生物製剤受託開発市場レポート：2030年までの動向、予測、 競合分析

生物製剤受託開発の動向と予測

世界の生物製剤受託開発市場の将来は、がん、免疫疾患、心血管疾患、血液疾患市場に機会があり、有望です。世界の生物製剤受託開発市場は、2024年から2030年までのCAGRが11.5%で、2030年までに推定409億米ドルに達すると予想されます。この市場の主な促進要因は、製薬企業による医薬品開発手順の増加、先端技術の採用拡大、発展途上国における臨床試験の有利な環境です。

• Lucintel社は、タンパク質の発現に哺乳類細胞の採用が増加しており、翻訳後修飾を適切に施した哺乳類タンパク質を開発することでネイティブな構造が得られるという大きな利点があるため、ソースカテゴリーでは哺乳類が予測期間中も大きなセグメントであり続けると予測しています。
• この疾患適応症の中では、治療に対する需要の高まりが研究開発やアウトソーシングへの投資を促すため、がん領域が最大のセグメントであり続けると思われます。
• 地域別では、研究開発投資の増加、臨床試験需要の高まり、大手企業の存在により、北米が予測期間中最大の地域であり続けると思われます。

生物製剤受託開発の戦略的成長機会

技術の向上、市場の新たな期待、政府の支援は、生物製剤受託開発業界に戦略的成長機会を提供します。これらの機会を見極め、成長と競争力強化のために活用すべきです。

• 新興市場の出現：新たな地域への進出は、業界関係者のリスクを軽減すると同時に、新たな収益源を開くことになります。これらの地域では、国際市場への参入やバイオテクノロジー産業の発展に伴い、生物製剤開発受託サービスへの関心が高まっています。
• 細胞・遺伝子治療サービスの発展：新しい細胞療法や遺伝子療法の台頭は、開発サービスに対する需要を生み出しています。CDOがこれらの能力に投資することで、これらの専門的なサービスを求めるクライアントのニーズに対応できるようになります。
• 経済的視点：様々な地域における経済的なエンパワーメントは、バイオテクノロジーの発展を促進するはずです。多くの顧客は、目先の投資回収にとらわれず、長期的な利益を追求できるようになった。
• 先端技術の統合：企業全体の戦略は、先端技術の開発と統合にプラスの影響を与えます。CDOは、市場での地位を維持・成長させるために、現在のサービス内容を共同開発する必要があります。
• 最先端の製造手法の活用：革新的な製造技術は生産性を高め、製造コストを削減します。CDOはこれらの技術を採用することで、より優れたサービスを提供し、スケーラブルで手頃な価格の生物製剤製造に対する需要の高まりに応えることができます。
• デジタル分析とAI統合の採用：AIと高度なアナリティクスは、意思決定とプロセスの最適化を改善します。これらのテクノロジーは業務効率を高め、開発時間を短縮することで競争力を強化します。
• 国際的パートナーシップへの参入：戦略的な世界・パートナーシップは、望ましい市場へのアクセスを提供し、リソースをプールし、社内の専門知識を活用します。協業はイノベーションを促進し、国際的な拡大を促し、市場での地位を強化します。

新興国市場への進出、細胞・遺伝子治療サービスの高度化、革新的な製造技術の採用、AIの統合、世界・パートナーシップの形成などの戦略的成長機会が、生物製剤受託開発市場を形成しています。これらの機会を捉えることが成長を促進し、競争力を向上させ、業界を構築することになります。

生物製剤受託開発市場の市場促進要因・課題

生物製剤受託開発市場は、技術の進歩、政治的支援、民間セクターの関与など、さまざまな要因によって牽引されています。これらの要因は、需要の増加、投資の誘致、効果的な戦略の策定に不可欠です。

生物製剤受託開発市場を牽引する要因は以下の通りである：

• 技術の進歩：技術の進歩：技術開発は生物製剤の生産効率と生産能力を向上させる。連続製造やプロセスの自動化などの新技術は安全性を高め、コストを削減するため、市場の成長を促進します。
• 生物製剤に対する需要の高まり：専門的な開発業務受託に対する需要の高まりは、生物製剤に対するニーズの高まりが原動力となっています。新しい治療法の出現に伴い、CDOはこれらの複雑な治療法の開発と生産をサポートするために業務を調整する必要があります。
• 規制当局の良好な経営環境：支援的な規制環境は、承認プロセスを加速させ、参入障壁を低くします。このような規制条項は投資家を惹きつけ、新規生物学的療法の出現を促進します。
• コスト効率とアウトソーシング動向：CDOに業務を委託することで、企業は中核業務に集中しながら経費を削減することができます。この動向はCDOサービスに対するニーズの高まりを生み、市場の拡大を促進します。
• 研究開発投資の増加：研究開発投資の増加は、新しい生物製剤の迅速な開発につながります。この投資は市場の成長を後押しし、CDOの能力を向上させる。

生物製剤開発受託開発市場の課題は以下の通り：

• 規制の複雑さ：規制の複雑さ：規制の複雑さは、開発期間を延長し、コストを増加させる可能性があります。企業は監査リソースを確保し、コンプライアンスポリシーの変更を監視し、必要な変更を確実に実施しなければならないです。
• 高い開発コスト：高い開発コストは市場参入を制限し、収益性に影響を与えます。この課題を克服するには、効果的なコスト管理と投資戦略が必要です。
• 高い競合：激しい競争は、市場シェアや価格設定に影響を与えます。優位に立つためには、技術革新、質の高い仕事、優れた顧客サービスを通じて、CDOが際立つ必要があります。

生物製剤開発受託開発市場の促進要因には、技術の進歩、生物製剤需要の増加、規制環境の整備、運営コストの削減、研究開発投資の増加などがあります。しかし、市場参入を成功させるためには、規制上のハードル、高い開発コスト、熾烈な競争といった課題を克服しなければならないです。これらの促進要因と課題のバランスをとることが、業界の成長と革新を達成する鍵です。

目次

第1章 エグゼクティブサマリー

第2章 世界の生物製剤受託開発市場：市場力学

• イントロダクション、背景、分類
• サプライチェーン
• 業界の促進要因と課題

第3章 2018年から2030年までの市場動向と予測分析

• マクロ経済動向（2018～2023年）と予測（2024～2030年）
• 世界の生物製剤受託開発市場の動向（2018～2023年）と予測（2024～2030年）
• 世界の生物製剤受託開発市場：供給源別
  • 微生物
  • 哺乳類
  • その他
• 生物製剤受託開発市場：製品サービス別
  • 細胞株の開発
  • プロセス開発
  • その他
• 別世界生物製剤受託開発市場：疾患適応症別
  • 腫瘍学
  • 免疫疾患
  • 心血管疾患
  • 血液疾患
  • その他

第4章 2018年から2030年までの地域別市場動向と予測分析

• 地域別生物製剤受託開発市場
• 北米の生物製剤受託開発市場
• 欧州の生物製剤受託開発市場
• アジア太平洋地域の生物製剤受託開発市場
• その他地域の生物製剤受託開発市場

第5章 競合分析

• 製品ポートフォリオ分析
• 業務統合
• ポーターのファイブフォース分析

第6章 成長機会と戦略分析

• 成長機会分析
  • 供給源別：世界の生物製剤受託開発市場の成長機会
  • 製品サービス別：世界の生物製剤受託開発市場の成長機会
  • 疾患適応症別：世界の生物製剤受託開発市場の成長機会
  • 地域別：世界の生物製剤受託開発市場の成長機会
• 世界の生物製剤受託開発市場の新たな動向
• 戦略分析
  • 新製品開発
  • 世界の生物製剤受託開発市場の能力拡大
  • 世界の生物製剤受託開発市場における合併、買収、合弁事業
  • 認証とライセンシング

第7章 主要企業の企業プロファイル

• WuXi Biologics
• Abzena
• Fujifilm Diosynth Biotechnologies
• KBI Biopharma
• AGC Biologics
• Thermo Fisher Scientific
• Curia Global
• GenScript
• Bionova Scientific
• BioXcellence

Biologics Contract Development Trends and Forecast

The future of the global biologics contract development market looks promising with opportunities in the oncology, immunological disorder, cardiovascular disorder, and hematological disorder markets. The global biologics contract development market is expected to reach an estimated $40.9 billion by 2030 with a CAGR of 11.5% from 2024 to 2030. The major drivers for this market are the rising number of drug development procedures by pharmaceutical companies, the growing adoption of advanced technologies, and a favorable environment for clinical trials in developing countries.

• Lucintel forecasts that, within the source category, mammalian will remain a larger segment over the forecast period due to the increasing adoption of mammalian cells for protein expression, which provides a major advantage by developing mammalian proteins with correct post-translational modifications that deliver a native structure.
• Within this disease indication category, oncology will remain the largest segment due to the growing demand for therapy, which encourages more investments in research and development and outsourcing.
• In terms of regions, North America will remain the largest region over the forecast period due to growing R&D investments, rising demand for clinical trials, and the presence of major players in the region.

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Emerging Trends in the Biologics Contract Development Market

The biologics contract development market is consistent with the development of technology, regulatory changes, evolving relationships, and the booming population. These trends are changing the marketplace and affecting how contract development organizations and pharmaceutical companies operate.

• Adoption of Advanced Manufacturing Technologies: Advanced manufacturing technologies enhance the efficiency, scalability, and flexibility in the production of biologics. For instance, continuous manufacturing reduces the time required in the production process and significantly reduces operational costs. Modular systems help optimize production by quickly reconfiguring processes.
• Growth of Cell and Gene Therapy: The growing popularity of cell and gene therapies creates a need for specialized contract development services. Contract development organizations (CDOs) are establishing competence in this area to offer services that are specific to the complex and regulation-heavy processes involved in manufacturing advanced therapies.
• Integration of Artificial Intelligence and Data Analytics: AI and data analytics enhance the quality of decision-making, increase efficiency in R&D processes, and improve production. These technologies help develop biologics by enhancing predictive modeling, adopting significant process control methods, and facilitating the analysis of data to reduce lead time and improve outcomes.
• Increasing Focus on Regulatory Compliance: As legal regulations become more complex, compliance has become a focal point for contract development organizations. Emphasizing the fulfillment of legal requirements reduces risks, improves product standards, and accelerates biological approval processes.
• International Partnerships and Collaborations: Collaborations allow organizations to develop new territories, pool assets, and capitalize on synergistic skills. Cooperation between contract development organizations and biotechnology companies from different countries promotes innovation, shortens development timelines, and helps distribute products in various regions.

Emerging trends such as innovations in manufacturing technologies increases in cell and gene therapy, AI applications, pressure to adhere to regulatory measures, and international partnerships are revolutionizing the biologics contract development industry. These factors lead to innovation and increased efficiencies, and address the growing demand for biologics, positioning the industry for continued growth and transformation.

Recent Developments in the Biologics Contract Development Market

Recent progress in the biologics contract development market highlights trends in technological advancement, supportive regulations, and market expansion. Key developments include advancements in manufacturing processes, increased R&D funding, and regulations that support the market's growth and evolution.

• New Manufacturing Technologies: New manufacturing technologies offer efficient and scalable operations, reducing production costs and time. Continuous manufacturing eliminates nonproductive time by allowing production processes to be altered as needed and increases product uniformity. Modular systems improve adaptability and allow quick responses to changing production requirements.
• Broader Cell and Gene Therapy Services: The increasing production of cell and gene therapies has led to more contract development services for these therapies. CDOs are investing in specific technologies and professionals to manage complex regulatory requirements for these specialized facilities.
• AI and Data Analytics in Processes: AI and data analytics optimize drug development processes and enhance performance during manufacturing. These technologies provide advanced modeling, system controls, and real-time data analytics to improve efficiency and shorten development timelines.

Recent trends, including advancements in manufacturing technologies, enhanced cell and gene therapies, AI integration, regulatory improvements, and growing international alliances, are greatly influencing the biologics contract development market. These efficiencies lead to technological advancements and international expansion, driving growth in the industry.

Strategic Growth Opportunities for Biologics Contract Development Market

Technological improvements, new market expectations, and government support provide strategic growth opportunities in the biologics contract development industry. These opportunities should be identified and leveraged to enhance growth and competitiveness.

• Emergence of Emerging Markets: Expanding into new regions reduces risk for industry players while opening new revenue streams. These areas are increasingly inclined toward biologics contract development services as they enter international markets or develop the biotech industry.
• Development of Cell and Gene Therapy Services: The rise of new cell and gene therapies has created a demand for development services. As CDOs invest in these competencies, they empower themselves to meet the needs of clients seeking these specialized services.
• Economic Perspectives: Economic empowerment in different regions should enhance biotechnology development. Many clients are now able to look beyond the immediate return on investment and explore long-term benefits.
• Integration of Advanced Technologies: Overall company strategies positively impact the development and integration of advanced technologies. CDOs must co-develop current service offerings to maintain or grow their position in the market.
• Utilizing Cutting-Edge Manufacturing Practices: Innovative manufacturing technologies increase productivity and reduce production costs. CDOs can adopt these technologies to provide better offerings and meet the increasing demand for scalable and affordable biologics production.
• Adoption of Digital Analytics and AI Integration: AI and advanced analytics improve decision-making and process optimization. These technologies enhance competitiveness by increasing operational efficiency and reducing development time.
• Entering International Partnerships: Strategic global partnerships provide access to desirable markets, pool resources, and leverage in-house expertise. Collaborations foster innovation, encourage international expansion and strengthen market position.

Strategic growth opportunities such as expanding into emerging markets, advancing cell and gene therapy services, adopting innovative manufacturing technologies, integrating AI, and forming global partnerships are shaping the biologics contract development market. Capturing these opportunities will drive growth, improve competitiveness, and build the industry.

Biologics Contract Development Market Driver and Challenges

The biologics contract development market is driven by various factors, including technological advancements, political support, and private sector involvement. These factors are essential for increasing demand, attracting investment, and formulating effective strategies.

The factors driving the biologics contract development market include:

• Advances in Technology: Technological developments improve the efficiency and capacity of biologics production. New technologies, such as continuous manufacturing and process automation, enhance safety and reduce costs, thereby fostering market growth.
• Increased Demand for Biologics: The rising demand for specialized contract development services is driven by the growing need for biologics. As new therapies emerge, CDOs must adjust operations to support the development and production of these complex therapies.
• Favorable Operating Environment for Regulatory Agencies: Supportive regulatory environments accelerate the approval process and lower entry barriers. Such regulatory provisions attract investors and facilitate the emergence of novel biological therapies.
• Cost Efficiency and Outsourcing Trends: Outsourcing operations to CDOs allows companies to reduce expenses while focusing on core activities. This trend creates a growing need for CDO services, driving market expansion.
• Rising Investment in R&D: Increased investment in R&D leads to faster development of new biologics. This investment boosts market growth and improves the capabilities of CDOs.

Challenges in the biologics contract development market include:

• Regulatory Complexity: Regulatory complexity can extend development timelines and increase costs. Companies must secure auditing resources, monitor changes in compliance policies, and ensure necessary changes are implemented.
• High Development Costs: High development costs can limit market entry and affect profitability. Effective cost control and investment strategies are necessary to overcome this challenge.
• High Degree of Competition: Intense competition can impact market share and pricing. To stay ahead, CDOs must stand out through technology innovation, quality work, and excellent customer service.

The drivers of the biologics contract development market include technological advancements, increasing demand for biologics, supportive regulatory environments, reduced operational costs, and increased R&D investment. However, challenges such as regulatory hurdles, high development costs, and fierce competition must be overcome for successful market participation. Balancing these drivers and challenges is key to achieving growth and innovation in the industry.

List of Biologics Contract Development Companies

Companies in the market compete on the basis of product quality offered. Major players in this market focus on expanding their manufacturing facilities, R&D investments, infrastructural development, and leverage integration opportunities across the value chain. With these strategies biologics contract development companies cater increasing demand, ensure competitive effectiveness, develop innovative products & technologies, reduce production costs, and expand their customer base. Some of the biologics contract development companies profiled in this report include-

• WuXi Biologics
• Abzena
• Fujifilm Diosynth Biotechnologies
• KBI Biopharma
• AGC Biologics
• Thermo Fisher Scientific
• Curia Global
• GenScript
• Bionova Scientific
• BioXcellence

Biologics Contract Development by Segment

The study includes a forecast for the global biologics contract development by source, product service, disease indication, and region.

Biologics Contract Development Market by Source [Analysis by Value from 2018 to 2030]:

• Microbial
• Mammalian
• Others

Biologics Contract Development Market by Product Service [Analysis by Value from 2018 to 2030]:

• Cell Line Development
• Process Development
• Others

Biologics Contract Development Market by Disease Indication [Analysis by Value from 2018 to 2030]:

• Oncology
• Immunological Disorders
• Cardiovascular Disorders
• Hematological Disorders
• Others

Biologics Contract Development Market by Region [Shipment Analysis by Value from 2018 to 2030]:

• North America
• Europe
• Asia Pacific
• The Rest of the World

Country Wise Outlook for the Biologics Contract Development Market

The biologics contract development market is shaped by advancements in technology, investment policies, and increasing demand for biologics. Countries like the United States, China, Germany, India, and Japan are actively participating in these developments and transforming the industry through innovation and investment.

• United States: In the U.S., the biologics contract development market is showing healthy growth due to rising investments in advanced manufacturing technologies and synergies between biotechnology companies and contract development organizations (CDOs)/contract manufacturing organizations (CMOs). Increasing process efficiencies and implementing new technologies like continuous manufacturing and cell/gene therapy remain priorities. Moreover, the U.S. regulatory framework continues to encourage innovation, especially in the approval of biologics.
• China: China is rapidly expanding its biologics contract development capabilities due to state policies supporting biotechnology and pharmaceutical innovation. Recent developments include new biomanufacturing plants and additional resources to improve the scaling up of biologics. China is positioning itself as a leader in global biologics development with significant investment in R&D and international collaboration.
• Germany: Germany is a leader in biologics contract development and production in Europe, supported by favorable policies and regulations. Recent changes include innovations in bioprocessing and increased capacity for high-throughput screening and analysis. As a member of the European Union, Germany benefits from transnational research cooperation and a broad market for biologics.
• India: India's biologics contract development market is growing due to improved infrastructure and increased biopharmaceutical capabilities. Modern factories and updated laws are facilitating quicker approvals. India's low-cost manufacturing and experienced labor are attracting offshore clients seeking cost-effective biologics development solutions.
• Japan: Japan is advancing its biologics contract development through technological innovations and industry collaboration. Recent developments include enhancements in biomanufacturing processes and the integration of cutting-edge technologies like artificial intelligence in drug development. Japan's supportive regulatory structure continues to drive growth and foster international partnerships.

Features of the Global Biologics Contract Development Market

Market Size Estimates: Biologics contract development market size estimation in terms of value ($B).

Trend and Forecast Analysis: Market trends (2018 to 2023) and forecast (2024 to 2030) by various segments and regions.

Segmentation Analysis: Biologics contract development market size by source, product service, disease indication, and region in terms of value ($B).

Regional Analysis: Biologics contract development market breakdown by North America, Europe, Asia Pacific, and Rest of the World.

Growth Opportunities: Analysis of growth opportunities in different sources, product services, disease indication, and regions for the biologics contract development market.

Strategic Analysis: This includes M&A, new product development, and competitive landscape of the biologics contract development market.

Analysis of competitive intensity of the industry based on Porter's Five Forces model.

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This report answers following 11 key questions:

• Q.1. What are some of the most promising, high-growth opportunities for the biologics contract development market by source (microbial, mammalian, and others), product service (cell line development, process development, and others), disease indication (oncology, immunological disorders, cardiovascular disorders, hematological disorders, and others), and region (North America, Europe, Asia Pacific, and the Rest of the World)?
• Q.2. Which segments will grow at a faster pace and why?
• Q.3. Which region will grow at a faster pace and why?
• Q.4. What are the key factors affecting market dynamics? What are the key challenges and business risks in this market?
• Q.5. What are the business risks and competitive threats in this market?
• Q.6. What are the emerging trends in this market and the reasons behind them?
• Q.7. What are some of the changing demands of customers in the market?
• Q.8. What are the new developments in the market? Which companies are leading these developments?
• Q.9. Who are the major players in this market? What strategic initiatives are key players pursuing for business growth?
• Q.10. What are some of the competing products in this market and how big of a threat do they pose for loss of market share by material or product substitution?
• Q.11. What M&A activity has occurred in the last 5 years and what has its impact been on the industry?

Table of Contents

1. Executive Summary

2. Global Biologics Contract Development Market : Market Dynamics

• 2.1: Introduction, Background, and Classifications
• 2.2: Supply Chain
• 2.3: Industry Drivers and Challenges

3. Market Trends and Forecast Analysis from 2018 to 2030

• 3.1. Macroeconomic Trends (2018-2023) and Forecast (2024-2030)
• 3.2. Global Biologics Contract Development Market Trends (2018-2023) and Forecast (2024-2030)
• 3.3: Global Biologics Contract Development Market by Source
  • 3.3.1: Microbial
  • 3.3.2: Mammalian
  • 3.3.3: Others
• 3.4: Global Biologics Contract Development Market by Product Service
  • 3.4.1: Cell Line Development
  • 3.4.2: Process Development
  • 3.4.3: Others
• 3.5: Global Biologics Contract Development Market by Disease Indication
  • 3.5.1: Oncology
  • 3.5.2: Immunological Disorders
  • 3.5.3: Cardiovascular Disorders
  • 3.5.4: Hematological Disorders
  • 3.5.5: Others

4. Market Trends and Forecast Analysis by Region from 2018 to 2030

• 4.1: Global Biologics Contract Development Market by Region
• 4.2: North American Biologics Contract Development Market
  • 4.2.1: North American Biologics Contract Development Market by Source: Microbial, Mammalian, and Others
  • 4.2.2: North American Biologics Contract Development Market by Disease Indication: Oncology, Immunological Disorders, Cardiovascular Disorders, Hematological Disorders, and Others
• 4.3: European Biologics Contract Development Market
  • 4.3.1: European Biologics Contract Development Market by Source: Microbial, Mammalian, and Others
  • 4.3.2: European Biologics Contract Development Market by Disease Indication: Oncology, Immunological Disorders, Cardiovascular Disorders, Hematological Disorders, and Others
• 4.4: APAC Biologics Contract Development Market
  • 4.4.1: APAC Biologics Contract Development Market by Source: Microbial, Mammalian, and Others
  • 4.4.2: APAC Biologics Contract Development Market by Disease Indication: Oncology, Immunological Disorders, Cardiovascular Disorders, Hematological Disorders, and Others
• 4.5: ROW Biologics Contract Development Market
  • 4.5.1: ROW Biologics Contract Development Market by Source: Microbial, Mammalian, and Others
  • 4.5.2: ROW Biologics Contract Development Market by Disease Indication: Oncology, Immunological Disorders, Cardiovascular Disorders, Hematological Disorders, and Others

5. Competitor Analysis

• 5.1: Product Portfolio Analysis
• 5.2: Operational Integration
• 5.3: Porter's Five Forces Analysis

6. Growth Opportunities and Strategic Analysis

• 6.1: Growth Opportunity Analysis
  • 6.1.1: Growth Opportunities for the Global Biologics Contract Development Market by Source
  • 6.1.2: Growth Opportunities for the Global Biologics Contract Development Market by Product Service
  • 6.1.3: Growth Opportunities for the Global Biologics Contract Development Market by Disease Indication
  • 6.1.4: Growth Opportunities for the Global Biologics Contract Development Market by Region
• 6.2: Emerging Trends in the Global Biologics Contract Development Market
• 6.3: Strategic Analysis
  • 6.3.1: New Product Development
  • 6.3.2: Capacity Expansion of the Global Biologics Contract Development Market
  • 6.3.3: Mergers, Acquisitions, and Joint Ventures in the Global Biologics Contract Development Market
  • 6.3.4: Certification and Licensing

7. Company Profiles of Leading Players

• 7.1: WuXi Biologics
• 7.2: Abzena
• 7.3: Fujifilm Diosynth Biotechnologies
• 7.4: KBI Biopharma
• 7.5: AGC Biologics
• 7.6: Thermo Fisher Scientific
• 7.7: Curia Global
• 7.8: GenScript
• 7.9: Bionova Scientific
• 7.10: BioXcellence