バイオシミラーの市場規模：製品別、適応症別、地域別、2024年～2031年

バイオシミラー市場の評価、2024年～2031年

バイオシミラー市場の2023年の市場規模は183億6,000万米ドルで、2031年には1,087億4,000万米ドルに成長すると予測され、予測期間中のCAGRは24.90%です。ヘルスケア価格が上昇し、高価な生物学的製剤の手頃な代替品が求められる中、バイオシミラー市場は急速に拡大しています。多くの生物製剤の特許が切れる中、バイオシミラーは同等の治療効果を低コストで提供するため、世界中で広く使用されています。バイオテクノロジーにおける規制上の後ろ盾と飛躍的な進歩も、バイオシミラーの成長を後押ししています。欧州やアジア太平洋地域の政府は、救命治療への患者のアクセスを向上させながら医療費を削減するため、バイオシミラーの採用を推進しています。

バイオシミラー市場定義／概要

バイオシミラーとは、既存の承認済み基準生物学的製剤と極めて類似した生物学的製剤であり、安全性、純度、有効性において目に見える変化はないです。バイオシミラー医薬品は、化学的に合成されるジェネリック医薬品よりも製造が複雑です。バイオシミラー医薬品は、がん、自己免疫疾患、糖尿病など様々な疾患の治療を目的としています。バイオシミラーはオリジナルの生物製剤よりも安価であるため、患者やヘルスケアシステムにとってより手頃な選択肢となります。

バイオシミラーの主な用途は、がん、関節リウマチ、自己免疫疾患などの慢性疾患や複雑な疾患の治療において、生物学的製剤に代わる費用対効果の高い代替品を提供することです。バイオシミラーは、生物学的製剤の有効性、安全性、品質を正確に模倣し、同等の治療効果を低コストで提供することを目的としています。これにより、患者が革新的な治療を受けられるようになると同時に、ヘルスケアシステムが薬剤費の高騰を管理し、クリティカルケアにおける全体的なアフォーダビリティを向上させることができます。

バイオシミラー医薬品は、生物学的製剤による治療をより身近で安価なものにする上で重要な役割を果たすため、その将来は明るいと思われます。さまざまな生物学的製剤の特許が切れるにつれて、バイオシミラーは、がん、自己免疫疾患、糖尿病などの複雑な疾患の治療に、より頻繁に利用されるようになると思われます。バイオテクノロジーの進歩により、バイオシミラー医薬品の製造は改善され、オリジナルの生物学的製剤と同等の効果と安全性が保証されるようになると思われます。ヘルスケアシステムが費用対効果の高い代替品を求めるようになるにつれ、バイオシミラーは世界中でより広く使用されるようになり、重要な治療法への患者のアクセスを向上させると思われます。

ヘルスケア費用の増加はバイオシミラー市場におけるバイオシミラーの需要をどのように促進するか？

ヘルスケア費用の上昇は、バイオシミラー事業における需要の主な促進要因です。ヘルスケアコストの上昇に伴い、患者、保険者、医療提供者はより安価な生物学的製剤を求めるようになっています。バイオシミラー医薬品は、同等の安全性と有効性を低価格で提供するため、患者は法外なコストに苦しむことなく必要な治療を受けることができます。このようなコストへの懸念は、長期にわたる生物学的製剤治療がヘルスケア財政を圧迫しかねない慢性疾患管理において特に顕著です。

さらに、ヘルスケアシステムはコスト上昇を抑制する必要に迫られており、政府は医療費全体を削減する手段としてバイオシミラーの使用を促進しています。多くの政府や保険会社は、償還率の引き下げや承認プロセスの迅速化など、バイオシミラーの採用を奨励する政策を打ち出しています。このような規制当局の支援は、バイオシミラー医薬品に対する信頼を高めるだけでなく、利害関係者が医療費に関する長期的な解決策を模索する中で、バイオシミラー医薬品の使用を促進し、バイオシミラー医薬品の需要を高めています。

バイオシミラー市場における患者やヘルスケア提供者のバイオシミラーに対する認識がもたらす抑制要因を、教育やアウトリーチ活動別どのように緩和することができるでしょうか？

教育やアウトリーチ活動は、患者やヘルスケア提供者がバイオシミラーに対する誤解を克服するのに役立ちます。こうした取り組みは、バイオシミラーの安全性、有効性、承認プロセスに関する正確でエビデンスに基づいた情報を提供することで、バイオシミラーに対する誤解を解き、不安を解消する一助となります。ワークショップ、ウェビナー、説明資料は特定の対象者向けにカスタマイズすることができ、医療従事者と患者の双方が、臨床転帰や実臨床での有効性に関するデータを含め、バイオシミラーと参照用生物製剤との比較について理解できるようにします。

さらに、著名なオピニオンリーダーやヘルスケア実務者と協力することで、教育イニシアチブの到達範囲と正当性を広げることができます。信頼できる専門家がバイオシミラーの使用を支持し、肯定的な経験を共有すれば、医療界の認識に大きな影響を与えることができます。さらに、患者支援団体は知識を普及させ、十分な情報に基づいた意思決定を促し、その結果、治療プロトコールにバイオシミラーが広く受け入れられ、患者が費用対効果の高い代替品を自信を持って選択できるようになります。

目次

第1章 世界のバイオシミラー市場：イントロダクション

• 市場概要
• 調査範囲
• 前提条件

第2章 エグゼクティブサマリー

第3章 VERIFIED MARKET RESEARCHの調査手法

• データマイニング
• 検証
• プライマリーインタビュー
• データソース一覧

第4章 世界のバイオシミラー市場展望

• 概要
• 市場力学
  • 促進要因
  • 抑制要因
  • 機会
• ポーターのファイブフォースモデル
• バリューチェーン分析

第5章 バイオシミラーの世界市場：適応症別

• 概要
• がん領域
• 炎症性疾患および自己免疫疾患
• 慢性疾患
• 血液疾患
• 成長ホルモン欠乏症
• 感染症
• その他の適応症

第6章 バイオシミラーの世界市場：製品別

• 概要
• モノクローナル抗体
• インスリン
• 顆粒球コロニー刺激因子
• エリスロポエチン
• 遺伝子組換えヒト成長ホルモン
• エタネルセプト
• フォリトロピン
• テリパラチド
• インターフェロン
• エノキサパリンナトリウム
• グルカゴン
• カルシトニン

第7章 バイオシミラーの世界市場：地域別

• 概要
• 北米
  • 米国
  • カナダ
  • メキシコ
• 欧州
  • ドイツ
  • 英国
  • フランス
  • その他欧州
• アジア太平洋
  • 中国
  • 日本
  • インド
  • その他アジア太平洋地域
• 世界のその他の地域
  • ラテンアメリカ
  • 中東・アフリカ

第8章 世界のバイオシミラー市場：競合情勢

• 概要
• 各社の市場ランキング
• 主な開発戦略

第9章 企業プロファイル

• Novartis AG
• Pfizer Inc.
• Sandoz
• Amgen
• Biocon
• Celltrion
• Samsung Biologics

第10章 主な発展

• 製品上市／開発
• 合併と買収
• 事業拡大
• パートナーシップと提携

第11章 付録

• 関連調査

Biosimilars Market Valuation - 2024-2031 The Biosimilars Market size was valued at USD 18.36 Billion in 2023 and is projected to grow USD 108.74 Billion by 2031 , exhibiting a CAGR of 24.90% during the forecast period. The market for biosimilars is fast expanding as healthcare prices rise and there is a need for affordable alternatives to costly biologic medications. With many original biologics patents expiring, biosimilars provide equivalent therapeutic results at a reduced cost resulting in their widespread use worldwide. Regulatory backing and breakthroughs in biotechnology are also driving biosimilar growth. Governments in Europe and the Asia Pacific are pushing biosimilar adoption to decrease healthcare costs while increasing patient access to life-saving therapies.

Biosimilars Market: Definition/ Overview

Biosimilars are biologic medical products that are extremely like an existing approved reference biologic medication with no discernible changes in safety, purity, or effectiveness. Biosimilars are more complex to create and produce than generic pharmaceuticals which are chemically synthesized. They are intended to treat a variety of ailments including cancer, autoimmune disorders, and diabetes. Biosimilars are less expensive than original biologics making them a more affordable alternative for patients and healthcare systems.

The primary use of biosimilars is to provide cost-effective alternatives to biological medications for the treatment of chronic and complex diseases such as cancer, rheumatoid arthritis, and autoimmune disorders. Biosimilars are intended to accurately mimic the efficacy, safety, and quality of the original biologic medications, providing comparable therapeutic benefits at a lower cost. This increases patient access to innovative treatments while also assisting healthcare systems in managing rising drug costs and improving overall affordability in critical care.

The future of biosimilars seems bright as they will play an important role in making biological treatments more accessible and inexpensive. As patents on various biologic medications expire, biosimilars will be utilized more frequently to treat complicated disorders such as cancer, autoimmune diseases, and diabetes. Biotechnology advancements will improve their manufacture guaranteeing that they are as effective and safe as original biologics. As healthcare systems seek cost-effective alternatives, biosimilars will become more widely used around the world, enhancing patient access to vital treatments.

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How Does the Rising Cost of Healthcare Expenditures Drive the Demand for Biosimilars in the Biosimilars Market?

Rising healthcare costs are a primary driver of demand in the biosimilar business. As healthcare costs rise, patients, insurers, and providers are increasingly looking for less expensive biologic medicines. Biosimilars provide equivalent safety and efficacy at reduced prices allowing patients to obtain necessary therapies without suffering exorbitant costs. This concern for cost is especially evident in chronic disease management where long-term biologic treatment can put a strain on healthcare finances.

Furthermore, healthcare systems are under pressure to contain rising costs encouraging governments to promote the use of biosimilars as a means of lowering overall healthcare costs. Many governments and insurance companies are establishing policies that encourage the adoption of biosimilars such as lower reimbursement rates and faster approval processes. This regulatory support not only enhances confidence in biosimilar goods but also encourages their use increasing demand in the biosimilar sector as stakeholders seek long-term solutions to healthcare cost concerns.

How can Education and Outreach Efforts Mitigate the Restraint Posed by Perceptions of Biosimilars among Patients and Healthcare Providers in the Biosimilars Market?

Education and outreach activities can help patients and healthcare providers overcome misconceptions about biosimilars. These initiatives can assist to demystify and relieve worries about biosimilars by providing accurate, evidence-based information about their safety, efficacy, and approval processes. Workshops, webinars, and instructional materials can be customized for specific audiences ensuring that both healthcare professionals and patients understand how biosimilars compare to reference biologics including data on clinical outcomes and real-world efficacy.

Furthermore, collaborating with prominent thought leaders and healthcare practitioners helps broaden the reach and legitimacy of educational initiatives. When trusted specialists advocate for the use of biosimilars and share positive experiences, they can have a substantial impact on perceptions in the medical community. Furthermore, patient advocacy groups can help disseminate knowledge and encourage informed decision-making, resulting in broader acceptance of biosimilars in treatment protocols and allowing patients to confidently choose these cost-effective alternatives.

Category-Wise Acumens

How has the Expiration of Patents for Blockbuster Monoclonal Antibodies Influenced the Growth of the Biosimilars Market?

Monoclonal antibodies are more dominant in the Biosimilars Market due to their broad application in the treatment of cancer, autoimmune disorders, and infectious diseases. As one of the most successful types of biologics, mAbs have considerably improved patient outcomes resulting in strong demand for these treatments. The expiration of patents for several blockbuster monoclonal antibodies has paved the way for biosimilars allowing manufacturers to create cost-effective replacements while maintaining therapeutic efficacy and safety.

Furthermore, regulatory frameworks developed by health authorities such as the FDA and EMA have shortened the approval process for mAbs biosimilars, allowing businesses to reach the market more easily. The vast clinical data available on original mAbs lays the groundwork for the development and approval of biosimilars fostering trust in healthcare professionals and patients. This combination of significant market demand established regulatory procedures, and mAbs' demonstrated performance places them at the forefront of the Biosimilars Market.

How Might Future Trends in Healthcare Impact the Demand for Biosimilars in the Treatment of GHD?

Growth Hormone Deficiency (GHD) is more dominant in the Biosimilars Market due to the rising awareness and diagnosis of this condition coupled with the increasing demand for affordable treatment options. As healthcare providers and patients become more informed about the benefits of growth hormone therapy, the incidence of diagnosed GHD has risen. This trend drives the need for effective and cost-efficient alternatives to expensive biological growth hormone treatments, positioning biosimilars as an attractive option for patients seeking access to necessary therapies.

Additionally, the expiration of patents for original growth hormone biologics has opened the door for biosimilars to enter the market. This regulatory shift allows manufacturers to develop and offer biosimilar products that mimic the efficacy and safety of established growth hormone therapies at lower prices. As healthcare systems worldwide emphasize cost containment and improved patient access, the demand for biosimilars for GHD treatment is likely to grow, solidifying their position in the Biosimilars Market.

Country/Region-wise Acumens

How can the Introduction of Biosimilars Improve Patient Access to Critical Therapies in the North American Region?

North America is more dominant in the biosimilar industry owing to its strong healthcare infrastructure and large investments in R&D. The region has a strong regulatory structure, led by the United States Food and Drug Administration (FDA) which has provided clear procedures for biosimilar approvals. This legal certainty promotes innovation and encourages pharmaceutical companies to invest in biosimilar development resulting in a varied range of new drugs on the market.

Furthermore, the increased prevalence of chronic diseases and the rising prices of biologic medicines in North America are pushing demand for less expensive treatment choices. Patients and healthcare professionals are looking for alternatives that give comparable therapeutic benefits at a lesser cost. As patents for several high-cost biologics expire, the introduction of biosimilars presents a chance to improve patient access to critical therapies reinforcing North America's position as a biosimilars industry leader.

How are Rising Healthcare Costs and the Prevalence of Chronic Diseases Influencing the Demand for Biosimilars in the Asia-Pacific Region?

Asia Pacific is the fastest-growing region in the Biosimilars Market owing to rising healthcare costs and a higher prevalence of chronic diseases. Governments in nations like as India and China are making significant investments in healthcare infrastructure and adopting policies that enable biosimilar development and licensing. The expanding middle-class population is also driving demand for low-cost treatment choices making biosimilars a viable alternative to expensive biologics.

Furthermore, the region benefits from a strong biotechnology sector and a huge pool of skilled professionals allowing for efficient biosimilar manufacture. The presence of several pharmaceutical businesses and contract manufacturing organizations in Asia Pacific drives innovation and lowers production costs. Furthermore, raising knowledge among healthcare professionals and patients regarding biosimilars' efficacy and safety helps to increase their acceptance. As regulatory organizations in the region continue to streamline approval processes, the Biosimilars Market is likely to grow significantly, meeting the population's expanding healthcare needs.

Competitive Landscape

The Biosimilars Market is a dynamic and competitive space characterized by diverse players vying for market share. These players are on the run for solidifying their presence through the adoption of strategic plans such as collaborations, mergers, acquisitions, and political support. The organizations focus on innovating their product line to serve the vast population in diverse regions.

Some of the prominent players operating in the Biosimilars Market include:

Pfizer Inc., Sandoz, Amgen, Biocon, Celltrion, Samsung Biologics, Novartis AG.

Latest Developments

In September 2021, BYOOVIZ (ranibizumab-Nuna), a biosimilar of LUCENTIS (ranibizumab), was approved by the Food and Drug Administration (FDA) for the treatment of myopic choroidal neovascularization, macular edema following retinal vein occlusion, and neovascular age-related macular degeneration. The first ophthalmology biosimilar to be authorized in the US was BYOOVIZ.

TABLE OF CONTENTS

1 INTRODUCTION OF GLOBAL BIOSIMILARS MARKET

• 1.1 Overview of the Market
• 1.2 Scope of Report
• 1.3 Assumptions

2 EXECUTIVE SUMMARY

3 RESEARCH METHODOLOGY OF VERIFIED MARKET RESEARCH

• 3.1 Data Mining
• 3.2 Validation
• 3.3 Primary Interviews
• 3.4 List of Data Sources

4 GLOBAL BIOSIMILARS MARKET OUTLOOK

• 4.1 Overview
• 4.2 Market Dynamics
  • 4.2.1 Drivers
  • 4.2.2 Restraints
  • 4.2.3 Opportunities
• 4.3 Porters Five Force Model
• 4.4 Value Chain Analysis

5 GLOBAL BIOSIMILARS MARKET, BY INDICATION

• 5.1 Overview
• 5.2 Oncology
• 5.3 Inflammatory And Autoimmune Diseases
• 5.4 Chronic Diseases
• 5.5 Blood Disorders
• 5.6 Growth Hormone Deficiency
• 5.7 Infectious Diseases
• 5.8 Other Indications

6 GLOBAL BIOSIMILARS MARKET, BY PRODUCT

• 6.1 Overview
• 6.2 Monoclonal Antibodies
• 6.3 Insulin
• 6.4 Granulocyte Colony-Stimulating Factor
• 6.5 Erythropoietin
• 6.6 Recombinant Human Growth Hormone
• 6.7 Etanercept
• 6.8 Follitropin
• 6.9 Teriparatide
• 6.10 Interferons
• 6.11 Enoxaparin Sodium
• 6.12 Glucagon
• 6.13 Calcitonin

7 GLOBAL BIOSIMILARS MARKET, BY GEOGRAPHY

• 7.1 Overview
• 7.2 North America
  • 7.2.1 U.S.
  • 7.2.2 Canada
  • 7.2.3 Mexico
• 7.3 Europe
  • 7.3.1 Germany
  • 7.3.2 U.K.
  • 7.3.3 France
  • 7.3.4 Rest of Europe
• 7.4 Asia Pacific
  • 7.4.1 China
  • 7.4.2 Japan
  • 7.4.3 India
  • 7.4.4 Rest of Asia Pacific
• 7.5 Rest of the World
  • 7.5.1 Latin America
  • 7.5.2 Middle East and Africa

8 GLOBAL BIOSIMILARS MARKET COMPETITIVE LANDSCAPE

• 8.1 Overview
• 8.2 Company Market Ranking
• 8.3 Key Development Strategies

9 COMPANY PROFILES

• 9.1 Novartis AG
  • 9.1.1 Overview
  • 9.1.2 Financial Performance
  • 9.1.3 Product Outlook
  • 9.1.4 Key Developments
• 9.2 Pfizer Inc.
  • 9.2.1 Overview
  • 9.2.2 Financial Performance
  • 9.2.3 Product Outlook
  • 9.2.4 Key Developments
• 9.3 Sandoz
  • 9.3.1 Overview
  • 9.3.2 Financial Performance
  • 9.3.3 Product Outlook
  • 9.3.4 Key Developments
• 9.4 Amgen
  • 9.4.1 Overview
  • 9.4.2 Financial Performance
  • 9.4.3 Product Outlook
  • 9.4.4 Key Developments
• 9.5 Biocon
  • 9.5.1 Overview
  • 9.5.2 Financial Performance
  • 9.5.3 Product Outlook
  • 9.5.4 Key Developments
• 9.6 Celltrion
  • 9.6.1 Overview
  • 9.6.2 Financial Performance
  • 9.6.3 Product Outlook
  • 9.6.4 Key Developments
• 9.7 Samsung Biologics
  • 9.7.1 Overview
  • 9.7.2 Financial Performance
  • 9.7.3 Product Outlook
  • 9.7.4 Key Developments

10 KEY DEVELOPMENTS

• 10.1 Product Launches/Developments
• 10.2 Mergers and Acquisitions
• 10.3 Business Expansions
• 10.4 Partnerships and Collaborations

11 Appendix

• 11.1 Related Research