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1498603

医薬品原薬（API）の市場規模、シェア、成長分析、タイプ別、合成別、薬剤別、力価別、治療用途別、エンドユーザー別、地域別- 産業予測、2024年～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: 2024年06月10日 | 発行: SkyQuest

| ページ情報: 英文 248 Pages | 納期: 3～5営業日

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概要
目次

概要

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医薬品原薬（API）の市場規模は2022年に2,100億1,000万米ドルと評価され、2023年の2,224億米ドルから2031年には3,518億1,000万米ドルに成長し、予測期間（2024-2031年）のCAGRは5.9%で成長する見通しです。

近年、医薬品原薬（API）市場は、慢性疾患の増加、ジェネリック医薬品の普及、研究開発活動の活発化などを背景に、消費者の嗜好や需要に変化が生じています。加えて、製造技術、特にバイオテクノロジー手法の進歩が市場成長に大きく寄与しています。特に、品質と安全性を最優先する受託製造機関（CMO）に医薬品原薬製造をアウトソーシングする傾向が強まっており、製薬会社は複雑な規制の枠組みを乗り越えながら中核機能に集中することができます。中国やインドといった国々は、コスト面での優位性と強固な医薬品製造インフラを背景に、アジア太平洋地域における主要な医薬品原薬製造拠点として台頭してきました。規制改革や承認プロセスの合理化への取り組みも市場力学を形成しています。APIは医薬品の主要成分として重要な役割を果たしており、単回投与の医薬品には単一のAPIが、合剤には複数のAPIが使用されます。これらの成分は、パラセタモールのような有効成分を含む鎮痛剤における鎮痛のような治療効果を達成するために、細心の注意を払って配合されます。医薬品原薬は、腫瘍学、循環器学、中枢神経系疾患、整形外科学、呼吸器学、消化器学、腎臓学、眼科学、内分泌学など、さまざまな専門分野を対象とした高品質の医薬品に不可欠なものです。医薬品原薬製造における継続的な革新と技術的進歩は、より持続可能なヘルスケア・システムを構築する上で有望です。

市場概要
合成API
- 汎用API
- 非汎用API
バイオテクノロジー
- 汎用API
- 非汎用API
製品
- モノクローナル抗体
- ホルモン
- サイトカイン
- 組み換えタンパク質
- 治療用酵素
ワクチン
- 血液因子
- 組み換えワクチン
発現システム
- 哺乳類発現システム
- 微生物発現システム
- 酵母発現システム
- 昆虫発現システム
- その他

医薬品原薬市場：力価別

市場概要
従来のAPI
高効力API

医薬品原薬市場：治療用途別

市場概要
伝染病
腫瘍学
心血管疾患
内分泌学
呼吸器科
消化器内科
腎臓学
眼科
その他

医薬品原薬市場：薬剤別

市場概要
処方箋
市販薬（OTC）

医薬品原薬市場：エンドユーザー別

市場概要
製薬およびバイオテクノロジー産業
CRO
CMO
その他

医薬品原薬市場規模：地域別

市場概要
北米
- 米国
- カナダ
欧州
- ドイツ
- スペイン
- フランス
- イタリア
- 英国
- その他欧州地域
アジア太平洋地域
- 中国
- インド
- 日本
- 韓国
- その他アジア太平洋地域
ラテンアメリカ
- ブラジル
- その他ラテンアメリカ地域
中東・アフリカ（MEA）
- GCC諸国
- 南アフリカ
- その他中東・アフリカ地域

競合情勢

上位5社の比較
主要企業の市場ポジショニング（2023年）
主な市場企業が採用した戦略
市場における最近の活動
主要企業の市場シェア（2023年）

主要企業プロファイル

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 N.V.（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）

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