New Research Report Unveils Future of Biosimilars
Research and Markets recently released its Biosimilars Market by Product & Application - Global Forecast to 2018
Research and Markets recently released its Biosimilars Market by Product & Application - Global Forecast to 2018, which analyzes the revenue market of recombinant glycosylated proteins, recombinant non-glycosylated proteins, and recombinant peptides—the three major drug classes of that market. Highlights of the report show that oncology—currently comprising 25% of the market—will the fastest-growing segment and biosimilars of insulin will be the fastest-growing products, estimated to grow at a CAGR of 35.6% from 2013 to 2018.
Unfortunately, regulatory issues will burden this market segment. The different terminology and guidelines for biosimilars across regions will be problematic. Generic versions of biologic drugs approved under the EMA regulatory pathway and section 351K of the U.S. FDA are considered as biosimilars. In the U.S., biosimilars are also known as follow-on-proteins and have been approved under section 501(b), whereas in Canada, biosimilars are called Substituent Entry Biologics (SEB).
Geographic analysis reveals that Europe is the largest contributor to the global market. Asia-Pacific (China, India, and South Korea), North America (U.S.), and Latin America (Brazil) are poised to grow at high double-digit rates.
The global market is highly consolidated with the top three players, namely, Sandoz (Germany), Hospira (U.S.), and Teva (Israel) accounting for approximately 90% of the market share. Other notable players in the market include Dr. Reddy's Laboratories (India), Biocon Ltd. (India), Mylan (U.S.), Biopartners (Switzerland), Amgen (U.S.), and IntasBiopharmaceutical Ltd. (India).
Read the full release here.
Empowering Sites and Patients: The Impact of Personalized Support in Clinical Trials
November 26th 2024To meet the growing demands of clinical research, sponsors must prioritize comprehensive support models, such as clinical site ambassadors and patient journey coordinators, who can address operational challenges and improve site relationships, patient satisfaction, and overall trial efficiency.
Driving Diversity with the Integrated Research Model
October 16th 2024Ashley Moultrie, CCRP, senior director, DEI & community engagement, Javara discusses current trends and challenges with achieving greater diversity in clinical trials, how integrated research organizations are bringing care directly to patients, and more.
FDA Finalizes Decentralized Clinical Trial Guidance
November 25th 2024The FDA's guidance is part of a broader effort to modernize clinical trials, improve efficiency, reduce participant burden, and expand access, particularly for underrepresented populations and those in geographically or economically constrained areas.
AI in Clinical Trials: A Long, But Promising Road Ahead
May 29th 2024Stephen Pyke, chief clinical data and digital officer, Parexel, discusses how AI can be used in clinical trials to streamline operational processes, the importance of collaboration and data sharing in advancing the use of technology, and more.
