The global market for in vitro toxicity testing is estimated to be $6,380m in 2018, with demand expected to grow at a CAGR of 6.8% over the next five years to reach $8,880 million by 2023, according to Kalorama Information’s In Vitro Toxicology Market report.
Europe is estimated to account for 41.1% of the global markets for in vitro toxicity testing, which Kalorama said is in line with the increasing awareness in Europe about animal testing and regulators commitment to promoting alternative testing methods.
Demand in Europe is expected to grow at a CAGR of 6.4% during the forecast period to reach $3,570 million by 2023.
Yet, due to the technical challenges faced in developing in vitro technologies, growth is expected to be restrained. Other challenges that will affect market growth negatively include: “Reluctance of regulatory agencies to include in vitro tests in their requirements due to consumer protection concerns, particularly since many in vitro methods currently lack convincing evidence of their effectiveness in accurately predicting toxicity in vivo,” according to the report.
The report also cites a “dearth of skilled manpower” as an important market restraint affecting the development and adoption of in vitro toxicity testing platforms.
Market growth in many directions
Clive Roper, head of in vitro sciences at Charles River Laboratories, said the in vitro market has grown in many different directions, including regulatory toxicology, discovery, immunology, and cellular tissue models.
“We have seen that the demand in these areas has grown at a greater rate than many other services albeit at a lower starting level,” he told us. “This growth is not just from like for like sales, but also from integrated toxicology, translational sciences, and investigational toxicology.”
Roper said in vitro toxicology demand will only increase, citing publication of a strategic roadmap which looks to establish new approaches to safety testing.
In the US, sixteen federal agencies recently came together to develop the strategic roadmap, which outlines a new framework for drug and chemical safety testing, aiming to reduce animal use while providing more human-relevant toxicology data.
The National Toxicology Program (NTP), a federal interagency program headquartered at the National Institute of Environmental Health Sciences (NIEHS) and part of the National Institutes of Health, published the roadmap in January of this year.
“New technologies and views on regulatory acceptance will also drive growth and in turn generate new technologies to answer scientific questions, which have not been possible to investigate or improve on current methods,” he said, noting that the Environmental Protection Agency (EPA) is now moving towards in vitro acute testing.
Microfluidic technologies, also known as “on-a-chip,” also has been taking the attention of Charles River, Roper said.
“As the number of suppliers and models increases, their success will be measured against reduced safety or efficacy attrition rates,” he explained. “They are unlikely to be formerly validated, as we have done in acute regulatory toxicology, but will be evaluated as fit for purpose prior to being repurposed for the next test articles needed.”
Among the companies working to develop microfluidic technologies is Emulate, which earlier this year raised $36m to scale its organ-on-chips technology. The Boston, MA-based firm has several partnerships with companies, including Merck, Roche, and AstraZeneca.
Animal-based toxicity testing: Ethical concerns and costs
While animal-based toxicity testing has been the standard for evaluating drug safety and efficacy, strong market trends are promoting alternatives, which has led to investment in new methods. “The main factors driving this trend are ethical concerns, cost of animal studies, and the growing skepticism on the relevance of animal-based toxicity data,” according to the report.
For industry, animal testing “can be painfully long and costly,” according to the report. “For example, the current rodent bioassay recommended for testing carcinogenicity potential of a chemical can take about five years to complete and cost around $4 million per chemical.”
The report also noted that animal-based methods are “impacting the efficiency of regulatory agencies to catch up with the frequency at which new chemicals are being introduced."
According to the report, thousands of chemicals on the market currently do not have sufficient data on environmental and human health impacts.
“Efficient high throughput In vitro methods capable of large scale screening of chemicals will be ideal for addressing this issue,” the report continued. “Development and validation of such methods are gaining the attention of regulatory agencies and other stake holders including pharmaceutical and chemical companies.”