According to the current analysis by Reports and Data, the Global Biosimilars Market was valued at USD 6.67 Billion in 2019 and is expected to reach USD 58.28 Billion by year 2027, at a CAGR of 30.8%. Biosimilar are alternatives to existing patented and approved biologics and possess similar medicinal properties as compared to the original biologics.
The biosimilars vary a little from original biologics in terms of structure but must have similar safety and efficacy as compared to the originator biologics. Biosimilars development does not require Phase II clinical trial for approval and the focus on determination of ‘biosimilarity’ to the reference originator biologics. Thus, it has much lower clinical development timelines and reduced product costs as compared to the use of original biologics.
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The global market is driven by various factors such as, the global rise in prevalence of target diseases across the globe, launch of biosimilars by various market players, favorable investments scenario, and imminent patent expiry. The Biosimilars market is characterized by the presence of a significant number of pharmaceutical giants as well as emerging players operating across the globe.
Additionally, the availability of research funding, demand for cheaper biologics alternatives, and favorable regulatory scenario in Europe and Asia pacific are propelling the market growth in these regions. However, some regions like the U.S are facing slow adoption of biosimilars with the first biosimilar gaining approval in 2015 for Sandoz’s Zarxio (filgrastim), and 3, 5, and 7, biosimilars earning approval from FDA in 2016, 2017, and 2018 respectively.
Further key findings from the report suggest
- Biosimilars market is growing at a CAGR of 2% in the Asia Pacific region, followed by North America and Europe at 21.0% and 31.4% respectively. High prevalence of chronic diseases across the globe is a key factor accelerating market growth during the forecast period across all regions.
- By 2018, Recombinant Non-glycosylated Proteins dominated the Biosimilars sector, holding over 60% of the global market. European regional market is the main revenue generating region for this product segment, followed by North America and Asia-Pacific.
- Recombinant Glycosylated Proteins is expected to be the fastest growing market segment during the forecast period with a CAGR of 33.4%. However, regulatory stringency and manufacturing complexity are major challenges for the growth of this market segment.
- Recombinant Peptides segment was estimated to be valued at USD 656.81 million in 2019 and is expected to reach USD 5.75 Billion by the year 2027.
- Asia Pacific is expected to control nearly 32.8% of the global Biosimilars market. Developing nations such as, China and India are expected to witness high growth.
- Some regions such as, the U.S. and Latin America are witnessing a slow adoption of biosimilars due to the stringent regulatory framework governing these regions.
- Key participants include Amgen, Biocon, Celltrion, Dr. Reddy’s Laboratories, Mylan, Pfizer, Samsung Biologics, Sandoz, Stada Arzneimittel, and Teva Pahrmaceutical.
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For this report, Reports and Data segments the Biosimilars market on the basis of type, disease type, and region:
Type (Revenue, USD Million; 2017–2027)
- Recombinant Non-glycosylated Proteins
- Recombinant Human Growth Hormone
- Granulocyte Colony-stimulating Factor
- Recombinant Glycosylated Proteins
- Monoclonal Antibodies
- Other Monoclonal Antibodies
- Recombinant Peptides
Disease Type (Revenue, USD Million; 2017–2027)
- Blood Disorders
- Chronic Diseases
- Autoimmune Diseases
- Growth Hormone Deficiency
- Infectious Diseases
- Other Diseases
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Regional Outlook (Revenue in USD Million; 2017–2027)
- North America
- Rest of the Europe
- Asia Pacific
- Rest of Asia-Pacific
- Middle East & Africa
- Latin America
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