Description

The global biologics safety testing market size is projected to reach USD 11.2 billion by 2030 from USD 4.4 billion in 2021, at a CAGR of 12.4% during the forecast period. Major pharmaceutical and biotechnology companies' growing production of new generation biologics is a high-impact rendering growth driver of the market. The subsequent increase is a consequence of the high global prevalence of target diseases, which has triggered the companies to produce advanced biologics. Consequently, the high need for biologics resulted in extraordinary growth in biopharmaceutical companies.

Moreover, the increasing number of R&D investments initiated by the companies is one of the key potential growth factors that will drive the market. Furthermore, the increasing chronic disease burden present over this region is anticipated to drive researchers and healthcare professionals' inclination toward advanced technologies, which in turn is further anticipated to widen the scope for growth.

Global Biological Safety Testing Market Definition

Biological tests describe the standardized experiments that determine the toxicity of a substance or material by evaluating its result on living organisms.

Tests are designed to use suitable organisms and sensitive effect measurements in the media of interest for a specified test duration.

Global Biological Safety Testing Market Dynamics

Drivers: Rising number of government initiatives and recommendations

The rising number of government initiatives to promote biological safety testing products is presumed to drive the overall market growth during the forecast period. The high microbial contamination rates and bioburden during pharmaceutical & biologics manufacturing are key factors driving the government and private organizations to improve the underlying biological safety practices. Microbial contamination is known to exert a huge impact on biologics & pharmaceuticals manufacturing, generally arising in product variability, significant loss of potency, early degradation due to high levels of bacterial endotoxins. In addition, laboratory-based contamination has stimulated the development and refinement of workstations by incorporating biological safety testing tools.

Restraints: Time-consuming approval process

The significant cost associated and time taken during the approval process for medical devices, biologics, and pharmaceutical is the most critical restraining factor for the industry. Moreover, the high amount of R&D investment involved in developing new technology of these systems is a key factor contributing to their high costs. Furthermore, the lack of availability & funding opportunities to new players in the emerging economies restricts these players from investing more in research and development. Moreover, low awareness levels associated with the biological safety testing procedures and their benefits in emerging economies are also anticipated to exert a negative impact on the global level and are considered one of the growth-restraining drivers for the market.

Global Biological Safety Testing Market Research Report Segmentation

The study categorizes the biological safety testing market based on product, test type, and application at the regional and global levels.

By Product Outlook (Sales, USD Million, 2017-2030)

• Reagents & kits
• Services
• Instruments

By Test Outlook (Sales, USD Million, 2017-2030)

• Sterility Tests
• Cell Line Authentication & Characterization Tests
• Bioburden Tests
• Endotoxin Tests
• Adventitious Agent Detection Tests
• Residual Host Contamination Detection Tests
• Others

By Application Outlook (Sales, USD Million, 2017-2030)

• Stem Cell
• Tissue & Tissue Based Products
• Gene Therapy
• Blood & Blood Based Products
• Vaccines & Therapeutics

By Region Outlook (Sales, USD Million, 2017-2030)

• North America (US, Canada, Mexico)
• South America (Brazil, Argentina, Colombia, Peru, Rest of Latin America)
• Europe (Germany, Italy, France, UK, Spain, Poland, Russia, Slovenia, Slovakia, Hungary, Czech Republic, Belgium, the Netherlands, Norway, Sweden, Denmark, Rest of Europe)
• Asia Pacific (China, Japan, India, South Korea, Indonesia, Malaysia, Thailand, Vietnam, Myanmar, Cambodia, the Philippines, Singapore, Australia & New Zealand, Rest of Asia Pacific)
• The Middle East & Africa (Saudi Arabia, UAE, South Africa, Northern Africa, Rest of MEA)

The reagents & kits segment accounted for the largest market share, by product

Based on product, the global biological safety testing market is divided into reagents & kits, services, and instruments. Reagents & kits held a dominant share in the product segment in 2021. 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 laboratory technicians' inclination to incorporate these products, specifically in toxicology assessment. The advancements include incorporating 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, contributing to the high segment share.

Asia Pacific accounts for the highest CAGR during the forecast period

Based on the regions, the global biological safety testing market has been segmented across North America, Asia-Pacific, Europe, South America, and the Middle East & Africa. Globally, Asia Pacific is the fastest-growing region with a CAGR of 13.1% during the forecast period. The exponential growth rate can be attributed to the increasing healthcare spending, the demand for better infrastructure quality in laboratory & clinical research, and the adoption of compact and low-cost techniques in clinical research. The lucrative growth registered by this region is also believed to be an outcome of the growing healthcare spending and rising awareness levels pertaining to the benefits of biological safety testing tools.

Moreover, regulatory policies enforced by the healthcare organizations favoring higher biosafety and improving healthcare infrastructure quality are further expected to widen the growth opportunities in the future. Additionally, the Asia?Pacific Biosafety Association trains the concerned professionals across the region on biosafety principles and practices, thus widening the growth prospects for this region.

Key Market Players

The biological safety testing market is mildly concentrated in nature, with few global players operating in the market such as Avance Biosciences, Cytovance Biologics, Eurofins Scientific, Lonza, Merck KGaA, Promega Corporation, Thermo Fisher Scientific, Toxikon, WuXi AppTec, and Biomerieux SA. Every company follows its own business strategy to attain the maximum market share.

Recent Developments

• In 2021, Charles River Laboratories, Inc. (US) had acquired Cognate BioServices to expand its cell and gene therapy development, testing, and manufacturing capabilities providing clients with a complete solution from basic research and discovery to CGMP manufacturing.
• In 2021, PyroTec PRO Automated Robotic Solution for Endotoxin Testing was introduced by Lonza. The new PyroWave Reader add-on was created specifically for use with the PyroGene Recombinant Factor C (rFC) Assay, which is long-lasting.
• In 2020, "Red One Automated Bioburden Detection," a new product from Redberry, enables instantaneous bioburden detection of microorganisms and is designed for water and pharmaceutical testing.

Key Issues Addressed

• What is the market size by various segmentation of the biological safety testing by region and its respective countries?
• What are the customer buying behavior, key takeaways, and Porter's 5 forces of the biological safety testing market?
• What are the key opportunities and trends for manufacturers involved in the biological safety testing supply chain?
• What are the fundamental dynamics (drivers, restraints, opportunities, and challenges) of the market?
• What and how regulations, schemes, patents, and policies are impacting the growth of the market?
• What are the upcoming technological solutions influencing market trends? How will existing companies adapt to the new change in technology?
• The market player positioning, top winning strategies by years, company product developments, and launches will be?
• How has COVID-19 impacted the demand and sales of biological safety testing in the global market? Also, the expected BPS drop or rise count of the market and market predicted recovery period.
• Detailed analysis of the competitors and their latest launch, and what are the prominent startups introduced in the target market? Also, detailed company profiling of 25+ leading and prominent companies in the market.