Biotecnologie BT, a European CRO located in north-central Italy, has seen the industry grow and change in the last 20 years of its operations.
The biopesticide market currently accounts for 5% of the total plant protection product market, which is predicted to hit USD $70.57 billion by 2022. That 5% biopesticide stake has been rising annually between 14% and 17%, with a projection to hit USD $4.1 billion by the end of 2018 and just over USD $6 billion by 2022.
The company attributes this rapid growth in the biopesticide sector due not only to changing regulations for chemical application globally, but also to end user demand. The growers are driven in part by government support for integrated pest management methods that include more environmentally-friendly products in order to safeguard the health of the overall plant.
Biotecnologie BT is seeing the rise in use and registrations of biopesticides globally (with hikes especially steep in Southeast Asia and China), and believes the movement will be beneficial for agriculture for an array of reasons. It encourages manufacturers entering this space to choose carefully, however, when selecting a CRO to see the long, and often complex testing and registration process through.
Things to keep in mind for entering into this product segment include:
- Biological doesn’t necessarily mean risk-free
Microbial Pest Control Agents (including botanical extracts, insect sex pheramones, and other compounds naturally present in the environment) shouldn’t be underestimated.Microorganisms behave in different ways depending on their surroundings. Their impact on one geography vs. another can vary greatly, potentially causing environmental imbalance if improperly handled. Furthermore, little is known about some microogranisms’ secondary metabolites and the hazards related to toxins produced.Biological inputs undergo many processes in use that and modify their structure. For this reason, in the testing phase, Biotecnologie BT emphasizes the necessity to address the fate of the substances in the different environmental compartments (soil, water and air), to assess their availability to plants and animals and their potential for bioaccumulation in the organisms.These tests, dubbed fate tests and simulated use trials, can save registering companies massive expenses and unforseen hurdles over time.When choosing a CRO to register your novel biological products, Biotecnologie BT recommends assessing potential partners’ testing breadth and predictive approaches. Biotecnologie BT counts its 2 GLP and GEP Test Facilities, greenhouses, 20 study directors, and state-of-the-art equipment as key to predictively staying ahead of these global expansion legislative challenges.They also recommend clients not skimp on the submitted paperwork just because a product is of biological origin. Keeping the lines of communication open throughout the process is key to endgame success.
- Test guidelines are in flux for microorganisms
Risk assessment methodologies, already in use for chemicals, are not suitable to evaluate the safety and risk associated with the use of “living” applications.The European regulatory committees are currently working on biopesticide legislation, including reviewing data requirements and promoting harmonization of the EU member states. This process includes the development of new test guidelines for microorganisms. As of now, there are currently no specific EU guidance documents that are internationally accepted.For this reason, choosing a CRO that specializes in a product segment such as biological control is key.Biotecnologie BT offers the complete range of suitable studies (from five batch to ecotox on pollinators) to successfully assemble a registration dossier for biopesticides.There is so much to know the world over related to the requirements for testing and registration. And, what is known now may rapidly change and require re-evaluation in the near future. Utilizing a partner who isn’t spread too thin across market segments will provide a much more beneficial outcome in the long term.