North America Active Pharmaceutical Ingredients (API) Market – Industry Trends and Forecast to 2031

North America Active Pharmaceutical Ingredients (API) Market Analysis and Size

The active pharmaceutical ingredients (API) market plays a vital role in drug formulation. High-quality APIs ensure efficacy, safety, and consistency in medications. Pharmaceutical companies benefit from a diverse API market by accessing cost-effective options, enabling rapid drug development, and meeting regulatory standards. Ultimately, patients receive reliable and affordable medications, improving global healthcare outcomes.

The World Health Organization (WHO) reports that cardiovascular diseases claim 17.9 million lives annually, making them the leading cause of global mortality. Active pharmaceutical ingredient (API) is the core substance driving medication efficacy, while formulation involves optimizing component mixtures for pharmaceutical use.                            

Data Bridge Market Research analyses that the North America active pharmaceutical ingredients (API) market size was valued at USD 68.32 billion in 2023, is projected to reach USD 90.67 billion by 2031, with a CAGR of 3.6% during the forecast period 2024 to 2031. This indicates that the market value. In addition to the insights on market scenarios such as market value, growth rate, segmentation, geographical coverage, and major players, the market reports curated by the Data Bridge Market Research also include depth expert analysis, patient epidemiology, pipeline analysis, pricing analysis, and regulatory framework.

North America Active Pharmaceutical Ingredients (API) Market Scope and Segmentation

Market Definition

Active pharmaceutical ingredients (API) are the biologically active ingredients in medications responsible for their therapeutic effects. They are the essence of pharmaceutical formulations, providing the desired medicinal properties. APIs undergo stringent testing and regulation to ensure safety and efficacy. These substances are crucial in drug manufacturing, pivotal in developing various pharmaceutical products.           

North America Active Pharmaceutical Ingredients (API) Market Dynamics

Drivers

• Growing Generic Drug Market

Generic drugs, reliant on APIs as active constituents, offer cost-effective alternatives to branded medications, fueling API production growth. This trend reflects the increasing preference for affordable pharmaceutical options, particularly in regions with limited healthcare resources and rising healthcare costs. The growing generic drug market, especially in developing nations, drives API demand.  

• Increasing Prevalence of Chronic Diseases

The surge in chronic diseases such as cancer, cardiovascular ailments, and diabetes fuels the demand for active pharmaceutical ingredients (APIs). APIs are indispensable in crafting medications to combat these conditions. Consequently, the escalating prevalence of chronic illnesses propels the need for APIs, essential components in the formulation of drugs targeting these ailments.

For instance, according to the 2022 statistics from the International Diabetes Federation (IDF), diabetic cases are forecasted to increase to 643 million by 2030 and to 784 million by 2045, highlighting a concerning trend in global diabetes prevalence.

Opportunities

• Increasing Outsourcing of API Production

Outsourcing API production to specialized manufacturers, driven by cost advantages and regulatory benefits, drives the growth of contract manufacturing organizations (CMOs) and contract development and manufacturing organizations (CDMOs), shaping the pharmaceutical manufacturing landscape. This trend reflects a strategic shift in API in pharmaceutical industry dynamics, optimizing production capabilities and enhancing global supply chains. 

For instance, in October 2022, Mendus AB partnered with Minaris Regenerative Medicine GmbH to facilitate technology transfer for manufacturing DCP-001, its lead development program. DCP-001 is undergoing evaluation in the ADVANCE II Phase 2 trial for preventing tumor recurrence in Acute Myeloid Leukemia (AML) and the ALISON Phase 1 trial in ovarian cancer.

• Technological Advancements in API Manufacturing

Technological advancements in API manufacturing have revolutionized synthesis and production techniques, boosting efficiency, cutting production costs, and elevating product quality. These innovations are pivotal drivers propelling the growth of the API market, ensuring the provision of high-quality pharmaceuticals while enhancing accessibility and affordability for patients worldwide.

Restraints/Challenges

• Rising Research and Development Costs

Research and development costs for new API discovery and development are soaring. The unpredictability of research and development outcomes and lengthy timelines add to the challenge. API manufacturers face substantial investment risks and must navigate through uncertain paths to bring new products to market, necessitating careful resource allocation and strategic decision-making to mitigate financial and operational hurdles. 

• Shift in Disease Patterns and Therapeutic Trends

Manufacturers must swiftly adapt to changing healthcare policies, emerging diseases, and shifting therapeutic preferences. Failure to anticipate and respond to these changes can result in reduced market share, diminished revenue streams, and potential obsolescence within the competitive pharmaceutical landscape. Shifts in disease patterns and therapeutic trends challenge the API market by altering demand dynamics.

本市场报告详细介绍了最新发展、贸易法规、进出口分析、生产分析、价值链优化、市场份额、国内和本地市场参与者的影响，分析了新兴收入领域的机会、市场法规的变化、战略市场增长分析、市场规模、类别市场增长、应用领域和主导地位、产品批准、产品发布、地域扩展、市场技术创新。如需获取更多市场信息，请联系 Data Bridge Market Research 获取分析师简报，我们的团队将帮助您做出明智的市场决策，实现市场增长。

近期发展

• 2023 年 4 月，Aurobindo Pharma 批准将两个 API 单元（单元 V 和 XVII）转让给其全资子公司 Apitoria Pharma Private Limited，从而简化了运营
• 2023 年 1 月，美国 FDA 接受了 Jardiance 的补充新药申请，将其适应症扩大到包括患有慢性肾病的成年人，解决了一项关键的医疗需求
• 2022 年 6 月，辉瑞向美国 FDA 提交了 paxlovid 的新药申请，推进了该组织的产品组合，有望在治疗方案方面实现创新
• 2021 年 10 月，勃林格殷格翰国际有限公司在奥地利维也纳启用了其最先进的生物制药生产设施——大规模细胞培养 (LSCC)，这体现了该公司对尖端技术的承诺和对进步的大量投资
• 2020 年 4 月，雷迪博士实验室有限公司 (Dr. Reddy's Laboratories Ltd.) 获得了美国医疗保健监管机构对其纳尔贡达 (Nalgonda) 活性药物成分制造商的 EIR，提高了制造能力并确保遵守严格的质量标准，提高了生产效率和产品质量

北美活性药物成分 (API) 市场范围

市场根据分子、类型、制造商类型、合成、化学合成、药物类型、用途、效力和治疗应用进行细分。这些细分市场之间的增长将帮助您分析行业中增长微弱的细分市场，并为用户提供有价值的市场概览和市场洞察，帮助他们做出战略决策，确定核心市场应用。

分子

• 小分子
• 大分子

 类型

• 创新活性药物成分
• 仿制创新原料药

制造商类型

• 专属 API 制造商
• 商户 API 制造商

合成

• 合成活性药物成分
• 生物技术活性药物成分

 化学合成

• 对乙酰氨基酚
• 青蒿素
• 沙格列汀
• 氯化钠
• 布洛芬
• 氯沙坦钾
• 依诺肝素钠
• 鲁非酰胺
• 萘普生
• 他莫昔芬
• 其他的

药物类型

• 处方药
• 在柜台

 用法

• 临床
• 研究

 效力

• 低至中等效力的活性药物成分
• 强效至高效活性药物成分

治疗应用

• 心脏病学
• 中枢神经系统和神经病学
• 肿瘤学
• 骨科
• 内分泌学
• 肺病学
• 胃肠病学
• 肾脏科
• 眼科
• 其他治疗应用

北美活性药物成分 (API) 市场区域分析/见解

对市场进行分析，并按国家、分子、类型、制造商类型、合成、化学合成、药物类型、用途、效力和治疗应用提供市场规模洞察和趋势，如上所述。

市场报告涵盖的国家包括美国、加拿大和墨西哥。

美国是该地区增长最快的国家，其增长动力来自制造商数量的激增、治疗产品审批的增加以及政府和制药组织提高疾病意识的举措。这些因素共同推动了该地区的市场扩张和创新。

报告的国家部分还提供了影响单个市场因素和国内市场监管变化，这些因素和变化会影响市场的当前和未来趋势。下游和上游价值链分析、技术趋势和波特五力分析、案例研究等数据点是用于预测单个国家市场情景的一些指标。此外，在提供国家数据的预测分析时，还考虑了全球品牌的存在和可用性以及它们因来自本地和国内品牌的大量或稀缺竞争而面临的挑战、国内关税和贸易路线的影响。   

医疗保健基础设施增长安装基础和新技术渗透

该市场还为您提供每个国家/地区资本设备医疗支出增长、全球自身免疫性疾病诊断市场不同类型产品的安装基数、使用生命线曲线的技术影响以及医疗监管情景的变化及其对市场的影响的详细市场分析。数据适用于 2016-2021 年的历史时期。

竞争格局和北美活性药物成分 (API) 市场份额分析

市场竞争格局按竞争对手提供详细信息。详细信息包括公司概况、公司财务状况、产生的收入、市场潜力、研发投资、新市场计划、全球影响力、生产基地和设施、生产能力、公司优势和劣势、产品发布、产品宽度和广度、应用主导地位。以上提供的数据点仅与公司对活性药物成分 (API) 市场的关注有关。

市场上的一些主要参与者包括：

• Dr. Reddy's Laboratories Ltd.（印度）
•  太阳制药工业有限公司 (印度)
• 葛兰素史克公司 (英国)
•  辉瑞公司 (美国)
•  Aurobindo Pharma（印度）
•  赛诺菲（法国）
•  鲁冰花（印度）
•  Cipla Inc.（美国）
• 巴斯夫公司（德国）
•  默克集团（德国）
•  诺和诺德公司（丹麦）
•  AbbVie Inc.（美国）
•  Alembic Pharmaceuticals Limited（印度）
•  阿斯利康（英国）
•  Teva Pharmaceutical Industries Ltd.（爱尔兰）
•  Alkem Labs（印度）
•  Saneca Pharmaceuticals（斯洛伐克）
•  Jubilant Pharmova Limited（印度）
• Neuland 实验室有限公司（印度）

SKU-1856