Biologics Safety Testing
Biologics Safety Testing Market by Product (Consumable, Instruments, Services), Test Type (Bioburden Tests, Endotoxin Tests, Mycoplasma Tests), Application, End-User - Global Forecast 2024-2030
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[180 Pages Report] The Biologics Safety Testing Market size was estimated at USD 5.62 billion in 2023 and expected to reach USD 6.43 billion in 2024, at a CAGR 14.71% to reach USD 14.70 billion by 2030.

Biologics safety testing is majorly the stringent testing of biopharmaceuticals conducted by drug manufacturers to ensure all biologic materials, across the development process, are safe and free of contaminants. The increased need for safety monitoring & testing in clinical trial activities, along with the growing focus on medical device evaluation, is expanding the adoption of biologics safety testing systems and services. The growing number of drug recalls and government initiatives and standards for biologics product safety are the major drivers for product penetration. However, the high-cost requirement of safety testing for the development of drugs and the limited availability of skilled professionals to perform accurate testing impedes proper testing activities. Technological innovation and advancements in biologics safety testing can assist in addressing operational factors and serve users with cost-effective products. Ongoing research for improved safety recombinant protein and cell & gene therapy is expected to proliferate the development of new customized testing services.

Regional Insights

The biologics safety testing market considering the Americas region, particularly in the United States, is well-established and highly regulated, fostering a robust demand for safety testing to ensure compliance with stringent FDA guidelines. This includes tests for contamination, potency, and purity of biological products. Moving to EMEA, Europe leads in market maturity similar to the Americas with strong regulatory frameworks provided by agencies such as the EMA (European Medicines Agency). The market is driven by advanced healthcare infrastructures and heightened awareness regarding biological safety. The Asia Pacific region showcases rapid growth in the biologics safety testing market, which is stimulated by increasing investments in biotechnology sectors, rising pharmaceutical outsourcing, and enhancements in healthcare infrastructures, particularly in countries including China and India. Overall, the global perspective on biologics safety testing underlines a convergence towards higher regulatory scrutiny, technological advancements in testing, and an expanded focus on ensuring the safety of biologic products across all regions.

Biologics Safety Testing Market
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Market Dynamics

The market dynamics represent an ever-changing landscape of the Biologics Safety Testing Market by providing actionable insights into factors, including supply and demand levels. Accounting for these factors helps design strategies, make investments, and formulate developments to capitalize on future opportunities. In addition, these factors assist in avoiding potential pitfalls related to political, geographical, technical, social, and economic conditions, highlighting consumer behaviors and influencing manufacturing costs and purchasing decisions.

  • Market Drivers
    • Exponential need for safety monitoring & testing in clinical trials activities
    • Growing number of drug recalls and government initiatives and standards for biologics product safety
    • Increasing production and trade of medical devices and their quality evaluation
  • Market Restraints
    • High-cost requirement of safety testing for the development of drugs
  • Market Opportunities
    • Technological innovation and advancements in biologic safety testing
    • Expanding research for improved safety recombinant protein and cell & gene therapy
  • Market Challenges
    • Lack of skilled professionals to perform accurate testing
Market Segmentation Analysis
  • Product: Cruciality of services for biopharmaceutical companies to navigate the complex regulatory landscapes

    Consumables include a range of items such as reagents, kits, and media that are used on a regular basis in laboratory environments. These materials are essential for carrying out experiments and tests to detect any potential contaminants or to verify the quality of biological samples. Instruments are the tools and devices used in these testing processes, including spectrometers, PCR machines, and chromatography systems. These sophisticated instruments help scientists and researchers in precisely measuring and analyzing biological materials. Services in biologics safety testing typically refer to the support offered by specialized companies, which may include laboratory testing, regulatory support, and consulting services. These services are crucial for biopharmaceutical companies to navigate the complex regulatory landscapes and to ensure compliance with global standards.

  • Application: Increasing adoption in vaccine & therapeutics development to validate the effectiveness and safety of vaccines and new therapeutic drugs

    Biologics safety testing in the development of blood and blood-related products is crucial to ensure that these substances are safe for use in medical treatments. This involves rigorous testing for contaminants, pathogens, and other potential risks to prevent transmission of infectious diseases. The tests help verify the purity and potency of the products, ensuring they meet strict regulatory standards before they reach patients. For cellular and gene therapy products, biologics safety testing focuses on ensuring that these advanced treatments are free of unwanted impurities and function as intended. This includes testing for viral contamination and genetic stability to ensure that these therapies are both safe and effective. These tests are vital as they help maintain the high standards required for treatments that can potentially alter genes or modify cellular functions in patients. In the development of monoclonal antibodies, safety testing plays a key role in confirming that these proteins are free from harmful agents and remain stable under various conditions. Monoclonal antibodies are used in a variety of therapeutic applications, including the treatment of cancers and autoimmune diseases, thus stringent testing ensures that these biologics are safe for patient use while maintaining their therapeutic efficacy. Vaccine and therapeutics development relies heavily on biologics safety testing to confirm that these products do not contain any contaminants and are capable of eliciting the desired immune response without causing adverse effects. This type of testing is fundamental in the development process, helping to validate the effectiveness and safety of vaccines and new therapeutic drugs, incorporating assessments for sterility, the presence of toxins, and other critical safety parameters.

Market Disruption Analysis

The market disruption analysis delves into the core elements associated with market-influencing changes, including breakthrough technological advancements that introduce novel features, integration capabilities, regulatory shifts that could drive or restrain market growth, and the emergence of innovative market players challenging traditional paradigms. This analysis facilitates a competitive advantage by preparing players in the Biologics Safety Testing Market to pre-emptively adapt to these market-influencing changes, enhances risk management by early identification of threats, informs calculated investment decisions, and drives innovation toward areas with the highest demand in the Biologics Safety Testing Market.

Porter’s Five Forces Analysis

The porter's five forces analysis offers a simple and powerful tool for understanding, identifying, and analyzing the position, situation, and power of the businesses in the Biologics Safety Testing Market. This model is helpful for companies to understand the strength of their current competitive position and the position they are considering repositioning into. With a clear understanding of where power lies, businesses can take advantage of a situation of strength, improve weaknesses, and avoid taking wrong steps. The tool identifies whether new products, services, or companies have the potential to be profitable. In addition, it can be very informative when used to understand the balance of power in exceptional use cases.

Value Chain & Critical Path Analysis

The value chain of the Biologics Safety Testing Market encompasses all intermediate value addition activities, including raw materials used, product inception, and final delivery, aiding in identifying competitive advantages and improvement areas. Critical path analysis of the <> market identifies task sequences crucial for timely project completion, aiding resource allocation and bottleneck identification. Value chain and critical path analysis methods optimize efficiency, improve quality, enhance competitiveness, and increase profitability. Value chain analysis targets production inefficiencies, and critical path analysis ensures project timeliness. These analyses facilitate businesses in making informed decisions, responding to market demands swiftly, and achieving sustainable growth by optimizing operations and maximizing resource utilization.

Pricing Analysis

The pricing analysis comprehensively evaluates how a product or service is priced within the Biologics Safety Testing Market. This evaluation encompasses various factors that impact the price of a product, including production costs, competition, demand, customer value perception, and changing margins. An essential aspect of this analysis is understanding price elasticity, which measures how sensitive the market for a product is to its price change. It provides insight into competitive pricing strategies, enabling businesses to position their products advantageously in the Biologics Safety Testing Market.

Technology Analysis

The technology analysis involves evaluating the current and emerging technologies relevant to a specific industry or market. This analysis includes breakthrough trends across the value chain that directly define the future course of long-term profitability and overall advancement in the Biologics Safety Testing Market.

Patent Analysis

The patent analysis involves evaluating patent filing trends, assessing patent ownership, analyzing the legal status and compliance, and collecting competitive intelligence from patents within the Biologics Safety Testing Market and its parent industry. Analyzing the ownership of patents, assessing their legal status, and interpreting the patents to gather insights into competitors' technology strategies assist businesses in strategizing and optimizing product positioning and investment decisions.

Trade Analysis

The trade analysis of the Biologics Safety Testing Market explores the complex interplay of import and export activities, emphasizing the critical role played by key trading nations. This analysis identifies geographical discrepancies in trade flows, offering a deep insight into regional disparities to identify geographic areas suitable for market expansion. A detailed analysis of the regulatory landscape focuses on tariffs, taxes, and customs procedures that significantly determine international trade flows. This analysis is crucial for understanding the overarching legal framework that businesses must navigate.

Regulatory Framework Analysis

The regulatory framework analysis for the Biologics Safety Testing Market is essential for ensuring legal compliance, managing risks, shaping business strategies, fostering innovation, protecting consumers, accessing markets, maintaining reputation, and managing stakeholder relations. Regulatory frameworks shape business strategies and expansion initiatives, guiding informed decision-making processes. Furthermore, this analysis uncovers avenues for innovation within existing regulations or by advocating for regulatory changes to foster innovation.

As a leading player in the biologics safety testing market, we at Lonza Group AG faced significant challenges in the increasing production and trade of medical devices and their quality evaluation. The Biologics Safety Testing Market Research Report by 360iResearch was a game-changer for us. It provided us with valuable insights and actionable strategies that we immediately implemented. The report's in-depth analysis helped us identify key market trends, optimize our production processes, and enhance our product quality. Since using the report, we have seen a notable improvement in our operational efficiency and market position. We are extremely satisfied with the positive impact it has had on our organization.
Lonza Group AG
FPNV Positioning Matrix

The FPNV positioning matrix is essential in evaluating the market positioning of the vendors in the Biologics Safety Testing Market. This matrix offers a comprehensive assessment of vendors, examining critical metrics related to business strategy and product satisfaction. This in-depth assessment empowers users to make well-informed decisions aligned with their requirements. Based on the evaluation, the vendors are then categorized into four distinct quadrants representing varying levels of success, namely Forefront (F), Pathfinder (P), Niche (N), or Vital (V).

Market Share Analysis

The market share analysis is a comprehensive tool that provides an insightful and in-depth assessment of the current state of vendors in the Biologics Safety Testing Market. By meticulously comparing and analyzing vendor contributions, companies are offered a greater understanding of their performance and the challenges they face when competing for market share. These contributions include overall revenue, customer base, and other vital metrics. Additionally, this analysis provides valuable insights into the competitive nature of the sector, including factors such as accumulation, fragmentation dominance, and amalgamation traits observed over the base year period studied. With these illustrative details, vendors can make more informed decisions and devise effective strategies to gain a competitive edge in the market.

Recent Developments
  • Oxford Nanopore Technologies and PathoQuest Collaborate on Groundbreaking Biopharmaceutical Safety Test

    Oxford Nanopore and PathoQuest in collaboration released GMP-accredited nanopore-based biologics genetic characterization test, takes safety testing of biologics to the next level, providing a new level of confidence in the safety and efficacy of biologics. The collaboration combines Oxford Nanopore's technology prowess with PathoQuest's expertise in biologics safety to create an innovative solution that stands to have a significant impact in the biopharmaceutical industry. This is a significant milestone for both companies as it heralds a new era in biologics safety testing. [Published On: 2023-03-21]

  • Expanding Biologics Production: A Strategic Look at Teva's Ulm Facility and Future Plans

    Teva is significantly increasing its investment in biologics production, with a keen focus on biosimilars and novel biologic products. The central hub of this expansion is Teva's Ulm facility in Germany, which represents a substantial investment exceeding one billion US dollars aimed at amplifying in-house manufacturing capabilities and improving supply reliability. Bioreactors, a critical component in the biotech production process, play an essential role at this site. These vessels facilitate the growth and product production of genetically modified cells under optimal conditions, controlling for factors such as temperature, pH, and oxygen levels. [Published On: 2023-03-11]

  • Expansion of Clean Cells Advances Biopharmaceutical Testing Capabilities in Europe

    Clean Cells launched a new biopharmaceutical quality testing service offering vital safety testing for biologics, ensuring that pharmaceutical products are free of contaminants and meet the highest safety standards. As the biologics market continues to expand, the demand for testing services has also increased, and Clean Cells is committed to delivering unparalleled quality and expertise to the industry. Backed by over 25 years of experience in the field, Clean Cells is uniquely positioned to provide comprehensive and reliable biopharmaceutical quality testing. With this newest offering, the company is poised to further solidify its reputation as a trusted partner for the biologics industry. [Published On: 2023-03-03]

Strategy Analysis & Recommendation

The strategic analysis is essential for organizations seeking a solid foothold in the global marketplace. Companies are better positioned to make informed decisions that align with their long-term aspirations by thoroughly evaluating their current standing in the Biologics Safety Testing Market. This critical assessment involves a thorough analysis of the organization’s resources, capabilities, and overall performance to identify its core strengths and areas for improvement.

As a leading global inspection, verification, testing, and certification company, SGS faced significant challenges in safety monitoring and testing for clinical trials. The Biologics Safety Testing Market Research Report by 360iResearch provided us with valuable insights and actionable strategies. The report highlighted emerging trends and technologies, allowing us to enhance our safety protocols. With the report's findings, we optimized our operational efficiency and ensured compliance with stringent regulatory standards. We are highly satisfied with how the report has positively impacted our operations, enabling us to address the exponential need for safety monitoring and testing in our clinical trial activities.
SGS Société Générale de Surveillance SA
Key Company Profiles

The report delves into recent significant developments in the Biologics Safety Testing Market, highlighting leading vendors and their innovative profiles. These include Lonza Group AG, SGS Société Générale de Surveillance SA, Creative Biolabs, Inc., Associates of Cape Cod, Inc., Becton, Dickinson and Company, Bio-Rad Laboratories, Inc., Maravai Lifesciences, BSL Bioservice Scientific Laboratories Munich GmbH, Nelson Laboratories, LLC by Sterigenics International LLC, Samsung Biologics, Eurofins Scientific Limited, F. Hoffmann-La Roche Ltd., Laboratory Corporation of America Holdings, Accugen Laboratories, Inc., PromoCell GmbH, QIAGEN GmbH, Promega Corporation, Thermo Fisher Scientific, Inc., SGS S.A., Microcoat Biotechnologie GmbH, Pacific BioLabs by Northview Biosciences, Inc., Agilent Technologies, Inc., Merck KGaA, Rockland Immunochemicals, Inc., Charles River Laboratories International, Inc., FUJIFILM Wako Pure Chemical Corporation, Sartorius AG, bioMérieux SA, Eagle Analytical Services, and Almac Group Limited.

Biologics Safety Testing Market - Global Forecast 2024-2030
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Market Segmentation & Coverage

This research report categorizes the Biologics Safety Testing Market to forecast the revenues and analyze trends in each of the following sub-markets:

  • Product
    • Consumable
    • Instruments
    • Services
  • Test Type
    • Bioburden Tests
    • Endotoxin Tests
    • Mycoplasma Tests
    • Residual Host-Cell Proteins & DNA Detection Tests
    • Sterility Tests
    • Virus Safety Tests
  • Application
    • Blood & Blood-Related Products Development
    • Cellular & Gene Therapy Products Development
    • Monoclonal Antibodies Development
    • Vaccine & Therapeutics Development
  • End-User
    • Academic & Research Institutes
    • Contract Research Organization/ Contract Manufacturing Organization
    • Pharmaceutical & Biotechnology Companies

  • Region
    • Americas
      • Argentina
      • Brazil
      • Canada
      • Mexico
      • United States
        • California
        • Florida
        • Illinois
        • New York
        • Ohio
        • Pennsylvania
        • Texas
    • Asia-Pacific
      • Australia
      • China
      • India
      • Indonesia
      • Japan
      • Malaysia
      • Philippines
      • Singapore
      • South Korea
      • Taiwan
      • Thailand
      • Vietnam
    • Europe, Middle East & Africa
      • Denmark
      • Egypt
      • Finland
      • France
      • Germany
      • Israel
      • Italy
      • Netherlands
      • Nigeria
      • Norway
      • Poland
      • Qatar
      • Russia
      • Saudi Arabia
      • South Africa
      • Spain
      • Sweden
      • Switzerland
      • Turkey
      • United Arab Emirates
      • United Kingdom

Our experience with the Biologics Safety Testing Market Research Report from 360iResearch has been immensely beneficial. Before accessing this report, our team faced significant challenges in keeping up with the rapidly evolving safety standards in recombinant protein and cell & gene therapy research. The comprehensive insights and actionable strategies provided by the report were transformative. For example, the analysis on emerging trends and regulatory developments equipped us to optimize our research protocols effectively. Since utilizing the report, we have witnessed a marked improvement in our operational efficiency and regulatory compliance. This report has undeniably become an essential tool in our strategic planning process. We couldn't be more satisfied with the positive impact it has had on our organization.
Creative Biolabs, Inc.
This research report offers invaluable insights into various crucial aspects of the Biologics Safety Testing Market:

  1. Market Penetration: This section thoroughly overviews the current market landscape, incorporating detailed data from key industry players.
  2. Market Development: The report examines potential growth prospects in emerging markets and assesses expansion opportunities in mature segments.
  3. Market Diversification: This includes detailed information on recent product launches, untapped geographic regions, recent industry developments, and strategic investments.
  4. Competitive Assessment & Intelligence: An in-depth analysis of the competitive landscape is conducted, covering market share, strategic approaches, product range, certifications, regulatory approvals, patent analysis, technology developments, and advancements in the manufacturing capabilities of leading market players.
  5. Product Development & Innovation: This section offers insights into upcoming technologies, research and development efforts, and notable advancements in product innovation.

Additionally, the report addresses key questions to assist stakeholders in making informed decisions:

  1. What is the current market size and projected growth?
  2. Which products, segments, applications, and regions offer promising investment opportunities?
  3. What are the prevailing technology trends and regulatory frameworks?
  4. What is the market share and positioning of the leading vendors?
  5. What revenue sources and strategic opportunities do vendors in the market consider when deciding to enter or exit?

Table of Contents
  1. Preface
  2. Research Methodology
  3. Executive Summary
  4. Market Overview
  5. Market Insights
  6. Biologics Safety Testing Market, by Product
  7. Biologics Safety Testing Market, by Test Type
  8. Biologics Safety Testing Market, by Application
  9. Biologics Safety Testing Market, by End-User
  10. Americas Biologics Safety Testing Market
  11. Asia-Pacific Biologics Safety Testing Market
  12. Europe, Middle East & Africa Biologics Safety Testing Market
  13. Competitive Landscape
  14. Competitive Portfolio
  15. List of Figures [Total: 24]
  16. List of Tables [Total: 384]
  17. List of Companies Mentioned [Total: 30]
Biologics Safety Testing: Ensuring the Safety of the Products We Use
June 26, 2023
Biologics Safety Testing: Ensuring the Safety of the Products We Use
As consumers, we trust that the products we use, especially those that are intended for our health and well-being, have undergone rigorous testing and are safe for use. In the case of biologics, which are complex, large-molecule drugs often used to treat life-threatening diseases such as cancer and autoimmune disorders, ensuring their safety is of utmost importance. There have been growing concerns with drug recalls and government initiatives focused on biologics product safety, driving the need for biologics safety testing. This blog will discuss the importance of biologics safety testing, the different methods used, and the impact it has on ensuring the safety of the products we use.

The development of biologics involves complex processes, including the use of living cells that produce the proteins that make up the drugs. Due to the size and complexity of these drugs, traditional methods of analytical testing cannot adequately determine their safety. Biologics safety testing is a vital step in ensuring the safety and efficacy of these drugs before they can be used in humans.

One approach to biologics safety testing is through in vitro testing, which involves testing the drugs on cells or tissues in a laboratory setting. These tests can assess the drugs' toxicity and potential side effects. Another approach is in vivo testing, which involves testing the drugs on animals, such as mice or monkeys, to determine their safety and efficacy. This method is more similar to human testing and can provide valuable information on possible side effects and dosing.

The safety and efficacy of biologics are further ensured through clinical trials, wherein the drugs are tested on humans in different phases, starting with a small group and progressing to larger populations. These trials gather data on the drugs' safety, tolerability, and effectiveness, providing critical information for regulatory agencies such as the US Food and Drug Administration (FDA) to approve the drugs for use.

Efforts in biologics safety testing are not new. Regulatory agencies such as the FDA have implemented guidelines and standards to ensure the safety of biologics since their inception. In addition, various government initiatives, such as the Biologics Price Competition and Innovation Act (BPCIA) and the Biosimilar User Fee Act (BsUFA), have been put in place to ensure the safety and affordability of biologics products.

Biologics safety testing plays a crucial role in ensuring the safety of the products we use. The complex nature of biologics requires rigorous testing methods, such as in vitro and in vivo testing and clinical trials, to determine their safety and efficacy. Regulatory agencies and government initiatives have also implemented guidelines to ensure the safety and affordability of these drugs. As consumers, we can trust that the drugs we use have undergone extensive testing and are safe for use due to the efforts of biologics safety testing.

Frequently Asked Questions
  1. How big is the Biologics Safety Testing Market?
    Ans. The Global Biologics Safety Testing Market size was estimated at USD 5.62 billion in 2023 and expected to reach USD 6.43 billion in 2024.
  2. What is the Biologics Safety Testing Market growth?
    Ans. The Global Biologics Safety Testing Market to grow USD 14.70 billion by 2030, at a CAGR of 14.71%
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