{"id":90160,"date":"2021-02-15T09:21:12","date_gmt":"2021-02-15T09:21:12","guid":{"rendered":"https:\/\/clarivate.com\/cortellis\/?p=60923"},"modified":"2021-02-15T09:21:12","modified_gmt":"2021-02-15T09:21:12","slug":"mainland-chinas-anticipated-biosimilar-boom-potential-and-key-drivers-of-the-market","status":"publish","type":"post","link":"https:\/\/clarivate.com\/life-sciences-healthcare\/blog\/mainland-chinas-anticipated-biosimilar-boom-potential-and-key-drivers-of-the-market\/","title":{"rendered":"Mainland China\u2019s anticipated biosimilar boom \u2013 potential and key drivers of the market"},"content":{"rendered":"

The market of major biologics in Mainland China has tripled since 2017, with the potential to grow five-fold over the next ten years \u2013 which could drive biosimilars growth. Clarivate expert Akash Saini discusses this market\u2019s potential and key drivers.\u00a0 <\/em><\/p>\n

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The approval of Shanghai Henlius Biotech\u2019s HLX01\u2014a biosimilar of rituximab (Roche\u2019s MabThera)\u2014in February 2019 marked the formal entry of biosimilars in Mainland China, even though copy biologicals such as Yisaipu (etanercept) have long existed in the country. Biosimilars of bevacizumab (Roche\u2019s Avastin), trastuzumab (Roche\u2019s Herceptin) and adalimumab (AbbVie\u2019s Humira) have since launched, while many others are in late-phase development. In fact, Mainland China currently has the biggest biosimilars pipeline compared to any other country.<\/p>\n

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Mainland China\u2019s biologics market is relatively small despite high patient burden<\/h3>\n

Mainland China has a high burden of cancer and lifestyle-related conditions, and according to Clarivate epidemiology research, the country bears the highest global footprint of many major diseases, including non-small-cell lung cancer, breast cancer, type-2 diabetes and hypertension. Despite the disease burden and population, Mainland China\u2019s market of premium-priced, targeted therapies\u2014including biologics and their biosimilars\u2014is relatively small compared to the United States and major European markets.<\/p>\n

According to our research, the 2019 sales in Mainland China of major anti-cancer and immunotherapeutic biologics\u2014that have either recently lost or are about to lose patent protection\u2014were nearly $3 billion, of which only less than 2% were from biosimilars. In contrast, sales of these drugs in the United States and the EU5 were much higher\u2014approximately $50 billion and $12 billion, respectively.<\/p>\n

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Regulatory and market access reforms are driving uptake of premium-priced medicines and encouraging domestic innovation<\/h3>\n

The reasons behind biologics\u2019 poor uptake in Mainland China are likely their relatively late approval, low patient affordability and poor rate of reimbursement. Even though more than 95% of Mainland China\u2019s population is covered under the government\u2019s public insurance schemes, most premium-priced therapies remained non-reimbursable and out of reach for patients until recently. Moreover, Mainland China\u2019s domestic pharma has historically focused very little on research and innovation, leaving a white space that was almost exclusively filled by expensive multinational corporation (MNC)-manufactured products.<\/p>\n

However, the scenario is improving quickly since 2017, when the Chinese government introduced major healthcare reforms to improve the regulatory, access and reimbursement landscape. The most impactful of these reforms is the regular yearly update of the national reimbursement drug list (NRDL), which now makes more than 1,400 western medicines reimbursable in Mainland China, including worldwide blockbuster biologics against various cancers (e.g., bevacizumab, trastuzumab, rituximab) and rheumatological diseases (e.g., etanercept, adalimumab).<\/p>\n

In addition, incentives for domestic innovation and research have allowed many Chinese manufacturers to enter this segment, who are now competing with the MNCs through their domestically developed, cost-effective biologics and biosimilars. In fact, local manufacturers overwhelmingly dominate the biosimilars pipeline of Mainland China while MNCs have very little representation in the space, likely because of the MNCs\u2019 unwillingness to compromise on prices in this highly competitive and price-sensitive market.<\/p>\n

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Mainland China\u2019s biosimilars market is set to grow exponentially with anticipated entry of nearly 40 biosimilars<\/h3>\n

With many biologics now reimbursable and many more expected to be approved and reimbursed in the coming years, Mainland China\u2019s biologics market has finally started to flourish. Therapies included under the NRDL have registered robust growth in sales following the inclusion, despite undergoing massive price cuts. Clarivate research suggests that the market of major biologics in Mainland China has tripled since 2017 and could further grow by five times of its current size over the next ten years.<\/p>\n

Considering that many of these biologics have lost or are about to lose patent protection, biosimilars are set to benefit significantly from this growth. Mainland China\u2019s biosimilars pipeline more than 100 candidates in various phases of clinical development, many of which will be available in the market soon. Clarivate research suggests that in the next five years, Mainland China\u2019s biopharma market could see the entry of more than 40 biosimilars of major anticancer and immunotherapeutic agents\u2014most notably those of trastuzumab, bevacizumab, cetuximab, adalimumab and rituximab \u2013 all of which are reimbursable and are approved for diseases with a high burden in Mainland China.<\/p>\n

With a plethora of cost-effective and reimbursable options available in the market, more and more patients will shift to biosimilar treatment options, driving growth in this market. Even with price erosion of branded drugs following the launch of their biosimilar counterparts \u2014as already seen in the case of Roche\u2019s Avastin and Herceptin (prices reduced by 23% and 24%, respectively) and AbbVie\u2019s Humira (prices reduced by 59%)\u2014 biosimilars will take away a significant proportion of patient share and sales from the brands.<\/p>\n

Clarivate forecasts suggests that Mainland China\u2019s biosimilars market will increase 2,500% by 2029, allowing it to become the second largest in the world after the United States. Mainland China\u2019s biosimilar market growth will be a game changer for the country\u2019s domestic pharma, which has so far had limited success in leveraging the country\u2019s growing demand for western medicine. On the other hand, MNCs are expected to gain very little from this trend.<\/p>\n

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