The biologics safety testing market was valued at USD 2.75 billion in 2017 and expected to grow at a CAGR of 12.2% to a USD 4.90 billion market by 2022. Growth in pharmaceutical and biotechnology industry driven by government support, the positive trend of R&D investment in the life science industry, and an increase in the number of new drug launches are factors driving the growth of this market. On the other hand, the time-consuming approval process for new drugs is considered a restraint for the market.

Kits & reagents segment is expected to register the highest CAGR during the forecast period

The biologics safety testing market is classified on the basis of product & service into kits & reagents, services, and instruments. The kits & reagents segment is expected to register highest growth rate during the forecast period. This growth can be attributed to the reoccurring purchase of kits & reagents, which is required for running tests.

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Endotoxin tests segment is accounted for largest share in the market

The biologics safety testing market is classified by test type into endotoxin tests, sterility tests, cell line authentification and characterization tests, residual host contamination detection tests, adventitious agent detection tests, bioburden tests, and other tests. The endotoxin tests segment is expected to register the highest growth rate during the forecast period. This growth can be attributed to the increase in the number of drug launches.

Increase initiative for immunization, increase company investment in vaccines development drives growth of the vaccines and therapeutics development segment

By application, the biologics safety testing 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 vaccine and therapeutics development segment are expected to register highest CAGR during the forecast period. The growth in this segment primarily attributed to initiatives for immunization and increased company investment in the development of vaccines.

North America is account for the largest regional segment in the market

Geographically, the biologics safety testing market is dominated by North America, followed by Europe. The North American region is estimated to account for the largest share of the market in 2017 and the trend is expected to continue during the forecast period. The growth in this market can be attributed to the presence of major key players in the region, a strong trend in R&D in life science industry and an increase in drug approvals.

The primary interviews conducted for this report can be categorized as follows:
- By Company Type - Tier 1 – 43%, Tier 2 – 14% and Tier 3 – 43%
- By Designation – C level – 14%, Director level – 43%, Others – 43%
- By Region – North America - 29%, Europe – 14%, APAC – 43%, RoW – 14%

Key players operating in the biologics safety testing market include Lonza Group LTD. (Switzerland), Charles River Laboratories (U.S.), Merck KGaA (Germany), SGS SA (Switzerland), WuXi Apptec (China), Thermo Fisher Scientific Inc. (U.S.), Sartorius AG (Germany), Cytovance Biologics, Inc. (U.S.), Pace Analytical Services Inc. (U.S.), and Toxikon Corporation (U.S.).

Study Coverage:
The report analyses the biologics safety testing market by product & service, test type, applications, and regions. Apart from comprehensive geographic and product & service analysis and market sizing, the report also provides the competitive landscape that covers the growth strategies adopted by industry players over the last three years. In addition, the report profiles companies with developments, and strategies adopted by key players to maintain and increase their shares in the market. The market research data, market size, and forecast of the future trends will help key market players and new entrants to make the necessary decisions to be successful in the market.

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