Industry Outlook

The biological safety testing market is set to reach US$ 8,935.4 Mn by 2026 from US$ 3,120.8 Mn in 2017 growing at an impressive pace with a compounded annual growth rate (CAGR) of 12.5% during the forecast period from 2018 to 2026. The primary features responsible for the biological safety testing market are rising prevalence of chronic diseases and rapid growth in the clinical laboratories worldwide. Global healthcare agencies have sanctioned stringent regulatory norms for the safety and efficacy of medicinal substances. Biologics and gene therapy are the medicine of the future due to rise in personalized medicine and severe adverse effects associated with current allopathic drugs. The limitations associated with this market are dearth of skilled workforce and gross negligence of health in developing countries.

Technological advancement and rampant growth in clinical laboratories to support reagents and kits market growth

Reagents and kits are currently leading the products segment for biological safety testing market. The key factors responsible for the dominance of reagents and kits are the rising prevalence of chronic disease and rampant growth in clinical laboratories throughout the globe. Technological advancement has resulted in quick interpretation of biological samples under investigation. Instruments are set to highlight magnificent growth during the forecast period on account of factors such as impressive ergonomic designs, easy to operate and quick turnaround time related to sample analysis and interpretation.

Rise in infectious disease and sanction of stringent regulatory norms drive the vaccines and therapeutics market growth

Vaccines and therapeutics segment will be the leading and fastest growing application segment for biological safety testing market. Rise in infectious disease and stringent regulatory norms sanctioned by healthcare agencies pertaining to safety and efficacy drive the vaccines therapeutics market. Gene therapy will register impressive growth during the forecast period on account of increasing number of patients suffering with advanced stage cancer and severe side effects associated with chemotherapy. There is burgeoning requirement of targeted drug therapy to ensure maximum patient compliance and less side effects.

Availability of diverse range of endotoxin tests is responsible for its supremacy in the test segment

In the present scenario endotoxin tests are dominating the market on account of factors such as increasing adoption by pharmaceutical and biotechnology industries and availability of diverse range of endotoxin tests. Turbidimetric method, gel clot endotoxin test and USP chromogenic endotoxin testing are employed during in process quality control to validate the sterility of manufacturing operation. Bioburden tests propose lucrative market growth during the forecast period due to its enhanced adoption in determining the bioburden limits biologics and medical devices. The recent integration of calorimetric method with bioburden testing has resulted in quick and precise bioburden quantification.

Flourishing biopharmaceutical industries and rising prevalence of chronic disease drive the market growth in North America

North America currently leads the regional segment for biological safety testing market with 35 % share. The features responsible for the impressive market growth in North America are flourishing biopharmaceutical industries and rising prevalence of chronic disease. Domicile of major players such as Charles Rivers Laboratories International, Inc., and Merck & Co., Inc. etc. contributes towards the dominance of North America. In Europe the market growth is determined by factors such as stringent regulatory norms stipulated by European Medical Agency (EMA) primarily focusing on medicine safety and efficacy. Presence of market leaders pioneering in analytical instruments propel the market growth in Europe region. Asia Pacific will progress at a steady pace during the forecast period on account of factors such as increasing demand for biologics, supportive regulatory environment and competitive scenario created by emerging local players.

Medical device manufacturers providing biological safety testing products are Avance Biosciences, Inc., Bsl Biosciences, Charles River Laboratories International, Inc., Cytovance Biologics, Inc., Lonza Group, Merck & Co., Inc., Sigma-Aldrich Corporation, SGS S.A., Toxikon Corporation and Wuxi Pharmatech (Cayman), Inc.

Historical & Forecast Period

This study report represents analysis of each segment from 2022 to 2032 considering 2023 as the base year. Compounded Annual Growth Rate (CAGR) for each of the respective segments estimated for the forecast period of 2024 to 2032.

The current report comprises of quantitative market estimations for each micro market for every geographical region and qualitative market analysis such as micro and macro environment analysis, market trends, competitive intelligence, segment analysis, porters five force model, top winning strategies, top investment markets, emerging trends and technological analysis, case studies, strategic conclusions and recommendations and other key market insights.

Research Methodology

The complete research study was conducted in three phases, namely: secondary research, primary research, and expert panel review. key data point that enables the estimation of Biological Safety Testing market are as follows:

• Research and development budgets of manufacturers and government spending
• Revenues of key companies in the market segment
• Number of end users and consumption volume, price and value.
• Geographical revenues generate by countries considered in the report
• Micro and macro environment factors that are currently influencing the Biological Safety Testing market and their expected impact during the forecast period.

Market forecast was performed through proprietary software that analyzes various qualitative and quantitative factors. Growth rate and CAGR were estimated through intensive secondary and primary research. Data triangulation across various data points provides accuracy across various analyzed market segments in the report. Application of both top down and bottom-up approach for validation of market estimation assures logical, methodical and mathematical consistency of the quantitative data.

Key questions answered in this report

• What are the key micro and macro environmental factors that are impacting the growth of Biological Safety Testing market?
• What are the key investment pockets with respect to product segments and geographies currently and during the forecast period?
• Estimated forecast and market projections up to 2032.
• Which segment accounts for the fastest CAGR during the forecast period?
• Which market segment holds a larger market share and why?
• Are low and middle-income economies investing in the Biological Safety Testing market?
• Which is the largest regional market for Biological Safety Testing market?
• What are the market trends and dynamics in emerging markets such as Asia Pacific, Latin America, and Middle East & Africa?
• Which are the key trends driving Biological Safety Testing market growth?
• Who are the key competitors and what are their key strategies to enhance their market presence in the Biological Safety Testing market worldwide?