Cloning and Mutagenesis Market - By Product (Cloning Kits, Mutagenesis Kits), Technology (Topo PCR Cloning, Site-directed Mutagenesis), End-use (Biotechnology & Pharmaceutical Companies, Academic & Research Institutes) & Forecast 2024 - 2032

Cloning and Mutagenesis Market Size

Cloning and Mutagenesis Market valued at USD 2.9 billion in 2023 and is expected to expand at over 19.4% CAGR between 2024 and 2032. Growing focus on genetic engineering and rising demand for genetically modified products is escalating the growth prospects for the market. Cloning and mutagenesis technologies play a crucial role in the development of precision medicine. Hence, increasing demand for precision medicine has a significant influence on the market demand.
 

Furthermore, rising investments and funding from both public and private sectors, government initiatives, venture capital funding, and collaborations between academic institutions and industry players have fuelled technological advancements and product innovation, thereby positively influencing cloning and mutagenesis market growth.
 

Cloning refers to the creation of identical copies of a particular DNA sequence. In molecular biology, cloning is commonly used to replicate genes or DNA fragments for further analysis or manipulation. Whereas mutagenesis is a technique in which the DNA of an organism is altered or changed, which results in the mutation of the genes. Cloning and mutagenesis methods are used to confirm the mutation effects in vitro and in vivo and study the structure and function of proteins.

COVID-19 Impact

The COVID-19 pandemic led to an increased usage of cloning and mutagenesis products in the past two years. The pandemic highlighted the importance of genomic research and sequencing to understand and track the virus. This increased focus on genomics has benefitted the cloning and mutagenesis market. Several key biotechnology and pharmaceutical companies and cloning and mutagenesis kit manufacturers have increased their R&D activities globally by adopting novel techniques for producing therapies, kits, and vaccines for COVID-19.
 

For instance, in September 2022, CanSino Biologics Inc. received approval from China’s National Medical Products Administration for emergency use of an inhalable version of the adenovirus-vectored COVID-19 vaccine. It is developed by cloning an optimized plasminogen activator signal peptide gene in the Ad5 vector along with the full-length gene of the S protein. Such increased adoption of cloning and mutagenesis techniques have proven beneficial for the market growth.
 

Cloning and Mutagenesis Market Trends

Cloning and mutagenesis plays a significant role in precision medicine by facilitating the development of customized therapies. Cloning and mutagenesis techniques allow researchers to produce recombinant proteins, antibodies, or cellular models that aid in the discovery and development of precision drugs. Therefore, the demand for precision medicine has accelerated the adoption and advancement of cloning and mutagenesis technologies. Further, these tools are instrumental in understanding the genetic basis of diseases, developing targeted therapies, and optimizing treatment outcomes for individual patients.
 

Cloning and Mutagenesis Restraint

Cloning and mutagenesis experiments often require specialized equipment such as thermal cyclers, DNA sequencers, electrophoresis systems, and others. These instruments are often expensive to purchase, and their calibration can be costly. The proper functioning of these tools requires regular maintenance, including cleaning, calibration, and replacement of worn-out parts. This maintenance work may need to be performed by specialized technicians, which adds to cloning and mutagenesis market expansion. Moreover, to ensure the accuracy and reliability of experimental results, regular quality control checks are necessary. This may involve running control experiments, performing validation tests, and monitoring instrument performance, all of which contribute to maintenance costs. Hence, high maintenance cost of cloning and mutagenesis tools & instruments may hamper the market growth to some extent.
 

Cloning and Mutagenesis Market Analysis

By product, the cloning and mutagenesis market is classified into cloning kits, mutagenesis kits, and other products. The cloning kits segment dominated the 53% of the market share in 2022. Cloning kits find a wide range of applications in gene cloning, protein expression, genetic engineering, and DNA sequencing among others. In biopharmaceutical industry, these kits are widely used to produce human proteins with biomedical applications. Additionally, in gene analysis, cloning kits are used for research to build recombinant and artificial versions of genes that help biologists to understand the functioning of normal gene in an organism.
 

Based on technology, the cloning and mutagenesis market is segmented into TOPO PCR cloning, blunt end cloning, seamless cloning, site-directed mutagenesis, and other technologies. The TOPO PCR cloning segment accounted for USD 832.6 million in 2022. TOPO PCR cloning technology offers several benefits that have contributed to its widespread use in molecular biology research. This technology provides a rapid and efficient method for cloning PCR products. It is convenient to use and is compatible with a wide range of PCR products, including blunt-ended, A-tailed, and phosphorylated PCR products. Additionally, TOPO cloning allows for seamless cloning without the need for DNA ligase or restriction enzymes. All these advantages of TOPO PCR technology aids in its high adoption, thereby facilitating segmental growth.
 

By end-use, the cloning and mutagenesis market is segmented into biotechnology & pharmaceutical companies, contract research organization (CROs) & CDMOs, and academic & research institutes. The biotechnology and pharmaceutical companies set to reach USD 6.4 billion by 2032. Biotechnology and pharmaceutical companies focus on drug discovery and development of novel therapies. Cloning and mutagenesis techniques play an important role in drug development by facilitating the production of therapeutic proteins and generating novel drug candidates. Moreover, these techniques can significantly impact human therapeutics by providing new cells for tissue engineering and transplantation. Such broad applications of cloning and mutagenesis in the biotechnology and pharmaceutical industry drives the segment growth.
 

North America captured around 38.6% of the cloning and mutagenesis market share in 2022. High market share can be attributed to the presence of key market players that has resulted in higher penetration of these products in the region. Additionally, higher adoption of genomics services and proteomic-based platforms in the region has led to an increase in the adoption of cloning and mutagenesis tools. Such aforementioned factors have contributed towards high market growth in the region.
 

Cloning and Mutagenesis Market Share

Major market players operating in the cloning and mutagenesis market include

• Agilent Technologies, Inc.
• Thermo Fisher Scientific, Inc.
• Takara Bio Inc.
• Merck KGaA
• Bio-Rad Laboratories, Inc.
• Danaher
• Jena Bioscience GmbH
• New England Biolabs
• Promega Corporation
• Assay Genie
• TransGen Biotech Co., Ltd.
• Genes2Me
• GenScript
• Genomax Technologies Pte Ltd 
   

Cloning and Mutagenesis Industry News:

• In March 2022, Takara Bio Inc. opened an expansion of its manufacturing facility, the Center for Gene and Cell Processing (CGCP), at Shiga, Japan. The facility features new equipment’s including 200 L bioreactors, 2,000 L fermenters, and large flow centrifuge and purification systems. This strategy helped the company increase its production capacity.
   
• In November 2021, Genes2Me launched its molecular biology product range, to accelerate research in the field of Biosciences. Enzyme technology, Cloning, Next-generation sequencing, and polymerase chain reaction are among the Genes2me product categories. This helped the company widen its product portfolio.
   

This cloning and mutagenesis market research report includes an in-depth coverage of the industry with estimates & forecast in terms of revenue in USD from 2018 to 2032, for the following segments:

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By Product

• Cloning Kits
• Mutagenesis Kits
• Other Products

By Technology

• Topo PCR Cloning
• Blunt End Cloning
• Seamless Cloning
• Site-directed Mutagenesis
• Other Technologies

By End-use

• Biotechnology & Pharmaceutical Companies
• CROs & CDMOs
• Academic & Research Institutes

The above information is provided for the following regions and countries:

• North America
  • U.S.
  • Canada
• Europe
  • Germany
  • UK
  • France
  • Spain
  • Italy
  • Rest of Europe
• Asia Pacific
  • Japan
  • China
  • India
  • Australia
  • Rest of Asia Pacific
• Latin America
  • Brazil
  • Mexico
  • Argentina
  • Rest of Latin America
• Middle East & Africa
  • South Africa
  • Saudi Arabia
  • Rest of MEA