North America Molecular Diagnostics Market, till 2035: Distribution by Test Type, Type of Offering, Type of Sample, Type of Technology, Therapeutic Area, End User and Geographical Regions - Industry Trends and Forecast 2026-2035

The North America molecular diagnostics market is estimated to grow from USD 6.5 billion in the current year to USD 11.6 billion by 2035 at a CAGR of 5.6% during the forecast period, 2026-2035.

NORTH AMERICA MOLECULAR DIAGNOSTICS MARKET: GROWTH AND TRENDS

Molecular diagnostic tests are designed to identify specific sequences in human genomic samples, including DNA or RNA, to diagnose a specific disease. Additionally, these tests seek to detect single nucleotide polymorphisms, deletions, rearrangements, and insertions within the genetic sequences.

The World Health Organization (WHO) states that there are more than 40,000 in vitro diagnostic products presently in the market. This extensive range of products emphasizes the essential importance of diagnostics in healthcare. It is important to note that more than 70% of healthcare decisions rely on laboratory test results, since they offer critical information that aids in diagnoses, directs treatment options, tracks disease progression, and evaluates responses to therapy. This highlights the crucial importance of laboratory specialists and diagnostic testing in providing precise, prompt, and efficient patient care.

Molecular diagnostic tests are essential for identifying different diseases, tracking healthcare reactions, and forecasting healthcare results. The growth of the North America molecular diagnostics market is largely propelled by the growing incidence of chronic and infectious illnesses, a higher adoption rate of personalized medicine, and innovations in technology, such as point-of-care testing and next-generation sequencing. Considering the advantages provided by these diagnostic solutions for delivering quick results and enhancing patient outcomes, the North America molecular diagnostics market is expected to expand at a robust CAGR throughout the projected period.

Growth Drivers: Strategic Enablers of Market Expansion

The North America molecular diagnostics market is driven by several important factors, including the increasing incidence of chronic and infectious diseases, such as cancer, heart diseases, and diabetes, which require rapid and precise testing techniques including PCR and next-generation sequencing. Innovations in technology, such as point-of-care testing, the integration of AI, and companion diagnostics, along with rising healthcare spending and an older population, further boost demand, especially in the US where millions of laboratory tests are conducted every year. Government initiatives aimed at early detection, personalized medicine, and pandemic preparedness also contribute to significant market growth.

Market Challenges: Critical Barriers Impeding Progress

The North America molecular diagnostics market encounters several challenges, including the high expenses associated with advanced diagnostic instruments, reagents, and tests, which hinder adoption particularly in smaller laboratories or underserved areas. Further, regulatory challenges are considerable, characterized by complex and rigorous approval procedures that delay market entry and escalate development costs. Furthermore, a lack of skilled laboratory professionals trained in molecular methodologies and bioinformatics also limits test precision. Additionally, concerns over data privacy related to the handling of genetic information and challenges with integrating electronic health records impede the scalability and comprehensive implementation of molecular diagnostic solutions in healthcare systems.

Polymerase Chain Reaction (PCR): Leading Market Segment

Currently, polymerase chain reaction (PCR) segment captures more than 40% of the overall market share, owing to its accuracy, speed, and widespread application in diagnosing infectious diseases, genetic disorders, and cancer. However, the next generation sequencing segment is likely to grow at a higher CAGR of 7.3% during the forecast period, which is most likely to be driven by its ability to provide comprehensive genomic information and advanced personalized medicine.

Blood, Serum and Plasma: Dominating Market Segment

In terms of sample, the North America molecular diagnostics market is segmented across blood, serum and plasma. Currently, majority (~80%) of the market share is held by blood, serum and plasma. This can be attributed to the fact that blood, serum, and plasma are routinely collected in clinical settings, making them convenient for large-scale testing and continuous monitoring. Further, the urine segment is likely to grow at a higher CAGR (7.1%) during the forecast period.

NORTH AMERICA MOLECULAR DIAGNOSTICS MARKET: KEY SEGMENTS

Test Type

• Laboratory
• Point-of-Care Testing

Type of Offering

• Reagents
• Instruments
• Services

Type of Sample

• Blood, Serum and Plasma
• Urine
• Others

Type of Technology

• PCR
• In situ Hybridization
• Isothermal Nucleic Acid Amplification Technology
• Next Generation Sequencing
• Microarrays
• Mass Spectrometry
• Others

Therapeutic Area

• Cardiovascular Diseases
• Genetic Diseases
• Others

End Users

• Hospitals
• Laboratories
• Others

Geographical Regions

• North America
• US
• Canada

Example Players in the North America Molecular Diagnostics Market

• Abbott
• Agilent Technologies
• BD
• Bio-Rad
• Danaher
• Hologic
• Illumina
• Perkin Elmer
• Thermo Fisher Scientific

KEY QUESTIONS ANSWERED IN THIS REPORT

• How many molecular diagnostic service providers are currently engaged in this market?
• Which are the leading companies in this market?
• Which country dominates the North America molecular diagnostics market?
• What are the key trends observed in the North America molecular diagnostics market?
• What factors are likely to influence the evolution of this market?
• What are the primary challenges faced by molecular diagnostic service providers in North America?
• What is the current and future North America molecular diagnostics market size?
• What is the CAGR of North America molecular diagnostics market?
• How is the current and future market opportunity likely to be distributed across key market segments?

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