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市场调查报告书
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1557329

全球医药 API 市场：2024-2029 年预测

Global Drug API Market - Forecasts from 2024 to 2029
出版日期: | 出版商: Knowledge Sourcing Intelligence | 英文 101 Pages | 商品交期: 最快1-2个工作天内

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简介目录

医药原料药市场预计将从 2024 年的 2,450.53 亿美元增至 2029 年的 3,096.42 亿美元，复合年增长率为 6.23%。

API（活性药物成分）是药物中能产生所需效果的成分。例如，联合治疗具有治疗不同症状或功能的多种活性成分。为满足市场需求持续成长而进行的开发新药热潮以及生物技术和合成药物开发的后续创新预计将推动市场扩张。

API 通常由製药公司内部生产。然而，近年来，许多公司将製造外包以降低成本。因此，这些药物的法规发生了重大变化，包括更严格的标准和测试实务。然而，市场扩张可能会受到一些国家药品价格监管、高製造成本和严格监管政策的阻碍。

全球原料药市场按药物合成类型、应用和地区进行细分。

医药原料药市场驱动因素：

  • 生物製药领域的有利投资和合作伙伴关係预计将支持 API 的全球成长

推动原料药市场的主要因素是药品生产研发活动的扩大、学名药的重要性日益增加以及生物製药消费的成长。例如，2024年5月，赛诺菲宣布对塞纳河畔维特里、Le Trait工厂和里昂热尔兰投资超过10亿欧元。该公司将建立生技药品生产设施，以扩大单株抗体生产并改善基本药物的整体生产。

同样，2023 年 7 月，辉瑞和 Flagship Pioneering 合作开发了一系列新的创新药物，以满足患有高度复杂疾病的广大患者群体未满足的需求。透过此次合作，两家公司将投资近 5,000 万美元开发 10 个单一资产项目，利用 Flagship 由 40 家人类健康公司和生物技术平台组成的网路。

慢性病发病率的增加预计将增加药物需求并推动 API 药物市场向前发展。据世界卫生组织 (WHO) 称，心血管疾病是世界上最主要的死亡原因，每年估计导致 1,790 万人死亡。

  • 随着对抗疾病的创新药物的需求激增，预计未来几年 API 的整体使用量将会增加。

药物原料药经过严格的测试，以确保它们对患者的病情产生预期的效果而不造成伤害。因此，与健康相关的 API 非常适合影响身体功能的特定疾病的药理活性、诊断、治疗和预防。老年痴呆症症等复杂疾病会对运动技能产生负面影响，尤其是老年人。

据阿兹海默症协会称，该疾病是美国第六大死因，主要影响 65 岁以上的人群，该年龄层的患者约有 560 万人。据同一消息来源称，到 2050 年，预计每 33 秒就会出现一例新病例。此类疾病的日益普及将增加对具有高度理想功能和最低功效的创新药物的需求，从而为医药原料药市场范围提供光明的前景。

医药原料药市场地域展望

  • 北美未来将占据重要市场占有率

从地区来看，全球原料药市场分为北美、南美、欧洲、中东和非洲以及亚太地区。由于疾病发病率上升和人口老化，预计北美地区将显着增长。例如，根据美国疾病管制与预防中心的数据，美国每年约有 795,000 人受到中风影响，其中缺血性中风占这些中风的 87%。

新兴经济体，特别是美国和加拿大，对开发新药和原料药技术的投资正在稳步成长。例如，礼来公司 (Eli Lilly and Company) 于 2024 年 5 月宣布，将额外投资 53 亿美元在印第安纳州建造製造工厂。这项投资将使 Mounjaro® 和 Zepbound® 注射的 API 製造能力成为可能，这些注射剂用于治疗成人 2 型糖尿病和肥胖症。

由于医疗保健支出的增加和製药公司的存在，预计亚太地区在预测期内将以该市场最快的速度发展。该地区受益于世界所依赖的低成本原料药生产经济体的存在，例如中国和印度。这进一步推动了亚太原料药市场的成长。

此外，新药和生物製药的推出、收购、合作伙伴关係和地理扩张也是该产业策略营运的一部分。例如，Bortezomib是一种用于治疗已接受过至少一种既往治疗的多发性骨髓瘤或套细胞淋巴瘤成年患者的药物。

目录

第一章简介

  • 市场概况
  • 市场定义
  • 调查范围
  • 市场区隔
  • 货币
  • 先决条件
  • 基准年和预测年时间表
  • 相关利益者的主要利益

第二章调查方法

  • 研究设计
  • 调查过程

第三章执行摘要

  • 主要发现

第四章市场动态

  • 市场驱动因素
  • 市场限制因素
  • 波特五力分析
  • 产业价值链分析
  • 分析师观点

第五章全球医药原料药市场：依合成类型

  • 介绍
  • 生技製药
  • 合成药物

第六章全球医药原料药市场：依药物类型

  • 介绍
  • 学名药
  • 品牌药品

第七章全球医药原料药市场：依应用分类

  • 介绍
  • 心臟病
  • 呼吸系统
  • 瘤
  • 眼科
  • 神经
  • 整形外科
  • 其他的

第八章全球医药原料药市场：按地区

  • 介绍
  • 北美洲
    • 美国
    • 加拿大
    • 墨西哥
  • 南美洲
    • 巴西
    • 阿根廷
    • 其他的
  • 欧洲
    • 德国
    • 法国
    • 英国
    • 西班牙
    • 其他的
  • 中东/非洲
    • 沙乌地阿拉伯
    • 以色列
    • 其他的
  • 亚太地区
    • 中国
    • 日本
    • 韩国
    • 印度
    • 其他的

第九章竞争环境及分析

  • 主要企业及策略分析
  • 市场占有率分析
  • 合併、收购、协议和合作
  • 竞争对手仪表板

第十章 公司简介

  • Teva Pharmaceutical Industries Ltd
  • Sun Pharmaceutical Industries Ltd
  • Novartis AG
  • Pfizer Inc.
  • Mylan NV
  • BASF SE
  • Boehringer Ingelheim GmbH
  • Dr. Reddy's Laboratories Ltd
  • Lupin Ltd
  • Aurobindo Pharma
简介目录
Product Code: KSI061612148

The global drug API market is projected to reach US$309.642 billion in 2029 from US$245.053 billion in 2024 at a CAGR of 6.23%.

The active pharmaceutical ingredient (API) is the component of medicine that generates the desired effects. Combination therapies, for example, have several active ingredients that treat different symptoms or function differently. The booming new drug development to cater to the ongoing increase in market demand, followed by innovations in biotech & synthetic drug development, is anticipated to drive market expansion.

APIs have generally been manufactured in-house by pharmaceutical businesses in their home nations. However, in recent years, many companies have outsourced manufacturing to save money. This has resulted in considerable changes in regulating these pharmaceuticals, including implementing more stringent criteria and inspections. However, the market's expansion will likely be hampered by negative medicine price control regimes in several countries, high manufacturing costs, and strict regulatory policies.

The global API market is segmented by drug synthesis type, application, and geography.

Global Drug API Market Drivers:

  • The favorable investment & collaboration in biological drugs is expected to boost the growth of API globally.

The key factors driving the API drug market are the expanding drug research and development activities for drug manufacturing, the increasing importance of generics, and the increasing consumption of biopharmaceuticals. For instance, in May 2024, Sanofi announced an investment of more than EUR1 billion in Vitry-sur-Seine, Le Trait site, and Lyon Gerland. The company will establish a biologics production facility that will expand its monoclonal antibody production, thereby improving the overall manufacturing of essential medicines.

Likewise, in July 2023, Pfizer Inc. and Flagship Pioneering Inc. partnered to develop a new pipeline of innovative medicines to address the unmet needs of a wide patient population suffering from highly complex diseases. As per the collaboration, both companies would invest nearly US$50 million to develop 10 single-asset programs that would leverage Flagship's network of 40 human health companies and biotech platforms.

The rising frequency of chronic diseases is predicted to boost medicine demand, which will drive the API drug market forward. Cardiovascular illnesses are the biggest cause of death worldwide, with an estimated 17.9 million people each year, according to the World Health Organization (WHO).

  • The booming demand for innovative drugs to fight diseases is expected to bolster overall API usage in the coming years.

Active Pharmaceutical Ingredients undergo rigorous testing to ensure they have the desired effect on the patient's condition without causing harm. Hence, health-related APIs are ideal for pharmacological activities, diagnosis, treatment, and prevention of certain diseases that affect the body's functioning. Complex diseases such as Alzheimer's, especially in the elderly population, negatively impact their motor skills.

According to the Alzheimer's Association, the disease is the sixth leading cause of death in the United States, and it primarily affects people over the age of 65, with approximately 5.6 million patients falling into this age bracket. As per the same source, by 2050, a new case of the disease is expected to occur every 33 seconds. The growing prevalence of such diseases will increase the demand for innovative drugs with highly desired functionality and minimal effects, thereby providing a positive outlook to the market scope of active pharmaceutical ingredients.

Global Drug API Market Geographical Outlook

  • North America is projected to constitute a considerable market share in the given time frame.

Region-wise, the global API drug market is segmented into North America, South America, Europe, the Middle East and Africa, and Asia Pacific. The North American region is poised for considerable growth, fuelled by increased disease rates and an aging population. For instance, according to the Centers for Disease Control and Prevention, approximately 795,000 people in the United States suffer from the effects of stroke each year, with ischemic stroke accounting for 87% of instances.

Major regional economies, mainly the United States and Canada, are experiencing positive growth in new drug development and investment in API medicinal technologies. For instance, in May 2024, Eli Lilly and Company announced an additional investment of US$5.3 billion for its Indiana manufacturing facility. This investment enables the company's API manufacturing capacity for Mounjaro(R) (tirzepatide) and Zepbound(R) (tirzepatide) injections that would be used for treating adults suffering from type 2 diabetes and obesity.

Due to rising healthcare expenditures and a high number of pharmaceutical businesses, Asia-Pacific is predicted to develop at the fastest rate in this market over the forecast period. The existence of economies like China and India, which the world relies on for low-cost API production, benefits the region. This further boosts the growth in the API market in Asia-Pacific.

Moreover, new pharmaceutical and biological product launches, acquisitions, collaborations, and geographic expansions are some of the industry's strategic operations. For instance, Bortezomib is a drug that is used to treat adult patients with multiple myeloma or mantle cell lymphoma who have had at least one previous treatment.

Global Drug API Key Market Developments

  • In May 2024, The United States Agency for International Development (USAID) launched a new project to provide US$5 million for sustainably producing, regulating, and exporting active pharmaceutical ingredients and other assured medical products to Kazakhstan and Uzbekistan. USAID's International Development Group-led Indo-Pacific Opportunity Program and the U.S. Pharmacopeia-led Promoting the Quality of Medicines Plus (PQM+) program will regulate the project.
  • In November 2023, Novo Nordisk announced plans to invest more than 42 billion Danish Krone to expand the company's active pharmaceutical ingredient production capacity at its Kalundborg facility. The investment would bolster the production scale of the product inclusive of GLP-1 products thereby enabling Novo to meet future demand.
  • In May 2023, the API Innovation Center announced a cooperation agreement to support the adoption of flexible pharmaceutical manufacturing technologies, improving the scale of critical drugs required in the United States. The agreement will further improve pharmaceutical companies' domestic API manufacturing.
  • In January 2023, Agilent Technologies announced an investment of US$275 million to double its therapeutic nucleic acid manufacturing capacity, which produces active pharmaceutical ingredients for drugs targeting cardiovascular, cancer, and other infectious diseases.

The Global Drug API market is segmented and analyzed as follows:

By Synthesis Type

  • Biotech Drugs
  • Synthetic Drugs

By Drug Type

  • Generic Drug
  • Branded Drug

By Application

  • Cardiology
  • Pulmonology
  • Oncology
  • Ophthalmology
  • Neurology
  • Orthopedic
  • Other Applications

By Geography

  • North America
  • United States
  • Canada
  • Mexico
  • South America
  • Brazil
  • Argentina
  • Others
  • Europe
  • Germany
  • France
  • United Kingdom
  • Spain
  • Others
  • Middle East and Africa
  • Saudi Arabia
  • Israel
  • Others
  • Asia Pacific
  • China
  • Japan
  • South Korea
  • India
  • Others

TABLE OF CONTENTS

1. INTRODUCTION

  • 1.1. Market Overview
  • 1.2. Market Definition
  • 1.3. Scope of the Study
  • 1.4. Market Segmentation
  • 1.5. Currency
  • 1.6. Assumptions
  • 1.7. Base and Forecast Years Timeline
  • 1.8. Key Benefits for the Stakeholder

2. RESEARCH METHODOLOGY

  • 2.1. Research Design
  • 2.2. Research Processes

3. EXECUTIVE SUMMARY

  • 3.1. Key Findings

4. MARKET DYNAMICS

  • 4.1. Market Drivers
  • 4.2. Market Restraints
  • 4.3. Porter's Five Forces Analysis
    • 4.3.1. Bargaining Power of Suppliers
    • 4.3.2. Bargaining Power of Buyers
    • 4.3.3. Threat of New Entrants
    • 4.3.4. Threat of Substitutes
    • 4.3.5. Competitive Rivalry in the Industry
  • 4.4. Industry Value Chain Analysis
  • 4.5. Analyst View

5. GLOBAL DRUG API MARKET BY SYNTHESIS TYPE

  • 5.1. Introduction
  • 5.2. Biotech Drugs
  • 5.3. Synthetic Drugs

6. GLOBAL DRUG API MARKET BY DRUG TYPE

  • 6.1. Introduction
  • 6.2. Generic Drug
  • 6.3. Branded Drug

7. GLOBAL DRUG API MARKET BY APPLICATION

  • 7.1. Introduction
  • 7.2. Cardiology
  • 7.3. Pulmonology
  • 7.4. Oncology
  • 7.5. Ophthalmology
  • 7.6. Neurology
  • 7.7. Orthopedics
  • 7.8. Other Applications

8. GLOBAL DRUG API MARKET BY GEOGRAPHY

  • 8.1. Introduction
  • 8.2. North America
    • 8.2.1. United States
    • 8.2.2. Canada
    • 8.2.3. Mexico
  • 8.3. South America
    • 8.3.1. Brazil
    • 8.3.2. Argentina
    • 8.3.3. Others
  • 8.4. Europe
    • 8.4.1. Germany
    • 8.4.2. France
    • 8.4.3. United Kingdom
    • 8.4.4. Spain
    • 8.4.5. Others
  • 8.5. Middle East and Africa
    • 8.5.1. Saudi Arabia
    • 8.5.2. Israel
    • 8.5.3. Others
  • 8.6. Asia Pacific
    • 8.6.1. China
    • 8.6.2. Japan
    • 8.6.3. South Korea
    • 8.6.4. India
    • 8.6.5. Others

9. COMPETITIVE ENVIRONMENT AND ANALYSIS

  • 9.1. Major Players and Strategy Analysis
  • 9.2. Market Share Analysis
  • 9.3. Mergers, Acquisitions, Agreements, and Collaborations
  • 9.4. Competitive Dashboard

10. COMPANY PROFILES

  • 10.1. Teva Pharmaceutical Industries Ltd
  • 10.2. Sun Pharmaceutical Industries Ltd
  • 10.3. Novartis AG
  • 10.4. Pfizer Inc.
  • 10.5. Mylan NV
  • 10.6. BASF SE
  • 10.7. Boehringer Ingelheim GmbH
  • 10.8. Dr. Reddy's Laboratories Ltd
  • 10.9. Lupin Ltd
  • 10.10. Aurobindo Pharma