Strategic Analysis of the Molecular Infectious Disease Testing Market Through 2029

The global Molecular Infectious Disease Testing Market, valued at US$8.49 billion in 2023, is forecasted to grow at a robust CAGR of 13.7%, reaching US$9.37 billion in 2024 and an impressive US$17.78 billion by 2029. Major drivers of market growth include rising burden of infectious diseases and rapid technological advancements in molecular diagnostics. The increased incidence of emerging infectious diseases and antibiotic-resistant infections leads to greater demand for accurate and reliable diagnostics. In addition, there are rapid advances in the efficiency of molecular testing techniques, such as PCR and next-generation sequencing, which have improved diagnostic capabilities. These provide results that are more sensitive and at a faster speed, and allow for the simultaneous identification of multiple pathogens, which becomes vital in handling complex and continually changing infectious disease threats. These are some of the major contributors to the growing market.

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An advancement in multiplex testing which could transform the molecular infectious disease testing market, is the integrated, fully automated multiplex diagnostic platforms. It will combine testing for multiple pathogens in a single reaction with the advantage of full automation, right from sample preparation to result interpretation. The automation of multiplex testing minimizes the chance of human error, enhances throughput, and accelerates the diagnostic process. These are the factors why this technology will thrive in environments of high demand such as hospitals, urgent care centers, and public health labs. The more these systems become user-friendly and affordable, the greater their potential will be to enhance access to multiplex tests in more rapid and comprehensive infectious disease surveillance and management across a range of healthcare settings.

Key Players

Key players in the molecular infectious disease testing market include Danaher (US), F. Hoffmann- La Roche Ltd (Switzerland), bioMérieux (France), Hologic, Inc. (US), Abbott (US), Thermo Fisher Scientific Inc. (US), QIAGEN (Netherlands), Revvity (US), Siemens Healthineers AG (Germany), BD (US), Grifols, S.A. (Spain), DiaSorin S.p.A. (Italy), and Seegene Inc. (South Korea). These companies have a diversified product portfolio and a good geographic presence also. With growing global burden of infectious diseases and increasing need for accurate diagnostics, such players are well-positioned to develop novel diagnostic technologies and further expand their offerings. They expand their market share through subsidiaries across the world based on the strength of their R&D capabilities and diversified product and services portfolios. Their product launches, agreements, acquisitions, and partnerships further enhance their portfolio while expanding the reach of their global business.

DRIVER: Rising financial support for molecular testing

Growing funding for molecular testing is an important growth factor for the molecular infectious disease testing market. Governments, healthcare organizations, and private investors are increasing financial support to advance diagnostic technologies and increase access to molecular testing. Such funding is also driving innovation in technologies such as real-time PCR and next-generation sequencing, which are becoming faster, more accurate, and cheaper. Public health efforts to control infectious disease outbreaks also lead to increasing investments in molecular testing infrastructure. The increased funding is also helping to integrate molecular testing into healthcare systems in low-resource settings, thereby improving global disease control efforts and patient outcomes.

RESTRAINT: Uneven reimbursement policies

Inconsistent reimbursement policies are a major restraint in the molecular infectious disease testing market. Differences in reimbursement rates and criteria between regions and healthcare systems can pose challenges for both providers and patients. Such inconsistencies may delay adoption, limit access to needed diagnostic tests, and increase the financial burden on healthcare providers. The lack of uniformity in policies for reimbursement might also discourage laboratories and healthcare facilities from investing in high-end molecular testing platforms, making them less accessible in routine clinical practice. This inconsistency regarding access and affordability might hamper the widespread use of molecular infectious testing.

 In 2023, PCR dominated the molecular infectious disease testing market by technology segment.

Based on technology, the molecular infectious disease testing market is divided into polymerase chain reaction (PCR), isothermal nucleic acid amplification technology, DNA sequencing & next-generation sequencing (NGS), in situ hybridization, DNA microarrays, and other technologies. The PCR segment dominated the molecular infectious disease testing market in the year 2023, which is primarily attributed to the high sensitivity and reliability of this technique in the detection of various pathogens. Since PCR has been proven as a reliable, sensitive method in diagnostics, it has been widely accepted in molecular infectious disease testing. The availability of well-optimized protocols along with high-quality commercial kits and reagents has made it simpler to use in laboratories. Advancements in the automation of PCR systems further increased its efficiency, and it became the preferred choice for diagnostic labs seeking to deliver fast, accurate results. The increased demand for testing solutions that are accurate and efficient is what drives the dominance of PCR as one of the primary technologies in facing the increasing problems in infectious disease management and detection.

Diagnostic laboratories are the fastest growing end user segment of the molecular infectious disease testing market.

The molecular infectious disease testing market is segmented into diagnostic laboratories, hospitals & clinics, and other end-users, based on end user. Diagnostic laboratories are the most rapidly growing segment among end-users in the molecular infectious disease testing market. Growth of this end user segment can be attributed to enhanced demand for accurate and rapid diagnostic solutions, as the burden of infectious diseases continues to rise globally. With the growing focus on precise pathogen identification, diagnostic labs are increasingly adopting advanced molecular testing methods including PCR, multiplex, and other new assays to identify pathogens quickly. Moreover, increased emphasis on early disease detection, especially because of global health crises, resulted in a high surge in demand for molecular diagnostics that positions diagnostic labs as the fastest growing end user segment in the market.

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The key players operating in this market are Danaher (US), F. Hoffmann-La Roche Ltd (Switzerland), bioMérieux (France), Hologic, Inc. (US), Abbott (US), Thermo Fisher Scientific Inc. (US), QIAGEN (Netherlands), Revvity (US), Siemens Healthineers AG (Germany), BD (US), Grifols, S.A. (Spain), DiaSorin S.p.A. (Italy), and Seegene Inc. (South Korea). The market players have adopted several strategies such as advanced product development, partnerships, expansions, and acquisitions to strengthen their market position. The organic and inorganic strategies have allowed the market players to expand across geographies through the provision of advanced molecular infectious disease tests.

Danaher emerged as the leader in the molecular infectious disease testing market in 2023. Its position as the leader in the market across the US serves as a platform from where it can penetrate more into the developing economies and build its global presence across more geographies. The company is also responsible for innovation in its products to cater to the varied needs of customers worldwide. This has assisted the company in building on its leadership position in the market. Additionally, the company also adopts certain organic growth strategies by launching new products and seeking relevant regulatory clearances. For example, in March 2024, the US FDA cleared the Xpert Xpress GBS test. In November 2022, it launched the Xpert Xpress MVP, a multiplexed PCR test. Such strategic steps have helped the company stay continuously in the lead in the molecular infectious disease testing market.

F. Hoffmann-La Roche Ltd is a significant global player in the molecular infectious disease testing market. Its broad portfolio and presence in all parts of the world have helped it sustain its competitive advantage. Roche has a very good direct and indirect distribution network around the world, which enables it to balance out demand fluctuations in the different markets. Its strategic emphasis on organic as well as inorganic growth strategies makes the company stronger in the marketplace. For example, in September 2024, Roche launched the cobas Respiratory flex test. This is the first test by Roche using Roche's innovative and proprietary TAGS (Temperature-Activated Generation of Signal) technology. This technology identifies as many as 15 pathogens in a single PCR test by using multiplex polymerase chain reaction testing combined with color, temperature, and data processing. All these strategies, coupled with its strong presence in the market, have given Roche further opportunities to enhance its position within the molecular infectious disease testing market.

bioMérieux is a prominent player in the molecular infectious disease testing market. Its robust position in the market is due to extensive distribution networks in America, Europe, the Middle East & Africa, and Asia Pacific. High investment in research & development, coupled with organic growth strategies, also helps bioMérieux strengthen its position in the market. Such initiatives include the launching of products and gaining appropriate regulatory approvals in order to extend its market shares. In December 2024, bioMérieux announced that the company's BIOFIRE FILMARRAY Tropical Fever (TF) Panel has achieved USD FDA Special 510(k) clearance. This new, innovative PCR-based testing solution brings fast and accurate pathogen identification in patients suffering from unexplained fever to clinicians, optimizing the treatment overall.

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