生物製药原料药製造服务市场报告：趋势、预测与竞争分析（至 2031 年）

全球生物製药原料药（生物技术 API）製造服务市场前景光明，在 API 製程开发和製造、分析测试和品管、监管提交支援以及扩大和商业製造市场方面都机会。预计到 2031 年全球生物製药原料药製造服务市场规模将达到 196 亿美元，2025 年至 2031 年的复合年增长率为 12.4%。该市场的主要驱动因素是对创新有效药物的需求不断增长、慢性病的流行、生技药品和生物仿製药的采用日益增多以及个性化医疗的趋势日益增长。

• Lucintel 预测，以业务规模计算，大型企业将在预测期内经历最高的成长。
• 按地区划分，预计亚太地区将在预测期内实现最高成长。这是由于该地区药品需求不断增加、人口增长、医疗支出不断增加以及慢性病的流行所造成的。

生物製药原料药製造服务市场的策略性成长机会

生物製药原料药製造服务市场在各个关键应用领域中呈现多种策略成长机会。

• 个人化医疗：针对个人病患资料客製化的 API 的需求日益增加，为专业化製造解决方案创造了机会。
• 生物相似药：生物相似药的接受度不断提高，为开发和製造具有成本效益的替代品创造了机会。
• 基因和细胞治疗：基因和细胞治疗的进步推动了对先进原料药的需求，为生物製药製造商创造了一个新的细分市场。
• 肿瘤学：对癌症治疗的关注正在创造对用于癌症治疗的创新原料药的需求，这表明具有成长潜力。
• 罕见疾病：罕见疾病治疗的兴起正在扩大利基原料药市场并为有针对性的製造提供机会。
• 生技药品：生技药品和单株抗体的持续扩张推动了对高品质原料药和先进製造能力的需求。

生物製药原料药製造服务市场的策略性成长机会受到个人化医疗、生物相似药和新型疗法的进步的推动，为扩张和创新提供了多种途径。

生物製药原料药製造服务市场驱动因素与挑战

生物製药原料药製造服务市场受到影响其成长和发展的多种驱动因素​​和挑战的影响。

推动生物製药原料药製造服务市场发展的因素如下：

• 技术创新：製造技术和数位化工具的进步正在提高生产效率和品质。
• 对生技药品的需求不断增加：生技药品和生物相似药的使用不断增加，推动了对生物製药原料药的需求。
• 监管支援：不断发展的法律规范正在促进药品的更快核准和进入市场。
• 全球市场成长：不断扩大的医疗需求和不断增加的患者数量正在推动对生物製药原料药的需求。
• 研发投资：大量的研发投资推动了创新和新产品开发。

生物製药原料药製造服务市场面临的挑战如下：

• 监管障碍：复杂且区域分散的监管阻碍了市场进入并增加了合规成本。
• 製造成本高：先进的製造技术和品管成本高。
• 竞争：激烈的竞争，尤其是在生物相似药领域的竞争，会影响市场占有率和盈利。
• 供应链问题：供应链中断可能会影响原料和原料药的可用性和成本。

虽然生物製药原料药製造服务市场受益于技术进步和需求不断增长，但它也面临着监管复杂性和高製造成本等挑战，必须解决这些挑战才能实现持续成长。

目录

第一章执行摘要

原料药2 章。

• 简介、背景和分类
• 供应链
• 产业驱动因素与挑战

第 3 章 市场趋势与预测分析（2019-2031）

• 宏观经济趋势（2019-2024）与预测（2025-2031）
• 全球生物製药原料药製造服务市场趋势（2019-2024 年）及预测（2025-2031 年）
• 全球生物製药原料药製造服务市场（依服务类型）
  • API（原料药）製程开发与製造
  • 分析测试和品管
  • 製药应用支援
  • 扩大规模和商业化生产
• 全球生物製药原料药製造服务市场（按业务规模）
  • 小规模
  • 中等规模
  • 大规模

第 4 章区域市场趋势与预测分析（2019-2031 年）

• 全球生物製药原料药製造服务市场（按地区）
• 北美生物製药原料药製造服务市场
• 欧洲生物製药原料药製造服务市场
• 亚太生物製药原料药製造服务市场
• 世界其他地区生物製药原料药製造服务市场

第五章 竞争分析

• 产品系列分析
• 营运整合
• 波特五力分析

第六章 成长机会与策略分析

• 成长机会分析
  • 全球生物製药原料药製造服务市场成长机会（依服务类型）
  • 全球生物製药原料药製造服务市场成长机会（按业务规模）
  • 全球生物製药原料药製造服务市场成长机会（按地区）
• 全球生物製药原料药製造服务市场的新兴趋势
• 战略分析
  • 新产品开发
  • 全球生物製药原料药製造服务市场产能扩张
  • 全球生物製药原料药製造服务市场的企业合併
  • 认证和许可

第七章主要企业简介

• 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