Trends in New Molecule Development: How Crop Protection Companies Are Delivering Innovative Solutions

Bringing new active ingredients (AI) to market is a lengthy, expensive, and challenging process … and each decade, the costs and time increase.

Every product that reaches the market today costs approximately $286 million and takes 11 years of research and development (R&D) to ensure the highest safety and efficacy standards, according to a 2021 report by Phillips McDougall, commissioned by CropLife International, CropLife America, and the European Crop Protection Association.

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That’s an increase of 55% since the turn of the century.

It’s no surprise that, as a result, the pace of new product introductions based on new AIs has tapered off in the last several years.

While the number of AIs companies bring to market decreases, regulatory challenges continue to mount. The process might not be getting any easier, but companies are continuing to invest, driven by one major goal — safeguarding yield.

According to the Food and Agriculture Organization, farmers will have to feed an estimated 9.7 billion people by 2050, requiring a productivity increase of 50% over the next 20 to 30 years, while also tackling climate change and protecting finite natural resources.

“We must use everything in our toolbox, including new crop protection products, new seed varieties, and new digital tools,” says Dr. Juergen Huff, Senior Vice President, R&D Crop Protection at BASF Agricultural Solutions. “Our innovation target is to help farmers achieve not only more, but better yield — yield produced in ways that meet the demands of future generations.”

REGULATORY CONSTRAINTS LIMIT NEW ACTIVES

The regulatory landscape continues to become trickier to navigate for businesses trying to collect farmer input and rapidly create and deliver the products they need. This is in large part because of much stronger scrutiny of each AI’s environmental impact.

“It’s still a lengthy and unclear process globally, making it more difficult for science-based companies to get much-needed tools and technologies into farmers’ hands quickly,” explains Ramnath Subramanian, Vice President of Crop Protection R&D, Corteva Agriscience.

He suggests a move to a more “harmonized, science-based global regulatory process like that used for pharmaceuticals.” Subramanian says that this process, “aligned with social acceptance, would enable us to develop and deliver innovative solutions to solve real farmer challenges and create a better food system for everyone.”

Although the rate of new product approvals has decreased in recent years, McDougall’s study says investment remains high and the industry has been able to maintain a decent level of product innovation, alongside other developments, such as integrated crop solutions, application technology, and precision farming.

While in 1960, there were 15 chemical groups on the market, today’s products come from more than 40 different groups, bringing new modes of action that address problems of resistance — whether that’s for insecticides, fungicides, or herbicides.

This reflects a continuous high-level R&D investment compared to other sectors, with the major companies investing 7% to 10% of their sales annually over the last 50 years.

The cost goes partly toward meeting the higher regulatory study requirements needed to properly characterize products. As regulators are faced with higher volumes of studies to review, the process takes longer — explaining the increase from an average of roughly 8 years to 11 years to introduce a new AI. In fact, today, it typically takes more than 150 studies to register a new AI, McDougall shares.

“Regulators are keen to ensure any approvals they provide satisfy growers’ technology needs while also meeting safety needs of the society at large, which also results in longer review timelines,” Subramanian adds.

Yet the number of new AIs introduced per decade has continued to decline since their peak in the 1990s, McDougall’s study points out. In keeping with new safety regulations, many products have been withdrawn from the market over the years, through banning or lack of support during a re-registration process.

DESPITE CHALLENGES, PRODUCT EFFICACY INCREASES

This continued and significant investment in crop protection products since the 1950s “has dramatically improved the efficacy and safety profile of new products,” McDougall reports. However, “the capacity of regulatory systems in low-income countries to protect confidential business information related to a new product is often insufficient, jeopardizing the industry’s investment, stifling innovation and sometimes leaving farmers without access to new technology,” McDougall adds.

But a huge positive for the crop protection industry from adapting to increased regulatory procedures is reduced application rates necessary to achieve equal or greater efficacy.

McDougall shares that the amount of AI used by a farmer today is approximately 95% lower than the rate used in the 1950s.

Some suppliers like Syngenta credit this to a dramatic acceleration in the use of new technologies, including precision application, satellite and drone imaging, internet-of-things sensors on farm machinery, and digital prescriptions to optimize yield and quality with minimum intervention.

“Crop protection products are now designed from the outset with these parameters in mind,” points out Camilla Corsi, Syngenta’s Global Head of Crop Protection Research.

“They are increasingly selective, require diminishingly small and focused applications, and are designed to be without detectable residues in the environment and the lowest possible environmental footprint.”

In Syngenta’s latest product pipeline, the products that fit this description are Adepidyn (recently launched in multiple countries), and Plinazolin and Tymirium, which are both currently being launched.

Adepidyn is a fungicide that targets several diseases and pathogens and is said to require fewer applications for longer-lasting control without needing re-sprays. Plinazolin is an insecticide that promises to target pests that existing products aren’t effectively controlling. The technology claims to allow for longer spray intervals and fewer applications. Tymirium will offer protection against a broad spectrum of plant-parasitic nematodes and soil-borne diseases across all major crops and geographies. The very low dose promises to help prevent nematode damage to improve crop yield and quality.

MERGING MULTIPLE SOLUTIONS FOR MORE EFFECTIVE PRODUCTS

As regulatory challenges increase, so do new opportunities for innovation. BASF, for instance, has redesigned its R&D process over the last decade. The company created a third party-audited “Sustainable Solutions Steering” method to evaluate and transparently classify products and solutions.

“In 2021, we spent about €900 million (US $964.8 million) in R&D in the agricultural solutions segment, focusing on seeds and traits, biological, and chemical crop protection, as well as digital solutions,” Huff shares.

“This includes research into new modes of action and development of new formulations of herbicides, insecticides, and fungicides — so, yes, we are committed to investments into new crop protection AIs.”

To connect innovations in seeds, crop protection, and digital solutions for soybean farmers, for instance, BASF is developing several new Revysol- and Xemium-based mixtures planned to launch mid-decade that are said to provide effective control of soybean diseases, including Asian soybean rust, and help manage resistance. In addition, soybean farmers will benefit from a novel trait in development for tolerance to nematodes — pests that have been known to induce yield losses of around 30%.

Another example is the company’s co-development of Smart Spraying solutions with Bosch to better control weeds. “Our joint work combines the agronomic intelligence of our xarvio Digital Farming Solutions with Bosch’s high-tech camera sensor technology and software,” Huff explains, adding that the technology promises to offer real-time, automated pre- and post-emergence weed identification and precision management.

BASF expects the Smart Spraying solution to launch in Brazil, North America, and Europe within the next 18 months.

In addition to meeting farmers’ agronomic needs and reducing environmental impacts, Bayer is also designing crop protection products “with an eye toward new technologies, digital tools, and data-driven systems that will become commonplace for application and optimization on future farms,” explains Bob Reiter, Head of R&D for Bayer’s Crop Science Division.

The company invests €2 billion (US $2.144 billion) annually in R&D. Since 2021, the company has advanced eight products in the pipeline, including a breeding approach for short stature corn, a fourth generation of Bollgard cotton, and the advancement of a fourth-generation cotton herbicide tolerance to Phase 3. Bayer has also launched roughly 500 new corn, soybean, cotton, and vegetable hybrids and varieties, as well as completed more than 300 new crop protection registrations.

“Between now and 2030, we expect to launch dozens of new crop protection formulations and products,” Reiter shares.

This year, Bayer is launching SmartStax PRO with RNAi technology to fight corn rootworm; Fox Supra, a soybean fungicide that includes Indiflin, which is said to help control Asian soybean rust; and ThryvOn biotechnology traits for piercing and sucking insects that affect cotton crops.

Bayer’s Smart Corn System commercial launch will include up to 75,000 acres across select geographies. This approach will combine new corn technologies with digital solutions, data-driven decision-making, modern and efficient management practices, a partnership approach, and potentially new business strategies, such as outcome-based models.

Bayer believes that “farmers of the future will use digital systems to manage every aspect of their farms and fields,” Reiter says.

The company is tailoring digital farming solutions to reduce greenhouse gas emissions and keep carbon in the ground through biotech traits that enable conservation farming, crop protection formulations, and biologicals that reduce the need for synthetic fertilizer.

Bayer’s FieldView digital farming platform is a key part of its Carbon Initiative, measuring on-field carbon capture and enabling growers to track their progress. The company is also partnering with Microsoft to create new tools and data science solutions, as well as Project Carbonview to a grower-faced technology solution to enable ethanol producers to report, analyze and better assess their end-to-end supply chain carbon footprint.

BIOLOGICALS EXPERIENCE A BOOST

While the number of new introduced AIs each year for conventional crop protection has declined over the past two decades, there has been a rapid increase in the number of biological products on the market, McDougall reports.

This amounts to roughly 11 new biologicals introduced per year between 1990 and 2016, an increase from an average of three biological introductions annually from 1960 to 1990.

McDougall credits the increase to the growth of integrated pest management and farmers’ demands for a more diverse product toolbox.

Corteva is focused on natural pesticide options, including biopesticides and molecular-based pesticides that exploit natural disruptors like fermented bacteria to interfere with pest and disease pathogenicity and resistance.

“[We’re] pursuing ‘green’ delivery systems, including targeted-delivery, low-use rates, and technologies that reduce drift and waste, while complying with customers and regulatory entities to ensure innovation meets the needs of producers in a safe and sustainable way,” Subramanian says.

A GROWING FOCUS ON SOIL

The importance of soil health has also become a more important part of the global crop protection product development conversation.

While crop protection products will always have a certain level of soil persistence to ensure the product is available for sufficient time to be effective against its target, they must strike a balance between effectiveness and minimal environmental impact. Reducing soil persistence is the goal.

According to McDougall’s research, new innovations have helped reduce persistence to an average of 53 days for those products introduced in the 2000s. Regulatory policies continue measuring soil persistence to a greater degree.

Many of the companies developing products today believe they can introduce products that play more essential roles in soil health. Syngenta is one of them.

“Our pipeline will broaden from a focus on pest, weed, and disease control to include holistic plant and soil health to improve the resilience of crops to environmental challenges and improve their ability to use natural resources and improve soil fertility,” Corsi points out.

“Soil health-based agricultural management practices are widely promoted to reduce erosion, increase nutrient efficiency, improve soil structure, and sustain or increase yields,” Corsi adds. “[We can change this] by developing innovative crop protection solutions that target soil health outcomes through direct impact on soil or enabling practices that promote soil health outcomes.”