
      • Exhibit: Threat of Substitute Products Impact of key factors, 2021
    • Bargaining power of buyers
      • Exhibit: buyers bargaining power Impact of key factors, 2021
    • Threat of new entrants
      • Exhibit: Threat of new entrants Impact of key factors, 2021
    • Bargaining power of suppliers
      • Exhibit: Threat of suppliers bargaining power Impact of key factors, 2021
  • Skyquest special insights on future disruptions
    • Political Impact
    • Economic impact
    • Social Impact
    • Technical Impact
    • Environmental Impact
    • Legal Impact

Market Size by Region

  • Chart on Market share by geography 2021-2027 (%)
  • Data Table on Market share by geography 2021-2027(%)
  • North America
    • Chart on Market share by country 2021-2027 (%)
    • Data Table on Market share by country 2021-2027(%)
    • USA
      • Exhibit: Chart on Market share 2021-2027 (%)
      • Exhibit: Market size and forecast 2021-2027 ($ million)
    • Canada
      • Exhibit: Chart on Market share 2021-2027 (%)
      • Exhibit: Market size and forecast 2021-2027 ($ million)
  • Europe
    • Chart on Market share by country 2021-2027 (%)
    • Data Table on Market share by country 2021-2027(%)
    • Germany
      • Exhibit: Chart on Market share 2021-2027 (%)
      • Exhibit: Market size and forecast 2021-2027 ($ million)
    • Spain
      • Exhibit: Chart on Market share 2021-2027 (%)
      • Exhibit: Market size and forecast 2021-2027 ($ million)
    • France
      • Exhibit: Chart on Market share 2021-2027 (%)
      • Exhibit: Market size and forecast 2021-2027 ($ million)
    • UK
      • Exhibit: Chart on Market share 2021-2027 (%)
      • Exhibit: Market size and forecast 2021-2027 ($ million)
    • Rest of Europe
      • Exhibit: Chart on Market share 2021-2027 (%)
      • Exhibit: Market size and forecast 2021-2027 ($ million)
  • Asia Pacific
    • Chart on Market share by country 2021-2027 (%)
    • Data Table on Market share by country 2021-2027(%)
    • China
      • Exhibit: Chart on Market share 2021-2027 (%)
      • Exhibit: Market size and forecast 2021-2027 ($ million)
    • India
      • Exhibit: Chart on Market share 2021-2027 (%)
      • Exhibit: Market size and forecast 2021-2027 ($ million)
    • Japan
      • Exhibit: Chart on Market share 2021-2027 (%)
      • Exhibit: Market size and forecast 2021-2027 ($ million)
    • South Korea
      • Exhibit: Chart on Market share 2021-2027 (%)
      • Exhibit: Market size and forecast 2021-2027 ($ million)
    • Rest of Asia Pacific
      • Exhibit: Chart on Market share 2021-2027 (%)
      • Exhibit: Market size and forecast 2021-2027 ($ million)
  • Latin America
    • Chart on Market share by country 2021-2027 (%)
    • Data Table on Market share by country 2021-2027(%)
    • Brazil
      • Exhibit: Chart on Market share 2021-2027 (%)
      • Exhibit: Market size and forecast 2021-2027 ($ million)
    • Rest of South America
      • Exhibit: Chart on Market share 2021-2027 (%)
      • Exhibit: Market size and forecast 2021-2027 ($ million)
  • Middle East & Africa (MEA)
    • Chart on Market share by country 2021-2027 (%)
    • Data Table on Market share by country 2021-2027(%)
    • GCC Countries
      • Exhibit: Chart on Market share 2021-2027 (%)
      • Exhibit: Market size and forecast 2021-2027 ($ million)
    • South Africa
      • Exhibit: Chart on Market share 2021-2027 (%)
      • Exhibit: Market size and forecast 2021-2027 ($ million)
    • Rest of MEA
      • Exhibit: Chart on Market share 2021-2027 (%)
      • Exhibit: Market size and forecast 2021-2027 ($ million)

KEY COMPANY PROFILES

  • Competitive Landscape
    • Total number of companies covered
      • Exhibit: companies covered in the report, 2021
    • Top companies market positioning
      • Exhibit: company positioning matrix, 2021
    • Top companies market Share
      • Exhibit: Pie chart analysis on company market share, 2021(%)

Methodology

For the Biologics Safety Testing Market, our research methodology involved a mixture of primary and secondary data sources. Key steps involved in the research process are listed below:

1. Information Procurement: This stage involved the procurement of Market data or related information via primary and secondary sources. The various secondary sources used included various company websites, annual reports, trade databases, and paid databases such as Hoover's, Bloomberg Business, Factiva, and Avention. Our team did 45 primary interactions Globally which included several stakeholders such as manufacturers, customers, key opinion leaders, etc. Overall, information procurement was one of the most extensive stages in our research process.

2. Information Analysis: This step involved triangulation of data through bottom-up and top-down approaches to estimate and validate the total size and future estimate of the Biologics Safety Testing Market.

3. Report Formulation: The final step entailed the placement of data points in appropriate Market spaces in an attempt to deduce viable conclusions.

4. Validation & Publishing: Validation is the most important step in the process. Validation & re-validation via an intricately designed process helped us finalize data points to be used for final calculations. The final Market estimates and forecasts were then aligned and sent to our panel of industry experts for validation of data. Once the validation was done the report was sent to our Quality Assurance team to ensure adherence to style guides, consistency & design.

Analyst Support

Customization Options

With the given market data, our dedicated team of analysts can offer you the following customization options are available for the Biologics Safety Testing Market:

Product Analysis: Product matrix, which offers a detailed comparison of the product portfolio of companies.

Regional Analysis: Further analysis of the Biologics Safety Testing Market for additional countries.

Competitive Analysis: Detailed analysis and profiling of additional Market players & comparative analysis of competitive products.

Go to Market Strategy: Find the high-growth channels to invest your marketing efforts and increase your customer base.

Innovation Mapping: Identify racial solutions and innovation, connected to deep ecosystems of innovators, start-ups, academics, and strategic partners.

Category Intelligence: Customized intelligence that is relevant to their supply Markets will enable them to make smarter sourcing decisions and improve their category management.

Public Company Transcript Analysis: To improve the investment performance by generating new alpha and making better-informed decisions.

Social Media Listening: To analyze the conversations and trends happening not just around your brand, but around your industry as a whole, and use those insights to make better Marketing decisions.

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FAQs

Biologics Safety Testing Market size was valued at USD 4.70 billion in 2022 and is poised to grow from USD 5.25 billion in 2023 to USD 12.72 billion by 2031, growing at a CAGR of 11.70% during the forecast period (2024-2031).

The Biologics Safety Testing Market showcases a competitive landscape characterised by a diverse mix of well-established brands, emerging players, and specialised producers. In this dynamic environment, innovation serves as a pivotal competitive edge. Leading brands dedicate significant resources to research and development endeavours, consistently introducing fresh flavours, innovative packaging formats, and health-focused variations in response to ever-evolving consumer preferences. 'Cytovance Biologics', 'Eurofins Scientific', 'Merck KGaA', 'Biomerieux SA', 'Lonza', 'Promega Corporation', 'Thermo Fisher Scientific', 'WuXi AppTec', 'Nelson Laboratories, LLC', 'Almac Group', 'GenScript', 'InvivoGen', 'Toxikon', 'Maravai LifeSciences'

The expansions witnessed in the pharmaceutical and biotechnology sectors, propelled by substantial investments in research and development, signify a pivotal epoch in healthcare progress. These industries stand at the forefront of creating pharmaceuticals, biologics, and vaccines, actively addressing the complexities associated with diverse healthcare challenges, especially in combating intricate diseases. This surge in innovation inevitably leads to an increased necessity for stringent safety evaluations, wherein biological safety testing plays a pivotal role in safeguarding patient well-being.

regulatory bodies have embarked on a path of heightened vigilance over biopharmaceutical products, prioritising both patient safety and product quality. These stringent regulations mandate an exhaustive spectrum of safety evaluations, elevating biological safety testing to a cornerstone in the landscape of drug approvals. For pharmaceutical and biotech enterprises, strict adherence to these evolving standards isn't just a necessity but a crucial pathway to securing product approval and market entry. This escalating emphasis on compliance fuels an increased demand for testing services, firmly cementing the pivotal role of biological safety testing within this framework.

North America emerges as the leader in shaping and propelling the market dynamics, poised to sustain its influential trajectory in the forecast period. This regional dominance is attributed to various key factors, notably the robust presence of a multitude of biotechnology and pharmaceutical companies. Renowned for its status as an innovation hub, North America consistently fosters the evolution of cutting-edge technologies, driving advancements and breakthroughs within the industry.

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