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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.
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:
Market Breakup by Indication Type
Market Breakup by Product Type
Market Breakup by Application
Market Breakup by Distribution Channel
Market Breakup by Region
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 Distribution Channel||
|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
1.1.1 Research Objectives
1.1.2 Key Findings of the Report
1.2 Limitations of the Study and Scope for Future Research
2 Research Methodology
3 Executive Summary
4 Global Pegfilgrastim Biosimilars Overview
4.1 Drug Overview
4.1.3 Adverse Events
5 Patient Profile
5.1 Patient Profile Overview
5.2 Patient Psychology and Emotional Impact Factors
5.3 Risk Assessment and Treatment Success Rate
6 Global Pegfilgrastim Biosimilars Market
6.1 Global Pegfilgrastim Biosimilars Market Overview
6.2 Global Pegfilgrastim Biosimilars Market Analysis
6.2.1 Market Overview
18.104.22.168 Global Pegfilgrastim Biosimilars Market Historical Value (2016-2022)
22.214.171.124 Global Pegfilgrastim Biosimilars Market Forecast Value (2023-2031)
6.3 Global Pegfilgrastim Biosimilars Market by Indication Type
6.3.1 Market Overview
126.96.36.199 Hematopoietic Subsyndrome
6.4 Global Pegfilgrastim Biosimilars Market by Product Type
6.4.1 Market Overview
188.8.131.52 Peg G-CSF
184.108.40.206 PEG Neutrogena
6.5 Global Pegfilgrastim Biosimilars Market by Application
6.5.1 Market Overview
220.127.116.11 Chemotherapy Induced Neutropenia
6.6 Global Pegfilgrastim Biosimilars Market by Distribution Channel
6.6.1 Market Overview
18.104.22.168 Hospital Based Pharmacies
22.214.171.124 Online Pharmacies
126.96.36.199 Retail Pharmacies
6.7 Global Pegfilgrastim Biosimilars Market by Region
6.7.1 Market Overview
188.8.131.52 North America
184.108.40.206.1 Historical Trend (2016-2022)
220.127.116.11.2 Forecast Trend (2023-2031)
18.104.22.168.1 Historical Trend (2016-2022)
22.214.171.124.2 Forecast Trend (2023-2031)
126.96.36.199 Asia Pacific
188.8.131.52.1 Historical Trend (2016-2022)
184.108.40.206.2 Forecast Trend (2023-2031)
220.127.116.11 Latin America
18.104.22.168.1 Historical Trend (2016-2022)
22.214.171.124.2 Forecast Trend (2023-2031)
126.96.36.199 Middle East and Africa
188.8.131.52.1 Historical Trend (2016-2022)
184.108.40.206.2 Forecast Trend (2023-2031)
7 North America Pegfilgrastim Biosimilars Market
7.1 United States of America
7.1.1 Historical Trend (2016-2022)
7.1.2 Forecast Trend (2023-2031)
7.2.1 Historical Trend (2016-2022)
7.2.2 Forecast Trend (2023-2031)
8 Europe Pegfilgrastim Biosimilars Market
8.1 United Kingdom
8.1.1 Historical Trend (2016-2022)
8.1.2 Forecast Trend (2023-2031)
8.2.1 Historical Trend (2016-2022)
8.2.2 Forecast Trend (2023-2031)
8.3.1 Historical Trend (2016-2022)
8.3.2 Forecast Trend (2023-2031)
8.4.1 Historical Trend (2016-2022)
8.4.2 Forecast Trend (2023-2031)
9 Asia Pacific Pegfilgrastim Biosimilars Market
9.1.1 Historical Trend (2016-2022)
9.1.2 Forecast Trend (2023-2031)
9.2.1 Historical Trend (2016-2022)
9.2.2 Forecast Trend (2023-2031)
9.3.1 Historical Trend (2016-2022)
9.3.2 Forecast Trend (2023-2031)
9.4.1 Historical Trend (2016-2022)
9.4.2 Forecast Trend (2023-2031)
9.5.1 Historical Trend (2016-2022)
9.5.2 Forecast Trend (2023-2031)
10 Latin America Pegfilgrastim Biosimilars Market
10.1.1 Historical Trend (2016-2022)
10.1.2 Forecast Trend (2023-2031)
10.2.1 Historical Trend (2016-2022)
10.2.2 Forecast Trend (2023-2031)
10.3.1 Historical Trend (2016-2022)
10.3.2 Forecast Trend (2023-2031)
11 Middle East and Africa Pegfilgrastim Biosimilars Market
11.1 Saudi Arabia
11.1.1 Historical Trend (2016-2022)
11.1.2 Forecast Trend (2023-2031)
11.2 United Arab Emirates
11.2.1 Historical Trend (2016-2022)
11.2.2 Forecast Trend (2023-2031)
11.3.1 Historical Trend (2016-2022)
11.3.2 Forecast Trend (2023-2031)
11.4 South Africa
11.4.1 Historical Trend (2016-2022)
11.4.2 Forecast Trend (2023-2031)
12 Current Scenario Evaluation and Regulatory Framework
12.1 Emerging Therapies and Clinical Trials Synopsis
12.2 Patent Landscape
12.2.1 Patent Overview
220.127.116.11 Patent Status and Expiry
18.104.22.168 Timelines from Drug Development to Commercial Launch
22.214.171.124 New Drug Application
126.96.36.199.1 Documentation and Approval Process
12.3 Cost of Treatment
12.4 Investment Scenarios
12.5 Regulatory Framework
12.5.1 Regulatory Overview
188.8.131.52 US FDA
184.108.40.206 EU EMA
220.127.116.11 INDIA CDSCO
18.104.22.168 JAPAN PMDA
13 Challenges & Unmet Needs
13.1 Treatment Pathway Challenges
13.2 Compliance and Drop-Out Analysis
13.3 Awareness and Prevention Gaps
14 Global Pegfilgrastim Biosimilars Market Dynamics
14.1 Market Drivers and Constraints
14.2 Drug Adoption Parameters
14.3 SWOT Analysis
14.4 Porter Five Forces Model
14.5 Key Demand Indicators
14.6 Key Price Indicators
14.7 Industry Events, Initiatives, and Trends
14.8 Value Chain Analysis
15 Supplier Landscape
15.1 Merck & Co., Inc.
15.1.1 Company Overview
15.1.2 Product Portfolio
15.1.3 Demographic Reach and Achievements
15.1.4 Mergers and Acquisitions
15.2 Zydus Lifesciences Limited
15.2.1 Company Overview
15.2.2 Product Portfolio
15.2.3 Demographic Reach and Achievements
15.2.4 Mergers and Acquisitions
15.3 Ratiopharm GmbH
15.3.1 Company Overview
15.3.2 Product Portfolio
15.3.3 Demographic Reach and Achievements
15.3.4 Mergers and Acquisitions
15.4 Jiangsu Hengrui Pharmaceuticals Co. Ltd
15.4.1 Company Overview
15.4.2 Product Portfolio
15.4.3 Demographic Reach and Achievements
15.4.4 Mergers and Acquisitions
15.5 Biocon Limited
15.5.1 Company Overview
15.5.2 Product Portfolio
15.5.3 Demographic Reach and Achievements
15.5.4 Mergers and Acquisitions
15.6 Dr. Reddy's Laboratories Ltd
15.6.1 Company Overview
15.6.2 Product Portfolio
15.6.3 Demographic Reach and Achievements
15.6.4 Mergers and Acquisitions
15.7 Pfizer Inc.
15.7.1 Company Overview
15.7.2 Product Portfolio
15.7.3 Demographic Reach and Achievements
15.7.4 Mergers and Acquisitions
15.8 Emcure Pharmaceuticals Limited
15.8.1 Company Overview
15.8.2 Product Portfolio
15.8.3 Demographic Reach and Achievements
15.8.4 Mergers and Acquisitions
15.9 USV Private Limited
15.9.1 Company Overview
15.9.2 Product Portfolio
15.9.3 Demographic Reach and Achievements
15.9.4 Mergers and Acquisitions
15.10 Apotex Pty Ltd
15.10.1 Company Overview
15.10.2 Product Portfolio
15.10.3 Demographic Reach and Achievements
15.10.4 Mergers and Acquisitions
15.11 Kyowa Kirin Co., Ltd.
15.11.1 Company Overview
15.11.2 Product Portfolio
15.11.3 Demographic Reach and Achievements
15.11.4 Mergers and acquisitions
15.12 Lupin Limited
15.12.1 Company Overview
15.12.2 Product Portfolio
15.12.3 Demographic Reach and Achievements
15.12.4 Mergers and Acquisitions
16 Recommendations and Discussion
17 Pricing Models and Strategies (Additional Insight)
17.1 Cost Model
17.1.1 Manufacturing Cost Analysis
17.1.2 Procurement Cost Analysis
17.2 Pricing Strategies
17.2.1 Competitor Pricing Analysis
17.2.2 Key Assessment of Product Attributes
17.2.3 Pricing Benchmark
18 Global Pegfilgrastim Biosimilars Distribution Model (Additional Insight)
18.2 Potential Distributors
18.3 Key Parameters for Distribution Partner Assessment
*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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