Biological Safety Testing Market By Product (Instruments, Services, Reagents And Kits), By Application (Gene Therapy, Stem Cells, Tissue & Tissue Based Products, Blood & Blood Based Products, Vaccines & Therapeutics), By Test (Sterility Test, Cell Line Authentication And Characterization Test, Bioburden Test, Endotoxin Test, Adventitious Agent Detection Test, Residual Host Contamination Detection Test, Others) - Growth, Future Prospects & Competitive Analysis, 2018 – 2026

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.

Market Synopsis

Biological Safety Testing Market

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.

Biological Safety Testing Market

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.

Biological Safety Testing Market

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.

Biological Safety Testing Market

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.

Biological Safety Testing Market

Historical & Forecast Period

2016 – Historical 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. Compounded annual growth rate (CAGR) for each respective segments are calculated for the forecast period from 2018 to 2026.

Biological Safety Testing Market

Report Scope by Segments

Compounded annual growth rate and market estimation for the forecast period 2018 to 2026 was 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 by product, application, test and geography.

By Product (2016–2026; US$ Mn)

  • Instruments
  • Services
  • Reagents and Kits

By Application (2016–2026; US$ Mn)

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

By Test (2016–2026; US$ Mn)

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

Geography Segment (2016–2026; US$ Mn)

  • 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
    • Rest 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 answered in this report

  • What are the drivers, restraints and opportunities related to biological safety testing market?
  • Who are the key players providing biological safety testing products?
  • Which is the leading and fastest growing product segment for biological safety testing market?
  • Which is the leading and fastest growing test segment for biological safety testing market?
  • Which is the largest and fastest growing application segment for biological safety testing market?
  • Which is the largest and fastest growing regional segment for biological safety testing market?
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Published Date:  Nov 2018
Category:  Medical Devices
Report ID:   58705
Report Format:   PDF
Pages:   120
Rating:    4.3 (65)
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