This blog was written by Fanny Deiss, with contributions and technical insights provided by Andermatt Canada.
Bioprotection products, which are derived from naturally occurring organisms or substances, provide numerous advantages and are often seen as safer alternatives to synthetic pesticides. However, bringing a bioprotection product to market is a complex process that can take years from initial research to final commercialization.
In this blog, we look at the main steps required to get a bioprotection product approved for use, featuring insights from Andermatt Canada, a company experienced in developing and registering biological solutions across multiple markets.
Step 1 – Lab research
Developing a new bioprotection product begins with laboratory research. The product can be based on a known active ingredient, such as a fungal strain, botanical substance, or a bacterium, which can then be reformulated, enhanced, or combined with other organisms. Alternatively, development may start with an entirely new active ingredient.
When working with new active ingredients, early experiments involve screening a large number of candidate organisms or substances to identify those that have the potential to control a target pest.
Once an active ingredient has been selected, further research is conducted to understand its mode of action, its efficacy against the pest under laboratory conditions, and its production potential. Researchers also evaluate the potential impact on non-target organisms and the environment.
Many initially promising active substances do not move past this first step, due to inconsistent results or production challenges.
Step 2 – Field testing and formulation development
Once the active ingredient is deemed suitable, additional studies are conducted in field settings, both at small and large scales. This helps researchers evaluate efficacy in the field and across multiple crops, while monitoring its effects on the environment and non-target organisms.
A significant challenge at this stage is product formulation, which aims to ensure the active substance remains effective and stable. Unlike synthetic pesticides, biological products can degrade more easily, so researchers experiment with solvents, carriers, storage conditions, and other technologies to optimize product performance.
Step 3 – Regulatory approval
Even though bioprotection products are made from naturally occurring substances, they still go through a strict approval process before they can be sold. Every product must be evaluated to ensure it is low-risk and works as intended.
Generally, manufacturers must submit a dossier of data to the registration authority. This includes studies on toxicology, environmental impact and product efficacy. While regulatory systems vary widely across countries and regions, many countries require separate evaluations of the active ingredient (if new) and the final product.
The regulatory approval process can take several years and requires significant financial investments. Requirements may also differ depending on the type of bioprotection product or location. For instance, countries, such as Spain or Brazil, require registration of macrobial products, while others do not.
To learn more about how this process works, we spoke with Sarah Murch, Research and Regulatory Affairs Manager at Andermatt Canada. She explains that in Canada, the registration process is overseen by Health Canada’s Pest Management Regulatory Agency (PMRA). According to Sarah, the process is comparable to registering conventional pesticides but includes nuances tailored for biological products. She notes that “The PMRA has done well with providing detailed guidance documents for both”, which helps applicants navigate requirements more efficiently.
Step 4 – Market entry
After approval, successfully bringing a product to market comes with its own challenges. Manufacturers must scale up production of their new product while maintaining consistent quality.
Distribution and logistics can also be complex considering the nature of bioprotection products, which may require specific storage or transport conditions to keep the active organisms viable. Establishing networks with local distributors and retailers is therefore essential to reach growers efficiently.
Even once a product is available, farmer adoption is a critical step in its market entry. Many growers are still unfamiliar with how biocontrol works and how to integrate bioprotection products into their pest management programmes. Sam Haley, Global Product Manager at Andermatt Canada, notes that growers benefit most from seeing these tools in action and that “experience shows that hands-on demonstrations and peer recommendations are highly effective in building trust and encouraging adoption.”.
To encourage adoption and properly educate farmers, Andermatt Canada invites growers to demonstrations of the products to observe trial work, or when working with a variety of products, Andermatt will host field days, in partnership with retailers and farmers. “Farmers trust farmers,” Sam explains. “When good news moves through the community, it carries real weight—and that’s something Andermatt Canada can rely on. Having trial results from the local area or on crops they grow makes a huge difference. Growers want to see proof that’s directly relevant to their own operation.” She adds that getting products into the hands of respected, influential growers accelerates momentum. “When those key farmers try something, see strong results, and share their experience, it spreads quickly. Positive feedback moves through the grapevine fast—and it naturally builds interest among other growers.”
What is the typical timeline?
The timeline from research to commercialization can vary, typically spanning several years depending on product complexity, data quality, and regulatory efficiency. In Canada, microbial products are generally considered lower risk, which means fewer data requirements and potentially shorter timelines. Invertebrate biocontrol agents do not require registration in the country, which can significantly shorten their route to market. However, unless the agent is already present in the country, the import, handling and release of invertebrate biocontrol agents is regulated by the Canadian Food and Inspection Authority (CFIA).
Sarah Murch notes that Canada’s system is rigorous but in line with international standards, adding that “each market has its quirks.” For example, Europe tends to have more stringent data requirements. In the EU, bioprotection products follow the same evaluation process as synthetic pesticides: the active ingredient is approved at the European level, while product registration occurs at the national level. The entire process, from research to market entry, can take up to 10 years.
Main factors that influence the timeline:
- Complexity of the product
- Quality and completeness of research data
- Country-specific regulatory requirements
- Product type (biopesticides vs invertebrate biological agents)
Key challenges along the way
Beyond the complexity and duration of the process, developing and bringing a bioprotection product to market comes with several hurdles, both financial and regulatory:
- High development cost: developing a single bioprotection product is a significant investment in research, development and regulatory compliance. This can heavily impact smaller companies that must seek donors, investors, or partnerships to secure financial support.
- Lack of regulatory pathways tailored to bioprotection products: In many countries, regulatory frameworks were originally designed for chemical pesticides, which can present unique challenges for biological products. Because biological products tend to be more target-specific and degrade quickly, many data requirements used for chemical products simply don’t apply. Continued dialogue and collaboration with regulators are helping to address these differences.
- Lack of international harmonization: A product approved in one country might require a new application in another, even when the data has already been validated. This can discourage smaller companies from expanding internationally.
Sarah Murch emphasizes that greater international harmonization would be “incredibly helpful” to accelerate the process and reduce duplication of work.
What’s next for bioprotection?
Bringing a new biocontrol product on the market can be a decade-long journey, yet these products play an essential role in the transition toward a more sustainable agricultural production.
As demand for biological pest management continues to grow, the need for efficient and tailored regulatory systems becomes even clearer. Data from the CABI BioProtection Portal indicates that, on average, countries with a regulatory framework specific for biopesticides registration have more registered products than those that treat biopesticides the same as conventional pesticides. This trend is also reflected in Portal updates; for example, Brazil, which has a biopesticide tailored process, consistently has many new registered products to add, while countries like UK or France, where regulations are not so tailored to biocontrol agents, have far fewer new products.
Sarah Murch notes that progress is happening. She’s seen regulators become more receptive to biological products in recent years. “There’s a growing recognition of their benefits,” she explains, “and a willingness to streamline processes where possible.” She adds that pre-submission consultations are proving particularly useful, allowing case-by-case assessments that can lead to expedited registration or reduced data requirements when justified.
“Regulators are becoming more open and pragmatic when it comes to biological products.” Still, she emphasizes that continued education and outreach are essential, both to help regulators understand these products’ unique characteristics and to strengthen farmer acceptance.
Streamlining approval processes and closer collaboration among regulators, researchers and industry, could make a real difference, helping to boost innovation and ensuring that farmers can access safe and effective solutions for pest management.
