首页 > 市场调查报告书 > 製药

医药品原料药

市场调查报告书

商品编码

1498603

活性药物原料药(API) 市场规模、份额、成长分析、按类型、按合成、按药物、按效力、按治疗应用、按最终用户、按地区 - 行业预测，2024-2031 年

Active Pharmaceutical Ingredients Market Size, Share, Growth Analysis, By Type, By Synthesis, By Drug, By Potency, By Therapeutic applications, By End User, By Region - Industry Forecast 2024-2031

出版日期: 2024年06月10日 | 出版商:

SkyQuest | 英文 248 Pages | 商品交期: 3-5个工作天内

价格

简介目录

2022年，活性药物原料药（API）市场规模为2100.1亿美元，从2023年的2224亿美元增长到2031年的3518.1亿美元，预测期（2024-2031年）预计复合年增长率为5.9%。

近年来，由于慢性病的增加、学名药的普及以及研发活动的活性化，活性药物原料药（API）市场出现了消费者偏好和需求的变化。此外，製造技术的进步，特别是生物技术方法，对市场成长做出了重大贡献。特别是，将原料药药生产外包给优先考虑品质和安全的契约製造组织 (CMO) 的趋势日益明显，这使得製药公司能够专注于核心职能，同时应对复杂的法律规范。中国和印度等国家凭藉其成本优势和强大的药品製造基础设施，已成为亚太地区主要的原料药药製造地。改革法规和简化核准流程的努力也在塑造市场动态。 API 作为药物的关键成分发挥重要作用，单一 API 用于单剂量药物，多种 API 用于组合药物。这些成分经过精心组合，可达到治疗效果，例如含有乙酰胺酚等活性成分的止痛药可缓解疼痛。活性药物原料药是多种专业的优质产品，包括肿瘤学、循环系统、中枢神经系统疾病、骨科、肺病学、胃肠病学、肾臟病学、眼科和内分泌学等医学必需品。原料药药製造领域的持续创新和技术进步有望建立更永续的医疗保健系统。

市场概况
合成API
- 一般API
- 非一般API
生物技术
- 一般API
- 非一般API
产品
- 单株抗体
- 荷尔蒙
- 细胞激素
- 重组蛋白
- 治疗酵素
疫苗
- 血液因素
- 重组疫苗
表达系统
- 哺乳动物表达系统
- 微生物表现系统
- 酵母表现系统
- 昆虫表达系统
- 其他的

原料药市场：依效力

市场概况
旧版 API
高效API

原料药市场：依治疗应用分类

市场概况
传染病
肿瘤学
心血管疾病
内分泌学
呼吸系统医疗设备
胃肠病学
肾臟病学
眼科
其他的

原料药市场：依药物分类

市场概况
处方笺
非处方药 (OTC)

医药原料药市场：依最终用户分类

市场概况
製药和生物技术产业
CRO
CMO
其他的

原料药市场规模：依地区

市场概况
北美洲
- 美国
- 加拿大
欧洲
- 德国
- 西班牙
- 法国
- 义大利
- 英国
- 其他欧洲国家地区
亚太地区
- 中国
- 印度
- 日本
- 韩国
- 其他亚太地区
拉丁美洲
- 巴西
- 其他拉丁美洲地区
中东和非洲 (MEA)
- 海湾合作委员会国家
- 南非
- 其他中东/非洲地区

竞争格局

前5名企业对比
主要企业市场定位（2023年）
主要市场参与者所采取的策略
近期市集活动
主要企业市场占有率（2023年）

主要企业简介

Boehringer Ingelheim（Germany）
Lonza Group AG（Switzerland）
Dr. Reddy's Laboratories Ltd.（India）
Merck Group（Germany）
Pfizer Inc.（US）
Sandoz International GmbH（Switzerland）
Teva Pharmaceutical Industries Ltd.（Israel）
Mylan NV（US）
F. Hoffmann-La Roche AG（Switzerland）
Catalent Pharma Solutions（US）
Samsung Biologics（South Korea）
WuXi AppTec（China）
Dishman Carbogen Amcis Ltd.（India）
Jubilant Life Sciences Limited（India）
Divi's Laboratories Ltd.（India）
Aurobindo Pharma Limited（India）
Zydus Cadila Healthcare Ltd.（India）
Sun Pharmaceutical Industries Ltd.（India）
Cipla Limited（India）
Hikma Pharmaceuticals PLC（UK）

简介目录

Product Code: SQMIG35I2125

Active Pharmaceutical Ingredients (API) Market size was valued at USD 210.01 Billion in 2022 and is poised to grow from USD 222.4 Billion in 2023 to USD 351.81 Billion by 2031, growing at a CAGR of 5.9% in the forecast period (2024-2031).

In recent years, the Active Pharmaceutical Ingredient (API) market has experienced shifts in consumer preferences and demands, driven by increasing rates of chronic illnesses, widespread adoption of generics, and intensified research and development activities. Additionally, advancements in manufacturing technology, particularly in biotechnological methods, have significantly contributed to market growth. There is a growing trend towards outsourcing API manufacturing, particularly to Contract Manufacturing Organizations (CMOs) that prioritize quality and safety, enabling pharmaceutical companies to concentrate on core functions while navigating complex regulatory frameworks. Countries like China and India have emerged as major API production hubs in the Asia Pacific region due to their cost advantages and robust pharmaceutical manufacturing infrastructure. Regulatory reforms and efforts to streamline approval processes are also shaping market dynamics. APIs play a crucial role as key ingredients in medications, with single APIs used in single-dose medications and multiple APIs in fixed-dose formulations. These ingredients are meticulously formulated to achieve therapeutic effects, such as pain relief in analgesics containing active ingredients like paracetamol. APIs are integral to high-quality drugs targeting a range of medical specialties, including oncology, cardiology, CNS disorders, orthopedics, pulmonology, gastroenterology, nephrology, ophthalmology, and endocrinology. Continued innovation and technological advancements in API production hold promise for creating a more sustainable healthcare system.

Top-down and bottom-up approaches were used to estimate and validate the size of the Active Pharmaceutical Ingredients (API) market and to estimate the size of various other dependent submarkets. The research methodology used to estimate the market size includes the following details: The key players in the market were identified through secondary research, and their market shares in the respective regions were determined through primary and secondary research. This entire procedure includes the study of the annual and financial reports of the top market players and extensive interviews for key insights from industry leaders such as CEOs, VPs, directors, and marketing executives. All percentage shares split, and breakdowns were determined using secondary sources and verified through Primary sources. All possible parameters that affect the markets covered in this research study have been accounted for, viewed in extensive detail, verified through primary research, and analyzed to get the final quantitative and qualitative data.

Active Pharmaceutical Ingredients (API) Market Segmental Analysis

The global active pharmaceutical ingredient market is segmented based on type, synthesis, drug, potency, therapeutic applications, end user, and region. Based on type, the market is segmented into generic APIs, and innovative APIs. Based on synthesis, the market is segmented into synthetic APIs (generic APIs, innovative APIs), biotech (type {generic APIs, innovative APIs}, product {monoclonal antibodies, hormones, cytokines, recombinant proteins, therapeutic enzymes, vaccines, blood factors}, expression systems (mammalian expression system, microbial expression system, yeast expression system, insect expression system, others). Based on drug, the market is segmented into prescription, and over-the-counter drugs (OTC). Based on potency, the market is segmented into traditional APIs, high potency APIs. Based on therapeutic applications, the market is segmented into communicable diseases, oncology, cardiovascular diseases, orthopaedic, cardiology, endocrinology, pulmonology, gastroenterology, nephrology, ophthalmology, and others. Based on end user, the market is segmented into pharmaceutical and biotechnological industry, contact research organization, contract manufacturing organization, and others. Based on region, the market is segmented into North America, Europe, Asia-Pacific, Latin America, Middle East & Africa.

Drivers of the Active Pharmaceutical Ingredients (API) Market

The expansion of manufacturing capacity for active pharmaceutical ingredients (APIs) in biopharmaceutical and pharmaceutical companies worldwide is driven by growing demand. This increase is supported by government investments in the sector, exemplified by initiatives such as Novo Nordisk's expansion of its manufacturing capacity in Denmark in November 2023. This expansion encompasses the entire production process, from API manufacturing to packaging, reflecting a concerted effort to meet rising demand in the pharmaceutical industry.

Restraints in the Active Pharmaceutical Ingredients (API) Market

A significant constraint in the marketplace is the complexity of regulations and the numerous stages of regulatory approvals. These factors have long-term effects on growth, expenses, intellectual property retention, and market dynamics, impacting the framework for trade. Additionally, environmental considerations further impose regulations on API business practices, emphasizing the importance of developing environmentally friendly green chemicals.

Market Trends of the Active Pharmaceutical Ingredients (API) Market

There is a rising demand for APIs customized to specific patient populations, emphasizing uniqueness in the pharmaceutical sector. Biopharmaceuticals, including monoclonal antibodies and gene therapies, are gaining prominence, reflecting an evolving industry trend and contributing to the development of new APIs. Moreover, the integration of advanced technology, including artificial intelligence and data analytics, into API development processes is becoming more prevalent, enhancing manufacturing efficiency. This trend is supported by increased investments from both companies and government entities in this field. The outsourcing of API production to contract manufacturing organizations (CMOs) is also increasing, enabling pharmaceutical companies to concentrate on core competencies and flexibility.

Introduction

Objectives of the Study
Definitions
Market Scope

Research Methodology

Information Procurement
Secondary & Primary Data Sources
Market Size Estimation
Market Assumptions & Limitations

Executive Summary

Market Overview Outlook
Supply Demand Trend Analysis
Segmental Opportunity Analysis

Market Dynamics & Outlook

Market Dynamics
- Drivers
- Opportunities
- Restraints
- Challenges
Porters Analysis
- Competitive rivalry
- Threat of Substitute Products
- Bargaining Power of Buyers
- Threat of New Entrants
- Bargaining Power of Suppliers

Key Market Insights

Technology Analysis
Ecosystem of the Market
Regulatory Landscape
Innovation Matrix
Top Investment Analysis
Key Success Factor
Trade Analysis
Patent Analysis
PESTEL Analysis
Pricing Analysis
Value Chain Analysis
Case Study Analysis
Supply Chain Analysis
Market Attractive Index
Degree of Competition

Active Pharmaceutical Ingredient Market by Type

Market Overview
Generic APIs
Non-Generic APIs

Active Pharmaceutical Ingredient Market by Synthesis

Market Overview
Synthetic APIs
- Generic APIs
- Non-Generic APIs
Biotech
- Generic APIs
- Non-Generic APIs
Product
- Monoclonal Antibodies
- Hormones
- Cytokines
- Recombinant Proteins
- Therapeutic Enzymes
Vaccines
- Blood Factors
- Recombinant vaccines
Expression Systems
- Mammalian Expression System
- Microbial Expression System
- Yeast Expression System
- Insect Expression System
- Others

Active Pharmaceutical Ingredient Market by Potency

Market Overview
Traditional APIs
High Potency APIs

Active Pharmaceutical Ingredient Market by Therapeutic applications

Market Overview
Communicable Diseases
Oncology
Cardiovascular Diseases
Endocrinology
Pulmonology
Gastroenterology
Nephrology
Ophthalmology
Others

Active Pharmaceutical Ingredient Market by Drug

Market Overview
Prescription
Over-the-Counter Drugs (OTC)

Active Pharmaceutical Ingredient Market by End User

Market Overview
Pharmaceutical and Biotechnological Industry
Contract Research Organization
Contract Manufacturing Organization
Others

Active Pharmaceutical Ingredient Market Size by Region

Market Overview
North America
- USA
- Canada
Europe
- Germany
- Spain
- France
- Italy
- UK
- Rest of Europe
Asia Pacific
- China
- India
- Japan
- South Korea
- Rest of Asia-Pacific
Latin America
- Brazil
- Rest of Latin America
Middle East & Africa (MEA)
- GCC Countries
- South Africa
- Rest of MEA

Competitive Landscape

Top 5 Player Comparison
Market Positioning of Key Players, 2023
Strategies Adopted by Key Market Players
Recent Activities in the Market
Key Companies Market Share (%), 2023

Key Company Profiles

Boehringer Ingelheim (Germany)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Lonza Group AG (Switzerland)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Dr. Reddy's Laboratories Ltd. (India)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Merck Group (Germany)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Pfizer Inc. (US)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Sandoz International GmbH (Switzerland)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Teva Pharmaceutical Industries Ltd. (Israel)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Mylan N.V. (US)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
F. Hoffmann-La Roche AG (Switzerland)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Catalent Pharma Solutions (US)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Samsung Biologics (South Korea)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
WuXi AppTec (China)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Dishman Carbogen Amcis Ltd. (India)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Jubilant Life Sciences Limited (India)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Divi's Laboratories Ltd. (India)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Aurobindo Pharma Limited (India)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Zydus Cadila Healthcare Ltd. (India)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Sun Pharmaceutical Industries Ltd. (India)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Cipla Limited (India)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Hikma Pharmaceuticals PLC (UK)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments