The Rise of CROs

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No one ever said registering a new agrichemical product was easy.

It’s a commitment, for sure — a costly and time-consuming one. From initial product synthesis to a registered product launch takes a minimum of eight to 10 years of research and more than $286 million. It begins with researching a new molecule, moves into the development phase that includes safety assessments and field trials, and continues through registration with the appropriate regulatory authorities before the final stage of launching in a crop market.

Part of the cost commitment is finding expertise in each segment of these phases to ensure the new molecule successfully makes its way through thorough vetting and testing. For some companies, managing this entire process in-house is too costly and time consuming. Enter the contract research organization (CRO). Pesticide manufacturers hire CROs to offer research support, conduct field trials, consult on product strategy and launch, and carry out complicated registration processes. And the trend to use CROs is growing as recruiting, retaining, and investing in research and development (R&D) staff becomes more difficult.

The Evolution of the CRO

Outsourcing of non-core services is certainly a common practice for companies today as they seek to reduce overhead.

Agrochemical companies have used CROs in numerous capacities for years to maximize cost benefits and geographic reach, as well as provide regulatory expertise.

CROs have been around for decades, mainly coming to market to initially assist with field trials, which make up the largest cost of the development part of the R&D budget at roughly $47 million, according to a CropLife report.

Field trials are certainly still crucial in the process, and CROs are continuing to help here. At CropTrials GmbH, an independent private company for agricultural field research and development based in Germany, “field trials are still important for agrochemical industries in relation to flexibility, fast delivery of reliable data and cost efficiency,” explains CropTrials GmbH Managing Director Paul Reh.

But over the years, CROs have also expanded to offer niche services in the process, as well as a complete suite of R&D services — and they are all growing.

When Staphyt started more than 30 years ago in France, the company offered field trial assistance, but has since expanded to offer a full range of R&D capabilities and regulatory affairs consultancy. And they’re seeing a growing trend in agribusiness companies using CROs.

The company’s growth shows the growing interest in CRO use. Seven years ago, Staphyt employed roughly 200 people, and today it has more than 500 employees.

And at Knoell, a scientific and regulatory team that helps products with global marketability based in Germany, growth was up 5% last year and another 3% to 5% this year “with more work in the pipeline and successful registrations,” says Piyatida Pukclai, Asia-Pacific Business Development and Regulatory Policy Lead with Knoell.

The CRO role has always been based on providing solutions and giving agribusiness companies more flexibility through the process. This was particularly important during the COVID-19 pandemic when they needed that additional flexibility and ability to virtually work with people based in multiple locations. They built trust in CROs during that time and “those relationships helped us grow and evolve,” Pukclai says.

Who is Using CROs?

While larger agribusiness companies have traditionally kept R&D in-house, they are looking for more CROs as partners in the process, “but they have tough criteria for selections, deadlines, communication flow, and expertise,” Vanel shares.

And smaller companies — not having an in-house R&D team — may contact a CRO from the very beginning to find out what they can do with their discovered molecule.

But some specific types of products are driving CRO growth as well, namely biologicals.

While biological insecticides and fungicides have been on the market for years, the drive toward insect pest management (IPM) has resulted in significant growth in these introductions more recently.

“We’re seeing a lot of new players and startups in the biological space that have active substances, and sometimes they don’t know how to enter the market,” Vanel says. “That’s where CROs and regulatory affairs consultants can come in to be part of the development process. They need help driving them in the right direction to bring the product to market in the most effective way.”

How has the Pandemic Changed how CROs Operate?

As regulations become stricter, agribusiness companies are seeking solutions to keep their work moving forward and registrations up to date. For instance, the registration process of pesticides in Europe takes more time and can be more cost intensive, Reh says.

And “sometimes biopesticides and biostimulants need extra trial designs, which are different from trials with classic chemical products,” he continues. “The long-time experience in field trials as well as the flexibility of CROs stands for a fast product development process, which is essential for these companies.”

In addition to helping smooth the registration process, some changes have recently happened in the R&D registration process since the COVID-19 pandemic.

First, the registration dossier submission process has changed, Pukclai says. “We can submit the dossier via an online system established by the governments and contact the authority via email. In some countries, in person meetings are [still] possible.”

Reh agrees that more video conferences took place during the pandemic since travel was restricted, and “now more video conferences take place than in the past compared to direct meetings,” he says.

CROs are also offering online tools to help their agribusiness clients stay abreast of their projects.

Some of the tools they use can help increase efficiency and speed in dossier preparation and report generation, like at Knoell. Staphyt offers Phytnet — a digital platform that clients can log into for updates and follow up on their field trials and project management.

“While these don’t replace physical visits, they do like the updates,” Vanel says.

While the R&D necessary to register an agrichemical product isn’t easy, CROs may help smooth this experience for businesses trying to navigate the ever-changing, time-consuming and expensive steps.

“We can’t change the process,” Vanel admits, “but our strength is to have teams with locally and regulatory people who know the specifics and how to speak with officials and submit the dossier, as well as dissecting the huge regulation text in the market product strategy. This helps them stay in line with regulations and bring the product to market in a better, safer way.”