ヨーロッパの G-CSF/PEG-G-CSF 市場 – 業界動向と 2030 年までの予測

ヨーロッパの G-CSF/PEG-G-CSF 市場分析と洞察

先進国におけるがん予防の増加により、政府は早期治療を啓発するための意識的な取り組みを導入し、バイオシミラーG-CSFのヨーロッパでの販売市場を促進しています。承認されたバイオシミラーであり、費用対効果が高く、発展途上国でも容易に入手できるGrafeel、Colstim、Neukine、Filcadは、市場の大幅な成長につながるでしょう。中国とインドは、がん患者数が増加している国であり、ヨーロッパ市場を押し上げる可能性があります。したがって、バイオシミラーの使用は、オリジナルの生物学的製剤の使用と比較して患者の医療費を削減するのに役立ち、ヨーロッパのG-CSFバイオシミラー販売市場での需要が増加します。個々のバイオシミラーの複雑な生物学的製造プロセスのため、バイオシミラーのコストはジェネリックほど安くはありません。自己免疫疾患とまれな慢性疾患の有病率の増加は、セグメント市場の成長を促進すると予想されます。

Data Bridge Market Research は、ヨーロッパの G-CSF/PEG-G-CSF 市場は、予測期間中に 5.1% の CAGR で成長し、2030 年までに 16 億 9,213 万米ドルに達すると予測しています。この市場レポートでは、価格分析、特許分析、技術進歩についても詳細に取り上げています。

欧州 G-CSF/PEG-G-CSF 市場の定義

顆粒球コロニー刺激因子 (G-CSF) は、好中球減少症の治療に使用される薬剤です。これは白血球数が平均より少なくなる疾患で、ある種の化学療法によって引き起こされます。G-CSF の主な種類は、レノグラスチム (Granocyte)、フィルグラスチム (Neupogen、zarzio、nivestim、accofil)、長時間作用型 (ペグ化) フィルグラスチム (pegfilgrastim、neulasta、pelmeg、ziextenco)、およびリペグフィルグラスチム (lonquex) です。レノグラスチムは、天然のヒト顆粒球コロニー刺激因子 (G-CSF) と化学的に類似または同一のグリコシル化組み換え治療薬です。さまざまな製品には錠剤やカプセル剤があり、がん、血液疾患、成長ホルモン欠乏症、慢性疾患および自己免疫疾患を治療します。

欧州のG-CSF/PEG-G-CSF市場の動向

このセクションでは、市場の推進要因、利点、機会、制約、課題について理解します。これらについては、以下で詳しく説明します。    

ドライバー

• 血液がんやがん性疾患の発生率増加

がんは、体のあらゆる部位に影響を及ぼす可能性のある多くの病気の総称です。がんの他の用語には、悪性腫瘍や新生物などがあります。がんの特徴の 1 つは、異常な細胞が急速に形成され、正常範囲を超えて増殖し、体の隣接部位を侵略して他の臓器に広がることです。後者のプロセスは転移と呼ばれます。広範囲の転移は、がんによる死亡の主な原因です。

フィルグラスチムは、血液中の好中球数の増加を助ける顆粒球コロニー刺激因子 (GCSF) です。フィルグラスチムとペグフィルグラスチムは、がん化学療法または放射線療法後の白血球数の増加によく使用されます。

したがって、血液がんやがん疾患の症例数の増加は、今後数年間、ヨーロッパの G-CSF / PEG-G-CSF 市場を牽引することになります。

• 発熱性好中球減少症の症例増加

発熱性好中球減少症とは、著しい好中球減少症中に起こる発熱を指します。患者が好中球減少症の場合、感染リスクが通常よりも高くなる可能性があり、特定の感染症の重症度も高くなる可能性があります。発熱性好中球減少症は、がん治療における最も一般的な生命を脅かす合併症であり、その治療はしばしば腫瘍学的緊急事態となります。

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

流通チャネルに基づいて、ヨーロッパの G-CSF/PEG-G-CSF はさらに病院薬局、オンライン薬局、小売薬局、その他に分類されます。

ヨーロッパの G-CSF/PEG-G-CSF 市場の地域分析/洞察

ヨーロッパの G-CSF/PEG-G-CSF 市場が分析され、国、適応症、投与量、投与経路、パッケージ、エンドユーザー、流通チャネルに基づいて市場規模の情報が提供されます。

ヨーロッパの G-CSF/PEG-G-CSF 市場は、ドイツ、イギリス、フランス、イタリア、ロシア、オランダ、スペイン、スウェーデン、ポーランド、ベルギー、スイス、デンマーク、ノルウェー、フィンランド、トルコ、その他のヨーロッパ諸国で構成されています。

ドイツは、G-CSF/PEG-G-CSFにおける最新の高度な技術と発明により、成長が期待されています。

レポートの国別セクションでは、市場の現在および将来の傾向に影響を与える国内市場における個別の市場影響要因と規制の変更も提供しています。新規販売、交換販売、国の人口統計、規制行為、輸出入関税などのデータ ポイントは、各国の市場シナリオを予測するために使用される主要な指標の一部です。また、国別データの予測分析を提供する際には、ヨーロッパ ブランドの存在と可用性、地元および国内ブランドとの競争が激しいか少ないために直面​​する課題、販売チャネルの影響も考慮されます。

競争環境と欧州の G-CSF/PEG-G-CSF 市場シェア分析

ヨーロッパの G-CSF/PEG-G-CSF 市場の競争状況は、競合他社ごとに詳細を提供します。含まれる詳細には、会社概要、会社の財務状況、収益、市場の可能性、研究開発への投資、新しい市場への取り組み、生産拠点と施設、会社の強みと弱み、製品の発売、製品試験パイプライン、製品の承認、特許、製品の幅と幅、アプリケーションの優位性、技術ライフライン曲線などがあります。提供されている上記のデータ ポイントは、ヨーロッパの G-CSF/PEG-G-CSF 市場への会社の重点にのみ関連しています。

この市場で取引を行っている大手企業としては、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. などがあります。

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