The global biosimilar market was estimated to be valued at USD 3,474.01 million in 2017, and is expected to register a CAGR of 43.85% during the forecast period of 2018-2023. North America accounted for the largest share of approximately 30% of the global market, in 2017, while Asia-Pacific region is anticipated to register the highest CAGR over the forecast period.
Upcoming Decade to Witness Patent Expiration of Several Biopharmaceuticals
In the recent past, several blockbuster biologic drugs of major pharmaceuticals companies, such as Remicade, Rituxan, Herceptin, Enbrel, Lantus, and others expired. In the coming decade, there would be a rise in the patent expiration of several existing biological drugs, such as Erbitux, Avastin, Orencia, and others, which would provide an opportunity for many innovator companies as well as generic manufacturers to offer services, specially tailored toward biosimilars. In addition, factors, such as cost effectiveness nature of biosimilars, rising acceptance and adoption by various stakeholders with the need of diversification in technology and business models, are expected to drive the global biosimilar market.
High Investments and Longer Timelines are needed
The development and manufacture of biosimilars are more complex compared to generics. A biosimilar takes around seven to eight years for its development, with high financial investments ranging between USD 100 million and USD 300 million, which are considerably much higher than the USD 1 million to USD 5 million for generic production. In addition, the manufacturing complexity in each step involves a high degree of variability and hundreds of controlling input parameters, for safety and efficacy. At the same time, with factors, such as lack of definitive standards for approval and adequate profitability, given the greater risk with concerns regarding substitutability and interchangeability, many companies are discouraged from investing in this market, thus impeding the growth of the market studied.
North America to Dominate the growth of Biosimilar Market
The global biosimilar market has been segmented by product class and geography. By geography, it has been segmented into North America, Europe, Asia-Pacific, Middle East & Africa, and South America.
North America accounted for the largest share, accounting for approximately 30% of the global market, in 2017. The North American segment of the market studied is majorly driven by the presence of many large research laboratories, such as Sandoz, Amgen, Teva Pharmaceutical, and others. According to a recent report, more than 40 biosimilars are under development, including approximately 20 biosimilars ready to be released into the market, and a significant number of biosimilars are in the pipeline. Owing to the immense economic developments and booming biotechnology companies in the region, Asia-Pacific is also expected to record robust growth over the forecast period.
Key Developments in the Biosimilar Market
- December 2017: Pfizer received the US FDA approval for infliximab biosimilar, for all eligible indications.
- December 2017: Mylan received the US FDA approval for Ogivri, the first biosimilar for trastuzumab, co-developed with Biocon.
- November 2017: Samsung Bioepis Co. Ltd received European Commission marketing approval for Ontruzant, a biosimilar for trastuzumab, for the treatment of breast cancer.
- November 2017: Samsung Bioepis Co. Ltd received the approval for Samfenet, a biosimilar for Herceptin, to be sold in South Korea.
Biosimilar Market Major Players:
- Pfizer Inc.
- Eli Lilly and Company
- Celltrion Healthcare
- Mylan NV
- Novartis AG
- Samsung Bioepis Co. Ltd
- Stada Arzneimittel AG
- Teva Pharmaceutical Industries Ltd
- Intas Pharmaceuticals Ltd
- LG Life Sciences
Reasons to Purchase Biosimilar Market Report
- Current and future biosimilar market outlook in the developed and emerging markets.
- Analyzing various perspectives of the market with the help of Porter’s five forces analysis.
- The segment that is expected to dominate the market.
- Regions that are expected to witness the fastest growth during the forecast period.
- Identify the latest developments, market shares, and strategies employed by the major market players.
- 3 months analyst support along with the Market Estimate sheet (in excel).
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1.1 Market Definition
2. Research Methodology
3. Executive Summary
4. Key Inferences
5. Biosimilar Market Overview
5.1 Current Market Scenario
5.2 Porters Five Forces Analysis
5.2.1 Bargaining Power of Suppliers
5.2.2 Bargaining Power of Consumers
5.2.3 Threats of New Entrants
5.2.4 Threat of Substitute Products and Services
5.2.5 Competitive Rivalry within the Industry
6. Drivers, Restraints, Opportunities, and Challenges Analysis (DROC)
6.1 Biosimilar Market Drivers
6.1.1 Several Blockbuster Biopharmaceuticals Going Off-Patent over the Next Five to Ten Years
6.1.2 Next-Gen Business Models
6.1.3 Market in the Nascent Phase but with High Growth Potential
6.1.4 Increasing Demand for Biosimilar Drugs due to Their Cost Effectiveness
6.2 Biosimilar Market Restraints
6.2.1 Concerns Regarding Substitutability and Interchangeability
6.2.2 Regulatory Uncertainty
6.2.3 Production Complexity
6.3 Biosimilar Market Opportunities
6.4 Biosimilar Market Challenges
7. Biosimilar Market Segmentation
7.1 Biosimilar Market By Product Class
7.1.1 Monoclonal Antibodies
188.8.131.52 Other Monoclonal Antibodies
7.1.2 Recombinant Hormones
184.108.40.206 Human Growth Hormone
220.127.116.11 Follicle-Stimulating Hormone
18.104.22.168 Other Recombinant Hormones
7.1.3 Recombinant Growth Factor
22.214.171.124 Granulocyte Colony-Stimulating Factor
126.96.36.199 Other Recombinant Growth Factors
188.8.131.52 Immunomodulatory Imide Drugs (IMIDS)
184.108.40.206 Other Immunomodulators
7.1.5 Anti-inflammatory Agents
220.127.116.11 TNF Inhibitors
18.104.22.168 Other Anti-inflammatory Agents
7.2 Biosimilar Market By Geography
7.2.1 North America Biosimilar Market Size (2018-2023)
22.214.171.124 United States Biosimilar Market Size (2018-2023)
126.96.36.199 Canada Biosimilar Market Size (2018-2023)
188.8.131.52 Mexico Biosimilar Market Size (2018-2023)
7.2.2 Europe Biosimilar Market Size (2018-2023)
184.108.40.206 France Biosimilar Market Size (2018-2023)
220.127.116.11 Germany Biosimilar Market Size (2018-2023)
18.104.22.168 United Kingdom Biosimilar Market Size (2018-2023)
22.214.171.124 Italy Biosimilar Market Size (2018-2023)
126.96.36.199 Spain Biosimilar Market Size (2018-2023)
188.8.131.52 Rest of Europe
7.2.3 Asia-Pacific Biosimilar Market Size (2018-2023)
184.108.40.206 China Biosimilar Market Size (2018-2023)
220.127.116.11 Japan Biosimilar Market Size (2018-2023)
18.104.22.168 India Biosimilar Market Size (2018-2023)
22.214.171.124 Australia & New Zealand Biosimilar Market Size (2018-2023)
126.96.36.199 South Korea Biosimilar Market Size (2018-2023)
188.8.131.52 Rest of Asia-Pacific
7.2.4 Middle East & Africa
184.108.40.206 GCC Biosimilar Market Size (2018-2023)
220.127.116.11 South Africa Biosimilar Market Size (2018-2023)
18.104.22.168 Rest of Middle East & Africa
7.2.5 South America Biosimilar Market Size (2018-2023)
22.214.171.124 Brazil Biosimilar Market Size (2018-2023)
126.96.36.199 Argentina Biosimilar Market Size (2018-2023)
188.8.131.52 Rest of South America
8. Biosimilar Market Competitive Landscape
8.1 Merger & Acquisition Analysis
8.2 Agreements, Collaborations, and Partnerships
8.3 New Product Launches
9. Biosimilar Market Key Players
9.1 Pfizer Inc.
9.2 Eli Lilly and Company
9.3 Celltrion Healthcare
9.4 Mylan NV
9.5 Novartis AG
9.6 Samsung Bioepis Co. Ltd
9.7 Stada Arzneimittel AG
9.8 Teva Pharmaceutical Industries Ltd
9.9 Intas Pharmaceuticals Ltd
9.10 LG Life Sciences
10. Outlook of the Global Biosimilar Market