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Report Overview

The cloning and mutagenesis market was valued at USD 5.80 Billion in 2025 and is expected to grow at a CAGR of 5.40%, reaching USD 9.81 Billion by 2035. The market growth is driven by rising research activities in genetic engineering and molecular biology.

2025

Base Year

2019-2025

Historical Period

2026-2035

Forecast Period

  • The rising prevalence of genetic disorders and chronic diseases is poised to augment the market demand in the forecast period.

  • One of the major market trends is the rising integration of automation and high-throughput screening in cloning and mutagenesis processes that enhance the efficiency and accuracy of genetic manipulation experiments.

  • The market share is impacted by the growing demand for personalized medicine, advancement in gene editing technologies, and increased investment in R&D activities.

Compound Annual Growth Rate

5.4%

Value in USD Billion

2026-2035


*this image is indicative*

Global Cloning and Mutagenesis Market Overview

Cloning refers to the creation of duplicates of organisms either artificially, or naturally, with nearly identical DNA coding. Mutagenesis is a method of changing the genetic information of an organism encoded into the DNA. The market growth for cloning and mutagenesis is driven by its rising use in finding new discoveries for therapeutics, vaccine development, and other emerging synthetic biology applications. Furthermore, the increasing research activities to develop next-generation cloning technology for creating custom vectors for various applications are likely to shape the market landscape.

The cloning and mutagenesis market is projected to witness substantial growth during the forecast period on account of the surging popularity of reproductive cloning. The rising penetration of personalized medications along with rising disease burden is further expected to boost the market demand across the globe. In addition, the growing investment in the research of treatment for genetic diseases is boosting the market share. The increasing efforts by governments such as providing funds for medical research coupled with the rapid growth of the biotechnology sector are encouraging market expansion.

Global Cloning and Mutagenesis Market Growth Drivers

Rising Prevalence of Genetic and Chronic Diseases to Affect the Market Landscape Significantly

The prevalence of genetic disorders fuels the demand for advanced genetic research to develop effective treatments, in which cloning, and mutagenesis techniques play a critical role in creating disease models and exploring gene therapy options. Cloning and mutagenesis tools also help to understand disease mechanisms and discover novel drugs for various chronic diseases.

With the growing prevalence of various genetic and chronic diseases, cloning of genes is extensively used in the detection of such conditions and in their treatment through methods like gene therapy. Hence, the rising cases of sickle cell anemia and leukemia, among others, are estimated to drive market growth in coming years.

Integration of Automation and High-Throughput Screening Set to Fuel Cloning and Mutagenesis Market Demand

The market is witnessing an increased integration of automation and high-throughput screening in cloning and mutagenesis processes that are shaping the market landscape. For instance, Beckman Coulter Life Sciences' Echo 525 Acoustic Liquid Handler automates the transfer of low-volume reagents for biochemical and genomic samples, enabling assay miniaturization and optimizing the efficiency of experiments. Moreover, Beacon Select, developed by Berkeley Lights, Inc. is a single cell optofluidic system that allows researchers to clone, culture, assay, as well as select top clones on a single platform in a single run. Such technological advancements are likely to enhance the speed, accuracy, and scalability of genetic manipulation experiments and are anticipated to be a significant growth driver of the market.

Global Cloning and Mutagenesis Market Trends

Global Cloning and Mutagenesis Segmentation

The EMR’s report titled “Cloning and Mutagenesis Market Report and Forecast 2026-2035" offers a detailed analysis of the market based on the following segments:

Market Breakup by Product

  • Cloning Kits
  • Others

Market Breakup by Technique

  • Topo PCR Cloning
  • Blunt End Cloning
  • Seamless Cloning
  • Site-Directed Mutagenesis

Market Breakup by End User

  • Biotechnology Companies
  • Academic and Research Institute
  • Others

Market Breakup by Region

  • North America
  • Europe
  • Asia Pacific
  • Latin America
  • Middle East and Africa

Global Cloning and Mutagenesis Market Share

Market Segmentation Based on Technique is Anticipated to Witness Substantial Growth

Based on the techniques, the market is segmented into Topo PCR cloning, blunt end cloning, seamless cloning, and site-directed mutagenesis. In TOPO PCR cloning, topoisomerase enzymes are used to ligate the PCR products directly into vectors, eliminating the need for restriction enzymes or ligase. It is widely used for cloning PCR products for sequencing or for creating recombinant DNA for protein expression. Since the TOPO PCR cloning technique offers a rapid and efficient cloning process and doesn't require any additional restriction enzyme digestion and ligation step, it is expected to drive the demand of the market segment. On the other hand, blunt-end cloning is used for the construction of plasmid libraries and general molecular cloning applications.

Global Cloning and Mutagenesis Market Analysis by Region

Based on the region, the market covers North America, Europe, Asia Pacific, Latin America, and the Middle East and Africa. North America holds a significant share of the market and is expected to register robust growth during the forecast period. This is on account of the huge investments in research and development in the medical field, coupled with the well-developed healthcare industry in the region.

Rising investments in biotechnology companies and the presence of market key players like Thermo Fisher Scientific Inc. and Codex DNA, Inc., among others, are expected to elevate the cloning and mutagenesis market value. Moreover, the surging investment in the development of stem cell and cancer cell studies is further anticipated to bolster the market growth in North America.

Meanwhile, the Asia Pacific region is expected to witness considerable market growth due to the rapidly growing healthcare industry and increasing investments in biotechnology.

Leading Players in the Global Cloning and Mutagenesis Market

The key features of the market report comprise strategic initiatives by the leading players including mergers and collaborations and new product launches. The major companies in the market are as follows:

Thermo Fisher Scientific Inc.

Thermo Fisher Scientific Inc. has a strong market presence and is actively working towards expanding its product portfolio to address various research needs. It offers a range of cloning kits, enzymes, and reagents, such as TOPO cloning kits, GeneArt Seamless Cloning kits, and Gateway cloning systems.

Takara Bio Inc.

Headquartered in Japan, Takara Bio Inc. develops and distributes life science reagents under the Takara®, Clontech®, and Cellartis® brands. It offers high-quality reagents and kits such as PrimeSTAR high-fidelity DNA polymerases and significantly contributes to the cloning and mutagenesis market growth.

Agilent Technologies, Inc.

California-based Agilent Technologies, Inc. is known for innovative solutions for cloning and mutagenesis. One of its key products includes QuikChange site-directed mutagenesis kits that are reported to expedite and simplify site-directed mutagenesis studies.

TransGen Biotech Co., LTD.

TransGen Biotech Co., LTD is a leading biotechnology company that manufactures over 200 molecular and cellular biology reagents. It holds a major market share by providing cost-effective and high-quality products including mutagenesis kits, cloning vectors, and PCR cloning kits.

*Please note that this is only a partial list; the complete list of key players is available in the full report. Additionally, the list of key players can be customized to better suit your needs.*

Other key players in the market include Merck KGaA, Bio-Rad Laboratories, Inc., Promega Corporation, GenScript, Genes2Me, and New England Biolabs.

Key Questions Answered in the Global Cloning and Mutagenesis Market Report

  • What was the global cloning and mutagenesis market value in 2025?
  • What is the global cloning and mutagenesis market forecast outlook for 2026-2035?
  • What are the regional markets covered in the EMR report?
  • What is market segmentation based on product?
  • What is the market breakup based on technique?
  • Who are the major end users in the market?
  • What are the major factors aiding the global cloning and mutagenesis market demand? 
  • How has the market performed so far and how is it anticipated to perform in the coming years?
  • What are the major drivers, opportunities, and restraints? 
  • Which regional market is expected to lead the market share in the forecast period? 
  • Which country is expected to experience expedited growth during the forecast period? 
  • How does the prevalence and incidence of genetic disorders affect the market landscape?
  • What are the major global cloning and mutagenesis market trends?
  • What product will dominate the market share? 
  • Which technique is expected to have a high market value in the coming years?
  • Which end user is projected to contribute to the highest market growth?
  • Who are the key players involved in the cloning and mutagenesis market?
  • What are the current unmet needs and challenges in the market?
  • How are partnerships, collaborations, mergers and acquisitions among the key market players shaping the market dynamics?

Cloning and Mutagenesis Market Report Snapshots

Cloning and Mutagenesis Companies

*While we strive to always give you current and accurate information, the numbers depicted on the website are indicative and may differ from the actual numbers in the main report. At Expert Market Research, we aim to bring you the latest insights and trends in the market. Using our analyses and forecasts, stakeholders can understand the market dynamics, navigate challenges, and capitalize on opportunities to make data-driven strategic decisions.*

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Report Summary

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Please note that the figures mentioned in the description serve as estimates and may vary from the actual figures presented in the final report.

REPORT FEATURES DETAILS
Base Year 2025
Historical Period 2019-2025
Forecast Period 2026-2035
Scope of the Report

Historical and Forecast Trends, Industry Drivers and Constraints, Historical and Forecast Market Analysis by Segment:

  • Product
  • Technique
  • End User
  • Region
Breakup by Product
  • Cloning Kits
  • Others
Breakup by Technique
  • Topo PCR Cloning
  • Blunt End Cloning
  • Seamless Cloning
  • Site-Directed Mutagenesis
Breakup by End User
  • Biotechnology Companies
  • Academic and Research Institute
  • Others
Breakup by Region
  • North America
  • Europe
  • Asia Pacific
  • Latin America
  • Middle East and Africa
Market Dynamics
  • Market Drivers and Constraints
  • SWOT Analysis
  • Porter’s Five Forces Model 
  • Key Demand Indicators
  • Key Price Indicators
  • Industry Events, Initiatives, and Trends 
  • Value Chain Analysis
Supplier Landscape
  • Market Structure
  • Company Profiles
    • Financial Analysis
    • Product Portfolio
    • Demographic Reach and Achievements
    • Mergers and Acquisitions
    • Certifications
Companies Covered
  • Thermo Fisher Scientific Inc. 
  • Takara Bio Inc.
  • Agilent Technologies, Inc.
  • TransGen Biotech Co., LTD. 
  • Merck KGaA 
  • Bio-Rad Laboratories, Inc. 
  • Promega Corporation 
  • GenScript 
  • Genes2Me
  • New England Biolabs

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