The use of gene-editing technologies in animal agriculture would revolutionize the US pork industry, but significant hurdles remain before full commercialization can be achieved.
Christine McCracken, senior analyst at RaboResearch, has highlighted the critical role of gene editing in addressing health challenges like porcine respiratory and reproductive syndrome virus (PRRSv), while also examining the regulatory and market barriers facing this innovative approach.
The rise of gene editing
First developed in the 1970s, genetic engineering has evolved significantly with the introduction of CRISPR in 2012, a groundbreaking tool now widely used in agriculture to enhance crop yields and resilience. In animal agriculture, adoption has been slower.
While traditional genetic-selection programs have helped improve disease resistance and productivity in hogs, emerging threats require new strategies.
The US Food and Drug Administration (FDA) is expected to approve the first gene-edited pig resistant to PRRSv within the next 12 months. That disease costs the US pork industry billions annually due to high mortality rates and productivity losses. Gene editing offers the potential to permanently eliminate it.
Gene editing breakthrough
In 2015, researchers at the University of Missouri published the first study identifying the CD163 protein as the entry receptor for PRRS in swine. Utilizing CRISPR-Cas9 editing reagents, the lab successfully modified the CD163 protein so the pigs could no longer produce it, creating PRRSv resistant pigs (PRP), without changing the function of the gene.
After demonstrating proof of concept, the lab licensed this technology to Genus PIC for development with the goal of commercialization in its elite porcine lines.
While not yet approved in the US, the technology has received a positive determination in Colombia and Brazil. It faces several regulatory hurdles to commercial adoption in the rest of the world.
Productivity and economic gains
As to productivity and economic gains for the industry from removing the PRRSv threat, McCracken explained:
“Ultimately, the benefits will largely depend on the rate of adoption. Several factors are currently slowing adoption, with global acceptance of the technology being the most significant. The pork industry is highly interdependent and heavily reliant on global trade, which means adoption is likely to be slow initially.”
Producers could see significant benefits from eliminating specific diseases entirely. The extent of the economic advantage would depend on the disease challenges faced by individual production units.
“For diseases with high mortality rates - particularly those affecting young pigs - the benefits could range from $3 to $20 per head. These are losses that could be avoided, much like using a pharmaceutical product to combat a disease. However, in this case, gene editing could permanently eliminate the disease.”
What the future may hold
The ability to eradicate diseases like highly pathogenic avian influenza or African swine fever (ASF) would be transformative.
But the existing tools and knowledge do not yet allow for such breakthroughs:
“The reality is that ASF is an exceptionally complex virus - the most complex, in fact - which is why vaccines have not been effective so far. So, is ASF manageable or something we can tackle right now? Unfortunately, no. However, advancements in technology continue to bring us closer.
“Significant progress has been made in human health, and I believe similar strides can be achieved in animal health. The challenge for companies pursuing these solutions is clear: if progress stalls due to delays in regulatory approvals and there is no clear path to commercialization, the research behind these critical projects is at risk of halting entirely.”
Uncertain regulatory landscape
Universities and private firms, which are leading much of the innovation in this space, are already expressing concerns about the uncertain regulatory environment, she cautioned.
McCracken noted that while the US regulatory system under the FDA has begun to formalize processes for gene-edited animals, approval in export markets remains slow and fragmented. Mexico has yet to develop a regulatory framework for gene-edited products. PRP research programs are underway in China and South Korea, but those countries lack clear regulations on gene editing of animals, raising the concern that US adoption of the technology might disrupt export trade.
Consumer perception
Consumer perception also plays a role. Although studies suggest that consumers may accept gene-edited products if the benefits, such as improved animal welfare and disease resistance, are effectively communicated.
Transparency and labeling will be crucial in this respect, remarked McCracken.
Her estimate is that it will likely be several years before we see anything reach the market. “I believe there is a path forward, but it will take a few more years. Even if this technology gains approval in the US, it won’t be commercialized until the approval process is completed in key export markets.”
Existing genetics
When asked how gene editing might complement or enhance existing genetic selection programs traditionally used by major producers to address health challenges like PRRSv, McCracken told us:
“I see it as another tool. Even if they’re not directly modifying the current breeding stock, gene editing allows them to learn and understand target genes more effectively. Many genetics companies, particularly in Europe, are gaining deeper insights into how genes function. This knowledge can be used to develop therapies or pharmaceutical products that work better with existing genetics while also refining natural genetic selection.
“By considering how specific genes interact within the existing framework, it’s not just about modifying a genetic line to make it resistant to PRRSv—though that would, of course, be a significant breakthrough with immediate economic benefits for the industry. Instead, gene editing is being used more broadly to understand foundational mechanisms.
“Technology in this field is advancing so rapidly that we’ve moved beyond CRISPR-Cas9, progressing at least two generations further. This progress is helping us better grasp how our food systems operate and how natural selection could influence responses to disease challenges.”
Broader implications
The success of gene editing in the pork industry could influence other sectors, including poultry and aquaculture, remarked McCracken. For example, efforts are underway to use gene editing to combat avian influenza in poultry. However, the technology must navigate similar regulatory and consumer hurdles, she said.
The failure of AquaBounty’s genetically modified salmon serves as a cautionary tale, she added. It was deemed to hold promise because it could grow much faster than conventional farmed salmon, but it saw push back from campaigners over perceived environmental and health concerns.
McCracken suggested that focusing on clear benefits like disease elimination and animal welfare will be key to gaining public trust and ensuring success in gene edited animals.