Cloning And Mutagenesis Market By Type (Cloning Kits & Reagents, Mutagenesis Kits & Reagents), By Technology (Site-Directed Mutagenesis, Random Mutagenesis, Seamless Cloning, Topo Cloning, Gibson Assembly), By Application (Gene Expression Studies, Protein Engineering, Functional Genomics, Drug Discovery, Agriculture Biotechnology), and By End-Use Industry (Pharmaceutical & Biotechnology Companies, Academic & Research Institutes, Contract Research Organizations (CROs)); Global Insights & Forecast (2024 - 2030)

As per Intent Market Research, the Cloning And Mutagenesis Market was valued at USD 3.0 Billion in 2024-e and will surpass USD 5.1 Billion by 2030; growing at a CAGR of 9.4% during 2025 - 2030.

The cloning and mutagenesis market is experiencing rapid growth, driven by the increasing demand for genetic engineering tools in biotechnology, pharmaceuticals, and academic research. Cloning and mutagenesis play a crucial role in molecular biology by enabling precise genetic modifications, which are essential for applications such as drug discovery, functional genomics, protein engineering, and agricultural biotechnology. Advancements in cloning technologies, the rise of synthetic biology, and the growing focus on personalized medicine are fueling market expansion. Additionally, the increasing investments in genomic research and the widespread adoption of CRISPR and other gene-editing technologies are further enhancing the development of cloning and mutagenesis tools.

Cloning Kits & Reagents Segment Is Largest Owing To Widespread Use In Genetic Research

Among the different product types, the cloning kits & reagents segment holds the largest market share due to their extensive use in genetic research, biotechnology, and pharmaceutical applications. Cloning kits enable researchers to create recombinant DNA, which is fundamental for gene expression studies, functional genomics, and drug development. The widespread adoption of cloning techniques in academic and industrial research laboratories has driven the demand for high-quality and efficient cloning kits. Moreover, the development of advanced cloning kits that streamline workflows and improve accuracy has further contributed to the dominance of this segment. As cloning continues to be a cornerstone of genetic engineering, this segment is expected to maintain its leadership in the market.

 Cloning And Mutagenesis Market  Size

Site-Directed Mutagenesis Technology Is Fastest Growing Due To High Precision And Customization

Site-directed mutagenesis is the fastest-growing technology in the cloning and mutagenesis market, owing to its precision and ability to introduce specific genetic changes. This technique is widely used in protein engineering, drug development, and functional genomics to study the effects of specific mutations on gene function. Advances in site-directed mutagenesis have led to the development of more efficient and error-free methods, enabling researchers to perform targeted genetic modifications with high accuracy. The growing application of site-directed mutagenesis in developing personalized therapeutics and synthetic biology solutions is further propelling its rapid adoption. As demand for highly customized genetic modifications increases, this segment is expected to witness substantial growth.

Drug Discovery Application Is Largest Due To Expanding Biopharmaceutical Research

In terms of application, drug discovery holds the largest share of the cloning and mutagenesis market. The pharmaceutical industry increasingly relies on genetic engineering techniques to develop novel biologics, targeted therapies, and gene-based treatments. Cloning and mutagenesis are essential tools for screening drug targets, optimizing protein structures, and studying disease mechanisms at the molecular level. The growing investment in biopharmaceutical research, coupled with the rising demand for precision medicine, has significantly boosted the use of cloning technologies in drug discovery. As pharmaceutical companies continue to explore innovative therapeutic approaches, this application segment will remain a major driver of market growth.

Pharmaceutical & Biotechnology Companies Segment Is Largest Due To High R&D Investments

Pharmaceutical and biotechnology companies represent the largest end-use industry in the cloning and mutagenesis market, driven by substantial investments in genetic research and drug development. These companies utilize cloning and mutagenesis techniques to develop biologics, gene therapies, and advanced diagnostic tools. With the rising demand for monoclonal antibodies, cell therapies, and recombinant proteins, pharmaceutical firms are continuously integrating cloning and mutagenesis solutions into their R&D processes. Additionally, the increasing adoption of automation and high-throughput screening techniques in drug discovery is further propelling the demand for cloning kits and mutagenesis reagents. As biotechnology continues to advance, pharmaceutical and biotech firms will remain key contributors to market expansion.

North America Is Largest Market Owing To Strong Research Infrastructure And Biotech Investments

North America holds the largest share of the cloning and mutagenesis market, driven by its well-established biotechnology industry, strong academic research infrastructure, and high R&D investments in pharmaceuticals and genetic engineering. The region is home to leading biotech and pharmaceutical companies, as well as renowned research institutes conducting cutting-edge genetic studies. The increasing focus on personalized medicine, synthetic biology, and gene therapy has further accelerated the adoption of cloning and mutagenesis technologies in North America. Moreover, government funding and initiatives supporting genomics and biotechnology research have strengthened the region’s position as the dominant market. As advancements in genetic engineering continue, North America is expected to maintain its leadership in the global market.

 Cloning And Mutagenesis Market  Size by Region 2030

Leading Companies And Competitive Landscape

The cloning and mutagenesis market is highly competitive, with key players such as Thermo Fisher Scientific, Merck KGaA, Agilent Technologies, New England Biolabs, and Takara Bio leading the industry. These companies are actively engaged in developing innovative cloning and mutagenesis solutions to enhance efficiency, accuracy, and scalability in genetic research. Strategic collaborations with research institutions, investments in automation, and continuous advancements in gene-editing technologies are shaping the competitive landscape. The market is also witnessing increased commercialization of user-friendly and high-throughput cloning kits to cater to the growing demand in pharmaceutical, academic, and industrial research. As genetic engineering becomes more sophisticated, competition among key players will continue to drive innovation and market expansion.

List of Leading Companies:

  • Thermo Fisher Scientific Inc.
  • Merck KGaA
  • Agilent Technologies Inc.
  • New England Biolabs Inc.
  • Takara Bio Inc.
  • QIAGEN N.V.
  • Promega Corporation
  • GenScript Biotech Corporation
  • Lonza Group Ltd.
  • Integrated DNA Technologies Inc.
  • Bio-Rad Laboratories Inc.
  • Oxford Genetics Ltd.
  • Origene Technologies Inc.
  • Eurofins Scientific SE
  • Lucigen Corporation

Recent Developments:

  • Thermo Fisher Scientific Inc. introduced a next-generation site-directed mutagenesis kit in February 2025, improving precision in genetic modification.
  • Merck KGaA expanded its gene-editing product portfolio in January 2025, adding new seamless cloning technologies for biotech research.
  • Agilent Technologies Inc. announced a collaboration with a leading biotech firm in December 2024 to develop novel mutagenesis tools for drug discovery.
  • New England Biolabs Inc. launched a high-efficiency DNA cloning system in November 2024, targeting academic and pharmaceutical research.
  • Takara Bio Inc. revealed an advanced PCR-based mutagenesis kit in October 2024, enhancing accuracy in gene modification techniques.

Report Scope:

Report Features

Description

Market Size (2024-e)

USD 3.0 Billion

Forecasted Value (2030)

USD 5.1 Billion

CAGR (2025 – 2030)

9.4%

Base Year for Estimation

2024-e

Historic Year

2023

Forecast Period

2025 – 2030

Report Coverage

Market Forecast, Market Dynamics, Competitive Landscape, Recent Developments

Segments Covered

Cloning And Mutagenesis Market By Type (Cloning Kits & Reagents, Mutagenesis Kits & Reagents), By Technology (Site-Directed Mutagenesis, Random Mutagenesis, Seamless Cloning, Topo Cloning, Gibson Assembly), By Application (Gene Expression Studies, Protein Engineering, Functional Genomics, Drug Discovery, Agriculture Biotechnology), and By End-Use Industry (Pharmaceutical & Biotechnology Companies, Academic & Research Institutes, Contract Research Organizations (CROs))

Regional Analysis

North America (US, Canada, Mexico), Europe (Germany, France, UK, Italy, Spain, and Rest of Europe), Asia-Pacific (China, Japan, South Korea, Australia, India, and Rest of Asia-Pacific), Latin America (Brazil, Argentina, and Rest of Latin America), Middle East & Africa (Saudi Arabia, UAE, Rest of Middle East & Africa)

Major Companies

Thermo Fisher Scientific Inc., Merck KGaA, Agilent Technologies Inc., New England Biolabs Inc., Takara Bio Inc., QIAGEN N.V., GenScript Biotech Corporation, Lonza Group Ltd., Integrated DNA Technologies Inc., Bio-Rad Laboratories Inc., Oxford Genetics Ltd., Origene Technologies Inc., Lucigen Corporation

Customization Scope

Customization for segments, region/country-level will be provided. Moreover, additional customization can be done based on the requirements

Frequently Asked Questions

The Cloning And Mutagenesis Market was valued at USD 3.0 Billion in 2024-e and is expected to grow at a CAGR of 9.4% of over from 2025 to 2030.

The cloning and mutagenesis market involves technologies and reagents used for genetic modification, including DNA cloning, gene expression studies, and protein engineering.

These technologies are widely used in gene expression studies, protein engineering, functional genomics, drug discovery, and agricultural biotechnology.

Pharmaceutical & biotechnology companies, academic & research institutes, and contract research organizations utilize these technologies for various genetic studies.

High costs of advanced gene editing tools, regulatory hurdles, and ethical concerns related to genetic manipulation are key challenges.

1. Introduction

   1.1. Market Definition

   1.2. Scope of the Study

   1.3. Research Assumptions

   1.4. Study Limitations

2. Research Methodology

   2.1. Research Approach

      2.1.1. Top-Down Method

      2.1.2. Bottom-Up Method

      2.1.3. Factor Impact Analysis

  2.2. Insights & Data Collection Process

      2.2.1. Secondary Research

      2.2.2. Primary Research

   2.3. Data Mining Process

      2.3.1. Data Analysis

      2.3.2. Data Validation and Revalidation

      2.3.3. Data Triangulation

3. Executive Summary

   3.1. Major Markets & Segments

   3.2. Highest Growing Regions and Respective Countries

   3.3. Impact of Growth Drivers & Inhibitors

   3.4. Regulatory Overview by Country

4. Cloning And Mutagenesis Market, by Type (Market Size & Forecast: USD Million, 2023 – 2030)

   4.1. Cloning Kits & Reagents

   4.2. Mutagenesis Kits & Reagents

   4.3. Others

5. Cloning And Mutagenesis Market, by Technology (Market Size & Forecast: USD Million, 2023 – 2030)

   5.1. Site-Directed Mutagenesis

   5.2. Random Mutagenesis

   5.3. Seamless Cloning

   5.4. Topo Cloning

   5.5. Gibson Assembly

6. Cloning And Mutagenesis Market, by Application (Market Size & Forecast: USD Million, 2023 – 2030)

   6.1. Gene Expression Studies

   6.2. Protein Engineering

   6.3. Functional Genomics

   6.4. Drug Discovery

   6.5. Agriculture Biotechnology

7. Cloning And Mutagenesis Market, by End-Use Industry (Market Size & Forecast: USD Million, 2023 – 2030)

   7.1. Pharmaceutical & Biotechnology Companies

   7.2. Academic & Research Institutes

   7.3. Contract Research Organizations (CROs)

   7.4. Others

8. Regional Analysis (Market Size & Forecast: USD Million, 2023 – 2030)

   8.1. Regional Overview

   8.2. North America

      8.2.1. Regional Trends & Growth Drivers

      8.2.2. Barriers & Challenges

      8.2.3. Opportunities

      8.2.4. Factor Impact Analysis

      8.2.5. Technology Trends

      8.2.6. North America Cloning And Mutagenesis Market, by Type

      8.2.7. North America Cloning And Mutagenesis Market, by Technology

      8.2.8. North America Cloning And Mutagenesis Market, by Application

      8.2.9. North America Cloning And Mutagenesis Market, by End-Use Industry

      8.2.10. By Country

         8.2.10.1. US

               8.2.10.1.1. US Cloning And Mutagenesis Market, by Type

               8.2.10.1.2. US Cloning And Mutagenesis Market, by Technology

               8.2.10.1.3. US Cloning And Mutagenesis Market, by Application

               8.2.10.1.4. US Cloning And Mutagenesis Market, by End-Use Industry

         8.2.10.2. Canada

         8.2.10.3. Mexico

    *Similar segmentation will be provided for each region and country

   8.3. Europe

   8.4. Asia-Pacific

   8.5. Latin America

   8.6. Middle East & Africa

9. Competitive Landscape

   9.1. Overview of the Key Players

   9.2. Competitive Ecosystem

      9.2.1. Level of Fragmentation

      9.2.2. Market Consolidation

      9.2.3. Product Innovation

   9.3. Company Share Analysis

   9.4. Company Benchmarking Matrix

      9.4.1. Strategic Overview

      9.4.2. Product Innovations

   9.5. Start-up Ecosystem

   9.6. Strategic Competitive Insights/ Customer Imperatives

   9.7. ESG Matrix/ Sustainability Matrix

   9.8. Manufacturing Network

      9.8.1. Locations

      9.8.2. Supply Chain and Logistics

      9.8.3. Product Flexibility/Customization

      9.8.4. Digital Transformation and Connectivity

      9.8.5. Environmental and Regulatory Compliance

   9.9. Technology Readiness Level Matrix

   9.10. Technology Maturity Curve

   9.11. Buying Criteria

10. Company Profiles

   10.1. Thermo Fisher Scientific Inc.

      10.1.1. Company Overview

      10.1.2. Company Financials

      10.1.3. Product/Service Portfolio

      10.1.4. Recent Developments

      10.1.5. IMR Analysis

    *Similar information will be provided for other companies 

   10.2. Merck KGaA

   10.3. Agilent Technologies Inc.

   10.4. New England Biolabs Inc.

   10.5. Takara Bio Inc.

   10.6. QIAGEN N.V.

   10.7. Promega Corporation

   10.8. GenScript Biotech Corporation

   10.9. Lonza Group Ltd.

   10.10. Integrated DNA Technologies Inc.

   10.11. Bio-Rad Laboratories Inc.

   10.12. Oxford Genetics Ltd.

   10.13. Origene Technologies Inc.

   10.14. Eurofins Scientific SE

   10.15. Lucigen Corporation

11. Appendix

 

A comprehensive market research approach was employed to gather and analyze data on The Cloning And Mutagenesis Market. In the process, the analysis was also done to analyze the parent market and relevant adjacencies to measure the impact of them on Cloning And Mutagenesis Market. The research methodology encompassed both secondary and primary research techniques, ensuring the accuracy and credibility of the findings.

Research Approach -

Secondary Research

Secondary research involved a thorough review of pertinent industry reports, journals, articles, and publications. Additionally, annual reports, press releases, and investor presentations of industry players were scrutinized to gain insights into their market positioning and strategies.

Primary Research

Primary research involved conducting in-depth interviews with industry experts, stakeholders, and market participants across the E-Waste Management ecosystem. The primary research objectives included:

  • Validating findings and assumptions derived from secondary research
  • Gathering qualitative and quantitative data on market trends, drivers, and challenges
  • Understanding the demand-side dynamics, encompassing end-users, component manufacturers, facility providers, and service providers
  • Assessing the supply-side landscape, including technological advancements and recent developments

Market Size Assessment

A combination of top-down and bottom-up approaches was utilized to analyze the overall size of Cloning And Mutagenesis Market. These methods were also employed to assess the size of various subsegments within the market. The market size assessment methodology encompassed the following steps:

  1. Identification of key industry players and relevant revenues through extensive secondary research
  2. Determination of the industry's supply chain and market size, in terms of value, through primary and secondary research processes
  3. Calculation of percentage shares, splits, and breakdowns using secondary sources and verification through primary sources

Bottom Up and Top Down -

Data Triangulation

To ensure the accuracy and reliability of the market size, data triangulation was implemented. This involved cross-referencing data from various sources, including demand and supply side factors, market trends, and expert opinions. Additionally, top-down and bottom-up approaches were employed to validate the market size assessment.

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