According to the Market Statsville Group (MSG), the global nucleic acid isolation & purification market size is expected to grow from USD 6,331.6 million in 2021 to USD 12,241.2 million by 2030, at a CAGR of 7.6% from 2022 to 2030. Isolation and purification of nucleic acids are critical for expanding medical applications such as research, medication discovery, and others. A wide range of scientific and therapeutic applications necessitate the use of high-quality, ultrapure nucleic acids such as DNA and RNA. Isolation and purification of DNA or RNA are required for genetic analysis and used in various medical, scientific, and forensic applications. Many approaches, such as column-based, reagent-based, and others, are used to carry out the procedure.
Various sources are accessible to purify and isolate nucleic acid, including hair, bones, blood, saliva, sperm, nails, and urine. These approaches are widely used in bioscience research, gene splicing, molecular diagnostics, and forensics. The isolation of nucleic acids decreases nucleic acid loss, speeds up sample processing, and improves the laboratory's efficacy and efficiency. It also aids in the purification of nucleic acid. In nucleic acid isolation and purification, several critical technologies such as magnetic bead-based, reagent-based, and column-based are used.
Factors such as increased R&D efforts, technological advancements, and automation are likely to drive the market's growth. However, one of the reasons expected to hamper the growth of the nucleic acid isolation and purification market is the high cost of automated devices. Furthermore, the high scope of development in the developed market, the improving regulating and repaying framework, and the molecular diagnostics and customized medicine are expected to create lucrative prospects in the growth of nucleic acid isolation and purification.
Because of the COVID-19 pandemic, disease testing and medication development have been on the huge rise. This research is being expanded to understand better the infection's dynamics, which is predicted to move the nucleic acid isolation and purification sector forward. On the other hand, it is expected that the majority of COVID-19 diagnostic assays, molecular testing, and customized medicine will constantly rise over the next years. There has been a significant rise in the number of manufacturers who have made critical efforts to augment patient access to coronavirus diagnostic testing, vaccine and medication research, and other testing locations around the country to guide patient treatment and protect public health.
Because of the coronavirus's rapid spread, the need for diagnostic kits and other critical care medical devices has increased exponentially in the previous two years. In 2020–2021, healthcare provider facilities worldwide were inundated with patient submissions for COVID-19 screening and treatment. This caused major interruptions in clinical workflows inside inpatient care facilities, prompting providers to prioritize vital patient care operations.
The market is a research-driven industry, as various market players and scientists have indulged in research and development. Pharmaceutical and biotechnology businesses, as key parts of the life science industry, invest extensively in research to discover breakthrough compounds to fulfill the rising healthcare sector's demands. Furthermore, the imminent patent cliff has increased biopharmaceutical firms' research activity. Companies in the kits, reagents, and instruments market expanded their R&D spending to produce novel products to fulfill the pharmaceutical and biotechnology industries' research needs. Thermo Fisher Scientific, for instance, boosted its R&D expenditure from USD 967 million in 2020 to USD 1,003 million in 2021.
Kits and automated nucleic acid isolation and purification instruments are more costly than traditional procedures. Automated instruments have important advantages such as simplified separation procedures, reduced working hours, greater safety, and higher throughput. However, the exorbitant cost of these equipment prevents their widespread use. NAIP automated instruments cost between USD 8,000 to USD 160,000. These devices also incur additional reagents, disposables, maintenance, and training costs. These expensive equipment are out of reach for institutes and businesses with limited R&D resources.
Despite the favorable funding landscape for personalized/precision medicine, the absence of reimbursement for precision medicine diagnostic tests was a barrier to implementing NGS technology for diagnostics. The US CMS did not implement a classification and reimbursement mechanism for reimbursement until early 2018, as NGS-based clinical treatments were considered experimental.
The CMS, however, determined that NGS was a reasonable and necessary diagnostic laboratory test and, in March 2018, decided it would be covered nationally when ordered by a treating physician and carried out in a CLIA-certified laboratory in the case of recurrent, relapsed, refractory, metastatic, or stage III or IV cancer, as well as other formulated criteria. This was due to the introduction of advanced NGS products for diagnostic applications and increased awareness of NGS's diagnostic applications. Furthermore, in April 2021, the FDA issued final advice to speed the submission and evaluation of NGS-based tests and to provide a flexible regulatory approach to allow the development of its standards in response to technological advances in the area of NGS.
The study categorizes the nucleic acid isolation & purification market based on product, type, application, method, and end user at regional and global levels.
Based on the end-use, the nucleic acid isolation & purification market is divided into hospitals & diagnostic centers, pharmaceutical & biotechnology companies, academic & government research institutes, contract research organizations, and other end users. The hospitals and diagnostic centers segment dominated the nucleic acid isolation and purification market in 2021 due to the increased need for early and precise illness detection. Techniques for isolating and purifying DNA/RNA are regarded as effective diagnostic tools for hereditary illnesses such as sickle cell anemia, hemophilia A, and Tay-Sachs disease. As a result, the availability of such effective technologies at reasonable to low prices is projected to boost their use in diagnostic centers and hospitals.
Based on the regions, the global nucleic acid isolation & purification market has been segmented across North America, Asia-Pacific, Europe, South America, and the Middle East & Africa. North America dominated the nucleic acid isolation and purification market in 2021, revenue share due to the presence of established companies and their efforts to create technologically enhanced quick purification and isolation devices. Furthermore, increased financing initiatives for biotechnology research propel the region's market growth.
As a result, such market trends are likely to assist North America is dominating the overall market.
The global nucleic acid isolation & purification market is highly competitive, with key industry players adopting strategies such as partnerships, product development, acquisitions, agreements, and expansion to strengthen their market positions. Most companies in the market are indulged in expanding business across regions, enhancing their capabilities, and molding strong partner relations.
Major players in the global nucleic acid isolation & purification market are:
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