The cloning and mutagenesis market size is estimated to be USD 2,678.1 million in 2022 and is expected to witness a CAGR of 18.99% during the forecast period 2023-2033. Increasing emphasis on protein engineering for medicine discovery and rising consumer demand for crops and other products that are genetically engineered are factors contributing to the market growth. Furthermore, growing demand for individualized medicine and surge in demand for personalized medicine is expected to support the market growth. However, high price of kits is expected to hinder the growth.

Increasing emphasis on protein engineering for medicine discovery is expected to propel the market growth during the forecast period. The fundamental techniques used in protein engineering during drug 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. Additionally, these methods encourage the development of affordable, more easily accessible, and safer medications. For instance, the FDA has currently approved more than 200 peptide and protein drugs.

Rising consumer demand for crops and other products that are genetically engineered is predicted to fuel the market growth during the projected period. Insect-resistant and herbicide-tolerant seeds that have undergone genetic modification have become extremely popular, and crops have easily adapted to them, supporting in the expansion of the agricultural sector. Cloning and mutagenesis have made it possible to modify crops’ genetic structure, increase soil production, and effectively fight pests. For instance, the Genetic Engineering Appraisal Committee (GEAC) approved the commercial release of GM mustard in October 2022. This initiative is anticipated to spur crop development to meet dietary needs.

Segmentation

By Product

The market is categorized into mutagenesis kits, cloning kits, others. In 2022, the cloning kits segment accounted for the highest revenue share due to the fact that 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 produce human proteins with biological uses. To treat and prevent strokes, tissue plasminogen activator (tPA) is employed. Similar to this, cloning kits are employed in gene analysis to create recombinant and synthetic versions of genes that aid biologists in understanding the role of the normal gene in an organism’s function. Thus, the use of these kits in the biotechnology industry is projected to fuel segment growth over the course of the forecast period. The mutagenesis kits are expected to expand at the fastest rate over the projected period. Mutagenesis kits are used to clone DNA, analyze the impact of mutagens, and design proteins. Additionally, these kits are used in medical settings to treat and research conditions including cancer and HIV, and 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.

By Technology

The market is categorized into site-directed mutagenesis, blunt end cloning, topo PCR cloning, seamless cloning, and others. In the global market, the topo PCR cloning segment accounted for the largest revenue share in 2022 owing to benefits of this method over competing alternatives are encouraging TOPO PCR cloning applications across a variety of end-users, including pharmaceutical and biopharmaceutical companies and academic and research institutes. This method uses DNA topoisomerase I’s biological activity to clone DNA fragments into particular vectors. This approach has a number of benefits, including high efficiency relative to conventional TA cloning, ligation and restriction-free cloning, straightforward primer design, and no need for post-PCR operations. The site-directed mutagenesis is expected to grow at the fastest rate during the projected period. A gene’s DNA sequence can be intentionally and precisely modified through the application of site-directed mutagenesis technology. This technology has applications in genetic research, gene technology, and protein engineering due to its ability to precisely modify genes and proteins. Furthermore, leading market companies are offering new site-directed mutagenesis-based kits that streamline and accelerate the process.

By End User

The market is segmented into academic & research institutes, biopharmaceutical & pharmaceutical companies, CROs & CMOs. In 2022, the segment accounted for the largest revenue share owing to increasing incidence of diseases, pharmaceutical and biopharmaceutical companies are concentrating on drug discovery and development. The therapeutic manipulation of disease-associated genes is facilitated by the use of cloning and mutagenesis techniques. In the preclinical stage of drug discovery, cloning is most appropriate for pharmacologic compounds. Growth hormone, erythropoietin, synthetic insulin, and vaccination are examples of successful therapeutic products derived through cloning. Furthermore, by providing new cells for tissue engineering and transplantation, these methods have a considerable impact on human therapies. The segment is driven by the pharmaceutical and biopharmaceutical industries’ extensive use of cloning and mutagenesis. The CROs and CMOs are expected to exhibit the fastest growth. For a number of reasons, pharmaceutical and biopharmaceutical companies are outsourcing cloning and mutagenesis to CROs and CMOs. These outsourcing strategies can result in time savings and increased output. Pharmaceutical and biopharmaceutical companies can get cloning and mutagenesis services from a number of CROs and CMOs.

Regional Markets

In 2022, North America region accounted for the highest revenue in the cloning and mutagenesis market and is expected to maintain its dominance during the forecast period. This is attributed to the rising demand for biotechnology methods. Additionally, the region’s increasing acceptance of platforms based on genomic and proteomic data has increased the use of cloning and mutagenesis techniques. The presence of leading innovators and market participants has resulted in greater product penetration in the area. For instance, the U.S. company Telesis Bio, Inc. announced in May 2021 that its BioXp technology currently supports long fragment cloning. With the aid of this initiative, researchers can create multivariant, error-corrected vectors and clone into custom vectors hand-free overnight. The Asia Pacific market is anticipated to expand at the fastest rate due to the region’s increasing demand for novel therapeutics. Additionally, a stronger economy, excessive government investment in R&D, and rapid infrastructure development are some of the drivers driving regional growth. Furthermore, funding is being provided to a number of local players to work on creating a treatment for a number of chronic diseases, including cancer. For instance, Immuneel Therapeutics raised USD 15 million in series A funding in June 2022 in order to provide a low-cost gene and cell therapy for cancer patients in India. Such initiatives in this region are projected to fuel market expansion during the research period.

Competitor Insights

Some of the key players operating in the cloning and mutagenesis market are Jena Bioscience GmbH, Thermo Fisher Scientific, Inc., New England Biolabs, Merck KGaA, Promega Corporation, Bio-Rad Laboratories, Inc., Assay Genie, Takara Bio Inc., Agilent Technologies, Inc., Danaher, and TransGen Biotech Co., Ltd.

To achieve a competitive edge, these companies are implementing a variety of growth strategies. Strategic partnerships, alliances, and agreements with different businesses and research institutions are seen to be the main strategies used by companies in this sector.

• For instance, Takara Bio, Inc. announced in February 2022 that it would be extending its manufacturing facility, the Center for Gene and Cell Processing in Japan.

This comprehensive research report focuses on the global and regional market size and forecasts of diverse segments including product, technology, and end user from 2023 to 2033.

Report Scope:

Segmentation: Cloning And Mutagenesis Market Report 2022 – 2033

Product (Revenue, USD Million), 2022 – 2033

• Mutagenesis Kits
• Cloning Kits
• Others

Technology (Revenue, USD Million), 2022 – 2033

• Site-directed Mutagenesis
• Blunt End Cloning
• Topo PCR Cloning
• Seamless Cloning
• Others

End user (Revenue, USD Million), 2022 – 2033

• Academic & Research Institutes
• Biopharmaceutical & Pharmaceutical Companies
• CROs & CMOs

By Region (Revenue, USD Million), 2022 – 2033

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