The global molecular diagnostics market was worth USD 15.30 billion in 2020 and is further projected to reach USD 32.10 billion by 2027, at a CAGR of 10.90% during the forecast period (2021-2027). The rising prevalence of infectious diseases, the occurrence of various types of cancer, along with scientific advancements in molecular test methods are all driving market growth.  The growing number of geriatric populations who are more likely to get infected by infectious diseases due to their weak immune system has further fueled the global molecular market. Molecular diagnostics are widely used to test samples of infectious diseases such as COVID-19 and cancer, as well as to deeply rectify the infected body's DNA molecule.

Global Molecular Diagnostics Market Overview

 Molecular diagnostics is the study of biomarkers in the genome and proteome using different strategies. For diseases such as cancer, communicable diseases (such as ebolavirus, malaria, dengue, coronavirus), and genetic abnormalities, these methods are used to direct patients from diagnosis to treatment. These methods aid in the discovery of disease-causing genetic variants.  PCR (Polymerase chain reaction), real-time PCR, fluorescence in situ hybridization, gel electrophoresis, RFLP (restriction fragment length polymorphism analysis), hybrid capture, single-stranded conformation polymorphism, and other assays are examples of molecular diagnostic procedures that are commonly utilized. The pace and sophistication of new molecular diagnostic methods have been increasing significantly. While some methods have proven to be extremely beneficial in clinical settings, others, such as genomics, continue to hold great potential in the global molecular diagnostic market. Molecular diagnostic procedures are also one of the fastest-growing segments of in-vitro diagnostics.

Global Molecular Diagnostics Market Trend

Growth Drivers

Increased Number of Geriatric Population

The rising prevalence of molecular diagnostics is due to the growing geriatric population, which has a weak immune system and is more vulnerable to infectious diseases such as seasonal change fever, cold, and cough. According to the United Nations, there were 703 million people over the age of 65 in 2019, with Asia leading the way in terms of the aging population. The three major countries contributing to the Asiatic regions are China, Japan, and India. Because of the growing geriatric population, hospitals are increasingly using molecular diagnostic techniques to detect and treat diseases that people are suffering from, thereby propelling the molecular diagnostic market forward. Rising government initiatives in emerging economies worldwide to improve medical infrastructure has fueled the growth of the global molecular diagnostics market.

Rise in Technological Advancement

The molecular diagnostics market is expected to grow as technological advancements help the general public obtain reliable results and cost-effective treatments. Auris Health Inc., for example, has developed a robotic that aids in the early detection of lung cancer with greater accuracy and low risk of complications. The innovation has been approved by the Food and Drug Association as this kind of promising innovation will undoubtedly help people fight deadly diseases such as cancer. Additionally, the adoption of Artificial Intelligence and Machine Learning in molecular diagnostics has helped the medical industry detect various diseases at an early stage, thereby fueling the market growth for the molecular diagnostic market.

Restraints

The High Cost of Instruments & Faulty Diagnostics Kit

The cost of instruments used in molecular diagnostics is extremely high, and their limited availability in hospitals has been creating a barrier in the market. Specialized laboratories and hospitals with a reasonable capital budget can only afford these costly instruments. Middle and low-income families cannot afford these lavish hospitals for their treatment, which may hinder the growth of the molecular diagnostics market. Thus, market development is expected to be limited to some extent in the near future due to an unfavorable reimbursement scenario and steep instrument costs. Moreover, several unauthorized diagnostics centers entice people with lower fees for a particular test that is conducted using faulty kits that yield inaccurate results, causing people to be treated improperly. These factors are further restraining the growth of the global molecular diagnostics market.

Impact of COVID-19

The COVID-19 pandemic has wreaked havoc on several economies around the world. Due to the high infection rates and adverse impact on public health systems, various countries had to enforce nationwide lockdowns, which significantly impacted industrial supply chains, trade, and related services. The world is now looking at ways for private laboratories to scale up research. Considering the current scenario, rigorous testing is the only way to slow down the virus's spread. According to the WHO, 146,841,882 to date has been affected by the virus. Laboratories are increasingly using the RTPCR test for detecting COVID-19 to determine if an individual is infected with COVID-19, which is fueling market development.

Though the outbreak of the pandemic has slowed the development of molecular diagnostics, because it is a sector linked to the medical field, the ease in restrictions on movements has resulted in sky-high sales. Now that countries, especially India, have been hit by the second wave of the COVID-19 virus, which has claimed the lives of many people, governments around the world have increased the rate of COVID-19 tests.

Global Molecular Diagnostics Market: By Product

Based on product, the global molecular diagnostics market is grouped into instruments, reagents, and others. Reagents generated the most significant revenue in the product segment of the molecular diagnostics market in 2020. The segment is likely to dominate the molecular diagnostic market even during the forecast period, as the adoption rate of reagents in research and clinical settings goes up owing to the spread of COVID-19 across the globe. Additionally, the molecular diagnostics market is expected to expand due to improved efficiency and cost-effectiveness in achieving accurate reagent results.

Global Molecular Diagnostics Market: By Application

Based on application, the global molecular diagnostics market is fragmented into oncology, pharmacogenomics, genetic testing, cardiovascular disease, neurobiological disease, microbiology, infectious disease, and others. The infectious diseases segment accounted for the largest share in the application segment in 2020.

The world is currently in the grip of a pandemic caused by COVID-19, also known as coronavirus. Coronavirus is a highly infectious disease that has afflicted millions of citizens globally. Countries across the world are increasingly using testing kits to identify the COVID-19 infection or the people infected by the virus. The use of RT-PCR (Reverse Transcription Polymerase Chain Reaction) kits has been crucial in deciding the accuracy of the results. RT-PCR kits have a high accuracy rating of more than 90%. The management and diagnosis of such infectious diseases contribute to an increase in the prescription rate for molecular diagnostics, thereby boosting the market's growth.

Global Molecular Diagnostics Market: Regional Insights

Geographically, the global molecular diagnostics market is categorized into North America, Europe, the Asia-Pacific, the Middle East & Africa, and Latin America. North America dominates the global molecular diagnostics market out of all the continents. The highly integrated healthcare system in the United States and Canada, the existence of several major global clinical laboratories, and convenient access to technically sophisticated instruments contribute to the growth of the North American molecular diagnostics industry. Additionally, the global molecular diagnostics market in the Asia Pacific is also catching up as a result of governments' efforts to raise awareness about early disease detection and daily health check-ups, especially in India as the country is currently experiencing the world’s worst COVID-19 outbreak. Also, there has been a steady rise in healthcare spending, as well as an increase in the number of hospitals and diagnostic laboratories in India and China, which will drive the growth of the market during the forecast period.

Competitive Landscape

The high growth potential of the molecular diagnostics market has drawn a slew of new entrants, creating a lucrative opportunity. The emergence of new entrants has resulted in healthier competition among long-established service providers in the industry.

Some of the key players include Bio-Rad Laboratories, Abbott, Agilent Technologies, Johnson & Johnson Services, Inc, Siemens Healthineers AG, Hologic Inc. (Gen-Probe), Danaher, F. Hoffmann-La Roche, Ltd., QIAGEN, Sysmex Corporation, Bayer Healthcare, Genomic Health Inc., and other prominent players. In order to improve their production capability, product portfolio, and provide competitive differentiation, companies are increasingly participating in acquisitions, alliances, and mergers.

Recent Development

·         In April 2021, Resolution Bioscience, a leader in the development and commercialization of NGS (next-generation sequencing)-based precision oncology solutions, was acquired by Agilent Technologies, Inc.

·         In February 2021, Exact Sciences completed the acquisition of Ashion Analytics, LLC[WU1] , order to expand its market presence and global reach.

Market Segmentation

By Product Type

Ø  Instruments

Ø  Reagents

Ø  Others

By Test Location

Ø  Point of Care

Ø  Self-test or Over the Counter

Ø  Central Laboratories

By Technology

Ø  PCR

·         Instruments

·         Reagents

·         Others

Ø  In-Situ Hybridization

·         Instruments

·         Reagents

·         Others

Ø  Isothermal Nucleic Acid Amplification Technology

·         Instruments

·         Reagents

·         Others

Ø  Chips and Microarrays

·         Instruments

·         Reagents

·         Others

Ø  Mass Spectrometry

·          Instruments

·          Reagents

·          Others

Ø  Sequencing

·         Instruments

·         Reagents

·         Others

Ø  Transcription Mediated Amplification

·         Instruments

·         Reagents

·         Others

Ø  Others

·         Instruments

·         Reagents

·         Others

By Application

Ø  Oncology

Ø  Pharmacogenomics

Ø  Genetic Testing

Ø  Cardiovascular Disease

Ø  Neurological Disease

Ø  Microbiology

Ø  Infectious Disease

Ø  Other

By Region

Ø  The Asia-Pacific

Ø  North America

Ø  Europe

Ø  The Middle East & Africa

Ø  Latin America