Molecular Diagnostics Market Growth: Persistence Market Research Projects US$ 85 Bn Valuation by 2032

The global molecular diagnostics in infectious disease testing market is witnessing robust growth as healthcare systems increasingly prioritize rapid, accurate diagnostic tools. Molecular diagnostics has emerged as a critical component in identifying infectious diseases like COVID-19, HIV/AIDS, tuberculosis, and hospital-acquired infections with high sensitivity and specificity.

As of 2024, the global market is valued at US$ 57 billion and is expected to reach approximately US$ 85 billion by 2032, expanding at a CAGR of 4.4% during the forecast period (2022-2032). This growth is propelled by several key drivers, including the rising prevalence of infectious diseases, rapid technological advancements, an aging global population, and expanding point-of-care testing demand.

The polymerase chain reaction (PCR) segment leads the market by product type, contributing over 90% of the revenue share in 2021. PCR remains the gold standard for molecular diagnostics due to its precision and reliability in pathogen detection.

North America continues to dominate the global landscape, driven by well-established healthcare infrastructure, strong government funding for infectious disease control, and the presence of leading molecular diagnostics firms. The U.S., in particular, has set benchmarks in adopting advanced diagnostics technologies and expanding test accessibility across various care settings.

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Key Highlights from the Report

➤ The global molecular diagnostics in infectious disease testing market is projected to reach $85 billion by 2032.
➤ North America dominates the market due to advanced infrastructure and funding.
➤ The PCR segment accounts for the highest revenue share.
➤ Rising demand for point-of-care diagnostics is fueling market expansion.
➤ Strategic partnerships are shaping competitive dynamics.
➤ Innovations in DNA/RNA amplification tech are creating new growth avenues.

How is the Market Segmented by Product, Application, and End-User?

The molecular diagnostics in infectious disease testing market is comprehensively segmented by product type, application, and end-user, helping stakeholders understand niche growth areas and strategic investment zones.

By Product Type

The market is broadly categorized into instruments, reagents and kits, and software and services. Among these, reagents and kits dominate due to their recurring demand in testing workflows. Instruments such as PCR machines, next-generation sequencers, and transcription-mediated amplification (TMA) systems are also seeing increased adoption thanks to technological innovation.

By Application

Applications include respiratory infections, HIV, hepatitis, HPV, and hospital-acquired infections (HAIs). Respiratory infection diagnostics-particularly for SARS-CoV-2 and influenza-have surged post-pandemic. The HIV diagnostics segment remains significant due to global screening programs and widespread use in low-to-middle-income countries.

By End-User

Key end-users include hospital laboratories, reference laboratories, academic institutions, and point-of-care (POC) settings. Hospitals and reference labs lead the market, but POC diagnostics are rapidly growing, particularly in rural or underserved regions where fast turnaround time is critical.

Which Regions Are Leading the Molecular Diagnostics Market and Why?

North America

North America, led by the United States, continues to hold the largest share of the global molecular diagnostics in infectious disease testing market. Key growth factors include government investments in infectious disease prevention, early adoption of diagnostic innovations, and favorable reimbursement policies. The region's high disease burden, especially in aging populations, has also prompted aggressive testing strategies and R&D investments.

Asia-Pacific & Emerging Markets

Meanwhile, the Asia-Pacific region is rapidly evolving into a high-growth market. Countries like China, India, and South Korea are increasing healthcare spending, enhancing laboratory infrastructure, and expanding access to molecular testing. Government programs focused on controlling TB, hepatitis, and drug-resistant infections are major catalysts. Additionally, Latin America and Africa present untapped opportunities with rising awareness and international funding for infectious disease management.

What Factors Are Driving Growth in the Molecular Diagnostics Market?

Market Drivers

Increased Prevalence of Infectious Diseases:
The surge in infectious diseases like COVID-19, HIV, tuberculosis, and emerging zoonotic infections has underscored the importance of early detection. According to the WHO, infectious diseases account for more than 15% of global deaths annually. Molecular diagnostics enables clinicians to identify pathogens rapidly and initiate treatment sooner, reducing complications and transmission.

Technological Innovations:
Tech advancements such as real-time PCR, next-generation sequencing (NGS), CRISPR-based diagnostics, and automated point-of-care platforms are reshaping the market. These tools offer superior accuracy, faster results, and can process multiple samples simultaneously, making them indispensable for pandemic preparedness and outbreak management.

Government Support and Initiatives:
Public health authorities and governments are actively funding molecular diagnostics platforms to strengthen disease surveillance. For instance, the U.S. Department of Health and Human Services (HHS) has allocated substantial resources to enhance pandemic preparedness and diagnostic capacity across federal and private labs.

Market Restraints

High Cost of Equipment and Testing:
Despite the benefits, molecular diagnostics tools are expensive. PCR machines, NGS platforms, and proprietary test kits involve substantial capital and operating expenses, limiting their adoption in resource-limited settings. Furthermore, high per-test costs can be a barrier for uninsured patients or underfunded healthcare systems.

Lack of Skilled Professionals:
The complexity of molecular testing procedures necessitates trained professionals, from sample handling to interpreting results. However, there's a global shortage of skilled lab personnel, particularly in developing nations, hindering the scalability of these technologies.

Regulatory Hurdles:
Stringent regulatory frameworks and time-consuming approval processes can delay product launches. Also, varying standards across countries complicate international expansion strategies for diagnostic manufacturers.

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Market Opportunities

Rising Demand in Emerging Economies:
Emerging economies offer fertile ground for market expansion due to rising healthcare spending, increasing awareness, and a growing burden of infectious diseases. International collaborations and public-private partnerships are helping establish testing networks and improve access to diagnostics.

Point-of-Care Testing (POCT):
The proliferation of portable and user-friendly molecular diagnostic devices for bedside or remote testing is transforming infectious disease management. POCT reduces diagnosis time, improves treatment outcomes, and is particularly effective in emergency or outbreak situations.

Personalized and Preventive Medicine:
Molecular diagnostics is increasingly being integrated into precision medicine strategies, helping tailor treatments based on a patient's genetic and microbial profile. This shift opens new revenue streams, especially in areas like antimicrobial resistance (AMR) detection and vaccine efficacy monitoring.

Frequently Asked Questions about the Molecular Diagnostics in Infectious Disease Testing Market

➤ How Big is the Molecular Diagnostics in Infectious Disease Testing Market in 2024?
➤ Who are the Key Players in the Global Molecular Diagnostics Market?
➤ What is the Projected Growth Rate of the Molecular Diagnostics Market?
➤ What is the Market Forecast for the Molecular Diagnostics Market through 2032?
➤ Which Region is Estimated to Dominate the Molecular Diagnostics Market during the Forecast Period?

Company Insights: Leading Players in the Molecular Diagnostics Market

✦ Abbott Laboratories
✦ F. Hoffmann-La Roche Ltd.
✦ Thermo Fisher Scientific Inc.
✦ Qiagen N.V.
✦ Becton, Dickinson and Company
✦ bioMérieux SA
✦ Luminex Corporation (Now part of DiaSorin)
✦ GenMark Diagnostics, Inc.

Recent Developments in the Molecular Diagnostics Market

■ Thermo Fisher Scientific launched a new multiplex molecular test panel targeting respiratory pathogens, including RSV and SARS-CoV-2.
■ Roche Diagnostics partnered with the Indian Council of Medical Research (ICMR) to expand access to molecular testing across rural India.

Conclusion

The global molecular diagnostics in infectious disease testing market was valued at US$ 53 billion in 2021 and is projected to reach US$ 85 billion by 2032, growing at a CAGR of 4.4%. With the PCR segment leading in revenue share, and North America continuing its dominance, the market is well-positioned for significant expansion driven by innovation, rising disease incidence, and growing global awareness of the benefits of early diagnosis.

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