Global Biosimilars Market

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Global Biosimilars Market was valued at US$ 5 Bn in 2019 and is expected to reach US$ 33.65 Bn by 2027, at a CAGR of 26.91 % during the forecast period.

The report includes an analysis of the impact of COVID-19 lockdown on the revenue of market leaders, followers, and disruptors. Since the lockdown was implemented differently in various regions and countries; the impact of the same is also seen differently by regions and segments. The report has covered the current short-term and long-term impact on the market, and it would help the decision-makers to prepare the outline and strategies for companies by region.

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Global Biosimilars Market Dynamics:

Biosimilars, sometimes referred as biogenerics, 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 biologically parallel to an already approved small molecule drug. They are also similar to the reference biological 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 biosimilar's commercialization and development.

The growth of the 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 the 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, factors will hamper the market of biosimilars in the near future.
Global Biosimilars Market Segment Analysis:

On the basis of product, the recombinant glycosylated proteins segment including monoclonal antibody, recombinant peptides, and erythropoietin contributed the largest market share in of biosimilars market in 2019 and is expected to grow at the highest rate during the forecast period owing to the 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 2019 and is expected to grow at highest CAGR during forecast period. Most of the 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 eliminate shipping and delivery costs.

On the basis of diseases, the blood disorder segment held largest share of the market in 2019 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 is a major factor contributing to the growth of this segment.
Global Biosimilars Market Regional Analysis:

Europe region held the highest share in the biosimilar market in 2019 and is also expected to grow at the highest rate during the forecast period owing to the number of factors including increasing cases of chronic disorders, the patent expiry of many biological products, the launch of new biosimilars, and the emergence of new market participants, these factors are expected to drive the market of the biosimilar.

Europe is followed by the Asia Pacific. Asia Pacific is also is expected to bloom the market of biosimilars at the highest CAGR from 2019 to 2027.
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.

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.
Global Biosimilars Market, Key Highlights:

• Global Biosimilars Market analysis and forecast, in terms of value.

• Comprehensive study and analysis of market drivers, restraints and opportunities influencing the growth of the Global Biosimilars Market

• Global Biosimilars Market segmentation on the basis of type, source, end-user, and region (country-wise) has been provided.

• Global Biosimilars Market strategic analysis with respect to individual growth trends, future prospects along with the contribution of various sub-market stakeholders have been considered under the scope of study.

• Global Biosimilars Market analysis and forecast for five major regions namely North America, Europe, Asia Pacific, the Middle East & Africa (MEA) and Latin America along with country-wise segmentation.

• Profiles of key industry players, their strategic perspective, market positioning and analysis of core competencies are further profiled.

• Competitive developments, investments, strategic expansion and competitive landscape of the key players operating in the Global Biosimilars Market are also profiled.

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Global Biosimilars Market, by Product

• Recombinant non-glycosylated Proteins
o Insulin
o Recombinant Human Growth Hormone
o Granulocyte Colony-stimulating Factor
o Interferon
• Recombinant Glycosylated Proteins
o Erythropoietin
o Monoclonal Antibodies
 Rituximab
 Infliximab
 Adalimumab
 Other Monoclonal Antibodies
o Follitropin
o Recombinant Peptides
 Glucagon
 Calcitonin
Global Biosimilars Market, by Type of Manufacturing

• In-house Manufacturing
• Contract Manufacturing
Global Biosimilars Market, by Disease

• Oncology
• Blood Disorders
• Chronic Diseases
• Autoimmune Diseases
• Growth Hormone Deficiency
• Infectious Diseases
• Other Diseases
Global Biosimilars Market, by Region

• North America
• Europe
• Asia Pacific
• Middle East & Africa
• South America
Key Players Operating in the Global Biosimilars Market:

• Pfizer
• Sandoz International
• Teva Pharmaceuticals
• Amgen
• Biocon
• Dr. Reddy’s Laboratories
• Celltrion
• Samsung Biologics
• Eli Lily & Company
• Hospira Inc.
• ctavis, Inc
• Teva Pharmaceutical Industries Ltd.
• Cipla Ltd.
• Stada Arzneimittel Ag
• Wockhardt Ltd
• Mylan, Inc.
• Biocad
• Coherus Bioscience
• Boehringer Ingelheim

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