レッドバイオテクノロジーの世界市場規模：製品タイプ別、用途別、エンドユーザー別、地域別、範囲および予測

レッドバイオテクノロジーの市場規模と予測

レッドバイオテクノロジー市場規模は、2024年に5,481億1,000万米ドルと評価され、2031年には1兆1,411億7,000万米ドルに達すると予測され、2024年から2031年までのCAGRは9.60%で成長します。バイオテクノロジーの一分野であるレッドバイオテクノロジーは、生物学的プロセスや生物を活用して革新的な医薬品や治療を開発することに重点を置いています。このダイナミックな分野は、創薬・開発、バイオ医薬品、ワクチン、診断、遺伝子治療、組織工学など、幅広い活動を包含しています。生物学的手法を駆使して、さまざまな疾患に対する新薬を特定し、開発します。

より効率的で効果的な治療を開発することで、レッドバイオテクノロジーはヘルスケア支出全体の削減に貢献することができます。

例えば、バイオテクノロジーの技術やツールの進歩は、技術革新を推進し、この分野の可能性を広げています。

この分野では、個々の患者の特定のニーズに対応するオーダーメイドの治療法の開発が可能であり、治療効果を高めることができます。

レッドバイオテクノロジーの世界市場力学

世界のレッドバイオテクノロジー市場を形成している主な市場力学

主な市場促進要因

慢性疾患の有病率の上昇

慢性疾患の世界の増加により、レッドバイオテクノロジー検査の需要が高まっています。世界保健機関（WHO）によると、2022年の世界の死亡者数の71％を慢性疾患が占めています。この動向が、高度な診断・治療ソリューションの必要性を高めています。

研究開発投資の拡大：

研究開発への投資の高まりが、レッドバイオ検査におけるイノベーションを後押ししています。米国国立衛生研究所（NIH）の生物医学研究予算は2023会計年度に451億米ドルに達し、2022年度から3.5％増加しました。この予算増により、遺伝子検査やバイオマーカー探索の進歩が加速しています。

個別化医療の動向：

個別化医療へのシフトは、バイオテクノロジー検査の展望を支配しています。米国FDAは2023年に26の個別化医薬品を承認し、これは新薬承認全体の39%に相当します。この動向はコンパニオン診断と標的療法の開発を促進しています。

遺伝子編集技術の進歩：

遺伝子編集技術の急速な進歩が、レッドバイオテクノロジー検査市場を前進させています。国立ヒトゲノム研究所によると、世界のCRISPR技術市場は2025年までに53億米ドルに達すると予測されています。こうした技術革新により、遺伝子検査や治療法開発に新たな道が開かれつつあります。

主な課題

市場成長を阻む規制上のハードル：

レッドバイオテクノロジーに関連する複雑な規制状況を乗り切ることは、大きな課題となりうる。医薬品開発、臨床試験、製品承認に関連する規制の遵守には時間とコストがかかり、市場参入と成長の妨げとなります。

イノベーションを妨げる倫理的懸念：

遺伝子組換え、幹細胞調査、その他のバイオテクノロジーの側面を取り巻く倫理的配慮は、課題や制限を生み出す可能性があります。こうした懸念に対処し、一般大衆の受容を得ることは、この分野の発展にとって不可欠です。

技術的限界による製品開発の課題：

著しい進歩にもかかわらず、レッドバイオテクノロジーには、生産の拡大、製品の一貫性の確保、免疫反応の克服といった課題など、技術的な限界が依然として存在します。革新的製品の商業化には、こうした限界を克服することが極めて重要です。

市場浸透を阻む高コスト：

レッドバイオテクノロジー製品の開発と商業化には多額の費用がかかり、研究開発、製造に多額の投資が必要となります。こうした高コストが市場浸透を阻み、患者の革新的治療へのアクセスを制限する可能性があります。

主要動向

ポイントオブケア検査に対する需要の高まり：

迅速なポイント・オブ・ケア検査に対する需要の高まりが、レッドバイオテクノロジーの技術革新を促進しています。米国メディケア＆メディケイドサービスセンターは、2019年から2023年までにCLIA免除検査施設が32%増加すると報告しています。この動向は、ポータブルで使いやすい診断機器の開発を促進しています。

政府のイニシアティブと支援政策の推進：

政府の取り組みと支援政策が赤色バイオ検査市場を推進しています。欧州委員会は、ホライゾン欧州（2021～2027年）に955億ユーロを割り当て、その大部分を健康研究に充てた。こうした取り組みが共同研究を促進し、市場の成長を加速させています。

次世代シーケンサー（NGS）の採用拡大：

次世代シーケンシングの採用拡大が、レッドバイオテクノロジー検査の成長を促進しています。National Center for Biotechnology Informationによると、世界のNGS市場規模は2023年に63億米ドルと評価されました。この技術は遺伝子検査と疾病診断に革命をもたらしています。

バイオマーカー探索への注目の高まり：

バイオマーカー発見への注目の高まりが、レッドバイオテクノロジー検査の進歩を後押ししています。FDAは、2020年から2023年にかけて医薬品承認のためのバイオマーカー関連の申請が40%増加すると報告しています。この動向は、新規診断ツールや標的療法の開発を後押ししています。

目次

第1章 世界のレッドバイオテクノロジー市場：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
• 市場の魅力

第4章 世界のレッドバイオテクノロジー市場の展望

• 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 レッドバイオテクノロジーの世界市場：製品タイプ別

• 概要
• モノクローナル抗体
• ポリクローナル抗体
• 組み換え
• タンパク質ワクチン
• 細胞ベースの免疫療法製品
• 遺伝子治療製品
• 細胞治療製品
• 組織工学製品
• 幹細胞
• 細胞培養
• ウイルスベクター
• 酵素
• キットと試薬
• 動物モデル
• 分子診断薬
• その他

第6章 レッドバイオテクノロジーの世界市場：用途別

• 概要
• ファーマコゲノミクス
• バイオ医薬品製造
• 遺伝子治療
• 遺伝子検査

第7章 レッドバイオテクノロジー世界市場：エンドユーザー別

• 概要
• 研究機関
• CMOおよびCRO
• バイオ医薬品産業
• その他

第8章 レッドバイオテクノロジーの世界市場：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9章 世界のレッドバイオテクノロジー市場の競合情勢

• 概要
• 各社の市場ランキング
• 主な開発戦略
• ACEマトリックス

第10章 企業プロファイル

• Amgen
• Gilead Sciences
• AbbVie
• Johnson & Johnson
• Pfizer
• Merck & Co.
• Roche
• Novartis
• Bristol Myers Squibb
• Takeda Pharmaceutical Company Limited

第11章 主な発展

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

第12章 付録

• 関連調査

Red Biotechnology Market Size and Forecast

Red Biotechnology Market size was valued at USD 548.11 Billion in 2024 and is projected to reach USD 1141.17 Billion by 2031 , growing at a CAGR of 9.60% from 2024 to 2031. Red biotechnology, a specialized branch of biotechnology, focuses on leveraging biological processes and organisms to develop innovative medical products and treatments. This dynamic field encompasses a wide spectrum of activities, including drug discovery and development, biopharmaceuticals, vaccines, diagnostics, gene therapy, and tissue engineering. Employing biological techniques to identify and develop novel drugs for a diverse range of diseases.

By developing more efficient and effective treatments, red biotechnology can contribute to reducing overall healthcare expenditures.

For instance, ingoing advancements in biotechnology techniques and tools are driving innovation and expanding the possibilities within this field.

The field enables the development of tailored therapies that address the specific needs of individual patients, enhancing treatment efficacy.

Global Red Biotechnology Market Dynamics

The key market dynamics that are shaping the global red biotechnology market include:

Key Market Drivers

Rising Prevalence of Chronic Diseases

: The increasing incidence of chronic diseases worldwide is propelling the demand for red biotechnology testing. According to the World Health Organization, chronic diseases accounted for 71% of global deaths in 2022. This trend is driving the need for advanced diagnostic and therapeutic solutions.

Growing Investments in R&D:

Escalating investments in research and development are fueling innovations in red biotechnology testing. The National Institutes of Health (NIH) budget for biomedical research reached $45.1 billion in fiscal year 2023, a 3.5% increase from 2022. This funding boost is accelerating advancements in genetic testing and biomarker discovery.

Dominating Trend of Personalized Medicine:

The shift towards personalized medicine is dominating the red biotechnology testing landscape. The U.S. FDA approved 26 personalized medicines in 2023, representing 39% of all new drug approvals. This trend is driving the development of companion diagnostics and targeted therapies.

Propelling Advancements in Gene Editing Technologies:

Rapid advancements in gene editing technologies are propelling the red biotechnology testing market forward. The global CRISPR technology market is projected to reach $5.3 billion by 2025, according to the National Human Genome Research Institute. These innovations are opening new avenues for genetic testing and therapy development.

Key Challenges:

Regulatory Hurdles Hindering Market Growth:

Navigating the complex regulatory landscape associated with red biotechnology can be a significant challenge. Compliance with regulations related to drug development, clinical trials, and product approval can be time-consuming and costly, hindering market entry and growth.

Ethical Concerns Hampering Innovation:

Ethical considerations surrounding genetic engineering, stem cell research, and other aspects of red biotechnology can create challenges and limitations. Addressing these concerns and obtaining public acceptance is essential for the advancement of the field.

Technological Limitations Challenging Product Development:

Despite significant advancements, there are still technological limitations in red biotechnology, such as challenges in scaling up production, ensuring product consistency, and overcoming immune responses. Overcoming these limitations is crucial for the commercialization of innovative products.

High Costs Obstructing Market Penetration:

The development and commercialization of red biotechnology products can be expensive, requiring substantial investments in research, development, and manufacturing. These high costs can limit market penetration and access to innovative treatments for patients.

Key Trends

Rising Demand for Point-of-Care Testing:

The growing demand for rapid, point-of-care testing is driving innovation in red biotechnology. The U.S. Centers for Medicare & Medicaid Services reported a 32% increase in CLIA-waived testing facilities from 2019 to 2023. This trend is fostering the development of portable and user-friendly diagnostic devices.

Propelling Government Initiatives and Supportive Policies:

Government initiatives and supportive policies are propelling the red biotechnology testing market. The European Commission allocated €95.5 billion for Horizon Europe (2021-2027), with a significant portion dedicated to health research. These initiatives are fostering collaborations and accelerating market growth.

Growing Adoption of Next-Generation Sequencing (NGS):

The increasing adoption of Next-Generation Sequencing is driving growth in red biotechnology testing. The global NGS market size was valued at $6.3 billion in 2023, according to the National Center for Biotechnology Information. This technology is revolutionizing genetic testing and disease diagnosis.

Rising Focus on Biomarker Discovery:

The escalating focus on biomarker discovery is propelling advancements in red biotechnology testing. The FDA reported a 40% increase in biomarker-related submissions for drug approvals from 2020 to 2023. This trend is driving the development of novel diagnostic tools and targeted therapies.

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Global Red Biotechnology Market Regional Analysis

Here is a more detailed regional analysis of the global red biotechnology market:

North America

North America dominates the global red biotechnology market, accounting for the largest share due to its advanced healthcare infrastructure and robust research ecosystem.

According to the National Institutes of Health (NIH), the U.S. invested $45.1 billion in biomedical research in fiscal year 2023, fueling innovation in the sector.

This substantial funding has led to significant advancements in areas such as gene therapy and personalized medicine.

For instance, in February 15, 2024, Moderna announced the expansion of its mRNA pipeline, including 15 new programs in rare diseases and oncology, further solidifying North America's leadership in red biotechnology.

The region's market dominance is also driven by a high prevalence of chronic diseases and a supportive regulatory environment.

The Centers for Disease Control and Prevention (CDC) reported that 6 in 10 adults in the U.S. have a chronic disease as of 2023, creating a strong demand for innovative biotechnology solutions.

This demand is met by cutting-edge research and development efforts from industry leaders.

For instance, on September 8, 2023, Pfizer received FDA approval for its gene therapy treatment for hemophilia B, marking a significant milestone in red biotechnology applications and reinforcing North America's position at the forefront of the global market.

Asia Pacific

Asia Pacific is poised to emerge as the fastest-growing region in the global red biotechnology market during the forecast period, attributable by the by rapidly aging populations, increasing prevalence of chronic diseases, and rising disposable incomes.

According to the World Health Organization's Western Pacific Region office, healthcare expenditure in the region is projected to increase by 7.5% annually through 2025, driving demand for advanced biotechnology solutions.

For instance, in March 10, 2024, Takeda Pharmaceutical Company announced a $600 million investment to expand its biologics manufacturing capacity in Singapore, reinforcing the region's position as a key hub for red biotechnology.

The region's growth is further propelled by supportive government initiatives and improving healthcare infrastructure.

China's National Medical Products Administration (NMPA) reported a 35% increase in innovative medical device approvals in 2023 compared to the previous year, indicating a favorable regulatory environment for biotechnology advancements.

in addition to this, the emerging markets like India and South Korea are witnessing rapid adoption of personalized medicine approaches. For instance, in July 5, 2023, Samsung Biologics unveiled its new R&D Center in Songdo, South Korea, focusing on developing novel biologics and biosimilars to address unmet medical needs in the Asia Pacific region.

Global Red Biotechnology Market: Segmentation Analysis

The Global Red Biotechnology Market is segmented based on By Product Type, By Application, By End-User, and Geography.

Red Biotechnology Market, By Product Type

• Monoclonal Antibodies
• Polyclonal Antibodies
• Recombinant
• Proteins Vaccines
• Others

Based on Product Type, the Global Red Biotechnology Market is bifurcated into Monoclonal Antibodies, Polyclonal Antibodies, Recombinant, Proteins Vaccines, Others. The monoclonal antibodies segment is currently dominating the global red biotechnology market, driven by their high specificity, sensitivity, and versatility. However, the recombinant proteins segment is growing at a rapid CAGR within the global red biotechnology market, fueled by advancements in genetic engineering and protein production technologies.

Red Biotechnology Market, By Application

• Pharmacogenomics
• Biopharmaceutical Production
• Gene Therapy
• Genetic Testing

Based on Application, the Global Red Biotechnology Market is bifurcated into Pharmacogenomics, Biopharmaceutical Production, Gene Therapy, Genetic Testing. The biopharmaceutical production segment is currently dominating the red biotechnology market, driven by the increasing demand for new and innovative drugs to treat various diseases. However, the gene therapy segment is experiencing rapid growth, fueled by advancements in gene editing technologies and the increasing potential of gene therapy to treat genetic disorders.

Red Biotechnology Market, By End-User

• Research Institutes
• CMOs & CROs
• Biopharmaceutical Industries
• Others

Based on End-User, the Global Red Biotechnology Market is bifurcated into Hospitals, Clinics, Insurance Companies, Government, Others. The biopharmaceutical industry is currently dominating the red biotechnology market, driven by the increasing demand for biologics in the treatment of chronic diseases and the rising investments in research and development by major pharmaceutical companies. However, the contract manufacturing organizations (CMOs) and contract research organizations (CROs) segment is experiencing rapid growth. These organizations provide specialized services to biopharmaceutical companies, such as manufacturing, clinical trials, and regulatory affairs.

Red Biotechnology Market, By Geography

• North America
• Europe
• Asia Pacific
• Rest of the world

Based on Geography, the Global Red Biotechnology Market is classified into North America, Europe, Asia Pacific, and the Rest of the world. North America dominates the global red biotechnology market, accounting for the largest share due to its advanced healthcare infrastructure and robust research ecosystem. However, the Asia Pacific is poised to emerge as the fastest-growing region in the global red biotechnology market during the forecast period, attributable by the by rapidly aging populations, increasing prevalence of chronic diseases, and rising disposable incomes.

Key Players

• The "Global Red Biotechnology Market" study report will provide valuable insight with an emphasis on the global market. The major players in the market are
• Hoffmann-La Roche, Ltd., Merck KGaA, Regeneron Pharmaceuticals, Inc., Pfizer, Inc. , Biogen Inc. , Amgen Inc. and AstraZeneca Plc. and etc.

Our market analysis also entails a section solely dedicated to such major players wherein our analysts provide an insight into the financial statements of all the major players, along with its product benchmarking and SWOT analysis. The competitive landscape section also includes key development strategies, market share, and market ranking analysis of the above-mentioned players globally.

Global Red Biotechnology Market Key Developments

• In June 2022, CRISPR-Combo enables the editing of many genes in plants while modifying the expression of other genes, according to research from the University of Maryland's College of Agriculture and Natural Resources.
• In September 2022, the US-FDA approved SKYSONA (elivaldogene autotemcel), often referred to as Eli-cel, in September 2022 for Bluebird Bio, Inc. to decrease the progression of neurologic deterioration in boys with early, active cerebral adrenoleukodystrophy (CALD) aged 4-17.

TABLE OF CONTENTS

1 INTRODUCTION OF GLOBAL RED BIOTECHNOLOGY 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
• 3.5 Market attractiveness

4 GLOBAL RED BIOTECHNOLOGY 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 RED BIOTECHNOLOGY MARKET, BY PRODUCT TYPE

• 5.1 Overview
• 5.2 Monoclonal Antibodies
• 5.3 Polyclonal Antibodies
• 5.4 Recombinant
• 5.5 Protein Vaccines
• 5.6 Cell-based Immunotherapy Products
• 5.7 Gene Therapy Products
• 5.8 Cell Therapy Products
• 5.9Tissue-engineered Products
• 5.10 Stem Cells
• 5.11 Cell Culture
• 5.12 Viral Vector
• 5.13 Enzymes
• 5.14 Kits and Reagents
• 5.15 Animal Models
• 5.16 Molecular Diagnostics
• 5.17 Others

6 GLOBAL RED BIOTECHNOLOGY MARKET, BY APPLICATION

• 6.1 Overview
• 6.2 Pharmacogenomics
• 6.3 Biopharmaceutical Production
• 6.4 Gene Therapy
• 6.5 Genetic Testing

7 GLOBAL RED BIOTECHNOLOGY MARKET, BY END USER

• 7.1 Overview
• 7.2 Research Institutes
• 7.3 CMOs & CROs
• 7.4 Biopharmaceutical Industries
• 7.5 Others

8 GLOBAL RED BIOTECHNOLOGY MARKET, BY GEOGRAPHY

• 8.1 Overview
• 8.2 North America
  • 8.2.1 U.S.
  • 8.2.2 Canada
  • 8.2.3 Mexico
• 8.3 Europe
  • 8.3.1 Germany
  • 8.3.2 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 Middle East and Africa

9 GLOBAL RED BIOTECHNOLOGY MARKET COMPETITIVE LANDSCAPE

• 9.1 Overview
• 9.2 Company Market Ranking
• 9.3 Key Development Strategies
• 9.4 ACE Matrix

10 COMPANY PROFILES

• 10.1 Amgen
  • 10.1.1 Overview
  • 10.1.2 Financial Performance
  • 10.1.3 Product Outlook
  • 10.1.4 Key Developments
• 10.2 Gilead Sciences
  • 10.2.1 Overview
  • 10.2.2 Financial Performance
  • 10.2.3 Product Outlook
  • 10.2.4 Key Developments
• 10.3 AbbVie
  • 10.3.1 Overview
  • 10.3.2 Financial Performance
  • 10.3.3 Product Outlook
  • 10.3.4 Key Developments
• 10.4 Johnson & Johnson
  • 10.4.1 Overview
  • 10.4.2 Financial Performance
  • 10.4.3 Product Outlook
  • 10.4.4 Key Developments
• 10.5 Pfizer
  • 10.5.1 Overview
  • 10.5.2 Financial Performance
  • 10.5.3 Product Outlook
  • 10.5.4 Key Developments
• 10.6 Merck & Co.
  • 10.6.1 Overview
  • 10.6.2 Financial Performance
  • 10.6.3 Product Outlook
  • 10.6.4 Key Developments
• 10.7 Roche
  • 10.7.1 Overview
  • 10.7.2 Financial Performance
  • 10.7.3 Product Outlook
  • 10.7.4 Key Developments
• 10.8 Novartis
  • 10.8.1 Overview
  • 10.8.2 Financial Performance
  • 10.8.3 Product Outlook
  • 10.8.4 Key Developments
• 10.9 Bristol Myers Squibb
  • 10.9.1 Overview
  • 10.9.2 Financial Performance
  • 10.9.3 Product Outlook
  • 10.9.4 Key Developments
• 10.10 Takeda Pharmaceutical Company Limited
  • 10.10.1 Overview
  • 10.10.2 Financial Performance
  • 10.10.3 Product Outlook
  • 10.10.4 Key Developments

11 KEY DEVELOPMENTS

• 11.1 Product Launches/Developments
• 11.2 Mergers and Acquisitions
• 11.3 Business Expansions
• 11.4 Partnerships and Collaborations

12 Appendix

• 12.1 Related Research