Challenges in the Development and Commercialization of Genome-Edited Crops: A Critical Review of Technical, Regulatory and Socio-Industrial Bottlenecks

Abstract

Since 2020, hundreds of proof-of-concept traits have been created using genome editing technologies such as the CRISPR/Cas nuclease, base editors and prime editors that can modify the genome of crops with high precision—many times without transgenes. Despite this technical maturity, few genome-edited crops have moved beyond lab demonstrations to market, such as high-oleic soybean, waxy corn and non-browning mushroom, demonstrating a chasm between the lab and the market. This review aims to identify and synthesise the peer-reviewed and policy literature to critically appraise the non-molecular bottlenecks to this transition. Despite progress in this area including GRF–GIF mediated regeneration and AI-assisted guide-RNA design, at the technical level, the deployment of these advances is being hindered by genotype-dependent regeneration, polyploidy genome complexity and the need for thorough off-target and transgene-free verification of new cultivars. Regulatory philosophies differ between product-based (United States, India, United Kingdom) and process-based (European Union), which creates a mix of trade friction, asynchrony in approvals and enforcement issues related to the analytical indistinguishability of SDN-1/SDN-2 edits and spontaneous mutations. A high number of patents block commercialization of CRISPR and the issue of Essentially Derived Variety has yet to be resolved and is focused on the perceived benefit rather than the process or naturalness of the product, all leading to concentration of market entry by well-resourced multinational companies. We define convergence towards outcome-based and risk-proportionate regulatory exemptions as most immediate steps towards harmonization, while calling attention to open-source licensing platforms and investment in delivery technologies for recalcitrant and orphan crops as priorities for equitable access globally. We believe that bringing to market the commercial potential of genome edited crops will necessitate an integrated multi-disciplinary programme of development, which must include both improvements in editing efficiencies and regulatory harmonisation and the development of an equitable regime for the governance of intellectual property, not just the former.

Keywords: CRISPR/Cas; genome editing; genome-edited crops; New Genomic Techniques (NGTs); regulatory harmonization; SDN classification; intellectual property; Essentially Derived Variety; consumer acceptance; agricultural biotechnology commercialization

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