Marché européen du G-CSF/PEG-G-CSF – Tendances et prévisions du secteur jusqu’en 2030

Analyse et perspectives du marché européen du G-CSF/PEG-G-CSF

Français L'augmentation de la prévention du cancer dans les pays développés et les gouvernements ont lancé des initiatives conscientes pour éduquer au traitement précoce, favorisant le marché des ventes en Europe du biosimilaire G-CSF. Grafeel, Colstim, Neukine et Filcad, qui sont des biosimilaires approuvés et qui sont également rentables et facilement disponibles dans les pays en développement, entraîneront une croissance significative du marché. La Chine et l'Inde sont les pays où le nombre de patients atteints de cancer augmente, ce qui est susceptible de stimuler le marché européen. Ainsi, l'utilisation de biosimilaires contribue à réduire les coûts de santé des patients par rapport à l'utilisation de produits biologiques originaux, ce qui augmente la demande sur le marché européen des ventes de biosimilaires G-CSF. En raison des processus de fabrication biologique complexes des biosimilaires individuels, les coûts des biosimilaires ne sont pas aussi bas que ceux des génériques. La prévalence croissante des maladies auto-immunes et chroniques rares devrait stimuler la croissance du marché segmentaire.

Data Bridge Market Research estime que le marché européen du G-CSF/PEG-G-CSF devrait atteindre la valeur de 1 692,13 millions USD d'ici 2030, à un TCAC de 5,1 % au cours de la période de prévision. Ce rapport de marché couvre également en profondeur l'analyse des prix, l'analyse des brevets et les avancées technologiques.

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

Sur la base du canal de distribution, le G-CSF/PEG-G-CSF européen est ensuite segmenté en pharmacie hospitalière, pharmacie en ligne, pharmacie de détail et autres.

Analyse/perspectives régionales du marché européen du G-CSF/PEG-G-CSF

Le marché européen G-CSF/PEG-G-CSF est analysé et des informations sur la taille du marché sont fournies en fonction du pays, de l’indication, du dosage, de la voie d’administration, de l’emballage, de l’utilisateur final et du canal de distribution.

Le marché européen du G-CSF/PEG-G-CSF comprend les pays Allemagne, Royaume-Uni, France, Italie, Russie, Pays-Bas, Espagne, Suède, Pologne, Belgique, Suisse, Danemark, Norvège, Finlande, Turquie, reste de l'Europe.

L'Allemagne devrait connaître une croissance grâce à sa technologie de pointe et à ses inventions dans le domaine du G-CSF/PEG-G-CSF.

La section pays du rapport fournit également des facteurs d'impact sur les marchés individuels et des changements de réglementation sur le marché national qui ont un impact sur les tendances actuelles et futures du marché. Des points de données tels que les nouvelles ventes, les ventes de remplacement, la démographie des pays, les actes réglementaires et les tarifs d'importation et d'exportation sont quelques-uns des principaux indicateurs utilisés pour prévoir le scénario de marché pour les différents pays. En outre, la présence et la disponibilité des marques européennes et les défis auxquels elles sont confrontées en raison de la concurrence importante ou rare des marques locales et nationales, ainsi que l'impact des canaux de vente sont pris en compte lors de l'analyse prévisionnelle des données nationales.

Analyse du paysage concurrentiel et des parts de marché du G-CSF/PEG-G-CSF en Europe

Le paysage concurrentiel du marché européen du G-CSF/PEG-G-CSF fournit des détails par concurrent. Les détails inclus sont la présentation de l'entreprise, les finances de l'entreprise, les revenus générés, le potentiel du marché, les investissements en R&D, les nouvelles initiatives du marché, les sites et installations de production, les forces et les faiblesses de l'entreprise, le lancement de produits, les pipelines d'essais de produits, les approbations de produits, les brevets, la largeur et l'ampleur du produit, la domination des applications, la courbe de survie technologique. Les points de données ci-dessus fournis ne concernent que l'orientation de l'entreprise sur le marché européen du G-CSF/PEG-G-CSF.

Français Certaines grandes entreprises présentes sur le marché sont 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., entre autres.

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