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市場調查報告書
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2048099

原料藥市場－全球產業規模、佔有率、趨勢、機會與預測：按類型、最終用戶、地區和競爭格局分類，2021-2031年

Bulk Drug Market - Global Industry Size, Share, Trends, Opportunity, & Forecast, Segmented By Type, By End-User, By Region & Competition, 2021-2031F
出版日期: | 出版商: TechSci Research | 英文 182 Pages | 商品交期: 2-3個工作天內

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簡介目錄

全球原料藥（ API）市場（包括API）預計將從2025年的4,651.2億美元大幅成長至2031年的9,259.6億美元，複合年成長率為12.16%。

這一成長主要受全球慢性病患病率上升以及重磅藥物專利到期所驅動，這將促進學名藥的生產。例如，預計印度2024-25會計年度原料藥和藥物中間體的出口額將達到48.7億美元，凸顯了該產業龐大的貿易量和產業規模。

市場概覽
預測期 2027-2031
市場規模：2025年 4651.2億美元
市場規模：2031年 9259.6億美元
複合年成長率：2026-2031年 12.16%
成長最快的細分市場 抗生素
最大的市場 亞太地區

市場促進因素

活性原料藥成分（API）市場的主要驅動力是專利到期後學名藥產量的激增，這反過來又催生了對API的巨大需求，以滿足這些經濟實惠的替代藥物的生產需求。醫療保健政策鼓勵採用低成本方案以控制支出，進一步強化了這一趨勢。根據可及藥品協會（Accessible Medicines Association）預測，到2024年，學名藥和生物相似藥預計將占美國處方箋的90%。美國食品藥物管理局（FDA）在前一年核准了956份簡化新藥申請（ANDA）。此外，政府獎勵正在透過加強國內API供應鏈從根本上改變產業結構。各國透過補貼本地生產來減少對特定地區的依賴，從而促進關鍵原料藥的自給自足。例如，印度的生產連結獎勵計畫（PLI）計劃已促成4155.77印度盧比的投資，以增強原料供應的穩定性並抵禦地緣政治不穩定的影響。

市場挑戰

原料藥）市場永續成長面臨的主要障礙在於其固有的供應鏈波動性和對特定地區原料供應的過度依賴。這種物流依賴造成了脆弱的商業環境，使製造商極易受到地緣政治緊張局勢和經濟不穩定等外部衝擊的影響。這些衝擊會導致生產延誤和採購成本飆升，從而擠壓利潤空間並擾亂生產計劃。這種不確定性阻礙了長期資本投資，導致資源從擴大產能轉向危機管理。印度2024-2025會計年度原料藥和中間體進口額高達46.5億美元，顯示其進口量龐大，凸顯了自身缺乏自給自足能力，並使市場容易受到全球供應鏈中斷的影響。這阻礙了藥品供應的穩定和整個產業的擴張。

市場趨勢

重塑全球原料藥(API) 市場的關鍵趨勢之一是擴大採用外包給合約研發生產機構 (CDMO) 的方式。這是因為製藥創新者正在加強與專業供應商的合作，以減少資本投入並利用先進的技術能力。這種結構性轉變使製藥開發公司能夠專注於研發和臨床研究，從而降低與大規模生產設施相關的風險。三星生物製劑等 CDMO 的強勁業績就反映了這一點，該公司 2024 年的銷售額成長了 23%，達到 4.55 兆韓元。同時，市場正將重心轉向策略性複雜的學名藥，特別是胜肽類和寡核苷酸類藥物。這些高附加價值 API 需要專門的合成技術，進入門檻高，因此競爭相對較小，利潤率也較高。對高度複雜分子的關注正在推動快速成長和密集的技術創新，藥明康德的 TIDES 業務就是一個典型的例子，該業務專注於這些先進治療方法。該公司2024年的銷售收入成長了70.1%，達到58億元。

目錄

第1章概述

第2章：調查方法

第3章執行摘要

第4章：客戶心聲

第5章：全球原料藥市場展望

  • 市場規模及預測
    • 按金額
  • 市佔率及預測
    • 按類型（抗生素、磺胺類藥物、維生素、類固醇、止痛藥、其他）
    • 依最終用戶（製藥、生技、獸藥）分類
    • 按地區
    • 按公司（2025 年）
  • 市場地圖

第6章：北美原料藥市場展望

  • 市場規模及預測
  • 市佔率及預測
  • 北美洲：國別分析
    • 美國
    • 加拿大
    • 墨西哥

第7章：歐洲原料藥市場展望

  • 市場規模及預測
  • 市佔率及預測
  • 歐洲：國別分析
    • 德國
    • 法國
    • 英國
    • 義大利
    • 西班牙

第8章：亞太地區原料藥市場展望

  • 市場規模及預測
  • 市佔率及預測
  • 亞太地區：國別分析
    • 中國
    • 印度
    • 日本
    • 韓國
    • 澳洲

第9章：中東和非洲原料藥市場展望

  • 市場規模及預測
  • 市佔率及預測
  • 中東與非洲：國別分析
    • 沙烏地阿拉伯
    • 阿拉伯聯合大公國
    • 南非

第10章：南美原料藥市場展望

  • 市場規模及預測
  • 市佔率及預測
  • 南美洲：國別分析
    • 巴西
    • 哥倫比亞
    • 阿根廷

第11章 市場動態

  • 促進因素
  • 任務

第12章 市場趨勢與發展

  • 併購
  • 產品發布
  • 近期趨勢

第13章 全球原料藥市場：SWOT分析

第14章：波特五力分析

  • 產業競爭
  • 新進入者的潛力
  • 供應商的議價能力
  • 顧客權力
  • 替代品的威脅

第15章 競爭格局

  • Dr. Reddy's Laboratories Ltd.
  • Bayer AG
  • Merck KGaA
  • Cambrex Corporation
  • Teva Pharmaceutical Industries Ltd.
  • Johnson & Johnson Service Inc.
  • BASF SE
  • Novartis AG
  • Pfizer Inc

第16章 策略建議

第17章：關於研究公司及免責聲明

簡介目錄
Product Code: 17648

The global bulk drug market, encompassing Active Pharmaceutical Ingredients (APIs), is projected for substantial growth, expanding from USD 465.12 billion in 2025 to USD 925.96 billion by 2031 with a 12.16% CAGR. This expansion is fundamentally driven by the increasing global prevalence of chronic diseases, requiring long-term medication therapies, and the expiration of blockbuster drug patents, which fuels generic manufacturing. For example, India's bulk drug and drug intermediate exports reached USD 4.87 billion in fiscal year 2024-25, highlighting the sector's significant trade volume and industrial scale.

Market Overview
Forecast Period2027-2031
Market Size 2025USD 465.12 Billion
Market Size 2031USD 925.96 Billion
CAGR 2026-203112.16%
Fastest Growing SegmentAntibiotics
Largest MarketAsia Pacific

Market Driver

A primary catalyst for the bulk drug market is the surge in generic drug production following major patent expirations, creating immense demand for Active Pharmaceutical Ingredients (APIs) to meet the output of cost-effective alternatives. Healthcare systems further amplify this trend by promoting low-cost options to manage expenditures, with generic and biosimilar medicines comprising 90% of US prescriptions in 2024, as per the Association for Accessible Medicines, and the U.S. FDA approving 956 Abbreviated New Drug Applications in the prior year. Additionally, government incentives are critically reshaping the industry by strengthening domestic API supply chains, with nations reducing reliance on concentrated regions through subsidies for local manufacturing to foster self-reliance in Key Starting Materials. India's Production Linked Incentive scheme, for instance, has realized an investment of INR 4,155.77 crores, ensuring greater stability in raw material availability and protecting against geopolitical disruptions.

Market Challenge

A critical barrier to the bulk drug market's sustainable growth is its inherent supply chain volatility and significant dependence on concentrated geographical regions for raw materials. This logistical reliance creates a fragile operating environment, leaving manufacturers highly susceptible to external shocks like geopolitical tensions or economic instability, which lead to unpredictable production delays and escalating procurement costs, eroding profit margins and destabilizing production schedules. This uncertainty deters long-term capital investment and redirects resources from capacity expansion to crisis management. The substantial import volume, evidenced by India's USD 4.65 billion in bulk drug and intermediate imports for fiscal year 2024-25, highlights a lack of self-sufficiency, exposing the market to global supply chain fractures that impede consistent medication delivery and overall industry expansion.

Market Trends

Key trends reshaping the global bulk drug market include the growing adoption of Contract Development and Manufacturing Organization (CDMO) outsourcing, as pharmaceutical innovators increasingly partner with specialized providers to reduce capital expenditure and leverage advanced technical capabilities. This structural shift allows drug developers to concentrate on discovery and clinical research, mitigating risks associated with large-scale production facilities, and is reflected in the strong financial performance of CDMOs like Samsung Biologics, which reported a 23% revenue increase to KRW 4.55 trillion in 2024. Concurrently, the market is strategically pivoting towards complex generics, particularly peptides and oligonucleotides. These high-value Active Pharmaceutical Ingredients require specialized synthesis technologies and face lower competition due to significant entry barriers, offering superior profit margins. This focus on high-complexity molecules is driving rapid growth and intense technological innovation, exemplified by WuXi AppTec's TIDES business, which saw a 70.1% revenue growth to RMB 5.8 billion in 2024, specializing in these advanced therapies.

Key Market Players

  • Dr. Reddy's Laboratories Ltd.
  • Bayer AG
  • Merck KGaA
  • Cambrex Corporation
  • Teva Pharmaceutical Industries Ltd.
  • Johnson & Johnson Service Inc.
  • BASF SE
  • Novartis AG
  • Pfizer Inc

Report Scope

In this report, the Global Bulk Drug Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

Bulk Drug Market, By Type

  • Antibiotics
  • Sulpha Drugs
  • Vitamins
  • Steroids
  • Analgesics
  • Others

Bulk Drug Market, By End-User

  • Pharmaceuticals
  • Biotechnology
  • Veterinary Medicine

Bulk Drug Market, By Region

  • North America
    • United States
    • Canada
    • Mexico
  • Europe
    • France
    • United Kingdom
    • Italy
    • Germany
    • Spain
  • Asia Pacific
    • China
    • India
    • Japan
    • Australia
    • South Korea
  • South America
    • Brazil
    • Argentina
    • Colombia
  • Middle East & Africa
    • South Africa
    • Saudi Arabia
    • UAE

Competitive Landscape

Company Profiles: Detailed analysis of the major companies present in the Global Bulk Drug Market.

Available Customizations:

Global Bulk Drug Market report with the given market data, TechSci Research offers customizations according to a company's specific needs. The following customization options are available for the report:

Company Information

  • Detailed analysis and profiling of additional market players (up to five).

Table of Contents

1. Product Overview

  • 1.1. Market Definition
  • 1.2. Scope of the Market
    • 1.2.1. Markets Covered
    • 1.2.2. Years Considered for Study
    • 1.2.3. Key Market Segmentations

2. Research Methodology

  • 2.1. Objective of the Study
  • 2.2. Baseline Methodology
  • 2.3. Key Industry Partners
  • 2.4. Major Association and Secondary Sources
  • 2.5. Forecasting Methodology
  • 2.6. Data Triangulation & Validation
  • 2.7. Assumptions and Limitations

3. Executive Summary

  • 3.1. Overview of the Market
  • 3.2. Overview of Key Market Segmentations
  • 3.3. Overview of Key Market Players
  • 3.4. Overview of Key Regions/Countries
  • 3.5. Overview of Market Drivers, Challenges, Trends

4. Voice of Customer

5. Global Bulk Drug Market Outlook

  • 5.1. Market Size & Forecast
    • 5.1.1. By Value
  • 5.2. Market Share & Forecast
    • 5.2.1. By Type (Antibiotics, Sulpha Drugs, Vitamins, Steroids, Analgesics, Others)
    • 5.2.2. By End-User (Pharmaceuticals, Biotechnology, Veterinary Medicine)
    • 5.2.3. By Region
    • 5.2.4. By Company (2025)
  • 5.3. Market Map

6. North America Bulk Drug Market Outlook

  • 6.1. Market Size & Forecast
    • 6.1.1. By Value
  • 6.2. Market Share & Forecast
    • 6.2.1. By Type
    • 6.2.2. By End-User
    • 6.2.3. By Country
  • 6.3. North America: Country Analysis
    • 6.3.1. United States Bulk Drug Market Outlook
      • 6.3.1.1. Market Size & Forecast
        • 6.3.1.1.1. By Value
      • 6.3.1.2. Market Share & Forecast
        • 6.3.1.2.1. By Type
        • 6.3.1.2.2. By End-User
    • 6.3.2. Canada Bulk Drug Market Outlook
      • 6.3.2.1. Market Size & Forecast
        • 6.3.2.1.1. By Value
      • 6.3.2.2. Market Share & Forecast
        • 6.3.2.2.1. By Type
        • 6.3.2.2.2. By End-User
    • 6.3.3. Mexico Bulk Drug Market Outlook
      • 6.3.3.1. Market Size & Forecast
        • 6.3.3.1.1. By Value
      • 6.3.3.2. Market Share & Forecast
        • 6.3.3.2.1. By Type
        • 6.3.3.2.2. By End-User

7. Europe Bulk Drug Market Outlook

  • 7.1. Market Size & Forecast
    • 7.1.1. By Value
  • 7.2. Market Share & Forecast
    • 7.2.1. By Type
    • 7.2.2. By End-User
    • 7.2.3. By Country
  • 7.3. Europe: Country Analysis
    • 7.3.1. Germany Bulk Drug Market Outlook
      • 7.3.1.1. Market Size & Forecast
        • 7.3.1.1.1. By Value
      • 7.3.1.2. Market Share & Forecast
        • 7.3.1.2.1. By Type
        • 7.3.1.2.2. By End-User
    • 7.3.2. France Bulk Drug Market Outlook
      • 7.3.2.1. Market Size & Forecast
        • 7.3.2.1.1. By Value
      • 7.3.2.2. Market Share & Forecast
        • 7.3.2.2.1. By Type
        • 7.3.2.2.2. By End-User
    • 7.3.3. United Kingdom Bulk Drug Market Outlook
      • 7.3.3.1. Market Size & Forecast
        • 7.3.3.1.1. By Value
      • 7.3.3.2. Market Share & Forecast
        • 7.3.3.2.1. By Type
        • 7.3.3.2.2. By End-User
    • 7.3.4. Italy Bulk Drug Market Outlook
      • 7.3.4.1. Market Size & Forecast
        • 7.3.4.1.1. By Value
      • 7.3.4.2. Market Share & Forecast
        • 7.3.4.2.1. By Type
        • 7.3.4.2.2. By End-User
    • 7.3.5. Spain Bulk Drug Market Outlook
      • 7.3.5.1. Market Size & Forecast
        • 7.3.5.1.1. By Value
      • 7.3.5.2. Market Share & Forecast
        • 7.3.5.2.1. By Type
        • 7.3.5.2.2. By End-User

8. Asia Pacific Bulk Drug Market Outlook

  • 8.1. Market Size & Forecast
    • 8.1.1. By Value
  • 8.2. Market Share & Forecast
    • 8.2.1. By Type
    • 8.2.2. By End-User
    • 8.2.3. By Country
  • 8.3. Asia Pacific: Country Analysis
    • 8.3.1. China Bulk Drug Market Outlook
      • 8.3.1.1. Market Size & Forecast
        • 8.3.1.1.1. By Value
      • 8.3.1.2. Market Share & Forecast
        • 8.3.1.2.1. By Type
        • 8.3.1.2.2. By End-User
    • 8.3.2. India Bulk Drug Market Outlook
      • 8.3.2.1. Market Size & Forecast
        • 8.3.2.1.1. By Value
      • 8.3.2.2. Market Share & Forecast
        • 8.3.2.2.1. By Type
        • 8.3.2.2.2. By End-User
    • 8.3.3. Japan Bulk Drug Market Outlook
      • 8.3.3.1. Market Size & Forecast
        • 8.3.3.1.1. By Value
      • 8.3.3.2. Market Share & Forecast
        • 8.3.3.2.1. By Type
        • 8.3.3.2.2. By End-User
    • 8.3.4. South Korea Bulk Drug Market Outlook
      • 8.3.4.1. Market Size & Forecast
        • 8.3.4.1.1. By Value
      • 8.3.4.2. Market Share & Forecast
        • 8.3.4.2.1. By Type
        • 8.3.4.2.2. By End-User
    • 8.3.5. Australia Bulk Drug Market Outlook
      • 8.3.5.1. Market Size & Forecast
        • 8.3.5.1.1. By Value
      • 8.3.5.2. Market Share & Forecast
        • 8.3.5.2.1. By Type
        • 8.3.5.2.2. By End-User

9. Middle East & Africa Bulk Drug Market Outlook

  • 9.1. Market Size & Forecast
    • 9.1.1. By Value
  • 9.2. Market Share & Forecast
    • 9.2.1. By Type
    • 9.2.2. By End-User
    • 9.2.3. By Country
  • 9.3. Middle East & Africa: Country Analysis
    • 9.3.1. Saudi Arabia Bulk Drug Market Outlook
      • 9.3.1.1. Market Size & Forecast
        • 9.3.1.1.1. By Value
      • 9.3.1.2. Market Share & Forecast
        • 9.3.1.2.1. By Type
        • 9.3.1.2.2. By End-User
    • 9.3.2. UAE Bulk Drug Market Outlook
      • 9.3.2.1. Market Size & Forecast
        • 9.3.2.1.1. By Value
      • 9.3.2.2. Market Share & Forecast
        • 9.3.2.2.1. By Type
        • 9.3.2.2.2. By End-User
    • 9.3.3. South Africa Bulk Drug Market Outlook
      • 9.3.3.1. Market Size & Forecast
        • 9.3.3.1.1. By Value
      • 9.3.3.2. Market Share & Forecast
        • 9.3.3.2.1. By Type
        • 9.3.3.2.2. By End-User

10. South America Bulk Drug Market Outlook

  • 10.1. Market Size & Forecast
    • 10.1.1. By Value
  • 10.2. Market Share & Forecast
    • 10.2.1. By Type
    • 10.2.2. By End-User
    • 10.2.3. By Country
  • 10.3. South America: Country Analysis
    • 10.3.1. Brazil Bulk Drug Market Outlook
      • 10.3.1.1. Market Size & Forecast
        • 10.3.1.1.1. By Value
      • 10.3.1.2. Market Share & Forecast
        • 10.3.1.2.1. By Type
        • 10.3.1.2.2. By End-User
    • 10.3.2. Colombia Bulk Drug Market Outlook
      • 10.3.2.1. Market Size & Forecast
        • 10.3.2.1.1. By Value
      • 10.3.2.2. Market Share & Forecast
        • 10.3.2.2.1. By Type
        • 10.3.2.2.2. By End-User
    • 10.3.3. Argentina Bulk Drug Market Outlook
      • 10.3.3.1. Market Size & Forecast
        • 10.3.3.1.1. By Value
      • 10.3.3.2. Market Share & Forecast
        • 10.3.3.2.1. By Type
        • 10.3.3.2.2. By End-User

11. Market Dynamics

  • 11.1. Drivers
  • 11.2. Challenges

12. Market Trends & Developments

  • 12.1. Merger & Acquisition (If Any)
  • 12.2. Product Launches (If Any)
  • 12.3. Recent Developments

13. Global Bulk Drug Market: SWOT Analysis

14. Porter's Five Forces Analysis

  • 14.1. Competition in the Industry
  • 14.2. Potential of New Entrants
  • 14.3. Power of Suppliers
  • 14.4. Power of Customers
  • 14.5. Threat of Substitute Products

15. Competitive Landscape

  • 15.1. Dr. Reddy's Laboratories Ltd.
    • 15.1.1. Business Overview
    • 15.1.2. Products & Services
    • 15.1.3. Recent Developments
    • 15.1.4. Key Personnel
    • 15.1.5. SWOT Analysis
  • 15.2. Bayer AG
  • 15.3. Merck KGaA
  • 15.4. Cambrex Corporation
  • 15.5. Teva Pharmaceutical Industries Ltd.
  • 15.6. Johnson & Johnson Service Inc.
  • 15.7. BASF SE
  • 15.8. Novartis AG
  • 15.9. Pfizer Inc

16. Strategic Recommendations

17. About Us & Disclaimer