The rising prevalence of leukaemia has been driving the demand for Pegfilgrastim biosimilars. The number of leukaemia cases was 0.54 million in 2022. With the alarming rise in the leukaemia cases, the global Pegfilgrastim biosimilars market is likely to grow at a CAGR of 7% during the forecast period of 2023-2031.
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Pegfilgrastim biosimilar is the PEGlyated form of filgrastim, a recombinant human granulocyte stimulating factor (GSF). It is mainly used to increase the production of neutrophils or white blood cells. Amgen originally developed this medication under the brand name Neulasta. It stimulates the bone marrow to make more neutrophils, which will help fight infections in patients suffering from immune systems attacking disorders.
Pegfilgrastim has been approved in the United States, United Kingdom, and Australia since 2002. There are a significant number of Pegfilgrastim biosimilars approved by the regulatory authorities. Biosimilars have become an effective treatment option due to their reasonable costs and effective clinical management parameters.
Fulphila, Pelmeg, Pegex, and Nyvepria are some of the approved biosimilars for the Pegfilgrastim drug. With the advent of extensive research and studies, the new biosimilars are expected to enter the market and facilitate the market growth.
The drug also has some adverse effects, including dizziness, vomiting, joint discomfort, hair loss, and chest pain. The World Health Organization has also included Pegfilgrastim under the Emergency Medicines list and considered it safe and effective.
According to the Pegfilgrastim biosimilars market research report, the market can be categorised into the following segments:
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Market Breakup by Indication Type
Market Breakup by Product Type
Market Breakup by Application
Market Breakup by Distribution Channel
Market Breakup by Region
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The emerging Pegfilgrastim biosimilars seem promising in commercial aspects. Key market leaders will be the biosimilars companies that will provide fast and effective treatment for debilitating diseases.
The growth of the Pegfilgrastim biosimilars market is driven by the increasing prevalence of the immune weakening disorders, like cancer and AIDS, among others. According to the International Agency for Research on Cancer, 1 out of 5 people is diagnosed with cancer in their lifetime all over the world.
The incidence of cancer increases with age, and hence, with the rising geriatric population, the demand for the product also increases.
The research and developmental activities have tremendously increased in the biosimilars sector. The key players are investing in research and development to get a market breakthrough by discovering novel Pegfilgrastim biosimilars. This will propel the expansion of the market further. For example, a biosimilar drug being developed by Fresenius Kabi, if approved, is expected to generate massive revenue for the company.
Additional factors, such as the low cost of biosimilars, greater awareness, and increased healthcare expenditure, are projected to drive the market growth forward.
Hospital-based pharmacies are expected to hold a significant share of the Pegfilgrastim biosimilars market. This is due to the drug's application in chronic disorders requiring hospital admissions.
North America is anticipated to demonstrate growth at the highest rate, while Europe’s regional market is projected to have the largest share in the global market. This is due to the rise in cancer prevalence and developed healthcare facilities in the region. The rapid increase in the number of cancer cases is likely to facilitate the demand the drug in the coming years across the globe.
Pegfilgrastim biosimilar is used for the management of autoimmune or immune weakening disorders. This medication alters the body’s mechanism by increasing the concentration of neutrophils. This boosts immunity and helps to fight foreign agents.
This medication also plays an essential role in reducing the chances of infection in people who have cancer or those receiving chemotherapy medications. Thus, the cancer segment is projected to witness a substantial market share in the Pegfilgrastim biosimilars.
Pegfilgrastim is also recommended for saving patients exposed to myelosuppressive radiations, which can cause life-threatening damage to bone marrow. Neulasta also decreases the incidence of neutropenia and non-myeloid malignancies.
The biosimilar is eliminated from the body through renal clearance and neutrophil-mediated clearance. However, pegylation of filgrastim makes renal clearance insignificant. Pegfilgrastim biosimilar exhibits non-linear pharmacokinetics, that is, with the increase in dose, the clearance of Pegfilgrastim biosimilar decreases.
With extensive research and development, novel biosimilars are also being discovered for various therapeutic indications. Hence, incorporating these biosimilars in novel therapeutic areas will add to the Pegfilgrastim biosimilars market size.
The expiry of the patent of the original Pegfilgrastim raised concerns about the discovery of new biosimilars. Scientists and researchers initiated clinical trials for new drug products that can be used to discover Pegfilgrastim biosimilars.
In clinical trials, the biosimilars are compared with the standard European Pegfilgrastim, United States Pegfilgrastim, or both. The pharmacodynamic and pharmacokinetic studies are compared to assess the clinical efficacy of the discovered products.
In 2022, the FDA approved a new biosimilar, Fylnetra, with the same clinical indications as Neulasta. In clinical trials, the common adverse effects were reported under the excepted criteria and are still under post-marketing surveillance.
In 2018, the FDA approved Udencya, a Pegfilgrastim biosimilar, for the management of neutropenia. During clinical trials, it demonstrated efficient results with minimal adverse effects.
The invention and development of novel biosimilars are essential to delivering a potent and cost-effective therapy. Thus, these economic benefits will help augment the better accessibility of healthcare services. The new targeted Pegfilgrastim biosimilar therapies will push the development of the market during the forecast period.
The report gives an in-depth analysis of the key players involved in the Pegfilgrastim biosimilars market, sponsors manufacturing the drugs, and putting them through trials to get FDA approvals. The companies included in the market are as follows:
|Scope of the Report||
Historical and Forecast Trends, Industry Drivers and Constraints, Historical and Forecast Market Analysis by Segment:
|Breakup by Indication Type||
|Breakup by Product Type||
|Breakup by Application||
|Breakup by Region||
*At Expert Market Research, we strive to always give you current and accurate information. The numbers depicted in the description are indicative and may differ from the actual numbers in the final EMR report.
1.1 Objectives of the Study
1.2 Key Assumptions
1.3 Report Coverage – Key Segmentation and Scope
1.4 Research Methodology
2 Executive Summary
3 Global Pegfilgrastim Biosimilars Market Overview
3.1 Global Pegfilgrastim Biosimilars Market Historical Value (2016-2022)
3.2 Global Pegfilgrastim Biosimilars Market Forecast Value (2023-2031)
4 Global Pegfilgrastim Biosimilars Market Landscape
4.1 Global Pegfilgrastim Biosimilars Developers Landscape
4.1.1 Analysis by Year of Establishment
4.1.2 Analysis by Company Size
4.1.3 Analysis by Region
4.2 Global Pegfilgrastim Biosimilars Product Landscape
4.2.1 Analysis by Indication Type
4.2.2 Analysis by Product Type
4.2.3 Analysis by Application
5 Global Pegfilgrastim Biosimilars Market Dynamics
5.1 Market Drivers and Constraints
5.2 SWOT Analysis
5.3 Porter’s Five Forces Model
5.4 Key Demand Indicators
5.5 Key Price Indicators
5.6 Industry Events, Initiatives, and Trends
5.7 Value Chain Analysis
6 Global Pegfilgrastim Biosimilars Market Segmentation
6.1 Global Pegfilgrastim Biosimilars Market by Indication Type
6.1.1 Market Overview
6.1.3 Hematopoietic Subsyndrome
6.2 Global Pegfilgrastim Biosimilars Market by Product Type
6.2.1 Market Overview
6.2.3 PEG – GCSF
6.2.4 PEG Neutrogena
6.3 Global Pegfilgrastim Biosimilars Market by Application
6.3.1 Market Overview
6.3.2 Chemotherapy Induced Neutropenia
6.4 Global Pegfilgrastim Biosimilars Market by Region
6.4.1 Market Overview
6.4.2 North America
6.4.4 Asia Pacific
6.4.5 Latin America
6.4.6 Middle East and Africa
7 North America Pegfilgrastim Biosimilars Market
7.1 Market Share by Country
7.2 United States of America
8 Europe Pegfilgrastim Biosimilars Market
8.1 Market Share by Country
8.2 United Kingdom
9 Asia Pacific Pegfilgrastim Biosimilars Market
9.1 Market Share by Country
10 Latin America Pegfilgrastim Biosimilars Market
10.1 Market Share by Country
11 Middle East and Africa Pegfilgrastim Biosimilars Market
11.1 Market Share by Country
11.2 Saudi Arabia
11.3 United Arab Emirates
11.5 South Africa
12 Patent Analysis
12.1 Analysis by Type of Patent
12.2 Analysis by Publication year
12.3 Analysis by Issuing Authority
12.4 Analysis by Patent Age
12.5 Analysis by CPC Analysis
12.6 Analysis by Patent Valuation
12.7 Analysis by Key Players
13 Grants Analysis
13.1 Analysis by year
13.2 Analysis by Amount Awarded
13.3 Analysis by Issuing Authority
13.4 Analysis by Grant Application
13.5 Analysis by Funding Institute
13.6 Analysis by NIH Departments
13.7 Analysis by Recipient Organization
14 Funding Analysis
14.1 Analysis by Funding Instances
14.2 Analysis by Type of Funding
14.3 Analysis by Funding Amount
14.4 Analysis by Leading Players
14.5 Analysis by Leading Investors
14.6 Analysis by Geography
15 Partnership and Collaborations Analysis
15.1 Analysis by Partnership Instances
15.2 Analysis by Type of Partnership
15.3 Analysis by Leading Players
15.4 Analysis by Geography
16 Regulatory Framework
16.1 Regulatory Overview
16.1.1 US FDA
16.1.2 EU EMA
16.1.3 INDIA CDSCO
16.1.4 JAPAN PMDA
17 Supplier Landscape
17.1 Merck & Co., Inc.
17.1.1 Financial Analysis
17.1.2 Product Portfolio
17.1.3 Demographic Reach and Achievements
17.1.4 Mergers and Acquisitions
17.2 Zydus Lifesciences Limited
17.2.1 Financial Analysis
17.2.2 Product Portfolio
17.2.3 Demographic Reach and Achievements
17.2.4 Mergers and Acquisitions
17.3 Ratiopharm GmbH
17.3.1 Financial Analysis
17.3.2 Product Portfolio
17.3.3 Demographic Reach and Achievements
17.3.4 Mergers and Acquisitions
17.4 Jiangsu Hengrui Pharmaceuticals Co. Ltd
17.4.1 Financial Analysis
17.4.2 Financial Portfolio
17.4.3 Demographic Reach and Achievements
17.4.4 Mergers and Acquisitions
17.5 Biocon Limited
17.5.1 Financial Analysis
17.5.2 Product Portfolio
17.5.3 Demographic Reach and Achievements
17.5.4 Mergers and Acquisitions
17.6 Dr. Reddy's Laboratories Ltd
17.6.1 Financial Analysis
17.6.2 Product Portfolio
17.6.3 Demographic Reach and Achievements
17.6.4 Mergers and Acquisitions
17.7 Pfizer Inc.
17.7.1 Financial Analysis
17.7.2 Product Portfolio
17.7.3 Demographic Reach and Achievements
17.7.4 Mergers and Acquisitions
17.8 Emcure Pharmaceuticals Limited
17.8.1 Financial Analysis
17.8.2 Product Portfolio
17.8.3 Demographic Reach and Achievements
17.8.4 Mergers and Acquisitions
17.9 USV Private Limited
17.9.1 Financial Analysis
17.9.2 Product Portfolio
17.9.3 Demographic Reach and Achievements
17.9.4 Mergers and Acquisitions
17.10 Apotex Pty Ltd
17.10.1 Financial Analysis
17.10.2 Product Portfolio
17.10.3 Demographic Reach and Achievements
17.10.4 Mergers and Acquisitions
17.11 Kyowa Kirin Co., Ltd.
17.11.1 Financial Analysis
17.11.2 Product Portfolio
17.11.3 Demographic Reach and Achievements
17.11.4 Mergers and Acquisitions
17.12 Lupin Limited
17.12.1 Financial Analysis
17.12.2 Product Portfolio
17.12.3 Demographic Reach and Achievements
17.12.4 Mergers and Acquisitions
18 Global Pegfilgrastim Biosimilars Market - Distribution Model (Additional Insight)
18.2 Potential Distributors
18.3 Key Parameters for Distribution Partner Assessment
19 Key Opinion Leaders (KOL) Insights (Additional Insight)
20 Company Competitiveness Analysis (Additional Insight)
20.1 Very Small Companies
20.2 Small Companies
20.3 Mid-Sized Companies
20.4 Large Companies
20.5 Very Large Companies
21 Payment Methods (Additional Insight)
21.1 Government Funded
21.2 Private Insurance
*Additional insights provided are customisable as per client requirements.
The market is expected to grow at a CAGR of 7% during the forecast period of 2023-2031.
Major factors driving the growth of the market include the increasing prevalence of cancer, rising expenditure in the R&D sector, and low cost of biosimilars.
The major regions in the global market are North America, Europe, Latin America, Asia Pacific, Middle East, and Africa. North America accounts for the largest share of the global market.
The distribution channels in the market are hospital-based pharmacies, online pharmacies, and retail pharmacies.
Based on the indication type, the market can be segmented into neutropenia, hematopoietic and subsyndrome, among others.
Based on the biosimilar type, the market has been divided into MK-6302, Peg G-CSF, PEG Neutrogena, Grasustek, LA-EP2006, R-TPR-029, Filgrastim, and PEG-GCSF among others.
Based on the application, the market can be categorised into chemotherapy induced neutropenia, and transplantation, among others.
Biosimilars are available at low costs and thus, have the potential to enhance treatment accessibility.
A biosimilar is a copy of a biologic medicine that is similar but not identical to the original drug.
The key role of Pegfilgrastim biosimilars is to increase the concentration of neutrophils to manage cancer and infections induced due to transplantation.
The key players in the market include Merck & Co., Inc., Zydus Lifesciences Limited, Ratiopharm GmbH, Jiangsu Hengrui Pharmaceuticals Co. Ltd, Biocon Limited, Dr. Reddy's Laboratories Ltd, Pfizer Inc., Emcure Pharmaceuticals Limited, USV Private Limited, Apotex Pty Ltd, Kyowa Kirin Co., Ltd., and Lupin Limited, among others.
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