As you are exploring biosimilar opportunities, we would be delighted to share our insights to help you advance your strategy. Our active work has enabled us to develop an in depth understanding of the global biosimilar opportunity, and many of our forecasts of the past decade are now being realized. In fact, that is why the title of the attached slide deck is “Creating a global biosimilars leadership – Combining complementary strengths of China and India” (Click here to download)
Global biosimilars sales are expected to reach $40B by 2025, as multiple initiatives converge to increase biosimilars adoption. Emerging markets, especially India and China, will be significant consumers of biosimilars due to growing middle class, high disease burden and low cost of biosimilars.
China and India are also the leading nations developing and marketing biosimilars. In fact, both countries began approving biosimilars more than 20 years ago. However, the standards were established and guidelines for these approvals were put in practice only in the last 3-4 years.
- China had >200 biosimilars approved before the 2015 guidelines whereas India had >50 biosimilars approved before 2016 guidelines.
- In China, the first biosimilar complying with the 2016 guidelines was approved only in Feb 2019, whereas in India, 15 biosimilars have been approves since the new guidelines.
- Chinese government has a number of initiatives underway to ease development as well as adoption of biosimilars throughout China. This is accelerating investments by domestic and MNCs in Chinese biosimilars opportunities.
- China has at least 25 and India has least 10 biosimilars in late phase of development. The real opportunity lies in the developed market where Chinese cos are rapidly progressing but 3 Indian cos already have 3 products approved in US, EU and Japan.
Every biosimilar company strives to be successful with focus on developed markets. To-date, each biosimilar development cost 3-digit millions of dollars and requires wide range of skill sets. Few biosimilars cos in China and India have these skill sets and resources, which include broad portfolio, funding, technical skill sets, manufacturing infrastructure and regulatory/IP knowhow. Naturally, therefore, it is prudent not to duplicate the effort. Rather, leveraging complementary skill sets can be an efficient way to build towards global leadership by saving time as well as costs. To-date, the ways Chinese and Indian cos have evolved seem to create natural complementarities. Chinese companies have access of capital, foundation for innovation and technical knowhow. Some of the Indian companies that have already progressed along a broad portfolio have established globally compliant manufacturing infrastructure and the process build up regulatory skill sets, partly due to developed market partnerships. Thus, it is clear that if like-minded Indian and Chinese cos were to join hands, they will gain a strong global position overnight.