CRISPR and CRISPR-associated (Cas) Genes Market

Market Overview

The global CRISPR and CRISPR-associated (Cas) genes market size was valued at USD 2,246.40 million in 2022. It is estimated to reach USD 8,811.78 million by 2031, growing at a CAGR of 16.4% during the forecast period (2023–2031).

CRISPR stands for clustered, regularly interspaced short palindromic repeats. CRISPR is a family of DNA sequences found in prokaryotic organisms like bacteria and archaea. These sequences were derived from the DNA fragments of bacteriophages that previously infected the prokaryote. During successive infections, they locate and eradicate DNA from similar bacteriophages. As a result, these sequences are essential to prokaryotes' antiviral (or anti-phage) defensive system and offer acquired immunity. CRISPR is present in about 50% of sequenced bacterial genomes and nearly 90% of archaeal genomes.

Cas9, also known as "CRISPR-associated protein 9," is an enzyme that recognizes and cleaves particular DNA strands complementary to CRISPR sequences by using the CRISPR sequences as a guide. The CRISPR-Cas9 technique can be used to modify the genes of organisms by combining Cas9 enzymes with CRISPR sequences. Applications for this editing technique include basic biological research, the creation of biotechnological products, and the therapy of disorders.

Highlights

• Products dominate the product and service segment
• Biomedical dominates the application segment
• Biotechnology and pharmaceutical companies dominate the end-user segment
• North America is the highest shareholder in the global market

Market Dynamics

Market Drivers

Introduction of Anti-CRISPR Protein

The application of CRISPR in developing medicines and treatments is restricted due to the possibility of off-targeting during the process. This off-targeting might lead to undesired mutations, thereby being a major barrier to human gene editing applications. Although CRISPR technology is highly specific, it exhibits rare errors in targeting that could prove to be a serious problem when used in human therapeutic applications. Therefore, the recent isolation of anti-CRISPR proteins that provide a solution to prevent the potential off-targeting effects is expected to expand the CRISPR market.

Additionally, anti-CRISPR technology can improve CRISPR technology's accuracy and safety levels for both basic and clinical research. The introduction of anti-CRISPR proteins is expected to provide a fail-safe mechanism to block technology's harmful uses and precise control in CRISPR. Adopting anti-CRISPR proteins is also expected to temporarily enhance or restrict gene activity or synchronize choreographed activities from interconnected genes in the genome. This application of anti-CRISPR proteins is anticipated to be significant in the study and treatment of complex, multigene diseases. Hence, introducing anti-CRISPR proteins is expected to increase the adoption of CRISPR and Cas gene-based technology for major diseases.

Ongoing Competition for CRISPR Commercialization

Due to its off-target effects, clinical application implementation of CRISPR technology is limited. Off-target effects in gene editing may lead to uncontrollable and unpredictable consequences in humans. These may affect transcription or gene functions that are desired to be imposed by CRISPR, thereby limiting its applications for medicine and therapy in humans. Moreover, algorithms that can predict off-target effects, such as one from MIT and one called E-CRISP, have failed to detect many off-target effects. Ongoing efforts to reduce these off-target effects, such as modification, construction, design, and optimization of various elements involved in the procedure, are expected to harness opportunities for the future.

Market Restraint

Off-Target Effects of CRISPR Technology

Due to its off-target effects, clinical application implementation of CRISPR technology is limited. Off-target effects in gene editing may lead to uncontrollable and unpredictable consequences in humans. These may affect transcription or gene functions that are desired to be imposed by CRISPR, thereby limiting its applications for medicine and therapy in humans. Moreover, algorithms that can predict off-target effects, such as one from MIT and one called E-CRISP, have failed to detect many off-target effects. Ongoing efforts to reduce these off-target effects, such as modification, construction, design, and optimization of various elements involved in the procedure, are expected to harness opportunities for the future.

Market Opportunities:

Expanding Gene and Cell Therapy Area

Conventional genome editing technologies cannot keep pace with the rapid progress of genome modification because these technologies are inefficient, time-consuming, and labor-intensive. Advent of CRISPR/Cas9 nuclease allows easy and precise genome editing. As one of the primary applications of gene editing technologies, the gene and cell therapy arena would be directly impacted by using CRISPR technology.

Cell and gene therapies are expected to be launched in the next 5 to 10 years. In 2018, researchers from MIT NEWDIGS predicted that by the end of 2022, about 40 gene therapies might be approved. Several in-house facilities and CDMOs for gene therapy manufacturing have begun investing in enhancing their production capacity, which is anticipated to create lucrative opportunities for market players.

Regional Analysis

North America Dominates the Global Market

Based on region, the global CRISPR and CRISPR-associated (Cas) genes market is bifurcated into North America, Europe, Asia-Pacific, Latin America, and the Middle East and Africa.

North America is the most significant global CRISPR and CRISPR-associated (Cas) genes market shareholder and is anticipated to exhibit a CAGR of 16.4% during the forecast period. North America's regional economy has resulted in North America's leading share in the global market. Several government initiatives in the U.S. and Canada support biotechnological research in agriculture and the introduction of CRISPR-based plant products. For instance, the U.S. Department of Agriculture did not impose regulations on CRISPR technology's first gene-edited mushroom product, which encouraged the use of CRISPR. In addition, several pharmaceuticals and seed companies are investing in growth strategies, such as acquisitions, partnerships, and collaborations, to boost the market for pharmaceuticals and plant breeding, which can help boost the demand for CRISPR technologies in these industries. For instance, in June 2019, Vertex Pharmaceuticals stated that it planned to expand its presence in gene editing by developing novel treatments for Myotonic Dystrophy Type 1 and Duchenne Muscular Dystrophy. The company planned to acquire Exonics Therapeutics, allowing it to use Exonics' SingleCut CRISPR gene-editing technology to develop the treatments above.

Asia-Pacific is expected to grow at a CAGR of 16.6% over the forecast period. The expansion of CRISPR technologies in China has considerably boosted regional growth. China holds an influential position in the CRISPR market due to continuous application investments. In addition, China is increasingly exploring genome editing to develop medicines and has recently launched several clinical trials involving CRISPR, especially in cancer treatments. Chinese researchers are also applying this technology to agriculture, as well as in animals, for human transplantation applications. These factors are expected to drive Asia Pacific's market growth significantly.

Europe's CRISPR and Cas genes market is affected by multiple positive and negative factors. In July 2019, a European court ruling imposed strict regulations on gene-edited crops, creating issues for food testing laboratories across Europe. In January 2020, owing to a lack of entitlement, the European Patent Office (EPO) revoked the patent for CRISPR-Cas technology provided by the Broad Institute of the U.S. Despite strict regulations, this region has rapidly adopted CRISPR for biomedical, therapeutic, and drug delivery applications. In addition, European authorities approach novel technologies with much tighter regulations, including gene editing and genetically modified products, compared to the U.S. The EU's Court of Justice's decision to allow countries to conduct genetic engineering research is expected to drive market growth. This verdict is anticipated to loosen the laws to some extent, enabling progress in studies and research on stem line engineering and gene editing, thereby boosting the market significantly.

Latin America is engaged in the large-scale production of Genetically Modified (GM) crops. Extensive research on CRISPR technology and experimenting with making bananas resistant to a strain of deadly fungus ravaging plantations in Latin America is expected to pave the way for numerous opportunities. Researchers from the International Center for Tropical Agriculture (CIAT), Columbia, were recently engaged in CRISPR experiments to develop resistant rice and cassava strains. Similarly, researchers from the Favet-Inbiogen, Chile, worked on applying CRISPR gene-editing technology to generate mutations in different gene pathways associated with genetic resistance to diseases in Norwegian and Chilean salmonids. Such research studies are expected to expand the utilization of CRISPR technology in this region.

The Middle East and African region was observed to have the lowest market penetration. However, the Middle East and Africa market is expected to grow considerably in the coming years, owing to the growing importance of CRISPR technologies in human disease treatment. Moreover, clinical studies conducted on gene editing in agriculture are expected to impact the growth of the Middle East and Africa's GM crop industry, thereby driving the market growth.

Segmental Analysis

The global market is segmented by product, service, application, and end-user.

Based on the product, the global market is segmented into kits and enzymes, libraries, design tools, antibodies, etc.

The libraries segment owns the highest market share. Reliable CRISPR libraries allow targeting a wide range of genes, reducing the risk of false positives and negatives and eliminating the need for time-consuming data deconvolution. In addition, pooled libraries of several defined single-guide RNA (gRNA or sgRNA) sequences allow the knockout or disruption of thousands of genes throughout a cell population in a single experiment. These libraries provided by manufacturers are usually available in pre-packaged forms with large portions for immediate usage.

Based on the product, the global market is segmented into cell line engineering, gRNA design, microbial gene editing, and DNA synthesis.

The cell line engineering segment dominates the global market. Cell line engineering services are the most common services provided by CRISPR-based gene editing companies. The companies leverage the advantages of CRISPR technology to engineer a wide range of CRISPR cell line models with several gene or locus-specific modifications. In addition, the development of cell lines for gene editing procedures is usually a time-consuming and complex procedure. This has resulted in the availability of cell engineering services provided by companies where different technologies are implemented to design customized, stable cell lines. Companies conduct the quality control testing of custom-design cell lines to ensure that the cell line meets the specific requirements.

Based on application, the global  market is divided into biomedical and agriculture. 

The biomedical segment is the most significant contributor to the market and is estimated to exhibit a CAGR of 16.3% over the forecast period. CRISPR technology facilitates the development of personalized platforms, e.g., models that can distinctly mimic malignant diseases and test drug susceptibility. Moreover, the modularity of the CRISPR technology has consequently increased the number of genome engineering applications of CRISPR, especially the ones executed in cell culture systems, majorly in vivo systems. In addition, the ease of use and efficiency of genome editing has also resulted in the establishment of CRISPR knockout libraries covering the whole genome. These libraries can knock out every gene in the genome, which is expected to drive the demand for CRISPR knockout libraries in the biomedical field.

Improvement in agricultural production through innovative breeding technology has increased access to nutrition-rich foods globally. Recent advancements in CRISPR/Cas genome editing allow for efficient, targeted modification in most crops, thereby promising crop improvement. CRISPR significantly makes plants more resistant to weather changes, such as rain or storm, resistant to drought, increases pest resistance, and significantly limits pesticide usage. The development of new agriculture products by using CRISPR technology is expected to drive the segment growth.

Based on the end-user, the global market is bifurcated into biotechnology and pharmaceutical companies, academics and government research institutes, and contract research organizations (CROs). 

The biotechnology and pharmaceutical companies segment dominates the global market and is predicted to exhibit a CAGR of 16.5% over the forecast period. Reduced cost and time associated with genetic modification and the availability of investments are anticipated to drive segment growth. Potential clinical applications of CRISPR-Cas9 have encouraged pharmaceutical startups to develop products with the help of CRISPR-mediated gene editing techniques. Moreover, the industry has witnessed mergers between prominent and emerging players with CRISPR-based products and services. In addition, most of the major players have been reported to adopt CRISPR technology to engineer immune cells and blood stem cells, as a tool for drug discovery, to create anticancer therapeutics and many more.

CRO's segment is expected to witness a substantial market. CROs provide facilities and services for gene editing. Carrying out gene editing in various cells requires the maintenance of cell lines, which makes the processing time and cost-consuming. Similarly, skills required for cell line establishment and maintenance differ from those of gene editing, making it essential for most biotechnological firms to adopt contract services. Biotechnology firms that focus on other specialty products or lack the required infrastructure commonly uptake CRO-based services to develop the products.

Recent Developments

• January 2023- ERS Genomics reported that the CVC group had been awarded its first Canadian patent, CA 2872241, which includes wide claims to compositions and procedures for employing CRISPR/Cas9 in people, animals, plants, and microorganisms.
• March 2023- Vertex Pharmaceuticals Incorporated and CRISPR Therapeutics announced that they had signed a new non-exclusive licensing agreement to utilize CRISPR Therapeutics' gene editing technology, CRISPR/Cas9, to accelerate the research and development of Vertex's hypoimmune cell therapies for type 1 diabetes (T1D).