issue 17

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IMS Observer - Issue 17 IMS HEALTH ASIA PTE LTD 8 Cross Street #21- 048424 Singapore E-mail: [email protected] Website: www.imshealth.com C 2016 IMS Health Incorporated and its affiliates. All rights reserved. Trademarks are registered in the United States and in various other countries China’s Progressive Market Outlook for Biologics Despite a late start, the biologics market in China is currently undergoing a crucial period of transition. The regulations for pharmaceutical manufacturers imposed by the revised Goods Manufacturing Practice (GMP) are having a marked impact across the market, spurring many well-known pharmaceutical companies to dive into the development of biologics. In 2014, the market share for the biologics market in China reached US$5 billion, with growth rate to remain steadfast within the macro-market, a characteristic unique to the Chinese market. The data compiled by IMS Health predicts that by the year 2020, the market share for Chinese biologics will rank second in the world, after the United States. The top five disease areas of biologics in China ranked in descending orders are: immune- stimulating agents (18%), diabetes (17%), oncology (11%), haemostatics (10%) and antithrombotic agents (8%) respectively. As illustrated in the below chart - Share by Chemical Family (2014), other protein and peptides held the largest market share, followed by insulin, haematopoietic GF, monoclonal antibodies and enzymes. The differentiating factor of the Chinese biologics market is showcased in the market share for monoclonal antibodies. Rheumatoid arthritis has a global market share of 20% and is traditionally used in the treatment of rheumatoid arthritis. However, in China, this share stands at a paltry 4%. The causations lie primarily in economic constraints of patients, but also the fact that production capability for macromolecular products has yet to reach the technological sophistication required as compared to overseas.

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Page 1: Issue 17

IMS Observer - Issue 17

IMS HEALTH ASIA PTE LTD 8 Cross Street #21- 048424 Singapore • E-mail: [email protected] • Website: www.imshealth.com

○C 2016 IMS Health Incorporated and its affiliates. All rights reserved. Trademarks are registered in the United States and in various other countries

China’s Progressive Market Outlook for Biologics

Despite a late start, the biologics market in China is currently undergoing a crucial period of transition. The regulations for pharmaceutical manufacturers imposed by the revised Goods Manufacturing Practice (GMP) are having a marked impact across the market, spurring many well-known pharmaceutical companies to dive into the development of biologics. In 2014, the market share for the biologics market in China reached US$5 billion, with growth rate to remain steadfast within the macro-market, a characteristic unique to the Chinese market. The data compiled by IMS Health predicts that by the year 2020, the market share for Chinese biologics will rank second in the world, after the United States. The top five disease areas of biologics in China ranked in descending orders are: immune-stimulating agents (18%), diabetes (17%), oncology (11%), haemostatics (10%) and antithrombotic agents (8%) respectively. As illustrated in the below chart - Share by Chemical Family (2014), other protein and peptides held the largest market share, followed by insulin, haematopoietic GF, monoclonal antibodies and enzymes.

The differentiating factor of the Chinese biologics market is showcased in the market share for monoclonal antibodies. Rheumatoid arthritis has a global market share of 20% and is traditionally used in the treatment of rheumatoid arthritis. However, in China, this share stands at a paltry 4%. The causations lie primarily in economic constraints of patients, but also the fact that production capability for macromolecular products has yet to reach the technological sophistication required as compared to overseas.

Page 2: Issue 17

IMS Observer - Issue 17

IMS HEALTH ASIA PTE LTD 8 Cross Street #21- 048424 Singapore • E-mail: [email protected] • Website: www.imshealth.com

○C 2016 IMS Health Incorporated and its affiliates. All rights reserved. Trademarks are registered in the United States and in various other countries

The top ten biologics pharmaceutical manufacturers in ranking acquire nearly 40% of the aggregate market share, indicating a highly concentrated nature of the market. MNCs still play the leading roles, owning the top 5 (biologics pharmaceutical manufacturing corporation) exclusively. Shangdong Qilu Fty, Shanghai Fosun Ph, Gd. Tianpu Biochem and Healthstar Pharm held the 6th-9th positions respectively. With the relatively low production costs and pricing, the market share for Chinese biologics manufacturer is increasing steadily, from 57% in 2010 to 60% in 2014.

The primary revenue source for the top ten ranking pharmaceutical manufacturers in China is from the sales of biologics products, with exception of Shandong Qilu Fty, Zhuhai Lizhu Group and Ah.Hf.Zhaofengkeda.

Page 3: Issue 17

IMS Observer - Issue 17

IMS HEALTH ASIA PTE LTD 8 Cross Street #21- 048424 Singapore • E-mail: [email protected] • Website: www.imshealth.com

○C 2016 IMS Health Incorporated and its affiliates. All rights reserved. Trademarks are registered in the United States and in various other countries

Market opportunities for biologics The impending expiration of patents for biologics like Adalimumab, Etanercept and Inflixmab presents monumental market opportunities, as these products have acquired over US$1 million in market share. Meanwhile, the newer generation biologics will trigger challenges for pricing and strategies in the pharmaceutical market. The revolving regulations and development of the pharmaceutical industry will indeed bring much needed changes to the biologics market. There are however, four factors that will affect the progress of the biologics market.

1. Clinical Value: The value of biologics will be unearthed in more disease areas, such as oncology, diabetes, rheumatoid arthritis

2. Values to physicians: Chinese pharmaceutical industry categorizes physicians into three distinct types: the conservative, the accepting and the progressive, with the latters actively seeking new information and new treatment methodology.

3. Market challenges: From a global perspective, for the treatments of acute diseases and terminal illnesses, biologics play a rather insignificant role. In contrast, biologics are playing a significant role in the treatment of chronic diseases and non-terminal illnesses.

4. Healthcare budgeting: The value of biologics must be justified with its associated costs and positive benefits to the pharmacists, manufacturers and patients.