On the occasion of the midterm management plan briefing session, please allow me to say a few words. Next page, please. This is my resume. In 1985, I joined the then TOA Medical Electronics, the current Sysmex. 41 years since this year. During my career, for 11 years, I worked overseas. As you can tell from my CV, I worked in the sales division almost throughout. What I value is the so-called Sangen Shugi, the three reality principle of management by walking around very close to the customers. By working there can be a variety of learnings and insights. This is very important. I value contact points with the customers. Going forward, I would like to continue this practice. Next page, please. Let's reflect on our desired future stat``e.
In 2023, when we developed the Long-Term Corporate Strategy, we created this message, Together for a better healthcare journey. Sysmex business domains include testing, diagnostics, personalized medicine, and treatment. We expanded business domains quite broadly. To do this, we have to expand our business domains, and we have to deepen certain business domains as well. There are changes in the environment internally and externally, and we have to watch our capabilities and timing. We have to keep a good balance between expansion and deepening. I think this is very important. Right now, what Sysmex should do, we have to deepen our business domains. Testing and diagnostics business, we have to deepen so that we can fulfill and master these domains. That's the requirement given to us right now. Let's review Sysmex business performance right now.
If you look at our sales, we made a steady growth because of the following background. Globally, the population is growing, and also healthcare investments are being made, and the size of the market expanded steadily. Sysmex were able to capture the wave of the expansion. To do so, we increased the number of countries and regions with direct sales and services, and we also increased the market share in the respective countries and regions. That's how we were able to secure high growth and high profitability. In the background, Sysmex should be a manufacturer of choice. It should be a brand of choice. We offer products with high reliability, and we have high-performing colleagues who are supporting our company. Based on the funding we gained from high growth and high profitability, we have been able to make investments into new businesses and DX.
On the other hand, there is some delay in getting the returns compared to what we expected. That's the current status Sysmex is facing. Next page, please. Based on this is what I would like to work on. In the new midterm management plan, there are three priorities. Number one, maintaining a strong focus on the diagnostics business. The most important thing for us as a manufacturer is to meet customer expectations, or we should even exceed customers' expectations by offering new products. Furthermore, globally, there are many customers using Sysmex product, and the customer base generated there, and also the precise testing data should be maximized and leveraged so that we can create new value. Number two is to build a more cost-competitive and profitable corporate structure. One of the main source of profits is the diagnostic reagents, and we are hoping to improve the profitability of diagnostic reagents.
From R&D up to customer care, we have a series of value chain. There, we think we can improve the profitability of diagnostic reagents. We think there are many clues to do so. As I said before, we made a lot of investments into DX so we can improve management efficiency and productivity. It is not just for the core system, but our colleagues are now using source code to develop software to improve the productivity. In this way, we would like to leverage DX. My predecessor, Asano, was working on pivoting these businesses here and R&D themes. We will conduct a board review of the business portfolio and R&D themes in the new midterm management plan. The third point is fulfilling our social responsibilities. Recently, there are geopolitical risks and economic security risks.
We need to appropriately manage these risks so that we do not have to stop testing through a stable supply of our products to be delivered to customers around the world. Today, we are explaining our business to our stakeholders, and very sincerely, we would like to explain the details and the contents of our company sincerely to the stakeholders. Here are the aims of the new midterm management plan. The last fiscal year in the new MTMP, FY 2028, is the year to commemorate the 60th anniversary of the founding of Sysmex. So we would like to be a company appropriate to celebrate the 60th anniversary. In a nutshell, we aim to reinforce the strength and earnings power of the diagnostics business. We have the following four measures to do this. Successfully execute the global launch of new product lines, delivering new customer value.
The details will be explained by Iizuka, who will speak after me. This is the most important thing for us as a manufacturer. That is our positioning. Next, we have Sysmex strength. We have customers around the world. We have such a customer base. We have to leverage this customer base to contribute to medical DX. Number three was also mentioned before. Given the global situation and the competition by emerging manufacturers in terms of their costs, we have to reform our corporate structure to sustain a cost base resilient to global volatility and competition, and capable of sustaining stable supply of our products to the customers around the world. By realizing these points, once again, Sysmex can return to a growth trajectory again. Then we can improve profitability and capital efficiency to enhance our corporate value.
So that is the scenario we are considering for the next midterm management plan.
That is all from me. Thank you very much. Iizuka speaking. I would like to talk about the contents of the next midterm management plan. Many of you may know this, but before, we had a three year midterm management plan based on a two year rolling. From the current midterm management plan, we switched to a three year planning. So the next midterm management plan is going to be a three year plan from FY 2026 to FY 2028, the 60th anniversary of Sysmex founding, as Matsui mentioned earlier. Next page. Next page, please. First of all, let me explain the status of the current midterm management plan expected to be achieved. In the hematology field, we have a new product XR-Series with the touch-free concept. Customers around the world are receiving this highly.
As a result, we expected to exceed the midterm management plan targets in the hemostasis field based on the new agreement with Siemens, particularly in the Americas and Europe. We have a direct sales and services system of the equipment and the reagents, and we completed the FDA submission for clearance. We made steady progress in preparation. In the hemostasis business, in Western countries, including the Americas, during the next midterm management plan, we can expect the growth. By destination, particularly in emerging markets, including India, Brazil, and the Middle East.
We have the results expected to be achieved from these regions, and we expected to exceed the midterm management plan targets. In China, government-led medical cost control policies affecting us last fiscal year and the current fiscal year, we are very much behind. Next page, please. Looking back on the past three years, in the first year and the second year, steady progress was made. In the current fiscal year, the third year, partly because we are behind in China, we are not expected to reach our targets. Sales are expected to decline by 10.7%, operating profit margin will be down by 7.6 percentage point. ROE is currently 8.5%, so there is a big variance compared to our plan. In the next midterm management plan, how we are going to make recovery is going to be a key. Next page, please.
Let me now explain our next midterm management plan. Next slide, please. First, regarding the environment, as we have already explained, in developed countries, a declining birth rate and aging populations are making issues such as more advanced healthcare and improving healthcare economics increasingly important social challenges. Meanwhile, in emerging and developing countries, population growth and economic expansion are driving improvements in healthcare infrastructure and medical demand remains very strong. However, it is not the case that everything is progressing smoothly. In emerging countries, challenges such as decentralized healthcare systems, improving access to care, and the shortages of healthcare professionals, despite the population growth, are becoming increasingly evident, just like we see in the developed countries. How we can fill in this shortage for the medical staff has been raised as the social challenge.
At the same time, one of our strengths is that centered on hematology, we serve customers in more than 190 countries, and our sales and service network quality and brand are highly valued, enabling us to maintain strong market share. By combining Sysmex strengths with the latest technologies, including AI, we aim to realize healthcare digital transformation unique to Sysmex, and this will be the central theme of the next midterm plan. Next slide, please. As shown earlier, and as Mr. Matsui mentioned earlier, we have identified four key themes for the next midterm plan. However, in order to execute these initiatives, strengthening human capital shown at the bottom will be essential. With that in mind, let me walk you through the details. Next slide, please. Next slide, please. First is strengthening the competitiveness of the diagnostic business.
During the next midterm period, as shown here, we plan to launch flagship models across each field, including hematology. These next generation flagship models equipped with AI will be deployed not only in the high-end market but also tailored to the needs of mid-range and low-end emerging market segments. We will explain Sysmex AI in more detail later in our technology section. Next slide, please. Next is the hemostasis. As I mentioned earlier, during the next midterm plan, we will expand our hemostasis business, particularly in Europe and the United States. Our target is to achieve a standalone market share of over 10%. Since hemostasis users are largely the same customers as hematology users, we intend to offer Sysmex value in hemostasis as well as to customers already using our hematology systems.
As mentioned earlier, the necessary preparations have been completed during this current midterm plan midterm, and we will now begin full scale sales expansion, and we expect to see a very high growth. Initially, instrument placement will lead the growth, but as installations increase, reagent sales will also expand. That expansion in reagent sales will contribute significantly to improved profitability. Next slide, please. Now, emerging market. We achieved a strong growth during the current midterm, and we intend to maintain this momentum in the next midterm. Our target is to exceed JPY 100 billion in revenue within three years. We will launch strategic products one after another. Emerging markets have challenges different from those in developed countries, and we will introduce products tailored to those needs for the emerging markets. That is how we want to accomplish this target figure.
As we have also practiced during this current midterm, we will also strengthen our direct sales support in these emerging markets as well, depending on the situation in those markets, and we will offer this service in a timely manner as needed. Next slide, please. Now it is China. Currently, there are headwinds due to government-led policies to control healthcare costs. At the same time, the five-year plan was announced the other day. I am sure you have seen it before. The Chinese government is promoting the Healthy China initiative to address aging population. The investment in healthcare will continue, led by the government, so it is not entirely negative. However, along with this medical cost control plan, the impact of new systems and the distributor consolidation is expected to continue to some extent. While monitoring these developments, we will prepare to capture the next phase of the market growth.
We will work on that at the same time. Just like in other developed countries, we will also strengthen direct sales support and also the local production in all the categories. We have already started during this midterm, but we will further reinforce such local production as well. During the next midterm plan, we will show you the sales for China later on, but we expect the environment in China to gradually change. Next slide, please. Next is healthcare digital transformation. Concretizing this digital transformation in healthcare will be a key theme in the next midterm plan. We will advance this through three pillars. First, in the center, the operational excellence. In the future, with a view towards eventually enabling fully automated labs, we will improve safety and labor efficiency in the labs.
The healthcare professionals that was mentioned at the beginning, even including those in our labs, I think this will help address the shortage of such professionals. Next, on the left, intelligent triage. This aims to enhance the quality of results from the current screening tests. The hematology testing is a screening test, but it is a simple and low-cost test, but it is still a screening test. There is a talk about there is a limit in understanding the results for the hematology, and that was mentioned before. We started to see such a limitation in terms of the growth of the market at the same time. This hematology testing is not just for hematology, but such screening testing we offer, if we could combine them with the new digital transformation technologies, we believe we can create even greater clinical value.
That is what we want to concretize in the next midterm, and so we can offer and bring that to all of you. Also on the right-hand side, instead of individual data, using a large scale data. Especially, this is a social issue in an emerging market, which is a public health issue, and we believe we can contribute to resolving the public health issues, and we will have more details in the technical part later on this point. Next slide, please. Such DX, digital transformation, it will also significantly improve our internal processes, not just customer solutions. During this midterm period, we have worked on digital investment, and we have completed them. We will further improve the efficiency of globally standard processes, and we can further improve the productivity of the processes.
In the next midterm period, and there is no doubt the people in AI increasingly will work together. It will be a normal practice for both parties to be there to work together. This will also support controlling the labor cost. Through these initiatives, we aim to generate more than JPY 10 billion in benefits over three years. Next slide, please. In particular, every reagents. Reagents are the core of our earnings. Actually, there is still room to improve profitability in this area. For the past three years, we have made additional investments. Using these investments, we will enhance profitability in reagents furthermore. Also, in hemostasis, by expanding reagents business, we can further improve profitability in hemostasis as well. We will also optimize our supply chain, as mentioned by Matsui. We will take geopolitical and economic security risks into account for further optimization.
In this way, our goal is to improve overall gross margin. As you can see towards the bottom, let us see the product business field mix, also the U.S. tariff situation. We have all these negative factors, but we will try to control these negative factors while increasing positive factors. Next slide, please. Outside the core business, as you see on the slide, we will continue advancing medical robotics, neurology, and regenerative cell therapy. The medical robot business has failed to accomplish the midterm target. But we do see a very strong demand. Even in the next midterm period, we will expand into non-Asian regions such as Europe, also in South America. We want to go global furthermore. There is a very high demand. However, such surgical robots are directly related to patients' lives. Our first priority is, of course, quality and also safety.
Those are our top priorities. We will expand carefully and steadily while paying enough attention to such quality and safety. Neurology and regenerative cell therapy will be explained later in the technology section. Next slide, please. Finally, human capital strategy. As I mentioned earlier, the nature of work will change significantly. Sysmex is a global company, so we aim to be a company where people around the world want to work, or to be a place where employees can realize their dreams and build their careers. This will enable them to perform at their best and ultimately contribute to solving social and healthcare challenges. That is the kind of company we aspire to be. From here on, I would like to talk about the specific management numerical goals. Next page, please. As for net sales, we are targeting JPY 600 billion or more.
Operating profit and operating profit margin, JPY 100 billion or more, and 16.7% or more as our targets. Capital efficiency, ROE, is currently under 10%. At around 8.5%, we would like to target 12% or more. ROIC is now under 10%, but we would like to achieve a target of 10.5% or more. As for efficiency, there are a variety of elements included in here, but in particular, the inventory turnover would be improved so that we can reduce the cash conversion cycle by 10 days. Cash generation capability targets are shown here as well. Next page, please. For your reference, our forecast for the current midterm management plan and the next plan's goals as a comparison by business and field and by destination, you can see the numbers.
By destination, these numbers are in Japanese yen, but on a local currency basis, in the Americas, $1 billion, EUR 1 billion in the EMEA region as our targets. As for the regional mix, as you know, in China, up until a few years ago, China accounted for one-fourth approximately, but in the last year under the current midterm management plan, it is under 15%. How other regions are going to grow is going to be a key. Next page, please. This is about materiality. We have been showing the double materiality from before. This time, we revised our materiality. In particular, creating innovation, that is the second line from the top, is a new theme added, implementation of innovative technologies and creation and protection of intellectual property. We would like to reinforce the diagnostic business and medical DX, which are essential.
That is why we have this now included. I will explain the specific KPIs later on. Next page. Next page, please. Capital allocation. In principle, in the diagnostics, we have the cash, and based on that, where necessary, we would like to use that debt to make investments for our future growth and our shareholder returns. We would like to watch the balance to allocate the capital. As Matsui said, diagnostic business would be reinforced. Business investments and R&D investments will be made. As you can see in the darker blue, a majority of this would be allocated with priority to the diagnostic business.
Also in the new business sectors, we would allocate, but with a certain cap. We are going to control this amount. As for the CapEx, JPY 150 billion is shown here. In principle, we would focus on our CapEx to generate cash. Shareholder returns. In the next midterm management plan, we will continue the progressive dividend policy and maintain 40% dividend payout ratio.
Recently, we had a share buyback. In addition to that, during the next midterm management plan period, we would like to consider this possibility where necessary. Sysmex could be the best owner in a certain deal, then we would consider M&A actively. So we have JPY 150 billion as strategic investments. This is not definitive. This is just the current image. Next page, please. As I mentioned earlier, ROE right now is less than 10%. In order to realize 12% or more, we would like to improve profitability first, and the capital efficiency should also be improved. Where necessary, we would like to utilize financial leverage to realize our ROE target. Next page, please. Shareholder returns. This was already explained earlier. In principle, for the future business growth, we will make investments, and we will make sure of shareholder returns, and the balance is important.
We would watch the situation and take necessary measures. We recently announced the share buyback, and the details are shown on the right-hand side. That is all from me. Thank you very much.
Yoshida from Sysmex is going to start my presentation in the R&D meeting. Earlier, Matsui and Iizuka explained we in R&D and technology development would like to achieve the targets in the next midterm management plan. We have long-term targets under VA 33. We would like to serve as an engine to work on various initiatives continuously, and we would like you to have a better understanding of what we are doing. Next page, please. You know this slide, Together for a Better Healthcare Journey, which is Sysmex's long-term vision. You can see a box in lighter blue, Domain Expansion. As Matsui explained before, we have the diagnostics business as the existing business.
How we can reinforce the diagnostic business and how we can expand our domains by leveraging such strengths, that is going to be a key. Next page, please. We have built our network with our customers and a high market share, and we have medical grade systems and reagents in terms of the quality. How this can spread in the so-called P4 medicine, that is going to be important. As for P4 medicine, in the previous R&D meeting, I explained this point: predictive, preventive, personalized, and participatory. We have to increase our customers on the market. That is one of the keys. We have worked on the existing diagnostics business. How we should proceed going forward will be explained from the next page. Next page, please. As the title shows, Data Readiness for the Realization of P4 Medicine, this is what we are aiming to achieve.
When we say data readiness, Sysmex is offering products. We have provided products, and we will offer these products. What kind of data can be analyzed from those products? How we can create such a situation, that is also an important point. For example, as you can see in the middle of this slide, we have screening data. A variety of information is included. Fukuda will give you an overview of the technology later on. Not just numbers, but the measurement principles will give us analysis which can spread for the prevention, early warning, and treatment of various diseases. We are beginning to see such signs. The data quality and testing standardization, and globally spreading access potential, and system access potential, and metadata are important. We have access to the big data in our business and also the valuable data, which is our strength.
In the next midterm management plan period, in addition to the large scale system such as XR-Series and CN-9000, we have made efforts to increase the quality and the quantity of the data and touch points in emerging markets as well. That is going to be a key in the next midterm management plan. Among our product portfolio, from the screening data, how we can turn this into a product with impact on our treatment, what kind of treatment would be provided? What is going to be the situation? To healthcare professionals, we would like to help their understanding as well as the understanding of the patients. We have been trying a lot of things recently. Amyloid accumulation, or p-tau, have been research trends in the market. How this can be spread as part of the daily testing, that is going to be a key.
iPS products originating from Japan are recently approved. In Japan, R&D for pharmaceuticals in rare diseases should be promoted according to a government policy, and in response, we would like to enrich healthcare. The keys include medical grade quality to be guaranteed in systems, and also the principles to create such systems and the biomarker meaning must be captured. That is going to be a key. As you can see here, motivation for behavior change is important. This is a small immunochemistry equipment which could be utilized in the daily settings. Together with Nippon Life Insurance Company, how we can leverage such data. This can be applied to the design of the insurance system, and in the previous midterm management plan, we discussed those issues. Next page.
We have built technologies and products and the medical grade quality, and we would like to have the compounding from not just generating earnings. The data we can accumulate would generate value in a compound fashion. That is how we would like to leverage data. The data generating systems would hopefully be offered to the customers for their better understanding. In reality, as you can see in number one, expansion of the product portfolio and improvement of measurement performance. Of course, we are going to use AI. This medical grade quality guaranteed equipment and the high-quality data from the analysis. How to interpret such data is important for individual patients. There is a high possibility that we can spread this to each individual patient. Not just in Japan, but globally, the data generated from such equipment can be aggregated for better use.
This is the so-called data platform by region, and we think we can leverage this kind of data. In the data and with the progress of the analysis, the systems and applications and biomarkers will have an accelerated development for new things. In each one of the products, and the data from customers who are using our products, how we can effectively utilize these to our business, that is going to be a key in the midterm management plan. This is going to be one of the driving force to achieve the A33. After my presentation, Fukuda is going to talk about Sysmex product and the new value we can generate because of our medical grade quality. Then Tsujimoto and Iwanaga will talk about the initiatives which can bring market changes in the near future. That's all from me. Thank you very much.
I am Fukuda from the Technology Innovation Division. I will explain how Sysmex aims to drive healthcare DX through data utilization. Next slide, please. This slide shows the value we aim to create through data utilization. We have our strength in our core business, and based on the operational excellence we gain through our core business.
We will further strengthen our touch-free concept, and also support hospital laboratory operations. Leveraging on the strengths we have built in our IVD core business, then we will further enhance the quality of test data generated by each analyzer. Using that data will support prevention and early detection, as well as personalization and even the visualization of population-level trends by using data. In other words, beyond laboratories and hospitals, we aim to provide value to individual healthcare professionals, governments, and communities, and to a much broader range of stakeholders by using the test data. Next slide, please. This is showing the hematology, the CBC testing as an example, and this slide shows Sysmex strengths in healthcare DX. The left side shows Sysmex unique data assets. In hematology, in CBC testing, the cells are detected and laser light is applied, and signals are obtained.
Those signals are then converted into analytical information such as scattergrams. Traditionally, we have delivered this information to clinical settings as test data reports. We'll now evolve this through new platform and new testing principles, and so we'll evolve this testing itself. In other words, we'll enhance both the quantity and quality of information. By combining this with AI analysis, we aim to create new value, a more precise testing, early detection, and contribution to population health. That is the value we intend to deliver. Next slide, please. Let me share a few examples. Refined testing. Next slide, please. This slide shows the value we aim to create in CBC, urinalysis, and hemostasis testing across our core business areas.
As I mentioned, we will roll out new platforms and next-generation instruments across these areas and combine them with AI analysis to improve disease risk assessment, advance abnormality detection algorithms, and enhance the accuracy of cell classification. In the bottom half, this is showing example of the hemostasis testing, and we've already presented this at academic conferences. By using AI to analyze waveform signals unique to hemostasis testing, we can generate new value such as sample quality assessment and disease risk evaluation for clinical practice. Now we are able to accomplish this. Next slide, please. These are the major products planned for release during the new midterm plan period. They're starting with the next-generation hematology products. We plan to offer a wide range of AI-enabled IVD products.
We are steadily bringing the products we have developed to the market during this period and deliver them to customer sites. Also, as I'll mention later, we also plan to release new AI-centered solutions to support laboratory and hospital operations. Next slide, please. This is early warning detection. This is again a conceptual diagram. By making a screening test, one of Sysmex strengths, the IVD testing, even more precise, and combining them with various kinds of medical information through AI, we will basically seamlessly connect to disease panels in areas such as dementia and cardiovascular disease, where Sysmex has strength. For example, in samples from patients with hematologic malignancies, we aim to detect early signs from CBC data and enhanced data, and then guide follow-up testing such as tumor markers and genetic tests. Next slide, please. This is one such example.
In joint research with Juntendo University, we analyzed test data from patients with chronic myeloid leukemia. By applying multivariate analysis and machine learning to internal test data features, we are becoming able to predict treatment response and stratify treatment effectiveness. By adding this new information, we hope to enable more appropriate treatment choices for each patient. Next slide, please. Next, please. We also aim to contribute to public health by visualizing population trends. This is a schematic view of results obtained through clinical evaluation in Pakistan. In Pakistan, we found that two types of anemia common in emerging markets, genetic anemia, beta thalassemia, and iron deficiency anemia related to lifestyle factors, we can potentially be stratified. By analyzing original test signals previously treated as research items in greater depth, this has become possible.
We are also considering introducing this as a solution that contributes to public health in emerging markets. Next slide, please. Finally, support for hospital and laboratory operations. As mentioned earlier, today's clinical settings are facing rising healthcare costs, staff shortage, stronger regulation, and work style reform, among many other challenges. To address these issues, we will use papers, SOPs, standard documents, guidelines, test data, and other forms of data to provide AI-based support. For example, support for handling inquiries, which often interrupt lab works, and support for document creation. In response to ISO 15189 and revisions to medical regulations, laboratories are required to handle a great deal of documentation. We'll provide solutions in these areas as well. This is the cell images, but we'll also address interpretations of images such as cell images and scattergrams, and supporting interpretation, recognition, and linkage to diseases.
Even experienced lab technologists sometimes face difficult cases. By presenting similar images, we are considering new solutions that provide disease-related medical information through image-based reference support.
This is Iwanaga. Let me talk about the liquid biopsy evolution. I want to put my focus on this topic. This is what was explained by Yoshida earlier, right in the middle in red. This is related to providing optimal innovation options. It is positioned as a part of our efforts to acquire new technologies for more precise understanding of patient disease characteristics. Next, please. This slide summarizes Sysmex efforts to advance liquid biopsy technology. For many years, we have worked to measure cells, proteins, and genes in blood components with high precision in order to better understand patient conditions.
We have studied a range of technologies including ultrasensitive quantification, specific detection, multiplexing, functional measurement, and label-free method. Among them, the three highlighted items are particularly relevant to today's presentation. Through these liquid biopsy technologies, we have advanced more precise testing, broader disease coverage, and expansion into early diagnosis and prevention. For example, in oncology, for pancreatic cancer testing, we detect DNA, not in blood, but in gastric lavage fluid using our proprietary artificial nucleic acid technology. This has enabled us to achieve very high accuracy with 80% sensitivity and 100% specificity. At last year's technology briefing, we also introduced a new liquid biopsy approach for cardiovascular disease. In the dementia field, we've also been developing blood testing for Alzheimer's disease. Today, I'll explain this blood test for Alzheimer's disease in more details. Next slide, please. This page shows the progression of blood biomarkers for Alzheimer's disease.
Blood tests in Alzheimer's disease. Look at the amyloid pathology and tau pathology to be tested in patients, which is said to be important according to reports in research. Aβ42/40, p-tau217, p-tau205 reflecting tau pathology more, and MTBR-tau243 in research are drawing a lot of attention as biomarkers. Amyloid disease-modifying therapies are becoming available from MCI to early AD. Treatment is being complemented. Treatments are offered, and biomarker research is also progressing. This shows the development status of therapeutic drugs and blood-based diagnostics. Therapeutic drugs include LEQEMBI and Kisunla, which are now being approved in various countries around the world. As for the blood-based diagnostics, not much progress in the global rollout of Aβ42/40. Fujirebio's p-tau217 and Roche p-tau181 in various regions around the world are beginning to get the regulatory approval. Aβ42/40 from our company is rolled out in Europe, U.S., and Japan.
p-tau217 reagent development is ongoing. At the bottom of this table, you can find APOE gene to diagnose the side effects of AD as a new genetic testing. This is approved in Japan recently. This is to be rolled out in Europe, and application is now in preparation. This shows the status of blood biomarker utilization. This is a report from U.S. commercial labs for your reference. p-tau217 is the biomarker utilized the most. In addition, Aβ42/40 ratio reagents are used in combination as well. As is shown in red bar, ATN profile, amyloid and tau, and neurodegeneration classification is being made to use multiple biomarkers to be measured. That's also being reported. Next page, please. We see progression of therapies. Diagnostics are also being developed. R&D of disease-modifying therapies and utilization blood biomarkers. There are two major directions.
Earlier application of approved amyloid beta-targeting disease-modifying therapies, and lecanemab started such clinical trials. The other is the R&D and clinical trials for tau-targeting disease-modifying therapies. In these two directions, we also would like to develop diagnostics, and we are engaging in R&D activities. In the ongoing clinical trials, blood biomarkers are used to stratify the patients to select the target population. Together with the approval of the therapeutics, diagnostics could also be approved at the same time as a future trend. Next page. Towards staging and stratification of Alzheimer's disease using HISCL, we have multiplex biomarker panels we are preparing for. By using these biomarkers, ATN can be classified appropriately to stratify the target patients appropriately. In the earliest phase, Aβ42/40 will be utilized. The next amyloid deposits will use p-tau217. For tau pathology, p-tau205, MTBR-tau243 could be utilized.
We are conducting R&D. Next page. Blood biomarkers reflecting amyloid pathology is going to be explained. Next page. On the left, you can find our HISCL Aβ42/40 compared against Aβ42/40 performance of other company's products. Amsterdam UMC performed this study. As you can see, HISCL, as you can see with the red solid line, the best performance and the best number was demonstrated in HISCL. Last year, guideline-recommended performance triage test is utilized. Sensitivity should be 90% or higher, and specificity 75% or higher. Aβ42/40 system, our system is the only one that meets this performance criteria. Next page. We are developing HISCL p-tau217 as well. Here as well, Amsterdam UMC verified the performance. Sorry, it may be difficult to see, but you see an enlarged diagram on the right. HISCL p-tau217 Aβ42 ratio showed the best performance, followed by p-tau217.
Compared to other company's products, the performance was superior. Next page, please. As I explained earlier, amyloid beta is an early biomarker in AD, and we are engaging R&D. We have a joint study with Hirosaki University to look at the amyloid status in a healthy cohort. The vertical line shows the amyloid beta 42/40 ratio. Horizontal axis shows the age of the participants. Amyloid beta is going to be positive with below the red dotted line. The blue dots are p-tau217 negative. The yellowish green is p-tau217 positive. As you can see, in the younger population, p-tau217 is negative. In the older population, p-tau217 is positive. So other researchers are reporting the same findings. After Aβ, p-tau217 is going to be positive. So Aβ can be an earlier biomarker, as is suggested by these results. Next page, please.
For amyloid pathology testing, Aβ42/40 and p-tau217 can be combined to proceed with testing from early stage, which can be effective. From the next page, I would like to talk about the tau pathology biomarker research. p-tau205 and MTBR-tau243 as markers on this slide. From tau protein, these biomarkers emerge. Because of the excessive phosphorylation of tau protein, p-tau205 would occur. This is similar to p-tau217 as a molecule. There is a slight difference in the site of the phosphorylation. MTBR-tau243 has the aggregation of tau protein with partial cleavage. The difference in molecular species is shown on the right. Reactivity to amyloid PET and tau PET is different, respectively, according to study reports. Multiple markers can be measured to capture the status of amyloid or tau pathology more accurately. Next page, please. Using HISCL to measure p-tau205, and we are developing such reagents.
Amyloid beta reagents are being developed using the similar strategy. We select the antibody combination with good correlation with mass spectrometry, so there is a good correlation with p-tau205 as well. As you can see on the right, in cerebrospinal fluid and blood, it is possible to distinguish healthy participants and AD patients in the development of reagents. This is MTBR-tau243 performance. Mass spectrometry performance data is not available yet, but MTBR-tau alone showed a response in the reagent. In CSF and blood, we can distinguish healthy participants and AD patients. Last year at CTAD, this was reported and various research institutes and pharmaceutical companies showed their interest. Next page, please. This is my last page. Perspective of technological development for IVD.
Starting with AD from pre-clinical to mid and late stages, we are developing our technologies, and we would like to promote market awareness activities aimed at insurance reimbursement. We would like to leverage these biomarkers, Aβ42/40, MTBR-tau243, our unique strengths. We would like to leverage these markers to demonstrate our presence. We can turn these biomarkers into a panel to measure. That is one differentiation point so that we can promote RUO and early IVD development. As for p-tau217, there is a slight delay, but we would like to have RUO in early FY 2026 and early IVD development. As has been reported before, we would like to combine other markers for other dementia and non-dementia CNS so that we can do blood diagnostics and blood biomarkers. That is all from me. Thank you very much.
I am Tsujimoto from Next-generation Medical Business Development. I would like to talk about initiatives targeting regenerative and cellular medicine. We have three pillars and initiatives we are promoting in the regenerative and cellular medicine business. The first is the development of regenerative medical products. Number two, shown on the right, the automation and manufacturing process. Number three is quality control testing on the left. For these three, they are not just standalone independently, but the knowledge, the know-how, and human network from each are combined as we proceed.
In the business that reflects Sysmex strengths, we would like to leverage Sysmex assets. And contribute to Sysmex IVD business. These are the features. From here on, I would like to talk about these three initiatives. Next page, please. First, regenerative medical product pipeline is going to be explained. Today, in particular, I would like to focus on the top one, inducible inhibitory T-cells. This is in collaboration with AlliedCel, a joint venture we established with JCR Pharmaceuticals, also based in Kobe.
The target indication is living donor liver transplants so that patients can minimize the use of immunosuppressants. That is the indication we are targeting. In the submission for regulatory approval, as you can see in blue, compared to last year's report, there is a slight delay. We had a PMDA consultation meeting recently, based on the results, we developed a plan. Regarding the plan, this is robust compared to before. Next page, please. As for the living donor liver transplant surgeries, in Japan, 400 cases received these surgeries. But in patients, liver engraftment is a challenge even over a long time. As you can see in the left bottom, adverse events are beginning to show up. Next page, please. Based on these results, recently, at Congress, the word minimization is being used to reduce the use of immunosuppressants as much as possible.
Organ rejection should be avoided for sure, and adverse events incidence should also be suppressed as much as possible to keep a good balance. That is going to be necessary for the use of immunosuppressants in patients on organ transplants. On the right you see an image of the balance. We have to keep a balance between the two. That is going to be a future trend. Next page, please. We believe these inducible inhibitory T-cells play a key role in maintaining this balance. So this project is called JB-101. It is produced by mixing lymphocytes from the donor and the patients. When this is administered to the recipient, it induces immune tolerance to the transplanted organ. So as a result, the transplanted organ can be successfully engrafted, as you see at the right bottom. In the future, immune monitoring will become increasingly important.
Therefore, as Sysmex, who are at the forefront of developing these drugs, we aim to develop new IVD diagnostics as well. At the bottom, we also have topics information. So this product belongs to a subset of regulatory T-cells, same as the T-cells that received Nobel Award last year. While this field is being explored globally, we believe we are among the front runners. Next slide, please. This slide explains the current clinical trial status. This is an investigator-initiated clinical trial led by Juntendo University. It has received Sakigake Designation. The patients receiving immunosuppressants are treated with JB-101. Then the immunosuppressants are then gradually reduced. The dose reduction period is 1.5 years, and this is followed by a one-year follow-up. Ten patients were enrolled, and one patient withdrew due to an underlying condition. The remaining nine completed the dose reduction phase.
The six have already completed the follow-up period. The remaining three are expected to complete follow-up period in the second half of fiscal 2026. So should be able to talk more details next year at this meeting. Regarding efficacy, we will refrain from discussing efficacy today, but we believe the results are very promising. So we are currently discussing regulatory strategy with authorities. Next slide, please. Next, I will discuss automation of cell manufacturing. Cell manufacturing is complex and labor-intensive because it handles live cells. However, automation can be introduced, so that way we can standardize quality and improve the labor cost efficiency. As you can see at the right bottom, governments are also supporting this with subsidies, and the market is projected to reach $4 billion as you see on the left.
Next slide, please. We were thinking what we can do in this area for the last several years, and today we want to introduce the concept that we reached, as you see in the blue area. This is what we call as the Modular Cell Manufacturing system. In cell manufacturing, we have culture, also centrifugal features, and they were all offered in a single box. Closed all-in-one systems have become quite common. Instead of having all-in-one systems, we actually take a modular approach. Functions such as culture, quality control, and imaging are modularized. Then these modules can be introduced individually or connected when scaling up. Depending on the small facility or large facility, or it could be a weird shape of the facility, depending on the facility or institution, this allows flexible design for different facilities.
It can serve academia, startups, and pharmaceutical companies. We have that merit. Also cell manufacturing staffs can actually focus their time more on value creation works. I believe that's something we can contribute and provide. Next slide, please. Next is quality control. Quality control is becoming increasingly important in cell therapy. As you see on the right-hand side, unfortunately, we do hear the recent adverse event reports from those patients who received this therapy. There is a growing demand for rapid sterility testing. There has been a guideline already also issued by the authority, and we are trying to accommodate this requirement. Our quality control business is also progressing under such environment. As you can see in this slide, quality control covers raw material inspections, in-process testing, and pre-release testing.
As you can see on this picture, our IVD instruments are basically utilized in many different timings of this process. We've accumulated all these experiences, and not just from domestic businesses, but we do hear inquiries from East Asia, Europe, and the U.S. as well. As you can read at the bottom of the page, some tests used here may also become IVD products. We are conducting feasibility studies for this. Next slide, please. This is the topics of quality control related actions. This is about the rapid sterility testing. It uses the RF-500 flow cytometer. It's quite quick, as you can see on the right-hand side in number one. It can distinguish live and dead microorganisms. That's why we are receiving expectation from the stakeholders.
Although we are still in a development, we were able to accumulate data a lot, and we aim for market launch in FY 2026, although with the limited customers. Next slide, please. Next is a case study from the Megakaryon, our subsidiary. In the middle, it shows the production process of iPS-derived platelets at Megakaryon. On the left, megakaryocytes are expanded, which then produce platelets, and these platelets are released at the end. This is the process. On the right-hand side, we are showing a bag of this product, and we actually brought the actual bag today since this is a good chance opportunity. This is no imitation. It's a real iPS-derived platelets. We call them platelets, and it has a blood in a Japanese character. People might think the platelets could be red, but pure platelets, in fact, appear milky white like this.
This is the pure iPS-derived platelet, and that is being proven. They actually sparkle under light. This also demonstrate high purity platelets. That is what doctors are recognizing them and accepting them. We do have a technology to be able to produce such platelets. Now remaining challenges are cost and speed. Sysmex and Megakaryon are working on them right now, and we are getting good results so far, so we will update when they are ready. In this production process at Megakaryon, I also want to touch on a couple of topics on quality control. Next slide, please. The left is the in-line monitoring system. It automatically samples culture media and analyzes cells. This will take the trouble, and also no contamination issues. We are able to track the conditions of cells.
As you see on the right-hand side, the platelets, the megakaryocytes, the number of cells and functions on them, Excel, FCM, CN-Series are utilized. We are doing development for the sake of Megakaryon. By accumulating all these developments, we are able to showcase these technologies for quality control, and merits and value of such a feature to the customers, to other customers. Next slide. These efforts cannot be completed only by ourselves. We think open innovation is essential for this type of action. We collaborate with many different companies, and we pursue the regenerative medicine technologies, and leveraging Sysmex assets will contribute to our IVD business. This concludes my presentation. Thank you very much.