NGS Based Molecular Diagnostics Market - Forecast(2024 - 2030)

NGS Based Molecular Diagnostics Market size is estimated to reach $ 2255.79M by 2025, growing at CAGR of 6.4% during the forecast period of 2020-2025. The NGS Based Molecular Diagnostics Market growth rate is attributed to the advancement in genomics and proteomics and increasing application of NGS based molecular diagnostic for human diseases hence, fostering the market growth. Next Generation Sequencing (NGS) is a DNA sequencing method that works on massive parallel sequencing employing Micro and Nanotechnologies that performs in less time and is cost effective. Moreover, Next Generation Sequencing (NGS) works on massive parallel sequencing that can sequence thousands of sequence simultaneously and can produce enormous amount of data. From wide application, the NGS technology used in molecular diagnosis allows the nucleotide sequencing that helps identify the genetic variants owing to which it is used in microbiology applications. It is recognized as the primary technology responsible for the burgeoning field of oncology as it offers advanced personalized treatment and is anticipated to propel the NGS Based Molecular Diagnostics Market during the forecast period 2020-2025.  Apart from this, the main advantage of NGS is it is more accurate, can be performed with less man power and can enhance the scope of research. However, lack of skilled labor, accuracy and standardization issues hinder the growth of the market.

The report: “NGS Based Molecular Diagnostics Market Forecast (2020-2025)”, by Industry ARC, covers an in-depth analysis of the following segments of the NGS Based Molecular Diagnostics Market: 

By Application: Oncology and Microbiology.

By End Use: Research Centers and Academics, Hospitals and Clinical Laboratories.

By Geography: North America, Europe, Asia-Pacific and RoW.

By Application, the oncology segment dominated the NGS based Molecular Diagnostic market in 2019 and it is estimated to be the fastest grow at a CAGR of 6.5% during the forecast period 2020-2025. This is owing to increased prevalence of various types of cancer such as breast, colorectal, and Non-Small Cell Lung Cancer among the world population. Additionally, increasing demand of NGS based advanced molecular diagnostics on the grounds of accuracy, speed and cost is driving the demand during forecast period 2020-2025. Furthermore, in case of routine molecular diagnostics, laboratories have to integrate high-throughput sequencing technologies in-order to improve clinical decision making for patient management. On the contrary, next-generation sequencing (NGS) has overcome the cited challenges, posing an attractive alternative to traditional molecular diagnostic testing for cancer.

North America is the major region dominating the NGS Based Molecular Diagnostic Market with revenue share of 39.87% in 2019. This is owing to increasing advancements in technologies related to NGS based molecular diagnostics, high prevalence of infectious diseases and various types of cancer and Modernization of Healthcare infrastructure. According to American Clinical Laboratory Association, Laboratory agencies constantly provide updated guidance documents pertaining to the design, development, and use of NGS‐based tests, recognizing the importance of NGS in cancer diagnostics and therapeutics which increases the demand for NGS based molecular diagnostics market. Furthermore, according to American Society of Clinical Oncology, in 2017 about 75.6% of oncologists are using NGS test to guide treatment decision for cancer patients which helps to increase the market growth of NGS based molecular diagnostics market.

However, Asia-Pacific region is estimated to grow at a fastest CAGR during the forecast period 2020-2025. This is owing to the increasing incidences of cancer among lower- and middle-income class countries in Asia Pacific supported by rising incidences of aging populations and changes in lifestyles related to economic developments. India and China are estimated to offer maximum potential for NGS based molecular diagnostic during the forecast period 2020-2025.

NGS Based Molecular Diagnostics technologies have advantages in the clinical diagnostic laboratory for routine detection, fingerprinting, and epidemiologic analysis of infectious microorganisms. It minimizes the requirement for cultivation, which reduces the time required for morphology and biochemistry diagnosis. Moreover, advances in NGS Based Molecular Diagnosis focuses on the areas such as Multi Parametric Molecular Diagnostics, Cancer Progression, and Diagnostics, Genomics in Infectious Diseases, Genetic Testing, Mass Spectrometry-Based Quantitative Metabolomics, etc. The validity and utility of NGS-based panel testing have been demonstrated for a wide range of conditions including hearing loss, vision loss, cardiovascular disorders, renal disorders, neurologic disorders, and cancer predispositions. Furthermore, the introduction of procedural code sets for next generation sequencing is a milestone toward financially sustainable clinical implementation which is in turn anticipated to increase the growth of the NGS Based Molecular Diagnostic Market during the forecast period 2020-2025.

The major challenge for the market is that regulatory and legal requirements applied to NGS based molecular diagnostics are becoming more stringent. For more than 20 years, the FDA has emphasized that it has supervisory authority over LDTs (laboratory-developed tests), but it has chosen to exercise enforcement discretion over NGS based molecular diagnostics tests. The FDA has declared that added oversight of LDTs is needed and that the agency plans to issue a guidance document on this. Hence, the issuance of the draft guidance is also set to hinder the growth of the NGS based molecular diagnostics market. Furthermore, owing to the rapid mutation of microbes and the increasing outbreak of epidemics, clinical laboratories need to adopt innovative technologies capable of timely sample diagnosis. Hence, all laboratories and setups must be well-versed with the techniques to begin practice. The reluctance to move from manual operations towards automation is another challenge for NGS based molecular diagnostic market growth. Thus, the shortage of skilled, well-trained, and technically knowledgeable laboratory technicians to operate advanced NGS based molecular diagnostic products is limiting their overall adoption, particularly in emerging markets.

Product launches, mergers and acquisitions, joint ventures and geographical expansions are key strategies adopted by players in the NGS Based Molecular Diagnostics Market. In 2019, NGS Based Molecular Diagnostics Market share is fragmented by the top ten players present in the market. NGS Based Molecular Diagnostics Market top 10 companies are Illumina Inc., F. Hoffmann-La Roche ltd., Thermo Fisher Scientific Inc., Abbott Laboratories, Danaher Corp., Agilent Technologies Inc., Becton Dickinson & Company, Qiagen N.V., BioMerieux SA, Bio-Rad Laboratories Inc. and others.

In October 2020, Thermo Fisher Scientific Set to Acquire Qiagen for $11.5Billion. With the acquisition, Waltham, MA-based Thermo Fisher Scientific has the potential to boost its molecular diagnostics offerings. The company also has a chance to expand its coronavirus detection offerings with Qiagen’s QIAstat-Dx Respiratory Panel 2019-nCoV test kit.

In January 2020, Agilent Technologies Inc. has launched SureSelect XT HS2 DNA Kit which accelerates capture-based enrichment library preparation with good quality and improves efficiency, especially in labs processing both DNA and RNA samples for NGS applications. The product has ability to multiplex hundreds of samples in one sequencing run, this reduces sequencing costs for labs.