The Pegfilgrastim Biosimilars Global Market Report 2020-30 by The Business Research Company describes and explains the global pegfilgrastim biosimilars market and covers 2015 to 2020, termed the historic period, and 2020 to 2025, termed the forecast period, along with further forecasts for the period 2025-2030. The report evaluates the market across each region and for the major economies within each region.
The Pegfilgrastim Biosimilars Global Market Opportunities And Strategies Report covers pegfilgrastim biosimilars market drivers, pegfilgrastim biosimilars market trends, pegfilgrastim biosimilars market segments, pegfilgrastim biosimilars market growth rate, pegfilgrastim biosimilars market major players, and pegfilgrastim biosimilars market size.
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The pegfilgrastim biosimilars market report focuses particularly on identifying the trends, opportunities, and strategies that can lead to success. O&S reports are available off the shelf and can be delivered to clients on the day of purchase.
Pegfilgrastim Biosimilars Global Market Opportunities And Strategies Report is the most comprehensive report available on this market and will help gain a truly global perspective as it covers 60 geographies. The chapter on the impact of COVID-19 gives valuable insights on supply chain disruptions, logistical challenges, and other economic implications of the virus on the market. The chapter also covers markets which have been positively affected by the pandemic.
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Trends in the market include:
Revised FDA Regulations To Facilitate Biosimilar Drug Development-
The US Food and Drug Administration (FDA) has revised its regulations to eliminate outdated biologics and biosimilar requirements, thus allowing drug manufacturers to employ new manufacturing technologies and testing capabilities. Standard preparations (standard solutions containing a precisely known concentration of an element), which help to ensure safety, purity and potency of biologics/biosimilar, can now be obtained from sources other than the FDA’s Center for Biologics Evaluation and Research (CBER), or can be developed internally by the biologics license applicant. The FDA has also removed a rule (Section 610.21 of FDA code) which specifies minimal potency limits to be met for certain antibodies and antigens. In addition, the FDA is also updating regulations (Section 610.53 of FDA code) regarding storage periods and storage conditions for biologics. These amendments in regulations are expected to increase regulatory flexibility by allowing the pharmaceutical industry and the FDA to incorporate current scientific technologies in the manufacture of licensed biological products. The average yearly number of new drug approvals was 25 between 2000 and 2009, and 41 between 2010 and 2018. The new biologic product approvals increased from a median of 5 between 2000 and 2013, to 12 between 2014 and 2018.
Robust Research & Development-
The pegfilgrastim biosimilar market is witnessing robust research and development activities. These research and development activities have led to increasing success rates in clinical trials for biosimilars. Research and development is being carried out by market leaders in the biosimilars market as they continuously strive to make breakthroughs in the market in the form of new and effective biosimilars. For instance, Fresenius Kabi is developing MSB11455, a biosimilar which stimulates the growth of white blood cells that are essential to fight infections, a common adverse event in patients receiving chemotherapy for cancer. MSB11455 was developed in Switzerland by Fresenius Kabi’s immunology and oncology research lab. Currently, the drug is in Phase I clinical study for oncology patients. In June 2020, Pfizer, an American multinational pharmaceutical company, received approval from the US Food and Drug Administration to introduce its biosimilar drug for lowering the incidence of infection as manifested by febrile neutropenia in patients with nonmyeloid malignancies receiving myelosuppressive anticancer drugs.
The market is segmented:
By Application-
1.Chemotherapy Induced Neutropenia
2.Transplantation
3.Others
By Distribution Channel-
1.Hospital Pharmacies
2.Retail Pharmacies
3.Mail Order/Online Pharmacies
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