장시간 작용형 PEG-rhG-CSF 시장 보고서 : 동향, 예측, 경쟁 분석(-2031년)

The future of the global long-acting PEG-rhG-CSF market looks promising with opportunities in the neoplastic disease and blood disorder markets. The global long-acting PEG-rhG-CSF market is expected to grow with a CAGR of 6.8% from 2025 to 2031. The major drivers for this market are the rising prevalence of cancer, the growing preference for long-acting biologics, and the increasing availability of biosimilars.

• Lucintel forecasts that, within the type category, generic drugs are expected to witness higher growth over the forecast period.
• Within the application category, neoplastic disease is expected to witness higher growth.
• In terms of region, APAC is expected to witness the highest growth over the forecast period.

Emerging Trends in the Long-acting PEG-rhG-CSF Market

The Long-acting PEG-rhG-CSF market is under the impact of a number of important trends that mirror changing paradigms in biopharmaceuticals, healthcare economics, and patient-centered treatment strategies in oncology.

• Biosimilar Domination and Price Erosion: The strongest trend is the growing market share gain experienced by biosimilar versions of pegfilgrastim. With additional biosimilars entering the market and securing regulatory approval across the world, price competition will strengthen, causing substantial cost savings to healthcare systems and possibly expanding patient access to this critical supportive care drug.
• Focus on Patient Convenience and Self-Administration: There is an increasing trend towards the creation and use of patient-convenient administration systems for pegfilgrastim. Auto-injector systems and pre-filled syringes with improved safety features are becoming increasingly popular, providing patients with more convenience, minimizing the frequency of clinic visits, and potentially enhancing compliance with the treatment regimen, especially in the outpatient environment.
• Emphasis on Value and Cost-Effectiveness Demonstration: As costs of healthcare rise, there is great stress on proving the cost-effectiveness and value of Long-acting PEG-rhG-CSF, particularly in relation to shorter-acting G-CSFs and the expense of treating chemotherapy-induced neutropenia and related complications, e.g., febrile neutropenia and hospitalization.
• Personalized Dosing Approaches: Recent evidence is highlighting that one uniform dose of pegfilgrastim might not be the best for everyone. There is a move towards researching individualized dosing approaches by using patient-specific parameters such as body weight, body surface area, and individual chemotherapy regimens in an effort to maximize efficiency and minimize side effects.
• Integration into Overall Cancer Care Pathways: Long-acting PEG-rhG-CSF is being increasingly integrated into overall cancer care pathways and treatment recommendations so that appropriate and timely prophylaxis against chemotherapy-induced neutropenia is provided, leading to improved overall management of and outcomes in patients with cancer.

These trends are transforming the Long-acting PEG-rhG-CSF market by reducing prices through biosimilar competition, improving patient convenience with newer delivery approaches, highlighting the economic value of the therapy, looking at more individualized treatment strategies, and integrating it seamlessly into routine cancer care practices.

Recent Developments in the Long-acting PEG-rhG-CSF Market

The Long-acting PEG-rhG-CSF market has seen a number of critical developments that highlight its continued transformation and influence on supportive cancer care.

• Successful Commercialization and Development of Several Biosimilar Products: One of the major developments is that several biosimilar versions of pegfilgrastim have been successfully developed, approved by the regulatory authorities, and launched across key pharma markets. This has brought immense competition to the originator brand and has been a primary driver of price cuts.
• Sustained Acceptance and Uptake of Biosimilars by Healthcare Professionals: With time, healthcare professionals have grown more accustomed and comfortable prescribing pegfilgrastim biosimilars, aware of their similar efficacy and safety profiles with the reference product. Sustained acceptance has promoted enhanced market penetration of biosimilars.
• Innovation in Drug Delivery Technologies for Patient Convenience: Pharmaceutical companies have focused on developing and implementing user-friendly drug delivery technologies for pegfilgrastim, such as pre-filled syringes with safety mechanisms and auto-injector pens. These innovations aim to simplify administration and improve the patient experience.
• Increasing Body of Real-World Evidence in Support of Use of Biosimilars: More real-world evidence studies are being reported documenting the efficacy and safety of pegfilgrastim biosimilars in everyday clinical practice, continuing to build prescriber and patient confidence.
• Repeated Expiration of Patents and New Biosimilar Players: Continued expiration of patents on important pegfilgrastim products continues to open the doors for new biosimilar players to come into the market, adding more competition and possibly pushing prices lower.

These advances are affecting the Long-acting PEG-rhG-CSF market by making it more affordable and accessible using biosimilars, making administration easier for patients with advanced delivery systems, establishing a robust evidence base for biosimilar safety and efficacy, and creating a more competitive market setting.

Strategic Growth Opportunities in the Long-acting PEG-rhG-CSF Market

The Long-acting PEG-rhG-CSF market, although mainly developed for the prevention of chemotherapy-induced neutropenia, has a number of strategic growth opportunities across key applications in oncology and hematology.

• Increasing Prophylactic Application in Moderate-Risk Chemotherapy Regimens: Pegfilgrastim is usually recommended by current guidelines for high-risk regimens. An emerging opportunity exists with the identification and expansion of its prophylactic application in certain moderate-risk regimens where the cost may be offset by the benefit of avoiding neutropenic complications, especially given the availability of biosimilars at lower costs.
• Tapering Dosing Strategies in Special Patient Populations: Studies on patient-specific dosing based on various factors like body weight, age, and comorbidities can result in more effective and cost-conscious utilization of pegfilgrastim among such patient groups, offering a future growth opportunity through resource optimization.
• Investigating Use with Next-Generation Cancer Therapies: With each new myelosuppressive cancer therapy introduced, such as targeted therapies and immunotherapies, integrated into treatment combinations, there might be an escalating demand for prophylactic pegfilgrastim to alleviate related neutropenia, constituting a strategic growth opportunity.
• Growing Adoption in Emerging Economies with Value Biosimilars: Availability of lower-priced biosimilar equivalents of pegfilgrastim presents a big growth opportunity to increase access to this critical supportive care in emerging economies where price can be an important obstacle to treatment. Distribution networks and partnership strategies will play a key role.
• Examining Use in Hematopoietic Stem Cell Transplant: Although mostly utilized in chemotherapy-induced neutropenia, the potential use of pegfilgrastim in hematopoietic stem cell mobilization can be studied further and optimized and may widen its use in transplantation.

Profiting from such strategic expansion opportunities demands constant clinical research to streamline treatment protocols and determine new uses, manufacturing specific dosing strategies and preparations, as well as successful market access tactics, especially for biosimilars in underdeveloped areas.

Long-acting PEG-rhG-CSF Market Driver and Challenges

The Long-acting PEG-rhG-CSF market is affected by an intricate interrelationship of drivers and challenges emanating from clinical demand, technological development, economic pressures, and regulatory frameworks controlling biopharmaceuticals.

The factors responsible for driving the long-acting PEG-rhG-CSF market include:

1. Established efficacy in prevention of chemotherapy-induced neutropenia: The strong clinical evidence that proves the efficacy of pegfilgrastim in the prevention of the incidence and severity of neutropenia continues to be the major reason for its application in patients undergoing myelosuppressive chemotherapy.

2. Growing global prevalence of cancer and chemotherapy use: The increasing global cancer burden and the persistent use of chemotherapy as an important treatment strategy guarantee an ongoing demand for supportive treatments such as pegfilgrastim.

3. Increasing availability and acceptance of biosimilars: Increased numbers of approved and commercially available pegfilgrastim biosimilars offer lower-cost treatment alternatives, increasing market access and overall market volume.

4. Convenience and friendly patient delivery device development: The availability and usage of auto-injectors increase patient convenience and compliance, further enhancing pegfilgrastim usage, especially among outpatients.

5. Reimbursement policy and supportive clinical practice guidelines: Favorable reimbursement policies in most healthcare systems and recommendations of oncology organizations allow the utilization of pegfilgrastim in suitable clinical practice settings.

Challenges in the long-acting PEG-rhG-CSF market are:

1. Increasing price competition from biosimilars: The rise in the number of biosimilar entrants creates huge price erosion, affecting the profitability and revenues of both biosimilar and originator manufacturers.

2. Optimal patient selection and personalized dosing: Who to treat and how much pegfilgrastim to give them remain subjects for ongoing investigation and optimization.

3. Coping with the cost burden on healthcare systems: Even in the presence of biosimilars, overall supportive cancer care costs, including pegfilgrastim, continue to pose a challenge for healthcare payers and systems around the world.

In summary, the Long-acting PEG-rhG-CSF market is fueled by its proven efficacy, the mounting demand for neutropenia treatment because of the rising burden of cancer globally, the availability of cheaper biosimilars, and improved delivery device advancements. Nevertheless, the market is challenged by heightening price competition, the demand for individually customized treatment strategies, and the sheer cost burden on healthcare systems.

List of Long-acting PEG-rhG-CSF Companies

Companies in the market compete on the basis of product quality offered. Major players in this market focus on expanding their manufacturing facilities, R&D investments, infrastructural development, and leveraging integration opportunities across the value chain. With these strategies, long-acting PEG-rhG-CSF companies cater to increasing demand, ensure competitive effectiveness, develop innovative products & technologies, reduce production costs, and expand their customer base. Some of the long-acting PEG-rhG-CSF companies profiled in this report include:

• Amgen
• Pfizer
• Mylan
• Sandoz
• Biocon Biologics
• Coherus BioSciences
• Fresenius Kabi
• CSPC
• Qilu Pharmaceutical
• Jiangsu Hengrui Medicine

Long-acting PEG-rhG-CSF Market by Segment

The study includes a forecast for the global long-acting PEG-rhG-CSF market by type, application, and region.

Long-acting PEG-rhG-CSF Market by Type [Value from 2019 to 2031]:

• Innovative Drugs
• Generic Drugs

Long-acting PEG-rhG-CSF Market by Application [Value from 2019 to 2031]:

• Neoplastic Diseases
• Blood Disorders
• Others

Long-acting PEG-rhG-CSF Market by Region [Value from 2019 to 2031]:

• North America
• Europe
• Asia Pacific
• The Rest of the World

Country Wise Outlook for the Long-acting PEG-rhG-CSF Market

The Long-acting PEG-rhG-CSF market, a cornerstone of supportive cancer care, continues to evolve with a strong emphasis on biosimilar competition and enhanced patient convenience. Designed to reduce the incidence of chemotherapy-induced neutropenia with less frequent dosing than short-acting G-CSFs, pegfilgrastim has become a standard of care. Recent developments are characterized by the increasing availability and uptake of biosimilar versions, driving price adjustments and expanding patient access globally. Delivery device innovations, including pre-filled syringes and auto-injectors, are also significantly contributing to defining market trends in various regions.

• United States: Significant biosimilar erosion has occurred within the US Long-acting PEG-rhG-CSF market, driving considerable cost savings for patients and healthcare providers alike. Recent changes have involved the ongoing introduction of new biosimilars, as well as fierce price wars between manufacturers. The emphasis lies in balancing affordability with maintaining a consistent level of access to this critical supportive treatment for patients on myelosuppressive chemotherapy.
• China: China's market for Long-acting PEG-rhG-CSF is experiencing swift growth, fueled by an expanding cancer patient base and rising uptake of sophisticated cancer therapies. Developments in the recent past include the approval and launch of multiple locally manufactured pegfilgrastim biosimilars. The biosimilars are reducing the cost of therapy and making it more accessible, driving strong market growth and greater competition with the reference product.
• Germany: The German healthcare system has easily adopted biosimilar forms of Long-acting PEG-rhG-CSF, leading to significant cost savings. Recent advancements include a high level of biosimilar prescribing, fueled by positive reimbursement policies and physician acceptance. The market focuses on guaranteeing the quality and effectiveness of biosimilars while maximizing healthcare spending for supportive cancer care.
• India: Long-acting PEG-rhG-CSF in India is marked by rising affordability and accessibility, which is mainly attributed to the availability of a number of local biosimilar producers. Recent trends encompass greater usage of these economic alternatives in both public and private sectors. Measures are being taken to implement strict quality control and increase access across the nation.
• Japan: Japan's market for Long-acting PEG-rhG-CSF is witnessing a slow but consistent rise in the adoption of biosimilars. Recent events include cautious assessment of the safety and performance of biosimilar products by regulators and healthcare professionals. Although the rate of adoption is relatively conservative, cost-containment pressures are likely to propel more biosimilar penetration in the next few years.

Features of the Global Long-acting PEG-rhG-CSF Market

• Market Size Estimates: Long-acting PEG-rhG-CSF market size estimation in terms of value ($B).
• Trend and Forecast Analysis: Market trends (2019 to 2024) and forecast (2025 to 2031) by various segments and regions.
• Segmentation Analysis: Long-acting PEG-rhG-CSF market size by type, application, and region in terms of value ($B).
• Regional Analysis: Long-acting PEG-rhG-CSF market breakdown by North America, Europe, Asia Pacific, and Rest of the World.
• Growth Opportunities: Analysis of growth opportunities in different types, applications, and regions for the long-acting PEG-rhG-CSF market.
• Strategic Analysis: This includes M&A, new product development, and the competitive landscape of the long-acting PEG-rhG-CSF market.

Analysis of the competitive intensity of the industry based on Porter's Five Forces model.

This report answers the following 11 key questions:

• Q.1. What are some of the most promising, high-growth opportunities for the long-acting PEG-rhG-CSF market by type (innovative drugs and generic drugs), application (neoplastic diseases, blood disorders, and others), and region (North America, Europe, Asia Pacific, and the Rest of the World)?
• Q.2. Which segments will grow at a faster pace and why?
• Q.3. Which region will grow at a faster pace and why?
• Q.4. What are the key factors affecting market dynamics? What are the key challenges and business risks in this market?
• Q.5. What are the business risks and competitive threats in this market?
• Q.6. What are the emerging trends in this market and the reasons behind them?
• Q.7. What are some of the changing demands of customers in the market?
• Q.8. What are the new developments in the market? Which companies are leading these developments?
• Q.9. Who are the major players in this market? What strategic initiatives are key players pursuing for business growth?
• Q.10. What are some of the competing products in this market and how big of a threat do they pose for loss of market share by material or product substitution?
• Q.11. What M&A activity has occurred in the last 5 years and what has its impact been on the industry?

Table of Contents

1. Executive Summary

2. Market Overview

• 2.1 Background and Classifications
• 2.2 Supply Chain

3. Market Trends & Forecast Analysis

• 3.1 Macroeconomic Trends and Forecasts
• 3.2 Industry Drivers and Challenges
• 3.3 PESTLE Analysis
• 3.4 Patent Analysis
• 3.5 Regulatory Environment

4. Global Long-acting PEG-rhG-CSF Market by Type

• 4.1 Overview
• 4.2 Attractiveness Analysis by Type
• 4.3 Innovative Drugs: Trends and Forecast (2019-2031)
• 4.4 Generic Drugs: Trends and Forecast (2019-2031)

5. Global Long-acting PEG-rhG-CSF Market by Application

• 5.1 Overview
• 5.2 Attractiveness Analysis by Application
• 5.3 Neoplastic Diseases: Trends and Forecast (2019-2031)
• 5.4 Blood Disorders: Trends and Forecast (2019-2031)
• 5.5 Others: Trends and Forecast (2019-2031)

6. Regional Analysis

• 6.1 Overview
• 6.2 Global Long-acting PEG-rhG-CSF Market by Region

7. North American Long-acting PEG-rhG-CSF Market

• 7.1 Overview
• 7.2 North American Long-acting PEG-rhG-CSF Market by Type
• 7.3 North American Long-acting PEG-rhG-CSF Market by Application
• 7.4 United States Long-acting PEG-rhG-CSF Market
• 7.5 Mexican Long-acting PEG-rhG-CSF Market
• 7.6 Canadian Long-acting PEG-rhG-CSF Market

8. European Long-acting PEG-rhG-CSF Market

• 8.1 Overview
• 8.2 European Long-acting PEG-rhG-CSF Market by Type
• 8.3 European Long-acting PEG-rhG-CSF Market by Application
• 8.4 German Long-acting PEG-rhG-CSF Market
• 8.5 French Long-acting PEG-rhG-CSF Market
• 8.6 Spanish Long-acting PEG-rhG-CSF Market
• 8.7 Italian Long-acting PEG-rhG-CSF Market
• 8.8 United Kingdom Long-acting PEG-rhG-CSF Market

9. APAC Long-acting PEG-rhG-CSF Market

• 9.1 Overview
• 9.2 APAC Long-acting PEG-rhG-CSF Market by Type
• 9.3 APAC Long-acting PEG-rhG-CSF Market by Application
• 9.4 Japanese Long-acting PEG-rhG-CSF Market
• 9.5 Indian Long-acting PEG-rhG-CSF Market
• 9.6 Chinese Long-acting PEG-rhG-CSF Market
• 9.7 South Korean Long-acting PEG-rhG-CSF Market
• 9.8 Indonesian Long-acting PEG-rhG-CSF Market

10. ROW Long-acting PEG-rhG-CSF Market

• 10.1 Overview
• 10.2 ROW Long-acting PEG-rhG-CSF Market by Type
• 10.3 ROW Long-acting PEG-rhG-CSF Market by Application
• 10.4 Middle Eastern Long-acting PEG-rhG-CSF Market
• 10.5 South American Long-acting PEG-rhG-CSF Market
• 10.6 African Long-acting PEG-rhG-CSF Market

11. Competitor Analysis

• 11.1 Product Portfolio Analysis
• 11.2 Operational Integration
• 11.3 Porter's Five Forces Analysis
  • Competitive Rivalry
  • Bargaining Power of Buyers
  • Bargaining Power of Suppliers
  • Threat of Substitutes
  • Threat of New Entrants
• 11.4 Market Share Analysis

12. Opportunities & Strategic Analysis

• 12.1 Value Chain Analysis
• 12.2 Growth Opportunity Analysis
  • 12.2.1 Growth Opportunities by Type
  • 12.2.2 Growth Opportunities by Application
• 12.3 Emerging Trends in the Global Long-acting PEG-rhG-CSF Market
• 12.4 Strategic Analysis
  • 12.4.1 New Product Development
  • 12.4.2 Certification and Licensing
  • 12.4.3 Mergers, Acquisitions, Agreements, Collaborations, and Joint Ventures

13. Company Profiles of the Leading Players Across the Value Chain

• 13.1 Competitive Analysis
• 13.2 Amgen
  • Company Overview
  • Long-acting PEG-rhG-CSF Business Overview
  • New Product Development
  • Merger, Acquisition, and Collaboration
  • Certification and Licensing
• 13.3 Pfizer
  • Company Overview
  • Long-acting PEG-rhG-CSF Business Overview
  • New Product Development
  • Merger, Acquisition, and Collaboration
  • Certification and Licensing
• 13.4 Mylan
  • Company Overview
  • Long-acting PEG-rhG-CSF Business Overview
  • New Product Development
  • Merger, Acquisition, and Collaboration
  • Certification and Licensing
• 13.5 Sandoz
  • Company Overview
  • Long-acting PEG-rhG-CSF Business Overview
  • New Product Development
  • Merger, Acquisition, and Collaboration
  • Certification and Licensing
• 13.6 Biocon Biologics
  • Company Overview
  • Long-acting PEG-rhG-CSF Business Overview
  • New Product Development
  • Merger, Acquisition, and Collaboration
  • Certification and Licensing
• 13.7 Coherus BioSciences
  • Company Overview
  • Long-acting PEG-rhG-CSF Business Overview
  • New Product Development
  • Merger, Acquisition, and Collaboration
  • Certification and Licensing
• 13.8 Fresenius Kabi
  • Company Overview
  • Long-acting PEG-rhG-CSF Business Overview
  • New Product Development
  • Merger, Acquisition, and Collaboration
  • Certification and Licensing
• 13.9 CSPC
  • Company Overview
  • Long-acting PEG-rhG-CSF Business Overview
  • New Product Development
  • Merger, Acquisition, and Collaboration
  • Certification and Licensing
• 13.10 Qilu Pharmaceutical
  • Company Overview
  • Long-acting PEG-rhG-CSF Business Overview
  • New Product Development
  • Merger, Acquisition, and Collaboration
  • Certification and Licensing
• 13.11 Jiangsu Hengrui Medicine
  • Company Overview
  • Long-acting PEG-rhG-CSF Business Overview
  • New Product Development
  • Merger, Acquisition, and Collaboration
  • Certification and Licensing

14. Appendix

• 14.1 List of Figures
• 14.2 List of Tables
• 14.3 Research Methodology
• 14.4 Disclaimer
• 14.5 Copyright
• 14.6 Abbreviations and Technical Units
• 14.7 About Us
• 14.8 Contact Us