Traditional in vivo animal methods for assessing safety and toxicity continue to be replaced by alternative methods: in vitro and in silico. In addition, these alternatives are evolving into key technologies, practices, and resources for future medical applications in efficacy and precision.
Having developed over the past 20 years into a global market recently estimated at $5 billion, in vitro and in silico products and services are now about the same size as the in vivo services (contract research organization) industry. While growth has leveled off and there have been significant reductions in some countries, the number of animals used in research globally still totals almost 100 million a year. And new markets such as China could drive significant increases unless alternative methods are adopted. Although the majority are mice, more can be done to encourage alternatives.
Increased adoption of alternative methods by pharma seems inevitable as the industry focuses on increasing productivity and decreasing adverse reactions. But how fast is this uptake likely to go?
The cosmetics industry has been largely responsible for the initial technical and commercial successes, in the form of skin tissue substitutes. Encouraged by regulatory initiatives dating back 15–20 years and public opinion pressures that have recently become more focused, these new developments ultimately enabled in 2013 the final passage in the European Union of an extremely stringent sales ban on animal testing.
This policy move may not seem especially relevant to pharma. Nonetheless, it reflects the alignment of technical (stem cells, imaging) as well as social developments (environmental concerns, consumer influence) that ultimately affect the cosmetics industry and pharma alike. Even allowing for conservative adoption by pharma, double-digit growth is expected for at least the next five years.
Recent innovations in the cells themselves (from immortalized to primary to stem cells), in the equipment used for detection and analysis, and in the nascent $1 billion marketplace for specialized assay kits and validated protocols, all support broader use of in vitro methods.
Data handling and other standards are still stretching to span from basic workflow across the vast landscape of transcriptomics, proteomics, metabolomics, and cellomics. Some platforms, however, have emerged as clear favorites, and in 2013 in silico disease models even garnered agency letters of support.