In order to effectively integrate humanized mouse technology into the drug and vaccine development process, the technology must be widely accessible and highly reproducible and allow the production of large numbers of animals at a reasonable cost. Humanizing mice is demanding and not only requires advanced technical skills but also an intricate logistical setup. A practical and possibly cost-effective short-term solution could be large-scale generation of humanized mice by third party providers who are also equipped to execute custom-designed drug treatment and vaccination regimens against human pathogens, thereby reducing costly setup and maintenance of biocontainment facilities.

CRO’s provide a portfolio of products, services, and solutions that focuses on drug discovery and early-stage development. They have research models and associated services, discovery research studies and services, and comprehensive safety assessment studies in both regulated and non-regulated environments. They collaborate with clients from target discovery through candidate selection. When critical decisions are made regarding which therapeutics will progress from discovery to development, they continue to work alongside their clients as the drug candidate moves downstream. Their expertise in early stage drug research and pharmacology provides with a competitive advantage enabling their clients to make critical drug development decisions more quickly.

Based on application, the market is segmented into oncology, immunology and infectious diseases, neuroscience, hematopoiesis, toxicology, and other applications. Oncology dominated the market in 2018. In cancer research, for example, isolated tumour cells are used to identify the characteristics and causes of cell degeneration. The true nature of cancer, however, becomes apparent only when its development is viewed in connection with other cells and tissues in the body. In order to trace the development of a tumour in the organism and test therapeutic approaches, animal experiments are necessary in which tumour cells are transferred into mice.

The close relationship between cellular basic research and animal testing also plays a central role in research on infectious diseases. It is the only path to understanding how bacteria and viruses infiltrate and attack the animal organism. Insights into the interaction between viruses and their host cells enable the targeted treatment of virus infections such as influenza, herpes or smallpox, and the development of preventive measures. A visible result of this type of research is the progress made in the area of vaccinations. Only a few years ago was it discovered that papilloma viruses are involved in the development of cervical cancer. Without animal experiments on mice this discovery would not have been possible.

A substantial number of therapeutic approaches are based on knowledge gained from animal experiments. For example, stem cell transplantations into the brain of mice, which were previously genetically modified or subjected to chemical substances producing pathologies similar to human diseases such as Parkinson’s disease, multiple sclerosis or stroke, led to improvements in the general condition and the disappearance of typical symptoms.

Knowledge gained from animal experiments is also used in the development of prosthetic devices and the treatment of paralysis. For example, using electrical stimulation of the spinal nerves, non-human primates suffering from paralysis of their limbs due to spinal cord injury were able again to move their hand and grasp objects. Nerve conduction could be partially restored in paraplegic rats by transplanting embryonic stem cells into their spinal cord. However, the molecular and cellular processes involved are not yet understood well enough to be applied to humans.

North America dominated the global humanized mouse and rat model market in 2018. Continuous R&D activities in biomedical research and advancing biotechnology industry are the major drivers for the growth in the region.

The US biotech industry remains the benchmark in international terms. It is considered to be the most successful in the world and it is likely to maintain this leading position for the foreseeable future. Scientific and technological advances and growing understanding of the underlying mechanisms of disease are fueling the development of new treatments and cures for patients. At the same time, the costs, time, and complexities of biopharmaceutical research have also increased, introducing additional challenges in the research and development process.

The growth of the biotechnology industry is a unique and yet it rests on foundations common to other segments of American industry. Years of research, both government funded and privately funded, continue to provide a knowledge base unequaled in the world. The domestic capital market provides the ability to transform this knowledge into unique products and processes for markets around the world. While there is inevitable tension between the industry’s desire to bring new products to market and the concerns of the industry’s regulators, both sides have found new and innovative ways to work together.