Global In Vitro Diagnostic Testing Market Highlights

• COVID-19 Still continuing to workIVD Market increase80 Billions of dollars

Revenue from the COVID-19 test market is estimated at $7.664 billion. Global sales distribution is still favored by laboratories technology accounted for 64%. Nearly 2/3 were molecular, most commonly RT-PCR, and the remaining 36% came from POC testing.

Core segments rebound from negative impact of COVID-19 impact

Lockdown, delayed treatment, and supply chain issues 2020-2022 for all near-term IVD segments negatively impacted by the COVID-19 pandemic. These markets have rebounded and are showing strong growth in 2023.

Multiple testing is no longer limited to the field of respiratory diseases:

In the post-epidemic era, multiple testing helps meet laboratory needs caused by staff shortages, less hands-on time, fewer reagents, and fewer laboratory resources. There has been a surge in respiratory tests involving SARS-CoV-2, influenza A and B, and RSV. Multiplex testing is now moving into other areas, such as differentiating between bacterial and viral microbes, to help doctors prescribe appropriate treatments. For example, Spindiag proprietary microfluidic technology enables Spindiag Rhonda to provide fast, accurate and convenient results for a range of infectious diseases.

The United States as a percentage of world market growth

In the past three years, the global share of the US market has increased by about 2%. COVID-19 is a contributing factor as well as high growth markets such as mass spectrometry, continuous glucose testing and nucleic acid testing.

Mass spectrometry gains power

Mass spectrometry is making progress through the popularization of automated mass spectrometry techniques. MS showed a significant increase of 8.2 percent from 2022 to 2023, and showed no evidence that the pace of predicted 10.4 percent growth in 2023-2028 could slow.

Staff shortage drives more interest in automation

The shortage of personnel in healthcare is a huge problem. The United States alone could face a shortage of 124,000 doctors by 2034. The shortage of personnel is one of the biggest challenges facing the health care system. The problem is complex and not new, but it has gotten worse in the last few years, with lab budgets being cut across the globe and not enough trained technicians to perform tests in current configurations. Automated instruments in the lab are helping to solve this problem.

Quality control supports growth

The 16th edition continues to evaluate the quality of the controls used in supporting immunoassays and molecular IVD. By 2023, the quality control market is estimated to be $1 billion billion, with 68% of the market using immunoassay technology and the rest using molecular technology. Since it does not reflect direct in-vitro diagnostic test revenue, this figure is not included in the total IVD market, but it is very important for advancing technology and testing.

The problem of sepsis remains highly regarded

Sepsis remains a growing problem and will only increase the focus on the care of infected patients. Early detection is crucial for patients. About 1.7 million people in the United States develop sepsis each year, and there is no gold standard for clinical diagnosis. Procalcitonin (PCT) and lactate are two established biomarkers of sepsis, but there are limitations. Culture is the standard method for sepsis diagnosis; however, there is a delay in diagnosis due to the time required for identification. The molecules have high sensitivity, but require a moderate amount of time to produce results and are costly.

Partnerships and Collaboration Overshadow Mergers and Acquisitions

The trend towards IVD in 2023 has shifted towards collaboration and partnerships to advance the technology and development of diagnostic tests. There are still plenty of mergers and acquisitions, but companies choose to merge their technologies to create better diagnostics. Recent examples include:

BioCartis partnered with Eli Lilly to explore the use of the Idylla platform for biomarker testing in NSCLC.

Illumina has a strategic partnership with Pillar Biosciences to commercialize Pillar's oncology portfolio, which can be used on any sequencer Illumina. These assays help identify mutations that lead to tumor growth.

MolBio Diagnostics partnered with startup CrisprBits to launch CRISPR-based POC testing.

Some firms perform better during COVID-19

Companies with a lower stake in the COVID-19 test report better revenue performance in 2023 compared to 2022. Abbott, for example, reported an 11% decline in overall sales in the second quarter of 2023 compared to the previous year, primarily due to a $0.223 billion decline in COVID-19 sales compared to $2.2 billion in the second quarter of 2022, an 89% decline. Exact Sciences reported a 19% increase in total sales in the second quarter of 2023, reflecting an 84% decrease in COVID-19 sales; however, sales in COVID-19 were only $2.1 million compared to $13.8 million in the second quarter of 2022.

• Moderate growth in blood bank testing

Despite the widespread adoption of NAT, about 50% of blood donations in 0.118 billion units are still not tested using NAT technology. Developing and resource-poor countries are among those that have recently begun to explore the use of NAT for advanced blood screening. The expansion of immunoassays is expected to be parallel to the molecule; growth here is achieved by the introduction of assays that screen for emerging pathogens. These efforts are detailed in Chapter 12.

Long-term bullish part

The following trends will tell us what the future IVD market size will reach for each segment.

Chinese market

The past few years have been a rocky road for China during the pandemic, but the country has survived. Economic activity in China has slowed. The country experienced a COVID-19 comeback early in 2023. However, due to the increase in the elderly population and the high burden of chronic diseases, the IVD market is expected to continue to grow in the foreseeable future.

China is one of the larger and faster growing in vitro diagnostics markets in the world, so it is a target for all major in vitro diagnostics suppliers to make up for some of the revenue lost due to slower growth in developed healthcare markets. Over the past decade, the global industry has seen an increase in activity in China, with companies not only selling IVDs, but also producing and distributing IVDs in China.

Kalorama Information noted at the AACC Summer Conference in July 2023 that the number of Chinese companies participating in the conference appears to have increased, and the IVD activity of Chinese IVD manufacturers has increased, especially in the POC sector.

In 2023, China's IVD market is estimated to be close to $5.9 billion, with an expected annual growth rate of 6.3 percent, reaching $8 billion billion by 2028. Blood glucose monitoring is the main focus area of the Chinese IVD market, accounting for about 18% of the IVD market value.

Readers should note that the impact of COVID-19 on China and the wider Asia-Pacific region is negative in many areas, inhibiting market opportunity and growth. However, some companies reported sporadic increases, including Bio-Mérieux, which reported an increase in equipment sales in China in the first quarter of 2023.

Emerging Market Growth

As detailed in Chapter 3 of this report, emerging markets have risen to some extent. There are not many places in the world where the IVD market will be twice the size of the world IVD market. South Korea is a rare example. With a 51.7 million population and a higher GDP per capita than China and close to Japan, this is a large and growing IVD market and will become one in the near future. The National Health Insurance scheme covers almost all residents for basic patient care services, including diagnostic tests. Similar to Japan, the country has a relatively high incidence of age-related diseases. Kalorama estimate that by 2028, the IVD market in South Korea will be $0.464 billion, with a growth rate of 5.9 percent, reaching nearly $0.617 billion. There is a problem, South Korea is an IVD-focused country with domestic global competitors such as Seegene and SD Biosensor.

A growing number of Southeast Asian countries-including Malaysia, Thailand, Cambodia and Indonesia-now offer basic health insurance to their citizens. This trend has led to a rapid expansion in demand for medical devices, drugs, diagnostic test kits and reagents, favoring Western companies to market their products in the region. These countries will have higher growth than the world market.

By 2023, Mexico's IVD market is worth about $0.743 billion; at a CAGR of 3.6 percent, the market size will reach $86 million 0.8 billion by 2028. Continued acceptance of advanced equipment and growing distribution channels support growth. Areas of strong demand include immunoassays, microbiology and histology/cytology.

Saudi Arabia is another important market-the sales trend of these products will reflect the procedures offered by 557 hospitals, 98,400 physicians and 9,800 clinical laboratories. The Saudi Arabian IVD market is driven by 4.9 million hospitalizations, 18.3 million inpatient days, 5.4 million surgical procedures and 0.188 billion outpatient visits. Health and living standards in Saudi Arabia are excellent. About 85% of the population has ready access to health care providers. Saudi Arabia's diagnostic market, estimated at $0.591 billion in 2023, is expected to grow by 5.9 per cent annually to $0.789 billion by 2028.

Globalization, climate change

Scientists are seeing a shift in the geographic expansion of infectious diseases. Whether climate change is man-made or naturally occurring, infectious disease emerges far more than expected, in unanticipated months and at unexpected levels of intensity. In the case of COVID-19, there is no scientific evidence that weather or climate has an effect on the spread of COVID-19 diseases, or that climate change makes the emergence or spread of COVID-19 more likely. Although climate change has not caused the emergence of COVID-19, it may indirectly make the effects of current or future pandemics worse. This is because it destroys the environmental conditions we need to stay healthy-access to water, clean air, food and shelter-and puts additional pressure on sanitation systems.

COVID-19 can be directly attributed to globalization, world travel, urbanization and population growth. Globalization and urbanization are driving the spread of infectious diseases, but higher temperatures and more extreme weather events are also affecting the scope and intensity of infectious diseases.

Researchers agree that it is difficult to predict the impact of climate bias on disease patterns. In addition, the monitoring plan is underfunded and inconsistent based on emergency needs. In 1999, for example, when West Nile arrived, there was a public outcry over the lapse in mosquito monitoring and a surge in new funding. As the threat receded, people returned to the status quo. Then 20 years later, Zika came along and everyone wondered why we weren't ready for it. So with the increase in monitoring programs and the increase in funding, this is starting again.

Infections transmitted through water, food or vectors such as mosquitoes and ticks are highly sensitive to weather and climatic conditions. As a result, warmer, wetter and more variable conditions brought about by climate change have made it easier to spread diseases such as malaria, dengue fever, chikungunya, yellow fever, Zika virus, West Nile virus and Lyme disease in many parts of the world.

For better preparedness, surveillance needs to be strengthened, as well as communication between hospitals and local health authorities to help improve outbreak preparedness. Pathogens such as Lyme disease or Vibrio parahaemolyticus are on the move. Early warning systems and prevention are key to protecting people.

Clinical laboratories will continue to be important participants in early warning systems through the development of real-time monitoring systems and rapid point-of-care testing, which will inform and make these monitoring systems more powerful.

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