Biologics Safety Testing Market Research Report - Forecast till 2027

Biologics Safety Testing Market Report: By Product (Kits & Reagents, Instruments, Services), Test (Sterility, Endotoxin, Cell Line Authentication), Application (Vaccine Development, Blood Products, Stem Cell Research)— Forecast till 2027

ID: MRFR/LS/5336-HCR | February 2021 | Region: Global | 100 pages

Biologics Safety Testing Market Scenario:

The biologics safety testing market size is expected to grow significantly over the forecast period. The market held a market value of USD 2.79 billion in 2017 and is projected to register a CAGR of 13.6% over the forecast period. Biologics safety testing is required for all biopharmaceutical products and vaccines to ensure that the product is safe and free of contaminants. Recently, CDER approved 46 novel drugs in 2017, whereas 22 in 2016.

Factors such as the growth in pharmaceutical and biotechnology industries, the increase in a number of drug launches, and increasing R&D investments in life science are expected to propel the growth of the market. However, stringent government regulations for the approval of biosimilars and high cost of drug development are likely to hamper the market growth over the forecast period.

Segmentation:

The global biologics safety testing market has been segmented into product, test type, and application.

Based on product, the market is segmented into kits and reagents, services, and instruments. The kits and reagents segment accounted for the largest share of the market in 2017.

Based on test type, the market is segmented into sterility tests, endotoxin tests, cell line authentication and characterization tests, residual host contamination detection tests, adventitious agent detection tests, bioburden tests, and others.

Based on application, the market is segmented into vaccine and therapeutics development, blood and blood-related products testing, cellular and gene therapy, tissue and tissue-related products testing, and stem cell research.

The market has been segmented, by region, into the Americas, Europe, Asia-Pacific, and the Middle East and Africa. The market in the Americas has further been segmented into North America and South America, with the North American market divided into the US and Canada.

The European market has been segmented into Western Europe and Eastern Europe. Western Europe has further been classified as Germany, France, the UK, Italy, Spain, and the rest of Western Europe.

The market in Asia-Pacific has been segmented into Japan, China, India, South Korea, Australia, and the rest of Asia-Pacific. The market in the Middle East and Africa has been segmented into the Middle East and Africa.

Regional Market Summary

Global Biologics Safety Testing Market Share (%), by Region, 2017

Source: Annual Reports, Sec Filings, and Press Release

Geographically, the Americas is anticipated to dominate the global biologics safety testing market owing to a well-established player, new product launches, and increasing demand for biological products.

Europe is expected to hold the second largest position in the global market.

The biologics safety testing market in Asia-Pacific region consists of countries namely China, Japan, Republic of Korea, India, Australia and Rest of Asia-Pacific. The Asia-Pacific region is expected to be the fastest growing region owing to the growth in pharmaceutical and biotech industries.

The Middle East & Africa has the least share of the market. Majority of the market of this region is expected to be held by the Middle East region due to a well-developed healthcare sector.

Global Biologics Safety Testing Market, by Product

Kits & Reagents

Services

Instruments

Global Biologics Safety Testing Market, by Test Type

Sterility Tests

Endotoxin Tests

Cell Line Authentication and Characterization Tests

Residual Host Contamination Detection Tests

Adventitious Agent Detection Tests

Bioburden Tests

Others

Global Biologics Safety Testing Market, by Application

Vaccine and Therapeutics Development

Blood and Blood-Related Products Testing

Cellular and Gene Therapy

Tissue and Tissue-Related Products Testing

Stem Cell Research

Global Biologics Safety Testing Market, by Region

Americas
- North America
  - US
  - Canada
- South America

Europe
- Western Europe
  - Germany
  - France
  - Italy
  - Spain
  - UK
  - Rest of Western Europe
- Eastern Europe

Asia-Pacific
- Japan
- China
- India
- Australia
- South Korea
- Rest of Asia-Pacific

Middle East & Africa
- Middle East
- Africa

Key Players:

Merck KGaA

Charles River Laboratories

Sartorius AG

Lonza Group Ltd.

SGS S.A.

Thermo Fisher Scientific Inc

Wuxi Apptec

Cytovance Biologics, Inc.

Avance Biosciences Inc.

Eurofins Scientific

Intended Audience

Biologics safety testing products manufacturers and vendors

Various research and consulting firms

Biologics safety testing Distributors

Biologics safety testing services providers

Report Scope:

Report Attribute/Metric	Details
Market Size	Significant Value
CAGR	13.6%
Base Year	2019
Forecast Period	2027
Historical Data	2018
Forecast Units	Value (USD Million)
Report Coverage	Revenue Forecast, Competitive Landscape, Growth Factors, and Trends
Segments Covered	Product, Test Type, and Application
Geographies Covered	North America, Europe, Asia-Pacific, and Rest of the World (RoW)
Key Vendors	3D Systems Corporations, Stratasys Ltd., SLM Solutions Group AG, EnvisionTEC, Arcam AB, Organovo Holdings, Inc., Oxford Performance Materials, Inc., Materialise NV, Bio3D Technologies, Cyfuse Medical K.K.EOS GmbHConcept, Laser GmbH, Renishaw plc, Prodways Group, 3T RPD Ltd.
Key Market Opportunities	Biologics safety testing products manufacturers
Key Market Drivers	Increase in a number of drug launches Increasing R&D investments in life science

Table of Contents:

Chapter 1. Report Prologue

Chapter 2. Market Introduction

2.1 Definition

2.2 Scope of the Study

2.2.1 Research Objective

2.2.2 Assumptions

2.2.3 Limitations

Chapter 3. Research Methodology

3.1 Introduction

3.2 Primary Research

3.3 Secondary Research

3.4 Market Size Estimation

Chapter 4. Market Dynamics

4.1 Drivers

4.2 Restraints

4.3 Opportunities

4.4 Challenges

4.5 Macroeconomic Indicators

4.6 Technology Trends & Assessment

Chapter 5. Market Factor Analysis

5.1 Porter’s Five Forces Analysis

5.1.1 Bargaining Power of Suppliers

5.1.2 Bargaining Power of Buyers

5.1.3 Threat of New Entrants

5.1.4 Threat of Substitutes

5.1.5 Intensity of Rivalry

5.2 Value Chain Analysis

5.3 Investment Feasibility Analysis

5.4 Pricing Analysis

Chapter 6. Global Biologics Safety Testing Market, by Product

6.1 Introduction

6.2 Kits & Reagents

Market Estimates & Forecast, by Region, 2020-2027