Nucleic Acid Isolation and Purification Market

Market Overview

The global nucleic acid isolation and purification market size was valued at USD 2.95 billion in 2022. It is projected to reach USD 5.51 billion by 2031, growing at a CAGR of 7.2% during the forecast period (2023-2031). 

In the laboratory of molecular biology, the extraction of nucleic acids is a common yet vital task. Removal of genetic material from the sample matrix, also known as nucleic acid isolation or nucleic acid purification, is the first step in many genetic and genomic studies. The extraction and isolation of nucleic acid begin with the disruption of the cellular structures containing the genetic material—nuclei, ribosomes, bacteria, and viruses; this is typically achieved by the addition of a compatible detergent, mechanical disruption, and/or heat. From there, numerous methods for purifying nucleic acid are prevalent. Each method of isolating nucleic acids is based on a distinct biochemical principle. The selection of a method is determined by the required throughput, the equipment available in the lab, or the required degree of purity. To isolate nucleic acids through organic extraction, phenol and guanidine isothiocyanate are added to separate DNA, RNA, and proteins into distinct organic phases. Organic extraction is a low-cost technique, and with modern reagents like TRIzol, it is a straightforward process that requires minimal equipment.

Increased investments in precision medicine research and development, increased adoption of sequencing platforms in clinical diagnostics, and rapid advancements in genomics and proteomics are driving market revenue growth. Due to the increase in the prevalence of chronic and debilitating disease conditions, scientists have continuously invested in analysis systems. Nucleic acids are naturally occurring molecules that serve as the cell's primary information-carrying molecules. DNA and RNA are the primary nucleic acids responsible for the storage and expression of genetic information. 

Market Dynamics

What are the primary factors driving the Nucleic Acid Isolation and Purification Market?

Rising Prevalence of STDs

Increasing demand for pure nucleic acids in pharmaceutical and biotechnological firms and rising application of nucleic acid-based tests in diagnosis drive market growth. Increasing government funding in R&D activities to develop technologically advanced solutions provide an impetus to market growth. Nucleic acid-based diagnostics are widely used to treat umpteen medical conditions in laboratory settings. The growing prevalence of cancer, infectious diseases, genetic disorders, and neglected tropical diseases is subsequently increasing the demand for DNA or RNA isolation for nucleic acid-based diagnostics. Nucleic acid has several diagnostic applications, which include STDs, congenital anomalies, and cancer. Almost all STDs can be diagnosed using nucleic acid isolation and identification procedures, further driving the market growth. The World Health Organization (WHO) states that, globally, over a million sexually transmitted infections are acquired daily. Currently, about 500 million people suffer from herpes simplex virus (HSV), and 290 million women have human papillomavirus (HPV) infection.

Increasing Automation in Laboratories

Automation is the transfer of laborious laboratory tasks from humans to machines. DNA analysis is a repeatable process that can be automated, whereas screening evidence is a one-time event. The robotic system allows the scientist to use more samples, analyze more plates, and step away from the process for longer periods of time. To reduce the backlog and increase productivity, a laboratory must be prepared to invest an excessive amount of time in validating and training analysts to switch from manual to robotic analysis.

What are the main factors that will slow down the Nucleic Acid Isolation and Purification Market?

High Cost of Equipment

The cost of kit-based and automated equipment for nucleic acid isolation and purification is higher than that of traditional techniques. Automated instruments have many advantages, such as quicker throughput, shorter working hours, and easier isolation processes. But these instruments' high price prevents more people from using them. From USD 8,000 to USD 160,000, automated instruments are priced for NAIP. Reagents, disposables, maintenance, training, and other costs are also added to the price of these instruments. The smaller R&D budgets of institutions and businesses make it impossible for them to purchase these pricy instruments. Thus, the higher cost of equipment can slow down the market growth throughout the forecast period.

What are the future opportunities for Nucleic Acid Isolation and Purification Market?

Increasing Technological Advancements

The advent of new technologies in molecular diagnostics, such as expression analysis and genotyping, provides an impetus to market growth. In the agriculture sector, the continuous advancement in science and technology has greatly revolutionized the production of genetically modified crops (GM). Multiple traits introduced in GM crops using genetic engineering technologies include herbicide tolerance, drought tolerance, and crop resistance to insects. In line with this, the leading market players are actively working to develop automated nucleic acid insulation and purification solutions that allow for a faster, cleaner, and more reliable process of nucleic acid extraction. In November 2019, Purigen Biosystems, Inc. launched the Ionic Purification System, which enables automated nucleic acid extraction from biological samples in an hour with higher yield and improved purity.

Regional Analysis

North America Dominates the Global Market

The global Nucleic Acid Isolation and Purification market is bifurcated into four regions, namely North America, Europe, Asia-Pacific, and LAMEA.

North America region is the highest contributor to the market and is expected to grow at a CAGR of xx% during the forecast period. North America leads the nucleic acid isolation, and purification market as the region possesses rapid technological advancements, increasing R&D funding in biotechnology and healthcare, and growing use of nucleic acid isolation in food production, farming, and environmental testing. The region is also backed by the presence of food safety regulatory bodies monitoring processed food products, such as the Food and Drug Administration (FDA) and the Food Safety and Inspection Service (FSIS).

As per the Centers for Disease Control and Prevention (CDC), in the U.S., hemophilia A affects one in every 5,000 male births, and approximately 400 babies are born with hemophilia A every year. The country is backed by the robust presence of prominent players, such as Thermo Fisher, Illumina, and Agilent Technologies, which are actively working to develop automatic systems for downstream applications, such as next-generation sequencing and PCR, in real time.

Europe is expected to witness dynamic growth in the nucleic acid isolation and purification market during the forecast period. Germany, the United Kingdom, France, Italy, Spain, and other nations in the rest of Europe are included in this region. The market's expansion can be attributed to rising R&D expenditures, growing company presence, and regional technological advancement. For instance, Agilent Technologies Inc. declared on July 20, 2021, that it had expanded the use of its PD-L1 IHC 22C3 pharmDx assay in patients with non-small cell lung cancer (NSCLC) in the European Union. Libtayo treatment for NSCLC patients with tumors that express PD-L1 with a Tumor Proportion Score (TPS) of 50% can be initiated using PD-L1 IHC 22C3 pharmDx (cemiplimab). Pathologists in Europe will be able to identify patients with NSCLC who might be qualified for treatment with Libtayo thanks to the expanded indication for PD-L1 IHC 22C3 pharmDx.

Asia-Pacific is expected to witness significant growth in the nucleic acid isolation and purification market during the forecast period. China holds the largest share of the regional market on account of the rapid growth in the preparation of DNA and RNA libraries for next-generation sequencing. Additionally, a large number of life science laboratories in China are conducting experiments on the purification of nucleic acids, further boosting regional market growth.

The LAMEA region is expected to witness moderate growth in the global nucleic acid isolation and purification market during the forecast period. Improving healthcare facilities in Middle-East and South American countries will contribute to the growth of the market throughout the forecast period. For instance, in 2022, at the Dubai World Trade Centre's hosting of the 2022 edition of MEDLAB Middle East, PerkinElmer, Inc. showcased its assortment of automated nucleic acid extraction solutions. 

Segmental Analysis

The global nucleic acid isolation and purification market are segmented by product, method, type, application, and end-user.

Based on product, the global nucleic acid isolation and purification market are bifurcated into kits and reagents, and instruments.

The kits and reagents segment is the highest contributor to the market and is expected to grow at a CAGR of xx% during the forecast period. The kits effectively isolate DNA or RNA from eukaryotic cells, bacteria, plasmids, viruses, plants, seeds, and yeast in several downstream applications, including polymerase chain reactions. Continuous production of new DNA or RNA insulation and purification kits by prominent players drive segment growth. In April 2019, Thermo Fisher introduced MagMax nucleic acid insulation kits based on magnetic bead technology.

The instruments segment is expected to witness a higher CAGR. The segment's expansion can be attributed to the introduction of new instruments that facilitate automation, rapid technological advancement, and rising demand for automated Nucleic Acid Isolation and Purification (NAIP) instruments. For instance, in April 2020, Thermo Fisher Scientific, Inc. and Hamilton Company created an automated nucleic acid extraction system for forensic lab use.

Based on the method, the global nucleic acid isolation and purification market are bifurcated into column-based isolation and purification, reagent-based isolation and purification, and magnetic bead-based isolation and purification.

The magnetic bead-based segment is the highest contributor to the market and is expected to grow at a CAGR of xx% during the forecast period as it uses high-capacity paramagnetic particles to isolate nucleic acids, providing higher yields and purity. Researchers are actively working to develop open-source protocols for magnetic bead-based methods, further driving the segment growth. For instance, the Bio-On-Magnetic-Beads (BOMB) is an open-source network consisting of magnetic bead process protocols that can assist a number of nucleic acid handling experiments.

The column-based isolation and purification segment are expected to grow at a significant rate. Silica columns are widely preferred for rapidly obtaining nucleic acids of superior quality. In addition, these techniques can be incorporated into microchips and spin columns, which offer a number of benefits, including cost-effectiveness, rapid natural extraction, and integration with automated instruments. Consequently, these techniques are widely utilized in nucleic acid isolation techniques.

Based on type, the global nucleic acid isolation and purification market are bifurcated into plasmid DNA isolation and purification, total RNA isolation and purification, and genomic DNA isolation and purification.

The total RNA isolation and purification segment is the highest contributor to the market and is expected to grow at a CAGR of xx% during the forecast period. Due to the increasing use in COVID-19 diagnostics and the rise in the use of purified mRNA for the design of the cDNA library, the demand for purified mRNA has increased. There are numerous applications for these libraries, including gene expression profiling, sequencing, and clinical diagnostics. In addition, the wide availability of kits for the processing and extraction of viral and bacterial RNA contributes to the expansion of the segment.

The plasmid DNA isolation and purification segment are expected to grow at a significant rate. The demand for purified mRNA has increased due to the increasing use in COVID-19 diagnostics and the rise in the use of purified mRNA for the design of the cDNA library. There are numerous applications for these libraries, including gene expression profiling, sequencing, and clinical diagnostics. In addition, the wide availability of kits for the processing and extraction of viral and bacterial RNA contributes to the expansion of the segment.

Based on application, the global nucleic acid isolation and purification market are bifurcated into diagnostics, drug discovery and development, precision medicine, and agriculture and animal research.

The diagnostics segment is the highest contributor to the market and is expected to grow at a CAGR of xx% during the forecast period due to the increasing use of DNA and RNA isolation in routine sample processing for the identification of pathogens. PCR techniques, for instance, are widely utilized for the rapid detection of microorganisms, which was not possible with conventional microbiological detection techniques.

The drug discovery and development segment is expected to grow at a significant rate due to the rapid technological advancement in the field of proteomics and genomics and the development of advanced therapeutics in the healthcare industry, such as antisense therapy, gene therapy, and DNA vaccines. The newly developed techniques enable rapid detection of pathogenic activity at the DNA and RNA level, resulting in the detection of antimicrobial-resistant genes and characterization of strains using genotyping, further driving the segment growth.

Based on end-user, the global nucleic acid isolation and purification market are bifurcated into hospital and clinics, pharmaceutical and biotechnology, and research centers and government institutes.

The hospital and clinics segment is the highest contributor to the market and is expected to grow at a CAGR of xx% during the forecast period due to the increasing demand for accurate and timely disease diagnosis. Even the diagnosis of genetic diseases such as sickle cell anemia, hemophilia A, and Tay-Sachs disease is considered feasible using DNA/RNA isolation and purification techniques. Consequently, the availability of such advanced equipment at moderate to low prices is anticipated to increase their rate of adoption in diagnostic centers and hospitals.

The pharmaceutical and biotechnology segment is expected to grow at a significant rate. The rapid adoption of emerging technologies for the development of various treatments by companies is anticipated to fuel market growth. As nucleic acid isolation and purification is the first step in the production of various drugs and therapies, it will undoubtedly drive the adoption of instruments and kits utilized in these processes.

Recent Developments

• April 2022, Thermo Fisher Scientific's world-class R&D center in Hyderabad has been inaugurated. Thermo Fisher's R&D Center of Excellence in India's newly expanded India Engineering Center (IEC) will add 140 new jobs to the region. Thermo Fisher Scientific invests more than USD 1.4 billion in research and development each year.
• March 2022, Promega Corporation announced a strategic partnership with FUJIFILM Cellular Dynamics for the advanced development of Novel Assay.