バイオ医薬品とワクチン製造の世界市場規模：製品タイプ別、技術別、用途別、地域範囲別および予測

バイオ医薬品とワクチン製造の市場規模と予測

バイオ医薬品とワクチン製造の市場規模は、ここ数年かなりの成長率で緩やかなペースで成長しており、市場規模は予測期間、すなわち2026～2032年にかけて大きく成長すると予測されます。

バイオ医薬品とワクチン生産の世界市場促進要因

バイオ医薬品とワクチン製造市場の市場促進要因は、様々な要因の影響を受ける可能性があります。これらには以下が含まれます。

感染症の増加：予防接種とバイオ医薬品のニーズは、肝炎、COVID-19、インフルエンザ、ヒトパピローマウイルス（HPV）などの感染症の有病率が上昇していることが背景にあります。世界的に、政府やヘルスケア機関は、これらの病気と闘うために、予防接種キャンペーンや投薬研究のイニシアチブを優先しており、これが市場拡大の原動力となっています。

バイオ医薬品へのニーズの高まり：バイオ医薬品は、がん、自己免疫疾患、感染症など様々な疾患に対して、標的を絞った個別化治療の選択肢を記載しています。こうした治療には、モノクローナル抗体、組み換えタンパク質、ワクチン、細胞療法などが含まれます。バイオ医薬品に対する需要の高まりを受けて、インフラや生産能力への投資が進んでいます。

製造プロセスの技術的進歩：バイオ医薬品やワクチンの製造は、シングルユースシステム、連続製造、自動化などのバイオプロセス技術の開発により、より効率的でスケーラブルかつ安価になってきています。これらの開発により、生産スケジュールが短縮され、生産性が向上し、開発の推進力となっています。

欧州医薬品庁（EMA）や米国食品医薬品局（FDA）のような組織が、ワクチンやバイオ医薬品の製造に関する指導や支援を行うことで、支援的な規制環境が構築されています。承認プロセスの迅速化、有利な規制、インセンティブはすべて、技術や産業施設への投資を促進するために働いています。

バイオテクノロジーの用途拡大：ワクチンやバイオ医薬品の開発、製造、発見はすべてバイオテクノロジーに大きく依存しています。遺伝子工学、細胞培養技術、バイオインフォマティクスの発展により、様々な疾患に対する革新的な治療法やワクチンの開発が可能になり、開発の推進力となっています。

世界の健康への取り組みとワクチン接種プログラム：感染症を予防・管理するため、ワクチン接種プログラムや世界ヘルスへの取り組みは、官民パートナーシップ、国際機関、政府のイニシアチブによって支えられています。こうした取り組みは、バイオ医薬品とワクチンメーカーに製品ラインを拡大し、新たな市場に参入する機会を与えます。

パンデミックへの備えと対応：COVID-19のパンデミックのような状況は、迅速な対応と準備の両方の対策を講じることの重要性を強調しています。新たな感染症の危険に対処するため、政府やヘルスケア機関はワクチン開発と生産インフラへの支出を優先しており、これが市場の需要を牽引しています。

研究開発費の増加：新規のバイオ医薬品やワクチンを発見・創出するため、製薬企業、バイオテクノロジー企業、学術機関は研究開発（R&D）に多くの資源を投入しています。イノベーション、パイプライン開発、開発はすべて研究開発投資によって推進されます。

高齢化の進展：高齢化に伴い、感染症や慢性疾患にかかりやすくなるため、予防接種やバイオ医薬品の必要性が高まります。治療用と予防用の生物製剤市場は、世界人口の高齢化に伴って拡大しています。

新興市場：ワクチンやバイオ医薬品の製造は、新興経済圏、特にラテンアメリカやアジア太平洋で大きな成長の可能性を秘めています。これらの地域における市場拡大の原動力は、ヘルスケアコストの上昇、ヘルスケアインフラの整備、疾病負担の増加です。

世界のバイオ医薬品とワクチン製造市場抑制要因

バイオ医薬品とワクチン製造市場にとって、いくつかの要因が市場抑制要因や課題として作用する可能性があります。これらには以下が含まれます。

高い開発・生産コスト：研究開発（R&D）、生産施設、設備は、バイオ医薬品やワクチンを開発・製造するために前もって購入しなければならないです。高額な費用は、中小企業や新興企業の市場参入を阻み、競争やイノベーションを低下させる可能性があります。

複雑な製造手順：細胞培養、発酵、精製は、バイオ医薬品やワクチンの製造に用いられる先進的バイオテクノロジーの手順のほんの一例に過ぎないです。一般的な医薬品に比べ、これらの技術は専門的なツール、知識、品質管理手順を必要とするため、製造コストが高く、リードタイムも長くなります。

規制要件とコンプライアンス：欧州医薬品庁（EMA）や米国食品医薬品局（FDA）のような保健当局は、ワクチンやバイオ医薬品の製造に厳しい規制管理を課しています。特に新製品や製造施設では、製品の品質、安全性、有効性に関する規制基準を満たすのに費用と時間がかかります。

特許保護と知的財産権：バイオ医薬品とワクチン産業は、強固な特許保護と知的財産権によって特徴付けられています。特許の独占期間は、革新的な製品に市場独占権を与え、ジェネリック医薬品やバイオシミラー医薬品の競合他社による競合低下を防ぎます。一方、特許切れによる競合の激化やブランド品の価格下落が起こる可能性もあります。

サプライチェーンの脆弱性：パンデミック、自然災害、地政学的不安などの事象は、バイオ医薬品やワクチン製造のための世界のサプライチェーンを混乱させる可能性があります。サプライチェーンの混乱は、重要な物資や機械、部品の不足を招き、生産量や製品の供給力に影響を与える可能性があります。

市場参入と償還の課題：流通網、ヘルスケアインフラ、価格・償還施策により、バイオ医薬品やワクチンへのアクセスが制限される地域があります。特に資源が乏しい新興経済諸国では、市場アクセスの問題によって革新的な製品の開発と普及に影響が及ぶ可能性があります。

技術の複雑性とイノベーションのリスクワクチンやバイオ医薬品の製造に使用される技術は、精製方法、バイオリアクタ設計、細胞株開発における画期的な進歩により、常に変化しています。新技術やイノベーションへの投資には、拡大性への懸念、規制の不確実性、技術的な困難など、固有のリスクが伴う。

製品ライフサイクル管理：ファーマコビジランス、プロダクト・スチュワードシップ、市販後調査は、バイオ医薬品や予防接種製品のライフサイクルを管理するために必要な継続的投資です。製品寿命の期間中、製造手順、規制要件、製品配合の変更により、高価なアップグレードや改訂が必要になる場合があります。

安全性と品質保証：バイオ医薬品や予防接種の効力、安全性、純度を保証することは、公衆衛生上極めて重要です。製品の品質を維持するためには、バッチテスト、バリデーションプロセス、品質管理技術が極めて重要です。

目次

第1章 バイオ医薬品とワクチン製造の世界市場の導入

• 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 バイオ医薬品とワクチン製造の世界市場展望

• 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 バイオ医薬品とワクチン製造の世界市場：製品タイプ別

• 概要
• ワクチン
• バイオ医薬品

第6章 バイオ医薬品とワクチン製造の世界市場：最終用途別

• 感染症
• 腫瘍学
• 自己免疫疾患
• 代謝疾患

第7章 バイオ医薬品とワクチン製造の世界市場：技術別

• 上流プロセス
• 下流プロセス
• 単一使用システム
• 常用製造

第8章 バイオ医薬品とワクチン製造の世界市場：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
  • その他の欧州
• アジア太平洋
  • 中国
  • 日本
  • インド
  • その他のアジア太平洋
• その他
  • ラテンアメリカ
  • 中東・アフリカ

第9章 バイオ医薬品とワクチン製造の世界市場：競合情勢

• 概要
• 各社の市場ランキング
• 主要開発戦略

第10章 企業プロファイル

• Novartis
• Pfizer
• Sanofi
• Roche
• Abbott
• Regeneron Pharmaceuticals
• Alexion Pharmaceuticals
• Johnson and Johnson
• GlaxoSmithKline
• Merck

第11章 付録

• 関連調査

Biopharmaceutical And Vaccine Production Market Size And Forecast

Biopharmaceutical And Vaccine Production Market size is growing at a moderate pace with substantial growth rates over the last few years and is estimated that the market will grow significantly in the forecasted period i.e. 2026 to 2032.

Global Biopharmaceutical And Vaccine Production Market Drivers

The market drivers for the Biopharmaceutical And Vaccine Production Market can be influenced by various factors. These may include:

Growing Incidence of Infectious Diseases: The need for vaccinations and biopharmaceuticals is driven by the rising prevalence of infectious diseases, including hepatitis, COVID-19, influenza, and human papillomavirus (HPV). Globally, governments and healthcare institutions provide priority to immunization campaigns and medication research initiatives in an attempt to combat these illnesses, which drives market expansion.

Growing Need for Biopharmaceuticals: Biopharmaceuticals provide targeted and individualized therapy choices for a range of ailments, including cancer, autoimmune disorders, and infectious diseases. Examples of these treatments include monoclonal antibodies, recombinant proteins, vaccines, and cell therapies. Infrastructure and production capacity are being invested in due to the rising demand for biopharmaceuticals.

Technological Progress in manufacture Processes: The manufacture of biopharmaceuticals and vaccines is becoming more efficient, scalable, and affordable thanks to ongoing developments in bioprocessing technologies, such as single-use systems, continuous manufacturing, and automation. These developments shorten production schedules and increase productivity, which propels market expansion.

A supportive regulatory environment is created by organizations like the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA), which offer direction and assistance in the creation of vaccines and biopharmaceuticals. Accelerated approval processes, favorable regulations, and incentives all work to promote investment in technology and industrial facilities.

Increasing the Uses of Biotechnology: The development, manufacture, and discovery of vaccines and biopharmaceuticals all depend heavily on biotechnology. The creation of innovative treatments and vaccines for a variety of diseases is made possible by developments in genetic engineering, cell culture technology, and bioinformatics, which propels market growth.

Global Health Initiatives and Vaccination Programs: In order to prevent and manage infectious diseases, vaccination programs and global health initiatives are supported by public-private partnerships, international organizations, and government initiatives. These initiatives give biopharmaceutical and vaccine producers the chance to grow their product lines and penetrate new markets.

Pandemic Preparedness and Response: Situations like the COVID-19 pandemic emphasize the significance of having both quick response and preparedness measures in place. To address new infectious dangers, governments and healthcare institutions prioritize expenditures in vaccine development and production infrastructure, which drives demand in the market.

Growing Research and Development Expenditure: To find and create novel biopharmaceuticals and vaccines, pharmaceutical corporations, biotechnology businesses, and academic institutions devote a large amount of their resources to research and development (R&D). Innovation, pipeline development, and market growth are all fueled by R&D investments.

Growing Aging Population: As people age, they become more vulnerable to infectious and chronic illnesses, which increases the need for vaccinations and biopharmaceuticals. The market for therapeutic and preventive biologics is growing as the world's population ages.

Emerging Markets: The manufacturing of vaccines and biopharmaceuticals has enormous growth potential in emerging economies, especially those in Latin America and Asia-Pacific. Market expansion in these regions is driven by rising healthcare costs, bettering healthcare infrastructure, and an increase in the burden of disease.

Global Biopharmaceutical And Vaccine Production Market Restraints

Several factors can act as restraints or challenges for the Biopharmaceutical And Vaccine Production Market. These may include:

High Development and Production Costs: Research and development (R&D), production facilities, and equipment must be purchased up front in order to create and manufacture biopharmaceuticals and vaccines. Expensive expenses may prevent smaller businesses and startups from entering the market, which would reduce competition and innovation.

Complex Manufacturing Procedures: Cell culture, fermentation, and purification are only a few examples of the sophisticated biotechnological procedures used in the production of biopharmaceuticals and vaccines. In comparison to typical pharmaceuticals, these techniques have greater manufacturing costs and longer lead times since they need specialized tools, knowledge, and quality control procedures.

Regulatory Requirements and Compliance: Health authorities like the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) impose strict regulatory control on the manufacture of vaccines and biopharmaceuticals. For new products or production facilities in particular, meeting regulatory criteria for product quality, safety, and efficacy can be expensive and time-consuming.

Patent Protection and Intellectual Property Rights: The biopharmaceutical and vaccine industries are distinguished by robust patent protection and intellectual property rights. Patent exclusivity periods give innovative products market exclusivity, preventing generic or biosimilar competitors from undercutting them. On the other hand, heightened competition and declining prices for branded goods may result from patent expiration.

Supply Chain Vulnerabilities: Events like pandemics, natural catastrophes, and geopolitical unrest have the potential to disrupt the world's supply chain for the production of biopharmaceuticals and vaccines. Supply chain disruptions can result in shortages of vital supplies, machinery, and parts, which can impact output and product availability.

Market Access and Reimbursement Challenges: Due to distribution networks, healthcare infrastructure, and price and reimbursement policies, access to biopharmaceuticals and vaccines may be restricted in some areas. Adoption and uptake of innovative products can be impacted by market access issues, especially in developing economies where resources are scarce.

Technological Complexity and Innovation Risks: Technologies used in the manufacture of vaccines and biopharmaceuticals are always changing due to breakthroughs in purification methods, bioreactor design, and cell line development. There are inherent risks associated with investing in new technologies and innovation, such as scalability concerns, regulatory uncertainties, and technological difficulties.

Product Lifecycle Management: Pharmacovigilance, product stewardship, and post-market surveillance are continuous investments needed to manage the lifecycle of biopharmaceutical and vaccination products. Over the course of the product lifespan, expensive upgrades and revisions may be required due to changes in manufacturing procedures, regulatory requirements, or product formulas.

Safety and Quality Assurance: It is crucial for public health to guarantee the potency, safety, and purity of biopharmaceuticals and vaccinations. To maintain product quality, batch testing, validation processes, and quality control techniques are crucial.

Global Biopharmaceutical And Vaccine Production Market Segmentation Analysis

The Global Biopharmaceutical And Vaccine Production Market is Segmented on the basis of Product Type, Technology, Application, and Geography.

Biopharmaceutical And Vaccine Production Market, By Product Type

• Biopharmaceuticals: Includes therapeutic proteins (such as monoclonal antibodies, hormones, cytokines, and growth factors), vaccines, recombinant proteins, nucleic acid-based therapeutics (such as RNA and DNA vaccines), and cell-based therapies (such as stem cell therapies and CAR-T cell therapies).
• Vaccines: Includes prophylactic vaccines (for prevention of infectious diseases) and therapeutic vaccines (for treatment of diseases such as cancer and chronic infections).

Biopharmaceutical And Vaccine Production Market, By Technology

• Upstream Processing: Includes cell culture, fermentation, and cell expansion techniques for the production of biopharmaceuticals and vaccines in bioreactors or cell culture systems.
• Downstream Processing: Includes purification, separation, and recovery techniques for isolating and purifying biopharmaceuticals and vaccines from cell culture supernatants or fermentation broths.
• Single-Use Systems: Utilizes disposable bioprocessing equipment and consumables for biopharmaceutical and vaccine production, offering flexibility, scalability, and reduced risk of contamination.
• Continuous Manufacturing: Utilizes continuous bioprocessing techniques, such as perfusion cell culture and continuous chromatography, for more efficient and cost-effective production of biopharmaceuticals and vaccines compared to traditional batch processing.

Biopharmaceutical And Vaccine Production Market, By Application

• Infectious Diseases: Includes vaccines and therapeutics for prevention and treatment of infectious diseases such as influenza, COVID-19, hepatitis, human papillomavirus (HPV), and HIV/AIDS.
• Oncology: Includes biopharmaceuticals and vaccines for treatment of cancer, including monoclonal antibodies, cancer vaccines, and cell-based immunotherapies.
• Autoimmune Disorders: Includes biopharmaceuticals for treatment of autoimmune diseases such as rheumatoid arthritis, multiple sclerosis, and Crohn's disease.
• Metabolic Disorders: Includes biopharmaceuticals for treatment of metabolic disorders such as diabetes and obesity.
• Neurological Disorders: Includes biopharmaceuticals for treatment of neurological disorders such as Alzheimer's disease, Parkinson's disease, and multiple sclerosis.
• Other Therapeutic Areas: Includes biopharmaceuticals and vaccines for treatment of cardiovascular diseases, respiratory diseases, rare diseases, and genetic disorders.

Biopharmaceutical And Vaccine Production Market, By Geography

• North America: Includes the United States and Canada, characterized by a strong biopharmaceutical industry, robust R&D infrastructure, and significant investments in vaccine development and production.
• Europe: Includes countries such as Germany, the UK, France, Italy, and Spain, with a well-established biopharmaceutical sector and leading vaccine manufacturers.
• Asia-Pacific: Includes China, Japan, India, South Korea, and Australia, where the biopharmaceutical and vaccine production market is rapidly expanding due to government initiatives, growing healthcare infrastructure, and increasing R&D investments.
• Latin America: Includes Brazil, Mexico, and other countries in Central and South America, with a growing demand for biopharmaceuticals and vaccines driven by population growth, disease burden, and government healthcare initiatives.
• Middle East and Africa: Includes countries such as Saudi Arabia, UAE, South Africa, and others, where the biopharmaceutical and vaccine production market is growing due to increasing healthcare expenditure, disease prevalence, and investments in pharmaceutical manufacturing.

Key Players

• The major players in the Biopharmaceutical And Vaccine Production Market are:
• F. Hoffmann-La Roche Ltd.
• Merck & Co. Inc.
• Johnson & Johnson
• Novartis International AG
• Pfizer Inc.
• Eli Lilly and Company
• Abbott Laboratories
• GlaxoSmithKline plc
• Amgen Inc.
• Sanofi S.A.

TABLE OF CONTENTS

1 INTRODUCTION OF GLOBAL BIOPHARMACEUTICAL AND VACCINE PRODUCTION 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 BIOPHARMACEUTICAL AND VACCINE PRODUCTION 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 BIOPHARMACEUTICAL AND VACCINE PRODUCTION MARKET, BY PRODUCT TYPE

• 5.1 Overview
• 5.2 Vaccine
• 5.3 Biopharmaceutical

6 GLOBAL BIOPHARMACEUTICAL AND VACCINE PRODUCTION MARKET, BY END-USE

• 6.1 Infectious Diseases
• 6.2 Oncology
• 6.3 Autoimmune Disorders
• 6.4 Metabolic Disorders

7 GLOBAL BIOPHARMACEUTICAL AND VACCINE PRODUCTION MARKET, BY TECHNOLOGY

• 7.1 Upstream Processing
• 7.2 Downstream Processing
• 7.3 Single-Use Systems
• 7.4 Continuous Manufacturing

8 GLOBAL BIOPHARMACEUTICAL AND VACCINE PRODUCTION MARKET: GEOGRAPHY

• 8.1 Overview
• 8.2 North America
  • 8.2.1 The U.S.
  • 8.2.2 Canada
  • 8.2.3 Mexico
• 8.3 Europe
  • 8.3.1 Germany
  • 8.3.2 The U.K.
  • 8.3.3 France
  • 8.3.4 Rest of Europe
• 8.4 Asia Pacific
  • 8.4.1 China
  • 8.4.2 Japan
  • 8.4.3 India
  • 8.4.4 Rest of Asia Pacific
• 8.5 Rest of the World
  • 8.5.1 Latin America
  • 8.5.2 The Middle East and Africa

9 GLOBAL BIOPHARMACEUTICAL AND VACCINE PRODUCTION MARKET: COMPETITIVE LANDSCAPE

• 9.1 Overview
• 9.2 Company Market Ranking
• 9.3 Key Development Strategies

10 COMPANY PROFILES

• 10.1 Novartis
  • 10.1.1 Overview
  • 10.1.2 Financial Performance
  • 10.1.3 Product Outlook
  • 10.1.4 Key Developments
• 10.2 Pfizer
  • 10.2.1 Overview
  • 10.2.2 Financial Performance
  • 10.2.3 Product Outlook
  • 10.2.4 Key Developments
• 10.3 Sanofi
  • 10.3.1 Overview
  • 10.3.2 Financial Performance
  • 10.3.3 Product Outlook
  • 10.3.4 Key Developments
• 10.4 Roche
  • 10.4.1 Overview
  • 10.4.2 Financial Performance
  • 10.4.3 Product Outlook
  • 10.4.4 Key Developments
• 10.5 Abbott
  • 10.5.1 Overview
  • 10.5.2 Financial Performance
  • 10.5.3 Product Outlook
  • 10.5.4 Key Developments
• 10.6 Regeneron Pharmaceuticals
  • 10.6.1 Overview
  • 10.6.2 Financial Performance
  • 10.6.3 Product Outlook
  • 10.6.4 Key Developments
• 10.8 Alexion Pharmaceuticals
  • 10.8.1 Overview
  • 10.8.2 Financial Performance
  • 10.8.3 Product Outlook
  • 10.8.4 Key Developments
• 10.8 Johnson and Johnson
  • 10.8.1 Overview
  • 10.8.2 Financial Performance
  • 10.8.3 Product Outlook
  • 10.8.4 Key Developments
• 10.10 GlaxoSmithKline
  • 10.10.1 Overview
  • 10.10.2 Financial Performance
  • 10.10.3 Product Outlook
  • 10.10.4 Key Developments
• 10.10 Merck
  • 10.10.1 Overview
  • 10.10.2 Financial Performance
  • 10.10.3 Product Outlook
  • 10.10.4 Key Developments

11 Appendix

• 11.1 Related Research