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, Share, Growth, Trends, Regional Outlook, and Forecast 2023-2032

Cloning and Mutagenesis Market Size and Growth 2023 to 2032

The global cloning and mutagenesis market size reached USD 2.96 billion in 2022 and is expected to hit around USD 17.14 billion by 2032, poised to grow at a CAGR of 19.2% during the forecast period 2023 to 2032. North America generated more than 36% of the revenue share in 2022.

Cloning and Mutagenesis Market Revenue 2023 To 2032

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Key Takeaways:

  • Asia Pacific is predicted growing at the largest CAGR between 2023 and 2032.
  • By Product, the cloning kits segment is predicted to capture the largest market share between 2023 and 2032.
  • By Product, the mutagenesis kits segment is expected to expand at the biggest CAGR between 2023 and 2032.
  • By Technology, the Topo PCR Cloning segment is expected to dominate the market between 2023 and 2032.
  • By Technology, the Site-directed Mutagenesis segment is predicted to grow at a remarkable rate between 2023 and 2032.

Cloning and Mutagenesis 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.

Cloning and Mutagenesis Market Scope:

Report Coverage Details
Market Size in 2023 USD 2.96 Billion
Market Size by 2032 USD 17.14 Billion
Growth Rate from 2023 to 2032 CAGR of 19.2%
Largest Market North America
Base Year 2022
Forecast Period 2023 to 2032
Segments Covered By Product, By Technology, and By End-User
Regions Covered North America, Europe, Asia-Pacific, Latin America and Middle East & Africa

Cloning and Mutagenesis Market Dynamics:


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.

Additionally, these methods support the creation of cheaper, more easily accessible, and safer medications. For instance, the FDA has currently approved more than 200 peptide and protein medications. Thus, it is anticipated that greater attention would be paid to protein engineering for drugs discovery during the forecasted period.


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.


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.

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.

Regional Insights:

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.

Cloning and Mutagenesis Market Share, By Region, 2022 (%)

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. 

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.

In India 1 out of 9 people has a lifelong risk of developing cancer. The most common cancer in men and women were lung and breast 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.

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.

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.

Cloning and Mutagenesis Market Companies:

  • 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.

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

Frequently Asked Questions

What is the cloning and mutagenesis market size?
The global cloning and mutagenesis market size is expected to increase USD 17.14 billion by 2032 from USD 2.96 billion in 2022.
What will be the CAGR of global cloning and mutagenesis market?
The global cloning and mutagenesis market will register growth rate of 19.2% between 2023 and 2032.
Who are the prominent players operating in the cloning and mutagenesis market?
The major players operating in the cloning and mutagenesis market are 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. and Others.
Which are the driving factors of the cloning and mutagenesis market?
The driving factors of the cloning and mutagenesis market are the increasing chronic disease across the globe, increasing innovative product launches in cloning and mutagenesis, Increasing research and development investment, and the growing COPD across the globe.
Which region will lead the global cloning and mutagenesis market?
North America region will lead the global cloning and mutagenesis market during the forecast period 2023 to 2032.


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