Europe G-CSF/PEG-G-CSF Market – Industry Trends and Forecast to 2030

Europe G-CSF/ PEG-G-CSF Market Analysis and Insights

The increase in cancer prevention in developed countries and governments have introduced conscious initiatives to educate early treatment, promoting the Europe sales market of biosimilar G-CSF. Grafeel, Colstim, Neukine and Filcad, which are approved biosimilars and are also cost-effective and readily available in developing countries, will lead to significant market growth. China and India are the countries where the number of cancer patients is increasing, which is likely to boost the Europe market. Thus, the use of biosimilars helps in reducing the healthcare costs of patients compared to the use of original biologics, which increases the demand in the Europe G-CSF Biosimilars sales market. Due to the complex biological manufacturing processes of individual biosimilars, the costs of biosimilars are not as low as generics.  Growing prevelance of autoimmune and rare chronic diseases is expected to drive the segmental market’s growth.

Data Bridge Market Research analyzes that the Europe G-CSF/ PEG-G-CSF market is expected to reach the value of USD 1,692.13 million by 2030, at a CAGR of 5.1% during the forecast period. This market report also covers pricing analysis, patent analysis, and technological advancements in depth.

Europe G-CSF/ PEG-G-CSF Market Definition

Granulocyte colony-stimulating factor (G-CSF) is a medication used to treat neutropenia. This is a disease in which the number of white blood cells is lower than average and is caused by some forms of chemotherapy. The main types of G-CSF are lenograstim (Granocyte), filgrastim (Neupogen, zarzio, nivestim, accofil), long-acting (pegylated) filgrastim (pegfilgrastim, neulasta, pelmeg, ziextenco), and lipegfilgrastim (lonquex). Lenograstim is a glycosylated recombinant therapeutic agent that is chemically similar or identical to naturally occurring human granulocyte colony-stimulating factor (G-CSF). Various products include tablets and capsules and treat cancer, blood disorders, growth hormone deficiency, and chronic and autoimmune diseases.

Europe G-CSF/ PEG-G-CSF Market Dynamics

This section deals with understanding the market drivers, advantages, opportunities, restraints, and challenges. All of this is discussed in detail below:    

Drivers

• Growing incidences of blood cancers and cancer diseases

Cancer is a general term for many diseases that can affect any part of the body. Other terms used for cancer are malignant tumors and neoplasm. One of the characteristics of cancer is the rapid formation of abnormal cells that grow beyond normal limits and can invade neighboring parts of the body and spread to other organs; the latter process is called metastasis. Extensive metastases are the leading cause of cancer death.

Filgrastim is a granulocyte colony-stimulating factor (GCSF) that helps increase the number of neutrophils in the blood. Filgrastim and pegfilgrastim are highly used to increase white blood cells after cancer chemotherapy or radiation therapy.

Thus, the increasing number of cases of blood cancer and cancer diseases is driving the Europe G-CSF / PEG-G-CSF market in the coming years.

• Increasing cases of febrile neutropenia

Febrile neutropenia refers to fever during significant neutropenia. If a patient is neutropenic, their risk of infection may be higher than usual, and the severity of a particular infection may also be higher. Febrile neutropenia is the most common life-threatening complication of cancer treatment; its treatment is often an oncological emergency.

Febrile neutropenia is neutropenia accompanied by fever. Neutropenia refers to a decrease in the concentration of neutrophils in the blood. Neutrophils are a type of white blood cell that help fight infections as part of the immune system. The Infectious Diseases Society of America defines neutropenia as an absolute neutrophil count (ANC) of less than 1500 cells/mm3. The risk of infection and neutropenic fever increases dramatically with severe neutropenia, defined as an absolute neutrophil count (ANC) of less than 500 cells/mm3. Fever is defined as a single oral temperature greater than or equal to 101° Fahrenheit (38.3° Celsius) or a persistent temperature greater than or equal to 100.4° Fahrenheit (38.0° Celsius) or greater for one hour or longer.

The latest guidelines from three international cancer organizations, the European Organization for Research and Treatment of Cancer, the American Society of Clinical Oncology, and the US National Cancer Network, agree that filgrastim or pegfilgrastim should be given prophylactically in febrile neutropenia with chemotherapy. > or = 20% or if the risk is 10-20% and the patient has other risk factors for febrile neutropenia.

Thus, the increasing cases of febrile neutropenia are further driving the Europe G-CSF / PEG-G-CSF market in the coming years.

Restraint

• Stringent Governmental Regulations

Pharmaceutical companies developing biosimilars such as filgrastim face a major challenge in the approval process for their products. Each country has a different approval process for all drugs, treatments, vaccines, and medical devices. However, these approval procedures are difficult to follow. This is due to the various regulations and evidence required to prove the effectiveness and safety of the product.

European Medicines Agency regulatory requirements ensure the same high quality, safety, and efficacy standards for biosimilars as for originator biologicals. They also include a rigorous comparability exercise with the reference product but are not universally accepted by regulatory bodies outside the European Union (EU). It should be noted that 'similar biologics' approved in India, 'biogenerics' approved in Iran, 'medicamento biológico similares' approved in Argentina, and non-originator biologicals approved in South Africa might not have been authorized if they had been subjected to the strict regulatory processes required for approval of biosimilars in the EU.

Due to this strict regulation by the government that has to be followed for the production and manufacturing of G-CSF / PEG-G-CSF by the various regulatory body, which impedes the market growth of the Europe G-CSF / PEG-G-CSF market.

Opportunity

• The use of biosimilars helps reduce healthcare costs for patients

Biosimilars have the potential to fundamentally change healthcare by providing more affordable, equally effective treatments for patients and providing more treatment options for physicians. Developing biosimilars requires rigorous analysis to demonstrate their equivalence to the reference product and ensure no clinically meaningful differences in their safety, efficacy, and purity. As a result, health systems can channel long-term savings into overall improvements in patient care. To help create a thriving biosimilar market and ensure patient access, policymakers can take steps to reduce or eliminate the cost of biosimilars and encourage physicians to prescribe biosimilars compared to Europe.

Biosimilars have the potential to expand treatment options and increase health equity. At the same time, they can save money for individual patients and health systems. Through legislative and advocacy efforts and future initiatives, access to these effective medicines can expand and fundamentally change the health services for patients who need them.

Thus, the use of biosimilars helps reduce healthcare costs for patients. This factor creates opportunities for market growth.

Challenge

• Multiple side effects of G-CSF

Granulocyte colony-stimulating factor (G-CSF) is a drug used to treat neutropenia, a disorder in which certain forms of chemotherapy cause a lower-than-average number of white blood cells. G-CSF is a type of growth factor that makes the bone marrow produce more white blood cells to reduce the risk of infection after some types of cancer treatment. But there are multiple side effects of G-CSF, such as bone or muscle pain, Bruising, bleeding gums or nosebleeds, diarrhea, high temperature (fever), breathlessness and looking pale, sore mouth, throat, gut and back passage, and, among others. These side effects can be seen in more than 10 in 100 people (more than 10%).

According to a study performed by NCBI, most normal donors receiving G-CSF experience side effects, but these are mild to moderate in degree. Ninety percent of donors experienced some side effects of G-CSF. The most frequent effects noted were bone pain (83%), headache (39%), body aches (23%), fatigue (14%), and nausea and vomiting (12%), which is expected to act as a challenge for market growth.

Thus, the increasing side effects of G-CSF are challenging market growth.

Post-COVID-19 Impact on Europe G-CSF/ PEG-G-CSF Market

The COVID-19 pandemic has had a somewhat positive impact on the G-CSF/ PEG-G-CSF market. The pandemic has imposed new norms and regulations, such as social distancing and lockdowns, to prevent the spread of the virus. As a result, people all over the world were forced to stay at home, which led to new trends such as work at home. This stay at home has led decrease in diagnosis and prognosis of diseases. The increased focus on self-care, exercise and health has helped fitness apps and platforms gain significant traction in the wake of the pandemic.

Manufacturers are making various strategic decisions to bounce back post-COVID-19. The players are conducting multiple R&D activities and product launch and strategic partnerships to improve the technology and test results involved in the transplant diagnostics market.

Recent Developments

• In July 2018, Accord Healthcare, a subsidiary of Intas Pharmaceuticals Ltd., launched a pegfilgrastim biosimilar across Europe after being given Green Light for Pelgraz® (pegfilgrastim) by CHMP (Committee for Medicinal Products for Human Use). This product launched helped the company to expand their business across Europe.
• In March 2022, Kashiv Biosciences announced the approval of its Biologics License Application (BLA) for filgrastim-ayow, a biosimilar referencing Neupogen by U.S. Food and Drug Administration (FDA). The product is marketed under the proprietary name RELEUKO.

Europe G-CSF/ PEG-G-CSF Market Scope

Europe G-CSF/ PEG-G-CSF market is segmented into indication, dosage, route of administration, packaging, end user, and distribution channel. The growth among segments helps you analyze niche pockets of growth and strategies to approach the market and determine your core application areas and the difference in your target markets.

EUROPE G-CSF / PEG-G-CSF MARKET, BY INDICATION

• NEUTROPENIA
  • CHEMOTHERAPY INDUCED FEBRILE NEUTROPENIA (MYELOSUPPRESSIVE CHEMOTHERAPY TREATMENT)
  • SEVERE CHRONIC NEUTROPENIA
  • RADIOTHERAPY INDUCED NEUTROPENIA
  • NEUTROPENIA IN HIV PATIENTS
  • CLOZAPINE INDUCED NEUTROPENIA
  • NEUTROPENIA IN HEPATITIS C PATIENTS
  • CONGENITAL NEUTROPENIA
• ONCOLOGY
  • ACUTE MYELOID LEUKEMIA RECEIVING CONSOLIDATION CHEMOTHERAPY
  • OTHERS
• CHRONIC AND AUTOIMMUNE DISEASES
• BLOOD DISORDERS
• GROWTH HORMONE DEFICIENCY
• OTHERS

On the basis of indication the Europe G-CSF/PEG-G-CSF is further segmented into neutropenia, oncology, chronic and autoimmune diseases, blood disorders, growth hormone deficiency and others.

EUROPE G-CSF / PEG-G-CSF MARKET, BY DOSAGE

• MONO
• COMBINATION

On the basis of dosage the Europe G-CSF/PEG-G-CSF is further segmented into mono and combination.

EUROPE G-CSF / PEG-G-CSF MARKET, BY ROUTE OF ADMINISTRATION

• INTRAVENOUS
• SUBCUTANEOUS

On the basis of route of administration the Europe G-CSF/PEG-G-CSF is further segmented into intravenous and subcutaneous.

EUROPE G-CSF / PEG-G-CSF MARKET, BY PACKAGING

• SINGLE USE VIALS
• PRE FILLED SYRINGES

On the basis of packaging the Europe G-CSF/PEG-G-CSF is further segmented into single use vials and pre filled syringes.

EUROPE G-CSF / PEG-G-CSF MARKET, BY END USER

• HOSPITALS & CLINICS
• RESEARCH & ACADEMIC INSTITUTES
• AMBULATORY SURGICAL CENTERS
• OTHERS

On the basis of end user the Europe G-CSF/PEG-G-CSF is further segmented into hospitals and clinics, research & academic institutes, ambulatory surgical centers and others.

EUROPE G-CSF / PEG-G-CSF MARKET, BY DISTRIBUTION CHANNEL

• HOSPITAL PHARMACY
• ONLINE PHARMACY
• RETAIL PHARMACY
• OTHERS

On the basis of distribution channel the Europe G-CSF/PEG-G-CSF is further segmented into hospital pharmacy, online pharmacy, retail pharmacy and others.

Europe G-CSF/ PEG-G-CSF Market Regional Analysis/Insights

The Europe G-CSF/ PEG-G-CSF market is analyzed and market size information is provided based on country, indication, dosage, route of administration, packaging, end user, and distribution channel.

The Europe G-CSF/ PEG-G-CSF market comprises od the countries Germany, U.K., France, Italy, Russia, Netherlands, Spain, Sweden, Poland, Belgium, Switzerland, Denmark, Norway, Finland, Turkey, Rest of Europe.

Germany is expected to grow due to its latest advanced technology and inventions in the G-CSF/ PEG-G-CSF.

The country section of the report also provides individual market impacting factors and changes in regulation in the market domestically that impact the current and future trends of the market. Data points such as new sales, replacement sales, country demographics, regulatory acts, and import-export tariffs are some of the major pointers used to forecast the market scenario for individual countries. Also, presence and availability of Europe brands and their challenges faced due to large or scarce competition from local and domestic brands, and impact of sales channels are considered while providing forecast analysis of the country data.

Competitive Landscape and Europe G-CSF/ PEG-G-CSF Market Share Analysis

Europe G-CSF/ PEG-G-CSF market competitive landscape provides details by competitor. Details included are company overview, company financials, revenue generated, market potential, investment in R&D, new market initiatives, production sites and facilities, company strengths and weaknesses, product launch, product trials pipelines, product approvals, patents, product width and breath, application dominance, technology lifeline curve. The above data points provided are only related to the company’s focus on the Europe G-CSF/ PEG-G-CSF market.

Some major companies which are dealing in the market are USV Private Limited, Viatris Inc., Biocon, Fresenius Kabi AG, Hangzhou Jiuyuan Gene Engineering Co., Ltd., Amgen Inc., Pfizer Inc., Sandoz International GmbH, Apotex Inc., Cadila Pharmaceuticals, Dr. Reddy’s Laboratories Ltd., Amneal Pharmaceuticals LLC., Coherus BioSciences, Accord Healthcare, NAPP PHARMACEUTICALS LIMITED., Intas Pharmaceuticals Ltd., Mundipharma International, Teva Pharmaceutical Industries Ltd., Spectrum Pharmaceuticals, Inc., Kyowa Kirin Co., Ltd., Jiangsu Hengrui Pharmaceuticals Co., Ltd., among others.

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