Molecular Diagnostics Market

Market Overview

The global molecular diagnostics market size was valued at USD 39.18 billion in 2022. It is projected to reach USD 60.52 billion by 2031, growing at a CAGR of 4.95% during the forecast period (2023–2031).

The field of molecular diagnosis has become increasingly important in modern clinical laboratories.  The collaboration between the pharmaceutical industry and diagnostic companies to advance the drug testing facility has also contributed to the instrument's prominence. Molecular diagnostics has emerged as a viable method for determining the cause of disease due to the increasing prevalence of chronic illness and the demand for individualized treatment plans. These methods are also helpful for diagnosing genetic disorders by pinpointing the underlying molecular abnormalities. However, the industry is growing because of technological progress, an aging population, and rising demand for genetic testing.

Market Dynamics

Global Molecular Diagnostics Market Drivers

Growing Incidence of Infectious Diseases and Genetic Disorders among the Population

The rising number of people affected by COVID-19 and rising infectious diseases and cancer rates are among the leading forces propelling this market forward. The global spread of these diseases comes with a greater need for reliable diagnostics. Cancer, heart disease, obesity, neurological disorders, and diabetes are just some of the illnesses that are becoming more common among the world's growing elderly population. Demand for diagnostics tools to diagnose a wide range of diseases around the globe is rising, which in turn is projected to fuel the expansion of the market as a whole. The rising prevalence of STIs like HIV and HPV is also anticipated to increase the pool of potential buyers, which will drive the industry forward.

Global Molecular Diagnostics Market Restraint

High Costs of Instruments

Molecular diagnostics have made inroads in the medical field due to the increasing frequency of chronic diseases and the demand for individualized treatments. These are also useful in diagnosing genetic disorders by pinpointing underlying molecular abnormalities. This equipment is extremely costly. There are also the costs of upkeep and insurance, having someone watch over the lab, and paying for general administration. It's important to note that not all health plans will cover the high cost of molecular diagnostics tests. As a result, this will likely slow the expansion of the diagnostics industry in the years ahead. Thus, it is anticipated that the high price of instrumentation will hinder market expansion.

Global Molecular Diagnostics Market Opportunities

Rising Focus on R&D and Growing Funding

The market for molecular diagnostics is expected to expand due to government programs, schemes, or financing activities that support and promote research and development. The National Institutes of Health (NIH) has a $200 million program called Rapid Acceleration of Diagnostics (RADx). This project aimed to speed up the process of creating and distributing COVID-19 testing technology. The market for diagnostics will increase in the coming years since diagnostic testing is crucial to effective infection control. Such funding and government initiatives are likely to contribute to the expansion of the diagnostics sector.

Regional Analysis

The global market is bifurcated into four regions, namely North America, Europe, Asia-Pacific, and LAMEA.

North America Dominates the Global Market

North America molecular diagnostics industry size is expected to grow during the forecast period.  Due to factors such as the continent's high incidence of infectious diseases, its advanced healthcare infrastructure, and the expanding role of diagnostics in diagnosing genetic disorders and detecting cancer, North America is expected to lead the global market for these products. Due to more healthcare spending and higher demand for better healthcare facilities, North America is currently the largest market for diagnostics. The regulatory framework is a significant market restrainer. The potential for patient harm has driven the U.S. Food and Drug Administration's premarketing rules. Due to the growing reliance on diagnostics in life-or-death situations, a highly complex regulatory environment is becoming much more so, and the FDA is taking extra precautions.

Europe is expected to grow during the forecast period. Rising infectious and chronic disease rates fueling increased research and development, which is driving the market forward. Growth is largely fueled by favorable macroeconomic conditions, such as a high standard of living, widespread consumer knowledge of the importance of early diagnosis, and a robust healthcare infrastructure. In the European Union, cardiovascular disorders are a more significant killer than cancer. The exponential rise in COVID-19 cases in Europe has had a devastating effect on the region's economy. Some of the worst-affected European countries are the United Kingdom, Germany, France, and Spain, and the death toll is correspondingly high. The need to screen for any cases of COVID-19 is projected to raise the demand for diagnostic kits in the region. In addition, the rising demand for at-home test kits and other methods of self-diagnosis has a beneficial effect on the diagnostics industry.

Due to the region's expanding healthcare infrastructure, rising disposable incomes, and well-established presence of domestic companies, Asia-Pacific offers a profitable market opportunity for key players operating in the diagnostics market, resulting in the fastest growth rate during the forecast period. The rising prevalence of infectious diseases, the aging population, and the rising adoption and usage of diagnostics all contribute to the region's booming market. Increased spending on customized medicine and the proliferation of hospitals with cutting-edge medical technology to meet the needs of a massive patient population are some factors propelling the industry forward.

Government health spending in Latin America is minor compared to wealthy economies; hence LAMEA is predicted to experience consistent growth. Around 1.1 million new cases and 600,000 deaths from cancer are expected each year in Latin America, according to the American Cancer Society. Market expansion is anticipated because of factors like the widespread availability of national clinical labs and cutting-edge technological devices. The growth of the diagnostic devices market is forecast to benefit from the efforts of various governments to improve reimbursement policies for these products. Market expansion in Mexico is driven by rising interest in customized treatment and increasing blood screening to detect changes in RNA or DNA in blood malignancies.

Segmental Analysis

The global market is segmented by product & service, technology, application, and end user.

Based on product & service, the global market is bifurcated into reagents and kits, instruments, and software & services.

The reagents and kits segment is the highest contributor to the market and is expected to grow during the forecast period. Due to its widespread use in academic and medical environments, it is anticipated to dominate for the foreseeable future. The expansion is attributable to the wide range of reagents and kits now on the market and the increasing demand from a wide range of therapeutic fields, including infectious diseases and cancer research. Using standard reagents facilitates rapid and precise outcomes. Market expansion is predicted to be supported by the standardization of products, the enhancement of efficiency, and the reduction of costs. Launches of quick kits and reagents for detecting the new coronavirus by various companies are expected to contribute to the expansion of this market. Regional authorities have actively approved emergency usage of these kits.

Based on technology, the global market is bifurcated into PCR, INAAT, DNA sequencing & NGS, in situ hybridization, DNA microarrays, and others.

The PCR segment is the highest contributor to the market and is expected to grow during the forecast period. Increased reliance on molecular diagnostics, especially PCR, for the diagnosis of COVID-19 is a significant factor in the market's current dominance. Technological advances like polymerase chain reaction (PCR) and in situ hybridization (ISH) have mitigated some of the drawbacks of conventional testing, such as lengthy turnaround times, insufficient in vitro kinetic development, challenges in cultivating organisms in manually prepared culture media, and inadequate sensitivity. For instance, Seegene is releasing the Allplex SARS-CoV-2 Fast PCR Assay in January 2022. The test may be completed in 60 minutes, making it ideal for large-scale testing.

Based on application, the global market is bifurcated into infectious disease diagnostics, oncology testing, genetic tests, and others.

The infectious disease molecular diagnostics segment is the highest contributor to the market and is expected to grow during the forecast period. Identifying and characterizing the infectious illness agent is the goal of infectious disease diagnostics. The diagnosis may be based merely on the patient's symptoms or may involve additional testing (such as cultivating the infectious agent, microscopy, biochemical screens, and molecular approaches). The presence of genes in the bacterium that confer resistance to particular antimicrobial medications can sometimes be detected through genetic testing. Increased reliance on diagnostics, especially PCR, for the diagnosis of COVID-19 is a significant factor in the market's current dominance.

Based on end-user, the global market is bifurcated into hospitals and academic laboratories, reference laboratories, and others.

The hospitals and academic laboratories segment is the highest contributor to the market and is expected to grow during the forecast period. Government attempts to expand access to essential services, such as molecular diagnostic test reimbursement, are also expected to be a significant driver of the market. As the need for point-of-care (POC) diagnostics grows, so does the demand for innovative diagnostic systems. Companies are developing assays and diagnostic platforms for point-of-care (POC) or near-patient testing. Since most diagnostic procedures are executed in hospitals, this market sector is dominated by hospitals and academic laboratories.

Recent Developments

• August 2022- Roche introduces a new diagnostic test to help researchers better understand the immune response to SARS-CoV-2.

• October 2022- Thermo Fisher Scientific Inc., the world's largest provider of scientific instruments and services, has announced that it has signed a legally binding contract to buy The Binding Site Group.