Thank you, Tuukka. Very warmly welcome. As Tuukka here mentioned, it's a beautiful, sunny morning here in Helsinki, and I hope you're enjoying the weather wherever you may be at this time. If I'll start, we have our whole investor relations team present here today. Here you see the Orion executive management board with the eight members. We have presentations here by Satu. She leads the commercial operations. We have a presentation also, of course, by our CFO, Jari Karlson, who most of you are familiar with. Virve Laitinen, who runs the specialty products business, will discuss about the generics business. Obviously the future will be discussed by Christer Nordstedt, who runs our R&D, and he will be joined to the podium by Professor Heikki Joensuu, who runs our oncology therapy area. As said, during the break time, we are all here available.
You will notice all the Orion people who have this oval name tag here. Any thoughts, questions you may have, please pop and state your questions. Okay. As Tuukka said, the agenda, we have first two presentations. We take a short Q&A after the presentations by each one, then we have a little bit longer break, so then there's an opportunity to mingle, state any comments you may have, questions, we'll continue with the two other presentations and then the concluding remarks. As said, the ones who choose to stay here, there's lunch available as well. That's the rundown of the day. Okay. Of course, the main story that we have is the growth story for Orion. Just to remind us what of a company we are, roughly about a EUR 1 billion company last year.
All the numbers that we present here, those are from continuing operation. Some of you may remember that last year Orion decided and did divest Orion Diagnostica, we've cleaned up the numbers from that, and these present only the continuing operations. The company's hallmark has been profitability. We are a company with more than 100 years of history, and of course, being in pharma, given the risk profile of the industry, we need to make a profit as well. Today, we are about 3,100 people in the company, and roughly 700 of those are outside Finland. We invest about, or expense about EUR 100 million in R&D, roughly. That's our own money. Given our business model that we also operate with several partners, of course, then that gets multiplied.
We manufacture our own products only in Finland, that then will be supplemented by several partners who produce products for us, which is very typical in our industry. Nobody manufactures all of their products by themselves. You will always need good partners, but Orion own production takes place only in Finland. Our commercial footprint covers pretty much across the Europe today, including then former CIS countries, most notably, of course, Russia, Ukraine, Kazakhstan, where we are present with our own commercial presence. If you look at the split of the business for the last year, the specialty products, which comprises of the generic prescription products, OTC and biosimilars, and also non-pharma products that are typically sold through a pharmacy channel, that was the biggest business. Came the proprietary business, which is for us the R&D-driven business.
On top of that, we have Animal Health, Fermion, and also contract manufacturing businesses. Out of all the markets, Finland continues to be the largest single country market. Obviously, the large European markets, the U.K., Germany, France, Italy, and Spain, as a totality are larger, but out of the single markets. Of course, also Scandinavia is very important for us. Eastern Europe and CIS countries, because especially our generics business is focused very much there. Today, our exposure to North America, most notably the U.S., is limited due to the patent expiries of our largest products in those markets. The story for the growth, this is something that we came out this early part of this year, put the goal to EUR 1.5 billion.
Here it is good to note that actually this is more of a communication matter because even earlier we've said that our goal is to grow faster than the underlying market. What this implies to, if you do the math, it implies roughly 6.5%, a little bit less than 7% annual growth on a CAGR basis. It's not that we are trying to reach the moon out of the sky. This is growing a little bit faster than the market, but not by the factor or anything. Of course, communicating this both internally and externally, EUR 1.5 billion is a more catchy and easier to communicate than faster than the market. One of the tools how we are now growing to that is to invest in growth.
Those means were given as an example by the divestment of Orion Diagnostica and releasing that capital, which is now available to grow, to fund the growth of the business, and also at the same time continue to maintain the attractive dividend payout. What we said that some of the investments that we have already undertaken, underwritten, one is the phase III trial for the ALS symptomatic treatment that we are running. Typically, we would have run this within a partnership with a company X, but now we are underwriting the entire program by ourselves, taking the risk thereof, and should the trial work out, also, of course, reaping the benefits of that. That investment alone is EUR 60 million over a three-year period of time. We've also initiated a program to augment our own pipeline by in-licensing or acquiring products.
Now in the past months, we've already completed two acquisitions. One is reacquiring the rights to Stalevo in Europe as well as for Comtan product. Our original Parkinson franchise products. We've also put a little bit extra effort in our sales and marketing operation in Germany, the largest market in Europe, especially focusing on Easyhaler. We more than doubled our sales force efforts in Germany in anticipation that we will actually outperform the market. In totality, all of these, for this year, we estimate that we get burdened by about EUR 30 million in our P&L with these investments. That would include, as an example, of writing down the acquisition of Stalevo in a two-year period. It is very conservative bookkeeping that this company has, and I think we are all very proud of that.
If we think how the value gets created by our different lines of businesses, of course, the proprietary products, that is the growth engine for the future, depends on the IPR, on the patents, on the exclusivity that can be created by running clinical trials, and in many jurisdictions, you actually get the rights for those data. We've also decided that actually we will focus more our R&D efforts within the therapy areas that we've chosen, meaning oncology and CNS. Maybe in the past, we were a little bit more opportunistic, but today we are very much focusing in certain niches within these areas. We are by no means shying away from investment in R&D. On the contrary, we have a very strong belief in R&D that will be one of the key drivers for the company.
Also building the competencies that when the opportunity proposes itself that we can acquire something externally, we need to be able, of course, to firstly evaluate that, make a wise decision on that, and then to develop that, place it to the marketplace. Very important. The specialty products have a very important role in our business lines. It has a very strong market position. It has genuinely the scale of economics in certain markets where we operate. We have focused our markets effort there in Scandinavia and certain Eastern European countries, as opposed to the truly global business of our proprietary products. Orion brand, of course, we focus on that. We use that as an umbrella brand for quite a few products. That and then generic business, you need a cost-efficient operating model.
I think we are one of the companies who are, of course, learning every day, not saying that we are world champions there or masters of the universe, but we have been able to balance having the both proprietary nature of business, where you have the longevity, high investment, high risk, huge opportunities, and then the specialty products where you have to have a much leaner operating model. Each opportunity that presents itself is short-lived. You have to have a very fast turnover of products. Animal Health is a very interesting part of our portfolio because that business, as opposed to the human side, it is truly a market pricing. You don't have the intervention by the regulator or the payer, because typically it's a cash business. Either you sell to the companion animal owners or you sell to the farmers who have livestock.
Clearly what we see is especially the companion Animal Health business correlates very well with the growth of the GDP. For our purpose, why that is very interesting is that whatever we develop in R&D, we always see if that opportunity would have utility in the Animal Health side. Irrespective if it advances in the human side to a real product, but then we always look at also opportunities for Animal Health. Actually we squeeze out of those assets the maximum. Fermion, which is the active pharmaceutical ingredient manufacturer or producer. That produces all of our proprietary molecules for our own purposes. On top of that, it actually commands a very high market share globally in certain generic compounds where Fermion has been able to capture that market share by being a very efficient producer.
The drivers that we see in the global megatrend scheme, what drive the business and how they affect us, of course, one is the aging population. The entire northern hemisphere is aging. As our bodies, as they age, we are certain to have mutations. We cannot avoid them. Some of them are mutations that barely have an effect during the lifetime. Some of them develop through carcinomas, and we develop cancer. That is one of the areas where as the bodies get older, we will see more need for oncology treatments. Also, what we see is that certainly the central nervous system was not designed for most of us, unfortunately, to last close to 100 years.
We will have an effect in our central nervous systems, be that movement disorders, be that in the memory side, and often also in pain, and that's where we are active. There's certainly no lack of the business opportunity there. We are all saddled in nations by the high healthcare costs. Orion, luckily, we have also products that shorten the time that the patient needs to spend in an expensive ward, be that in emergency care or other type. We can bring the patients quicker to the productive life or in a lighter care. On top of that, what we have, we have a generic business, which offers quality medicines at the lower cost and thus relieving the resources from something else. Science is making huge advancements.
Over the past 10 to 15 years, we have actually seen more publications in science than during the mankind. The science is taking huge leaps. Unfortunately, there is still a lot to do. There are very few diseases that we can cure. Mostly, we are treating symptoms. That's the best that we can do. But even that is very important because that increases the quality of life for many of our patients. Of course, only the medicines that are taken as prescribed, taken properly, that actually has the efficacy that was intended, including the side effect profile. That's why Orion is involved in quite a few activities, how we will help the patients to adhere to the compliance of the medication, be that different wearables or be that different applications when to administer the prescribed product.
Lastly, of course, today, the sustainability, transparency is very much name of the game. Not only does that mean environment, where Orion has been one of the front runners by making a commitment to reduce our CO2 burden by 75% in the next six years period. We've also reduced dramatically our API, so the active pharmaceutical ingredient content in our wastewater treatment, close to 100%. Also by acting every day in a transparent manner is really what is called for, especially in the pharmaceutical and healthcare industry. When we look at then the opportunities that the business offers, this entire industry, this is one of the largest industries available. If we leave aside the petroleum industry and the real estate, where, of course, the price of the real estate plays a major role, this is a very, very large industry.
The projection is that we are going to see about EUR 1.5 trillion industry over the next couple of years, which mostly is driven by the U.S. U.S. is a very important market, commands a little bit less than 50% of the market share today. When we look at the new products, it is often we see that about 60% of the revenue of the new products actually comes from the U.S. It is not difficult to see that whatever product you have in your pipeline, your first goal is to develop that to the U.S. market, and then the rest will follow. Of course, Europe is our home market. That is an important business for us, and there are several niches. Of course, if you introduce new products, you always have the opportunity to grow.
It's not only at the macro level that you need to look at these markets, but in a more refined markets. For us today in Orion, Japan is an important market. It's a large market. It's a high-priced market until you hit the end of the patent life. The emerging market, despite the fact that they are growing very fast, their current proportion is still limited compared to the more developed world. The growth that we will see over the next period is certainly driven by proprietary products. Of course, we have products that are in-line products today, so we need to maximize those. We need to be successful in commercializing the opportunities that are in our late-stage portfolio.
Also, of course, look for in-licensing opportunities to augment our current business. What we have in our late-stage portfolio are the darolutamide, that will be discussed more by Professor Heikki Joensuu today. We have an ALS program, as I mentioned, in late stage recruiting in phase III, and there are several animal health projects as well. The industry has no obligation to disclose those as the competition does that neither, so we don't do that either for competition reasons. In animal health, of course, apart from the R&D programs, we have a portfolio today that we operate with by ourselves and including our partners. Fermion continues to be an important part of our structure where they are very efficient and compliant in API manufacturing. The specialty products have a very unique role.
Apart from that being the largest business that we have today, and we have to keep hold of that and develop that. It has a very strong cash-generating potential. It has a portfolio that we need to maintain, look after that, continue to develop that portfolio, because the life cycle of many new introductions there are quite limited. We are also evaluating should there be opportunities to enter into some of the new markets, with low-key investments, but yet those could bring us incremental revenue. Of the new markets with low-key investments, but yet those could bring us incremental revenue. Some of the key themes that we've had for the corporate responsibility, of course, the patient comes always first. The patient's safety is extremely important in our industry, and that's why we've seen the regulators are taking very stringent steps also when they audit different companies.
The environment, of course, we are all concerned about the environment, as said, Orion is taking big steps on that. An important element that where we have had a major program over the years is for us internally. Operating in a safe environment and operating safely is a professional manner as well that we are internally focusing on. High ethics and transparency is paramount in healthcare because in most jurisdictions, we actually operate with public money. The public also has a reason and I think the right to understand how the tax money is being spent. A couple building blocks, what we've achieved over the past few years. We have a great responsibility of having also our products in the marketplace, and here's one example of the methotrexate that is used for cancer and some other osteoarthritis applications.
We have about one-third of the global market for that. That means that we need to make the product available for patients. We audit about 200 to 300 partners annually. We are being audited by more than 100 times a year. We get also customer complaints, and here we track that per million events. I said the environment, we take care of that, and I think we are one of the front runners in reduction on our commitment of CO2 emissions. When we do this all in a right manner correctly, the company is profitable, it can generate profit, that the company is known one of the hallmarks that it has a high dividend payout. This is in many of our shareholders, this is an important part of holding Orion stock, that it has an interesting dividend yield.
Here, if we look at the longer period of time, of course, there have been a couple of special events, when there has been a capital distribution, then when the company had its 100th anniversary, we had a special dividend on that, but it's been a growing trend over the past years. Here we also flag our dividend policy, where we stated the floor for dividend payout of EUR 130. How has that then turned out to be a total shareholders return? We have two periods here that we are describing. One is a five-year period when the TSR has been 70%, and compounded growth has been 11% over the years. That has been combined by, of course, the stock price appreciation as well as the dividend return.
When we take a little bit longer perspective here, a 10-year period, the CAGR has been roughly 17%, and about half of that in a stock price appreciation and about half of that in dividend return. Those have been the end result, how you can judge us, which we believe is a very attractive return also to the capital markets in our industry.
Good morning from my part as well. I will continue with some of the themes Timo already started with and also some of the themes already discussed during the questions. I'm not going to go through that much of numbers, but more like the growth themes. I think the title already here very clearly says that while we want to achieve growth, definitely, of course, we want to also make it in such way that we maintain good profitability of the company. Just a reminder, we have not changed our financial targets. They are the same as they have been already for several years. Growing faster than the market, maintaining good profitability with operating profit of at least 25%, strong balance sheet, and also good dividends with, in the longer run, growth in the dividends.
If we look at how we have performed against these financial targets, one can clearly see that the one where we have had some challenges over the last few years is the growth. The profitability, dividends, balance sheet, all of those, we have very well achieved the targets we have set to ourselves. Growth definitely has been a challenge for us and why we are now talking so much about the growth. There are lots of different reasons why growth is important. Of course, one of the key things is that no matter how well you manage your cost structures and your operations, the fact is that if you don't grow in longer run, it's going to be very difficult to maintain the high profitability of the company. Also when you have a larger scale, it helps to carry the overall cost structure.
This is an industry where you have to have a fairly large fixed cost base. Quality, lots of other things demand a lot of money, and the bigger you are, the smaller share these certain fixed type of costs are out of your total income. That, of course, helps in the profitability and helps, of course, in the return of capital employed as well. Larger scale of opportunity, of course, also it creates an opportunity to proceed with higher risk opportunities. Of course, also the bigger you are, the more resources you have to execute some of these growth opportunities. The growth as such helps you to achieve more growth. Then, of course, finally, the fact is that if you are not growing, it becomes increasingly difficult to retain the talented people if you cannot provide them growth opportunities.
That also is a very important aspect. You need growth in order to make sure that you have the right type of skills in the company. As a consequence of this, of course, ultimately the value of the company is driven by the profits and dividends you are paying out. Of course, in short run, also the future expectations of the value in the company are very important driver of the share value. That, of course, requires that you can continuously fund R&D pipeline and build on that to create the future growth opportunities. That's why growth has become so important part of our agenda over the last few years. Maintaining high operating profit margins alone is not enough because that's not sustainable in long run without growth.
We decided, like Timo already explained, make the growth target a little bit more concrete. In reality, this growing faster than the market and this EUR 1.5 billion by 2025, they are actually not that far away from each other, so they pretty much are telling the same story. We have realized both externally and internally that giving a number, it's much more powerful message. It makes this whole target so much more concrete than what it used to be when we were talking about only growth percentages. This gives EUR 500 million is very different than saying that we grow 6% a year. Just a reminder of this slide Timo already went through. These are some of the ongoing actions we have had in the company to achieve the growth. There are many elements.
One, for example, is that we are now spending money to achieve the growth. This year's profitability without this growth initiative probably would be better. Of course, you cannot achieve the long-term growth if you don't invest upfront. Also the sale of Orion Diagnostica was part of this growth story. Reallocation of the resources from the business, which still was a good business, but was not growing that fast and was a little bit of isolated from the core of the company. Now we are working on using those assets we received by these divestments to generate growth in the core business areas. What could be the ways to grow? I think it's good to now say immediately that there is no one individual way of achieving the growth.
That would of course include also very high risk if everything we are doing would be targeted only one way to grow. Like Timo already said, it's clear that the robust, good R&D work, innovative new products, that is probably the number one way how we are trying to achieve the growth. Of course, if darolutamide and the ALS program are complete successes, those alone might take us to very close, at least to this EUR 1.5 billion. At the same time, we of course know that world is not always proceeding as you would like to have, and that's why we also need, at the same time, have different approaches, other ways to achieve growth. Another thing is that many of these are related.
If we really want to achieve growth, it also means that in longer run, we need to find a way to capture larger share of the value of our own innovative products than earlier. As long as we are only taking 20% royalty, it's very difficult to achieve long-term top line growth. At the same time, if you want to get more than 20%, it means that we need to be prepared to fund the R&D programs internally more than we have done maybe in the past. Another thing is also that, of course, achieving this higher share requires that we need to also be prepared to capture probably a little bit larger share geographically of the sales than earlier.
There, of course, U.S. is the key consideration because such a large part of all the new innovative product revenues are coming from the U.S. today, more than half of it, typically. We need to really think about that alternative as well. It's also good to have the own R&D, but of course, it would be also good, especially from the timing perspective, to be able to find also proprietary type of products for our sales organizations from outside. Of course today, especially here in Europe, where we have a presence in almost every country. Again, there is link to these earlier stages that if we have large geographical presence, that probably increases the opportunities for us to in-license good interesting molecules. A lot of these approaches are linked to each other and the timing considerations here are very key.
At the same time, one is to remember that if we want to achieve this EUR 1.5 billion, it also means that we cannot see declines in the other existing legacy businesses. We need to make sure that also they stay viable. Of course, we are trying to grow also the other businesses, even though the main focus from this EUR 500 million growth target probably comes from the proprietary side of the overall business concept. We are willing to make some focused investments, but I think at the same time, it's clear to say that the idea is not that the EUR 500 million growth is going to be achieved by one acquisition or merger. It has to come from utilizing lots of these approaches at the same time, and hopefully we find a way where they actually are supporting each other.
Like explained already earlier, more R&D funding, geographical expansion, more in-licensing opportunities and so forth. That's kind of the big picture of these ideas, which we are currently working through and which hopefully gradually over the next few years, we can step by step tell more and more about. Also one needs to think the ways to fund all this growth. Of course, one obvious way which we already had discussed, for example, with this EUR 30 million investment this year is that you are investing on growth today, which of course means that the profits and the dividends today are not maximized, but more money is spent to achieve growth in longer run. Partnering with big pharma, of course, has been one of the ways Orion has been funding growth initiatives in the past. I will get back to the plusses and minuses of that approach.
Divesting like the Orion Diagnostica divestment, that's one way, of course, to allocate resources to the growth initiatives. Then as an example of what is happening in the world, I put there also this finding new ways of financing. Traditionally you could raise equity or you could get bank debt or something like that, but today the financial markets are evolving and we have been discussing over the years with some parties who are providing kind of a risk type of financing. There are today organizations who are interested in funding R&D programs and accepting the fact that they will lose their money if the program fails. Far, though, it has to be admitted that from the IFRS accounting point of view, it has been very difficult to make these work in such way that they actually would generate the benefits we would like to see.
There are ways like that also today available more than earlier. Finally, of course, it's a reality that we need to make sure that the operations are run in a good way. We make smart allocation decisions, we have a good cost discipline and so forth in order to make sure that from our existing operations, as much as possible of the funding internally can be directed to these growth initiatives. Elements of partnering. That of course has been in the case of Orion, one of the key ways of running our operations for many, many years and Novartis earlier and now Bayer of course are the two prime examples of that. There are lots of elements which actually in both of these cases are all present there. There of course are some differences.
The main difference maybe between this Novartis and Bayer case has been that in case of Bayer, they have paid a major part of the phase III program, while in the case of Novartis, Orion paid the phase III program and was rewarded only after the fact. As a consequence, in the case of Novartis deals, we got roughly one third of the market value. In the case of Bayer, the royalty rate is about 20%. Both have milestone packages. In both cases, Orion has been manufacturing the goods and so forth. If we think of this type of a partnering, of course the big positive is that this partner is carrying the risk and funding the programs. They also have good global presence and strong commercialization capabilities.
Of course, especially taking into account this financial target of high EBIT percentage, of course, this approach generates very high operating profit margins because when you are getting royalties, which is basically almost 100% margin, of course that pushes up the percentages of operating profit. On the other hand, the fact is that like in the case of Bayer, we get 20% only out of the absolute market value of the product. It really limits our growth opportunities. And it also when you are partnering out the molecules, it kind of limits your geographical expansion opportunities because you don't have the assets you could then sell yourself and which you could utilize to build on the next generation products.
There are certain limitations and, of course, ultimately, if you get the whole market value, even though you have to fund the commercialization, assuming that you are capable of selling the product, also the absolute monies you are earning definitely would be larger. The second, coming to the cost side, the biggest cost item in our profit and loss statement is, of course, cost of goods sold. Couple of years ago, I showed the same type of slide about our supply chain growth or improvement initiatives, and this is just kind of an update. I guess the couple of key messages here are that first, in this triangle, you need to make sure that all of these elements are present there. You cannot only cut costs if that has a negative impact on your quality or supply capabilities.
Also, of course, the other way around, especially in the generic side, you need to have competitive cost structure in order to manage in the market. There are no individual single answers to how to improve that. It's a long list of all kinds of actions which we have been taken. Have these been successful? I would like to say yes, they have been. This picture shows that even though our business portfolio has become much more generic over the last five, six years, and also we have had a fairly big hit from the price decreases in some of our key markets, like the reference price products, generics here in Finland, Parkinson's Dexdor. Our overall margin has still been relatively stable throughout all these years.
Of course, it's partly also explained by the fact that the difference between the growth profits in our key business areas are not maybe as large as one would assume. This just illustrates that, of course, the proprietary side is making much higher growth profit, but not that dramatically as one might think. The second largest cost item is the sales general and administrative costs. There couple of years back, I actually had the same slide in the previous capital markets day, and there we were able to show a continuously decreasing trend as a percentage of sales. Now there has been some changes, and those mainly are due to the fact that we have, for example, here in Finland, had the declining sales because of the price preference, but also because we have started to invest for the longer-term future.
That, of course, is most apparent in our European sales operations. As a percentage of sales, the cost of running the European sales operation are now somewhat higher than they were a few years back, but still at lower level than they were five, six years ago. I would like to say that we have a fairly good control on how we run our cost base. At the same time, we have realized that we need to start now investing for the longer-term future. Here, for example, the Easyhaler investments are one way of doing that. Achieving growth, there are, of course, a lot of challenges in different areas, and here are some examples of how we try to manage this risk of targeting for the growth.
Of course, we all know that when the main way to grow is R&D, there are a lot of risks. There are some ways, for example, we need to have broad enough R&D portfolio, but not too broad. I guess that's self-evident. If you rely only on one or two programs, and if those fail, you don't have anything. On the other hand, if you split your resources to large portfolio of programs, you don't have enough resources to manage them. We need to have a very disciplined way of deciding that if we don't believe in a program or if we have better alternatives, that we really make those decisions.
There one example, for example, is now that recently we decided that we will not invest our own money further on the next generation COMT inhibition program, the ODM-104, but rather target our internal resources to the oncology portfolio, where we believe that we can generate more value in long run. Then, of course, partnering has always been a key way of managing this risk as well. Timing, and here I'm especially referring to a little bit this fact that when you are investing for growth, it means that in short run, the profitability probably is not as high as it could be because you need to target and allocate resources to the growth initiatives. Here we have some ways of mitigating.
One way, of course, from the dividend point of view is the fact that when we divested the Orion Diagnostica, we got a lot of retained earnings and also cash, and that was demonstrated already last year when the dividend for last year was more than 100%. We need to take good care of our legacy business areas. They need to continue providing the cash flow and profit during this time frame. The cost discipline needs to be in good place. Also, of course, when we have these growth initiatives, we really need to make certain that they are executed in the right way. Then, of course, ultimately, we need to be open to the markets. For the shareholders or potential shareholders, they need to be aware of what we are doing and why we are doing.
This is like today, it's one way of getting this done. If we think of opportunities, especially beyond our current existing key market areas, there are, of course, a lot of market risks. One way of managing that, of course, is that you enter the markets only when you have the right type of a portfolio available to sell there. If we think back 15, 20 years, we did in year of certain market entries where that probably was not in good enough shape and the outcome was not what we want it to be. We need to be flexible in the partnering. We need to also be flexible in the use of our own resources. Here, for example, using service providers during the startup phase is one way of doing that for you.
No need to recruit immediately large number of Orion people if you enter a new country, but you can utilize contracts with contract sales forces and so forth. Then, of course, you really need to have good enough advanced preparation before you do entries to new areas. Finally, kind of a summary of what I've been discussing here. The idea very much today is that if we want in long run to achieve all of our financial targets, the growth is really the driver also for achieving the other targets. Here are just as a summary, some of the key ways of achieving this growth. Of course, the execution of the R&D pipeline is really key.
Geographical expansion probably is another one, but also in addition to own programs, we really need to look at in-licensing opportunities to complement the portfolio with ideas coming from outside of Orion. Like I said earlier, all these approaches support to some extent each other. It's easier to in-license something if you have a broader territory to offer. The steady development of existing businesses, finally, of course, a good control of the existing operations, whether it's compliance, whether it's a cost of goods structures or any other costs. If those are in place, achieving this good profitability should be quite possible. Of course, also it means that we need to be able to manage the complexity.
As long as we continue having all of these different business areas, we really need to be very good in understanding how to run the total company, and also very disciplined in how we decide to allocate resources to these different areas in the company. If the profitability is good, the balance sheet very likely, especially as long as the main way of growing for us is not planned to be acquisitions. Of course, in addition to good profitability, we also need to make sure that our working capital structures are well managed and the CapEx is used in a wise way. If all of these other three elements are in place, I think it's fairly easy to say that also the dividend stream probably should follow.
Especially now in the coming few years when we are investing for the growth, we also now have available this money from the Orion Diagnostica divestment to do a little bit of balancing of the short-term profitability and then the fact that we try to maintain a steady dividend stream. These were the prepared words from my part. We have a lot of different growth initiatives ongoing and finding the right balance and timing between those is the key.
Well, good morning, everyone. My name is Christer Nordstedt, and I'm the head of R&D here at Orion, and I've been so for two years now. In a couple of minutes, I will be joined here on the podium by my colleague, Professor Heikki Joensuu, who will provide some more insights and in-depth information about our darolutamide molecule. R&D, the key engine for profitable growth. In the foreseeable future, we will have three main strategic goals for R&D. First, of course, to deliver our late-stage portfolio. Also it is very tempting, of course, to move too much of our resources into the late-stage portfolio. What we also need to do is, of course, to build our early portfolio to ensure long-term sustainability in our deliveries of new products to the market.
The third goal that is equally important, I would say, is to maximize the value of the assets that we have. What do I mean by maximizing the value? Of course, identify all these patients that can benefit from our molecules, from our products. We also would like to do the opposite, identify those patients that will not benefit from them and therefore can be avoided to use them when they don't bring any benefits to the patients. Then, of course, as Jari was talking about here earlier, try to take the molecule as far as possible into the development. If we decide to partner it at a certain stage, preferentially do it as late as possible in order to capture as much value as possible for it. Now, in achieving more in R&D, one of our key strategic moves here is, of course, collaborations of various types.
Early on, we see that it's very important to generate collaborations with academic institutions. We are incredibly dependent on science coming out of academia, of course, but also establishing collaborations with smaller biotechs. We are very much aware that Orion R&D represents a very small fraction of the global scientific community, and it's necessary for us to expand and benefit from everything that is going on the globe. Also collaborations with bigger pharmas like, for example, Bayer in the darolutamide project, various hospital institutions like HUS, who's been very important for us over the last years. We also have a more focused R&D now than what we've had in the past. In order to build long-term growth in R&D so we can help patients with their unmet medical needs, we have identified some key actions that we need to do.
We need to increase the number of projects and not just increasing the actual number, because that's very easy to do. We need to increase the number of what we believe is promising projects that actually can deliver this value to the patients. During the first 102 years of our existence, we've been a small molecule company only. We realize, of course, that we also need to expand into other modalities, such as protein drugs and more specifically, monoclonal antibodies. This is something that we actually have established within Orion by now, and I will tell you more about that later on. Building our strength in disease biology, because if you want to address disease and treat it successfully, you of course need to understand the underlying mechanism so you can identify the right targets for your compounds.
Then, of course, build a balanced portfolio with very novel targets that holds a lot of promise, but on the other hand, also carries a lot of risk. That needs to be balanced with more established, or I would call, robust targets. We've seen a lot of changes over the last couple of years, the last two years, I would say, in our organization. What we've done first is that we have restructured it from what I would call a process focus. Earlier on, we were separated into discovery, early development, later development. Now we have instead a structure that is based around the therapy areas that we have. We now have established our in-house capability to discover protein drugs, primarily monoclonal antibodies.
We are also planning on expanding into more, what should I say, exotic and newer modalities that have perhaps not yet arrived, but we're pretty sure that will arrive in the not too distant future. We made several key recruitments, both from here in Finland and people coming from abroad to join us from various parts on the globe. What we also have done is that we have focused our two main R&D sites, Espoo and Turku. Previously, they were essentially each other's mirror images. What we've done now is that we've said that Turku is our center for biotechnology and what we call translational research, which is more basic biology. Our site here in Espoo has taken more focus towards the chemical aspects of medicines, synthetic chemistry, pharmacy and so on, and also clinical development. What are our focus areas here in Orion R&D?
Of course, it was central nervous system medicines that built the modern Orion, and we're still very much committed to it. Oncology is emerging as a very exciting area for us now with darolutamide leading the way. As you may know, oncology is coming out of our previous efforts in endocrinology, and that is something we're going to capitalize on, of course, but we're also going to expand into new aspects of oncology. Respiratory, the Easyhaler franchise. There, we are not working with any new proprietary molecules, but we're trying now to, or want to use this device also for new generic molecules, new for us. Animal health is also a very exciting area. There we use our R&D for our proprietary human molecules to develop new medicine also for primarily companion animals. Then we have Fermion which is our chemical production arm.
What we're doing there is we're developing our active pharmaceutical ingredient for Orion's proprietary products. We're doing generic APIs, but we're also doing some contract development for other pharmaceutical companies. If we take a look at our clinical drug development programs, it looks like this today. I will dig deeper into each and every one of them further on in the presentation. We have our Easyhaler franchise, as I mentioned before, there we're doing the bioequivalence studies for tiotropium. We have the darolutamide phase III programs that Heikki will talk a lot more about later on. We have ODM-109, which is oral formulations of levosimendan, that we want to develop in ALS. ODM-203 and ODM-207 are two oncology programs that we have decided to out-partner, and I will tell you a little more later on why we've made that decision.
Then finally, we have something unusual for Orion. We have ODM-208 and 209, which are two entirely new molecules with a new mode of mechanism that is unique for Orion. Of course, they are chemically different from each other, but they have exactly the same mode of action. What we're doing here is that we're actually progressing two molecules with the same mechanism in parallel in the clinic in patients. I will tell you more about that also later on. We're not restricting our work to do clinical development, of course. We also have several earlier non-clinical project under investigation. That, of course, in order to ensure long-term success in R&D.
If we first take a look at our CNS therapy area, what we have done there is that we have stopped all our work in dementia, because we think we are too far behind there, and we cannot really be competitive in that area. Instead, what we have said is that we want to capitalize on our long experience in neurodegenerative movement disorders. What that means in this case is Parkinson's disease, where we have a very long history, but also amyotrophic lateral sclerosis, ALS, and also chronic pain. Currently, we are primarily working on symptomatic treatments in these areas. Of course, we also would like to expand into what we call disease modifiers. Which means a compound that actually slows down, perhaps even halts the progress of these two diseases.
Even with success in this area, and nothing really exists for that currently, we believe that the need for symptomatic treatment is going to increase dramatically, even after the arrival of such molecules. For the very simple reasons that at least the first and second generations of these will not reverse the process but will slow it down. Which means that, of course, the need for new and better symptomatic treatments will increase quite dramatically. In oncology, we are primarily working with what we call common cancer types, such as those steroid hormone-dependent tumors, such as prostate cancer and estrogen receptor positive breast cancer. We are also interested in expanding into more or rarer forms of cancer. You will hear more about that also later on. We have a new therapeutic area for us, which is rare or orphan diseases.
This is still very small, and we are building it. We are building it quite rapidly. Orphan diseases, that is a group of more than 8,000 disorders, and this number is increasing almost on a daily basis. Of course, we need to focus there as well. What we have said that we would like to do is to focus on a group of genetic conditions called the Finnish heritage diseases. That is a group of 36 different diseases that is especially common in the Finnish population. Since Finland is a very tiny country, we have the majority of these patients, of course, living outside of Finland.
The great thing with doing this type of research in Finland is that the academic expertise, which we absolutely need to collaborate with, you find the vast majority of them here at an arm length here in Helsinki actually, but also in Kuopio and other parts of Finland. We have access to the patients. Of course, there is a lot of commitment among our scientists for this class of diseases. As I said, it is 36 of them. We cannot do all of them. We have decided to focus on a smaller group, primarily in the central nervous system, where we can also see synergies with our CNS therapy area. Balancing an R&D portfolio, that is a very challenging task. You have on the X-axis, the commercial potential of a project, and on the Y-axis you have the probability for technical success.
What you of course want to do at any cost is to avoid the lower left-hand part of this graph here, low commercial potential with low probability of technical success. What you instead want to do is to end up in what we call the sweet spot here, where you have a high probability of technical success and high commercial potential. What usually happens during the progress of a project is that you're starting further down here, in the probability of technical success. By learning more and more about what you're doing, you can increase your chances and end up in the area you would like to be. I think we will hear more of an example of such a project that have evolved into this sweet spot.
I would like to ask my colleague here, Professor Heikki Joensuu to join me here on the podium and tell you more about that.
Thank you, Christer. Now it's my pleasure to talk about darolutamide, something that I consider very exciting. My name is Heikki Joensuu, and I have been working at Orion for about one and a half years. Before that, I was an oncologist working at the Helsinki University Hospital. Also as a professor of oncology at the University of Helsinki. I'm going to talk about darolutamide, but actually, I remember darolutamide from my days at the hospital, where I treated a few patients with prostate cancer with this drug within a clinical trial. As I remember, darolutamide, it was effective, but it was also extremely well tolerated by the patients, so they complained virtually no side effects. I'm very glad that these observations have now been verified in a large randomized trial. Let's move on to darolutamide.
I'm going to talk about some scientific details here. If there's something that is not clear to you, please do not hesitate to ask. I'll try to explain. Darolutamide, it was invented at Orion and developed by scientists working at Orion. Orion partnered darolutamide with Bayer to carry out the late clinical stage of development together with Bayer. Darolutamide is called a second generation anti-androgen. This means that it blocks the signaling of the androgen receptor, that mediates the effects of the male sex hormones in the body. A point that I want to make here is that darolutamide is a unique drug. The other second generation anti-androgens, enzalutamide and apalutamide, have structures with only subtle differences as shown on this diagram. Whereas darolutamide, as you can see, is very different from these two other molecules.
The distinct structure of darolutamide results in properties that may be important to the patient. For example, the data we have suggests that darolutamide has few drug-drug interactions, and this is important for those patients who need to take many medications. Darolutamide concentrations in the central nervous system remain low, which helps keeping the frequency of central nervous system related side effects low. Two large randomized, placebo-controlled, phase III trials with more than 1,000 patients in each are now evaluating darolutamide. The ARAMIS trial and the ARASENS trial. The ARAMIS target population are men with localized prostate cancer that no longer responds to conventional hormonal treatments, and whose blood prostate specific antigen levels increase despite standard treatments. The target population of the ARASENS trial are men who have overt metastasis from prostate cancer detected, for example, by computed tomography, and who have not received conventional hormonal treatments.
We expect to see the, or get the ARASENS trial results in about three years from now. We now already have the first results from the ARAMIS trial. I'll now move on to the main result of this study. Here you can see a survival curve of the primary endpoint in the ARAMIS trial, which was metastasis-free survival. By metastasis-free survival, we mean the time period from the date of randomization to the date of first detection of distant metastasis. As you can see from this graph, darolutamide clearly improved metastasis survival in these patients. The upper curve is darolutamide, and the lower curve is placebo, the control group. You see the space between these curves, and that is measured something we call the hazard ratio. If the hazard ratio is smaller than one, that's good.
When it gets lower than 0.5, that's very, very good. We do not get that kind of hazard ratios with most cancer drugs we actually have in oncology. This is a very good result, showing significant efficacy for darolutamide. The metastasis-free survival improved from 18 months to 40 months with darolutamide, about two years. That's, in my opinion, very significant for the patients. What is even more significant to the patients is, of course, survival. How long will I live if I get this type of prostate cancer that progresses despite conventional hormonal treatments? That's called overall survival. Overall survival means the time from the date of randomization to the date of death, or to the date of last follow-up visit if the patient is still alive. This is the analysis of the overall survival. It also favored the darolutamide group.
The darolutamide curve is running on top of the placebo curve. You can see the P value of 0.045. Traditionally, that is considered as significant by a statistician. All P values that are smaller than 0.05 are considered significant. In this case, we cannot claim statistical significance, because of the design of the study. Overall survival will be analyzed twice and not once, therefore the P value required is smaller than the traditional 0.05. There's a strong trend, as you can see, for better survival, longer survival for patients who receive darolutamide. The second analysis for overall survival is still pending. These results were recently published in the New England Journal of Medicine, which is probably the most highly valued medical journal there is, that accepts only a small fraction of the manuscript offered to the journal for publication.
We suspect that the ARAMIS results were accepted to New England Journal of Medicine due to the substantial efficacy we saw with darolutamide that parallels that of enzalutamide and apalutamide, in particular, due to the excellent safety profile of darolutamide that resembled placebo. The only side effect that occurred in more than 10% of the patients was fatigue, 12% in the darolutamide arm, and 9% in the placebo group. The discontinuation rate was similar in both arms, 9%. As predicted from the preclinical data, there was no increase in central nervous system-related side effects such as dizziness and cognitive disorders. We detected no increase in several other important side effects such as falls or fractures or skin rash. The FDA recently granted a priority review for darolutamide.
This supports our view that darolutamide has properties that will benefit prostate cancer patients, despite enzalutamide and apalutamide already on the market. Taken together, we believe that darolutamide is unique, new agent for the treatment of prostate cancer, which is the most common male cancer in many countries, including Finland, Western Europe, United States, and second only to lung cancer globally. It has a high efficacy and an excellent safety profile. Thank you.
Thank you, Heikki. Now, let's continue with oral levosimendan, or that we call ODM-109, and the ongoing phase III trial in ALS. As you may know, levosimendan is an older Orion compound that is used for cardiac failure. You can ask, of course, why use a cardiac drug for ALS? Well, it's all due to the mode of mechanism of this molecule, because what it's doing is actually through interacting with certain proteins in the muscle fibers, makes the muscle fibers stronger. What happens in ALS is that it's a neurodegenerative process, leading to progressive lack of control of muscles. That in turn leads to paralysis and usually what happens is that the patient dies within three to five years after diagnosis due to respiratory failure.
What we would like to achieve now with this molecule is to increase the strength of those motor units, as they are called, the nerve connected to the muscle fiber that still remain and help the patients, especially with the respiratory function. Now we have an ongoing REFALS phase III trial that we're doing entirely on our own, and it was started almost a year ago from now. It's progressing as planned. What is important to point out also is that this is not only based upon a hypothesis of strengthening the remaining motor units, but we actually have phase II data pointing in that direction. The LEVEL phase II study, where we could show that with the treatment with one to two milligrams of this compound, we could see a significant change in what is called supine slow vital capacity.
Unfortunately, that study was too short to assess changes in overall function of these patients. It strongly points in the direction that this could be beneficial to the patient's respiratory function. Considering the lack of alternative for these patients, we also felt that we were obliged to test these findings in a bigger, more informative study. The objective to demonstrate the benefit on respiratory and overall function in ALS and also to study the safety in the prolonged study in ALS patients. Now, it's phase III, 450 patients randomized 2 to 1. What we're doing is that we're studying it over 48 weeks. Then of course with an optional long-term extension study at the end of these 48 weeks. The primary endpoints here is supine slow vital capacity at 12 weeks. Then we also have these secondary endpoints. It's a global study.
U.S. having 48 of the total of 104 ALS centers. We're also performing this study in numerous other countries as well. As I said, recruitment into this study is going really well. We see very low dropout rates as well. We hope to have the last patient visit in July of next year and the study results during the second half of 2020. I mentioned earlier that I personally am very excited over this what we call CYP11A1 platform. I will tell you a little about why I'm so excited. CYP11A1 is an enzyme that catalyzes the first step in the formation of steroid hormone. It's unique in a way in that there is no redundancy in this system. Meaning that if you inhibit this enzyme, there is no other enzyme that can take over or help.
If you're successful in inhibiting CYP11A1, you will wipe out steroid production completely. This is a mechanism where we seem to be alone, to the best of my knowledge. We're certainly ahead of the pack here. We've been able to show in animal experiments, of course, that indeed the molecule is doing, or the molecules I should say, are doing what they are supposed to be doing, and that is to totally eradicate steroid production in the body. Of course, what you need to do then is that you need to supplement the animals and also the people that you're treating with glucocorticoids and mineralocorticoids, because they are necessary for life for obvious reasons. There are numerous other steroid hormones as well, including testosterone, the male sex hormone, and estrogen.
That is the basis why we believe that we have a mechanism that can work in several types of cancers. Prostate cancer, 1.3 million cases per year, the second most common in males in the world. 70% of all breast cancer, meaning what we call the estrogen receptor positive breast cancer, those that are dependent on estrogen for the growth. There are also some less common cancers, such as endometrial cancer of the uterus, where we have about 0.4 million cases. Adrenal carcinoma, which is very rare. Here in Finland, we have about five cases per year. Still, it's a very important cancer, very severe form. Also some hormone-producing benign tumors. As I said, what we're doing here is that we are progressing two molecules in parallel, or somewhat staggered, in human phase I, II trials.
The reason why we're doing that is not that we have encountered any issues with the first molecule, but simply knowing that small molecule drugs can have surprises. We know that it's usually candidate number 3, 4, or 5 that eventually becomes a product. We have a leading position here, and we want to make sure that we maintain that position, and that's why we decided to do that. In the first trial that started up in March of last year, we're only studying prostate cancer, and these are more severe form of the cancer. It's patients that are progressing in spite of novel hormonal therapy and chemotherapy. Here we are doing the study in Finland, France, and in the U.K. The more recent studies, STACIDES, that open up for patient enrollment in April of this year.
That is what we call a basket trial, because here we're studying not only patients with what I could call treatment-resistant prostate cancer, but also breast cancer patients that have progressed in spite of two or more systemic treatments. I would also like to give you an update on two other oncology molecules, ODM-203 and ODM-207. As I mentioned earlier on in the presentation, these two molecules we have decided to partner with outside companies, and these are ongoing activities. 203 is, as you may know, a tyrosine kinase inhibitor that inhibits fibroblast growth factor and vascular endothelial growth factors. There we have the key phase I to II trial with 84 patients altogether. We have seen some encouraging results. 9% of the patients have responded, and 44 have seen a disease stabilization.
That means that we have a clinical benefit rate of 52%, and also mostly mild side effects. ODM-207 is a BET inhibitor, quite a crowded area. What that is doing is that it indirectly inhibits key oncogenes such as MYC. Also there, we've seen a molecule that has been generally well-tolerated, and we have ongoing partnering activities. As I said earlier in the presentation, we need to focus and focus our resources on these projects that we strongly believe in. Therefore, we have decided to deprioritize these two compounds or these two projects. Easyhaler franchise, that's an important growth area for Orion as well. We are continuing investing in this franchise, of course. What we want to achieve here now is to develop tiotropium for Easyhaler. Tiotropium is, as you may know, used for the treatment of chronic obstructive pulmonary disease.
What we're doing here is the bioequivalent studies that is necessary for its registrations. Of course, here we've been able to benefit from our previous studies with other compounds, and that is helping us to progress this as rapid as possible. We also would like to take our Easyhaler into the 21st century by producing an addition to the device that we call the connected Easyhaler. That is that we would like these Easyhalers to be able to communicate with the patients and with the caregivers. What we're doing here is that we develop an electronic device that will be physically attached to the Easyhaler. This device will communicate with the patient's smartphone, and the smartphone will communicate with the caregivers and the healthcare professionals. By doing that, we hope that we will be able to increase treatment adherence.
We will strengthen the patient-physician relationship and, of course, hopefully also reduce hospitalizations, leading to an overall benefit for the patients' disease control and quality of life. My last slide here, Orion's R&D vision for future success. We believe that we have a company with the brain power and the muscle of a large company, but also the agility of a small biotech. I strongly believe that we have a balanced pipeline that can deliver what we call clinically meaningful differentiation over a prolonged period of time, with lots of exciting things happening now in the immediate and more medium term. We would like to be a preferred partner for other pharma companies, biotechs, and academic institutions. We believe it's absolutely necessary to have the capability to deliver small proprietary molecule drugs, but also new modalities such as biologics.
An increased visibility in the academic community is important for many reasons, including our ability to recruit the best and the brightest from academia, but also to establish exciting collaborations. Of course, we don't only want to be a benefitor of what the global scientific community is producing, but we also want to be a significant contributor to it.
Thank you, Tuukka. Good morning, everybody. It's my great pleasure to share you some of the highlights about the proprietary business and discuss about some market prospect as well. Before I go to the businesses, I like to tell you a few words about the operation. I'm heading the commercial operation, and it is actually two units which were put together six months ago, the sales operation and then the proprietary business. Although the colleagues in the proprietary products, they had done great job there, but now we thought that if we combine these two units, maybe we could find some synergies which we could then utilize for the benefits of Orion. First of all, there is this sales operation.
Which sells specialty products, that means generics, OTC, and biologicals, and then also we sell proprietary products in 26 countries. We have operations in 26 countries. Then outside Europe, as you know, we operate via partners. Then of course the proprietary business and the three sub-businesses, it's an important element of this unit. I will talk about those businesses later. Then the global marketing and brand building, since of course, we create our brands for European level and then also in the future, hopefully for global avenues. Market access and business support, that's also very important part of this operation since all the businesses at Orion are looking for growth. Fermion, animal health, specialty products, and proprietary products.
This unit here serves all of these different businesses to help them to analyze the market and think about the market access, how to do that. That's why it's so important. Talking about these businesses, here, of course, I echo very much what my colleague, Christer, just explained about the R&D and Orion's therapeutic area. Of course, our businesses, they are very much linked there. We are active in the CNS business, and for us, it mainly means Parkinson's disease, ALS, and pain management. In oncology and hospital care, you might remember this was earlier called oncology and critical care, since we have there our critical care product, Simdax and Dexdor.
We are still, of course, looking for critical care, now we want to expand a little bit our focus to cover the whole hospital customer and look for opportunities there which could support our current portfolios and which we could utilize our current hospital sales force. In oncology, of course, the prostate care and other hormonal cancers are in our focus. Easyhaler Business we nowadays call Easyhaler and Respiratory Business, since although this Easyhaler franchise it's so vital and important for us and we expect big growth there in the future. We would like to look for other opportunities, product opportunities also for these respiratory conditions. The beginning of this year, it was kind of a new era for proprietary business. For several years, entacapone family, the Parkinson's disease products, they had been in the number 1 position.
Now it's a new era, the Easyhaler family is our best-sold product line. Of course, there was a great growth last year, these are the MAT March figures. There is the decline in the Parkinson's products as well. Dexdor, which is now facing the generic competition, it was the same level than in 2017. Of course, this year we have been seeing more and more competition in more countries. Simdax, our old warhorse, is still delivering growth, which we are very delighted about. The Precedex is actually the same product than Dexdor that our partners are selling that outside Europe. We are living in the era of Easyhaler. When thinking about the proprietary products and the growth opportunities, what we are having there in the coming five, six years, I would categorize them into 4 different areas.
First of all, we have our existing portfolio. As said, we still have lots of room to grow and improve there in Easyhaler and Simdax especially. There are a bunch of these R&D projects, which Christer shared. Of course, the most prospect we have in darolutamide, both indications there, ODM-109 and tiotropium. There is this list of other compounds as well. It's important that we have a very rich pipeline there as well. In licensing and product acquisition area, our teams are really working very hard to look for new opportunities and going through multiple cases there. Mainly those new ideas or initiatives, they are focusing on these 5 areas, Parkinson's disease, ALS, pain, cancers, and respiratory. I think that there's no pharma company who can do everything by themselves, they are in different kind of collaborations, so is Orion as well.
We have these research collaborations together with companies and universities. That's of course long-term. We are in co-promotion deals with arrangements like with Bayer, for instance. These digital projects which are becoming more and more interesting and important. There we also cooperate with multiple companies in areas where we are otherwise also active. A few words about the CNS business. This is the business, as you know, Orion has been in that many decades already. Aging population is certainly one of the drivers here. CNS consists of many progressive diseases. Unfortunately, usually there is no cure to those diseases. That makes it very challenging area. On the other hand, also very rewarding area, both scientifically and economically said. The Parkinson's disease, it's a progressive nervous system disorder that affects the movement.
There is about seven million Parkinson's disease patients in the world. About 100,000 people die in the Parkinson's disease every year. It is an interesting market, about $3.3 billion, and I truly believe that it is even increasing, the size is increasing due to this aging population, hopefully also through new innovative treatments which companies will develop to the patients. Orion has a very broad knowledge about Parkinson's disease through our Stalevo and Comtan products. We are widely known by the patients, but also the treating doctors. That is something we want to build on. I think that the very good signal of that wish and aim is this repatriation of Stalevo and Comtan from Novartis in Europe. This is the area we want to be also in the future. We definitely look opportunities there.
Our commitment is to expand the current portfolio for Parkinson's disease patients. Medication is, of course, the main thing in treating the Parkinson's disease patient. Also we have to have a holistic view to this patient. There are other areas as well which have a huge impact to quality of life of the PD patients. There is nutrition, sleep, and physical exercise. Our vision is to develop this kind of global solution for these patients, which is personalized and data-driven to manage this Parkinson's disease. It will be device independent. You can combine it to whatever phone or computer or any other gadget. It would collect the real-life data of these Parkinson's disease patients. It would make these visits between the patient and the doctor more efficient when you have the records about what has happened during the last weeks.
Also, that facilitates the connection between the doctor and the patient between the visits. Of course, the ultimate goal here is to increase the daily on time for these Parkinson's disease patients, which is very vital. I move on to ALS, also the disease which Christer here covered very well. Really, this devastating disease is leading to death due to respiratory failure in approximately three to five years. Of course, there are also patients who live longer, but this is kind of the average. It is a market of about 60,000 patients. We are now considering the major market here. It's usually hitting the patients or people over 50 years or so. There is a huge unmet need there since there is no proper cure.
We truly think that if the phase III results are then as what we are expecting, This ODM-109 could be really a solution and at least it could offer a solution to this respiratory function for these ALS patients. This is the size of the ALS market. It is about EUR 330 million market last year, and it is expected to be 4 times bigger in less than 10 years' time. There are a couple of products already on the market, but mainly this market will become bigger due to these new treatments, and one of them hopefully will be ODM-1009. There is currently lots of research activity in this area, there is about 50 molecules under development. Mainly they are in preclinical states and none of them is as advanced level as Orion compound here.
That is good that there is so much activity because the knowledge about this disease, it will increase all the time. That will, of course, benefit all the ALS patients. Really this will be an interesting treatment option for the patients. The results are expected second half of 2020, and we are currently evaluating the commercial structure in the U.S. and Europe. As said many times, this is an orphan drug disease, it means that there is relatively a small amount of patients and then also treating doctors. For instance, if you take U.S., there is about 100 clinics which treat these ALS patients, and then 80% of these clinics are actually located in 22 states. That just gives you a little bit the magnitude about the treating doctors in the U.S.
What is also interesting that these clinics are very much there's overlapping between ALS and Parkinson's disease, There is a clear synergy there. In Europe, in these big 5 countries, there is 67,000 patient in each of the country, and these patients are treated in university and big central hospitals. I move on to oncology and hospital care. As said, we have these our old brands, Dexdor for ICU sedation and Simdax for acute heart failure. They are still there in our portfolio, and we continue to work around those products. Of course, the oncology, as it is important in our R&D, it is the future where we want to go also in the business. Talking about these hormonal cancers, there is listed all the cancers, and out of those, hormonal cancers represent about more than 20% of all cancers.
As said, this Orion's interest is in breast, prostate, and uterus cancer, among others. Our aspiration is really to become an oncology house in prostate and also in hormonal-dependent cancers. If you look the market, there is definitely lots of potential. The prostate cancer is the second biggest market, second most common cancer in men, and there is more than 1.2 million cases annually. Usually the prostate cancer hits the men at age of 50, but I suppose the average age when you get prostate cancer is 65, 69 years. However, that means that those men are still in a very active phase. They are in work, they have families, friends, hobbies. Therefore, it is important that treatment that it is effective, but also that it has a safety profile which is well tolerated. The market is big.
It was last year about $8.5 billion US dollars. It is expected to about double in 10 years' time. 60% of this market is covered by U.S. and it is dominated by the next generation anti-androgens like apalutamide and enzalutamide. apalutamide sold last year more than EUR 3 billion, but the patent expired last quarter in U.S. and they face generic competition, which of course had an impact to the price levels. enzalutamide have been on the market from 2012, which I just need to check. They have the both indications. Nowadays they have both metastatic and non-metastatic indication.
Although darolutamide is not yet on the market, it is still in the registration, I dare to say that it's efficacious, it's also tolerable and the profile, there is no difference to placebo and that's of course very rare when you think about the cancer products. We have big hopes for this product. The U.S. launch is expected this year and Europe and Japan to follow next year. We will co-promote this together with Bayer in 16 countries in Europe. This has a huge potential. According to Bayer, they see their in markets a big sales potential, more than EUR 1 billion and we will get then the 20% royalty and then of course also some one-off payments, depending on the certain sales targets. Last but not least, I'd like to talk about our Easyhaler family.
Orion started in this business more than 30 years ago. The first product was launched in 1993. It was the Easyhaler Salbutamol. Nowadays we have the world's largest franchise with six different products. This is a busy picture, but I just want to highlight here two things. Big market potential. $2.5 billion US when we look at the top five countries. They actually represent about 70% of the European market. In this market, the biggest share is covered by this so-called LABA/ICS, long-acting beta-agonist and the inhaled corticosteroid, the combination product. It is a big share there, and also it's big amount of share of the business today and it will be also in 2027 and we have there the combination products. We have also mono products which is this 6% share.
I think that we are in right segments. There is the COPD market, equally big market and also here, Orion is in this 27% segment, which is the combination product and then the tiotropium, it would fit into this 18% segment. Again, I think that we are in the right segments there. When talking about the Easyhaler, you of course always have to talk about the device as well and one of the challenges in respiratory and asthma and COPD treatment is adherence to the treatment. Therefore it's very important that the device is as such that the patients is very willing to use it and that's why we have studied this topic also a little bit.
We have run some of the market research. We have really given these asthma COPD patients, try different kinds of devices, hold them. We videotape those interviews and really try to learn what patients want to have, what they expect from the device. One of them was really easy to use. It has to be the size that fits to your pocket or your purse very well. It should have the dose counter, inhale gap. The design should be at least somehow that you like to look at it or that you dare to put it on the table. Easyhaler as a device actually did quite well in this market research. We were very pleased about the results.
Of course, however, we always want to see if there are any needs to develop the device further and we have to be alert there as well. Really the key benefits of this Easyhaler is that it has a full portfolio in only one device. It's easy to learn, easy to teach. It's very important for the doctors because that saves time when they have these patients coming over. It's important factor. Accurate dosing and very robust device. As said, this patient satisfaction, it improves the adherence to this treatment. These digital projects, they are, as said, very interesting area, very important to the patients as well. As Christer explained, our connected Easyhaler, this is really something what we are very enthusiastic about. We will follow what kind of input we will get from our patients.
Of course, this is now the early steps. In the future, we will also develop it further and add other characteristics as well. As said, proprietary products business is really, we are ready for growth. We are really enthusiastic about the different projects we have internally. These new innovations, what we will get through our own R&D, we will definitely would like to commercialize them ourselves. We enhance our in-licensing activities to find these products to be launched and benefit our current businesses. We have the European-wide sales force to take over products. Also this current portfolio, as said, it is still really offering lots of growth opportunities and potential, which we want to exploit fully. Thank you.
Thank you, Satu. It's great to have an opportunity to also introduce specialty product business. We have a little bit different kind of dynamics in this business. I will briefly tell you the key facts from the specialty products business point of view. I will review the market situation. I will tell what are the strategic actions, how we are in specialty product business going to support the growth initiatives of Orion. The specialty product business is the biggest business in Orion at the moment. Our key market area is Nordic. Our value proposal and value promise for the healthcare professionals and also for the patients is that we will provide a very wide product portfolio of affordable generic drugs for them. We like to give an access to biological treatments.
We also have a promise for the consumers and patients to support the healthier lifestyles. We also provide a very wide product portfolio, especially here in Finland, OTC products, which are medicinals and non-medicinals. We see that we have extremely important role in this healthcare sector, especially here in the Nordic market. We are keeping these promises by providing products with three different business lines. We have products for the generic portfolio, where we have substitutable generic products and also branded generics. We also have OTC products with medicinal products and non-medicinal products, and we are also having a small portfolio of biosimilar products. If you look at the history of the specialty products business, we have a long history within the company, and it is a very nice development during the 10 past years.
We have managed to develop this business from EUR 240 million up to almost up to EUR 500 million business. During the last year, there has been a slight drop because of the market dynamics and changes, especially here in Finland. There are several factors behind this development of this business. First of all, we have continuously managed to develop our product portfolio, always introducing new products for the society and for the patients. We have all the time managed to optimize the value chain and also increase the efficiency of our sales operations. If you look at this business from regional point of view, Finland is our main market area, and also Scandinavia is important for us. Totally Nordic is presenting 73% of our net sales. We are also present in Eastern Europe, especially in Poland, and Russia is also a growth area for us.
We also have 13% of the sales coming from other areas, and we are utilizing there also business-to-business opportunities. The biggest business comes from the generic drugs, and the growth comes from the generic drugs, and 24% is from the self-care products, and biosimilars are quite small part of the business at the moment. If you look at the global trends and how do we see the generic market development in general, we see that the trend is positive and there is really need for the generic products also in the future. As we know, there is a very high pressure to decrease the cost of the healthcare and medicines, and really the generic products are the response for that need. There is an aging population and all the time need for the additional volumes and additional needs by the customers and patients.
We also see that the penetration of the generic products in country level, there is still opportunities. Totally, the global generic market is estimated to grow 7%, and in our key market area in Nordic, the growth rates are also quite nicely increasing from 2.5%-5%. The estimated growth for Poland is 7%, so that market is also developing more and more to the generic markets. There is a need for the generics also in the future. One, in a way, change in this area and this market trend is that the growth is really coming, the next double-digit growth is coming from the biosimilars. In Europe, the biosimilars growth opportunity has been estimated to be 25%. Biosimilars are big opportunity for the industry and for the patients and also for the society.
70% of biosimilar markets are from Europe. The growth rate is 25%. There are some strengths and also some weaknesses within this industry. If you think about the benefits of the biosimilars, there are cheaper opportunities to do R&D, have a better access for the biological products to the patients. Also the weaknesses of these opportunities is that they require high investment levels. What we have seen within this industry and with the biosimilars, it is extremely dynamic market environment, especially here in Nordic. Great opportunity, and it is important that there is a sustainability within this biosimilar industry also in the future. Many stakeholders have important role there. How we are proceeding with generic business in European level and in Finland? Here you can see the main market areas.
First of all, the generic markets are very complex markets. There are several similarities and differences already in the Nordic countries. Differences comes from the pricing of the different countries and also the tendering processes in hospital sales. That brings a lot of complexity in the market and a lot of dynamics and competition situation is very strong there. You really need to have a good understanding of the market dynamics, have flexible operations in place. If you think about Finland, in Finland, the market had decreased 7%. We are number 1 company there. I will go a little bit further with the details briefly. Also in the Scandinavian countries, we are among the top 10 generic companies. Of course, we want to improve our situation there and be in a better position also in the future.
In Poland, the growth is nice, 3%. Our ranking with the generics is number 20 at the moment. Finland is our biggest market area, and specialty products are part of that business is very big. Majority of the business from Finland is coming from specialty products business. The market value is almost EUR 3 billion market, and our market there with the reference price prescription drugs is 26%. We have managed to keep that market share in this demanding market situation. With the self-care products, our market share is 25%, and there has been a slight decrease compared to the earlier situation. The biggest product portfolio for us is the reference priced prescription drugs. There we have seen that the market has declined about 7% last year. Our position has there been also declined, so our market development has been 9%.
Of course, we have a very wide portfolio. That has an effect to our market position. We see that we have been managed to keep it very well, and we have a lot of different kind of plans and opportunities to improve our share there. Just to summarize the opportunities and challenges in the market. In Finland, we see that the price competition is going to continue. We see that the pipeline of the generic drugs is going to be from the small molecule products to the large molecule products in the future. There is also a lot of opportunities in this market. We see that we have great opportunities with the continuous renewal of the product portfolio. We have plans to restructure our product portfolio. I will share a little bit our ideas and actions in that area.
It's extremely important we also start to look more and more the new market entry opportunities within this business. One key market trend in this generic environment is that the management of the supply chain is becoming more and more important. We are really working within the global supply chain. We are sourcing and delivering products to global supply chains. I will little bit open to complexity and competence aspects from the specialty business point of view. First of all, we have a very wide product portfolio in place, and that's advantage for us, and you really need to have a competitive product portfolio in place. If you look at the biggest products in specialty product business. The top 10 products generate about 30% of the total sales. We have a different kind of products there. We have generic products, biosimilars, and OTC.
The product portfolio is very balanced. We all the time do the constant flow of the new product launches. For example, last year we did totally 65 different launch activities within this portfolio. Totally we have 2,500 MAs available, and that brings us to the 3,200 SKUs. When you have this kind of wide product portfolio and you really need to be competitive with the cost of goods, it's extremely important that you manage the value chain extremely efficient way and have a different kind of tools and business models in use. One dimension with this generic business is the supply chain management. It's very important that we meet four different requirements when we are managing these global supply chains. Compliance is extremely important.
It's not only the compliance of GxP aspects and product quality, it's more and more also environmental health and safety aspects what we are managing throughout the global supply chains. The sustainability is becoming more and more important in this area, and for example, we as a company are a member of Pharmaceutical Supply Chain Initiative forum, where we have an opportunity to all the time benchmark and improve activities in this sustainability area. We are putting a lot of effort for that and doing a lot of activities within this area.
Service level is very important for us and for example, if you think about this industry, we have several times that kind of issues and challenges that the market itself, for example, for APIs and intermediates, is very fragmented. There's only a few companies which can provide APIs for the open markets, and if there is any issues that will have an effect to the whole supply chain. Not only regional effects, but also it can have a global effect. It's very important that there is all the time end-to-end supply chain management in place. Productivity is extremely important. Like we discussed, how much the gross profit has been managed to develop also in the generic product portfolio. It's important that we have productivity improvements ongoing throughout the value chain. Every day we need to have improvements there in place.
How we are in the specialty products business going to support Orion's growth initiatives? In the generic business, we like to and we will strengthen our position in Finland. We always like to have the optimized synergies with the Nordic, with our portfolio. This really requires continuous development of the generic product portfolio. There we have different opportunities in our hand and different tools. We are actively doing in-licensing. We are also starting to do more and more generic development to have more value-adding generics in our portfolio. We are also evaluating portfolio acquisitions, and brand acquisitions in this area. We evaluate all the time expansions to the new market. If we have competitive product portfolio available, we have opportunities to expand also outside the Nordic. We are utilizing out-licensing opportunities, by business to business sales and through the partners globally.
We are also evaluating all the time opportunities to do cooperation with other generic companies. With the biosimilars, our vision and our plans are to be the Nordic commercialization partner for biosimilars. We like to offer for our key stakeholders and key patients also access to the biosimilar and biological treatments. Here, our strategy is that we are not investing to the value chain, we are the partner for the commercialization, and we like to have extremely competitive product portfolio in place by partnerships. We also have started to evaluate opportunities to enter to the markets outside the Nordic. Within the OTC business, we are doing changes in our ways of operate to come from the product-driven company more to customer-driven company. We are fine-tuning and improving our portfolio to be more customer centricity.
With this area, we have the biggest portfolio in Finland, but we are also evaluating focused investments to the brands in different areas. The areas where we are evaluating these are the Scandinavian, Poland, and Russia. This gives also us opportunities to grow this OTC business. Of course, also in this area, we are very open for the cooperation opportunities. In big picture, our role within this company is to make sure that there is a solid profitability which enables Orion's growth initiatives. As a business, we have a target to grow faster than markets, and we are ready to do, and we are doing all the time, focused investments to the areas which I presented. These are the main elements how we in specialty products are going to support Orion's growth initiatives.
Thank you, Virve. Now it is good time to give maybe some key takeaways, some of the summaries, what has been discussed throughout the morning. The way the company is now prepared to grow, really the growth drivers as we've seen from the business perspective, that is certainly the proprietary products, that is fuel is provided by R&D, both the captive R&D as well as the in-licensing opportunity. Also, that provides the opportunity for the expansion of our commercial footprint, should we choose to do that. Clearly as already mentioned, one of the key opportunities would be obviously the U.S., but not necessarily the only one option that we could have to expand our commercial footprint.
Focusing on both investments in proprietaries per se, especially the product, getting new products, also appreciating that putting those products to the availability of patients that becomes one of the key growth drivers for the company moving forward. The Specialty Products has a very important and special role within the business portfolio of Orion. The focused investments in that business, certainly we will see and continue to see that in attracting new business, be that again in products, be that in selected entries into new markets. The backbone of that business is to sustain its good cash generation property, keeping the profitability up, supporting your growth by driving that business. We've seen that volatility that relates to that business. One of the aspects is certainly the biosimilar tendering.
However, what we've also indicated in the past that provides a lot of volume, but the margins in that business have eroded, so the impact of that to the EBIT line is relatively modest. The animal health is a very interesting part of the business. Our focus there are companion animals, feline and canine. When we look at all the opportunities that we develop in the human side, and there are actually quite numerous trials that we are running currently, hopefully those will make into the marketplace in the next few years, and already earlier, that will actually drive the growth of that business. That business also is tilted very much towards the U.S. There we have great partnerships that we are working on. Our own business here is very much focused here in Scandinavia.
Itself, we believe that this is a great platform to continue the growth. As said, this is one of those businesses in healthcare which still today is very independent from the interference by the payers or reimbursement actions. Fermion is a very different animal in our business concept because it's a capital expenditure heavy industry. Its maturity of that you invest are in capital in a machinery equipment to keep the plants running. The R&D part there is extremely important for our own proprietary molecules. To develop those to the scale of production, and then at the commercial scale, but also to continuously, of course, make sure that we are in compliance and also that we maintain our productivity because at one point of time we will lose the market exclusivity, be that based on the patents or on the data.
At that date, we need to continue to be competitive so that we don't give up that market. I think there are great examples there. If we look at our Parkinson franchise where we lost the patent coverage, yet we continue to supply to the market, we continue to supply to the major players also in the generic space. I think this demonstrates that we have high capabilities there as well. Of course when we look at the healthcare industry in general and the subsegment of that which is called pharma, so far pharma has been a defensive part from the investor perspective. Obviously there's volatility within the companies and of course for a size of company of Orion, any given innovation may actually make a very big difference. As now the data suggests, darolutamide could be a very interesting treatment option for prostate cancer patients.
That has a major impact to the company, as did Stalevo. It catapulted the company to the next level, and I think darolutamide certainly has the power to do that in the next years. In the pipeline, if we look at the next ones, what we have, which are underserved markets, ALS, I think that was very vividly put by Satu here earlier on. Of course, in a totally new mechanism, should the 208/209 pan out, we are addressing patients who, despite the fact that they have very high number of treatments, are untreatable. If we are able to treat those patients, I think this would be great for the patients, of course, caretakers, their close ones, and for the society at the end of the company as well.
This is not to say that we will not be immune for macroeconomic development, at least so far, the signs from the, be that the trade wars or alike, we cannot see the direct impact. If we have the chain reaction, then compounding, who knows? There may be issues, still, personally, I'm optimistic that the politicians that are in power, they will take care of their people and of course, their healthcare and the pharmaceutical products, the access to those are very important to all the people, all the ones who are typically in power. I think there are great opportunities from the industry perspective. The mega trends are driving for the increased need of healthcare and then that part also, of course, by the pharma. I think Orion is very well-positioned. We have both the generic business, we have the high tech business of proprietary.
We have great opportunities in our pipeline, there's a strong will now to make this company grow and see where that takes us. It is very likely that this milestone that we set for ourselves, it's only an intermediate goal. That's the good start, and then we'll continue from there.