Towards Healthcare
Endonucleases Market
Updated Date : 22 December 2025   |   Report Code : 6533

Endonucleases Market Growth Aligned with Gene Therapy Expansion

According to market projections, the global endonucleases market, valued at USD 394.3 million in 2025, is anticipated to reach USD 963.86 million by 2035, growing at a CAGR of 9.35% over the next decade.The endonucleases market is increasing rapidly, as these enzymes are contributing to recognizing and cutting up foreign DNA incoming the cell; their most likely role is thus protecting the bacteria against phage infection.

Last Updated : 22 December 2025 Category: Biotechnology Insight Code: 6533 Format: PDF / PPT / Excel
Revenue, 2025
USD 394.3 Million
Forecast, 2035
USD 963.86 Million
CAGR, 2026 – 2035
9.35%
Report Coverage
Global

Endonucleases Market Size, Key Players with Dynamics and Shares

The global endonucleases market size was estimated at USD 394.3 million in 2025 and is predicted to increase from USD 431.17 million in 2026 to approximately USD 963.86 million by 2035, expanding at a CAGR of 9.35% from 2026 to 2035.

Endonucleases Market Trends and Growth (2026)

Key Takeaways

  • Endonucleases sector pushed the market to USD 431.17 million by 2026.
  • Long-term projections show USD 963.86 million valuation by 2035.
  • Growth is expected at a steady CAGR of 9.35% in between 2026 to 2035.
  • North America dominated the endonucleases market in 2025 with 38% share.
  • Asia Pacific is expected to grow at the fastest CAGR in the market during the forecast period.
  • By product type, the restriction endonucleases segment dominated in 2025 with 40% of the share.
  • By product type, the CRISPR-Cas endonucleases segment is expected to grow at the fastest CAGR in the market during the forecast period.
  • By application, the genome editing and CRISPR applications segment led the market in 2025 with a share 35%.
  • By application, the NGS & DNA sequencing workflows segment is expected to grow at the fastest CAGR in the market during the forecast period.
  • By technology, the enzyme-based DNA cleavage segment is dominant in the market with 50% of the share.
  • By technology, the recombinant endonuclease platforms segment is expected to grow at the fastest CAGR in the endonucleases market during the forecast period.
  • By end-user, the pharmaceutical & biotechnology companies segment is dominant in the market with 40% of the share.
  • By end-user, the CROs and genomics service providers segment is expected to grow at the fastest CAGR in the market during the forecast period002E.

Executive Summary Table

Key Elements Scope
Market Size in 2026 USD 431.17 Million
Projected Market Size in 2035 USD 963.86 Million
CAGR (2026 - 2035) 9.35%
Leading Region North America by 38%
Market Segmentation By Product Type, By Deployment Type, By Application, By Technology / Mode of Action, By End-User, By Region
Top Key Players New England Biolabs (NEB), Thermo Fisher Scientific, Promega Corporation, Sigma-Aldrich, Takara Bio, Agilent Technologies, Qiagen

Market Overview: What are the Advances in Endonucleases?

The Endonucleases Market refers to the global market for enzymes that cleave the phosphodiester bonds within nucleic acid chains, playing a critical role in molecular biology, genomics and biotechnology research. These enzymes are widely utilized in applications such as DNA and RNA analysis, genome editing, cloning, next-generation sequencing (NGS), and CRISPR-based therapies.

Endonucleases support precision cutting of nucleic acids for both research and therapeutic purposes, contributing to advancements in diagnostics, drug development, and personalized medicine. Market growth is driven by increasing adoption of molecular biology techniques , rising investments in R&D, expansion of genomics and biotechnology sectors, and the growing focus on gene therapies and precision medicine globally.

How is AI Governing the Endonucleases Market?

Integration of AI-based technology in endonucleases drives the growth of the market as the incorporation of AI-driven technology with genome editing systems provides unparalleled precision and effectiveness, which could potentially transform the treatment of mutational diseases and oncology. The AI-driven technology tool searches datasets of known enzyme structures and suggests sequence variations. By the incorporation of AI-based sequence and structural bioinformatics, enzyme developments have been quicker, lowering timelines and efforts in the lab, which drives the growth of the market.

CRISPR & Gene Editing:

pyogenes Cas9 (SpCas9) is the most significantly used CRISPR endonuclease for genome engineering, but there are other Cas enzymes available. These enzymes have unique properties and can target various types of nucleic acids, including dsDNA (Cas9, Cas12), ssRNA (Cas13), or ssDNA (Cas14).

Cell & Gene Therapy:

Restriction endonucleases can facilitate genetic recombination and genome rearrangement by cutting DNA at specific sites. This causes the exchange of genetic material among different DNA molecules, involving to genetic evolution and diversity.

Molecular Diagnostics:

Restriction enzymes have been one of the major forces that enabled the cloning of genes and transformed molecular biology. New technologies, like Golden Gate Assembly and Gibson Assembly, continue to emerge and expand our ability to create novel DNA molecules.

Approved gene, cell, and RNA therapies in 2024

Type of Therapy Approval
Gene 32
Cell 75
RNA 35

Approved Gene, Cell and RNA Therapies in 2024

Segmentation Analysis

Product Type Insights

Which Product Led the Endonucleases Market in 2024?

In 2025, the restriction endonucleases segment held the dominant market with a 40% share, as restriction endonucleases have been a staple in molecular biology for decades, often appearing as a simple tool for cutting DNA. They offer unparalleled opportunities for diagnosing DNA sequence content and are used in fields as disparate as criminal forensics and basic research. Enzymes are that they provide the means to actually precisely cut through a double strand of DNA.

CRISPR-Cas Endonucleases

Whereas the CRISPR-Cas endonucleases segment is the fastest growing in the market, as CRISPR-Cas9 gene editing works by creating double-stranded breaks in the DNA and then taking advantage of cellular DNA repair mechanisms. CRISPR-Cas systems are becoming the most extensively used genome editing technology in molecular biology laboratories.

By Application Insights

Why did the Genome Editing & CRISPR Applications Segment Dominate the Market in 2024?

The genome editing and CRISPR applications segment captured 35 % of the market share of the endonucleases market in 2025, as the CRISPR/Cas9 technology is characterized by its excessive versatility. In result, the sgRNA directs the endonuclease to a particular site in the genome. By attaching functional domains to Cas9, it is likely to target any functionality to a particular genomic location, including promoter introns, and sites.

NGS & DNA Sequencing Workflows 

Whereas the NGS & DNA sequencing workflows segment is the fastest growing in the market as they are significant for targeted sequencing processes, like Restriction Site Associated DNA Sequencing (RAD-seq) and certain amplicon-based methods. This strategy focuses the sequencing effort on specific genomic regions of interest, creating the process more affordable and enabling greater sequencing sensitivity and depth.

Technology / Mode of Action Insights

Why is the Enzyme-Based DNA Cleavage Segment Dominant in the Market?

In 2025, the enzyme-based DNA cleavage segment held the dominating with 50% share of the endonucleases market, as they cut to completion DNA substrates with only one site, as effective as they cleave substrates with numerous sites. Their cleavage capability is not inhibited at high enzyme concentration because of site-saturation, and is not improved by adding particular oligos.

Recombinant Endonuclease Platforms

Whereas the recombinant endonuclease platforms segment is the fastest growing in the market, as recombinant endonucleases such as restriction enzymes and engineered nucleases like ZFNs, TALENs, and CRISPR/Cas systems recognize and cut DNA at particular nucleotide sequences. Recombinant DNA technology supports improving food production. Fruits and vegetables, which were prone to attacks from pests, have undergone genetic modifications to be more resistant.

End-User Insights

Why is the Pharmaceutical & Biotechnology Companies Segment Dominant in the Market?

In 2025, the pharmaceutical & biotechnology companies segment held the dominating 40% share of the endonucleases market, as endonuclease enzymes are significant for repairing damaged DNA. Bacterial restriction endonucleases kill invading viruses in pharmaceutical organizations. In food biotechnology, restriction endonucleases enable the development of genetically modified organisms with enhanced characteristics.

CROs & Genomics Service Providers

Whereas the CROs and genomics service providers segment is the fastest growing in the market, as endonucleases offer contract research organizations (CROs) and genomics service providers with exact and reliable tools for fundamental DNA manipulation, allowing efficient molecular cloning, advanced gene editing, and specialized next-generation sequencing (NGS) library preparation.

Regional Distribution

Endonucleases Market Share, By Region, 2025 (%)

  • North America registered dominance in the market share by 38% in 2025.
  • The U.S. led the market by capturing the largest revenue share of the market in 2025.
  • Asia Pacific is expected to be the fastest-growing region in the studied years.
  • India is anticipated to grow at a rapid CAGR during the forecast period.
  • Europe held a notable share in 2025 and is expected to grow significantly in the coming years.
  • The UK is expected to grow at a lucrative CAGR during 2026-2035.

How did North America Dominate the Market in 2024?

In 2025, North America led the endonucleases market with 38% of the share, driven by a well-developed research infrastructure, including various academic institutions and commercial laboratories, which drives innovation in enzyme-associated technologies and the acceptance of cutting-edge equipment such as CRISPR-Cas9. Supportive guidelines and an emphasis on quality and safety, particularly by agencies such as the FDA, promote trust in advanced-quality, GMP-grade endonucleases.

For instance,

  • In May 2025, BioMarin Pharmaceutical Inc and Inozyme Pharma, Inc. announced that BioMarin had entered into a definitive agreement to acquire Inozyme for $4.00 per share in an all-cash transaction for a total consideration of approximately $270 million. The transaction has been unanimously approved by the Boards of Directors of both companies and is expected to close in the third quarter of 2025, subject to regulatory approval, successful completion of a tender offer, and other customary closing conditions.

The U.S. has a well-developed biotechnology sector and robust research infrastructure, which drives demand for advanced-quality endonucleases in different applications, including drug discovery and manufacturing of vaccines, biologics, and cell and gene therapies.

For instance,

  • In December 2025, IDEAYA Biosciences, Inc., a leading precision medicine oncology company, announced the submission of an investigational new drug (IND) application to the U.S. Food and Drug Administration (FDA) for IDE574, a potential first-in-class KAT6/7 dual inhibitor with high selectivity over related KAT5/8 enzymes.

Asia Pacific: Increasing Initiatives in Cell Therapy

Asia Pacific is set to experience rapid growth in the endonucleases market, as this region is experiencing rapid manufacturing growth with the increase of biotech startups, generics production, and novel biomanufacturing services, all of which need endonucleases for applications such as nucleic acid cleanup and purification during manufacturing.

Increasing India's leadership in Atmanirbhar Bharat, genomic medicine, and cost-effective advanced therapeutics. India is vigorously promoting genome editing (GE) in farming and healthcare, launching the world's first GE rice varieties for environment resilience, which drives the growth of the market.

Europe: Strong Biotechnology and Pharmaceutical Sectors

Europe is growing significantly in the endonucleases market as a strong presence of leading biopharmaceutical organizations, and a focus on robust therapies like cell and gene therapies increases the demand for endonucleases in production technology, like the production of monoclonal antibodies and recombinant proteins, which contributes to the growth of the market.

The UK possesses an advanced biotechnology infrastructure that helps extensive R&D in genomics and precision medicine. Increasing partnerships among the universities and biotech firms further enhances market growth and revolution in the field.

Gene therapy pipeline for rare diseases

Diseases Number of therapies
Myeloma 100
Acute myelogenous leukemia 80
Non-Hodgkin’s lymphoma 81
B-cell lymphoma 75
Ovarian cancer 62

Gene Therapy Pipeline for Rare Diseases in 2024

Value Chain Analysis – Endonucleases Market

R&D:

  • Research and Development (R&D) processes, including endonucleases, primarily focus on their discovery, application, and characterization in different molecular biology and biotechnology sector
  • Key players:   Promega Corporation and QIAGEN N.V.

Clinical Trials: 

  • Clinical trials involving endonucleases generally fall into two major categories: using engineered endonucleases for gene editing therapies and using endonuclease inhibitors as drug treatments.
  • Key players:  Merck KGaA and Takara Bio Inc.

Patient Services:

  • It offers patient solutions like genetic disease diagnosis, DNA repair, cancer therapy, and the advancement of gene editing technologies.
  • Key players: Thermo Fisher Scientific Inc. and New England Biolabs (NEB)

Latest Updates of Key Players in the Endonucleases Market

Endonucleases Market Key Players

Company Headquarters Latest Update
New England Biolabs (NEB)  United States In February 2025, New England Biolabs to Present Latest Innovations in Next Generation Sequencing Sample Preparation.
Thermo Fisher Scientific United states In August 2025, the MagMAX HMW DNA Kit is intended for the high-integrity isolation of High Molecular Weight DNA for long-read sequencing applications.
Promega Corporation United States In September 2025, Promega entered a strategic partnership with Watchmaker Genomics to license a novel engineered reverse transcriptase.
Sigma-Aldrich United States Benzonase endonucleases are chosen for an endonuclease that ensures exceptionally high purity and activity for the finished product.
Takara Bio Japan In September 2025, Takara Bio Europe announced the launch of Cellartis MSC EV Wonder, a defined, xeno-free medium engineered.
Agilent Technologies United States In December 2025, Agilent Technologies Inc. launched new 21 CFR Part 11 compliant software for its xCELLigence Real-Time Cell Analysis (RTCA) eSight system. 
Qiagen Germany In July 2025, QIAGEN announced the launch of its novel QIAseq xHYB Long Read Panels, a suite of target enrichment solutions intended to unlock long-read sequencing of genomically challenging regions. 

SWOT Analysis

Strengths 

  • Homing endonucleases (HE) are double-stranded DNases that target large recognition sites (12–40 bp). HE-encoding sequences are generally embedded in either introns or inteins.
  • Restriction endonucleases have importantly transformed the sector of molecular biology by allowing progress in recombinant//DNA//technology, gene cloning, DNA//fingerprinting, and gene mapping.
  • Different endonucleases are involved in natural DNA repair pathways in the cells, like AP endonuclease, which is significant for the repair of damaged DNA by cutting the backbone at particular sites.

Weaknesses

  • Restriction endonucleases lose their activity because of improper handling or storage. This will result in the partial or no digestion of DNA.
  • Use of too much or too little restriction enzymes results in the incomplete digestion of DNA.

Opportunities

  • Restriction endonucleases have been a staple in molecular biology for a long time, often perceived as easy tools for cutting DNA.
  • Restriction enzymes proved to be significant for the physical mapping of DNA. They provide unparalleled innovative technology for diagnosing DNA sequence content and are applied in fields as disparate as illegal forensics and basic research.

Threats

  • Sometimes restriction enzymes show star activity or off-target cleavage, where these will cleave sites that are the same, but do not match the recognition sequences.
  • If restriction enzymes cut at random sites, then vector DNA and DNA of interest would get fragmented creating it unfit for forming rDNA.

Recent Developments in the Endonucleases Market

  • In December 2025, BlossomHill Therapeutics, Inc., announced the closing of an $84 million Series B extension, bringing total capital raised by BlossomHill to $257 million to date. Proceeds from the financing will be used to accelerate BlossomHill’s two lead clinical programs, BH-30643 and BH-30236, and to further advance the company’s wholly-owned pipeline of intelligently designed cancer medicines.
  •  In October 2025, BASF, one of the world’s largest chemical companies and leader in sustainable product innovation, announced a strategic collaboration with International Flavors & Fragrances Inc. (IFF), a global leader in bioscience innovation, to saccelerate the development of IFF’s Designed Enzymatic Biomaterials™ technology platform and create next-generation enzyme technologies for fabric, dish and personal care as well as industrial cleaning applications.
  • In July 2024, Avantor, Inc., a leading global provider of mission-critical products and services to customers in the life sciences and advanced technologies industries, announced the launch of two innovative products that together sustainably optimize the gene therapy harvest process: J.T.Baker® Cell Lysis Solution and J.T.Baker® Endonuclease.

Segments Covered in the Report

By Product Type

  • Restriction Endonucleases
  • Type I & Type II restriction enzymes
  • Site-specific endonucleases
  • CRISPR-Cas Endonucleases
  • Cas9
  • Cas12 / Cas13
  • Meganucleases
  • Homing endonucleases
  • Engineered meganucleases
  • Zinc Finger Nucleases 
  • Engineered ZFNs
  • Therapeutic-grade ZFNs
  • Ancillary Reagents & Kits
  • Buffers & master mixes
  • Assay kit

By Deployment Type

  • On-Premise
  • Cloud-Based / Remote Platforms
  • Hybrid 

By Application

  • Genome Editing & CRISPR Applications
  • NGS & DNA Sequencing Workflows
  • Molecular Biology & Cloning
  • Therapeutic & Clinical Research
  • Other Applications

By Technology / Mode of Action

  • Enzyme-Based DNA Cleavage
  • Recombinant Endonuclease Platforms
  • Synthetic / Engineered Nucleases
  • CRISPR-Cas System Platforms
  • Other Technologies

By End-User

  • Pharmaceutical & Biotechnology Companies
  • Academic & Research Institutes
  • CROs & Genomics Service Providers
  • Diagnostic Laboratories
  • Other End-Users

Regional Outlook

  • North America
    • U.S.
    • Canada
    • Mexico
  • Europe
    • UK
    • Germany
    • France
    • Italy
    • Spain
    • Denmark
    • Sweden
    • Norway
  • Asia Pacific
    • China
    • Japan
    • India
    • South Korea
    • Australia
    • Thailand
  • Latin America
    • Brazil
    • Argentina
  • Middle East and Africa (MEA)
    • South Africa
    • Saudi Arabia
    • UAE
    • Kuwait

FAQ's

The endonucleases market currently in 2026 records USD 431.17 million and is anticipated to grow to USD 963.86 million by 2035, advancing at a CAGR of 9.35% from 2026 to 2035.

North America is currently leading the endonucleases market by 38% due to the strong biotechnology sector and substantial R&D spending.

The endonucleases market includes five segments By product type, applications, technology, end user, and region.

Key trends include rising demand in diagnostics and biomanufacturing.

Type II restriction endonucleases are the most commonly used restriction enzymes in several research applications, such as cloning, forensic DNA analysis, and molecular taxonomy.

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Meet the Team

Shivani Zoting is a dedicated research analyst specializing in the healthcare industry. With a strong academic foundation, a B.Sc. in Biotechnology and an MBA in Pharmabiotechnology, she brings a unique blend of scientific understanding and strategy.

Learn more about Shivani Zoting

Aditi Shivarkar is a seasoned professional with over 14 years of experience in healthcare market research. As a content reviewer, Aditi ensures the quality and accuracy of all market insights and data presented by the research team.

Learn more about Aditi Shivarkar

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