生物製剤市場：製品、供給源、適応症、流通チャネル、地域別、2026-2032年

生物製剤市場の評価、2026-2032年

糖尿病やがんのような慢性疾患の有病率の増加と、治療へのアクセスや有効性を向上させる個別化医療やバイオテクノロジーの市場開発が、生物製剤市場を推進する主な要因です。Verified Market Researchのアナリストによると、生物製剤市場は2024年の3,529億5,000万米ドルを下回り、予測期間中に5,294億6,000万米ドルの評価に達すると推定されています。

生物学的製剤製造能力を向上させる受託研究機関の成長、大手製薬会社からの多額の投資、新規治療法の受け入れ拡大は、生物学的製剤市場の拡大を促進する重要な要因です。このような需要の増加により、市場は2026年から2032年にかけてCAGR 5.2%で成長します。

生物製剤市場定義/概要

生物製剤は、細胞、タンパク質、核酸などの生物またはその構成成分から作られる治療用製品です。化学的に作られる従来の医薬品とは異なり、生物製剤は通常、高度なバイオテクノロジー技術を用いて作られる巨大で複雑な分子です。そのユニークな構造は、生物学的プロセスに直接関与することを可能にし、様々な疾患の治療に効果を発揮します。生物学的製剤の治療への応用範囲は広く、特に腫瘍学では、モノクローナル抗体が健康な臓器への傷害を抑えながらがん細胞を標的とします。また、免疫機能を完全に抑制することなく、免疫反応を調節して症状を軽減することにより、自己免疫疾患の治療にも使用されています。

慢性疾患の増加はどのように生物学的製剤の採用を促進するのか？

がん、糖尿病、自己免疫疾患のような慢性疾患の有病率の増加は、生物製剤市場の重要な促進要因です。世界保健機関（WHO）によると、がんは世界最大の死因であり、2020年には約1,000万人が死亡します。WHOは、新たながん患者数は2040年までに2020年比47%増の3,020万人に達すると予測しています。このような患者層の拡大により、複雑な疾患の治療により優れた効果を発揮する生物学的製剤の需要が高まることが予想されます。

バイオテクノロジーの絶え間ない進歩とオーダーメイド治療へのシフトが、生物学的製剤市場を前進させています。米国食品医薬品局（FDA）はこの動向を積極的に支援しています。2022年、FDAの生物製剤評価研究センター（CBER）は、遺伝子・細胞療法を含む17の新規生物製剤を認可しました。これは2021年の10件の承認から大幅に増加しており、アンメット・メディカル・ニーズを満たす上で生物製剤の重要性が高まっていることを示しています。

さらに、製薬会社は生物学的製剤の研究開発に多大なリソースを費やしており、これが市場開発に拍車をかけています。米国研究製薬工業協会（PhRMA）によると、米国のバイオ医薬品企業だけでも2020年に910億米ドルを研究開発に費やしています。これは、業界の研究開発費全体のかなりの額を占めており、医薬品部門の革新と将来の成長に不可欠な分野として生物製剤が重視されていることを示しています。

生物製剤市場が直面する主な課題とは？

生物製剤の開発は、研究、臨床試験、生産に多額の投資を必要とする、時間と資本集約的なプロセスです。初期投資から市場承認までの期間が数年と長いため、こうした高価格が新規参入の妨げとなっています。この経済的障壁が競争と技術革新を制限し、患者にとって革新的な生物学的製剤の利用可能性を低下させています。

さらに、生物学的製剤は生きた細胞を含む精巧な製造手順を用いて作られるため、一般的な医薬品よりもはるかに複雑です。翻訳後の変化に起因する重要な品質パラメータのばらつきは、製品の品質にばらつきを生じさせる。このような複雑さは、製造コストを上昇させるだけでなく、厳しい規制基準への準拠を確実にすることを困難にし、市場拡大をさらに妨げます。

目次

第1章 世界の生物製剤市場の導入

• 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
• バリデーション
• 一次資料
• データソース一覧

第4章 世界の生物製剤市場の展望

• 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 世界の生物製剤市場、製品別

• 概要
• モノクローナル抗体
• ワクチン
• 組換えホルモン／タンパク質
• 遺伝子ベースの生物製剤
• 細胞ベースの生物製剤

第6章 世界の生物製剤市場、供給源別

• 概要
• 微生物
• 哺乳類

第7章 世界の生物製剤市場：適応症別

• 腫瘍学
• 免疫疾患
• 心血管疾患
• 血液疾患

第8章 世界の生物製剤市場：流通チャネル別

• 病院薬局
• 小売薬局
• オンライン薬局

第9章 世界の生物製剤市場：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

第10章 世界の生物製剤市場の競合情勢

• 概要
• 各社の市場ランキング
• 主な開発戦略

第11章 企業プロファイル

• Abbvie Inc.
• Amgen Inc.
• Eli Lilly & Company
• Pfizer Inc.
• Samsung Biologics
• Sanofi
• Overview
• Merck & Co. Inc.
• F Hoffman La Roche
• Celltrion
• Addgene

第12章 付録

• 関連調査

Biologics Market Valuation - 2026-2032

The increasing prevalence of chronic illnesses like diabetes and cancer, along with developments in personalized medicine and biotechnology that improve treatment accessibility and efficacy, is the main factor propelling the biologics market. According to the analyst from Verified Market Research, the biologics market is estimated to reach a valuation of USD 529.46 Billion over the forecast subjugating around USD 352.95 Billion valued in 2024.

The growth of contract research organizations that improve biomanufacturing capabilities, significant investments from large pharmaceutical companies, and the increasing acceptance of novel therapies are important factors driving the biologics market expansion. This increase in demand enables the market to grow at a CAGR of 5.2% from 2026 to 2032.

Biologics Market: Definition/ Overview

Biologics are therapeutic products made from living creatures or their components, such as cells, proteins, and nucleic acids. Unlike conventional medications, which are chemically made, biologics are usually huge, complex molecules created using advanced biotechnological technologies. Their unique structure enables them to engage directly with biological processes, making them effective in treating a variety of disorders. Biologics have a wide range of therapeutic applications, most notably in oncology, where monoclonal antibodies target cancer cells while limiting injury to healthy organs. They are also used to treat autoimmune illnesses by regulating the immune response and reducing symptoms without completely suppressing immune function.

How Does Increasing Prevalence of Chronic Diseases Drive the Adoption of Biologics?

The increased prevalence of chronic diseases like cancer, diabetes, and autoimmune disorders is a significant driver of the biologics market. According to the World Health Organization (WHO), cancer is the biggest cause of death worldwide, accounting for approximately 10 million deaths in 2020. The WHO predicts that the number of new cancer cases will reach 30.2 million by 2040, a 47% increase over 2020. This expanding patient group is likely to drive up demand for biologic medicines, which are more successful in treating complicated disorders.

Continuous biotechnology advancements and a shift toward customized therapy are moving the biologics market ahead. The United States Food and Drug Administration (FDA) has aggressively supported this trend. In 2022, the FDA's Center for Biologics Evaluation and Research (CBER) authorized 17 new biologics, including gene and cell therapies. This is a huge rise from the ten approvals granted in 2021, illustrating the growing importance of biologics in meeting unmet medical needs.

Furthermore, pharmaceutical companies are spending significant resources on biologics research and development, which is fueling market growth. According to the Pharmaceutical Research and Manufacturers of America (PhRMA), biopharmaceutical businesses in the United States alone spent USD 91 Billion on research and development in 2020. This accounts for a considerable amount of the industry's total R&D spending and demonstrates the increased emphasis on biologics as an essential field for innovation and future growth in the pharmaceutical sector.

What are the Primary Challenges Faced by the Biologics Market?

Biologics development is a time-consuming and capital-intensive process that requires significant investment in research, clinical trials, and production. These high prices hinder new competitors from entering the market, as the lengthy timelines-from initial investment to market approval-last several years. This financial barrier limits competition and innovation, reducing the availability of innovative biologic drugs for patients.

Furthermore, biologics are made using elaborate manufacturing procedures that include living cells, making them far more complex than typical medications. Variability in important quality parameters due to post-translational changes causes discrepancies in product quality. This complexity not only raises production costs but also makes it difficult to ensure compliance with tight regulatory standards, further impeding market expansion.

Category-Wise Acumens

What are the Potential Factors Driving the Monoclonal Antibodies in the Market?

According to VMR analysis, the monoclonal antibodies segment is estimated to hold the largest market share during the forecast period. The growing prevalence of chronic diseases, such as cancer and autoimmune disorders, drives up demand for monoclonal antibodies. In comparison to standard medicines, these therapies provide tailored therapy alternatives that improve patient results while minimizing adverse effects. As healthcare professionals seek efficient treatments for managing complex illnesses, the dependence on monoclonal antibodies grows, cementing their market dominance.

Continuous advances in biotechnology have improved the development and production methods for monoclonal antibodies. Innovations such as enhanced cell line engineering and more efficient production procedures have resulted in larger yields at cheaper costs. These developments not only facilitate the introduction of new monoclonal antibody medicines but also make them more accessible to patients, contributing to their market leadership in biologics.

Furthermore, the strong pipeline of monoclonal antibody candidates in clinical trials is a key reason for this segment's dominance. Numerous new medicines are being developed to address a variety of ailments, including previously difficult-to-treat conditions. The approval and subsequent commercialization of these novel treatments are projected to drive growth in the monoclonal antibody segment, garnering considerable investment and interest from pharmaceutical firms.

How Does the Rising Cancer Incidence Drive Biologics for Oncology?

The oncology segment is estimated to dominate the biologics market during the forecast period. The rising global incidence of cancer is a primary driver for the oncology segment. As the number of cancer cases increases, there is a growing desire for better treatment options. Biologics, specifically monoclonal antibodies, and immunotherapies, have demonstrated extraordinary success in targeting cancer cells, resulting in better patient outcomes and driving market expansion in this segment.

Biotechnology innovations have resulted in the creation of targeted therapies that attack cancer cells while causing minimal damage to healthy tissues. These developments improve therapy efficacy while reducing side effects, making biologics the favored option for oncologists. The ongoing research and development in this area strengthens the oncology segment's position in the biologics market.

Furthermore, significant investments in cancer research by both the governmental and private sectors are moving the oncology segment forward. Clinical studies and the development of innovative biologic therapeutics are receiving increased funding, making it easier to bring new treatments to market. This infusion of cash promotes discovery and accelerates the availability of sophisticated biologics for cancer treatment, thereby reinforcing the segment's leadership.

Country/Region-wise Acumens

What Drivers Contribute to the Dominance of North America in the Market?

According to VMR analyst, North America is estimated to dominate the biologics market during the forecast period. North America has a high incidence of chronic diseases that are frequently treated using biologics. According to the Centers for Disease Control and Prevention (CDC), by 2020, 6 in 10 adults in the United States had a chronic condition, with 4 in 10 having two or more. According to the CDC, 34.2 million Americans (10.5% of the population) have diabetes, for which numerous biologic therapies are available. The region's high prevalence of chronic diseases fuels the need for innovative biologics.

Furthermore, North America, particularly the United States, has a strong R&D ecosystem for biologics. The FDA said that in fiscal year 2021, it authorized ten new biologics licensing applications (BLAs). Also, the National Institutes of Health (NIH) budget for fiscal year 2021 was $42.9 billion, with a sizable amount going toward research that supports biologic development. This solid R&D foundation adds to the region's dominant position in the biologics market.

What are the Significant Factors Driving the Asia Pacific's Biologics Market?

The Asia Pacific region is estimated to exhibit the highest growth within the market during the forecast period. The Asia Pacific region is undergoing tremendous population expansion and aging, which raises the demand for innovative medical therapies such as biologics. According to the United Nations Economic and Social Commission for Asia and the Pacific (ESCAP), the region's population is predicted to increase from 4.3 billion in 2020 to 4.7 billion in 2050. Also, the proportion of individuals aged 65 and up is expected to quadruple from 13% in 2020 to 26% by 2050. This demographic transition is expected to increase the prevalence of age-related disorders, driving up demand for biologics.

Furthermore, the Asia-Pacific region is experiencing an increase in chronic diseases, many of which are efficiently treated using biologics. According to the World Health Organization (WHO), non-communicable diseases (NCDs) account for 71% of all deaths worldwide, with a disproportionate impact on low- and middle-income nations, many of which are in Asia Pacific. According to the International Diabetes Federation (IDF), 463 million persons globally have diabetes in 2019, with the Asia Pacific area accounting for 60% of the total. This substantial illness burden is a strong motivator for the use of biologics.

Competitive Landscape

The competitive landscape of the biologics market is distinguished by a dynamic interaction between innovation, collaboration, and regulatory challenges. As the need for biologic medicines grows due to increased chronic disease occurrences and advances in customized medicine, companies are increasing their investment in R&D to improve their product offerings.

Some of the prominent players operating in the biologics market include:

• Abbvie, Inc.
• Amgen, Inc.
• Eli Lilly & Company
• Pfizer, Inc.
• Samsung Biologics
• Sanofi
• Merck & Co., Inc.
• F Hoffman La Roche
• Celltrion
• Addgene

Latest Developments

• In March 2023, Sandoz announced plans to invest USD 400 million in developing a biologics manufacturing facility in Slovenia.

Biologics Market, By Category

• Product:
• Monoclonal Antibodies
• Vaccines
• Recombinant Proteins
• Antisense, RNAi & Molecular Therapy
• Cell-based Therapies
• Source:
• Microbial
• Mammalian
• Indication:
• Oncology
• Immunological Disorders
• Cardiovascular Disorders
• Hematological Disorders
• Distribution Channel:
• Hospital Pharmacies
• Retail Pharmacies
• Online Pharmacies
• Region:
• North America
• Europe
• Asia-Pacific
• South America
• Middle East & Africa

TABLE OF CONTENTS

1 INTRODUCTION OF GLOBAL BIOLOGICS 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 BIOLOGICS 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 BIOLOGICS MARKET, BY PRODUCT

• 5.1 Overview
• 5.2 Monoclonal Antibodies
• 5.3 Vaccines
• 5.4 Recombinant Hormones/Proteins
• 5.5 Gene Based Biologics
• 5.6 Cellular Based Biologics

6 GLOBAL BIOLOGICS MARKET, BY SOURCE

• 6.1 Overview
• 6.2Microbial
• 6.3 Mammalian

7 GLOBAL BIOLOGICS MARKET, BY SOURCE

• 7.1 Oncology
• 7.2 Immunological Disorders
• 7.3 Cardiovascular Disorders
• 7.4 Hematological Disorders

8 GLOBAL BIOLOGICS MARKET, BY DISTRIBUTION CHANNEL

• 8.1 Hospital Pharmacies
• 8.2 Retail Pharmacies
• 8.3 Online Pharmacies

9 GLOBAL BIOLOGICS MARKET, BY GEOGRAPHY

• 9.1 Overview
• 9.2 North America
  • 9.2.1 U.S.
  • 9.2.2 Canada
  • 9.2.3 Mexico
• 9.3 Europe
  • 9.3.1 Germany
  • 9.3.2 U.K.
  • 9.3.3 France
  • 9.3.4 Rest of Europe
• 9.4 Asia Pacific
  • 9.4.1 China
  • 9.4.2 Japan
  • 9.4.3 India
  • 9.4.4 Rest of Asia Pacific
• 9.5 Rest of the World
  • 9.5.1 Latin America
  • 9.5.2 Middle East

10 GLOBAL BIOLOGICS MARKET COMPETITIVE LANDSCAPE

• 10.1 Overview
• 10.2 Company Market Ranking
• 10.3 Key Development Strategies

11 COMPANY PROFILES

• 11.1 Abbvie Inc.
  • 11.1.1 Overview
  • 11.1.2 Financial Performance
  • 11.1.3 Product Outlook
  • 11.1.4 Key Developments
• 11.2 Amgen Inc.
  • 11.2.1 Overview
  • 11.2.2 Financial Performance
  • 11.2.3 Product Outlook
  • 11.2.4 Key Developments
• 11.3 Eli Lilly & Company
  • 11.3.1 Overview
  • 11.3.2 Financial Performance
  • 11.3.3 Product Outlook
  • 11.3.4 Key Developments
• 11.4 Pfizer Inc.
  • 11.4.1 Overview
  • 11.4.2 Financial Performance
  • 11.4.3 Product Outlook
  • 11.4.4 Key Developments
• 11.5 Samsung Biologics
  • 11.5.1 Overview
  • 11.5.2 Financial Performance
  • 11.5.3 Product Outlook
  • 11.5.4 Key Developments
• 11.6 Sanofi
• 11.1 Overview
  • 11.6.2 Financial Performance
  • 11.6.3 Product Outlook
  • 11.6.4 Key Developments
• 11.7 Merck & Co. Inc.
  • 11.7.1 Overview
  • 11.7.2 Financial Performance
  • 11.7.3 Product Outlook
  • 11.7.4 Key Developments
• 11.8 F Hoffman La Roche
  • 11.8.1 Overview
  • 11.8.2 Financial Performance
  • 11.8.3 Product Outlook
  • 11.8.4 Key Developments
• 11.9 Celltrion
  • 11.9.1 Overview
  • 11.9.2 Financial Performance
  • 11.9.3 Product Outlook
  • 11.9.4 Key Developments
• 11.10 Addgene
  • 11.10.1 Overview
  • 11.10.2 Financial Performance
  • 11.10.3 Product Outlook
  • 11.10.4 Key Developments

12 Appendix

• 12.1 Related Research