Cloning And Mutagenesis Market Size, Share and Trends 2026 to 2035
Cloning And Mutagenesis Market (By Product: Cloning Kits, Mutagenesis Kits, Others; By Technology: Topo PCR Cloning, Blunt End Cloning, Seamless Cloning, Site-directed Mutagenesis, Others; By End-User: Biopharmaceutical & Pharmaceutical Companies, CROs & CMOs, Academic & Research Institutes) - Global Industry Analysis, Size, Trends, Leading Companies, Regional Outlook, and Forecast 2026 to 2035
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Table Of Content
What is the Cloning and Mutagenesis Market Size?
The global cloning and mutagenesis market size is valued at USD 5.01 billion in 2025 and is predicted to increase from USD 5.98 billion in 2026 to approximately USD 24.80 billion by 2035, expanding at a CAGR of 17.34% from 2026 to 2035.
Cloning And Mutagenesis Market Key Takeaways
- North America generated more than 36% of the revenue share in 2025.
- Asia Pacific is predicted growing at the largest CAGR between 2026 and 2035.
- By Product, the cloning kits segment is predicted to capture the largest market share between 2026 and 2035.
- By Product, the mutagenesis kits segment is expected to expand at the biggest CAGR between 2026 and 2035.
- By Technology, the Topo PCR Cloning segment is expected to dominate the market between 2026 and 2036.
- By Technology, the Site-directed Mutagenesis segment is predicted to grow at a remarkable rate between 2026 and 2036.
Market Overview
Cloning is the process of making genetically identical duplicates of an organism, either spontaneously or intentionally. The process of mutagenesis is when the genetic structure of an organism is changed, resulting in a mutation. Mutagenesis occurs when DNA is purposefully altered to create mutant proteins, genes, or strains of an organism in a lab setting. Two of the best techniques used to study the connections between protein structure and function are cloning and mutagenesis. They are applied to verify mutational effects both in vitro and in vivo.
The global cloning and mutagenesis industry is anticipated to increase as a result of the expanding use of cloning in several genetic applications, such as reproductive cloning. Both the prevalence of genetic and chronic illnesses and the demand for personalized therapy are predicted to rise. Cloning and mutagenesis technologies are becoming more and more essential as funding for research and development to cure genetic problems and other diseases, including cancer and HIV, increases.
The rise in hereditary and chronic illness prevalence, the rise in demand for personalized medication, and the rise in new companies joining the market are the main drivers of the global market. Favorable funding conditions for gene synthesis and cloning services, technological developments in the cloning sector, and a surge in complementary commercial operations all contribute to the industry's growth.
- According to the World Cancer Research Fund International, in 2020, there will be 18.1 million new cases of cancer worldwide. 9.3 million of these instances involved men, while 8.8 million involved women.
- As per Centers for Disease Control and Prevention, around 523 million population worldwide had some kind of cardiovascular disease in 2020 and 19 million fatalities were directly related to CVD; this amounts to almost 32% of all deaths globally and is an absolute increase of 18.7% from 2010.
- According to the CDC, COPD affects 12.5 million Americans in 2020 and it is the third leading cause of death in the United States.
What is the Role of AI in the Cloning and Mutagenesis Market?
Artificial intelligence (AI) is increasingly being applied in cloning and mutagenesis to improve the success rate of experimental design and execution. AI-driven software helps design primers, select vectors, and predict mutations by analyzing sequence and experimental data, while machine learning models enable accurate predictions of protein structure–function relationships to guide targeted mutations. AI also supports automation by optimizing reaction conditions, enzyme selection, and cloning strategies, reducing reliance on trial-and-error approaches.
In synthetic biology, AI accelerates pathway engineering by translating simulated genetic modifications into practical laboratory workflows. Additionally, AI-enabled data management systems enhance reproducibility, scalability, and efficiency in high-throughput cloning laboratories, supporting more reliable and streamlined research outcomes.
Cloning And Mutagenesis Market Growth Factors
- Increasing usage of cloning in genetic testing is anticipated to boost the market.
- The rise in the prevalence of chronic diseases is expected to drive the market growth.
- Rising demand for personalized medicines and therapies fuel the market.
Market Outlook
- Market Growth Overview: The cloning and mutagenesis market is growing rapidly due to increasing demand for advanced research in genetics, drug development, and biotechnology applications. Rising investments in molecular biology, genome editing technologies, and personalized medicine are also driving the market.
- Global Expansion: The market is growing worldwide, driven by the increasing adoption of CRISPR, gene-editing tools, and recombinant DNA technologies for research, therapeutics, and agriculture. Emerging regions such as Asia-Pacific, Latin America, and the Middle East & Africa present opportunities due to growing biotech research initiatives, expanding academic and industrial labs, and supportive government policies for biotechnology innovation.
- Major Investors: Major investors include biotech and pharmaceutical companies, research institutions, and venture capital firms specializing in life sciences. They contribute by funding R&D, developing innovative cloning and mutagenesis technologies, supporting genome-editing startups, and enabling large-scale adoption in research and therapeutic applications.
Market Scope
| Report Coverage | Details |
| Market Size in 2025 | USD 5.01 Billion |
| Market Size by 2035 | USD 24.80 Billion |
| Growth Rate from 2026 to 2035 | CAGR of 17.34% |
| Largest Market | North America |
| Base Year | 2025 |
| Forecast Period | 2026 to 2035 |
| Segments Covered | Product, Technology, End-User, Region |
| Regions Covered | North America, Europe, Asia-Pacific, Latin America, and the Middle East & Africa |
Market Dynamics
Driver
The growing attention on protein engineering for drug development
The market's growth prospects are strengthening due to the increasing attention being paid to protein engineering for therapeutic development. The fundamental techniques used in protein engineering during medication development include cloning and mutagenesis. These methods support the development of therapeutic proteins by enabling the insertion, deletion, or replacement of nucleotides in protein sequences.
- In June 2024, Daicel Arbor Biosciences launched the next generation of its myTXTL kits. These kits are specially designed to simplify and accelerate antibody discovery and protein engineering.
Restraints
High cost of cell and gene therapy
Researchers contend that patients are unable to obtain cell and gene therapies due to high production costs, and that industry-wide capacity increase and manufacturing method optimization would be beneficial. Cell and gene therapy is expensive. The Institute for Clinical and Economic Review (ICER) found that the average cost of a single dose of gene therapy is between USD $1 million and USD $2 million. Similar to this, cell therapy has an average cost per treatment of USD $1 million, though costs vary greatly depending on the product and the indication. Consequently, this is anticipated to limit market growth throughout the anticipated timeframe.
Opportunities
Rising demand for genetically modified products
Growing consumer demand for GM products, such as crops, is propelling market expansion. Insect-resistant and herbicide-tolerant seeds that have undergone genetic modification have become extremely popular, and crops have quickly adapted to them, aiding in the expansion of the agricultural sector. Cloning and mutagenesis have made it possible to modify crops' genetic makeup, increase soil production, and effectively combat pests.
For instance, the Genetic Engineering Appraisal Committee (GEAC) authorized the commercial release of GM mustard in October 2022. This program is anticipated to spur crop development to satisfy dietary needs. In the upcoming years, it is anticipated that the development of novel genetic resources and genome modification methods like cloning and mutagenesis will advance knowledge of plant biology.
Segment Insights
Product Insights
Based on the product, the global cloning and mutagenesis market is segmented into cloning kits, mutagenesis kits and others. The cloning kits segment is expected to hold the largest market share during the forecast period. Cloning kits are used in a variety of fields, including biopharmaceuticals, gene therapy and gene analysis. These kits are commonly used in the biopharmaceutical sector to create human proteins with biological uses.
To treat and prevent strokes, Tissue Plasminogen Activator (TPA) is employed. Additionally, cloning kits are also used in gene analysis to create recombinant and synthetic versions of genes that aid biologists in comprehending the role of the normal gene in an organism's function. Thus, this is expected to fuel the segment growth during the forecast period.
The mutagenesis kits segment is expected to grow at the highest CAGR during the forecast period. Mutagenesis kits are used to clone DNA, study the effects of mutagens, and design proteins. Additionally, these kits are utilized in medical settings to treat and research conditions like cancer and HIV, as well as to assist individuals who are immunocompromised. As a result, the market is being driven by the growing use of mutagenesis kits in biomedical research, which is boosting kit usage in R&D activities.
Technology Insights
Based on the technology, the market is bifurcated into Topo PCR Cloning, Blunt End Cloning, Seamless Cloning, Site-directed Mutagenesis and Others. The Topo PCR Cloning segment is expected to dominate the market during the forecast period. This technology uses DNA topoisomerase biological activity to clone DNA fragments into particular vectors. This method has several benefits over conventional TA cloning, including ligation and restriction-free cloning, straightforward primer design, no need for post-PCR steps, and higher efficiency. Because of this, TOPO PCR cloning is seeing increased use across a variety of end users, including pharmaceutical and biotechnology companies and academic and research institutions.
The Site-directed Mutagenesis segment is expected to grow at a significant rate over the forecast period. The DNA sequence of a gene can be intentionally and specifically modified through the use of site-directed mutagenesis technology. By enabling precise gene and protein modification, this approach has applications in genetic research, gene technology and protein engineering. Furthermore, leading market companies are offering innovative site-directed mutagenesis-based kits that streamline and expedite the process.
For instance, the Phusion Site-Directed Mutagenesis Kit from Thermo Fisher Scientific Inc. is a productive and adaptable tool for adding point mutations, insertions, or deletions into any kind of plasmid DNA. Thus, this is expected to propel the segment revenue over the forecast period.
End-user insights
The biopharmaceutical and pharmaceutical companies segment dominated the market in 2025. The segment's growth is attributed to the increasing emphasis on drug discovery and development by biopharmaceutical and pharmaceutical companies. Cloning and mutagenesis techniques are helpful in therapeutics and drug discovery, offering new cells for tissue engineering and transplantation.
The CROs and CMOs segment is anticipated to grow at the fastest rate over the forecast period. Several pharmaceutical companies outsource cloning and mutagenesis to CROs and CMOs for different purposes. These outsourcing initiatives can reduce time and increase productivity. The rising need to outsource cloning and mutagenesis services for the development of personalized medicines is likely to contribute to segmental growth.
Regional Insights
What is the U.S. Cloning and Mutagenesis Market Size?
The global cloning and mutagenesis market size is valued at USD 1,270 million in 2025 and is predicted to be worth around USD 6,340 million by 2035, poised to grow at a CAGR of 17.44% from 2026 to 2035.
North America is expected to dominate the market during the forecast period. The growth in the region is attributed to the rising geriatric population coupled with the increasing prevalence of the chronic disease. For instance, according to the Administration on Aging (AoA), in the US, there were 54.1 million people 65 and over as of 2019. More than one in seven Americans or 16% of the population are Americans. Since 2009, there have been 14.4 million more older Americans than there were in 2009, a rise of 36% compared to a 3% rise in the population under 65.
U.S. Cloning and Mutagenesis Market Analysis
The U.S. market is growing due to strong investment in biotechnology and life sciences research. Rising prevalence of genetic and chronic diseases, increasing demand for personalized medicine, and extensive use of gene editing in drug discovery are key drivers. Additionally, advanced research infrastructure, favorable funding, and active participation of biotech startups and academic institutions support sustained market growth.
Canada Cloning and Mutagenesis Market Trends
Canada is expected to grow at the fastest CAGR during the projected period. The growth of the country can be linked to the surge in investment in understanding gene function and genetic diseases, coupled with the rising demand for personalized medicine. Moreover, the shift towards personalised medical treatments can impact positive market growth further.
The number of Americans aged 45 to 64 increased by 4% between 2009 and 2019, from 80.3 million to 83.3 million. Americans aged 60 and over climbed from 55.7 million to 74.6 million, a 34% rise. In addition, according to the Journal of the American College of Cardiology, it is expected that cardiovascular risk factors and disease will rise significantly by 2060. Moreover, the growing prevalence of chronic obstructive pulmonary disease in the US is expected to drive market growth over the forecast period. For instance, according to the secondary analysis, COPD affects 12.5 million Americans, and it is the third leading cause of death in the US.
What Makes Asia Pacific the Fastest-Growing Region in the Market?
The Asia Pacific is growing at the highest CAGR during the forecast period. The growing prevalence of cancer in countries like India and China is expected to drive market expansion in the region. For instance, as per the US Department of Health and Human Services (HHS), 14,61,427 incident cases of cancer were determined to be the projected total in India for 2022.
India Cloning and Mutagenesis Market Analysis
In India 1 out of 9 people has a lifelong risk of developing cancer. The most common cancer in men and women were lung andbreast cancer. According to the estimates, there will be 12.8% more cancer instances in 2025 than there were in 2020. Moreover, the growing heart failure in the countries like India and China is further driving the market growth.
China Cloning and Mutagenesis Market Analysis
The frequency of HF cases in China has significantly increased between 1990 and 2019. More specifically, there were 7.03 million prevalent cases overall in 1990 and 18.51 million instances in 2019. Thus, this is expected to propel the cloning and mutagenesis industry during the forecast period.
Why is Europe Considered a Notably Growing Region in the Market?
Europe is expected to grow at a notable rate in the cloning and mutagenesis market due to rising investment in genomics and biomedical research. Increasing focus on personalized medicine, strong academic–industry collaborations, and supportive government funding for life science innovation are driving growth. Additionally, the growing burden of genetic and chronic diseases and advancements in gene editing technologies are accelerating adoption across research and therapeutic applications.
Germany Cloning and Mutagenesis Market Trends
In Europe, Germany is expected to grow at the fastest CAGR over the forecast period. The growth of the country can be driven by the growing demand for gene therapies and the robust presence of major market players such as Jena Bioscience. The country also benefits from innovative research frameworks with various biotechnology organizations, fostering advancements.
UK Cloning and Mutagenesis Market Analysis
The market in the UK is expanding due to strong government and institutional funding for life science research. Growing emphasis on genomics, personalized medicine, and drug discovery, along with advanced academic research infrastructure and collaborations between universities and biotech firms, is driving adoption. Additionally, increasing focus on genetic disease research and innovative therapies is supporting steady market growth.
Why is the MEA Cloning & Mutagenesis Market Gaining Momentum?
The Middle East & Africa market is growing because investments are being made in the field of biotechnology, genomics, and biomedical research. Gulf countries, including Saudi Arabia, the UAE, and Qatar, are enhancing research capacity through the national life sciences and precision medicine programs. The demand for advanced genetic engineering equipment is also on the rise, owing to the development of research bases and higher educational institutions. In Africa, the market is expanding, where more consideration is being given to infectious disease research, vaccine development, and agricultural biotechnology. International collaborations and funding programs also contribute to the market.
Saudi Arabia Cloning and Mutagenesis Market Trends
The growth of the market in the country can be attributed to the growing incidence of chronic diseases and growing R&D spending by public and private entities. Also, robust national emphasis on diversifying the economy into healthcare and biotech boosts funding for medical and genomic research in the country.
How is the Opportunistic Rise of Latin America in the Cloning and Mutagenesis Market?
Latin America is experiencing an opportunistic rise in the market, riven by expanding research and development activities in biotechnology and pharmaceuticals. Strong academic research networks and collaborations with international biotech companies are supporting innovation and market growth. Increasing use of biotechnology in agriculture, particularly for crop improvement and disease resistance, is further boosting adoption. In addition, government funding programs and international partnerships are strengthening laboratory capabilities, while improved access to affordable cloning kits, mutagenesis technologies, and AI-based design tools is enabling broader market penetration across the region.
Brazil Cloning and Mutagenesis Market Trends
In Latin America, Brazil led the market due to increasing emphasis on personalized medicine and substantial innovations in genomic technologies. Furthermore, the ongoing shift towards personalized medical treatments based on genetic profiles of individuals is crucial for developing patient-specific cell therapies and tools.
Cloning and Mutagenesis Market Value Chain Analysis
- R&D
This stage emphasizes creating innovative tools for personalized medicine, gene editing, and synthetic biology, and developing treatments for genetic diseases.
Major Players: Takara Bio, Agilent Technologies. - Clinical Trials and Regulatory Approvals
This stage mainly focused on supplying kits, research tools, and services to academic institutions, pharmaceutical companies, and biotechnology firms.
Major Players: Promega Corporation, Takara Bio Inc.
Cloning and Mutagenesis Market Companies
- Takara Bio Inc.: Provides cloning and mutagenesis kits, PCR enzymes, gene-editing tools, and molecular biology reagents for research, diagnostics, and therapeutic applications.
- Promega Corporation: Offers DNA/RNA extraction kits, cloning and mutagenesis tools, PCR reagents, and gene-editing solutions for molecular biology and life science research.
- Bio-Rad Laboratories, Inc.: Supplies cloning kits, mutagenesis reagents, PCR instruments, and gene-editing products for academic, industrial, and clinical research.
- Jena Bioscience GmbH: Provides molecular biology enzymes, cloning and mutagenesis kits, PCR reagents, and nucleic acid manipulation tools for research applications.
- Danaher Corporation: Offers comprehensive life science solutions, including molecular cloning reagents, mutagenesis tools, gene-editing technologies, and analytical instruments.
- Assay Genie: Supplies cloning and mutagenesis kits, PCR reagents, gene-editing tools, and molecular biology consumables for research laboratories.
Other Major Key Players
- Thermo Fisher Scientific, Inc.
- Agilent Technologies, Inc.
- New England Biolabs
- Merck KGaA
- Takara Bio Inc.
- Promega Corporation
- Bio-Rad Laboratories, Inc.
- Jena Bioscience GmbH
- Danaher
- Assay Genie
- TransGen Biotech Co., Ltd.
Recent Developments
- In February 2022, Tamara Bio, Inc., a hub for cell and general processing in Japan, announced the expansion of its production facilities. The new laboratory will produce products including Cancer Immunotherapy Medications, Gene Therapy, DNA and RNA Vaccines, and the use of cloning and mutagenesis techniques in regenerative medicine.
- In March 2023, from a recently opened cGMP manufacturing facility next to UCSF Medical Centers Mission Bay Campus, Thermo Fisher Scientific Inc., the global leader in serving science, and the University of California, San Francisco (UCSF) will expedite advanced cell therapies for challenging-to-treat conditions, such as cancer, rare diseases, and others.
- In June 2022, to produce gene therapies on a large scale, RegenxBio opened a new manufacturing facility in the United States. To ensure complete control of gene therapy manufacturing at the institutes, the company committed to investing around 65 million.
- In April 2025, GenScript Biotech introduced a cloud-based, AI-driven plasmid design platform, integrated with its cloning and synthesis services, to streamline and speed up gene construct ordering.
(Source: https://www.genscript.com) - In March 2025, Twist Bioscience collaborated with a major pharmaceutical firm to deliver high-throughput cloning and synthetic biology solutions, supporting accelerated drug discovery efforts.
(Source: https://investors.twistbioscience.com)
Segments Covered in the Report
By Product
- Cloning Kits
- Mutagenesis Kits
- Others
By Technology
- Topo PCR Cloning
- Blunt End Cloning
- Seamless Cloning
- Site-directed Mutagenesis
- Others
By End-User
- Biopharmaceutical & Pharmaceutical Companies
- CROs & CMOs
- Academic & Research Institutes
By Geography
- North America
- Europe
- Asia-Pacific
- Latin America
- Middle East and Africa
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