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Cloning & Mutagenesis Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, 2020-2030F

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    Report

  • 185 Pages
  • May 2025
  • Region: Global
  • TechSci Research
  • ID: 5768468
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The Cloning & Mutagenesis Market was valued at USD 2.67 Billion in 2024, and is expected to reach USD 7.58 Billion by 2030, rising at a CAGR of 18.99%. This market is witnessing rapid growth, largely fueled by expanding applications of cloning techniques in fields such as genetic and reproductive research. The increasing number of product launches involving cloning and mutagenesis kits, along with rising governmental investment in stem cell research for therapeutic development, is further driving demand.

Additionally, the global rise in the aging population - more susceptible to chronic illnesses and metabolic disorders - is expected to significantly contribute to market expansion. Heightened awareness of gene therapy benefits and early diagnostic tools, combined with increased healthcare spending on chronic disease management, also supports the market’s growth trajectory. Moreover, the global burden of diseases like head and neck cancer continues to drive demand for genetic engineering tools for advanced treatment solutions.

Key Market Drivers

Rising Demand for Genetically Engineered Products in Biotechnology and Pharmaceuticals

The global demand for genetically engineered products is one of the major growth catalysts for the cloning and mutagenesis market. These technologies are vital in developing new drugs, gene therapies, vaccines, and synthetic biological products. Cloning and mutagenesis techniques allow scientists to manipulate genes for desired traits, making them indispensable in genetic research and biopharmaceutical manufacturing. Significant public investments reinforce this trend - for instance, the U.S. Department of Health and Human Services allocated over $2.5 billion to BARDA in 2023 to support advanced vaccine and therapeutic development, much of which relies on gene manipulation techniques. Similarly, under its Horizon Europe framework, the European Commission has earmarked over €1 billion for health innovation, focusing on gene-based solutions and personalized medicine.

Key Market Challenges

Ethical and Regulatory Concerns Around Genetic Manipulation

The ethical and regulatory landscape surrounding genetic engineering poses a major challenge for the cloning and mutagenesis market. Concerns about biosafety, environmental impact, and moral implications, especially in human applications like germline editing and embryonic cloning, have led to global scrutiny. While somatic cell gene editing is generally accepted, public and institutional opposition to germline modifications persists.

Following incidents like the unauthorized editing of human embryos in 2018, regulatory bodies such as the WHO and UNESCO have called for stricter oversight. Regulatory inconsistencies between regions further complicate the market - while agencies like the FDA and EMA allow controlled gene therapy, other countries enforce bans on certain genetic techniques. The EU, for example, imposes rigorous regulations on GMOs, often delaying their approval. These regulatory and ethical hurdles not only slow innovation but also increase compliance costs, especially for companies operating in sensitive sectors like human therapeutics and agricultural biotechnology.

Key Market Trends

Integration of Artificial Intelligence in Genetic Engineering Workflows

The adoption of artificial intelligence in genetic research is a transformative trend in the cloning and mutagenesis market. AI and machine learning technologies are being increasingly utilized to automate gene synthesis, select optimal mutagenesis sites, design primers, and predict protein behavior after mutation. These tools help researchers conduct high-precision experiments more efficiently and cost-effectively.

AI-driven analysis of large genomic datasets enables faster identification of gene targets and potential phenotypic outcomes, streamlining drug development and genetic research. Government support is also fostering this integration. For instance, the U.S. has prioritized AI in healthcare through the National Artificial Intelligence Initiative Act and allocated over $1.5 billion for related research in 2023. Similarly, Europe’s Horizon Europe program promotes AI-based innovation in biotechnology. As AI systems become more advanced and widely adopted, their impact on genetic engineering is expected to enhance the reproducibility, speed, and accuracy of cloning and mutagenesis experiments across the pharmaceutical, agricultural, and research sectors.

Key Market Players

  • Agilent Technologies, Inc.
  • Eurofins Scientific SE
  • Sartorius AG
  • Collecta, Inc.
  • Codex DNA Inc.
  • Lonza Group AG
  • Charles River Laboratories International, Inc.
  • TransGene Biotech Co. Ltd.
  • Takara Bio, Inc.
  • Thermo Fisher Scientific Inc.

Report Scope:

In this report, the Global Cloning & Mutagenesis Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

Cloning & Mutagenesis Market, By Gene Type:

  • Standard
  • Complex

Cloning & Mutagenesis Market, By Product Type:

  • Cloning Kits
  • Mutagenesis Kits

Cloning & Mutagenesis Market, By Technique:

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

Cloning & Mutagenesis Market, By Application:

  • Gene Synthesis
  • Gene Expression
  • Gene Therapy
  • Vaccine Research
  • Others

Cloning & Mutagenesis Market, By End User:

  • Pharmaceutical & Biotechnology Companies
  • Academic & Research Institutions
  • Others

Cloning & Mutagenesis Market, By Region:

  • North America
  • United States
  • Mexico
  • Canada
  • Europe
  • France
  • Germany
  • United Kingdom
  • Italy
  • Spain
  • Asia-Pacific
  • China
  • India
  • South Korea
  • Japan
  • Australia
  • South America
  • Brazil
  • Argentina
  • Colombia
  • Middle East and Africa
  • South Africa
  • Saudi Arabia
  • UAE

Competitive Landscape

Company Profiles: Detailed analysis of the major companies present in the Global Cloning & Mutagenesis Market.

Available Customizations:

With the given market data, the publisher offers customizations according to a company's specific needs. The following customization options are available for the report.

Company Information

  • Detailed analysis and profiling of additional market players (up to five).

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Table of Contents

1. Product Overview
1.1. Market Definition
1.2. Scope of the Market
1.2.1. Markets Covered
1.2.2. Years Considered for Study
1.2.3. Key Market Segmentations
2. Research Methodology
2.1. Objective of the Study
2.2. Baseline Methodology
2.3. Key Industry Partners
2.4. Major Association and Secondary Sources
2.5. Forecasting Methodology
2.6. Data Triangulation & Validation
2.7. Assumptions and Limitations
3. Executive Summary
3.1. Overview of the Market
3.2. Overview of Key Market Segmentations
3.3. Overview of Key Market Players
3.4. Overview of Key Regions/Countries
3.5. Overview of Market Drivers, Challenges, Trends
4. Voice of Customer
5. Global Cloning & Mutagenesis Market Outlook
5.1. Market Size & Forecast
5.1.1. By Value
5.2. Market Share & Forecast
5.2.1. By Gene Type (Standard, Complex)
5.2.2. By Product Type (Cloning Kits, Mutagenesis Kits)
5.2.3. By Technique (Topo PCR Cloning, Blunt End Cloning, Seamless Cloning, Site-Directed Mutagenesis, Others)
5.2.4. By Application (Gene Synthesis, Gene Expression, Gene Therapy, Vaccine Research, Others)
5.2.5. By End User (Pharmaceutical & Biotechnology Companies, Academic & Research Institutions, Others)
5.2.6. By Region
5.2.7. By Company (2024)
5.3. Market Map
5.3.1. By Gene Type
5.3.2. By Product Type
5.3.3. By Technique
5.3.4. By Application
5.3.5. By End User
5.3.6. By Region
6. North America Cloning & Mutagenesis Market Outlook
6.1. Market Size & Forecast
6.1.1. By Value
6.2. Market Share & Forecast
6.2.1. By Gene Type
6.2.2. By Product Type
6.2.3. By Technique
6.2.4. By Application
6.2.5. By End User
6.2.6. By Country
6.3. North America: Country Analysis
6.3.1. United States Cloning & Mutagenesis Market Outlook
6.3.1.1. Market Size & Forecast
6.3.1.1.1. By Value
6.3.1.2. Market Share & Forecast
6.3.1.2.1. By Gene Type
6.3.1.2.2. By Product Type
6.3.1.2.3. By Technique
6.3.1.2.4. By Application
6.3.1.2.5. By End User
6.3.2. Canada Cloning & Mutagenesis Market Outlook
6.3.2.1. Market Size & Forecast
6.3.2.1.1. By Value
6.3.2.2. Market Share & Forecast
6.3.2.2.1. By Gene Type
6.3.2.2.2. By Product Type
6.3.2.2.3. By Technique
6.3.2.2.4. By Application
6.3.2.2.5. By End User
6.3.3. Mexico Cloning & Mutagenesis Market Outlook
6.3.3.1. Market Size & Forecast
6.3.3.1.1. By Value
6.3.3.2. Market Share & Forecast
6.3.3.2.1. By Gene Type
6.3.3.2.2. By Product Type
6.3.3.2.3. By Technique
6.3.3.2.4. By Application
6.3.3.2.5. By End User
7. Europe Cloning & Mutagenesis Market Outlook
7.1. Market Size & Forecast
7.1.1. By Value
7.2. Market Share & Forecast
7.2.1. By Gene Type
7.2.2. By Product Type
7.2.3. By Technique
7.2.4. By Application
7.2.5. By End User
7.2.6. By Country
7.3. Europe: Country Analysis
7.3.1. France Cloning & Mutagenesis Market Outlook
7.3.1.1. Market Size & Forecast
7.3.1.1.1. By Value
7.3.1.2. Market Share & Forecast
7.3.1.2.1. By Gene Type
7.3.1.2.2. By Product Type
7.3.1.2.3. By Technique
7.3.1.2.4. By Application
7.3.1.2.5. By End User
7.3.2. Germany Cloning & Mutagenesis Market Outlook
7.3.2.1. Market Size & Forecast
7.3.2.1.1. By Value
7.3.2.2. Market Share & Forecast
7.3.2.2.1. By Gene Type
7.3.2.2.2. By Product Type
7.3.2.2.3. By Technique
7.3.2.2.4. By Application
7.3.2.2.5. By End User
7.3.3. United Kingdom Cloning & Mutagenesis Market Outlook
7.3.3.1. Market Size & Forecast
7.3.3.1.1. By Value
7.3.3.2. Market Share & Forecast
7.3.3.2.1. By Gene Type
7.3.3.2.2. By Product Type
7.3.3.2.3. By Technique
7.3.3.2.4. By Application
7.3.3.2.5. By End User
7.3.4. Italy Cloning & Mutagenesis Market Outlook
7.3.4.1. Market Size & Forecast
7.3.4.1.1. By Value
7.3.4.2. Market Share & Forecast
7.3.4.2.1. By Gene Type
7.3.4.2.2. By Product Type
7.3.4.2.3. By Technique
7.3.4.2.4. By Application
7.3.4.2.5. By End User
7.3.5. Spain Cloning & Mutagenesis Market Outlook
7.3.5.1. Market Size & Forecast
7.3.5.1.1. By Value
7.3.5.2. Market Share & Forecast
7.3.5.2.1. By Gene Type
7.3.5.2.2. By Product Type
7.3.5.2.3. By Technique
7.3.5.2.4. By Application
7.3.5.2.5. By End User
8. Asia-Pacific Cloning & Mutagenesis Market Outlook
8.1. Market Size & Forecast
8.1.1. By Value
8.2. Market Share & Forecast
8.2.1. By Gene Type
8.2.2. By Product Type
8.2.3. By Technique
8.2.4. By Application
8.2.5. By End User
8.2.6. By Country
8.3. Asia-Pacific: Country Analysis
8.3.1. China Cloning & Mutagenesis Market Outlook
8.3.1.1. Market Size & Forecast
8.3.1.1.1. By Value
8.3.1.2. Market Share & Forecast
8.3.1.2.1. By Gene Type
8.3.1.2.2. By Product Type
8.3.1.2.3. By Technique
8.3.1.2.4. By Application
8.3.1.2.5. By End User
8.3.2. India Cloning & Mutagenesis Market Outlook
8.3.2.1. Market Size & Forecast
8.3.2.1.1. By Value
8.3.2.2. Market Share & Forecast
8.3.2.2.1. By Gene Type
8.3.2.2.2. By Product Type
8.3.2.2.3. By Technique
8.3.2.2.4. By Application
8.3.2.2.5. By End User
8.3.3. Japan Cloning & Mutagenesis Market Outlook
8.3.3.1. Market Size & Forecast
8.3.3.1.1. By Value
8.3.3.2. Market Share & Forecast
8.3.3.2.1. By Gene Type
8.3.3.2.2. By Product Type
8.3.3.2.3. By Technique
8.3.3.2.4. By Application
8.3.3.2.5. By End User
8.3.4. South Korea Cloning & Mutagenesis Market Outlook
8.3.4.1. Market Size & Forecast
8.3.4.1.1. By Value
8.3.4.2. Market Share & Forecast
8.3.4.2.1. By Gene Type
8.3.4.2.2. By Product Type
8.3.4.2.3. By Technique
8.3.4.2.4. By Application
8.3.4.2.5. By End User
8.3.5. Australia Cloning & Mutagenesis Market Outlook
8.3.5.1. Market Size & Forecast
8.3.5.1.1. By Value
8.3.5.2. Market Share & Forecast
8.3.5.2.1. By Gene Type
8.3.5.2.2. By Product Type
8.3.5.2.3. By Technique
8.3.5.2.4. By Application
8.3.5.2.5. By End User
9. South America Cloning & Mutagenesis Market Outlook
9.1. Market Size & Forecast
9.1.1. By Value
9.2. Market Share & Forecast
9.2.1. By Gene Type
9.2.2. By Product Type
9.2.3. By Technique
9.2.4. By Application
9.2.5. By End User
9.2.6. By Country
9.3. South America: Country Analysis
9.3.1. Brazil Cloning & Mutagenesis Market Outlook
9.3.1.1. Market Size & Forecast
9.3.1.1.1. By Value
9.3.1.2. Market Share & Forecast
9.3.1.2.1. By Gene Type
9.3.1.2.2. By Product Type
9.3.1.2.3. By Technique
9.3.1.2.4. By Application
9.3.1.2.5. By End User
9.3.2. Argentina Cloning & Mutagenesis Market Outlook
9.3.2.1. Market Size & Forecast
9.3.2.1.1. By Value
9.3.2.2. Market Share & Forecast
9.3.2.2.1. By Gene Type
9.3.2.2.2. By Product Type
9.3.2.2.3. By Technique
9.3.2.2.4. By Application
9.3.2.2.5. By End User
9.3.3. Colombia Cloning & Mutagenesis Market Outlook
9.3.3.1. Market Size & Forecast
9.3.3.1.1. By Value
9.3.3.2. Market Share & Forecast
9.3.3.2.1. By Gene Type
9.3.3.2.2. By Product Type
9.3.3.2.3. By Technique
9.3.3.2.4. By Application
9.3.3.2.5. By End User
10. Middle East and Africa Cloning & Mutagenesis Market Outlook
10.1. Market Size & Forecast
10.1.1. By Value
10.2. Market Share & Forecast
10.2.1. By Gene Type
10.2.2. By Product Type
10.2.3. By Technique
10.2.4. By Application
10.2.5. By End User
10.2.6. By Country
10.3. MEA: Country Analysis
10.3.1. South Africa Cloning & Mutagenesis Market Outlook
10.3.1.1. Market Size & Forecast
10.3.1.1.1. By Value
10.3.1.2. Market Share & Forecast
10.3.1.2.1. By Gene Type
10.3.1.2.2. By Product Type
10.3.1.2.3. By Technique
10.3.1.2.4. By Application
10.3.1.2.5. By End User
10.3.2. Saudi Arabia Cloning & Mutagenesis Market Outlook
10.3.2.1. Market Size & Forecast
10.3.2.1.1. By Value
10.3.2.2. Market Share & Forecast
10.3.2.2.1. By Gene Type
10.3.2.2.2. By Product Type
10.3.2.2.3. By Technique
10.3.2.2.4. By Application
10.3.2.2.5. By End User
10.3.3. UAE Cloning & Mutagenesis Market Outlook
10.3.3.1. Market Size & Forecast
10.3.3.1.1. By Value
10.3.3.2. Market Share & Forecast
10.3.3.2.1. By Gene Type
10.3.3.2.2. By Product Type
10.3.3.2.3. By Technique
10.3.3.2.4. By Application
10.3.3.2.5. By End User
11. Market Dynamics
11.1. Drivers
11.2. Challenges
12. Market Trends & Developments
12.1. Recent Developments
12.2. Mergers & Acquisitions
12.3. Product Launches
13. Global Cloning & Mutagenesis Market: SWOT Analysis
14. Porters Five Forces Analysis
14.1. Competition in the Industry
14.2. Potential of New Entrants
14.3. Power of Suppliers
14.4. Power of Customers
14.5. Threat of Substitute Products/Services
15. Competitive Landscape
15.1. Agilent Technologies, Inc.
15.1.1. Business Overview
15.1.2. Company Snapshot
15.1.3. Products & Services
15.1.4. Financials (As Reported)
15.1.5. Recent Developments
15.1.6. Key Personnel Details
15.1.7. SWOT Analysis
15.2. Eurofins Scientific SE
15.3. Sartorius AG
15.4. Collecta, Inc.
15.5. Codex DNA Inc.
15.6. Lonza Group AG
15.7. Charles River Laboratories International, Inc.
15.8. TransGene Biotech Co. Ltd.
15.9. Takara Bio, Inc.
15.10. Thermo Fisher Scientific Inc.
16. Strategic Recommendations17. About the Publisher & Disclaimer

Companies Mentioned

  • Agilent Technologies, Inc.
  • Eurofins Scientific SE
  • Sartorius AG
  • Collecta, Inc.
  • Codex DNA Inc.
  • Lonza Group AG
  • Charles River Laboratories International, Inc.
  • TransGene Biotech Co. Ltd.
  • Takara Bio, Inc.
  • Thermo Fisher Scientific Inc.

Table Information

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