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醫藥品原料藥

市場調查報告書

商品編碼

1498603

活性藥物原料藥(API) 市場規模、佔有率、成長分析、按類型、按合成、按藥物、按效力、按治療應用、按最終用戶、按地區 - 行業預測，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個工作天內

價格

簡介目錄

2022年，活性藥物原料藥（API）市場規模為2100.1億美元，從2023年的2224億美元成長到2031年的3518.1億美元，預測期（2024-2031年）預計複合年成長率為5.9%。

近年來，由於慢性病的增加、學名藥的普及以及研發活動的活性化，活性藥物原料藥（API）市場出現了消費者偏好和需求的變化。此外，製造技術的進步，特別是生物技術方法，對市場成長做出了重大貢獻。特別是，將原料藥藥生產外包給優先考慮品質和安全的契約製造組織 (CMO) 的趨勢日益明顯，這使得製藥公司能夠專注於核心職能，同時應對複雜的法律規範。中國和印度等國家憑藉其成本優勢和強大的藥品製造基礎設施，已成為亞太地區主要的原料藥藥製造地。改革法規和簡化核准流程的努力也在塑造市場動態。 API 作為藥物的關鍵成分發揮重要作用，單一 API 用於單劑量藥物，多種 API 用於組合藥物。這些成分經過精心組合，可達到治療效果，例如含有乙醯胺酚等活性成分的止痛藥可緩解疼痛。活性藥物原料藥是多種專業的優質產品，包括腫瘤學、循環系統、中樞神經系統疾病、骨科、肺病學、胃腸病學、腎臟病學、眼科和內分泌學等醫學必需品。原料藥藥製造領域的持續創新和技術進步有望建立更永續的醫療保健系統。

市場概況
合成API
- 一般API
- 非一般API
生物技術
- 一般API
- 非一般API
產品
- 單株抗體
- 荷爾蒙
- 細胞激素
- 重組蛋白
- 治療酵素
疫苗
- 血液因素
- 重組疫苗
表達系統
- 哺乳動物表達系統
- 微生物表現系統
- 酵母表現系統
- 昆蟲表達系統
- 其他

原料藥市場：依效力

市場概況
舊版 API
高效API

原料藥市場：依治療應用分類

市場概況
傳染病
腫瘤學
心血管疾病
內分泌學
呼吸系統醫療設備
胃腸病學
腎臟病學
眼科
其他

原料藥市場：依藥物分類

市場概況
處方箋
非處方藥 (OTC)

醫藥原料藥市場：依最終用戶分類

市場概況
製藥和生物技術產業
CRO
CMO
其他

原料藥市場規模：依地區

市場概況
北美洲
- 美國
- 加拿大
歐洲
- 德國
- 西班牙
- 法國
- 義大利
- 英國
- 其他歐洲國家地區
亞太地區
- 中國
- 印度
- 日本
- 韓國
- 其他亞太地區
拉丁美洲
- 巴西
- 其他拉丁美洲地區
中東和非洲 (MEA)
- 海灣合作理事會國家
- 南非
- 其他中東/非洲地區

競爭格局

前5名企業對比
主要企業市場定位（2023年）
主要市場參與者所採取的策略
近期市集活動
主要企業市場佔有率（2023年）

主要企業簡介

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）

簡介目錄

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