Biologics Safety Testing Market by Product, Test Type, Application, End-User - Cumulative Impact of COVID-19, Russia Ukraine Conflict, and High Inflation

Description

List of Tables

The Global Biologics Safety Testing Market is forecasted to grow significantly, with a projected USD 5,623.85 million in 2023 at a CAGR of 14.65% and expected to reach a staggering USD 14,702.45 million by 2030.

The Cumulative Impact of COVID-19, the Russia-Ukraine Conflict, and High Inflation is expected to have significant long-term effects on the Global Biologics Safety Testing Market. The ongoing research considers the changes in consumer behavior, supply chain disruptions, and government interventions caused by the pandemic. Similarly, the report considers the ongoing political and economic uncertainty in Eastern Europe caused by the Russia-Ukraine Conflict and its potential implications for demand-supply balances, pressure on pricing variants, and import/export and trading. Additionally, the report addresses the impact of High Inflation on the global economy and details fiscal policies measuring and reducing its effects on demand, supply, cash flow, and currency exchange.

Market Segmentation & Coverage:

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

Based on Product, market is studied across Consumable, Instruments, and Services. The Instruments commanded largest market share of 48.75% in 2022, followed by Services.

Based on Test Type, market is studied across Bioburden Tests, Endotoxin Tests, Mycoplasma Tests, Residual Host-Cell Proteins & DNA Detection Tests, Sterility Tests, and Virus Safety Tests. The Bioburden Tests commanded largest market share of 22.77% in 2022, followed by Endotoxin Tests.

Based on Application, market is studied across Blood & Blood-Related Products Development, Cellular & Gene Therapy Products Development, Monoclonal Antibodies Development, and Vaccine & Therapeutics Development. The Vaccine & Therapeutics Development commanded largest market share of 28.63% in 2022, followed by Blood & Blood-Related Products Development.

Based on End-User, market is studied across Academic & Research Institutes, Contract Research Organization/ Contract Manufacturing Organization, and Pharmaceutical & Biotechnology Companies. The Contract Research Organization/ Contract Manufacturing Organization commanded largest market share of 41.24% in 2022, followed by Pharmaceutical & Biotechnology Companies.

Based on Region, market is studied across Americas, Asia-Pacific, and Europe, Middle East & Africa. The Americas is further studied across Argentina, Brazil, Canada, Mexico, and United States. The United States is further studied across California, Florida, Illinois, New York, Ohio, Pennsylvania, and Texas. The Asia-Pacific is further studied across Australia, China, India, Indonesia, Japan, Malaysia, Philippines, Singapore, South Korea, Taiwan, Thailand, and Vietnam. The Europe, Middle East & Africa is further studied across Denmark, Egypt, Finland, France, Germany, Israel, Italy, Netherlands, Nigeria, Norway, Poland, Qatar, Russia, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Turkey, United Arab Emirates, and United Kingdom. The Americas commanded largest market share of 38.45% in 2022, followed by Europe, Middle East & Africa.

Market Statistics:

The report provides market sizing and forecasts across 7 major currencies - USD, EUR, JPY, GBP, AUD, CAD, and CHF; multiple currency support helps organization leaders to make well-informed decisions. In this report, 2018 to 2021 are considered as historical years, 2022 is base year, 2023 is estimated year, and years from 2024 to 2030 are considered as forecast period.

FPNV Positioning Matrix:

The FPNV Positioning Matrix is essential for assessing the Global Biologics Safety Testing Market. It provides a comprehensive evaluation of vendors by examining key metrics within Business Strategy and Product Satisfaction, allowing users to make informed decisions based on their specific needs. This advanced analysis then organizes these vendors into four distinct quadrants, which represent varying levels of success: Forefront (F), Pathfinder (P), Niche (N), or Vital(V).

Market Share Analysis:

The Market Share Analysis offers an insightful look at the current state of vendors in a particular market space. By comparing vendor contributions to overall revenue, customer base, and other key metrics, we can give companies a greater understanding of their performance and what they are up against when competing for market share. The analysis also sheds light on just how competitive any given sector is about accumulation, fragmentation dominance, and amalgamation traits over the base year period studied.

The report provides insights on the following pointers:

1. Market Penetration: Provides comprehensive information on the market offered by the key players

2. Market Development: Provides in-depth information about lucrative emerging markets and analyzes penetration across mature segments of the markets

3. Market Diversification: Provides detailed information about new product launches, untapped geographies, recent developments, and investments

4. Market Trends: Provides comprehensive understanding of the Cumulative Impact of COVID-19, the Russia-Ukraine Conflict, and the High Inflation

5. Competitive Assessment & Intelligence: Provides an exhaustive assessment of market shares, strategies, products, certification, regulatory approvals, patent landscape, and manufacturing capabilities of the leading players

6. Product Development & Innovation: Provides intelligent insights on future technologies, R&D activities, and breakthrough product developments

The report answers questions such as:

1. What is the market size and forecast of the Global Biologics Safety Testing Market?

2. What are the inhibiting factors and impact of COVID-19 shaping the Global Biologics Safety Testing Market during the forecast period?

3. Which are the products/segments/applications/areas to invest in over the forecast period in the Global Biologics Safety Testing Market?

4. What is the competitive strategic window for opportunities in the Global Biologics Safety Testing Market?

5. What are the technology trends and regulatory frameworks in the Global Biologics Safety Testing Market?

6. What is the market share of the leading vendors in the Global Biologics Safety Testing Market?

7. What modes and strategic moves are considered suitable for entering the Global Biologics Safety Testing Market?

Product Code: MRR-437D45957966

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. Limitations
1.7. Assumptions
1.8. 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

4.1. Introduction
4.2. Biologics Safety Testing Market, by Product, 2022 vs 2030
4.3. Biologics Safety Testing Market, by Test Type, 2022 vs 2030
4.4. Biologics Safety Testing Market, by Application, 2022 vs 2030
4.5. Biologics Safety Testing Market, by End-User, 2022 vs 2030
4.6. Biologics Safety Testing Market, by Region, 2022 vs 2030

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 Trends
5.3. Cumulative Impact of COVID-19
5.4. Cumulative Impact of Russia-Ukraine Conflict
5.5. Cumulative Impact of High Inflation
5.6. Porter's Five Forces Analysis
- 5.6.1. Threat of New Entrants
- 5.6.2. Threat of Substitutes
- 5.6.3. Bargaining Power of Customers
- 5.6.4. Bargaining Power of Suppliers
- 5.6.5. Industry Rivalry
5.7. Value Chain & Critical Path Analysis
5.8. Regulatory Framework
5.9. Client Customization

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. FPNV Positioning Matrix
13.2. Market Share Analysis, By Key Player
13.3. Competitive Scenario Analysis, By Key Player
- 13.3.1. Merger & Acquisition
  - 13.3.1.1. Solvias acquires Cergentis to boost biologics testing capabilities.
  - 13.3.1.2. Charles River to acquire Cognate BioServices for USD 875 Million.
- 13.3.2. Agreement, Collaboration, & Partnership
  - 13.3.2.1. Oxford Nanopore and Pathoquest Announce the First Steps in a Strategic Collaboration to Bring the First Gmp-Accredited, Nanopore-Based Biologics Genetic Characterisation Test to Market.
  - 13.3.2.2. Nykode Therapeutics and Richter-Helm BioLogics Announce Partnership.
- 13.3.3. New Product Launch & Enhancement
  - 13.3.3.1. Identifysensors Biologics Partners with Jabil Healthcare to Manufacture Digital Diagnostic Platform.
- 13.3.4. Investment & Funding
  - 13.3.4.1. Why Teva is Investing Over One Billion Dollars in Biologics in Europe.
- 13.3.5. Award, Recognition, & Expansion
  - 13.3.5.1. Clean Cells Launches Biopharmaceutical Quality Control Facility.
  - 13.3.5.2. Abzena Opens a New Biologics Testing Lab.

14. List of Company Mentioned

15. Appendix

15.1. Discussion Guide
15.2. License & Pricing