The market is driven by the rising prevalence of chronic disease, growing investment in research and development by biopharmaceutical organizations, vast pipeline of biosimilars, surging geriatric population, and the cost-efficient nature of biosimilars as compared to approved drugs.

Based on technology, the biosimilars market is classified into monoclonal antibody (mAb), bioassays, nuclear magnetic resonance (NMR), recombinant deoxyribonucleic acid (rDNA), and electrophoresis. Biosimilars manufactured using the mAb technology held 56.0% share in the market in 2018. This technology is further anticipated to be the fastest growing due to its large-scale deployment in the development of therapeutics to treat various diseases, such as immunological, cancer, and infections.

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On a global ground, in 2018, Europe dominated the biosimilars market with nearly 47.7% share. This is ascribed to the flexible regulatory parameters, surging aging population, and increasing R&D investments by biopharmaceutical organizations in the region.

Companies in North America have more freedom to price their products as they want compared to other regions, and advanced technologies and trained scientific personnel are readily available in here, which make it ideal for pharmaceutical companies.

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According to the Population Reference Bureau report, titled Aging in the United States, the aging population is anticipated to double by 2060, resulting in the need for old age-related disease management. Furthermore, according to the Centers for Disease Control and Prevention (CDC), around 60.0% of the adults in the U.S. are suffering from one or more chronic diseases.

Furthermore, in January 2019, Samsung Bioepis Co. Ltd. partnered with 3SBio Group to expand the business of biosimilars in China. With the collaboration, Samsung Bioepis Co. Ltd. will seek to enlarge its biosimilars portfolio, while 3SBio Group will be supported by the sales of Avastin.

Some of the key players operating in the market, globally, are Samsung Bioepis Co. Ltd., AMEGA Biotech, Synthon Holding B.V., Coherus BioSciences Inc., Celltrion Inc., BIOCAD, Zydus Cadila, Teva Pharmaceutical Industries Limited, Pfizer Inc., Novartis AG, Dr. Reddy’s Laboratories Ltd., and Mylan N.V.

The Report “Biosimilars Market: By Product (Recombinant Glycosated Proteins and Others) Technology (mAbs, Chromatography, Mass Spectroscopy and Others); By Application (Blood & Oncology Diseases, Chronic Diseases and Others); By Geography-Forecast (2016 - 2021)”, published by IndustryARC.

Browse Market Tables, Figures spread through 152 slides and an in-depth TOC on “Biosimilars Market (2016 - 2021)".

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Biosimilars are biologic inventions that are analogous but not the same as the original reference biologic products. Initial biologics like insulin and growth hormones have been helpful in the healing of severe illnesses like anemia, diabetes and other diseases. Unlike the biologics, biosimilars are articulated in living cells which brings flexibility in the properties of the biosimilars. The Biosimilars market report is a comprehensive study of the market for different technologies, product types, applications and geography. The global market size is estimated to reach $11.12 billion by 2021 growing at a CAGR of around 27.9% during the forecast period of 2016 and 2021.

The market is mainly driven by rising demand from patients who do not have access and cannot afford exorbitantly priced biologics. Along with this, there is a constant growing demand from various governments for development of their domestic pharmaceutical industries. Mounting demand for curing chronic diseases coupled with blood, oncology and hormonal diseases are set to bring an upsurge in the biosimilars market.

Rising need for affordable biologics and balanced solutions combined with changes in regulations of contemporary times are amassing the influence of biosimilars in various segments of health care industry. Developed markets like the U.S. and Europe, deliver short-term development prospects for biosimilars, assisted by governments which are dispensing approvals in terms of regulatory frameworks, along with providers and payers, who are set to push the uptake of biosimilars for cost containment.

Recombinant Glycosylated Protein dominated the market with the largest share and generated revenue of $1.43 billion in 2015. On the other hand, the same trend has been followed by recombinant non-glycosylated proteins which held a share of 33%. The majority of biosimilars are now being developed with the help of Recombinant DNA technology. The emphasis on recombinant glycosylated proteins has amplified considerably owing to the development of mAbs (monoclonal antibodies) which are considered to be, by far the best innovation utilized for the treatment and cure of cancer.

The global market for biosimilars is dominated by European region, which is poised to remain the largest market in 2021 as well. The fastest growth is however attributed to the American region which is anticipated to grow at a CAGR of nearly 33% during the forecast period. With respect to Europe, Germany by far has been the most progressive nation in educating and incentivizing physicians to drive the demand for biosimilars. The important thing to understand is that biosimilars provide better access as it improves the prospects for treatment option, not just for the patients, but physicians and payers as well.

There is big room for biosimilars to grow with large untapped potential. The healthcare savings can be reutilized or channeled back into the system to improve the healthcare processes. On the pharmaceutical front, innovation is only going to better the patient outcomes and that is the sole purpose of biosimilars. The number of manufacturers across the world for Biosimilars has increased manifold. These manufacturers are vigorously exploiting in surmounting their position in the market and are able to entice profitable deals.

Some of the major players are:
Novartis International AG
Hospira Inc.
Celltrion Pharma Inc.
Biocon Limited
Teva Pharmaceutical Industries Ltd.

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Diabetes is a group of metabolic disease characterized by high blood sugar level due to inadequate secretion of insulin. Common symptoms of diabetes include increased hunger, tiredness, weight loss, and excessive thirst and urination. The prevalence of diabetes is increasing, in turn, boosting demand for insulin biosimilar. For instance, according the World Health Organization (WHO) report in 2014, globally around 422 million adults were living with diabetes and 1.5 million people died due to the disease in 2012. Insulin biosimilar has the ability to increase access to treatment of diabetes mellitus among the patients while reducing treatment costs. Click To Read More On Insulin Biosimilars Market

Biosimilar is a medicine developed on the original biological reference product. The production process of biopharmaceuticals vary from one manufacturer to another, thus every biosimilar product is unique from the other. Biosimilar manufactures use different culture conditions, master cell lines, purification techniques, and raw materials. This in turn, helps meet the rising prevalence of diabetes due to inadequate healthcare services, rising prevalence of obesity, For instance, According to 2013 American Society For Metabolic And Bariatric Surgery report, obesity was a major independent risk factor for developing the disease, and more than 90% of type 2 diabetics population are overweight or obese due to growing adoption of unhealthy lifestyle. Insulin is distributed and manufactured by small number of multinational companies in emerging economies, beyond the established biosimilar manufactures, and a handful of small players are developing insulin manufacturing capacities based on modern biotechnological methods in turn, boosting growth of the insulin biosimilars market size.

Insulin Biosimilars Market – Dynamics

Increasing number of manufacturers are developing biosimilar insulin to provide clinical aid that are similar to current insulin analogs at the more affordable price. Moreover, the patents of several insulin manufacturing companies are soon expected to lose patent protection, For instance, LEVEMIR an Insulin detemir by Novo Nordisk is going to lose its patent rights in year 2019, which is influencing numerous pharmaceutical key manufacturers to develop alternatives to patents, referred as biosimilar. The low cost of biosimilar insulin for diabetes treatment and effectiveness is helping treat patients suffering from diabetes mellitus. Companies are also focusing on developing medical devices that allows for less painful and safe delivery of the biosimilar insulin treatment, which in turn, is boosting market growth. Government agencies are focusing on the endorsement of insulin biosimilar by funding research and development. Furthermore, rising geriatric population across the globe and increasing demand for rapid-acting insulin analogues is boosting growth of the insulin biosimilar market. For instance, according to a consensus report published in 2012 American Diabetes Association, showed over 25% of the U.S. population aged ≥65 years suffered from diabetes.

Insulin Biosimilars Market – Competitive Insights

The key players operating in the global insulin biosimilars market includes Boehringer Ingelheim, Pfizer Inc., Biocon, Merck & Co., Mylan N.V., Eli Lilly & Co., Wockhardt Limited, NOVO Nordisk A/S, Sanofi S.A., Ypsomed AG and others Key players are engaged in developing new technologies and collaborations in order to retain dominant position in the market. For instance on 2018 Sandoz, a Norartis division and Asia’s premier biopharmaceutical company, Biocon announced exclusive global collaboration for next generation biosimilars.

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Insulin Biosimilars Market – Regional Insights

On the basis of region, the global insulin biosimilars market is segmented into North America, Europe, Latin America, Asia Pacific, Middle East, and Africa. North America leads the global insulin biosimilar market, owing to rising geriatric population and high prevalence of diabetes-related disorders in the region. Moreover, government support for diabetes-free states is accelerating growth of the insulin biosimilar market in North America. For instance, Centers for Disease Control and Prevention (CDC) runs a National Diabetes Prevention Program in various U.S states.

The market in Europe accounts for the second-leading share in the global market, mainly due to increasing number of primary approvals for biosimilar insulin. For example, European Commission (EC) approved Mylan and Biocon’s biosimilar insulin—Glargine—for treating diabetes on March 27, 2018. Asia Pacific market is expected to gain significant traction over the forecast period due to increasing government support, improving healthcare conditions and growing diabetes incidence in the region. For instance, 2011 World Health Organization report shows that diabetes deaths will double between 20011 and 2030.

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The global biosimilars market size was anticipated to reach $xx billion supported by a CAGR of xx% over the forecast period. Occurrence of large number of chronic disorders and affordability of biosimilar drugs are the main factors participating in the growth of the global biosimilars market.

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Biosimilar products are similar to their accredited products on the basis of biological activity, efficacy, and safety and quality characteristics. An occurrence of chronic disorders such as cancer, anemia, diabetes, autoimmune diseases, kidney failure, rheumatoid arthritis, infectious diseases and deficiency of growth hormones is projected to fuel the global biosimilars industry in the coming years.

Specialty biologics is the biggest factor for pharmaceutical cost growth in the market. In the U.S., as per research around nine patents for top 20 retailing biologics are supposed to expire by 2020. However, biosimilars are less expensive than the original drugs hence, more usage of biosimilars will lead to cost savings. The first biosimilar was accepted by European Medicines Agency in 2006 and has approved out of 40 biosimilars. Food and Drug Administration (FDA) confirmed their first biosimilar through Zarxio, which is a biosimilar of filgrastim used in treating low blood neutrophils. Overall, total 11 biosimilars were approved by FDA out of which only 3 biosimilars are launched.

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Product segment in the biosimilars market consists of Erythropoietin, Human Growth Hormone, Insulin, Monoclonal Antibodies, Colony Stimulating Factors, Interferon and more. Biosimilars market is divided into oncology diseases, growth hormone deficiency, blood disorders, autoimmune and chronic disorders. Use of biosimilars in the treatment of blood disease is the maximum revenue making segment. Increase in use of biosimilars for treating several diseases is helping to scale up the global biosimilar market size.

The biopharmaceutical industry is dependent on advanced technologies used in several processes of manufacturing and development. Some of the important technologies involved in biosimilars are Recombinant DNA technology, Monoclonal Antibodies Technology, Chromatography, Nuclear Magnetic Resonance Technology, Bioassay, Western Blotting, and Mass Spectrometry. Bioassay and Monoclonal Antibodies technology are the most important technologies used for validation and development of global biosimilars market share.

Pharmaceutical companies are mainly focusing on development of biosimilars and they are accepting clinical trials strategies and approval. Approval and clinical trials strategies are the main factors in the biosimilar market globally. Companies such as Merck Serono, Celltrion and Sandoz are looking for approvals across the world. These companies are branches of global industries such as Novartis and Merck, which allows investing in biosimilar market. The plans accepted by manufacturers in an integrated manner where all clinical trials conducted for approvals and commercialization. Joint venture, License, product launch, partnership are the policies accepted by companies who had got permission from the authorities and have successfully copied the original drugs. Thus, development of biosimilars by manufacturers are increasing the growth of the global biosimilars industry.

Benefits of the global biosimilars market:

• Cost of treatment is less by using biosimilars rather than using the biological drug.
• The profit margin of operating original biological drug is around 30%, but for operating, the biosimilar product, profit margin is around 40%.
• As license of original product expires thus, opportunities for a generic version of biopharmaceutical products is very large.
• Funding is easily available across the world.

Regional Overview:

Geographically, global biosimilar industry is divided into Europe, South America, North America, Asia Pacific and Middle East & Africa. North America holds the largest share of the global biosimilar market. The market of North America is mainly driven due to the presence of research laboratories, such as Amgen, Sandoz, Teva Pharmaceuticals and many more. Due to the development of biotechnology companies, Asia Pacific is anticipated to experience growth over the forecast period.

Key Players:         

Companies involved in expanding the global biosimilar market size are Teva Pharmaceutical Industries Ltd., Amgen Inc., Sandoz International, Hoffmann-La Roche Ltd., Dr. Reddy’s Laboratories Ltd., Pfizer Inc., Mylan, Biocon, and Samsung Bioepis.

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