Biologics Safety Testing Market: Opportunities and challenges

November 14 18:00 2019
Biologics Safety Testing Market: Opportunities and challenges

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.).
Expanding pipelines of pharmaceutical and biopharmaceutical companies is further expected to drive the outsourcing of biologics safety testing to CROs.

The Biologics Safety Testing Market was valued at USD 2.75 Billion in 2017 and is expected to grow at a CAGR of 12.2% to reach USD 4.90 Billion in 2022, as per a report by MarketsandMarkets. 

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How increasing pharmaceutical outsourcing offers an opportunity?

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. This is done because the emergence of new technologies has made it unfeasible for companies to undertake all testing functions in-house. CROs can afford to invest in extensive drug discovery infrastructure as they cater to multiple clients. Thus, through outsourcing various functions to CROs, pharmaceutical and biotechnology companies can reduce their operational costs and R&D budgets. Cost savings, commercial sustainability, and optimal staffing are some of the key advantages driving the outsourcing of analytical testing and clinical trial services for large companies. In addition, expanding pipelines of pharmaceutical and biopharmaceutical companies is further expected to drive the outsourcing of biologics safety testing to CROs.

The global CRO services market is projected to reach USD 41.86 billion by 2021 from USD 29.29 billion in 2016, at a CAGR of 7.4% from 2016 to 2021. The market for services offered by CROs (contract research organizations) is expected to witness significant growth in the coming years due to the increased demand for outsourcing of biologics safety testing and clinical trial services majorly by pharmaceutical, biopharmaceutical, and medical device companies. Similarly, company focuses on outsourcing of clinical trial services was increased from 25% in 2014 to 34% in 2015. (Source: Contract Pharma Annual Outsourcing Survey, 2015).

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Why dearth of skilled professionals is a challenge?

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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