The global Genome Editing Market size was valued at USD 6.20 billion in 2022 and is projected to reach USD 25.26 billion by 2031, with a CAGR of 16.9 % during the forecast period 2023–2031.
Genomic editing refers to the strategies and techniques used to modify the genetic information of any living organism. genome editing involves the modification of genes in multiple locations using recombinant technology, which increases insertion precision and decreases cell toxicity. It is a collection of technologies that allow scientists to alter an organism's DNA. These technologies enable adding, deleting, or modifying genetic material at specific locations within the genome. Several methods for editing the genome have been developed. CRISPR-Cas9 is a well-known gene-editing system. The CRISPR-Cas9 system is faster, cheaper, more accurate, and more efficient than other genome-editing techniques.
CRISPR-Cas9 was derived from a naturally occurring bacterial immune defense system that edits genomes. When bacteria are infected with viruses, they capture small pieces of the viruses' DNA and insert them into their DNA in a specific pattern to form CRISPR arrays. CRISPR arrays enable bacteria to "remember" viruses (or closely related ones). If the viruses reappear, the RNA segment produces bacteria from the CRISPR arrays that recognize and attach to specific regions of the DNA of the viruses. The bacteria then use Cas9 or a similar enzyme to cut the virus' DNA, rendering it ineffective.
|Market Size||USD 25.26 billion by 2031|
|Fastest Growing Market||Asia Pacific|
|Largest Market||North America|
|Report Coverage||Revenue Forecast, Competitive Landscape, Growth Factors, Environment & Regulatory Landscape and Trends|
The rapid evolution of CRISPR technology, with its broad range of gene-editing applications, is a key factor in accelerating technological progress. This technology primarily facilitates access to genetically modified crops by delivering gene-editing reagents to plants. Additionally, this technology is available for genetically modified animals with applications in agricultural and biomedical fields. Gene editing or genome editing is primarily used to modify an organism's DNA using various technologies. This technique permits genetic material replacement, addition, or deletion at specific locations in the genome. Therefore, numerous editing strategies have been developed for use in the industry.
Gene editing also prevents and treats diseases such as cystic fibrosis, sickle cell disease, HIV infection, and cancer. Increasing funding for genetic research in developed regions, such as North America, will fuel the market growth during the forecast period. More than 20 federal agencies in the United States funded research and development firms to produce useful materials, devices, and methods. In addition, the U.S. government finances several research companies that aid in developing and producing drugs for rare genetic diseases. The National Human Genome Research Institute, for instance, funds research programs and initiatives to advance the field of genomics.
In addition, The data obtained from genetic testing can be utilized in the gene-editing procedure, which is proving advantageous for the industry's growth. During the forecast period, the market is anticipated to be driven by a growing number of market innovators investing significant revenue shares in R&D for genome applications. The increasing demand for creating and upgrading genome databases and the increasing adoption of single-cell-based genomic analysis is anticipated to stimulate the growth of the market. Gene editing includes the use of mutated genes for multiple applications in industry and agriculture. For instance, gene editing is utilized in the creation of organically engineered crops to increase yield. In addition, the government is funding various research projects related to treating various diseases, which will propel the market.
CRISPR-off-target Cas9's effects are a major concern. Consequently, Cas9 promotes double-stranded breaks, and any off-target nuclease activity can result in mutations in these genes, potentially leading to oncogenesis. CRISPR-Cas9 can tolerate up to three mismatches in its target, resulting in off-target nuclease activity. Also of great concern is the high frequency of off-target activity (50%) or mutations at sites other than the intended on-target site. CRISPR can, for instance, target the tumor suppressor gene or the cancer-causing gene. Due to this unintended consequence, several organizations planning clinical trials have encountered obstacles. Clinical trials have been halted, and regulatory authorities are demanding additional research to improve the method's safety.
Applications of genomics include the documentation of human genetic disorders, drug discovery, agriculture, veterinary sciences, and forensic science. The in forensic studies has increased significantly with Next Generation Sequencing, especially because Illumina (US) offers products designed specifically for forensic science. Previously, DNA analysis was utilized for fingerprint profiling. In contrast, today, NGS aids in analyzing a crime scene specimen and enables more data extraction from a trace or damaged DNA sample.
Future developments in genomic engineering include its application in marine engineerings, such as creating nutraceuticals from algae. Additionally, forensic sciences and personalized medicine are emerging application areas. During the evaluation of fish populations, NGS can be used for DNA barcoding to identify fish larvae and eggs, along with a comprehensive description of fish communities. The use of genomics in food quality and safety testing is increasing. genome editing technologies play a vital role in drug discovery and the diagnosis and treatment of human genetic disorders. In addition to its use in NGS, DNA analysis and profiling, and plant and animal genetic engineering, genome editing is also employed in NGS and DNA analysis and profiling. As a result of the expanding applications of genomics, the global demand for genome editing technologies is anticipated to increase during the forecast period.
The global market for genome editing has been segmented based on geography into North America, Europe, Asia Pacific, and LAMEA.
North America's market held the largest revenue share in 2021 due to the region's increased adoption of advanced techniques. In addition, the increase in the prevalence of chronic diseases contributes to revenue growth in this region. Due to an increase in funding for gene editing research, the United States market had the largest revenue share. For example, on 20 April 2021, Vertex Pharmaceuticals Incorporated and CRISPR Therapeutics modified their collaboration agreement for the investigational CRISPR/Cas9-based gene editing therapy CTX001, which is being developed as a potentially curative treatment for Sickle Cell Disease (SCD) and Transfusion-Dependent Beta-Thalassemia (TDT). 60% of program expenses will be covered by Vertex, and 60% of potential international sales of CTX001 will benefit the company. A further USD 900 million will be paid upfront to CRISPR, with a potential USD 200 million payment due upon initial regulatory approval of CTX001.
Due to the expansion of life science research and the rise in R&D spending, the Europe market maintained a stable revenue share in 2021. In addition, the widespread application of genomics in medicine has significantly impacted the expansion of the gene editing market in Europe. The United Kingdom market generated the largest revenue share. The introduction of new regulations for gene editing technology adoption primarily drives this region's revenue growth. For example, on January 20, 2022, the British government announced that researchers and developers working on plants in England would have easier access to genetic technologies such as gene editing.
In 2021, the Asia-Pacific market had a moderate revenue share due to personalized medicine and biotechnology research. Due to extensive research on gene editing technologies, Japan's market accounted for the largest revenue share. In 2021, Sanatech Seed introduced Japan's first genome-edited tomato for direct consumption. The Japanese government has declared that genome-edited tomatoes will not be regulated as a genetically modified products. Sicilian Pink Sanatech Seed's high GABA tomato was created using CRISPR-Cas9 gene editing. Tomatoes contain high levels of Gamma-Aminobutyric Acid (GABA), an amino acid that promotes relaxation and aids in lowering blood pressure. The International Seed Federation supported the announcement of the release of the genome-edited tomato with a high GABA content in Japan. This is a significant step in the implementation of Japanese policy on genome editing and presents opportunities for the seed industry to continue its efforts on plant breeding innovation and support the development of a sustainable food system.
The global genome editing market is segmented into Technology, application, and end-use.
The gene editing market is segmented by technology into CRISPR/Cas9, TALENS, ZFN, restriction enzymes, and others. In 2021, the CRISPR/Cas9 segment had the largest revenue share. CRISPR/Cas9 outperforms other genome editing methods in terms of speed, cost, precision, and efficiency. CRISPR-Cas9 has great potential to treat diseases with a genetic component, including cancer, hepatitis B, and even high cholesterol. Various industries, ranging from agriculture to human health, are investigating the method's applications. Also being investigated is the possibility of obtaining human organs from transgenic pigs, possibly in conjunction with pluripotent stem cells. These initiatives aim to address the shortage of organs available for transplantation and the risks associated with organ transplantation, such as graft-versus-host disease. Using CRISPR-Cas9 technology, researchers now conduct extremely accurate and extensive screening trials for drug discovery research, which makes it easier to comprehend the relationship between genotype and phenotype. In addition, by performing multiple gene knockouts in a healthy cell line, researchers can determine which genes are important in disease pathogenesis and which genes are good candidates for therapeutic targets in diseased cell lines.
In 2021, the TALENS segment maintained a stable revenue share. Transcription Activator-Like Effector Nucleases (TALENs) or Transcription activator-like (TAL) are frequently used techniques for precise and efficient gene editing in living cells. This method of genome editing has been demonstrated to be effective in various host systems, including bacteria, yeast, plants, insects, zebrafish, and mammals. A non-specific DNA-splitting nuclease and DNA-binding domain, which can be easily engineered to enable TALENs to effectively target different gene sequences, are recent developments in TALEN, a gene-editing technique frequently used in plants. It is possible to investigate gene function through targeted modification of the plant genome. In addition, it can be used to create plants with novel characteristics, such as disease and herbicide resistance, altered physiology, increased yield, etc.
The market is segmented by application into diagnostics, drug discovery and development, cell lines, animal and plant genetic engineering, and other applications. In 2021, the cell line segment had the largest revenue share. Utilizing this technology for cell lines combines DNA and cell technology. The publication of genomic sequences of numerous Chinese Hamster Ovary (CHO) cell lines has accelerated the rational genetic engineering of biotherapeutic proteins. Due to CRISPR technology, researchers working with CHO have clarified the molecular underpinnings of high-level protein synthesis and relevant Product Quality Attributes (PQAs). The bioactivity and quality of biological products can be enhanced by modifying their glycosylation patterns, and N-linked glycosylation is crucial to the efficacy of therapeutic proteins. In addition, numerous glycoengineered proteins have demonstrated therapeutic utility, which has prompted the development of new, enhanced expression platforms (such as those employing mammalian cells) for the production of nonfucosylated antibodies. In 2021, the drug discovery and development segment maintained a consistent revenue share. CRISPR gene editing is frequently used in drug discovery. These models can evaluate potential treatment targets prior to clinical trials and provide novel insights into the disease. CRISPR-Cas9 enables target-specific gene modifications and enables the identification of therapeutic targets, validation of existing drugs, and improvement targets. Researchers can use these tools to conduct whole-genome analyses when combined with recent advances in sequencing technology, such as Next-Generation Sequencing (NGS) and single-cell sequencing. Significant progress has been made in identifying disease-specific targets in recent years. These instruments can assist scientists in developing more intricate cellular models that more accurately depict how individuals may respond to a new treatment.
The market is divided into academic institutions, research centers, contract research organizations, and pharmaceutical and biotech companies based on end-use. In 2021, the pharmaceutical and biotech companies segment brought in the most money. The number of research efforts to find new therapeutics is growing, which drives revenue growth. Market growth is also expected to be driven by a rise in the number of strategic moves made by the big players in the market. For example, on April 27, 2021, CANbridge Pharmaceuticals, Inc., a biopharmaceutical company based in China that makes life-changing medicines, and LogicBio Therapeutics, Inc., a clinical-stage genetic medicine company, announced a strategic partnership and option agreement to treat rare and serious diseases in children and adults. According to this agreement's terms, CANbridge can get an exclusive license for LogicBio's LB-001 investigational in-vivo gene editing technology based on the GeneRideTM platform. This technology could be used to treat Methylmalonic Acidemia (MMA) in Greater China.
The academic institutions and research institutes segment had a steady share of revenue in 2021. This was because technology was being used more and more on university campuses. Several institutes are putting together high school and college lessons to help students understand how gene editing works. For example, on January 15, 2022, the ChristianaCare Gene Editing Institute will bring its groundbreaking CRISPR in Box Educational Toolkit to high schools and colleges to raise awareness about one of the most powerful biomedical technologies that are getting closer every day to changing the way diseases are treated. This existing kit only has safe and man-made materials, so it can't be used to change living things. Instead, it can be used to show how CRISPR works in real life.
During this COVID-19 pandemic, market players are striving to offer reagents to clinicians and researchers working on understanding COVID-19 and developing cures for the disease. Genomics products are a critical tool for infectious disease research because they provide a detailed understanding of how the virus infected people, how the immune system is mobilized, which immune cells react to pathogens, and several other aspects of the disease and potential therapies. Genomic data is essential to develop tests, and find drugs and vaccines. It is also of utmost importance to find if there has been a mutation of the virus. All these applications associated with genomics will drive market growth during the COVID-19 pandemic situation.