生物製藥原料藥製造服務市場報告：趨勢、預測與競爭分析（至 2031 年）

全球生物製藥原料藥（生物技術 API）製造服務市場前景光明，在 API 製程開發和製造、分析測試和品管、監管提交支援以及擴大和商業製造市場方面都機會。預計到 2031 年全球生物製藥原料藥製造服務市場規模將達到 196 億美元，2025 年至 2031 年的複合年成長率為 12.4%。該市場的主要促進因素是對創新有效藥物的需求不斷成長、慢性病的流行、生技藥品和生物學名藥的採用日益增多以及個性化醫療的趨勢日益成長。

• Lucintel 預測，以業務規模計算，大型企業將在預測期內經歷最高的成長。
• 按地區分類，預計亞太地區將在預測期內實現最高成長。這是由於該地區藥品需求不斷增加、人口成長、醫療支出不斷增加以及慢性病的流行所造成的。

生物製藥原料藥製造服務市場的策略性成長機會

生物製藥原料藥製造服務市場在各個關鍵應用領域中呈現多種策略成長機會。

• 個人化醫療：針對個人病患資料客製化的 API 的需求日益增加，為專業化製造解決方案創造了機會。
• 生物相似藥：生物相似藥的接受度不斷提高，為開發和製造具有成本效益的替代品創造了機會。
• 基因和細胞治療：基因和細胞治療的進步推動了對先進原料藥的需求，為生物製藥製造商創造了一個新的細分市場。
• 腫瘤學：對癌症治療的關注正在創造對用於癌症治療的創新原料藥的需求，這表明具有成長潛力。
• 罕見疾病：罕見疾病治療的興起正在擴大利基原料藥市場並為有針對性的製造提供機會。
• 生技藥品：生技藥品和單株抗體的持續擴張推動了對高品質原料藥和先進製造能力的需求。

生物製藥原料藥製造服務市場的策略性成長機會受到個人化醫療、生物相似藥和新型療法的進步的推動，為擴張和創新提供了多種途徑。

生物製藥原料藥製造服務市場促進因素與挑戰

生物製藥原料藥製造服務市場受到影響其成長和發展的多種促進因素​​和挑戰的影響。

推動生物製藥原料藥製造服務市場發展的因素如下：

• 技術創新：製造技術和數位化工具的進步正在提高生產效率和品質。
• 對生技藥品的需求不斷增加：生技藥品和生物相似藥的使用不斷增加，推動了對生物製藥原料藥的需求。
• 監管支援：不斷發展的法律規範正在促進藥品的更快核准和進入市場。
• 全球市場成長：不斷擴大的醫療需求和不斷增加的患者數量正在推動對生物製藥原料藥的需求。
• 研發投資：大量的研發投資推動了創新和新產品開發。

生物製藥原料藥製造服務市場面臨的挑戰如下：

• 監管障礙：複雜且區域分散的監管阻礙了市場進入並增加了合規成本。
• 製造成本高：先進的製造技術和品管成本高。
• 競爭：激烈的競爭，尤其是在生物相似藥領域的競爭，會影響市場佔有率和盈利。
• 供應鏈問題：供應鏈中斷可能會影響原料和原料藥的可用性和成本。

雖然生物製藥原料藥製造服務市場受益於技術進步和需求不斷成長，但它也面臨著監管複雜性和高製造成本等挑戰，必須解決這些挑戰才能實現持續成長。

目錄

第1章執行摘要

原料藥2 章。

• 簡介、背景和分類
• 供應鏈
• 產業促進因素與挑戰

第 3 章 市場趨勢與預測分析（2019-2031）

• 宏觀經濟趨勢（2019-2024）與預測（2025-2031）
• 全球生物製藥原料藥製造服務市場趨勢（2019-2024 年）及預測（2025-2031 年）
• 全球生物製藥原料藥製造服務市場（依服務類型）
  • API（原料藥）製程開發與製造
  • 分析測試和品管
  • 製藥應用支援
  • 擴大規模和商業化生產
• 全球生物製藥原料藥製造服務市場（按業務規模）
  • 小規模
  • 中等規模
  • 大規模

第 4 章區域市場趨勢與預測分析（2019-2031 年）

• 全球生物製藥原料藥製造服務市場（按地區）
• 北美生物製藥原料藥製造服務市場
• 歐洲生物製藥原料藥製造服務市場
• 亞太生物製藥原料藥製造服務市場
• 世界其他地區生物製藥原料藥製造服務市場

第5章 競爭分析

• 產品系列分析
• 營運整合
• 波特五力分析

第6章 成長機會與策略分析

• 成長機會分析
  • 全球生物製藥原料藥製造服務市場成長機會（依服務類型）
  • 全球生物製藥原料藥製造服務市場成長機會（按業務規模）
  • 全球生物製藥原料藥製造服務市場成長機會（按地區）
• 全球生物製藥原料藥製造服務市場的新興趨勢
• 戰略分析
  • 新產品開發
  • 全球生物製藥原料藥製造服務市場產能擴張
  • 全球生物製藥原料藥製造服務市場的企業合併
  • 認證和許可

第7章主要企業簡介

• 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