The Growing Crop Protection Challenge of Active Ingredient Development

For years, the cost of bringing active ingredients (AIs) to market has risen significantly due to extensive regulatory reviews, safety assessments, and compliance requirements, making it harder for companies to invest in new solutions. As a result, many focus on reformulating existing products rather than developing new ones. Syngenta, for example, is introducing two new molecules this year, pending regulatory approval: PLINAZOLIN^® technology and TYMIRIUM^® technology. PLINAZOLIN features a new active ingredient with no known resistance or cross-resistance, providing growers with top-tier broad spectrum insecticide.

TYMIRIUM targets key challenges in row crops, including nematodes and sudden death syndrome in soybeans. “These two new molecules will provide enhanced protection against insects, plant parasitic nematodes, and diseases while preserving beneficial organisms crucial for soil health and biodiversity,” Jeff Cecil, Head of Marketing for Crop Protection, Syngenta, North America says.

What Is Driving Up Costs?

The rising costs of developing new active ingredients in agriculture are driven by factors such as stricter regulatory requirements, research and development technologies, and extensive testing for sustainable solutions.

“While the economic and political climate is certainly a contributor, with inflation, rising interest rates, and new tariffs and sanctions affecting the economy, the regulatory environment is the main factor driving up costs for developing new AIs,” Cecil says, “The time it takes to get an AI to market has significantly increased, resulting in higher overall costs.”

Meeting registration requirements has become more costly as more extensive data is needed. And wait time becomes longer due to staff shortages and increased number of product submissions. “Another key factor is investment in R&D. Multiple processes, including formulation development, improving product shelf life, enhancing efficacy, and optimizing user experience, all require significant investment.

Most importantly, many companies struggle with scaling up production to meet cost-of-goods (COGs) targets and ensure affordability,” Karla Medina-Ortega, Ph.D. Director of Field Development at Certis Biologicals says.

Challenges

Regulatory challenges significantly impact the ability to bring new active ingredients to market, as they often result in delays, higher costs, and complex approval processes. Some of the greatest impacts in bringing new active ingredients to the market is the uncertainty of timing and costs when it comes to the registration process.

Companies such as Attune Agriculture have recently faced these struggles firsthand. “We were registering a biochemical and had been advised by EPA to expect approval within 90 days. With less than 45 days from expected approval, we were advised by EPA that our product had to go through an endangered species risk assessment. It took over 2 years to complete the risk assessment process. This meant the company went from having expended considerable resources in preparation of a product launch to securing additional resources to address the unexpected risk assessment,” Dr. Ed Quattlebaum PhD, Director of Product Development at Attune Agriculture says.

Regulatory challenges are significantly impacting timing of new products coming to market. The process is time intensive, requiring extensive data and consultations which can cause major delays. As new changes are implemented, companies are having to navigate the delays and uncertainties that affect the ability to provide products to customers who need them in a timely manner and for a reasonable cost. “The continual adaptation of nature to pests, pest shifts, and resistance challenges, growers urgently need new technologies to address the challenges they are facing to remain profitable while overcoming each new challenge,” Syngenta’s Cecil says.

The cost of biologicals is lower compared to synthetic chemistry, but regulatory registration can still take up to a decade, if not more, before the new active ingredient can be sold. “The regulatory pathway for biological products follows the same structure as for chemicals. However, due to their generally non-toxic mode of action, biologicals often have favorable toxicity profiles and screening processes, allowing them to advance more quickly toward registration. Time is money — so the sooner a company can begin recovering its investment, the better,” says Certis’ Medina-Ortega

Looking Forward

Agriculture is increasingly focused on incorporating biological products to address environmental and health concerns, meet consumer demand, and offer alternatives for managing resistant pests and diseases. As resistance to many synthetic chemicals grows, the expansion ad adoption of sustainable, effective biological solutions will continue. “Holistic approaches that fully integrate biological tools into production cycles are becoming more common. Today, we have more effective tools than ever before — we just need to focus on education and best practices for integrating them into diverse food production systems,” Medina Ortega says, “The optimization of proven technologies and existing active ingredients — improving formulations, production, and efficacy to enhance shelf life and deliver a more user-friendly experience.”

“While it is difficult to predict the full impact of artificial intelligence, it will likely revolutionize pesticide discovery, allowing for identification of new active ingredients which will substantially reduce the impact on human health and the environment,” Quattlebaum says. New innovations will improve efficiency, sustainability, and the overall effectiveness of crop protection strategy.