Biologics Safety Testing Market by Product, Test Type, Application, End-User

Description

List of Tables

[181 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.

KEY MARKET STATISTICS
Base Year [2023]	USD 5.62 billion
Estimated Year [2024]	USD 6.43 billion
Forecast Year [2030]	USD 14.70 billion
CAGR (%)	14.71%

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.

Market Insights

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

Market Disruption Analysis
Porter's Five Forces Analysis
Value Chain & Critical Path Analysis
Pricing Analysis
Technology Analysis
Patent Analysis
Trade Analysis
Regulatory Framework Analysis

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.

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 Accugen Laboratories, Inc., Agilent Technologies, Inc., Almac Group Limited, Associates of Cape Cod, Inc., Becton, Dickinson and Company, Bio-Rad Laboratories, Inc., bioMerieux SA, BSL Bioservice Scientific Laboratories Munich GmbH, Charles River Laboratories International, Inc., Creative Biolabs, Inc., Eagle Analytical Services, Eurofins Scientific Limited, F. Hoffmann-La Roche Ltd., FUJIFILM Wako Pure Chemical Corporation, Laboratory Corporation of America Holdings, Lonza Group AG, Maravai Lifesciences, Merck KGaA, Microcoat Biotechnologie GmbH, Nelson Laboratories, LLC by Sterigenics International LLC, Pacific BioLabs by Northview Biosciences, Inc., Promega Corporation, PromoCell GmbH, QIAGEN GmbH, Rockland Immunochemicals, Inc., Samsung Biologics, Sartorius AG, SGS S.A., SGS Societe Generale de Surveillance SA, and Thermo Fisher Scientific, Inc..

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

Product Code: MRR-437D4595795B

1. Preface

1.1. Objectives of the Study
1.2. Market Segmentation & Coverage
1.3. Years Considered for the Study
1.4. Currency & Pricing
1.5. Language
1.6. Stakeholders

2. Research Methodology

2.1. Define: Research Objective
2.2. Determine: Research Design
2.3. Prepare: Research Instrument
2.4. Collect: Data Source
2.5. Analyze: Data Interpretation
2.6. Formulate: Data Verification
2.7. Publish: Research Report
2.8. Repeat: Report Update

3. Executive Summary

4. Market Overview

5. Market Insights

5.1. Market Dynamics
- 5.1.1. Drivers
  - 5.1.1.1. Exponential need for safety monitoring & testing in clinical trials activities
  - 5.1.1.2. Growing number of drug recalls and government initiatives and standards for biologics product safety
  - 5.1.1.3. Increasing production and trade of medical devices and their quality evaluation
- 5.1.2. Restraints
  - 5.1.2.1. High-cost requirement of safety testing for the development of drugs
- 5.1.3. Opportunities
  - 5.1.3.1. Technological innovation and advancements in biologic safety testing
  - 5.1.3.2. Expanding research for improved safety recombinant protein and cell & gene therapy
- 5.1.4. Challenges
  - 5.1.4.1. Lack of skilled professionals to perform accurate testing
5.2. Market Segmentation Analysis
- 5.2.1. Product: Cruciality of services for biopharmaceutical companies to navigate the complex regulatory landscapes
- 5.2.2. Application: Increasing adoption in vaccine & therapeutics development to validate the effectiveness and safety of vaccines and new therapeutic drugs
5.3. Market Disruption Analysis
5.4. Porter's Five Forces Analysis
- 5.4.1. Threat of New Entrants
- 5.4.2. Threat of Substitutes
- 5.4.3. Bargaining Power of Customers
- 5.4.4. Bargaining Power of Suppliers
- 5.4.5. Industry Rivalry
5.5. Value Chain & Critical Path Analysis
5.6. Pricing Analysis
5.7. Technology Analysis
5.8. Patent Analysis
5.9. Trade Analysis
5.10. Regulatory Framework Analysis

6. Biologics Safety Testing Market, by Product

6.1. Introduction
6.2. Consumable
6.3. Instruments
6.4. Services

7. Biologics Safety Testing Market, by Test Type

7.1. Introduction
7.2. Bioburden Tests
7.3. Endotoxin Tests
7.4. Mycoplasma Tests
7.5. Residual Host-Cell Proteins & DNA Detection Tests
7.6. Sterility Tests
7.7. Virus Safety Tests

8. Biologics Safety Testing Market, by Application

8.1. Introduction
8.2. Blood & Blood-Related Products Development
8.3. Cellular & Gene Therapy Products Development
8.4. Monoclonal Antibodies Development
8.5. Vaccine & Therapeutics Development

9. Biologics Safety Testing Market, by End-User

9.1. Introduction
9.2. Academic & Research Institutes
9.3. Contract Research Organization/ Contract Manufacturing Organization
9.4. Pharmaceutical & Biotechnology Companies

10. Americas Biologics Safety Testing Market

10.1. Introduction
10.2. Argentina
10.3. Brazil
10.4. Canada
10.5. Mexico
10.6. United States

11. Asia-Pacific Biologics Safety Testing Market

11.1. Introduction
11.2. Australia
11.3. China
11.4. India
11.5. Indonesia
11.6. Japan
11.7. Malaysia
11.8. Philippines
11.9. Singapore
11.10. South Korea
11.11. Taiwan
11.12. Thailand
11.13. Vietnam

12. Europe, Middle East & Africa Biologics Safety Testing Market

12.1. Introduction
12.2. Denmark
12.3. Egypt
12.4. Finland
12.5. France
12.6. Germany
12.7. Israel
12.8. Italy
12.9. Netherlands
12.10. Nigeria
12.11. Norway
12.12. Poland
12.13. Qatar
12.14. Russia
12.15. Saudi Arabia
12.16. South Africa
12.17. Spain
12.18. Sweden
12.19. Switzerland
12.20. Turkey
12.21. United Arab Emirates
12.22. United Kingdom

13. Competitive Landscape

13.1. Market Share Analysis, 2023
13.2. FPNV Positioning Matrix, 2023
13.3. Competitive Scenario Analysis
- 13.3.1. Oxford Nanopore Technologies and PathoQuest Collaborate on Groundbreaking Biopharmaceutical Safety Test
- 13.3.2. Expanding Biologics Production: A Strategic Look at Teva's Ulm Facility and Future Plans
- 13.3.3. Expansion of Clean Cells Advances Biopharmaceutical Testing Capabilities in Europe
13.4. Strategy Analysis & Recommendation

14. Competitive Portfolio

14.1. Key Company Profiles
14.2. Key Product Portfolio