Molecular Diagnostics Market Size and Forecasts (2020 - 2030), Global and Regional Share, Trends, and Growth Opportunity Analysis Report Coverage: By Disease Area (Oncology, Infectious Disease, Genetic Testing, Cardiac Diseases, Immune System Disorders, a

Molecular Diagnostics Market Size and Forecasts (2020 - 2030), Global and Regional Share, Trends, and Growth Opportunity Analysis Report Coverage: By Disease Area (Oncology, Infectious Disease, Genetic Testing, Cardiac Diseases, Immune System Disorders, and Others), Technology (Polymerase Chain Reaction, Isothermal Nucleic Acid Amplification Technology, DNA Sequencing & Next-Generation Sequencing, DNA Microarrays, In-Situ Hybridization, and Others), Product & Services (Assays & Kits, Instruments, and Services & Software), End User (Hospitals & Clinics, Diagnostic Laboratories, Research & Academic Institutes, and Others), and Geography

The molecular diagnostics market size is expected to reach US$ 45,875.65 million by 2030 from US$ 18,173.87 million in 2022; it is estimated to register a CAGR of 12.3% from 2022 to 2030. The report highlights trends prevailing in the market and the factors driving and hindering the molecular diagnostics market growth. The growth of the market is attributed to the development of new products and increase in demand for point-of-care testing and surging prevalence of associated diseases. However, limitations associated with molecular testing hinders the market growth.

Molecular Diagnostics in Personalized Medicine for Molecular Diagnostics Market Growth in the Upcoming Years

With progress in high-throughput techniques, genome research has become more convenient and cost effective. Molecular diagnostics is becoming increasingly indispensable in clinical laboratories as these kits and tests provide rapid detection results as opposed to the conventional tests, which also involved culturing microbes in laboratory conditions in some cases. Using precision medicine, medical treatments and interventions are tailored to each patient based on their unique genetic makeup, lifestyle, and environment. Molecular diagnostics plays an important role in this approach, as it enables the identification of specific biomarkers, genetic mutations, and gene expression patterns that impact decision-making related to the treatment of patients. Drug development has become increasingly dependent on molecular diagnostics. A wide range of molecular imaging techniques are used in screening, detecting, diagnosing, treating, and assessing heterogeneity; making progression plans; examining molecular characteristics; and monitoring patient outcomes. In addition, molecular imaging can aid in the detection of tiny tumors and assessment of their activities, contributing significantly to the development and expansion of personalized medicine, research, clinical trials, and medical practice in oncology. A high-throughput genotyping platform can be used to detect genetic aberrations in clinical samples, and next-generation sequencing can be used to identify all types of cancer-causing changes. The introduction of these techniques into clinical practice would enable the identification of molecular targets in each patient, along with facilitating the tracking of the molecular progression of diseases. With these approaches, cancer patients will be able to receive personalized medicine. Thus, with technology ever evolving, the market for molecular diagnostics seems to have a bright future.

Limitations Associated with Molecular Testing Hampers the Market Growth

The outcomes of molecular testing depend on sampling and testing processes, technicians’ skill sets, etc., which may lead to variations in test results. Further, some test procedures take longer for producing results. Several times, test kits may show false positive or negative results. Thus, uncertainties associated with molecular tests hamper their adoption, especially in diagnostics and treatment of life-threatening diseases. The limited awareness of point-of-care tests, particularly in developing and underdeveloped countries, also hinders the market growth. In addition, the cost of molecular testing for indications such as cancer and viral infections, and the shortage of supplies are hampering the molecular diagnostics market.

Molecular Diagnostics Market, By Disease Area Insights

Based on disease area, the molecular diagnostics market is segmented into oncology, infectious disease, genetic testing, cardiac diseases, immune system disorders, and others.

The infectious disease segment held the largest market share in 2022. However, oncology segment is anticipated to register the highest CAGR of 12.6% during the forecast period. Oncology molecular diagnostics are tests that expose inherited material, proteins, associated molecules and assess metabolic functions, drug metabolism, and disease induction grounded on DNA, RNA, and proteins that deliver oncological information. As stated by World Health Organization (WHO), cancer reckoned for roughly 10 million demises in 2020. Furthermore, as per the 2021 statistics by the American Cancer Society, by 2040, the global burden of carcinoma is anticipated to raise to 27.5 million fresh cases and 16.3 million cancer deceases. Such like high figures denote that the evaluated rising frequency of cancer is chipping into the accelerating requirement for primitive diagnosis and preventive cure. There are numerous methods to diagnose carcinoma comprehending PCR, INAAT, and NGS etc. Among all the conception of PCR (polymerase chain reaction) led to an enormous advancement in clinical DNA testing. PCR-based methodologies demand straightforward instrumentation and infrastructure, exploit only minute quantities of biological material and are extensively harmonious with clinical routine.

Although the cost of PCR is lofty, most accurate real-time PCR approach (with more than 99% accuracy) is the one substantially used in numerous developed countries including Korea, while developing countries substantially exploit the conventional PCR (more than 90% accuracy), which is affordable than real-time PCR. Because of the high prices of the other options, underdeveloped countries generally use Rapid PCR (60 – 70% accuracy). Within the field of oncology molecular diagnostics, NGS is another technology flaunting the loftiest rate of growth. Numerous companies are working intensely to make economic use of this technology. For instance, in April 2021, Illumina Inc. blazoned its partnership with Kartos Therapeutics to co-develop an NGS- Based TP53 Companion Diagnostic, which aided to reduce the costs associated with storing and managing of genomic data.

Molecular Diagnostics Market, By Technology-Based Insights

Based on technology, the molecular diagnostics market is segmented into polymerase chain reaction, isothermal nucleic acid amplification technology, DNA sequencing & Next-Generation sequencing, DNA microarrays, in-situ hybridization, and others. The PCR is further sub segmented into RT-PCR, qPCR, Multiplex PCR, and others. The PCR segment held the largest share of the market in 2022, and the same segment is anticipated to register the highest CAGR of 12.7% in the market during the forecast period. PCR is mainly used to make or amplify DNA by copying the nucleic acid strands. Thermal cyclers are employed to denature and anneal DNA strands during amplification, along with reagents such as enzymes, nucleotides, and buffers to build the novel DNA. This technique is widely used in various application such as functional analysis of genes, diagnosis of hereditary, DNA cloning, paternity testing, detection of infectious diseases, and forensic sciences. Polymerase chain reaction has been classified into traditional PCR, real-time PCR, and digital PCR. However, ongoing technological advances and surging demand amid the pandemic will continue to fuel the need for PCR tests in India as well as other Asia Pacific countries. Consistent prevalence of diseases like tuberculosis, Hepatitis, flu, and serious infections will foster PoC molecular diagnostic industry trends. Presently, the outbreak of novel COVID-19 pandemic would create lucrative growth aspects for the market as this approach is highly critical to detect virus in individuals who exhibit no symptoms of signs of disease. PCR’s exquisite sensitivity, relative simplicity, and cost-effectiveness makes PCR stand apart from other nucleic acid amplification techniques, cementing it as a mainstay in molecular laboratories. PCR has become an indispensable tool for various clinical and diagnostic applications or examinations due to continuous research & development on PCR technologies. Therefore, it offers many opportunities for rapid point-of-care diagnostics for various infectious diseases. For instance, F. Hoffmann-La Roche Ltd is continuously working on the advancements of Digital PCR (dPCR) techniques. dPCR has extended its applications to the clinical field and has emerged as an important clinical tool. dPCR offers ultrasensitive and absolute nucleic acid quantification without reference standard. Thus, it offers a broader aspect for standardizing and comparing results between laboratories.During pandemic outbreak, one of the first mover startup, Mylab PathoDetect COVID-19 Qualitative PCR kit was among the first in the country to receive commercial approval from the Central Drugs Standard Control Organisation (CDSCO) last year. Following the approval, Mylab had partnered with biotech giant Serum Institute of India and local firm AP Globale. PCR is further sub-segmented into RT-PCR, qPCR, multiplex PCR and others. Molecular Diagnostics Market, By Purchase Mode-Based Insights.

Based on product & services, the molecular diagnostics market is segmented into assays & kits, instruments, and services & software. The assays and kits segment are held the largest share of the market in 2022, and it is anticipated to register the highest CAGR in the market during the forecast period. Molecular Diagnostics assays are among the widely used technique for analysis. Various types of assays such as rapid molecular assays, reverse transcription-polymerase chain reaction (RT-PCR), antigens, and others are used to identify and analyze various diseases such as influenza COVID 19, tuberculosis, and others. As part of product innovation and business strategies, the market players offer diagnostic kits for different test kits. The regional players are actively involved in business development related to the segment. For instance, In September 2021, Mylab Discovery Solutions acquired a majority stake in Sanskritech, developer of a platform Swayam a point of care testing system that can perform about 70 tests on the point. Moreover, in the COVID19 pandemic, various global market players offer their kits through their regional business divisions. Based on the above factors, the segment is expected to contribute remarkably during the forecast period.

Based on end user, the molecular diagnostics market is segmented into hospitals & clinics, diagnostic laboratories, research & academic institutions, and others. In 2022, the diagnostic laboratories segment held the largest share of the market. Moreover, the segment is also expected to witness growth in its demand at a fastest CAGR of 12.7% during 2022 to 2030, owing to the rise in the detection and diagnosis of various medical conditions across the regions. Diagnostic laboratories are the primary uses for molecular diagnostics products and services. It has well-established facilities as per the regulatory requirements. The laboratories use all possible molecular diagnostic products and services. The sample collected from the patients is analyzed and studied using different instruments, reagents, methods, and technologies. The labs provide services to hospitals, clinics, at-home care, and others. The increasing prevalence of chronic diseases, infectious diseases, outsourcing the molecular diagnostics activities by individual researchers are among the factors supporting the segment growth during the forecast period.

Molecular Diagnostics Market: Competitive Landscape and Key Developments

Abbott Laboratories, Agilent Technologies Inc., Thermo Fisher Scientific Inc, F. Hoffman-La Roche Ltd., Qiagen NV, bioMerieux SA, Illumnia Inc., Danaher, Siemens Healthineers AG, Novartis AG, and TBG Diagnostics Limited are among the leading companies operating in the molecular diagnostics market.

Market players are launching new products to the market. Below are few instances:

In January 2023, Agilent to Collaborate with Quest Diagnostics to Extend Access to the Agilent Resolution ctDx FIRST Liquid Biopsy Test. The agreement between Quest and Agilent will enable broad adoption for ctDx FIRST, a single-site premarket approved (ssPMA) test performed at the Resolution Bioscience CLIA laboratory in Washington.
In July 2023, Thermo Fisher launched new software for molecular diagnostics labs. This software helps in streamlining routine diagnostics testing for standardization and rapid time-to-results. It can enhance the potential of a lab to dynamically respond to quickly changing testing environments by connecting workflow steps within a single interface.
In October 2021, Agilent Technologies Inc. has announced its Ki-67 IHC MIB-1 pharmDx (Dako Omnis) is now FDA approved as an aid in identifying patients with early breast cancer (EBC) at high risk of disease recurrence, for whom adjuvant treatment with Verzenio (abemaciclib) in combination with endocrine therapy.