Sanjiv Rana (SR): What are some commercialization challenges specific to biological products that make them easier or harder to bring to market compared with chemical actives?
Jan Mostert (JM): There are a number of challenges in bringing biologicals/biorationals to market as they are: more expensive overall to produce than synthetic conventional crop protection products; mainly contact products; rather quickly bio-degradable; require optimal leaf coverage and repeated applications for good control. As the coverage is often not optimal, applications must be repeated more often than with a strong and/or systemic conventional product. This increases the cost for pest control per hectare, not only from a product perspective, but possibly also because of additional spraying time. Sometimes the biologicals also have a shorter shelf life or require specific storage or application conditions, which makes them less easy to store and use (see question 5).
SR: Does the introduction of biologicals in a market involve higher levels of farmer training and stewardship compared with chemical actives?
JM: Whilst some products slip into existing programs and existing understanding very easily and some farmers are very much at the cutting edge of this technology, in most cases, further training needs to be carried out to better understand biorational products. Biorationals behave and act in ways that are completely new to them so it is a case of changing their mindset. The effectiveness of biologicals/biorationals is not by definition weaker than a conventional chemical and understanding that biologicals are a puzzle piece of the total solution is the first step to embracing them in a crop system.
Almost all biologicals are contact products, so it is very important to apply the product directly where the pest or disease is. The better we do this, the better the effect is. For many farmers used to conventional systemic products, this is not intuitive, and they need training.
In general, registered biorationals, foliar fungicides or insecticides, are usually a lot more sensitive to environmental conditions or sensitive to particular timings and methods of application than chemical actives so the next step is to understand and provide training about climate (the best conditions in which to spray biorationals), pest and disease knowledge, spray techniques, etc. Certis conducts training for farmers and advisors to communicate these extra variables that are involved with using such products, to achieve the best possible performance.
SluxxHP (ferric phosphate) is a good example: Certis conducted many training events with agronomists as well as farmers over the past ten years, aiming to increase their understanding of how ferric phosphate works as well as promoting its benefits. With historical molluscicide products, farmers were used to seeing dead slugs on the soil surface - clear evidence of effective control. With SluxxHP the slugs are killed in a different way. It takes a little longer and the slugs will bury themselves deeper into the soil profile – hence no dead slugs are seen on the soil surface, raising the question, for the uninitiated: is the product working correctly? Thus, understanding of the mode of action is vital.
Another example of the need for intensive grower education relates to the application techniques required for Eradicoat in tropical crops such as cocoa. This can provide sustainable control of Mealy bugs, which are vectors for the Cocoa Swollen Shoot Virus Disease (CSSVD), but it is essential that the product is correctly applied to achieve effective control.
SR: Some of the drivers of increased interest and investment in biologicals have been pressures of public opinion and increased regulatory scrutiny of existing chemical actives. Do you view biologicals as having a role in tackling pest resistance to chemical actives in all crops?
JM: Yes. Any product with an alternative mode of action can play a role in mitigating the risk of resistance development and biologicals do play a role, but in fact only where very good leaf coverage (to all surfaces) is achieved, as almost all biologicals/biorationals are contact acting products. They can definitely have an impact on pest / disease resistance levels where correct and effective application is achieved. But without contact, the biorational product will not offer effective control.
SR: New EU rules for biopesticide approval are expected to come into place by November. Will the new rules reduce the regulatory burden on companies? Will it make registration easier and faster?
Nicolas Colombo: First of all, these new requirements relate to active ingredients and plant protection products based on microbials only (for instance, they are not applicable to other biopesticides such as natural substances). It aims at deviating from the chemical approach, focusing on the biological properties of the microorganism (including the potential production of secondary metabolites). So, depending on the profile of the microorganism, this approach may reduce the burden for the applicant, since some data can be waived based on the literature information and weight of evidence approaches.
However, the legal text is flexible and open to interpretation due to the lack of published guidance documents, and, in addition, there are no specific provisions to solve the lack of capacity among authorities or to speed up the evaluations.
It is therefore not clear that the regulatory burden will be reduced or that registration will be either easier or faster.
SR: What have been Certis Belchim’s highlights in the past year in terms of licensing deals with other companies or any acquisitions made?
JM: Last year, SMART Expertise funding from the Welsh Government was granted for an 18-month research project called “Novel fungal volatile compounds for pest control (FUMIGATE)”. It was led by [the UK] Swansea University, with Certis Europe as co-founder and industry partner, alongside major Welsh growers. This project, ongoing with Certis Belchim, looks to develop new and innovative products to control soil pests, primarily nematodes and slugs.
SR: Which new biological products were launched by Certis Europe during 2021/2022? In which of the recently launched biological products do you see the most potential for success?
Laurence Antonio Gutierrez (LAG): Several new biorational products have been launched in the last year. With particular potential for future success, we launched the insecticides/ acaricides, Majestik (maltodextrine 476 g/L SL): and Neudosan (potassium salts of fatty acids 515g/L SL).
Majestik was launched in 2021/2022 in Spain to replace the old formulation, Eradicoat. In other countries, Majestik has a different brand name, Eradicoat Max. The launch of Majestik in Spain has seen particular success in fruiting vegetables for the control of mites and white fly. We expect further growth in 2022/2023 for fruiting vegetables and, in the medium term, the business will expand again as soon as the label extension to open field crops, including citrus and pears, is granted, including new pests such as psylla and scales.
Neudosanwas an exceptional launch in 2021/2022. Certis became the leading company for this kind of insecticide in fruiting vegetables (greenhouse) during the last campaign in Spain. The product is used to control aphids and white flies. Further growth is expected in the short term (2022/2023) for Neudosan in fruiting vegetables. In the medium to long term, two to three years out, more growth can be expected with granting of the label extension to open field crops including citrus. Label extension to further pests like scales, mites and trips is also likely to result in expansion of this business.
In addition, two new biorational products were launched in the fungicide sector. Valcure, a liquid formulation of Bacillus amyloliquefaciens strain D-747, is a soil fungicide to be applied by drip irrigation. It was successfully launched in 2021/2022 with an excellent strategy for segmentation versus Amylo-X solid formulation (based on the same ai) to be applied by foliar spraying. Valcure controls soil diseases in vegetables and other crops.
Tri-soil (Trichoderma atroviride strain I-1237) is a soil fungicide for application by drip irrigation and drench. This product is also used to control soil diseases in fruiting vegetables and other crops.
Furthermore, an important label extension was granted on the fungicide, Kumar (potassium hydrogen carbonate), in the Netherlands for use on carrots, marking a major step forward for outdoor crops.
SR: Which are some promising biological products about to be launched or in the registration pipeline?
LAG: In the development pipeline within Certis, at least 50% of the products are biologicals/biorationals and, of these, around half are likely to be launched in the next five years and the remainder in five to ten years.
In the registration pipeline, we have two new biological products:
Problad(sweet lupin seed extract), a promising broad-spectrum biological fungicide for foliar spraying, is to be included in IPM programmes to control powdery mildew and Botrytis in fruiting vegetables and other crops. It has been registered in Malta. Registration is expected in the first quarter of 2023 in Spain.
A promising biological nematicide for IPM soil management to control nematodes in fruiting vegetables is based on Purpureocillium lilacinum PL 11. Registration is expected in the first quarter of 2023 in Spain.
SR: What are the expected growth and trends in the biopesticides market compared with chemical actives?
JM: The speed of growth of biologicals (crop protection products) has more recently and more realistically been defined at a compound annual growth rate (CAGR) of around a maximum of 10%. The registration process is not very different for biological crop protection products, nor is it easier than for synthetic / conventional products, so not many new biological products are registered each year and they obtain more or less the same use / label limitations as conventional products. For example, these can include a limited number of applications per year, no application during flowering, spray free zones from waterways, etcetera. The expected CAGR for conventional products is however, lower, at just a few percent.
SR: Is Certis Belchim on the lookout for new acquisition opportunities or is the focus more on organic growth of existing strains within your portfolio?
JM: Most companies are looking for possible interesting acquisitions and so is Certis. However, we also focus on setting up development and distribution deals for specific products from third parties and on organic growth, exploiting the pipeline of our existing partnerships. For this, we have set up a specific focused biorational innovation team, to explore biological product opportunities anywhere in the world. Our aim is to screen potential products to streamline the development process in the search for products that fit our portfolio and country/market needs technically and commercially. So far, this approach has been quite successful, bringing at least one new biological/biorational to market every year.
SR: Most biopesticides have been insecticides or fungicides or nematicides. Do you see a market for bioherbicides?
JM: The planned reductions in the use of pesticides and the aim of increasing organic production raise enormous challenges for farmers and growers, especially as an increasing number of agrochemical products, some of which have no real alternative, is already being lost. Some segments are already identified with more biorational input than others: insecticides, simply on account of the reduced number of new conventional solutions, are high on the list and are used in IPM programmes in stone fruit, citrus and vines; and fungicides too, where there are many biorational candidates, are registered in wheat, rice, cabbages, tobacco as well as in vines for both table and wine grapes. Biorational molluscicide products and potato sprout suppressants are also already widely used.
The successful transfer of biorational herbicide products to achieve effective pest control in field crops is a major challenge. Almost no biorational products have any systemic activity. So, to be effective, the product must have contact with its target, preferably even on the underside of leaves, and application quality is therefore key. Biorational products also degrade more quickly than conventional synthetic crop protection products and are therefore more susceptible to adverse weather conditions, potentially reducing performance. Work on application techniques and characteristics such as rainfastness to improve the performance of biorational products for outdoor crops is ongoing and there have already been some promising results. Indeed, several biorational product registrations have been granted for open field crops in other segments and the portfolio is growing.
However, the herbicide segment seems more likely to remain mainly conventional for longer. In the case of herbicides, there are at present still plenty of conventional products available from the major companies that meet market registration requirements, so farmers are generally not looking to change their current practices dramatically. It therefore seems likely that the introduction of biorational herbicides in open field crops will be rather a matter of changing habits and being part of the new solutions using combinations of conventional and biorational products, along with new ways of working, including crop rotations and cropping systems, mechanised weed control, new precision technologies using satellites and digital cameras, and robots for crop protection product applications.
The search for active ingredients that can compete on price and efficacy with conventional products to protect open field crops and that would be acceptable to farmer practices continues, but biological herbicides do not really seem a realistic prospect for at least the next eight years.