And so, I think, we are both prepared from a commercial perspective and from a manufacturing perspective with the expectation, as I said that, this should go with a very strong quick uptake. And the other thing I would highlight is given the strength of the data, we do expect to see approval in Europe next year, which we originally thought would require a further study. So not only are we preparing in the United States, but we are also preparing in Europe as well and we feel good about both. But Caroline, anything you would want to add.
Caroline Litchfield: No. I think you captured it Rob. Dean, anything you would want to.
Dr. Dean Li: Yeah. I just want to emphasize sotatercept, this is the first drug out there that really is targeting the fundamental genetic basis of the disease. It’s going to be the first activin inhibitor, but most important is activin is what the genetics tells you imbalance that occurs in pulmonary artery hypertension. So this is a really important and I said watershed previously, I do think this is going to be a watershed moment for PAH. Rob already talked about the U.S. and EU, and the reason why that happened is because of the stellar data was quite impressive and that’s what drove the ability to do EU. What I would remind everyone is that we have other trials coming through. We have Zenith, Hyperion and Cadence. Zenith, for example, is one that’s going to look at mortality and those sort of endpoints, as the primary endpoints.
Should that read-out in the next year or something like that, relatively soon to the launch, I think whatever estimates that, Caroline and Rob have talked about sotatercept that will only help the uptake of sotatercept. And as Rob has mentioned, this is a field that up many of the physicians, this was a place where I did research back-in the academic days. The phone calls, I am getting is that people are warehousing patients in anticipation of that March launch.
Rob Davis: Thanks, Louise. Next question please.
Operator: Thank you. Our next question comes from Chris Schott with JPMorgan. Your line is open.
Chris Schott: Great. Thanks so much. I just had a question on GARDASIL, we have seen obviously some very impressive growth over the past few years, but looking ahead, I am just interested in how much more opportunity for you see for this franchise to ramp from here. So maybe just elaborate a little bit more on what are the kind of unmet needs at this point, where is the biggest opportunity to do kind of roll-out the product and just, ultimately, how much larger can this franchise become over time? Thank you.
Dr. Dean Li: Yeah. Chris, no, I appreciate the question. So, one, I would say, we feel very proud of GARDASIL [Technical Difficulty] of this business and the fact that people increasingly recognize that we can fundamentally do what’s the most important, which is prevent cancer — prevent cervical cancer, increasingly prevent certain head-and-neck cancers if we can get people fully vaccinated. So the fact that you are starting to see that progress is important. As we look at the business going forward, I would start by saying, we remain very confident that this as a business that’s going to continue to grow and that we will achieve the expectations we have communicated of over $11 billion in revenue by 2030, so nothing has changed and how we see the business.
As you know, we have made significant investments in manufacturing capacity and from that perspective now, we are well-positioned, we have brought on our two sites and they are ramping now, and so we are doing quite well from that perspective. And then as far as the opportunities that exist to potentially continue to drive even beyond, what we just discussed, really, I would put it in three buckets and our ability to achieve that objective and then potentially exceed that objective really come down to these three variables. And first and foremost, while we have had great penetration in the developed world, huge opportunity still exists in the low and middle income markets. And I can tell you we have a focus and an intention to drive this business into the low and middle income markets.
Obviously, that’s going to require us to continue to drive down our manufacturing costs, which we have plans to do and I have confidence that we will do and just think about lower price points. But that said, that will be meaningful incremental revenue, as we achieve that over time. And then as you look at the established markets, there is still a large population to address. Obviously, to-date we have been driving largely through public vaccination programs outside the United States, in the United States through the national immunization program, primarily aimed at young women and young girls. Increasingly, the opportunity to go to a broader age cohorts, as we think about going now to people aged 45. That ability to move into the mid adult segment is a real opportunity in the United States that continues to be a driver of growth, it’s increasingly going to be a growth driver in Europe and it is currently an important part of why we are driving growth with the recent expansion we got in China and there are more markets to come.
So as we look at that, that’s going to be another lever of growth. Obviously, the difference here is this requires consumer activation that takes commercial investments and a lot of heavy lifting. We have demonstrated we can do it like we have started to do in China and as we are starting to do in the United States. But it is going to take a lot of work and investment and we are committed to doing that. So that’s another variable that we look at it. And then, lastly, this is still largely seen as a female vaccine, we only I think it’s only 70 markets have gender neutral approvals. And even in the markets that do have it, particularly if you look at markets like Europe. There is still a real opportunity to increasingly bring people to understand that this is not just a female cancer vaccine, it is a gender neutral cancer vaccine.
And with the growing incidence of head-and-neck cancers, which is primarily a male-dominated cancer, we do see real opportunity to continue to push and drive both getting more markets to gender neutral and in the markets, where we have those approvals drive vaccination rates up and probably one more bigger near-term opportunities is to get gender neutral approved in China, which is an opportunity. So across all of those, there’s opportunities and potential. It’s a heavy lift, I don’t want to indicate that it’s going to be easy and we are going to invest behind it. But that really will determine ultimately our success across those variables will determine the success we see long-term with this franchise. But maybe Dean or Caroline, anything you would add.
Dr. Dean Li: Yeah. I would just emphasize two points. One, directly related to what you said. This is a highly effective vaccine to prevent women’s cancer, cervical cancer and that is something that everyone recognizes, but the gender neutral part is really important and at MRL we are advancing studies and filings in relationship to make sure that as many places that can adopt gender neutral can it — can be in a position to do gender neutral. I also want to just make one comment about cervical cancer itself. We talk about Carticel in relationship to cervical cancer, but I would also emphasize that at ESMO, we had KEYNOTE-A18. I would remind people that cervical cancer is still the fourth leading cause of women cancer and this was another trial that showed the effect of KEYTRUDA in earlier stage in combination with chemo radiation.
