Biological Safety Testing Market Report

Biological Safety Testing Market Analysis By Product (Reagents & Kits, Instruments, Services), By Application (Stem Cell, Tissue & Tissue-Based Products, Gene Therapy, Blood & Blood-Based Products, Vaccines & Therapeutics), By Test (Sterility Tests, Cell Line Authentication & Characterization Tests, Bioburden Tests, Endotoxin Tests, Adventitious Agent Detection Tests, Residual Host Contamination Detection Tests), And Segment Forecasts To 2024

  • Published Date: Oct, 2016
  • Base Year for Estimate: 2015
  • Report ID: GVR-1-68038-140-5
  • Format: Electronic (PDF)
  • Historical Data: 2013-2015
  • Number of Pages: 106

The biological safety testing market is primarily driven by heightening production of new generation biologics by major pharmaceutical and biotechnology companies.

The global biological safety testing market accounted for USD 1.97 billion in 2015 and is anticipated to grow at a CAGR of over 12.2% during the forecast period. The growing production of new generation biologics by major pharmaceutical and biotechnology companies is a high-impact rendering growth driver of the market. The subsequent increase is believed to be a consequence of high global prevalence of target diseases, which has triggered the companies to produce advanced biologics.

Consequently, the high need for biologics resulted in an unprecedented growth in the number of biopharmaceutical companies. This rise in the number of companies has engendered a high demand for biological safety tools to eliminate contamination risks through the use of safety assurance measures in the manufacturing processes.

In addition, viral safety testing is proving to be one of the primary concerns of majority of the companies. As a consequence of viral testing being a critical component of chemistry, manufacturing, and control of biologics in their development and subsequently during product launch, it is anticipated to present the market with potential growth opportunities in the future.

North America biological safety testing market revenue, by product, 2014 - 2024 (USD Million)

North America biological safety testing market

Moreover, the presence of regulatory authorities working toward enforcing significant biological safety standards to ensure patient safety is anticipated to provide an upsurge in the adoption of testing tools. The consistent guidelines and recommendations laid down by these authorities, increases the incorporation of these tools by quality assurance technicians, thus providing significant boost to the overall industry.

Reagents & kits accounted for the largest share in the product segment in 2015.

Reagents & kits held a dominant share in the product segment in 2015. The substantial share is attributed to reagents being a major component of biological safety testing. In addition, increasing advancements and modifications in the formulation of reagents & kits are presumed to be responsible for driving the inclination of laboratory technicians in incorporating these products, specifically in toxicology assessment.

The advancements include incorporation of enzyme technology, marker DNAs, and profiling technologies, such as transcriptomes, proteomics, and metabolomics. The products are also preferred in quality comparability studies to demonstrate their efficacy levels, hence contributing toward the high segment share.

Vaccine & therapeutics held the largest share in the application segment in 2015.

Vaccine & therapeutics held a dominant share within the application segment in 2015. Clearly defined guidelines ensuring the safety of developed vaccines with unaltered therapeutic value and reduced toxicity, which may result from constituent materials and pharmacodynamic action of the vaccine, are presumed to be responsible for the heightened demand of this segment in 2015.

Bioburden test is expected to be the fastest growing test segment.

Bioburden tests are expected to grow at a lucrative rate throughout the forecast period. The significant growth is attributable to a gradual increase in the adoption rate of this test to determine bioburden limits in wide ranging biologics and medical devices. Moreover, consistent advancements in this segment are expected to provide a high growth potential platform to the segment.

The emergence of technological modifications, which include the incorporation of next generation sequencing and bioinformatics, in viral safety testing are resulting in benefits such as rapid turnaround time in performing time-critical studies and burden assessment studies.

North America is the largest regional market for this industry.

In 2015, North America captured a substantial share of over 36.0% of the regional biological safety testing sector. The share attained by this region is primarily a consequence of the presence of prominent market players undertaking extensive expansion strategies.

Moreover, increasing number of R&D investments initiated by the companies is one of the key potential growth factors presumed to be responsible for the sizeable share garnered by North America. Furthermore, the increasing chronic disease burden present over this region is anticipated to be driving the inclination of researchers and healthcare professionals toward advanced technologies, which in turn is further anticipated to widen the scope for growth.

The Asia Pacific regional market is anticipated to exhibit a lucrative CAGR of over 13.0% throughout the forecast period. The exponential growth can be attributed to the growing healthcare spending and rising awareness levels pertaining to the benefits of biological safety testing tools. Moreover, strengthening favorable regulatory policies enforced by the healthcare organizations to improve safety, as well as the improving healthcare infrastructure quality is further expected to widen the growth opportunities in the future.

Charles River Laboratories International, Inc., Lonza Group, Sigma Aldrich Corporation, and Wuxi Pharmatech were found to be some of the dominant players of this industry.

The registered growth in this sector is a consequence of undertaking extensive expansion strategies, geographical expansions, new product development, and mergers & acquisitions. In June 2016, Charles River acquired Blue Stream Laboratories, Inc, an analytical contract research organization. This acquisition was carried out to enhance its existing capabilities in safety assessment and biologics development. Also in October 2012, Charles River Laboratories announced the acquired majority of stakes in Vital River, a commercial research model provider in China. This acquisition was carried out to enhance its geographical presence.

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