Biosimilars Market is Expected to Reach $69.45 bn by 2027
The Biosimilars Market was valued at US $8.6 billion in the year 2019 and is estimated to reach US $69.45 billion by 2027, at a CAGR of 29.84%.
Biosimilars are referred as biological medicines that contain a highly similar version of the active substance of an already approved biologic reference product.
A biosimilar depicts similar mechanisms of actions to that of the reference biologic, and its condition of use is the same as the approved indication. Besides, extrapolation is permitted across indications under regulatory guidance. Biosimilar is a biologic which includes wide range of products like vaccines, blood components, tissues, gene therapy and cell signaling proteins. Biologics are larger, complex molecules created from living cells, from which reference biologics, biosimilar development and manufacturing is done. Biosimilars are synthesized by using biologic components that include monoclonal antibodies, proteins, hormones, nucleic acids, colony stimulating factors, interleukins, and enzymes. There is wide range of applicative areas for biosimilars like oncology, autoimmune, growth hormone disorders and many others.
A biosimilar should have a similar route of administration, dosage, and strength as the reference biologic. Biosimilars development includes few technologies like bioassay technology, Monoclonal Antibodies (MAb) Technology and Recombinant DNA Technology (rDNA technology). Stringent regulatory guidelines play a vital role in biosimilar commercialization and development. Commitment to quality, competitive technological advancements in marketplace replacing biologics, attaining regulatory approvals lead to biosimilar development.
In recent times, biosimilars are gaining more attention owing to more efficacy and lesser side effects. Increase in the use of biosimilars replacing the conventional biologics is observed at present due to less cost, approximately 20-25% than reference biologics. Increased demand of biosimilars is observed particularly in developing countries. Increase in research opportunities in biopharmaceutical segments and active funding, collaborative strategies might positively impact the biosimilar market growth. Development cost optimization and innovative methodology; streamlined regulatory process will accelerate biosimilar market with sustainable future.
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High prevalence of chronic disorders, more investment in R&D, demands of Pharmaceutical Drugs, advancements of technologies and cost-effectiveness are major market drivers for Biosimilars Market. The key restraints include stringent government regulations, financial burden, patent expiration, consumer brand preferences and low prescription rate. Increased timeline for production and approval, interchangeability and substitution, cost & reimbursement and reliance on post-marketing report are major challenges faced in Biosimilars Market.
Major companies for Biosimilars Market include Allergan plc., Amgen INC., Boehringer Ingelheim, Biocon Ltd., Celltrion INC., Dr. Reddy's Laboratories Ltd., Fujifilm Diosynth Biotechnologies, Neuclone, Pfizer Inc., Samsung Bioepis Co. Ltd., Wockhardt ltd., Zydus Cadila and many more…
Based on Product Technology (Market Size and Forecast, and Y-o-Y Growth, (US$ Mn):
- Recombinant Non-Glycosylated Protein
- Growth Hormones
- Granulocyte Colony-Stimulating Factor
- Recombinant Glycosylated Protein
- Monoclonal Antibodies
Based on Application (Market Size and Forecast, and Y-o-Y Growth, (US$ Mn):
- Blood Disorders
- Growth Hormone Deficiency
- Infectious Diseases
- Autoimmune Diseases
Based on Geographic Region (Market Size and Forecast, and Y-o-Y Growth, (US$ Mn)
- North America
- Provides a detailed Analysis of the Market Structure along with forecast of the various segments and sub-segments.
- Provides a Comparative Analysis of Key Marketed and Pipeline Products.
- Provides Key Information on Players involved.
- Provides a Complete Overview of Market Segments and the Regional Outlook.
- Provides In-depth Coverage of Key News, including Major Mergers, Acquisitions and Product Development updates such as clinical trial progression updates and regulatory updates.
The Report Provides Key Insights on
- History of the Biosimilars Market, 2015 to 2018
- Forecast of the Biosimilars Market Growth till the year 2027
- The key market drivers, restraints, challenges, future opportunities and the market dynamics driving the Biosimilars Market
- Analysis of potential growth segments which will drive the market
- Landscape analysis of the major companies, and new market entrants and companies which possess disruptive technologies which can change the trend of the entire market
- Key market approaches adopted by the organizations and in-depth intelligence of potential strategies which could alter the market dynamics
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