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市場調査レポート
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390843

バイオシミラー市場-成長、動向、Covid-19の影響、および予測(2021~2026年)

Biosimilars Market - Growth, Trends, Covid-19 Impact, and Forecasts (2021 - 2026)

出版日: | 発行: Mordor Intelligence Pvt Ltd | ページ情報: 英文 116 Pages | 納期: 2-3営業日

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バイオシミラー市場-成長、動向、Covid-19の影響、および予測(2021~2026年)
出版日: 2021年02月01日
発行: Mordor Intelligence Pvt Ltd
ページ情報: 英文 116 Pages
納期: 2-3営業日
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  • 概要
  • 目次
概要

バイオシミラーの市場規模は2020年に約282億3,500万米ドルとなりました。

同市場は、予測期間中に24.2%のCAGRで拡大し、2026年には1,036億3,800万米ドルの収益が見込まれています。

COVID-19のバイオシミラー市場への影響は甚大であるとみられ、バイオシミラーの開発に焦点を当てた製薬会社に大きな課題を課しています。現在のパンデミック中の非COVID治療薬のFDA承認が減少していることで、製品の承認と上市のプロセスを遅らせると予想され、それによって市場の成長が妨げられるとみられています。また、ほとんどの臨床試験はCOVID-19の状況において、参加者間の感染を最小限に抑えるために延期されているため、ほとんどのパイプライン製品は研究開発活動が遅延しています。また、世界中のロックダウンと旅行制限のために、サプライチェーンと原材料が不足しており、バイオシミラーの生産に影響を与える可能性があります。したがって、COVID-19は同市場に大きな影響を及ぼしています。

Truvada、Chantix、Forteo、Ciprodex、Afinitorなどの主要な製薬会社のブロックバスター生物製剤、および他の多くの医薬品は、2020年に米国の独占権を失うと予想されます。今後10年間で、既存のErbitux、Avastin、Orenciaなどの生物学的医薬品は、多くのイノベーター企業やジェネリックメーカーに、特にバイオ市ミラーに合わせたサービスを提供する機会を創出します。さらに、バイオシミラーの費用対効果の高い性質、技術やビジネスモデルの多様化を必要とするさまざまな利害関係者による受け入れと採用の高まり、慢性疾患の蔓延が、世界のバイオシミラー市場を牽引すると予想されます。同時に、代替可能性と互換性に関する懸念のリスクを考慮すると、承認と適切な収益性に関する明確な基準が欠如しているため、多くの企業がこの市場への投資を思いとどまらせ、市場の成長を妨げています。

当レポートでは、バイオシミラー市場について調査し、市場の概要とともに、製品クラス別、用途別、地域別の動向、および市場に参入する企業のプロファイルなどを提供しています。

目次

第1章 イントロダクション

第2章 調査手法

第3章 エグゼクティブサマリー

第4章 市場力学

  • 市場概要
  • 市場の推進力
    • 今後5年から10年で特許を失ういくつかのブロックバスターバイオ医薬品
    • 慢性疾患の負担の増大と研究開発投資の増加
    • 費用対効果別バイオシミラーの需要拡大
  • 市場の抑制要因
    • 代替性と互換性に関する懸念
    • 規制の不確実性とバイオベターの競合激化
    • 製造における高コストの関与と複雑さ
  • ポーターのファイブフォース分析

第5章 市場セグメンテーション

  • 製品クラス別
    • モノクローナル抗体
    • 組換えホルモン
    • 免疫調節剤
    • 抗炎症剤
    • その他
  • 用途別
    • 血液疾患
    • 成長ホルモン欠乏症
    • 慢性および自己免疫疾患
    • 腫瘍学
    • その他
  • 地域別
    • 北米
    • 欧州
    • アジア太平洋
    • 中東とアフリカ
    • 南米

第6章 競合情勢

  • 企業プロファイル
    • Pfizer Inc
    • Eli Lilly and Company
    • Celltrion Healthcare
    • Mylan NV(Viatris, Inc)
    • Novartis AG
    • Samsung Bioepis Co. Ltd
    • Stada Arzneimittel AG
    • Teva Pharmaceutical Industries Ltd
    • Intas Pharmaceutical Ltd
    • LG Life Sciences(LG Chem)
    • Biocon Limited
    • Amgen, Inc.

第7章 市場機会と動向

目次
Product Code: 48957

The Biosimilars Market is valued at approximately USD 28,235 million in 2020 and is expected to witness a revenue of USD 103,638 million in 2026, with a CAGR of 24.2% over the forecast period.

The impact of COVID-19 on the Biosimilars market may be significant and has imposed a great challenge to the pharmaceutical companies, focused on biosimilar development.The reduction in the FDA approval of non-COVID therapeutics during the current pandemic is expected to delay the process of product approvals and launches, thereby hindering market growth. Also, as most of the clinical trials have been postponed to combat the COVID-19 situation and to minimize the infection among participants, most of the pipeline products are exhibiting a slow pace of research and development activities. Also, due to the lockdown and travel restrictions across the globe, there is a shortage in supply chain and raw materials, which would impact biosimilar production. Thus, because of the above-mentioned factors, COVID-19 has a great impact on th studied market.

Several blockbuster biologic drugs of major pharmaceuticals companies, such asTruvada, Chantix, Forteo, Ciprodex, Afinitor, and many other drugs are expected to lose US exclusivity in 2020. In the coming decade, there would be a rise in the patent expiration of several existing biological drugs, such as Erbitux, Avastin, Orencia, and others, which would provide an opportunity for many innovator companies as well as generic manufacturers to offer services, specially tailored toward biosimilars. Besides, factors, such as the cost-effective nature of biosimilars, rising acceptance and adoption by various stakeholders with the need for diversification in technology and business models, growing prevelence of chronic diseases are expected to drive the global biosimilar market. At the same time, with factors, such as lack of definitive standards for approval and adequate profitability, given the greater risk with concerns regarding substitutability and interchangeability, many companies are discouraged from investing in this market, thus impeding the growth of the market studied.

Key Market Trends

Oncology Segment Holds the Major Share in Global Biosimilars Market

The oncology segment is expected to hold the major market in Biosimilars Market and the high incidence of cancers worldwide is the major factor driving the growth of the studied market over the forecast period. According to the Globocan 2020, the incidence of new cancer cases was estimated to be 19,292,789 in 2020, with nearly 9,958,133 deaths due to cancers. Additionally, the new cancer incidence is estimated to reach 30.2 million by 2040 as per International Agency for Research on Cancer (IARC).

In the COVID-19 era, nearly 88% of the cancer care centers faced challenges in delivering usual cancer care for many reasons, including precautionary measures, lack of personal protective equipment, and staff shortage as per the research article published in the JCO Global Oncology, 2020. Additionally, this impact was more pronounced in low-income countries. Therefore, COVID-19 is expected to hinder the number of cancer therapies offered to cancer patients, which indirectly is expected to impact the studied segment.

Additionally, the increasing research and development activities by key players focused on oncology along with rising in FDA approvals is expected to drive the studied market growth. For instance, in Dec 2020, Amgen received US FDA approval for its RIABNI (rituximab-arrx), a biosimilar to Rituxan (rituximab), for the treatment of adult patients with Non-Hodgkin's Lymphoma, Chronic Lymphocytic Leukemia, Granulomatosis with Polyangiitis and Microscopic Polyangiitis. Thus, because of the aforementioned factors, the Biosimilars Market on Oncology segment is anticipated to witness significant growth over the forecast period.

North America Holds the Major Share and is Expected to Dominate the Biosimilars Market Over the Forecast Period

North America is anticipated to observe a significant CAGR over the forecast period in Biosimilars Market. The major factors driving the growth of the studied market in the region include high incidence of chronic diseases such as cancers, along with the increased investment on research and development activities by the major players. According to the GLOBOCON 2020, the new cancer cases diagnosed were 2,281,658 in the United States in 2020, with 612,390 deaths. Among all cancers, breast cancer had the highest incidence with 253,465 cases, followed by lung (227,875), Prostate(209,512) and colon(101,809) new cancer cases in 2020 in United States.

Also, according to the research article published in Biosimilar Development, 2020, most of the Biosimilars products are injectables and require a physician to administer those products to patients. However, most of the hospitals and clinics in the United States have restricted physical consultations, owing to the high rate of SARS-CoV2 viral transmission. This factor is expected to impede the studied market growth in the region during the pandemic

Also, North America is the hub for a large number of key players of the studied market such as Pfizer, Inc, Mylan NV, Amgen, Inc and Coherus Biosciences, Inc among others. The increasing pipeline of products and new product launches surges the market growth in the region. For instance, in June 2020, Pfizer, Inc., received FDA approval for its pegfilgrastim biosimilar Nyvepria, indicated for use in lowering the incidence of infection as manifested by febrile neutropenia. Thus, in view of the high incidence of chronic diseases such as cancers and increasing R & D activities, the studied market is expected to propel significantly over the forecast period in North America.

Competitive Landscape

The Biosimilars market is highly competitive, with many key players dominating the market. The major players of the studied market comprise of Novartis AG, Pfizer, Inc., Amgen, Inc, Coherus Biosciences, Inc., Mylan NV (Viatris, Inc.) and Samsung Bioepis Co., Ltd among others. Most of the market players are adopting various growth strategies such as acquisitions, partnerships, new product launches to secure the position in the global market. For instance, in December 2020, Coherus has filed FDA 351(K) application for its CHS-1420, a Biosimilar of Adalimumab, and the regulatory decision is expected by Q4 of 2021.

Reasons to Purchase this report:

  • The market estimate (ME) sheet in Excel format
  • 3 months of analyst support

TABLE OF CONTENTS

1 INTRODUCTION

  • 1.1 Study Deliverables
  • 1.2 Study Assumptions
  • 1.3 Scope of the Study

2 RESEARCH METHODOLOGY

3 EXECUTIVE SUMMARY

4 MARKET DYNAMICS

  • 4.1 Market Overview
  • 4.2 Market Drivers
    • 4.2.1 Several Blockbuster Biopharmaceuticals Going Off-Patent over the Next Five to Ten Years
    • 4.2.2 Growing Burden of Chronic Diseases and Increasing R & D investments
    • 4.2.3 Increasing Demand for Biosimilar Drugs due to Their Cost Effectiveness
  • 4.3 Market Restraints
    • 4.3.1 Concerns Regarding Substitutability and Interchangeability
    • 4.3.2 Regulatory Uncertainty and Growing Competition from Biobetters
    • 4.3.3 High Cost Involvement and Complexities in Manufacturing
  • 4.4 Porter's Five Force Analysis
    • 4.4.1 Threat of New Entrants
    • 4.4.2 Bargaining Power of Buyers/Consumers
    • 4.4.3 Bargaining Power of Suppliers
    • 4.4.4 Threat of Substitute Products
    • 4.4.5 Intensity of Competitive Rivalry

5 MARKET SEGMENTATION

  • 5.1 By Product Class
    • 5.1.1 Monoclonal Antibodies
    • 5.1.2 Recombinant Hormones
    • 5.1.3 Immunomodulators
    • 5.1.4 Anti-Inflammatory Agents
    • 5.1.5 Others
  • 5.2 By Applications
    • 5.2.1 Blood Disorders
    • 5.2.2 Growth Hormonal Deficiency
    • 5.2.3 Chronic and Autoimmune Disorders
    • 5.2.4 Oncology
    • 5.2.5 Others
  • 5.3 Geography
    • 5.3.1 North America
      • 5.3.1.1 United States (By Product Class, and By Application)
      • 5.3.1.2 Canada (By Product Class, and By Application)
      • 5.3.1.3 Mexico (By Product Class, and By Application)
    • 5.3.2 Europe
      • 5.3.2.1 Germany (By Product Class, and By Application)
      • 5.3.2.2 United Kingdom (By Product Class, and By Application)
      • 5.3.2.3 France (By Product Class, and By Application)
      • 5.3.2.4 Italy (By Product Class, and By Application)
      • 5.3.2.5 Spain (By Product Class, and By Application)
      • 5.3.2.6 Rest of Europe (By Product Class, and By Application)
    • 5.3.3 Asia-Pacific
      • 5.3.3.1 China (By Product Class, and By Application)
      • 5.3.3.2 Japan (By Product Class, and By Application)
      • 5.3.3.3 India (By Product Class, and By Application)
      • 5.3.3.4 Australia (By Product Class, and By Application)
      • 5.3.3.5 South Korea (By Product Class, and By Application)
      • 5.3.3.6 Rest of Asia-Pacific (By Product Class, and By Application)
    • 5.3.4 Middle East and Africa
      • 5.3.4.1 GCC (By Product Class, and By Application)
      • 5.3.4.2 South Africa (By Product Class, and By Application)
      • 5.3.4.3 Rest of Middle East and Africa (By Product Class, and By Application)
    • 5.3.5 South America
      • 5.3.5.1 Brazil (By Product Class, and By Application)
      • 5.3.5.2 Argentina (By Product Class, and By Application)
      • 5.3.5.3 Rest of South America (By Product Class, and By Application)

6 COMPETITIVE LANDSCAPE

  • 6.1 Company Profiles
    • 6.1.1 Pfizer Inc
    • 6.1.2 Eli Lilly and Company
    • 6.1.3 Celltrion Healthcare
    • 6.1.4 Mylan NV(Viatris, Inc)
    • 6.1.5 Novartis AG
    • 6.1.6 Samsung Bioepis Co. Ltd
    • 6.1.7 Stada Arzneimittel AG
    • 6.1.8 Teva Pharmaceutical Industries Ltd
    • 6.1.9 Intas Pharmaceutical Ltd
    • 6.1.10 LG Life Sciences(LG Chem)
    • 6.1.11 Biocon Limited
    • 6.1.12 Amgen, Inc.

7 MARKET OPPORTUNITIES AND FUTURE TRENDS