DNA Extraction Kits Market

Market Overview

The global DNA extraction kits market was valued at USD 1,494.47 million in 2022. It is estimated to reach USD 2,874.86 million by 2031, growing at a CAGR of 7.54% during the forecast period (2023–2031). 

The global DNA extraction kits market is expected to grow because of a rise in rare genetic diseases. Companies are focused on offering next-generation, technologically advanced DNA extraction kits to reduce the burden of genetic diseases. More R&D in biologics, molecular science, and genomics will further increase the use of DNA extraction kits.

The DNA Extraction Kit offers a straightforward, non-toxic method for isolating high-molecular-weight DNA from tissue, whole blood, and cultured cells. The extraction requires only two to three hours, depending on the starting material, and neither phenol nor chloroform is required. The DNA extracted with the DNA Extraction Kit is contaminant-free and suitable for restriction digests, cloning, Southern blotting, PCR amplification, and other DNA analysis techniques.

The DNA Extraction Kit is a modification of a procedure based on salt precipitation to separate contaminating protein from DNA. The procedure entails the digestion of cellular proteins, the subsequent removal of the proteins by "salting out" with standard sodium chloride, the precipitate of the DNA with ethanol, and the resuspension of the DNA in the buffer of choice. The only limitation on the number of samples that can be processed simultaneously using this method is the available centrifuge space.

Market Dynamics

Global DNA Extraction Kits Market Drivers

Rise in Product Launches

Product launches are among the best strategies to gain market share and acquire new end-users. Vendors in the global market also focus on launching new DNA extraction kits that are better than the existing products. Some market players have developed DNA extraction kits to extract a large DNA volume within a few seconds. This will largely revolutionize the market. For example, New England Biolabs launched a unique product that enables users to extract heavy molecular-weight DNA.

Similarly, in May 2021, Isohelix launched the GeneFix Salivalyse Direct to PCR Kit. This kit enables the preparation of PCR-ready DNA from GeneFix- and BuccalFix-stabilized samples. Therefore, the surging product launches are expected to drive market growth.

Growing Number of Patients with Genetic Disorders

In 2019, the global population of individuals affected by uncommon diseases exceeded 300 million. Rare diseases impact over 10% of the global population, roughly. It is anticipated that 80% of rare diseases are genetic in origin and require personalized medicines or the modification of genetic materials for a cure. DNA extraction is one of the significant steps in treating these diseases.

The increase in treatment options for these diseases will have a huge demand for DNA-extraction kits. For instance, genome sequencing-based diagnosis offers a promising alternative for rare disease management. The number of rare diseases is around 7,000, most chronically debilitating or even life-threatening, posing a huge burden on society. Therefore, an increase in genome sequencing activities will accelerate the use of DNA extraction kits.

Global DNA Extraction Kits Market Restraint

High Cost of DNA Extraction Kits 

The cost and time required to develop a single DNA extraction reagent are high. DNA from various samples, such as the human genome, plants, bacteria, forensic dried blood samples, etc., have distinct features and characteristics and need to be extracted or processed with the right DNA extraction methods. The cost of R&D increases as vendors are focused on developing next-generation, technologically advanced, high-yielding, and fast-processing DNA extraction kits. This, in turn, makes commercial DNA extraction kits expensive in the market, which is also expected to restrain the market growth.

Global DNA Extraction Kits Market Opportunities

Increase in Genomics and Regenerative Medicine Projects

Advancements in genomics post the Human Genome Project revolutionized the field of healthcare. The benefits of the Human Genome Project encouraged many similar projects across the globe, which was a major step in genomic medicine. Some developed countries, such as the US, Japan, and Australia, are involved in genome projects that study unique or diseased genes to find treatment methods. The success of various genomic projects and the subsequent development of personalized medicines and solutions for rare genomic disorders drive the use of DNA extraction kits in the market.

There is huge progress in studies related to regenerative medicine, which has led to the development of treatments for various rare genetic disorders. Large companies invest in research in regenerative medicine to develop personalized medicines. Some companies have also launched DNA extraction kits exclusively for certain applications. For instance, Thermo Fisher Scientific's PureLink Expi Endotoxin-free plasmid DNA isolation kit helps extract and purify DNA for unique applications, such as gene therapy, vaccine research, and more. Such advances in regenerative medicine will increase the demand for DNA extraction kits.

Regional Analysis

Based on region, the global market is bifurcated into North America, Europe, Asia-Pacific, Latin America, and the Middle East and Africa. 

North America Dominates the Global Market

North America is the most significant global market shareholder and is estimated to exhibit a CAGR of 6.77% during the forecast period. North America is one of the largest markets for DNA extraction kits globally. It leads other countries to increase the use of genome sequencing-based healthcare and diagnostics in the medical sector. Countries such as the US and Canada are the major revenue contributors in North America. The market is likely to grow in North America owing to the advanced healthcare infrastructure and increased awareness among the patient population. Many cell and gene therapy-based clinical trials are conducted in the US. North America has more than 534 gene therapy, cell therapy, and tissue engineering therapeutic developers; the number of people preferring these treatments is also high.

In addition, regulatory approvals for cell and gene therapies are higher in North America than in other regions. The region also has highly advanced genomic laboratories and research centers for large-scale research projects per the market demand. They collaborate with pharmaceutical and biotechnology companies across the world.

Europe is anticipated to exhibit a CAGR of 7.38% over the forecast period. Europe is a pioneer in advanced technologies in genetics, plant genomics research, molecular diagnostics, regenerative medicine, and more. The increased target population in developed economies in the region drives the value of innovative medicines in the market. This includes therapies, such as cell and gene therapies, which require DNA extraction, PCR, and genome sequencing. Similarly, it is the first region to approve a gene therapy product, Glybera, for commercialization. This has largely increased the use of DNA extraction kits in the region.

Additionally, the adoption of personalized medicine is rising in the region. For instance, multiple hospitals, research institutes, and pharmaceutical and biotechnology companies in Europe provide treatments and diagnostic tests based on genome sequencing. In addition, the large number of laboratories, advanced infrastructure, and increased number of genome mapping projects will drive the demand for DNA extraction kits in the region.

The market in Asia-Pacific has the highest growth rate among all regions as it comprises various emerging countries expanding their healthcare infrastructure. Countries such as China, India, Japan, Australia, and South Korea are prominent contributors to the market in Asia-Pacific. These countries also have the highest prevalence rate of infectious diseases. Since early 2000, various countries in Asia-Pacific have emerged as strong players in the R&D of cell and gene therapies. Large genomic and pharma companies are established in Asia-Pacific countries, which drives the use of DNA extraction kits in the region. Several global vendors are attracted to the Asian market due to its large population size and rapidly aging society. There are various reasons, such as the high patient population and investments in clinical trials, for the region's surging demand for cell and gene therapy products.

Latin America has huge social and economic contrasts among countries, accounting for more than 5% of the global population. Due to an increase in the target population, it is likely to be a significant market for DNA extraction kits and genomics. The high prevalence of rare diseases increases the geriatric population, and the growth in cancer patients contributes to the demand for specialized medicines, such as genome-based medicines, molecular diagnostics, and personalized medicines in the region. In addition, the penetration of genome-based products is much lesser in Latin America compared with North America and Europe. The lack of infrastructure, shortage of trained professionals, high cost of products, and less availability of genome and genetic research-based products limit the market's growth prospects in the region.

Segmental Analysis

The global market is bifurcated into product type, application, sample type, and end-user.

Based on product type, the global market is bifurcated into cell-free DNA, genomic DNA, and others.

The cell-free DNA segment is the highest contributor to the market and is anticipated to exhibit a CAGR of 7.44% over the forecast period. cfDNA (cell-free DNA) was first discovered in 1948 by Mandel and Metals. It is released from cells into the circulatory system throughout the body. cfDNA is found in plasma and other body fluids, such as CSF, pleural fluid, urine, saliva, etc. Previous clinical studies have shown that most plasma cfDNA molecules come from the hematopoietic system of healthy individuals. However, in certain physiological or pathological conditions, such as organ transplantation, pregnancy, or cancers, the affected tissue may release additional DNA into the peripheral circulation. Therefore, the extraction of cfDNA from peripheral blood can identify an individual's abnormalities non-invasively. Various techniques based on non-invasive prenatal testing (NIPT), organ transplant monitoring, and analysis of cfDNA for detecting immune disorders and cancers have emerged in recent years.

Based on application, the global market is segmented into PCR, sequencing, cloning, and others. 

The PCR segment is the largest revenue contributor to the market and is projected to exhibit a CAGR of 7.06% over the forecast period. It is the enzymatic amplification of a specific DNA fragment targeted by two oligonucleotide primers. An exponential amount of a targeted fragment that is amenable to various types of analysis can result from repeated cycles of DNA denaturation, primer annealing, and polymerase-mediated primer extension. In addition, PCR is a widely popular and advanced technology used in modern laboratories. PCR is a common and often indispensable technique in medical and biological research laboratories. The technique also allows for complex DNA sequencing, electrophoresis, or custom DNA chains by directly cloning the DNA strands into plasmids.

Based on sample type, the global market is bifurcated into blood, tissue, and FFPE, cells, and others. 

The blood, tissue, and FFPE segment dominates the global market and is predicted to exhibit a CAGR of 7.96% over the forecast period. Genetic testing on various samples, like blood, tissue, and FFPE, is popular owing to the rise in NGS. Companies offer extensive products for DNA extraction from serum or blood samples at the required purity and scale. Large-scale genetic epidemiological studies require high-quality analyses of samples, like blood or saliva, from multiple patients, which is difficult at the point of care. In addition, FFPE tissue provides a valuable source of stable DNA samples for gene expression analysis.

The clinical advantage of FFPE tissue samples is considerable, as retrospective analysis of archived tissue permits the correlation of molecular findings with treatment response and clinical outcomes. FFPE is also the preferred technique for archiving clinical tissue biopsies for histopathological examination. There is an increased need for reliable FFPE extraction methods as advances in clinical molecular pathology continue.

Based on end-users, the global market is bifurcated into healthcare facilities, research institutes, pharma and biotech companies, and others. 

The healthcare facilities segment owns the highest market share and is expected to exhibit a CAGR of 7.36% over the forecast period. Commercial and public health laboratories largely use DNA extraction kits. Commercial laboratories are higher in number and prefer the latest equipment. This business model generates revenue by performing in-vitro tests. There are many genomic laboratories across the globe. Many of them provide genome-based diagnostics, research applications, and more. These service providers customize their genomic solutions to meet the diverse needs of end-users.

For instance, the Beijing Genome Institute's (BGI's) immune repertoire sequencing (IR-SEQ) service enables end users to examine the adaptive immune system, which allows researchers to understand adaptive immune-mediated diseases better and supports research in other applications and single-cell sequencing services. The increased number of genomic labs will largely drive the use of DNA extraction kits in the market.

Recent Developments

• June 2023- Bionano Genomics, Inc. announced the commercial release of new packages for its Ionic® Purification System. It features new chemistry for nucleic acid extraction from formalin-fixed paraffin-embedded (FFPE) and tumor tissue.
• August 2023- CD Bioparticles, a company with years of experience in the pharmaceutical and life science industries, introduced its new line of DNA Extraction and Purification Kits. The kits are intended for the rapid and reliable isolation of genomic DNA, plasmid DNA, tissue DNA, mitochondrial DNA, cell-free DNA (cfDNA), and PCR products.