Infectious Disease Molecular Diagnostics Market

Market Overview

The global infectious disease molecular diagnostics market size was valued at USD 35.5 billion in 2022. It is estimated to reach USD 62.58 billion by 2031, growing at a CAGR of 6.5% during the forecast period (2023–2031). Introducing technologically advanced products and the growing prevalence of target diseases boost market growth.

Regarding infectious disorders, molecular diagnostic assays aim to make diagnosing the underlying condition more accurate. It is common practice first to amplify the target, then employ a nucleic acid probe to identify the organism once it has been amplified. These treatments are effective against bacterial, fungal, and parasite infections. The ability to identify particular organisms is where molecular diagnostic technologies shine when studying infectious diseases. For instance, a lymph node might exhibit characteristics typical of cat-scratch disease (CSD), but the pathologist will first want to eliminate any other possibilities.

The combination of traditional laboratory testing with the accuracy of molecular biology has resulted in a revolution in how clinical and public health laboratories explore the human, viral, and microbial genomes, as well as the genes and products they encode. Molecular diagnostic testing lies at the heart of this revolution. Molecular diagnostics are a battery of widely used, powerful, and sensitive techniques to identify biological markers in a genome and proteome. This is accomplished by detecting bacterial genes (using techniques based on PCR) and measuring expressed bacterial infection-specific proteins (using enzyme-linked immunosorbent assay or ELISA).

Market Dynamics

Global Infectious Disease Molecular Diagnostics Market Drivers:

Introduction of Technologically Advanced Products

This industry is predicted to be driven by rapid technical improvements that produce accurate findings, portability, and cost-effectiveness. To get precise and accurate results, businesses are improving their goods. By engaging in R&D projects to produce kits that target developing diseases or by signing agreements with other kit manufacturing businesses, key players are upgrading their selection of testing choices for qPCR devices. Among them is Roche Diagnostics' introduction of the Cobas HPV test assay in the Cobas 4800. Another development is Cepheid's introduction of the Expert assay for tuberculosis testing on its GeneXpert platform.

The global market for molecular diagnostics for infectious diseases is expected to grow due to these developments. Increasing adoption of ELISA and Fluorescence In Situ Hybridization (FISH) technologies is also projected to fuel market expansion throughout the forecast period. Due to the variety of infectious diseases and increasing causative agent resistance, the infectious disease molecular diagnostics test menus cannot afford to be static or shallow.

Growing Prevalence of Target Diseases

The Centers for Disease Control and Prevention (CDC) estimates that hospital-acquired infections in the United States account for 1.7 million illnesses and 99,000 deaths yearly. In addition, the prevalence of hospital-acquired illnesses is projected to rise over the next ten years, according to experts' predictions. This is because the incidence of infectious diseases is expected to continue to rise. As they can provide accurate and quick results, molecular diagnostics are crucial in testing for infectious diseases.

As a result, rising rates of hospital-acquired infections and infectious disorders are expected to be the primary drivers of market growth during the forthcoming forecast period. In addition, the increased prevalence of sexually transmitted infections (STIs), including HIV and HPV, is anticipated to offer the industry a significant boost.

Global Infectious Disease Molecular Diagnostics Market Restraint:

Presence of Ambiguous Regulatory Framework

The pharmaceutical, biotechnology, and medical technology businesses have long faced significant barriers due to the regulatory structure for approvals. The U.S. FDA premarketing recommendations were motivated by the potential for patient damage. Since infectious disease molecular diagnostics are increasingly relied upon for making important medical decisions, the existing complicated regulatory environment forces the FDA to exercise further caution. To guarantee that performance and claims are equal, the FDA routinely conducts post-market investigations of molecular diagnostics. For instance, Companies that don't live up to their claims face severe penalties. Therefore, market development is constrained by the strict rules associated with the approval process for infectious disease molecular diagnostics.

Global Infectious Disease Molecular Diagnostics Market Opportunities:

Expanding Possibilities in Expanding Economies

Growing economies such as India, South Korea, Brazil, and Mexico would offer prospective growth chances in the not-too-distant future for the major players now functioning in the infectious illness diagnostics market. This conclusion may be attributed to several factors, including a high disease prevalence, a large patient population, improved healthcare infrastructure, rising disposable income, and medical tourism in these nations. In addition to the aspects that have already been mentioned, the Asia-Pacific region has developed into a flexible and business-friendly hub due to significantly less stringent rules and data requirements. This is one of the reasons why the region has been recognized. This has been an important factor in the development of the region.

Regional Analysis

North America Dominates the Global Market

Based on region, the global infectious disease molecular diagnostics market is bifurcated into North America, Europe, Asia-Pacific, Latin America, and the Middle East and Africa.

North America is the most significant global Infectious Disease Molecular Diagnostics market shareholder and is estimated to exhibit a CAGR of 15.24% over the forecast period. The rising health consciousness among clients and growing demand for highly nutritious products drive the region's adoption of Infectious Disease Molecular Diagnostics products. People are facing lifestyle disorders due to changes in lifestyle and irregularities in nutrition consumption, which also triggers the demand for Infectious Disease Molecular Diagnostics products. The market is expected to expand during the forecast period due to the growing use of nutritional products to maintain and improve the immune system.

Furthermore, factors such as the increasing popularity of digital solutions and preference for customized diet plans drive the market's growth. Poor dietary choices are one of the key factors for the increasing prevalence of lifestyle diseases in the region. Changing lifestyles and irregularities in the consumption of adequate nutrients also contribute to the surge in lifestyle disorders.

Europe is anticipated to exhibit a CAGR of 13.94% over the forecast period. The expansion of Infectious Disease Molecular Diagnostics in this area is driven by the rising trend of customizing food to achieve a healthier diet, awareness of healthy foods, and promoting health and nutrition. The personalized approach toward health and wellness helps achieve specific goals within a specified time frame. Furthermore, the increasing innovations in customer-facing technologies give customers access to information about customized nutritional solutions. The region's growing popularity of Infectious Disease Molecular Diagnostics has caused a major shift in food consumption patterns. The rising demand for natural foods is also a key factor in the market.

Moreover, market players are constantly working on Infectious Disease Molecular Diagnostics and health products, which will drive the Infectious Disease Molecular Diagnostics market in this region.

Asia-Pacific has emerged as one of the fastest-growing regions in the global market. Consumers' growing health consciousness, a better understanding of proper fitness and health, and an increase in the use of digital healthcare are some of the key growth drivers for the industry. Additionally, the growing acceptance of Infectious Disease Molecular Diagnostics solutions will enable the regional market to grow fastest during the forecast period. Despite the COVID-19 epidemic, the business has expanded as more people choose nutritional items to strengthen their immune systems. Also, the market is expected to maintain growth during the post-pandemic phase.

In Latin America, the Infectious Disease Molecular Diagnostics market is expanding due to the growing prevalence of health disorders, which has increased the adoption of a healthier lifestyle to improve overall health. In addition, changing lifestyle patterns have encouraged consumers to adopt Infectious Disease Molecular Diagnostics solutions. The market has developed as people focus on healthy lifestyles and well-being. The market has also grown due to the increasing use of wholesome food products to improve health.

The Middle East and Africa market has grown significantly due to high consumer preference for a healthy lifestyle and healthier dietary choices. Initially, the regional market had witnessed slow growth due to unperceptive changes in individual approaches to wellness and well-being. Despite the COVID-19 outbreak, the market has witnessed steady growth due to increased consumption of nutritional products to boost the immune system.

Segmental Analysis

The global infectious disease molecular diagnostics market is bifurcated into product, application, technology, and end-user.

Based on the product, the global infectious disease molecular diagnostics market is bifurcated into instruments, reagents, and services. 

The reagents segment dominates the global market and is predicted to exhibit a CAGR of 3.1% during the forecast period. The category of reagents now holds the largest proportion of the market, and it is also the subcategory with the highest growth rate. This is due to the broad application of reagents in research and clinical settings. When producing results, using reagents that are considered to be standard helps to ensure that they are accurate and efficient. It is anticipated that standardized results, improved efficiency, and cost-effectiveness will all contribute to the market's growth. In addition, the production and dissemination of new reagents will play a big role in the market expansion they are driving.

Regarding reagent provision, the three most important businesses in the market are Abbott, BD., and Roche Diagnostics. The key obstacle acting as a brake on the expansion of this industry is, however, the steep prices of the reagents involved with infectious disease molecular diagnostics. Consequently, the cost of FDA-approved tests could run anywhere from ten to eighty dollars in United States currency.

Based on application, the global infectious disease molecular diagnostics market is bifurcated into respiratory diseases, tuberculosis, meningitis, gastrointestinal tract infections, HPV, sexually transmitted infections, sepsis, drug resistance disease, and other infectious disease.

The Sexually transmitted infections segment owns the highest market share and is predicted to exhibit a CAGR of 9.39% over the forecast period. Sexual contact is the transmission mode for sexually transmitted diseases (STDs). Various pathogens, including bacteria, viruses, and parasites, can bring on infections like this. In addition, the prevalence rate of these infectious diseases is considerable; for instance, in the United States, sexually transmitted infections affect about 2.5 million people every year. Chlamydia, gonorrhea, and syphilis are three of the most common sexually transmitted illnesses (STIs). Diagnosing these illnesses can be made easier with the help of some products, such as Roche Diagnostics' Cobas CT/NG, Abbott's Realtime CT/NG Assay, and Hologic's Aptima STIs. In addition, innovative products like the Randox STI assay, which is scheduled to be released in March 2020 and is a multiplex assay that enables the detection of nine different STIs, are projected to drive the demand for complex, unique, and more effective diagnostics in the years to come.

Based on technology, the global infectious disease molecular diagnostics market is divided into polymerase chain reaction (PCR), in situ hybridization, isothermal nucleic acid amplification technology (INAAT), chips and microarrays, mass spectrometry, sequencing, transcription-mediated amplification, and others. 

The polymerase chain reaction (PCR) segment is the most significant contributor to the market and is estimated to exhibit a CAGR of 2.1% over the forecast period. When amplification of DNA is required to perform a molecular diagnosis, PCR is the most established and reliable gold-standard technology. The first and simplest step in any molecular diagnostic study involving genetic material is to run PCR. The increased use of PCR technologies in diagnosing disorders like acquired immunodeficiency syndrome and other conditions is directly influenced by the growth in molecular diagnostic applications in these disciplines.

The terms "quantitative PCR," "reverse transcription PCR," "inverse PCR," "assembly PCR," and "multiplex PCR" are used to describe a few of the methods that fall within the PCR umbrella. Because multiplex PCR has several uses and related advantages over traditional PCR techniques, it has a sizable market share. Market expansion is anticipated to be fuelled by the growing usage of high-throughput PCR technology to identify coronaviruses.

Based on end-users, the global infectious disease molecular diagnostics market is divided into hospitals, clinics, diagnostics laboratories, and research institutes.

The diagnostics laboratories segment is the most significant contributor to the market and is estimated to exhibit a CAGR of 1.4% over the forecast period. The diagnostic laboratories segment holds the largest share of this market due to its significant market penetration and the volume of procedures it performs. An increase in the number of programs started by the government to provide various services, such as funding for diagnostic tests, would be a major factor that drives the market. Another reason that is expected to be a big driver of the market is technological advancement. Detecting microorganisms is one of the many tests now being developed via the cooperative efforts of many healthcare facilities and laboratories.

In addition, a substantial market share can be attributed to many laboratories in developing and emerging nations. This can be explained by the fact that these economies are experiencing economic growth. In addition, the authorities in charge of regulating the industry are formulating plans to implement initiatives to streamline the diagnostic process and expand the number of laboratories offering their services.

Recent Developments

• February 2023- C-CAMP InDx announced InDx 2.0 National Diagnostics Catapult to Scale Up India’s molecular diagnostics capacity for COVID-19 and beyond.
• January 2023- Alveo Technologies and the Government of Barbados collaborated to co-develop advanced molecular disease diagnostics across multiple end markets.