Table of Contents
STUDY GOALS AND OBJECTIVES
BCC Research’s goal in conducting this study was to update the status of the global in vitro toxicity testing market and assess its growth potential over the five-year period from 2012 to 2017. We were particularly interested in understanding the current market adoption, and analyzing drivers for increasing this in terms of both scope (more applications) and scale (larger volume applications).
In addition, we were interested in understanding the impact of these methods on different industry sectors, specifically the pharmaceutical, cosmetic and chemical industries. Another key objective was to analyze the adoption of in vitro toxicity testing in developed and emerging markets.
REASONS FOR DOING THE STUDY
Classical toxicology testing programs have been in place for many decades now. Over the past 20 years, animal welfare and scientific activities have spurred the development of alternative testing methods.
This report details the recent key technical advances in different toxicology categories, and the extent of adoption by commercial customers and regulatory authorities. We also were interested in identifying the impact of new bioinformatics advancements with possible application to toxicology, and examining their growth potential.
There are many groups of suppliers that provide equipment, assays, cells, reagents, and services used in toxicity testing. Previously, there was broad coverage of the services landscape, and this study sought to analyze the others in greater depth.
SCOPE OF REPORT
The scope of the report encompasses the major types of traditional toxicity testing that have been used, and the in vitro techniques that are being developed by industry, government agencies and nonprofits. It analyzes current market status, examines drivers on future markets and presents forecasts of growth over the next five years.
Technology developments, including the latest trends, are discussed. Other influential factors such as validation and testing strategies for pharmaceuticals, cosmetics, and chemicals have also been included.
Regulatory drivers play a large role in toxicology, determining the specific parameters of tests that have been explicitly required. They also heavily influence the testing that is performed by companies in earlier stages of research. The report examines the regulatory role and the different federal and international agencies that play an active role in in vitro toxicology research, development and adoption.
The term ‘predictive’ is often used in conjunction with in vitro toxicology, and historically predictive approaches (also called ‘nonmechanistic’) have been contrasted with mechanistic approaches. This report does discuss where applicable the relative magnitude of the two. However, our research shows that increasingly the two are used in tandem, and that they are being viewed as complementary parts of an overall toolkit. Thus, our use of the term ‘Predictive Toxicology’ as a subject/discipline throughout is intended to encompass both predictive and mechanistic, and to connote an evolution of the overall toolkit. In keeping with the ‘Tox 21’ vision detailed later, the key attribute of this overall evolution is being more and more able to use in vitro methods to predict in vivo outcomes.
Relative to the pharmaceutical industry, this report covers the testing of pharmaceutical or so-called ‘small molecule’ drugs, synthesized from chemical compounds. Biologics, so-called ‘large molecule’ drugs, are tested via completely different approaches and technologies. Biologics safety testing is outside the scope of this report.
This report is designed to satisfy the information needs of a wide variety of individuals involved in the toxicology, in vitro and in silico marketplaces, including company senior management executives seeking to base their strategic decisions on the latest insights into toxicology market forces and trends. It is also aimed at managers and executives in product research and development and particularly those responsible for bringing new products to market.
METHODOLOGY AND INFORMATION SOURCES
Both primary and secondary research methodologies were used in preparing this study. Primary research included interviews with leading individuals in relevant companies and associations; primary sources of published data included research studies, company annual reports and government publications. Secondary sources consisted of literature searches, industry journals and other commercial publications. Data for market estimates and forecasts are pooled from a range of sources, critically assessed by BCC Research.
Robert Hunter has over 20 years of experience in life sciences as an analyst, business development executive, project manager and management consultant for business processes, organizational development and systems implementation. Recent studies have included multiple stem cell lines for true genetic diversity and proteomic biomarkers for cancer via label-free imaging. He is an early investor in a company using stem cells for in vitroscreening of pharmaceutical compounds.
The global in vitro toxicity testing market was valued at $4 billion in 2011 and more than $4.9 billion in 2012. This market is estimated to reach nearly $9.9 billion in 2017, with a compound annual growth rate (CAGR) of 14.7% for the five-year period, 2012 to 2017.
This report provides:
• An overview of the global in vitro toxicity testing market, with assessments of its growth potential over the next five years and the current market scenario for alternative measures to animal testing.
• Analyses of market trends, with data from 2011 and 2012, and projections of CAGRs for the period 2012 and 2017.
• Discussion of the two major technology-based approaches, mechanistic and nonmechanistic.
• A breakdown of influential factors, such as validation of the alternative measures for toxicity and toxicity testing strategies for chemicals, pesticides, and food additives.
• Comprehensive company profiles of major players.
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