Global Biosimilars Industry Analysis: Market Insights, Risk Analysis, Y-O-Y Growth Rate, Manufacturers, Size, Market Segmentation Based on Product Type, Based on Implications, Based on Manufacturing & by Region with Forecast 2017-2030

Biosimilars Market in the Global Industry Landscape

Biosimilars are like generic drugs, as such they intend to replace biologics in the market. Unlike original brand drug which are made of chemical substances, biologics are made from living organisms. The FDA approval process for biosimilars is much complex than generic drugs. Though biologics are made from living organisms, but the biosimilars uses the nearby compounds used in biologics. Therefore the result of biosimilar might vary with their biologics and thus are difficult to get approved. But biosimilars are low cost and have better response on the diseases as compared to other drugs.

Further, biosimilars in Europe has achieved most advanced and developed position across the world. European biosimilar market (EMA) has approved 16 biosimilars till 2017. As per European Commission (EC), 19 biosimilar therapeutic medicines are approved for marketing and in total 40 biosimilars across different categories have been approved by EC till March 2018. In 2017, Roche Herceptin has achieved USD 2.0 billion sales across Europe, demonstrating attractive opportunities in biosimilars industry.

 Global Biosimilars Market Segmentation

Based on Product Type

• Recombinant Non-Glycosylated Proteins

  • Insulin
  • Human Growth Hormone
  • Granulocyte Colony-stimulating Factor (G-CSF)
  • Interferons
• Recombinant Glycosylated Proteins
  • Erythropoietin
  • Monoclonal Antibodies
  • Follitropin
• Recombinant Peptides
  • Glucagon
  • Calcitonin

Based on Implications

• Oncology
• Nephrology
• Autoimmune Disorders
• Infectious Diseases
• Others

Based on Manufacturing 

• In-House Manufacturing
• Contract Manufacturing

Based on Geography

• North America (U.S. & Canada)  Biosimilars  Market {Market Share (%), Market Size (USD Billion)}
• Latin America (Brazil, Mexico, Argentina & Rest Of Latin America)  Biosimilars  Market {Market Share (%), Market Size (USD Billion)}
• Europe (The U.K., Germany, France, Italy, Hungary, Spain, Poland, Sweden & Roe)  Biosimilars  Market {Market Share (%), Market Size (USD Billion)}
• Asia-Pacific (China, India, Japan, Singapore, South Korea, Australia, New Zealand, Rest Of Asia)  Biosimilars  Market {Market Share (%), Market Size (USD Billion)}
• Middle East & Africa (GCC, South Africa, North Africa, Romea) Biosimilars  Market {Market Share (%), Market Size (USD Billion)}

Global Biosimilars Market Outlook comprises of the following data:

• Biosimilars market size and market compounded annual growth rate, 2017-2030
• Marketed biosimilars sales and revenue, by region, 2017-18
• Biosimilars approval scenario, 2017-18
• Number of Oncology cases and growth rate of oncology cases, 2017-18

In 2017 on the basis of implications, biosimilars for oncology segment accounted for largest market share in the global biosimilars market. Most of the biosimilars currently available or under research are to treat one or other type of cancer, such as rituximab biosimilars Truxima (Mundipharma and Celltrion) and Rixathon (Sandoz) are available for the treatment of non-Hodgkin lymphoma (NHL) and chronic lymphocytic leukemia (CLL), the first monoclonal antibody biosimilars which was approved in 2017 in Europe.

AbbVie’s Humira (adalimumab) patent, a biologic to treat moderate-to-severe Crohn’s disease (CD), is set to expire in 2020 in US including the manufacturing methods and drug formulation (though expired in 2016), and in Europe it is to expire in December 2018. This will pose competition to AbbVie from the biosimilars. Humira (adalimumab) biosimilar Amjevita by Amgen was approved by both EC and FDA in March 2017 and September 2016 respectively. But the legal dispute between AbbVie and Amgen has led to pause the manufacturing and sales of biosimilar by Amgen till 2023. This though reflects the struggle of biosimilars in the market in terms of both the approval process and marketing process.

Competition Analysis: Biosimilars have changed the landscape of competition in the pharmaceutical industry. The branded drug manufacturers and pharmaceuticals as seen till now were in competition with the generic drug manufacturers. Whereas, now the branded drug manufacturers are likely to shift their interest towards biosimilars. Moreover, the low profit margin in the manufacturing and marketing of biosimilars has led the companies are pursuing the pharmacists and doctors advocating quick and effective response of biosimilars than the other drugs.