"Staphyt leading biological product registration in Brazil and Europe": an article on AgriBusiness Global

Navigating the Future of Agriculture: How Staphyt is Leading Biological Products Registration in Brazil and Europe.

By Adriana Puralewski, PhD
Business Development Manager, North America
Email: apuralewski@staphyt.com

originally published on AgriBusiness Global.

The agricultural industry is undergoing a significant transformation driven by a global shift towards sustainability, moving from traditional chemical inputs to biological alternatives such as biopesticides, biostimulants, and biofertilizers. This shift has fueled rapid growth in the biologicals market, which is projected to surpass USD 24 billion globally by 2027. Within this dynamic landscape, microbial and biochemical products dominate the biocontrol market, accounting for over 90% of total revenue and maintaining this lead through 2029. The microbial sector alone represents over 40% of the global biocontrol market and is expanding rapidly in Latin America (LATAM), fueled by strong growth in Brazil.

The Biocontrol and Biostimulant Market: A Snapshot

The LATAM region, particularly Brazil, is a significant growth driver, with its market share anticipated to rise from 26% in 2021 to 39% by 2029. Bioinsecticides continue to lead the biocontrol segment, experiencing robust adoption in both LATAM and the Asia-Pacific regions. While biofungicides maintain a stable market position, bionematicides are expected to grow rapidly, particularly in Brazil, where their market presence is projected to increase by nearly 400% by 2029.
The Brazilian biostimulants market is projected to grow from $306.6 million in 2024 to $520.09 million by 2029, with a compound annual growth rate (CAGR) of 11.15%. This growth is driven by Brazil’s status as the fastest-growing country in South America and a dominant market presence, particularly in soybean crops. Climate change is a key factor fueling this growth, as biostimulants help mitigate productivity losses. In Europe, the market is expected to grow from $1.59 billion in 2024 to $2.34 billion by 2029, with a CAGR of 8.07%. This growth is supported by the EU Fertilizing Products Regulation (FPR), implemented in July 2022, which facilitates market access across the EU’s 27 member states.

Unique Opportunities in Brazil and Europe

Registration in Europe and Brazil Unique opportunities for biological product registration in Brazil offer significant benefits to the US market, providing a pathway to enter a rapidly growing market with strong demand for sustainable agricultural solutions. Brazil’s favorable climate conditions enhance the effectiveness of biological products, while the National Bioinputs Program supports their adoption through environmental protection strategies, creating a supportive regulatory environment. As the global leader in using biological pesticides, biostimulants, and biofertilizers, with over half of its crops utilizing biopesticides, Brazil represents a robust market for US companies to expand their reach, increase sales, and establish a foothold in Latin America by aligning with Brazil’s commitment to sustainable agriculture.

The ‘Farm to Fork Strategy’ under the EU’s Green Deal offers opportunities for US market entry by promoting sustainable agricultural practices. With targets to reduce chemical pesticide use by 50% and expand organic farming to 25% of agricultural land by 2030, the EU is driving demand for organic and biological products. This creates a market for US companies specializing in biopesticides, biostimulants, and sustainable solutions. Supported by initiatives like the EU Organic Action Plan and the Common Agricultural Policy, US businesses can align agricultural products with the EU’s regulatory framework and meet the rising demand for eco-friendly agriculture.

Staphyt’s Strategic Role in the Development of Biological Products

Staphyt features the Bio-team, a multidisciplinary group of experts specializing in developing biological products, including biopesticides, biostimulants, and biofertilizers. Since 2011, the team has combined expertise in plant physiology, phytopathology, agronomy, and regulatory affairs to support every stage of product development. Through consultancy services, project management, and registration dossier preparation, the Bio-team helps clients navigate the regulatory landscape and accelerate market entry in Brazil and Europe.

With experienced leaders like Daniela Maia in Brazil and Aurély Beghin in Europe, Staphyt offers invaluable local expertise in navigating complex regulatory landscapes. Daniela Maia’s deep understanding of Brazilian regulations ensures effective communication with agencies like MAPA, ANVISA, and IBAMA, facilitating compliance and minimizing delays. In Europe, Aurély Beghin and her team leverage their expertise in regulatory frameworks, working with EFSA and ECHA to streamline the registration process despite strict regulatory requirements.

In Brazil, the registration process for biochemicals is assessed on a case-by-case basis, determining whether the technical product needs to be registered. For other product categories, technical product registration is not required, but details about the active ingredient must be provided. The registration process involves submitting a comprehensive package of laboratory studies, including physico-chemical, ecotoxicology, and toxicology assessments. International studies are accepted, if they adhere to Good Laboratory Practices (GLP). Efficacy trials must be conducted within Brazil, typically requiring three trials per target or crop across different regions. However, if a similar product is already registered, only one trial may be necessary. Residue studies are generally not required, except for biochemical products, which are evaluated on a case-by-case basis. Staphyt supports this process with a well-established network of trial stations in key agricultural regions throughout Brazil.

In Europe, the registration process for biologicals involves compliance with EFSA and ECHA guidelines. This includes providing a comprehensive dossier with data on product safety, efficacy, and environmental impact, as well as studies on toxicology, ecotoxicology, and residues, if applicable. Field trials are often required across different European climates and agricultural zones to ensure efficacy and safety. Aurély Beghin’s team helps navigate these complexities, optimizing the process to meet European standards efficiently.

With a proven track record and deep expertise, Staphyt is well-positioned to help companies navigate the future of agriculture, driving the adoption of innovative biological solutions worldwide. By partnering with Staphyt, companies can ensure they meet regulatory requirements and lead the market in sustainable agricultural innovations. As the global biocontrol market continues to expand, particularly in regions like LATAM, Staphyt remains a critical partner in achieving regulatory success and market leadership.