バイオ医薬品原薬製造サービス市場レポート：動向、予測、競合分析 (2031年まで)

世界のバイオ医薬品原薬 (バイオテックAPI) 製造サービス市場の将来は、APIプロセス開発・製造、分析試験・品質管理、薬事申請支援、スケールアップ・商業生産の市場に機会があり、有望視されています。世界のバイオ医薬品原薬製造サービス市場は、2025年から2031年までのCAGRが12.4%で、2031年までに推定196億米ドルに達すると予想されています。この市場の主な促進要因は、革新的で効果的な医薬品に対する需要の高まり、慢性疾患の蔓延、生物製剤とバイオシミラーの採用拡大、個別化医療への傾向の高まりです。

• Lucintel社は、事業規模別では大規模企業が予測期間中に最も高い成長を遂げると予測しています。
• 地域別では、アジア太平洋が予測期間中に最も高い成長を遂げると予想されます。これは、同地域における医薬品需要の増加、人口増加、医療支出の増加、慢性疾患の蔓延によるものです。

バイオ医薬品原薬製造サービス市場の戦略的成長機会

バイオ医薬品原薬製造サービス市場は、様々な主要用途においていくつかの戦略的成長機会を提示しています。

• 個別化医療：個々の患者のプロファイルに合わせたAPIに対する需要が高まっており、専門的な製造ソリューションの機会が創出されています。
• バイオシミラー：バイオシミラー医薬品の受け入れが拡大しており、費用対効果の高い代替品を開発・製造する機会が生じています。
• 遺伝子・細胞治療：遺伝子治療と細胞治療の進歩は高度な原薬の必要性を促し、バイオ医薬品メーカーに新たな市場セグメントをもたらします。
• がん領域：がん治療への注目は、がん治療に使用される革新的な原薬への需要を生み出し、成長の可能性を示しています。
• 希少疾患：希少疾患の治療が増加しているため、ニッチな原薬市場が拡大し、ターゲットを絞った製造の機会がもたらされています。
• 生物製剤：生物製剤とモノクローナル抗体の継続的な拡大が、高品質の原薬と高度な生産能力へのニーズを後押ししています。

バイオ医薬品原薬製造サービス市場の戦略的成長機会は、個別化医療、バイオシミラー、新規治療薬の進歩によってもたらされ、多様な拡大・革新の道を提供しています。

バイオ医薬品原薬製造サービス市場促進要因・課題

バイオ医薬品原薬製造サービス市場は、その成長と開拓に影響を与えるいくつかの促進要因・課題の影響を受けています。

バイオ医薬品原薬製造サービス市場を牽引する要因には以下のようなものがあります：

• 技術革新：製造技術とデジタルツールの進歩により、生産効率と品質が向上しています。
• 生物製剤の需要増加：生物製剤やバイオシミラーの使用増加がバイオ医薬品原薬の需要を押し上げています。
• 規制支援：進化する規制の枠組みは、医薬品の迅速な承認と市場参入を促進しています。
• 世界市場の成長：医療ニーズの拡大と患者数の増加がバイオ医薬品原薬の需要を促進しています。
• 研究開発への投資：研究開発への多額の投資が、技術革新と新製品開発を促進しています。

バイオ医薬品原薬製造サービス市場における課題は以下の通りです：

• 規制上のハードル：複雑で地域によって異なる規制は、市場参入を妨げ、コンプライアンス・コストを増加させます。
• 高い製造コスト：高度な製造技術や品質管理には多額のコストがかかります。
• 競合：激しい競合、特にバイオシミラー分野では市場シェアと収益性に影響を与える可能性があります。
• サプライチェーンの問題：サプライチェーンの混乱は、原料や原薬の入手可能性やコストに影響を与える可能性があります。

バイオ医薬品原薬製造サービス市場は、技術の進歩や需要の増加から恩恵を受ける一方で、規制の複雑さや製造コストの高さなど、持続的な成長のために対処すべき課題に直面しています。

目次

第1章 エグゼクティブサマリー

第2章 世界のバイオ医薬品原薬製造サービス市場：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 市場動向と予測分析 (2019年～2031年)

• マクロ経済動向 (2019～2024年) と予測 (2025～2031年)
• 世界のバイオ医薬品原薬製造サービス市場の動向 (2019～2024年) と予測 (2025～2031年)
• 世界のバイオ医薬品原薬製造サービス市場：サービスの種類別
  • API (原薬) プロセス開発・製造
  • 分析試験・品質管理
  • 薬事申請支援
  • スケールアップ・商業製造
• 世界のバイオ医薬品原薬製造サービス市場：事業規模別
  • 小規模
  • 中規模
  • 大規模

第4章 地域別の市場動向と予測分析 (2019年～2031年)

• 世界のバイオ医薬品原薬製造サービス市場：地域別
• 北米のバイオ医薬品原薬製造サービス市場
• 欧州のバイオ医薬品原薬製造サービス市場
• アジア太平洋のバイオ医薬品原薬製造サービス市場
• その他地域のバイオ医薬品原薬製造サービス市場

第5章 競合分析

• 製品ポートフォリオ分析
• 運用統合
• 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
  • 世界のバイオ医薬品原薬製造サービス市場の成長機会：サービスの種類別
  • 世界のバイオ医薬品原薬製造サービス市場の成長機会：事業規模別
  • 世界のバイオ医薬品原薬製造サービス市場の成長機会：地域別
• 世界のバイオ医薬品原薬製造サービス市場の新たな動向
• 戦略的分析
  • 新製品の開発
  • 世界のバイオ医薬品原薬製造サービス市場の生産能力拡大
  • 世界のバイオ医薬品原薬製造サービス市場における企業合併・買収 (M&A)、合弁事業
  • 認証とライセンシング

第7章 主要企業のプロファイル

• Lonza
• WuXi AppTec
• Boehringer Ingelheim Biopharmaceuticals
• Le Vise Products
• Location Based Technologies
• Trax
• Nanjing Hungjie Semiconductor Technology
• Almac
• FUJIFILM Diosynth Biotechnologies
• Abzena

The future of the global biotech API manufacturing service market looks promising with opportunities in the API process development & manufacturing, analytical testing & quality control, regulatory support, and scale-up & commercial manufacturing markets. The global biotech API manufacturing service market is expected to reach an estimated $19.6 billion by 2031 with a CAGR of 12.4% from 2025 to 2031. The major drivers for this market are the rising demand for innovative and effective drugs, the increasing prevalence of chronic diseases, the growing adoption of biologics and biosimilars, and the rising trend toward personalized medicine.

• Lucintel forecasts that, within the scale of operation category, large-scale companies are expected to witness the highest growth over the forecast period.
• In terms of regions, APAC is expected to witness the highest growth over the forecast period due to the growing demand for pharmaceutical products in the region, population growth, rising healthcare spending, and the increasing prevalence of chronic diseases.

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Emerging Trends in the Biotech API Manufacturing Service Market

The biotech API manufacturing service market is rapidly evolving with several key trends shaping its future.

• Adoption of Advanced Technologies: Continuous manufacturing, single-use systems, and digital integration are revolutionizing the industry, improving efficiency and scalability.
• Rise of Personalized Medicine: Increased focus on precision medicine is driving demand for custom APIs tailored to individual patient needs.
• Growth of Biosimilars: The expansion of biosimilars is creating new opportunities and intensifying competition in the biotech API sector.
• Sustainability Initiatives: There is a growing emphasis on green manufacturing practices to reduce environmental impact and improve sustainability.
• Regulatory Advancements: Evolving regulatory frameworks are promoting innovation while ensuring compliance and safety.

The biotech API manufacturing service market is witnessing transformative trends driven by technological advancements, regulatory changes, and an increased focus on personalized medicine, highlighting a dynamic and evolving landscape.

Recent Developments in the Biotech API Manufacturing Service Market

Recent developments in the biotech API manufacturing service market reflect a dynamic and rapidly evolving industry landscape.

• Technological Advancements: Companies are investing in state-of-the-art technologies such as continuous bioprocessing and digital solutions to enhance efficiency and flexibility.
• Expansion of Production Capabilities: There has been a notable increase in the construction and upgrading of manufacturing facilities to meet rising global demand.
• Regulatory Evolution: Regulatory bodies are updating frameworks to accelerate drug approvals and streamline compliance processes.
• Focus on Biosimilars: The market is seeing a surge in biosimilar development, driven by the need for affordable alternatives to original biologics.
• Sustainability Efforts: Green manufacturing practices and sustainable production methods are becoming more prevalent in response to environmental concerns.
• Global Collaborations: Strategic partnerships and collaborations across borders are fostering innovation and expanding market reach.

The biotech API manufacturing service market is undergoing significant changes, with advancements in technology, regulatory frameworks, and global collaborations driving its development and growth.

Strategic Growth Opportunities for Biotech API Manufacturing Service Market

The biotech API manufacturing service market presents several strategic growth opportunities across various key applications.

• Personalized Medicine: There is a growing demand for APIs tailored to individual patient profiles, creating opportunities for specialized manufacturing solutions.
• Biosimilars: The increasing acceptance of biosimilars offers a significant growth avenue, with opportunities for companies to develop and produce cost-effective alternatives.
• Gene and Cell Therapies: Advances in gene and cell therapies are driving the need for advanced APIs, opening new market segments for biotech manufacturers.
• Oncology: The focus on oncology treatments is creating demand for innovative APIs used in cancer therapies, presenting growth potential.
• Rare Diseases: The rise in treatments for rare diseases is expanding the market for niche APIs, offering opportunities for targeted manufacturing.
• Biologics: The continued expansion of biologics and monoclonal antibodies is driving the need for high-quality APIs and advanced production capabilities.

Strategic growth opportunities in the biotech API manufacturing service market are driven by advancements in personalized medicine, biosimilars, and emerging therapies, offering diverse avenues for expansion and innovation.

Biotech API Manufacturing Service Market Driver and Challenges

The biotech API manufacturing service market is influenced by several drivers and challenges impacting its growth and development.

The factors responsible for driving the biotech API manufacturing service market include:

• Technological Innovation: Advances in manufacturing technologies and digital tools are enhancing production efficiency and quality.
• Rising Demand for Biologics: The increasing use of biologics and biosimilars is boosting demand for biotech APIs.
• Regulatory Support: Evolving regulatory frameworks are facilitating faster drug approvals and market entry.
• Growing Global Market: Expanding healthcare needs and rising patient populations are driving demand for biotech APIs.
• Investment in R&D: Significant investments in research and development are fueling innovation and new product development.

Challenges in the biotech API manufacturing service market include:

• Regulatory Hurdles: Complex and varying regulations across regions can impede market entry and increase compliance costs.
• High Production Costs: The cost of advanced manufacturing technologies and quality control can be substantial.
• Competition: Intense competition, especially in the biosimilar segment, can impact market share and profitability.
• Supply Chain Issues: Disruptions in the supply chain can affect the availability and cost of raw materials and APIs.

While the biotech API manufacturing service market benefits from technological advancements and rising demand, it faces challenges such as regulatory complexities and high production costs that need to be addressed for sustained growth.

List of Biotech API Manufacturing Service 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. Through these strategies biotech API manufacturing service companies cater increasing demand, ensure competitive effectiveness, develop innovative products & technologies, reduce production costs, and expand their customer base. Some of the biotech API manufacturing service companies profiled in this report include-

• Lonza
• WuXi AppTec
• Boehringer Ingelheim Biopharmaceuticals
• CordenPharma
• Sterling Pharma
• AbbVie
• HIKAL
• Almac
• FUJIFILM Diosynth Biotechnologies
• Abzena

Biotech API Manufacturing Service by Segment

The study includes a forecast for the global biotech API manufacturing service market by service type, scale of operation, and region.

Biotech API Manufacturing Service Market by Service Type [Analysis by Value from 2019 to 2031]:

• API Process Development & Manufacturing
• Analytical Testing & Quality Control
• Regulatory Support
• Scale-Up & Commercial Manufacturing

Biotech API Manufacturing Service Market by Scale of Operation [Analysis by Value from 2019 to 2031]:

• Small-Scale
• Mid-Scale
• Large-Scale

Biotech API Manufacturing Service Market by Region [Analysis by Value from 2019 to 2031]:

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

Country Wise Outlook for the Biotech API Manufacturing Service Market

Major players in the market are expanding their operations and forming strategic partnerships to strengthen their positions. The image below highlights recent developments by major biotech API manufacturing service producers in key regions: the USA, China, India, and Japan.

• USA: Recent developments in the US biotech API manufacturing sector include a strong focus on advanced biomanufacturing technologies and regulatory advancements. Companies are investing in cutting-edge production techniques such as continuous manufacturing and single-use technologies to enhance efficiency and flexibility. There is also significant growth in personalized medicine, driving demand for specialized APIs. The FDA's evolving regulatory frameworks are promoting innovation while ensuring safety and efficacy. Additionally, the rise of biosimilars is reshaping the landscape, leading to increased competition and opportunities for new entrants.
• China: China's biotech API manufacturing sector is rapidly expanding due to significant investments in infrastructure and technology. The country is increasingly becoming a global hub for biotech production, supported by government initiatives like the "Made in China 2025" plan. Chinese firms are focusing on advanced production techniques and quality improvements to meet international standards. Additionally, there is a strong push towards developing biosimilars and increasing domestic production capabilities to reduce reliance on imports. China is also enhancing its regulatory environment to support industry growth.
• India: In India, the biotech API manufacturing sector is experiencing robust growth due to cost advantages and a skilled workforce. The country is a leading player in the production of generic APIs and biosimilars, driven by increasing global demand. Recent developments include the expansion of manufacturing facilities and investments in R&D to improve process efficiency. India is also seeing enhancements in regulatory practices to align with international standards. The rise of new biotech startups and collaborations with global firms is further boosting the sector's growth prospects.
• Japan: Japan's biotech API manufacturing market is evolving with a focus on high-quality production and innovation. The country is investing in advanced manufacturing technologies, including automation and precision engineering. The Japanese government is supporting the sector through various initiatives aimed at enhancing R&D capabilities and international competitiveness. There is also a strong emphasis on developing biologics and novel therapeutics. Recent regulatory changes are aimed at speeding up drug approvals and improving market access for biotech products.

Features of the Global Biotech API Manufacturing Service Market

Market Size Estimates: Biotech API manufacturing service market size estimation in terms of value ($B).

Trend and Forecast Analysis: Market trends (2019 to 2024) and forecast (2025 to 2031) by various segments and regions.

Segmentation Analysis: Biotech API manufacturing service market size by service type, scale of operation, and region in terms of value ($B).

Regional Analysis: Biotech API manufacturing service market breakdown by North America, Europe, Asia Pacific, and Rest of the World.

Growth Opportunities: Analysis of growth opportunities in different service type, scale of operation, and regions for the biotech API manufacturing service market.

Strategic Analysis: This includes M&A, new product development, and competitive landscape of the biotech API manufacturing service 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 biotech API manufacturing service market by service type (API process development & manufacturing, analytical testing & quality control, regulatory support, and scale-up & commercial manufacturing), scale of operation (small-scale, mid-scale, and large-scale), 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 Biotech API Manufacturing Service 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 2019 to 2031

• 3.1. Macroeconomic Trends (2019-2024) and Forecast (2025-2031)
• 3.2. Global Biotech API Manufacturing Service Market Trends (2019-2024) and Forecast (2025-2031)
• 3.3: Global Biotech API Manufacturing Service Market by Service Type
  • 3.3.1: API Process Development & Manufacturing
  • 3.3.2: Analytical Testing & Quality Control
  • 3.3.3: Regulatory Support
  • 3.3.4: Scale-Up & Commercial Manufacturing
• 3.4: Global Biotech API Manufacturing Service Market by Scale of Operation
  • 3.4.1: Small-Scale
  • 3.4.2: Mid-Scale
  • 3.4.3: Large-Scale

4. Market Trends and Forecast Analysis by Region from 2019 to 2031

• 4.1: Global Biotech API Manufacturing Service Market by Region
• 4.2: North American Biotech API Manufacturing Service Market
  • 4.2.1: North American Market by Service Type: API Process Development & Manufacturing, Analytical Testing & Quality Control, Regulatory Support, and Scale-Up & Commercial Manufacturing
  • 4.2.2: North American Market by Scale of Operation: Small-Scale, Mid-Scale, and Large-Scale
• 4.3: European Biotech API Manufacturing Service Market
  • 4.3.1: European Market by Service Type: API Process Development & Manufacturing, Analytical Testing & Quality Control, Regulatory Support, and Scale-Up & Commercial Manufacturing
  • 4.3.2: European Market by Scale of Operation: Small-Scale, Mid-Scale, and Large-Scale
• 4.4: APAC Biotech API Manufacturing Service Market
  • 4.4.1: APAC Market by Service Type: API Process Development & Manufacturing, Analytical Testing & Quality Control, Regulatory Support, and Scale-Up & Commercial Manufacturing
  • 4.4.2: APAC Market by Scale of Operation: Small-Scale, Mid-Scale, and Large-Scale
• 4.5: ROW Biotech API Manufacturing Service Market
  • 4.5.1: ROW Market by Service Type: API Process Development & Manufacturing, Analytical Testing & Quality Control, Regulatory Support, and Scale-Up & Commercial Manufacturing
  • 4.5.2: ROW Market by Scale of Operation: Small-Scale, Mid-Scale, and Large-Scale

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 Biotech API Manufacturing Service Market by Service Type
  • 6.1.2: Growth Opportunities for the Global Biotech API Manufacturing Service Market by Scale of Operation
  • 6.1.3: Growth Opportunities for the Global Biotech API Manufacturing Service Market by Region
• 6.2: Emerging Trends in the Global Biotech API Manufacturing Service Market
• 6.3: Strategic Analysis
  • 6.3.1: New Product Development
  • 6.3.2: Capacity Expansion of the Global Biotech API Manufacturing Service Market
  • 6.3.3: Mergers, Acquisitions, and Joint Ventures in the Global Biotech API Manufacturing Service Market
  • 6.3.4: Certification and Licensing

7. Company Profiles of Leading Players

• 7.1: Lonza
• 7.2: WuXi AppTec
• 7.3: Boehringer Ingelheim Biopharmaceuticals
• 7.4: Le Vise Products
• 7.5: Location Based Technologies
• 7.6: Trax
• 7.7: Nanjing Hungjie Semiconductor Technology
• 7.8: Almac
• 7.9: FUJIFILM Diosynth Biotechnologies
• 7.10: Abzena