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Human Gene Editing
Overview
For decades, medical science has been foraging for permanent cures for a large array of diseases. Great strides have been made in the field of genetic technologies within the last decade, which hold the potential to fundamentally disrupt the human evolutionary process and bring forth unprecedented benefits to the human race.
Gene editing is an emerging technology that can alter and modify a species' DNA for a specific purpose. In simple words, gene editing is similar to how an author edits or corrects a book or an artist amends an art piece. The technology is not necessarily new; it is already used in agriculture to create genetically modified animals and plants. For humans, gene editing can potentially deliver permanent cures—in potentially one-time treatments—for a myriad of diseases across various therapeutic areas, such as neurology and oncology.
Human gene editing achieved a key milestone in December 2023. The first gene-editing therapy (“Casgevy” developed by CRISPR Therapeutics) was approved by the FDA to treat sickle cell disease in patients aged 12 and above. The same drug was later approved for patients with beta thalassemia in January 2024. More gene-editing treatments are underway in Phase I and II clinical trials and can be expected to enter the market in the next few years.
Industry Updates
Market Sizing
The US Human Gene Editing market could reach USD 26.3 billion–47.9 billion by 2030
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Market Mapping
CRISPR technology dominates the human gene editing space
The majority of companies in gene editing are focused on research and development of novel CRISPR/Cas9-based treatments, due to the technology’s simplicity, versatility, and cost-effectiveness. Although low in number, a number of drug-developing companies, including several early-stage disruptors, are leveraging other older yet evolving technologies such as TALEN and ZFN owing to fewer observed off-target effects and greater efficiency (in certain gene applications such as heterochromatin—the gene responsible for Fragile X syndrome and sickle cell anemia) compared to CRISPR.
On the other hand, gene editing SaaS platforms remain the smallest segment, with a relatively low number of startups in the space due to most companies choosing to use internally developed gene editing platforms and technologies at present. However, demand for these platforms could increase as gene editing becomes commercialized, and more pharma and drug developers plan to enter the space quickly, using pre-built gene editing platforms.
Most companies across the space fall under the seed stage, with only a limited number of startups in the early stage. This reflects the industry’s current nascent stage, with no FDA-approved, commercially available treatments; most companies are either in the preclinical or early clinical trial stages.
The incumbent involvement in the industry is predominantly focused on the CRISPR/Cas9 segment, which includes prominent big pharma companies such as Merck, AstraZeneca, and Bayer.
The Disruptors
Funding History
Competitive Analysis
Incumbents
Incumbents set foot into gene editing mostly via partnerships
Major big pharma companies such as AstraZeneca, Pfizer, Bayer, Eli Lilly, and Bristol-Myers Squibb are involved in the CRISPR/Cas9 drug developers segment owing to the high potential and increasing popularity of the technology.
The most common method used by incumbents to enter the gene editing space has been through partnerships and research collaborations with startup companies. Although the number of incumbents with in-house gene editing capabilities is low, a few prominent big pharma incumbents such as Novartis, Merck, and AstraZeneca have initiated in-house R&D initiatives over the last few years in order to stay at the forefront of gene editing.
Notable Investors
