Pharmaceutical and biotechnology companies are the largest end users in the biologics safety testing market. Biologics safety testing is carried out at all levels of manufacturing to minimize the risk of product contamination in these industries. According to the International Trade Administration, the global pharmaceuticals market is projected to grow from USD 1 trillion in 2015 to USD 1.3 trillion by 2020, at a CAGR of 4.9%.

Major Growth Drivers:

The major factors driving the growth of this market are the growth in pharmaceutical & biotechnology industry driven by government support, the positive trend of R&D investment in the life science sector, increasing number of drug launches, and high incidence & large economic burden of chronic diseases. In the coming years, emerging markets and increasing pharmaceutical outsourcing are expected to offer growth opportunities for players in the biologics safety testing market.

Expected Revenue Growth:

The global biologics safety testing market is expected to reach USD 4.90 Billion by 2022 from USD 2.75 Billion in 2017, at a CAGR of 12.2% during forecast period.

Accessories to Fuel the Growth of Biologics safety testing market :

Biologics are pharmaceutical products that are extracted from biological sources. Biologics safety testing is carried out by manufacturers to detect contaminants like bacterial toxins, mycoplasma, and viruses. It is a mandatory process in these companies for the quality control of raw materials as well as for process control and validation of end products.

The success of biological safety tests depends mainly on the expertise of the analysts themselves as much as the environmental conditions under which the test is performed. For optimal efficacy, biologics safety testing needs to be conducted by skilled professionals with sufficient knowledge of the nuances of this field. Handling the instruments used in biologics safety testing also requires expertise. Consequently, the lack of a skilled workforce poses a key challenge to the growth of the biologics safety testing market.

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CROs act as outsourcing partners for pharmaceutical & biotechnology companies and academic institutes. CROs provide a number of services such as cell and virus bank characterization, genetic stability testing, raw material testing, bulk-lot release testing, final product release testing, sterility testing services, analytical services for biologics, biodistribution studies, immunoassay & cell-based assay services, cleaning validation studies, biorepository services, next-generation sequencing, and endotoxin determination. Several pharmaceutical & biotechnology companies and academic institutes opt to outsource numerous core functions like manufacturing, clinical trial management, and portions of drug discovery to CROs.

By product, kits & reagents segment is expected to grow at the highest growth rate during the forecast period

The kits & reagents segment is projected to register the highest during the forecast period. The growth of this market segment is driven by repeat purchase of kits and reagents as compared to instruments and increasing adoption of kit-based testing.

By application, Vaccine and Therapeutics Development segment to record the highest CAGR during the forecast period

Vaccine and Therapeutics Development segment is projected to register a higher CAGR during the forecast period. Factors such as the rising prevalence of diseases, increasing initiatives for immunization, and increasing company investments in vaccine development are expected to drive the growth of this market segment.

By test type, endotoxin test segment to record the highest CAGR during the forecast period

Endotoxin test segment is projected to register a higher CAGR during the forecast period. The market is mainly driven by the increase in disease prevalence and growth in the number of drug launches. Moreover, Endotoxin testing is used in cell therapy, monoclonal antibody testing, vaccine testing, gene therapy, and drug development.

North America to account for the largest market size during the forecast period.

North America is expected to account for the largest share of this market. The strong R&D trend in life sciences and growth in pharmaceutical industries will drive the biologics safety testing market in the North American region.

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Key Market Players :

Lonza Group LTD, Charles River Laboratories, Merck KGaA, SGS SA, WuXi Apptec, Thermo Fisher Scientific Inc, Sartorius AG, Cytovance Biologics, Inc, Pace Analytical Services Inc, and Toxikon Corporation.