Global Pegfilgrastim Biosimilars Market Is segmented By Application (Chemotherapy Treatment, Transplantation, Others), By Distribution Channel(Hospital Pharmacies, Retail Pharmacies,Mail Order/Online Pharmacies), and By Region (North America, Latin America, Europe, Asia Pacific, Middle East, and Africa) – Share, Size, Outlook, and Opportunity Analysis, 2023-2030
Market Overview
The global "pegfilgrastim biosimilars market" size is estimated to reach at a high CAGR during the forecast period 2023-2030
Pegfilgrastim drug is used to prevent infections after chemotherapy. It is a growth factor that stimulates the bone marrow to produce white blood cells. These cells protect the body against infections. Biosimilars are biological products produced to be identical to the biologic already approved, known as reference drugs. Biosimilars should have same safety and efficacy compared to the reference biological product.
Market Dynamics
The global pegfilgrastim biosimilars market growth is driven by the increased prevalence of cancer, increased adoption of the biosimilars, growing government initiatives for biosimilars, increase in healthcare expenditure, and increase in pharmaceutical R&D expenditure and low costs of biosimilars.
Increase in pharmaceutical R&D expenditure is expected to drive the growth in the forecast period
Growing research and development activities have led to increasing success rates in clinical trials for biosimilars. Market leaders are conducting research and development in the biosimilars market as they continuously strive to make breakthroughs in the market in the form of novel and effective biosimilars. For example, Fresenius Kabi is developing MSB11455, a biosimilar that 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. Moreover, 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 non-myeloid malignancies receiving myelosuppressive anti-cancer drugs.
Less approvals by the FDA due to strict standards is likely to hamper the market growth
The low number of drug approvals by the FDA. The market currently only has four drugs approved for treatment, thus restraining the growth of the market. This can be attributed to strict standards for manufacturing and high drug efficacy standards set by the regulatory bodies for approval of this therapy, thus increasing the time required for approval and limiting the market's growth.
Industry Analysis
Supply Chain Analysis
COVID-19 Impact Analysis
The COVID-19 is expected to be negatively impacted on the market situation and its economic implications. The majority of countries suffering from the impact of COVID-19, various countries are looking for a way to cure COVID-19. The pandemic has had a serious and disruptive effect on the conduct of oncology clinical trials, with both immediate and delayed consequences. The short-term effects include research staff and resources being reassigned to deal with COVID patients. In the longer term, trials testing treatments for COVID-19 have been prioritized. A sharp reduction in recruitment to ongoing trials and a delay in the planned launch of new oncology studies are expected to impact the market negatively. The market is also expected to be negatively impacted by patients preferring the biologic Neulasta. Its option of an on-body injector allowed immunocompromised patients undergoing chemotherapy to skip at least a couple of in-person visits to the infusion center without exposing them to higher risks of neutropenia and infection. Therefore, there was a higher demand for the biologic, thus restraining the market's growth, as biosimilars are only available for administration by syringe at this time.
Segment Analysis
The chemotherapy induced neutropenia segment is expected to hold the largest share in this market segment
Pegfilgrastim biosimilar is used to treat low blood neutrophils levels and fight various infections in patients who undergo radiation poisoning and chemotherapy. The products from the pegfilgrastim biosimilar market are gaining immense traction worldwide because of their cost-effectiveness than pegfilgrastim. Consequently, this depicts that the market for pegfilgrastim biosimilar will expand at a rapid pace in the coming years.
Moreover, in October 2018, Mundipharma, a UK-based company engaged in manufacturing, developing, and commercializing high-quality biosimilars for inflammatory diseases and oncology, acquired Cinfa Biotech. Mundipharma acquired all shares of Cinfa, including Pelmeg (pegfilgrastim, biosimilar). This acquisition is projected to expand Mundipharma’s biosimilar product portfolio. Cinfa Biotech was founded in 2013 as a part of Cinfa Group and is a Spanish biotechnology company that focuses on developing biosimilars.
Geographical Analysis
North America region holds the largest market share of global pegfilgrastim biosimilars market
North America is one of the most significant regions of the market for pegfilgrastim biosimilar. It is due to the improved expenditure on healthcare, the growing number of people living with cancer, and the affordability of health services in this region. According to the National Cancer Institute (NCI) report, it was estimated that 1.7 million new cases of cancer are diagnosed in the US in 2019, and 606,880 people are expected to die from the disease. Therefore, the rise in the prevalence of chronic diseases like cancer is projected to propel the region's market's growth.
In addition, the major players are involved in many key strategies like product launches, acquisitions, and collaborations, which are contributing to the growth of the market globally. For instance, on November 05, 2019, Sandoz, a Novartis division and a global leader in biosimilars, received the US Food and Drug Administration (FDA) approval of its biosimilar Ziextenzo (pegfilgrastim-bmez). With the approval of Ziextenzo, Sandoz is the first and only company to offer US physicians long- and short-acting filgrastim biosimilar treatment options.
Competitive Landscape
The global pegfilgrastim biosimilars market is highly competitive with the presence of local as well as global companies. Some of the key players which are contributing to the growth of the market include Coherus Biosciences Inc, Biocon, Mundipharma, Pfizer, Viatris Inc, Fresenius Kabi AG, Intas Pharmaceuticals Ltd, USV Private Limited, STADA Arzneimittel AG, and Genova Biopharmaceuticals Limited. The major players are adopting several growth strategies such as product launches, acquisitions, and collaborations, which are contributing to the growth of the calcium channel blocker globally. For instance, In Nov 2019, India-based generics maker Lupin announced plans to launch the drug on the US market soon after, alongside a pegfilgrastim biosimilar, which stimulates the production of white blood cells and helps patients undergoing chemotherapy to ward off infection. It was also originally marketed by Amgen, with the brand name Neulasta.
Key Companies to Watch
Pfizer Inc.
Overview: Pfizer Inc. (Pfizer), incorporated on June 2, 1942, is a research-based global biopharmaceutical company. The Company is engaged in the discovery, development, and manufacture of healthcare products. Its global portfolio includes medicines and vaccines. The Company manages its commercial operations through two business segments: Pfizer Innovative Health (IH) and Pfizer Essential Health (EH). IH focuses on developing and commercializing medicines and vaccines that improve patients' lives. IH therapeutic areas include internal medicine, vaccines, oncology, inflammation and immunology, and rare diseases. EH includes legacy brands, branded generics, generic sterile injectable products, and biosimilars and infusion systems. EH also includes a research and development (R&D) organization, as well as its contract manufacturing business. The Company sold its products in over 125 countries.
Product Portfolio: NYVEPRIA is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.
Key Developments: On June 11, 2020, Pfizer Inc got the United States (U.S.) Food and Drug Administration (FDA) approval of NYVEPRIA (pegfilgrastim-apgf), a biosimilar to Neulasta (pegfilgrastim).
