Health care increasingly is subject to demands for better health and quality of life and limitations on the spending required to deliver these improvements. Molecular Diagnostics, aid in responding to such demands by enabling precise detection of health risks and disease at earlier stages and improving treatment and disease management, while diminishing subsequent health problems and their associated costs. Diagnostics serve a key role in the health value chain by influencing the quality of patient care, health outcomes, and downstream resource requirements. From consumer-friendly at-home pregnancy and glucose monitoring tests to more complex automated laboratory-based systems, these tests are often first-line health decision tools. While diagnostics comprise less than 5% of hospital costs and about 1.6% of all insurance costs, their findings influence as much as 60-70% of health care decision-making. The value of diagnostics accrues not only to clinicians and patients but to health care managers, third-party payers and quality assurance organizations that use diagnostic performance to measure and improve health care quality.
Diagnostics have evolved with an understanding of biological systems and disease, along with advances in science and technology. Emerging today are entirely new categories of diagnostics, based on the full continuum of care and personalized medicine approaches. With the potential to fundamentally alter clinical practice, these technologies are intended to match the “right patient with the right treatment at the right time.” As such products mature, clinicians and patients are expected to assess the risks and benefits of care options and customized health management strategies to optimize individual health and quality of life. Considering the increasing reliance on diagnostics in all phases of patient care, they afford substantial opportunities to improve quality and efficiency. Despite the value and potential of diagnostics, certain internal and external constraints, including regulatory, reimbursement, market, scientific/technical and societal issues, can inhibit the development, adoption and appropriate use of diagnostic products. Among all types of Molecular Diagnostics product type, reagents segment is expected to dominate the market, however, the market for instruments services segment is expected to grow at the highest CAGR of 7.12% over the forecast period owing to the recent advancements in IVD instruments, growth in demand for fully automated instruments in market, as they simplify the task and provide more accurate and reliable results. The molecular diagnostics has grown, due to advances in the chemistries and instrumentation, including automation, integration, throughput, and the ability to use the instrumentation in a random-access mode.
In terms of technique type; the Molecular Diagnostics market is bifurcated into Polymerase Chain Reaction (PCR), Transcription-Mediated Amplification (TMA), In Situ Hybridization & FISH, DNA Sequencing & Next-Generation Sequencing (NGS), Chips and Microarrays and Others. PCR is the most widely used technology in Molecular Diagnostics. The PCR occupied the largest share and is expected to maintain its dominance throughout the forecast period 2019-2025 owing to the increased usage and advancements in PCR techniques such as multiplex PCR. It is expected to grow considerably and DNA Sequencing & Next-Generation Sequencing is anticipated to grow at a CAGR of 5.73% and 8.64% respectively over the analyzed period owing to its increasing demand and nature of being cost-efficient. DNA Sequencing is expected to show the fastest growth over the forecast period owing to factors such as a possible decrease in cost and rise in the portability of DNA sequencers combined with the development of NGS techniques, providing high throughput analysis and sequencing of genomic data. There is tremendous market growth of molecular diagnostics because of the growing use of NGS and PCR technology. Industry growth is further propelled by increased access to healthcare services and rapidly increasing government investments. Moreover, increased awareness pertaining to the benefits of early diagnosis and high adoption rates for technologically advanced methods will also propel the molecular diagnostics market’s growth. Furthermore, In Situ Hybridization (ISH) is projected to witness a substantial growth rate during the forecast period. An increase in the size of cancer affected the population and the need for early cancer diagnosis are some of the drivers of this segment.
The Molecular Diagnostics market is fragmented into various application types such as Microbiology, Virology, Hospital Acquired Infections (HAI), Genetic Testing, Oncology, Pharmacogenetics, Human Leukocytes Antigen (HLA), Blood Screening and others. Virology is anticipated to dominate this segment in 2025. However, the Oncology application type will rise with the highest CAGR during the forecast due to the rising trend. An increase in the incidence of cancer and the development of advanced cancer diagnostic tests, such as companion diagnostics, are some of the factors estimated to attribute to the high CAGR of the oncology segment over the forecast period. Companion diagnostics is based on the concept of personalized medicine and involves the identification of biomarker response in a population of patients with the same type of cancer. Moreover, the introduction of such advanced diagnostic technologies will prove to be cost-effective and will further boost the growth of the oncology segment. On the basis of the end-user analysis of the molecular diagnostics industry, the Hospitals segment contributed USD 3,450 million by revenue and is expected to grow with the highest CAGR of 5.43% over the forecast period through 2025. The hospitals dominate the market due to high procedure volume and extensive presence of ancillary support in terms of manpower and infrastructure. Many specialties currently have fully automated and advanced equipment, which produce results within minutes of loading the sample. Even the more ‘hands-on’ specialties like microbiology are gradually becoming more streamlined as machinery is created to decrease result time and allow researchers and pathologists to concentrate on results analysis and individual patient care.
Major companies in the global molecular diagnostics market are fragmented as Abbott Laboratories, Becton, Dickinson and Company, Biomérieux SA, Danaher Corporation, Hologic, Inc., Qiagen, Roche Diagnostics, Siemens Healthineers, Sysmex Corporation and Thermo Fisher Scientific. These players are working endlessly to offer consumer a better and sustainable mobility service across the globe. Innovative product launch and expansion through the strategic partnership are foremost strategies adopted by the companies to garner a higher market share. Technological advancements and growing R&D initiatives are expected to drive industry growth. Products with superior technologies such as broader range application equipment and multitasking reagents will continue to find a deeper penetration in the molecular diagnostics market. New technologies will also bring greater effectiveness to current methods. Technologies such as nanotechnology are also likely to support the development of the molecular diagnostics field. The Molecular Diagnostics market is presently at its growing stage in India and is expected to capture a significant share in the In-Vitro Diagnostics market in the coming years. The Molecular Diagnostics market is becoming increasingly crowded. It is estimated that more than 100 companies compete in this market, although some are still in the development stage. It is worth noting that this crowded market exists even though there have been numerous acquisitions in this field to date. As an example, Qiagen has purchased several small and large molecular diagnostic companies over the last decade, including the 2018 acquisition of Spain based STAT-Dx for its sample-to answer POC platform. In 2016, Luminex purchased Nanosphere for its Verigene multiplex platform, and Danaher acquired Cepheid. Another notable example is bioMerieux’s acquisition of BioFire in 2014 for US$ 450 million. The BioFire division with its unique high multiplex FilmArray product generated more than US$ 400 million in product sales in 2017. EAC’s analysis reveals that nine companies controlled almost 76% of the US$ 6.6 billion MDx markets in 2017 (based on manufacturer’s revenues). Nonetheless, numerous small companies continue to emerge and grow in this dynamic market.
The preceding figure gives the forecast value of the global Molecular Diagnostics Market from 2018 to 2025. The Global Molecular Diagnostics market generated revenue of US$ 6,242.6 million in 2018 and is expected to witness a CAGR growth of 6.3% during the forecast period 2019-2025, to reach a market size of US$ 9,546.2 million by 2025.