The molecular diagnostics sector is projected to grow significantly, reaching a value of approximately US$ 45,875.65 million by 2030, up from US$ 18,173.87 million in 2022. This growth represents a compound annual growth rate (CAGR) of 12.3% from 2022 to 2030.
This report outlines the prevailing trends in the molecular diagnostics market, along with the factors that are both propelling and restraining its growth. The expansion of this market is primarily driven by the introduction of innovative products, a rising demand for point-of-care testing, and an increase in the prevalence of related diseases. Conversely, certain limitations associated with molecular testing pose challenges to market growth.
The Role of Molecular Diagnostics in Personalized Medicine and Future Market Growth
Advancements in high-throughput technologies have made genomic research more accessible and cost-effective. Molecular diagnostics are becoming essential in clinical laboratories, as these tests provide quicker results compared to traditional methods, which often require microbial cultures. In the realm of precision medicine, treatments are customized for each patient based on their unique genetic profiles, lifestyles, and environmental factors. Molecular diagnostics are crucial in this context, as they facilitate the identification of specific biomarkers, genetic mutations, and gene expression patterns that influence treatment decisions. The drug development process increasingly relies on molecular diagnostics, utilizing various imaging techniques for screening, diagnosing, and monitoring patient outcomes. Moreover, molecular imaging is instrumental in detecting small tumors and evaluating their activity, significantly contributing to the advancement of personalized medicine, clinical trials, and oncology practices. High-throughput genotyping platforms can identify genetic abnormalities in clinical samples, while next-generation sequencing (NGS) can uncover all types of cancer-related changes. The integration of these technologies into clinical settings will enable the identification of molecular targets for individual patients and allow for tracking disease progression. As technology continues to advance, the future of the molecular diagnostics market appears promising.
Challenges in Molecular Testing Affecting Market Growth
The reliability of molecular testing results can be influenced by various factors, including sampling and testing procedures, as well as the expertise of technicians, which may lead to inconsistent results. Additionally, some testing methods may require extended periods to yield results. There are instances where test kits may produce false positives or negatives, creating uncertainties that hinder their adoption, particularly in the diagnosis and treatment of critical illnesses. Furthermore, limited awareness of point-of-care testing, especially in developing regions, poses another barrier to market growth. The high costs associated with molecular testing for conditions like cancer and viral infections, along with supply shortages, further impede the molecular diagnostics market.
Molecular Diagnostics Market Insights by Disease Area
The molecular diagnostics market is categorized by disease area into oncology, infectious diseases, genetic testing, cardiac conditions, immune system disorders, and others.
In 2022, the infectious disease segment dominated the market share. However, the oncology segment is expected to exhibit the highest CAGR of 12.6% during the forecast period. Oncology molecular diagnostics involve tests that analyze inherited materials, proteins, and metabolic functions based on DNA, RNA, and proteins to provide oncological insights. According to the World Health Organization (WHO), cancer accounted for approximately 10 million deaths in 2020. Furthermore, the American Cancer Society's 2021 statistics predict that by 2040, the global incidence of cancer will rise to 27.5 million new cases and 16.3 million cancer-related deaths. Such alarming statistics highlight the increasing demand for early diagnosis and preventive treatment. Various diagnostic methods for cancer, including PCR, INAAT, and NGS, are available. Among these, the introduction of PCR (polymerase chain reaction) has significantly advanced clinical DNA testing. PCR methodologies require minimal instrumentation and infrastructure, utilize small amounts of biological material, and are compatible with clinical routines.
While PCR costs can be high, the most accurate real-time PCR method (boasting over 99% accuracy) is widely used in developed nations like Korea, whereas developing countries often rely on conventional PCR (over 90% accuracy), which is more affordable. In underdeveloped regions, Rapid PCR (60-70% accuracy) is commonly employed due to cost constraints. Within oncology molecular diagnostics, NGS is rapidly growing, with numerous companies striving to make this technology more economically viable. For example, in April 2021, Illumina Inc. announced a partnership with Kartos Therapeutics to co-develop an NGS-based TP53 Companion Diagnostic, aimed at reducing costs associated with genomic data management.
Molecular Diagnostics Market Insights by Technology
The molecular diagnostics market is also segmented by technology, including polymerase chain reaction, isothermal nucleic acid amplification technology, DNA sequencing & next-generation sequencing, DNA microarrays, in-situ hybridization, and others. The PCR segment, which includes RT-PCR, qPCR, multiplex PCR, and others, held the largest market share in 2022 and is projected to achieve the highest CAGR of 12.7% during the forecast period. PCR is primarily utilized to amplify DNA by replicating nucleic acid strands, employing thermal cyclers to denature and anneal DNA strands during the amplification process, along with necessary reagents. This technique is widely applied in various fields, including gene functional analysis, hereditary diagnosis, DNA cloning, paternity testing, infectious disease detection, and forensic science. PCR has evolved into traditional PCR, real-time PCR, and digital PCR. Continuous technological advancements and heightened demand during the pandemic are expected to sustain the need for PCR tests in India and other Asia-Pacific nations. The ongoing prevalence of diseases such as tuberculosis, hepatitis, flu, and severe infections will further drive trends in point-of-care molecular diagnostics. The COVID-19 pandemic has created significant growth opportunities for the market, as PCR is critical for detecting asymptomatic individuals. The sensitivity, simplicity, and cost-effectiveness of PCR distinguish it from other nucleic acid amplification techniques, solidifying its role in molecular laboratories. PCR has become an essential tool for various clinical and diagnostic applications due to ongoing research and development in PCR technologies, offering numerous opportunities for rapid point-of-care diagnostics for infectious diseases. For instance, F. Hoffmann-La Roche Ltd is actively advancing digital PCR (dPCR) techniques, which have found clinical applications and emerged as vital clinical tools, providing ultrasensitive and absolute nucleic acid quantification without reference standards. During the pandemic, Mylab PathoDetect's COVID-19 Qualitative PCR kit was among the first to receive commercial approval from the Central Drugs Standard Control Organisation (CDSCO) in India, leading to partnerships with major biotech firms.
Molecular Diagnostics Market Insights by Product and Services
The molecular diagnostics market is categorized by product and services into assays & kits, instruments, and services & software. The assays and kits segment held the largest market share in 2022 and is expected to register the highest CAGR during the forecast period. Molecular diagnostics assays are widely utilized for analysis, with various types such as rapid molecular assays, RT-PCR, and antigen tests employed to identify and analyze diseases like influenza, COVID-19, and tuberculosis. Market players are innovating and developing diagnostic kits for various tests. For instance, in September 2021, Mylab Discovery Solutions acquired a majority stake in Sanskritech, which developed the Swayam point-of-care testing system capable of performing around 70 tests. Additionally, during the COVID-19 pandemic, numerous global market players offered their kits through regional divisions, contributing to the segment's expected growth.
Molecular Diagnostics Market Insights by End User
Based on end users, 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 market share and is anticipated to experience the fastest growth with a CAGR of 12.7% from 2022 to 2030, driven by the increasing need for detection and diagnosis of various medical conditions. Diagnostic laboratories are the primary users of molecular diagnostics products and services, equipped with facilities that meet regulatory standards. They utilize a range of molecular diagnostic products and services to analyze patient samples using various instruments, reagents, methods, and technologies. These laboratories provide services to hospitals, clinics, and home care, among others. The rising prevalence of chronic and infectious diseases, along with the outsourcing of molecular diagnostics activities by individual researchers, supports the growth of this segment during the forecast period.
Molecular Diagnostics Market: Competitive Landscape and Key Developments
Key players in the molecular diagnostics market include Abbott Laboratories, Agilent Technologies Inc., Thermo Fisher Scientific Inc., F. Hoffman-La Roche Ltd., Qiagen NV, bioMerieux SA, Illumina Inc., Danaher, Siemens Healthineers AG, Novartis AG, and TBG Diagnostics Limited.
These companies are actively launching new products. Here are a few notable examples:
- In January 2023, Agilent announced a collaboration with Quest Diagnostics to enhance access to the Agilent Resolution ctDx FIRST Liquid Biopsy Test, facilitating broader adoption of this premarket approved test.
- In July 2023, Thermo Fisher introduced new software for molecular diagnostics labs, designed to streamline routine testing and improve response times in dynamic testing environments.
- In October 2021, Agilent Technologies Inc. received FDA approval for its Ki-67 IHC MIB-1 pharmDx (Dako Omnis) as an aid in identifying early breast cancer patients at high risk of recurrence, for whom adjuvant treatment with Verzenio (abemaciclib) is indicated.