The biological safety testing market is expected to reach US$ 8,935.4 million by 2026, up from US$ 3,120.8 million in 2017, with a compounded annual growth rate (CAGR) of 12.5% from 2018 to 2026. The primary features responsible for the biological safety testing market are the rising prevalence of chronic diseases and the rapid growth of 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 the rise of personalized medicine and the severe adverse effects associated with current allopathic drugs. The limitations associated with this market are the dearth of a skilled workforce and the gross negligence of health in developing countries.
Market Synopsis
Technological advancement and rampant growth in clinical laboratories support the growth of the market for reagents and kits.
Reagents and kits are currently leading the product segment for the biological safety testing market. The key factors responsible for the dominance of reagents and kits are the rising prevalence of chronic disease and the rampant growth of clinical laboratories throughout the globe. Technological advancement has resulted in the 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, ease of operation, and quick turnaround time related to sample analysis and interpretation.
The rise in infectious diseases and the implementation of stringent regulatory standards drive the vaccine and therapeutics market.
The vaccines and therapeutics segment will be the leading and fastest-growing application segment for the biological safety testing market. The rise in infectious diseases and stringent regulatory norms sanctioned by healthcare agencies pertaining to safety and efficacy drive the vaccine therapeutics market. Gene therapy will register impressive growth during the forecast period on account of the increasing number of patients suffering from advanced-stage cancer and the severe side effects associated with chemotherapy. There is a burgeoning requirement for targeted drug therapy to ensure maximum patient compliance with fewer side effects.
The availability of a 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 the pharmaceutical and biotechnology industries and the availability of a diverse range of endotoxin tests. The turbidimetric method, gel clot endotoxin test, and USP chromogenic endotoxin test are employed during in-process quality control to validate the sterility of manufacturing operations. Bioburden tests propose lucrative market growth during the forecast period due to their enhanced adoption in determining the bioburden limits of biologics and medical devices. The recent integration of the calorimetric method with bioburden testing has resulted in quick and precise bioburden quantification.
Flourishing biopharmaceutical industries and the rising prevalence of chronic disease drive market growth in North America.
North America currently leads the regional segment for the biological safety testing market with 35 %of the market. The flourishing biopharmaceutical industries and the rising prevalence of chronic diseases are the factors driving North America's impressive market growth.The domicile of major players such as CharlesRivers Laboratories International, Inc., Merck & Co., Inc., etc., contributes to the dominance of North America. In Europ,e-market growth is determined by factors such as stringent regulatory norms stipulated by the European Medical Agency(EMA),) primarily focusing on medicine safety and efficacy. The presence of market leaders who are pioneers in analytical instruments drives the market growth in Europe. Asia Pacific will progress at a steady pace during the forecast period on account of factors such as increasing demand for biologics, a supportive regulatory environment, and ad competitive scenario created by emerging local players.
Periods of History and Forecast
2016 is a historic year.
2017: Base Year
2018-2026: Forecast Period
This research report presents the analysis of each segment from 2016 to 2026, considering 2017 as the base year for the research. The compound annual growth rate (CAGR) for each of the respective segments is calculated for the forecast period from 2018 to 2026.
Report Scope by Segments
The compound annual growth rate and market estimation for the forecast period of 2018 to 2026 were determined by studying the current market trends prevalent in the biological safety testing market. In the scope of the report, the market segmentation is based on product, application, test, and geography.
By Product (2016-2026; US Dollar Millions)
Instruments
Services
Reagents and Kits
According to Application (2016-2026; US$ Mn)
Gene Therapy
Stem Cells
Tissue and Tissue-Based Products
Blood and Blood-Based Products
Vaccines and Therapeutics
By test (2016-2026; millions of dollars)
Sterility Test
Cell Line Authentication and Characterization Test
Bioburden Test
Endotoxin Test
Adventitious Agent Detection Test
Residual Host Contamination Detection Test
Others
Geography Segment (2016-2026; millions of dollars)
North America
United States
Canada
Europe
United Kingdom
Germany
Rest of Europe
Asia Pacific
China
Japan
Rest of Asia Pacific
Latin America (LATAM)
Brazil
Mexico
rest of Latin America
Middle East and Africa (MEA)
GCC
the remainder of MEA
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.
Key questions are answered in this report.
What are the drivers, restraints, and opportunities related to the biological safety testing market?
Who are the key players providing biological safety testing products?
Which is the leading and fastest-growing product segment for the biological safety testing market?
Which is the leading and fastest-growing test segment for the biological safety testing market?
Which is the largest and fastest-growing application segment for the biological safety testing market?
Which is the largest and fastest-growing regional segment for the biological safety testing market?
Frequently Asked Questions:
The market for Biological Safety Testing is expected to reach US$ 8,935.4 Mn in 2026.
The Biological Safety Testing market is expected to see significant CAGR growth over the coming years,at 12.5%.
The report is forecasted from 2018-2026.
The base year of this report is 2017.
Avance Biosciences Inc,Bsl Bioservice,Charles River Laboratories International, Inc.,Cytovance Biologics, Inc.,Lonza Group are some of the major players in the global market.
