Biosimilars Device Market is valued at USD 7.49 Billion in 2018 and expected to reach USD 34.39 Billion by 2025 with the CAGR of 24.32% over the forecast period.
Biosimilars Device Market: Global Size, Trends, Competitive, Historical & Forecast Analysis, 2018-2025. Rising prevalence of chronic disease and increasing geriatric population across the globe driving the biosimilars market.
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Scope of Biosimilars Device Market -
Biosimilars is also referred as the follow-on biologics. Biosimilars are the biologic medical products which is highly similar to another already approved biological medicine which is available in the market. Biosimilar are the copied and licensed versions of those reference biologics products those have undergone patent expiration. Development and validation of biosimilars with reference biologics products are very crucial aspect of the overall development process. Biosimilars are approved as per the same standards of pharmaceutical quality, efficacy, safety that apply to all biological medicines.
However, biosimilars are differ from generics and are not treated as generics, as entire manufacturing process of biosimilar, right from the raw materials used in the manufacturing are different from generic products manufacturing. Similar to generic, biosimilar are the low-cost medicine and can be used in many treatment therapies including some of the most critical diseases like cancer, inflammatory bowel disease, anemia and autoimmune disorders including multiple sclerosis, psoriasis, rheumatoid arthritis, Crohn’s and among others.
Under solid legal framework, which is introduced in 2004 by European Union (EU), prepared dedicated route for the approval of biosimilars and hence in 2006, growth hormone somatropin got the first approval of EU as a biosimilar. Whereas, on March 6, 2015, Zarxio obtained the first approval of FDA for Sandoz's Zarxio is biosimilar to Amgen's Neupogen which was originally licensed in 1991.
Biosimilar market report is segmented based on products, manufacturing, indication and by regional & country level. based upon products, biosimilar market is classified into insulin, recombinant human growth hormone (rhgh), granulocyte colony-stimulating factor, interferon, erythropoietin, etanercept, monoclonal antibodies, follitropin, glucagon, calcitonin, teriparatide and enoxaparin sodium. based upon type of manufacturing, biosimilar market is classified into in-house manufacturing and contract manufacturing. based upon type of manufacturing, biosimilar market is classified into oncology, chronic disorder, autoimmune disease, blood disorders, infectious disease and other diseases.
The regions covered in this Biosimilars market report are North America, Europe, Asia-Pacific and Rest of the World. On the basis of country level, market of biosimilar is sub divided into U.S., Mexico, Canada, U.K., France, Germany, Italy, China, Japan, India, South East Asia, GCC, Africa, etc.
Eli Lily & Company
Sandoz International GMBH
Teva Pharmaceutical Industries Ltd.
Dr. Reddy’s Laboratories Ltd.
Stada Arzneimittel Ag
True North has acquired about 3 per cent of Biocon Biologics India Ltd (BBIL)
News: On Jan 06, 2020, Biocon Biologics India Ltd is the wholly owned subsidiary of Biocon has announced the dilution of its share and sell its 3% share to True North for USD 100 million, by valuing the unlisted subsidiaries at around USD 3.5 billion. Biocon Biologics is formed in December 2017 to house all Biocon’s’ biologics business including biosimilars that include monoclonal antibodies, recombinant insulins and novel biologics. Biocon is the parent company of Biocon Biologics India Ltd, company aim to list Biocon Biologics in the next few years in similar fashion to its contract research arm Syngene.
Biosimilars Market Dynamics –
Increasing prevalence of chronic diseases including cancers, diabetes, rheumatoid arthritis, CVDs, autoimmune diseases, kidney failure, growth hormone deficiency, haematological diseases and infectious diseases driving the growth of biosimilar market. For instance, as per the WHO, the number of people with diabetes rose from 108 million in 1980 to 422 million in 2014 and in 2016, an estimated 1.6 million deaths were directly caused by diabetes. Additionally, growing geriatric population is another major factor identified to primarily drive the market for biosimilars. Moreover, increasing investment on R&D and increasingly gaining preference over follo on biologics, these all factors driving the growth of market.
On the other flip, high processing costs and complexity in the manufacturing as it requires extensive analytical characterization to establish manufacturing of biosimilar and may restrain to mainstream production of biosimilars, additionally, availability of cost-effective generic drugs in market may also remain standing roadblocks to sales of biosimilars. Nevertheless, biosimilar manufacturers are likely to trial production on different scales and significantly marginal profitability of manufacturing multiple biosimilar products in the same facility can create lucrative growth opportunity for biosimilar manufacturing companies over the forecast period.
Biosimilars Market Regional Analysis –
Europe is dominating the biosimilar market owing to early adaptation of biosimilars. For instance, European healthcare Agency is the pioneer in biosimilar, the establishment of favorable regulations such as Article 10(4) of Directive 2001/83/EC by the European Medical Association (EMA) has clarified the clinical aspect of biosimilars and the first biosimilar was approved by the EU in 2006. However, North America stands after Europe, In the year of 2018, 11 biosimilars have been approved by Food and Drug Administration (FDA).
Asia Pacific is anticipated to grow at a highest CAGR over forecast period due to relatively lower manufacturing costs, skilled labor and less complicated regulatory measures present in the region. The biosimilars market is currently witnessing active growth in regions, including countries like China, India, and Japan. Upsurge in FDA approval in India and finalized the biosimilars guidelines confined to the market for biosimilars production, sale, and consumption across the region.
Key Benefits for Biosimilars Market Reports –
Market report covers in depth historical and forecast analysis.
Market research report provides detail information about Market Introduction, Market Summary, market Revenue (Revenue USD), Market Drivers, Market Restraints, Market opportunities, Competitive Analysis, Regional and Country Level.
Market report helps to identify opportunities in market place.
By Type of Manufacturing
Regional & Country Analysis
North America, U.S., Mexico, Canada , Europe, UK, France, Germany, Italy , Asia Pacific, China, Japan, India, Southeast Asia, South America, Brazil, Argentina, Columbia, The Middle East and Africa, GCC, Africa, Rest of Middle East and Africa.
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