Global Biosimilars Market was valued US$ 5 billion in 2018 and is expected to reach US$ 33.65 billion by 2026, at CAGR of 26.91 %during forecast period.
The objective of the report is to present comprehensive assessment projections with a suitable set of assumptions and methodology. The report helps in understanding Global Biosimilars Market dynamics, structure by identifying and analyzing the market segments and projecting the global market size. Further, the report also focuses on the competitive analysis of key players by product, price, financial position, growth strategies, and regional presence. To understand the market dynamics and by region, the report has covered the PEST analysis by region and key economies across the globe, which are supposed to have an impact on market in forecast period. PORTER’s analysis, and SVOR analysis of the market as well as detailed SWOT analysis of key players has been done to analyze their strategies. The report will to address all questions of shareholders to prioritize the efforts and investment in the near future to the emerging segment in the Global Biosimilars Market.
Global Biosimilars Market: Overview
Biosimilars, sometimes referred as biogenerics, they are highly close versions of biologic medicines made from living microorganisms found in animal or plant cells that are already licensed by the U.S. Food and Drug Administration (FDA). The term “generic” refers only to traditional or small molecule drugs that are bio9logically parallel to an already approved small molecule drug. They are also similar to the reference biologic product in terms of safety, purity and potency, but may have minor differences in clinically inactive components. Biosimilars development and validation from the reference biological products is a critical part of the overall development process. Regulations on biosimilars play key role to continue the viability and balance between original and biosimilars products. Different regulatory authorities such as European Medicines Agency (EMA) and Food and Drug Administration (FDA) actively control the biosimilars commercialization and development.
Global Biosimilars Market: Drivers and Restraints
The growth of biosimilars market is highly driven by, increasing incidences of chronic diseases such as diabetes, cancer and other and strategic collaborations resulting in enhanced productivity and clinical trial activities. Moreover, increasing patient access to treatment due to its less cost over the biological drugs, reassuring pipeline of biosimilars with the expiration of biologics patents, and an increased demand for such drugs in the developing countries, these are the primary factors will drive the biosimilar global market during forecast period.
On the other hand, A complex manufacturing process coupled with high cost of development, and limited availability of biosimilar products developmental cost and complexities, strategies from originators and interchangeability concerns and lack of regulatory guidelines, these factor will hamper the market of biosimilars in near future
Global Biosimilars Market: Segmentation Analysis
On the basis of product, the recombinant glycosylated proteins segment including monoclonal antibody, recombinant peptides and erythropoietin held largest market share in of biosimilars market at 2018 and is expected to grow at highest rate during the forecast period owing to cost effectiveness of biosimilars over biological drugs and wide range therapeutic applications.
On the basis of type of manufacturing, the in-house manufacturing segment held largest market share in 2018 and is expected to grow at highest CAGR during forecast period. Most of key players in the biosimilars market prefer the in-house method for manufacturing as they can develop biosimilars in their own laboratories so it will eliminates shipping and delivery costs.
On the basis of diseases, the blood disorder segment held largest share of the market in 2018 and expected to grow at highest rate in forecast period attributed to increasing cases of blood disorders all over the world and low cost of biosimilars compared to biologics. Moreover, an increasing pressure to reduce healthcare expenditure are major factor for contributing the growth of this segment.
Global Biosimilars Market: Regional Analysis
Europe region held highest share in biosimilar market at 2018 and is also expected to grow at highest rate during forecast period owing to number of factors including an increasing cases of chronic disorders, the patent expiry of many biological products, the launch of new biosimilars, and an emergence of new market participants, these factors are expected to drive the market of biosimilar.
Europe is followed by Asia Pacific. Asia Pacific is also is expected to bloom the market of biosimilars at the highest CAGR from 2019 to 2026.
Recent Highlights in Biosimilars Market
• New federal rules are supposed to make biosimilars more accessible. the US Food and Drug Administration has released a bunch of guidelines purposely to fuel the market for biosimilars, generic versions of complex biological drugs, mainly proteins, which are used for treatment of diseases like cancer and autoimmunity. The FDA has already passed 19 biosimilars.
• Biosimilars achieving Popularity for Rheumatoid Arthritis predicted by experts in the European League against Rheumatism 2019 Congress.
• Canadian advisory council recommended the use of biosimilars in a final report that lays out 60 recommendations for how the country can create a CAN $15.3 billion (about US $11.4 billion) universal, single-payer, public system for pharmaceutical coverage.
• Data to be introduced at the European Congress of Rheumatology (EULAR) 2019 highlight real-world evidence confirming the safety and efficacy of anti-TNF biosimilars and high adherence of patients to treatment
• Biogen’s three biosimilar treatments – BENEPALI™ (etanercept), FLIXABI™ (infliximab) and IMRALDI™ (adalimumab) – are estimated to save the European healthcare system 1.8 billion euros in 2019
• Biogen and its collaboration partner Samsung Bioepis are the first companies in Europe to market biosimilars that reference the three most prescribed anti-TNF biologic treatments, with approximately 145,000 patients currently on treatment
Scope of Global Biosimilars Market
Global Biosimilars Market, by Product
• Recombinant Non-glycosylated Proteins
o Recombinant Human Growth Hormone
o Granulocyte Colony-stimulating Factor
• Recombinant Glycosylated Proteins
o Monoclonal Antibodies
Other Monoclonal Antibodies
o Recombinant Peptides
Global Biosimilars Market, By Type of Manufacturing
• In-house Manufacturing
• Contract Manufacturing
Global Biosimilars Market, By Disease
• Blood Disorders
• Chronic Diseases
• Autoimmune Diseases
• Growth Hormone Deficiency
• Infectious Diseases
• Other Diseases
Global Biosimilars Market, by Region
• North America
• Asia Pacific
• Middle East & Africa
• South America
Key players operating in the Global Biosimilars Market
• Sandoz International
• Teva Pharmaceuticals
• Dr. Reddy’s Laboratories
• Samsung Biologics
• Eli Lily & Company
• Hospira Inc.
• ctavis, Inc
• Teva Pharmaceutical Industries Ltd.
• Cipla Ltd.
• Stada Arzneimittel Ag
• Wockhardt Ltd
• Mylan, Inc.
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