Biologics Safety Testing Market Research Report, Analysis and Forecast till 2030

Biologics Safety Testing Market Analysis

The global Biologics Safety Testing Market size in  2025 is expected to be $ 4.5 billion and is expected to grow at 10% CAGR during the period (2022-2030). The global Biologics Safety Testing Market is segmented into North America, Europe, APAC & Rest of the world.

Biologics is a part of biotechnology that utilizes living organisms such as humans, animals, and microorganisms to obtain biological drugs. However, there always remains a risk of contamination of the product during its recovery from its source. Therefore, the safety testing of novel biologics, viral-based products, or vaccines is the primary goal of the health care authorities.

The research report titled “Biologics Safety Testing Market, Business and Opportunity Analysis” published by Datavagyanik presents a detailed analysis of the Biologics Safety Testing Market with country-wise market statistics, qualitative insights, and market player analysis. One of the prime objectives of the report is to provide an assessment of the market potential, market revenue, growth and business opportunities for Biologics Safety Testing Market in each country.

Biologics Safety Testing Market

North America Biologics Safety Testing Market size is expected to be – million and is expected to grow at a CAGR of –% till 2030. US & Canada will drive the most of the revenue in the region. North America has a huge chunk of global market.

Europe Biologics Safety Testing Market Size is expected to be—million and is expected to grow at a CAGR of –%. APAC Biologics Safety Testing Market Size is Expected to grow at a CAGR of –. APAC will grow fastest as the market is still in its nascent stage.

Primary Safety Tests for Biologics

Biologics safety testing offers a quality assurance of the product before its use in its target organism. In addition to removing microbial or viral contagion, safety testing also makes the product free of contaminants that can interfere with the analytical testing. Manufacturers can run on-site testing of their products. Moreover, some commercial vendors are also offering biologics safety testing services.

With advances in the medical field, biologics have been increasing. Therefore, the biologics safety testing market is growing at a rapid pace. As a result, different organizations are investing in this market to ensure the safety of biologics.

The preliminary safety tests for biologics include testing for the presence of adventitious agents, mycoplasma, and endotoxins. Moreover, sterility testing also confirms the absence of bacterial and fungal contamination.

Key Insights that the Biologics Safety Testing Market analysis report presents are:
  • Biologics Safety Testing Market revenue and demand by countries
  • Break-down of the Biologics Safety Testing Market in terms of application areas, target customers, and other potential market segments
  • Areas that are relatively more potential and are faster growing
  • Biologics Safety Testing Market competitive scenario, market share analysis
  • Biologics Safety Testing Market business opportunity analysis
Global and Country-Wise Biologics Safety Testing Market Statistics
  • Global and Country-Wise Biologics Safety Testing Market Size ($Million) and Forecast – (till 2030)
  • Global and Country-Wise Biologics Safety Testing Market Trend Analysis
  • Global and Country-Wise Biologics Safety Testing Market Business Opportunity Assessment
Biologics Safety Testing Market Demand and Supply Side Analysis

The report analyzes Biologics Safety Testing Market from the demand as well as the supply side. In supply-side analysis, we reach out to the Biologics Safety Testing Market players to collect information on their portfolio, revenue, target customers, and other insights. During this process, paid interviews and surveys are conducted for obtaining and validating the data pointers. We also deep dive into the available paid industry databases, research studies, white papers, and annual reports.

As a part of our demand-side analysis, we reach out to the end-users of the Biologics Safety Testing Market, to gauge the application areas, demand trends, and similar insights.

Sample Data Tables Covered for Each Region and Country:

This business analysis report on the Biologics Safety Testing Market presents a regional as well as country-level analysis. The regions covered in the report are – North America, Europe, Asia Pacific and Rest of the World. In these four regions, all the countries have been covered in detail with information on Biologics Safety Testing Market size, trends, and forecast.

The report covers Biologics Safety Testing Market revenue and forecast for the period (till 2030), by regions, (further split into countries):

  • North America (United States, Canada, Mexico)
  • Asia Pacific (China, Japan, South Korea, India, Indonesia, Vietnam, Rest of APAC)
  • Europe (UK, Germany, France, Italy, Spain, Benelux, Poland, Rest of Europe)
  • Latin America (Brazil, Argentina, Rest of Latin America)
  • Middle East & Africa

Market Growth, Dynamics, and Trends

The biologics safety testing market has grown ta CAGR of 12.4% during 2021. If it keeps growing at this pace, the global market is expected to reach twice its present size at the end of the forecast period in 2026. Increasing concerns over cell culture contamination and rising government and private investments are mainly responsible for market growth spikes.

Moreover, during the covid-19 times, the biologics safety testing market showed a significant spike because of the involvement of this field in checking the integrity of corona testing and vaccination services.

Driving Factors of Market Growth

As discussed before, many companies are investing in firms related to biologics or biosimilars. Most remarkably, almost half of the research drugs in the top 100 pharmaceutical companies are biologics. Therefore, in the upcoming years, biologics will contribute nearly half of those companies’ revenue.

Moreover, there has been an increase in growth in pharmaceutical industries driven by government funding. Therefore, increased government involvement and demand for newer drugs are the potential driving factors of the biologics safety testing market.

The story doesn’t end here. The incidence of chronic illnesses has also increased significantly. Most traditional methods do not offer the optimal management of chronic diseases. Therefore, it’s time for modern technology drugs that deal with the disease and eradicate it from its root. The need for modern medicines is also a driving factor accelerating the biologics market’s growth.

Biologics Safety Testing Market REVENUE ($MILLION), AND FORECAST, till 2030
Year 2023 2025 2027 2029 CAGR
(till 2030)
Biologics Safety Testing Market Revenue ($Million) XX XX XX XX XX

*Note – Country-level break-down has been covered in the report

Biologics Safety Testing Market Player Analysis:

  • Company overview, portfolio analysis, market share, and target customers
  • Estimated segment revenue and relative positioning
  • Business and growth strategies

Segment Analysis of the Global Market

The Biologics safety testing market depends on multiple factors, including products, test type, applications, end-users, and region. This article segment aims to provide brief information about each of these factors that helps to understand the market dynamics.

Product Type

The product segment of this market involves consumables, instruments, and services. However, due to limited finances, complex manufacturing requirements, and lack of investments, the consumables and instruments segment doesn’t account for a significant share of the global market. All this has resulted in a shift towards the services segment, which dominated the biologics safety testing market during the past few years. But with increasing investments, experts are also hopeful to see a rise in the instruments and consumables segment of the market.

Test Type

As discussed before, the biologics safety testing market is segmented into endotoxin tests, adventitious tests, mycoplasma tests, DNA detection tests, and sterility tests depending upon the test type. Recently, there has been an increased focus on the quality of the drug. Therefore, segments relating to DNA detection and adventitious tests accounted for a significant global market share.


Applications of biologics safety testing include the formation of vaccines, monoclonal antibodies, gene therapy, and blood products. In the last few years, monoclonal antibodies have been used significantly for treating several diseases. Therefore, in terms of applications, monoclonal antibodies contribute the most significant share to the whole market.

“Every Organization is different and so are their requirements”- Datavagyanik

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