Diagnostic instruments, test kits, tools, and techniques play essential roles in disease diagnosis and management. Access to accurate and rapid tests that support early detection of disease leads to more cost-effective treatment and better patient outcomes. Advances in artificial intelligence and machine learning algorithms, genomics and molecular diagnostics capabilities, automation systems enabling high-throughput analysis while still ensuring high-quality results, point-of-care testing options, the integration of diagnostics with therapeutics, and other innovations are leading to improved performance, earlier detection and continuous monitoring, more rapid turnaround times, and diagnoses that lead to tailored and more effective treatments. These innovations, along with novel solutions for ensuring patient confidentiality and cybersecurity and demonstrating the value of advanced diagnostics, will address regulatory concerns while providing new, more efficient, and more effective tools and techniques for diagnosing disease.
Need for Simpler, Faster, Cost-Effective, and Accurate Diagnostics
Medical diagnostic tools and technologies are critical to achieving optimal outcomes in the healthcare industry. Whether tests for detection of biomarkers in blood, urine, and other bodily fluids, physical tissue samples (biopsies), or radiological imaging techniques (e.g., X-ray, magnetic resonance imaging (MRI), computer tomography (CT) scanning), such tests are crucial for not only diagnosing medical conditions but monitoring disease progression.
However, traditional testing often requires long wait times for samples to be submitted to a lab and for the results to be transmitted to the doctor and then the patient. Some test methods (e.g., blood and biopsy collection) can be painful, while imaging is often expensive. Analysis of diagnostic results may also be subject to human error, leading to misdiagnoses and delay of treatment.1
These issues were brought to the fore during the COVID-19 pandemic,2 and since that time much effort has been invested in developing diagnostic techniques that are simpler, faster, more cost-effective, and more accurate. New technologies are enabling much earlier detection of disease and identification of genetic data in support of medication selection tailored to the patient, while tools for continuous monitoring of patients enabling better disease management and less invasive methods.3 Digital technologies (e.g., wearables), point-of-care tests, advanced algorithms (artificial intelligence (AI) and machine learning (ML)), lab-on-a-chip and microfluidics tools, and continually expanding genomics capabilities are all key factors driving diagnostic developments.3,4
Overall, the value of the global diagnostic testing market is predicted to expand at a compound annual growth rate (CAGR) of 3% from approximately $208 billion in 2025 to nearly $273 billion by 2034.5 The value of the global in vitro diagnostics market subsegment is estimated to be expanding at a slightly higher CAGR of 4.45% from $81.47 billion in 2024 to $123.45 billion by 2034,6 while the rapid diagnostics market is anticipated to grow at a much stronger CAGR of 9.2% from $22.7 billion in 2023 to $45.9 billion by 2032.7
Major Impacts for Artificial Intelligence and Machine Learning
In addition to benefitting many aspects of drug discovery, development, and manufacturing, the ability of AI and ML to rapidly analyze tremendous quantities of data is enhancing the capability of many diagnostic techniques.8,9 One of the biggest impacts is in the area of image analysis, where software systems leveraging AI and ML are able to evaluate diagnostics images more rapidly and accurately, and in some cases to detect the presence of disease much earlier than is possible using conventional systems.10 These digital pathology systems are also able to identify unique patterns in patients, supporting personalized treatments. They may also enable more targeted therapies. In one example, a study conducted at the University of California-Los Angeles showed that an AI-powdered cancer contouring system was 45 times more accurate at determining the margins of cancerous tissue than conventional imaging.11
ML is also being used to develop models that use real-time patient data to more accurately predict the expected progression of disease in individual patients and support more informed disease management.8,9 Real-time monitoring systems leveraging AI and ML are, meanwhile, allowing for early intervention, often without the need for doctor visits. Continuous glucose monitoring (CGM) systems for diabetes patients enable enhanced glucose control while reducing the need to take blood samples.12
Advanced Imaging
In addition to improving diagnostic imaging with the power of AI and ML, the development of more advanced imaging techniques is helping to improve disease diagnosis and monitoring.1 Even advanced techniques, such as MRI and CT scans, are being improved. Functional MRI (fMRI) and diffusion tensor imaging (DTI) are now used to obtain more information on brain function and diseases of the nervous system. Meanwhile, photoacoustic and optoacoustic imaging involve the use of both ultrasound and light to generate high-resolution images of many types of tissues. Optical coherence tomography (OCT) is another technique for tissue imaging, particularly of the eye and heart. Many methods are also being developed that leverage nanoparticles, quantum dots, and other advanced technologies to achieve higher imaging resolution. In addition, vision transformers (ViTs), which are advanced models for image classification, have been shown to be more accurate than traditional convolutional neural networks (CNNs) when diagnosing diseases such as dermatological conditions.11
Genomic and Molecular Testing
Advances in technology improving medical diagnostic capabilities are not limited to synthetic intelligence systems. Indeed, expanding genetics understanding of and the increasing ability to rapidly determine genomic information are having a tremendous impact in the medical diagnostics sector. Next-generation sequencing (NGS) technologies allow detailed analysis of complex genetic information rapidly and accurately,10 and, as they have evolved, costs for sequencing the human genome have dropped precipitously from billions to less than $1,000 and continue to fall.12 Numerous companies are simultaneously developing software with increasing capabilities with respect to analyzing the vast quantities of genomic data to generate insights useful for understanding disease and identifying optimal treatment solutions.
Advanced genomics are being leveraged in many new ways.8 The biggest impact has been the ability to detect biomarkers in blood samples rather than tissue samples. Unlike traditional biopsies, which typically require some type of surgery, liquid biopsies are noninvasive and allow detection of biomarkers in blood and other bodily fluids, allowing for much earlier disease diagnosis and treatment. They are also more cost-effective and accessible.13 One challenge for developers of these new liquid biopsies is regulatory approval, which many are working to achieve by demonstrating performance in clinical studies.12 Some companies are also conducting health economic evaluations to show the cost savings provided by their new tests to insurers.
Advanced genomics and molecular testing also allow physicians to gain much deeper understanding of the genetic profiles of diseases for individual patients and thus support the development of truly personalized medicines.10 Other advances are enabling more rapid detection of disease. In one example, a new diagnostic test leveraging microfluidics, nanopore technology, and an amplification- and label-free approach was shown to more easily and rapidly detect viruses in hours rather than the days it can take to get results using polymerase chain reaction (PCR)-based methods.11
Wearables
The glucose monitors mentioned earlier are one example of a new category of medical devices — wearables that track various health attributes, including pulse, breathing rate, oxygen levels, heart rhythms, and so on.1,9,10 These devices enable continuous, real-time collection of health data in remote settings, allowing for earlier disease detection and care, monitoring of disease progression, and adjustment of treatment regimens. Key to the development of these technologies are hardware miniaturization, software advances (mobile applications) that allow for easy user interfaces and secure data transmission, and the Internet of Things (IoT). Wearable devices are often combined with telehealth/telemedicine services.
Point-of-Care Testing
Complementary to wearables are point-of-care testing (POCT) solutions that allow for rapid diagnosis in the physician’s office rather than requiring samples be sent to a third-party testing laboratory.1,8 More rapid diagnoses lead to earlier treatments, greater efficiency, and generally better outcomes. Those focused on infectious disease can also help prevent their spread.
In addition, POCT is also often much more cost-effective than traditional testing methods, increasing affordability. Furthermore, these solutions can be implemented in regions of the world with limited healthcare facilities and testing laboratories, increasing access. They initially focused on common illnesses, but the potential benefits are driving interest in the development of options for a broader selection of diseases. POCTs designed for use in the home, meanwhile, fit well with the trend for more active patient participation in their own healthcare journeys.2
Advances enabling the wider use of POCTs include, as is the case with wearables, hardware miniaturization, and programming improvements, as well as genomics, AI/ML, and automation solutions that support easy, rapid analysis of test results at hospitals and clinics. In 2025, the value of the global point-of-care-diagnostics market was estimated to be approximately $64 billion and expanding at a CAGR of nearly 3% to reach close to $83 billion by 2034.14
One interesting that solution researchers at MIT’s Microsystems Technology Laboratories are working to develop is a miniature, portable mass spectrometer for use in the clinic or the home.11 The scientists are working to develop cost-effective components that would allow construction of such an instrument. So far they have 3D-printed mass filters and a low-cost ionizer that potentially can be mass produced and incorporated via robotic assembly into small mass-spectrometers.
Company Activities
The technology advances driving innovation in the diagnostics industry have created opportunities for both established and emerging firms to increase their presence in the market. Well-known companies such as F-Hoffman La-Roche Ltd., Becton Dickinson (BD), Danaher, Thermo Fisher Scientific, Qiagen, Siemens Healthineers, and Agilent Technologies have been joined by startups located around the world. Some focus on developing new diagnostic tests; others on raw materials, such as unique proteins and antibodies; some on automation solutions for implementing high-throughput testing; and others on customized laboratory services.
Selected company activities include:
Danaher in May 2024 announced a collaboration with John Hopkins University to develop diagnostic tests for traumatic brain injury.15
Qiagen announced in June 2024 plans to submit a new test panel for syndromic diagnosis of meningitis in the U.S.15
AstraZeneca and Qiagen announced in August 2024 expansion of their partnership to develop companion diagnostics for chronic diseases beyond oncology.16
Researchers at the University of Chicago's Pritzker School of Molecular Engineering and UCLA's Samueli School of Engineering reported in September 2024 the development of a hybrid biosensor integrating a field-effect transistor with a paper-based analytical cartridge and leveraging AI to achieve highly accurate analysis of cholesterol levels in serum samples.16
BD introduced expanded fingertip blood collection and testing technologies for use in urgent care, physician, and other settings in the United States in December 2024.15
In December 2024, Roche launched the cobas® Mass Spec solution, including the cobas® i 601 analyzer and the first Ionify® reagent pack of four assays for steroid hormones for use in routine laboratories. A total of 60 analytes will eventually be available for testing steroid hormones, vitamin D metabolites, immunosuppressant drugs (ISD), therapeutic drug monitoring (TDM), and drugs of abuse testing (DAT).17
Roche is also investing $50 billion in U.S. diagnostic sites over the next five years and is collaborating with AI-driven pathology technology developer PathAI and numerous other partners to expand its digital pathology open environment.7
Sova Health introduced the Gut Microbiome Test (GMT) and the Food Intolerance Test (FIT) in April 2025 in India.5
SEKISUI Diagnostics announced in May 2025 the launch of a new rapid respiratory syncytial virus (RSV) diagnostic testing tool for use in physicians’ offices.14
Lumos Diagnostics in May 2025 announced that its rapid POCT for distinguishing between bacterial and non-bacterial acute respiratory infections will be covered by Medicare.
The Philips ECG AI Marketplace, a platform of cardiac diagnostic tools from multiple vendors, was launched in July 2025.5
Other companies of note include Mammoth Biosciences, Codix Bio, Talis Biomedical, and Clip Health, which are developing rapid, high-specificity CRISPR-based diagnostics, rapid diagnostic tests for various infectious diseases, diagnostic panels for infectious diseases and women's health, and diagnostic testing solutions run on smartphones, respectively.
Regulatory Challenges Will not Hold Back Diagnostic Innovations
Access to accurate, rapid, tests that support early detection of disease leads to more cost-effective treatment and better patient outcomes. Unfortunately, many diseases exist today that lack any relevant diagnostic tools, and many patients that could benefit from modern diagnostic tests do not have access to them.
Development of cost-effective diagnostics can be challenging, particularly with respect to ensuring patient data privacy and achieving regulatory approval across global markets.13 Uncertainties and lack of harmonization inhibit innovation and widespread introduction of the most advanced diagnostic technologies. Other challenges include limited access to crucial data that can inform advanced diagnostics tools, lack of reliable data connectivity in many parts of the word, and a shortage of qualified, skilled experts and technicians.
The industry is aware of these challenges and the need to find more efficient approval pathways. As importantly, advances in AI and ML algorithms, genomics and molecular diagnostics capabilities, automation systems enabling high-throughput analysis while still ensuring high quality results, point-of-care testing options, the integration of diagnostics with therapeutics, and other innovations are leading to improved performance, earlier detection and continuous monitoring, more rapid turnaround times, and diagnoses that lead to tailored and more effective treatments. These innovations, along with novel solutions for ensuring patient confidentiality and cybersecurity and demonstrating the value of advanced diagnostics, will address regulatory concerns while providing new, more efficient, and more effective tools and techniques for diagnosing disease.
References
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2. “Diagnostic Technology Advancements Driven by the COVID-19 Pandemic.” Meridian Bioscience. Accessed 4 Oct. 2025.
3. Yusef, S, PE Tay, and SY Baik. “The integration of diagnostics and technology: Insights from global healthcare leaders.” Roche. 2 Ap. 2024.
4. “Diagnostic Tools Engineered for Early Detection.” Johns Hopkins Institute for Nanobiotechnology. Accessed 4 Oct. 2025.
5. Diagnostic Testing Market Size, Share, and Trends 2025 to 2030. Precedence Research. 26 Aug. 2025.
6. In Vitro Diagnostics Market 2025 to Gain from AI, POCT and Strategic Investments. Market Insights. 11 Aug. 2025.
7. Rapid Diagnostics Market. GM Insights. 2024.
8. Buxton, Andrew. “What are the 2025 Trends in Diagnostics?” Hartmann Young. 18 Dec. 2024.
9. “8 Medical Technology Trends to Watch in 2025.” AMN Healthcare. 28 Oct. 2024.
10. “How Technological Advancements Are Transforming Medical Diagnostics Today.” Great Lakes Medical Imaging. 3 Apr. 2024.
11. Bowlby, Beatrice. “Recent innovations in diagnostic development.” Biotechniques. 18 Jun. 2024.
12. “Diagnostic industry dynamics in life sciences: Growth, challenges, and key trends.” West Monroe. 24 Apr. 2024.
13. Rodriguez-Manzano, Jesus, et al. “Innovative diagnostic technologies: navigating regulatory frameworks through advances, challenges, and future prospects.” The Lancet Digital Health. 6: e934-e943 (2024).
14. Point-of-Care Diagnostics Market Accelerates with Technological Advancements. Precedence Research. 18 Aug. 2025.
15. Clinical Diagnostics Market Size, Share & Trends Analysis Report By Product (Instrument, Reagent), By Application (Infectious Disease, Oncology), By End Use (Hospitals & Clinics, Diagnostic Laboratory, Home Care Settings), By Region, And Segment Forecasts, 2024 – 2030. Grand View Research. Accessed on 4 Oct. 2025.
16. Global Diagnostic Tests Market Size, Share, and Trends Analysis Report – Industry Overview and Forecast to 2032. Data Bridge Market Research. Feb. 2025.
17. Roche transforms mass spectrometry diagnostics with launch of cobas® Mass Spec solution. Roche. 17 Dec. 2024.
