Meganuclease Genome Editing Market Report 2025

The meganuclease genome editing market size has grown rapidly in recent years. It will grow from $1.05 billion in 2024 to $1.23 billion in 2025 at a compound annual growth rate (CAGR) of 17.4%. The growth in the historic period can be attributed to rising regulatory approvals for gene-editing products, advancements in delivery methods for genome-editing tools, increasing government and private sector funding, growing demand for cost-effective gene-editing therapies, and heightened interest in addressing rare and inherited diseases.

The meganuclease genome editing market size is expected to see rapid growth in the next few years. It will grow to $2.3 billion in 2029 at a compound annual growth rate (CAGR) of 17%. The growth in the forecast period can be attributed to the increasing prevalence of genetic disorders, rising investment in biotechnology and genetic research, growing adoption of genome editing in personalized medicine, heightened awareness of gene therapy solutions, and expanding applications in agriculture for crop enhancement. Major trends in the forecast period include improvements in meganuclease specificity and efficiency, advancements in targeted gene-editing delivery systems, developments in high-throughput genome-editing screening techniques, technology enabling multiplex genome editing for complex traits, and innovations aimed at minimizing off-target effects in meganuclease editing.

The rising prevalence of genetic diseases is expected to drive the growth of the meganuclease genome editing market in the coming years. Genetic diseases are disorders caused by mutations or alterations in an individual's DNA that disrupt normal bodily functions. This increase is partly due to higher rates of consanguineous marriages, which raise the likelihood of inheriting genetic disorders. Meganuclease genome editing enables precise DNA modifications to correct, remove, or replace defective genes, allowing for targeted gene therapies with minimal off-target effects and potential cures for inherited conditions. For example, in May 2024, the National Health Service in the UK reported that approximately 17,000 people in England live with sickle cell disease, an inherited blood disorder, with around 250 new cases diagnosed each year. This growing prevalence of genetic diseases is therefore fueling the expansion of the meganuclease genome editing market.

Companies in the meganuclease genome editing market are increasingly focusing on advanced solutions, such as in vivo gene insertion programs, to improve therapeutic applications and expand the possibilities for correcting genetic disorders. In vivo gene insertion programs deliver genetic material directly into living organisms, allowing the insertion or correction of specific genes within their natural cellular environment, enabling precise treatment of genetic disorders. For instance, in May 2024, iECURE Inc., a U.S.-based gene editing company, launched ECUR-506, an in vivo gene insertion program designed to treat neonatal-onset ornithine transcarbamylase (OTC) deficiency. This therapy, which received fast-track designation from the U.S. FDA, is intended for newborn males with severe OTC deficiency and aims to restore functional OTC enzyme activity through a single intravenous infusion. The first infant treated achieved a complete clinical response, allowing discontinuation of ammonia scavenger medications and a return to normal protein intake, with only manageable side effects reported.

In November 2023, AstraZeneca Plc, a UK-based pharmaceutical company, partnered with Cellectis S.A. to accelerate the development of next-generation gene-editing therapies. The collaboration aims to advance up to ten novel cell and gene therapy products addressing high unmet medical needs in oncology, immunology, and rare diseases, leveraging Cellectis’ meganuclease-based gene editing technologies alongside AstraZeneca’s expertise. Cellectis S.A., based in France, specializes in the development and application of meganuclease genome editing technologies.

Major players in the meganuclease genome editing market are Thermo Fisher Scientific Inc., Danaher Corp., Merck KGaA, Lonza Group Ltd., Charles River Laboratories International Inc., Bio-Rad Laboratories Inc., Genscript, Takara Bio Inc., Sangamo Therapeutics Inc., Horizon Discovery, Applied StemCell Inc., Intellia Therapeutics Inc., Synthego Corporation, Editas Medicine Inc., Cellectis SA., New England Biolabs, Origene Technologies, Bluebird Bio Inc., Precision Biosciences Inc., Caribou Biosciences Inc., CRISPR Therapeutics AG.

North America was the largest region in the meganuclease genome editing market in 2024. The regions covered in meganuclease genome editing market report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East and Africa. The countries covered in the meganuclease genome editing market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA, Canada, Italy, Spain.

Note that the outlook for this market is being affected by rapid changes in trade relations and tariffs globally. The report will be updated prior to delivery to reflect the latest status, including revised forecasts and quantified impact analysis. The report’s Recommendations and Conclusions sections will be updated to give strategies for entities dealing with the fast-moving international environment.

The sudden escalation of U.S. tariffs and the consequent trade frictions in spring 2025 are severely impacting the pharmaceutical companies contend with tariffs on APIs, glass vials, and lab equipment inputs with few alternative sources. Generic drug makers, operating on razor-thin margins, are especially vulnerable, with some reducing production of low-profit medicines. Biotech firms face delays in clinical trials due to tariff-related shortages of specialized reagents. In response, the industry is expanding API production in India and Europe, increasing inventory stockpiles, and pushing for trade exemptions for essential medicines.

Meganuclease genome editing is a technique that utilizes meganucleases, naturally occurring endonucleases with long DNA recognition sequences, to create precise double-strand breaks at targeted genomic sites. These enzymes leverage the cell’s DNA repair mechanisms to achieve highly accurate genetic modifications. Meganuclease genome editing enables precise gene insertion, deletion, or correction with minimal off-target effects, supporting the development of enhanced traits and potential therapies for genetic disorders.

The primary types of meganuclease genome editing technologies include clustered regularly interspaced short palindromic repeats (CRISPR)/Cas9, transcription activator-like effector nucleases (TALENs) or meganuclease-TALENs (MegaTALs), zinc finger nucleases (ZFNs), meganucleases, and others. CRISPR/Cas9 is a gene-editing platform that uses guide RNA to direct the Cas9 enzyme to specific DNA sequences, allowing precise genetic alterations. These technologies are implemented through various modes, including contract and in-house operations, and delivered via ex vivo and in vivo approaches. Applications span genetic engineering, cell line development, plant and animal genetic modification, clinical research, diagnostics, and therapy development, serving end users such as biotech and pharmaceutical companies, academic and government research institutions, and contract research organizations.

The meganuclease genome editing market research report is one of a series of new reports that provides meganuclease genome editing market statistics, including meganuclease genome editing industry global market size, regional shares, competitors with a meganuclease genome editing market share, detailed meganuclease genome editing market segments, market trends and opportunities, and any further data you may need to thrive in the meganuclease genome editing industry. This meganuclease genome editing market research report delivers a complete perspective of everything you need, with an in-depth analysis of the current and future scenario of the industry.

The meganuclease genome editing market consists of revenues earned by entities by providing services such as custom genome editing, gene therapy development, and functional genomics. The market value includes the value of related goods sold by the service provider or included within the service offering. The meganuclease genome editing market also includes sales of engineered meganuclease enzymes, gene editing kits and tools, and therapeutic gene editing solutions. Values in this market are ‘factory gate’ values; that is, the value of goods sold by the manufacturers or creators of the goods, whether to other entities (including downstream manufacturers, wholesalers, distributors, and retailers) or directly to end customers. The value of goods in this market includes related services sold by the creators of the goods.

The market value is defined as the revenues that enterprises gain from the sale of goods and/or services within the specified market and geography through sales, grants, or donations in terms of the currency (in USD unless otherwise specified).

The revenues for a specified geography are consumption values that are revenues generated by organizations in the specified geography within the market, irrespective of where they are produced. It does not include revenues from resales along the supply chain, either further along the supply chain or as part of other products.

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