日本 API (API) 市场评估：依合成、药理活性、製造领域、类型、药物、应用、疾病应用和地区划分的机会和预测（2017-2031 年）

日本原料药（API）市场规模预计将从2023年的201.1亿美元成长到2031年的327.9亿美元，预计在2024-2031年期间复合年增长率为6.3%。

健康疾病的增加、医药研发方面的大规模医疗保健支出以及生物製剂技术的进步正在推动日本 API（活性药物成分）市场的发展。在日本，老年人口的增加对慢性病的增加产生了重大影响。市场扩张的主要驱动力是原料药在癌症和糖尿病领域的日益增长的应用。日本原料药市场监管严格，政府在支持该产业方面发挥重要作用。政府补贴原料药生产商并投资研发。政府已采取多项措施来促进仿製药的使用。日本製药公司越来越多地将 API 製造外包给 CMO。

慢性病负担增加和老年人口增加：

日本人口老化不断加剧，使他们更容易受到伤害和疾病等各种健康问题的影响，促使对原料药的需求大幅激增。根据总务省截至2022年9月15日的数据，过去一年日本总人口减少了82万人。另一方面，65岁以上人口增加6万人，达到3,627万人的历史新高（与2021年相比增加0.03%）。癌症、糖尿病和心血管疾病等慢性疾病盛行率的上升是推动日本原料药市场的主要因素。据IDF（国际糖尿病联盟）称，日本有超过1100万名糖尿病患者。

製药公司扩大生产设施：

日本製药公司正在积极扩大其生产设施，以满足 API 市场不断增长的需求。这种激增是由稳定供应链的需求、医疗保健要求的增加以及政府对国内生产的支持等因素所推动的。公司正在大力投资最先进的设备，以确保高品质的原料药生产符合严格的监管标准。此次扩张加强了日本在全球原料药市场的地位，促进了製药业的创新和经济成长，并确立了在全球製药业的关键地位。

科技的发展：

日本一直处于 API 市场技术进步的前沿，并表现出对创新和品质的承诺。日本製药公司在研发方面取得了重大进展，利用人工智慧、机器人技术和进阶分析等创新技术来加速药物发现和生产过程。这些进步提高了 API 製造的效率和精确度，并促进了新型疗法的开发。

本报告调查了日本API（活性药物成分）市场，并提供市场定义和概述、市场规模趋势和预测、各个细分市场和地区的详细分析、行业结构以及影响市场成长的因素分析、案例研究、竞争格局。

目录

第一章研究方法论

第二章 专案范围与定义

第三章 COVID-19 对日本原料药（API）市场的影响

第 4 章执行摘要

第五章 日本原料药（API）市场展望

• 市场规模/预测
• 依成分分类
  • 生物技术
  • 合成
• 依药理活性
  • 传统API
  • 高压API
• 依製造类别
  • 专属API
  • 商家API
• 依类型
  • 一般API
  • 创新API
• 透过药物
  • 处方药
  • 非处方药
• 依用途
  • 临床
  • 研究
• 依疾病用途
  • 心血管疾病
  • 肿瘤
  • 神经
  • 骨科
  • 糖尿病
  • 呼吸科
  • 胃肠病学
  • 肾
  • 眼科
  • 其他
• 依地区
  • 北（北海道/东北部）
  • 中部（关东/中部）
  • 南部地区（关西、中国、四国、九州、冲绳）
• 依公司划分的市场占有率

第六章 市场测绘，2023

• 依成分分类
• 依药理活性
• 依製造类别
• 依类型
• 透过药物
• 依用途
• 依疾病用途
• 依地区

第七章 宏观环境与产业结构

• 供需分析
• 进出口分析
• 供应/价值链分析
• PESTEL 分析
• 波特五力分析

第八章市场动态

• 增长动力
• 成长限制因素（课题与限制）

第九章 监理架构与创新

• 临床试验
• 专利情况
• 监管审批
• 创新/新兴技术

第十章 主要公司情况

• 前 5 名市场领导者的竞争矩阵
• 前 5 名市场领导者的市场收入分析
• 併购/合资（如适用）
• SWOT分析（5家参与企业）
• 专利分析（如果适用）

第11章价格分析

第十二章案例研究

第十三章 主要公司展望

• Pfizer, Inc.
• Cipla Limited
• Sun Pharmaceutical Industries Ltd.
• AbbVie Inc.
• AstraZeneca plc
• GlaxoSmithKline plc
• Sanofi S.A.
• Teva Pharmaceutical Industries Ltd.
• Novartis International AG
• Boehringer Ingelheim International GmbH
• Piramal Enterprises Ltd.
• Aurobindo Pharma

第十四章 战略建议

第十五章关于我们公司/免责声明

Japan Active pharmaceutical ingredient market size was valued at USD 20.11 billion in FY2023, and is expected to reach USD 32.79 billion in FY2031, with a CAGR of 6.3% for the forecast period between FY2024 and FY2031. The rising prevalence of health disorders, robust healthcare expenditure on R&D of pharmaceutical medications, and progress in biologics technology will drive Japan's active pharmaceutical ingredient market. The rise in the elderly population in Japan has been a major influence on the spread of chronic diseases. The key driver of API market's expansion is the increasing application of APIs in oncology and diabetes. The Japanese API market is highly regulated, and the government plays a significant role in supporting the industry. The government provides subsidies to API manufacturers and invests in research and development. The government is laying several initiatives to promote the use of generic drugs. Japanese pharmaceutical companies are increasingly outsourcing the manufacturing of APIs to contract manufacturing organizations.

Increasing Burden of Chronic Diseases and Growing Geriatric Population

The rising elderly population in Japan, which is more vulnerable to various health issues such as injuries and diseases, has led to a substantial surge in the demand for active pharmaceutical ingredients (APIs). According to data from the Ministry of Internal Affairs and Communications as of September 15, 2022, Japan's total population declined by 820,000 over the past year. Concurrently, the number of individuals aged 65 years and older increased by 60,000, reaching a record high of 36.27 million, reflecting a 0.03% increase from 2021. The rise in chronic disease incidence, such as cancer, diabetes, and cardiovascular diseases, is a primary factor driving the Japanese API market. As per IDF (International Diabetes Federation), there are more than 11 million adults in Japan with diabetes.

Expansion of Production Facilities by Pharmaceutical Companies

Pharmaceutical companies in Japan are aggressively expanding their production facilities to cater to the growing demand in the active pharmaceutical ingredient (API) market. The surge is driven by factors such as the need for a stable supply chain, increasing healthcare requirements, and the government's support for domestic production. Companies are investing heavily in state-of-the-art facilities to ensure high-quality API manufacturing, adhering to stringent regulatory standards. The expansion strengthens Japan's position in the global API market and fosters innovation and economic growth within the pharmaceutical sector, positioning it as a pivotal player in the worldwide pharmaceutical industry.

In October 2023, Chugai Pharmaceutical, based in Japan, announced plans to develop a new bio active pharmaceutical ingredients (APIs) manufacturing facility and injection building at its Utsunomiya Plant, a subsidiary of the Chugai Group. By developing a new facility for intermediate to later-stage manufacturing of investigational pharmaceuticals, including Phase 1 and 2 projects, the new bio-API manufacturing building (UT3) will target the clinical development stage to initial commercial production.

Technological Advancements

Japan has been at the forefront in terms of technological advancement taking place in the active pharmaceutical ingredient (API) market, demonstrating its commitment to innovation and quality. Japanese pharmaceutical companies have made significant strides in research and development, leveraging innovative technologies such as artificial intelligence, robotics, and advanced analytics to accelerate drug discovery and production processes. These advancements have improved the efficiency and precision of API manufacturing and have contributed to the development of novel therapies.

Japan's stringent regulatory standards and dedication to pharmaceutical safety have propelled the country's API industry to a global leadership position. Continuous investment in state-of-the-art manufacturing facilities and adherence to good manufacturing practices have solidified Japan's reputation for producing high-quality APIs.

Impact of COVID-19

Japan API market is primarily influenced by the COVID-19 pandemic, as it led to a rise in health issues. Japan, in response to the heightened demand for vaccines, had significantly increased its consumption of API to facilitate vaccine production. It accelerated the need for domestic API production to ensure a stable supply chain, reducing dependency on foreign sources. The shift towards self-sufficiency in pharmaceutical manufacturing expanded the country's resilience in times of crisis and created new opportunities for Japanese API manufacturers. Additionally, the pandemic prompted increased investment in research and development of APIs, leading to advancements in pharmaceutical innovation and production efficiency. Japanese pharmaceutical companies were at the forefront of vaccine and antiviral drug development, during the pandemic.

Prescription Drugs Account for the Dominant Share

Prescription drugs hold a significant share in Japan API market compared to over the counter (OTC) drugs. The prescription drugs segment accounts for the largest share in the APIs market, as most drugs are sold with a doctor's prescription. The Japanese government has made efforts to promote the use of generic drugs, such as changing prescription forms to make it easier for physicians to allow generic substitution and incentivizing pharmacies with dispensation fees that reward generic usage. These factors contribute to the dominance of prescription drugs in Japan API market.

Key Players Landscape and Outlook

The active pharmaceutical ingredients market in Japan exhibit considerable fragmentation. Numerous API manufacturers are actively pursuing the expansion of their presence through diverse business strategies, including partnerships, facility expansion, and obtaining drug approvals. In March 2022, Sumitomo Chemical Co., Ltd. opened a new manufacturing plant for APIs in Osaka. The plant is expected to reduce production costs and improve the efficiency of API manufacturing.

Table of Contents

1. Research Methodology

2. Project Scope & Definitions

3. Impact of COVID-19 on Japan Active Pharmaceutical Ingredient Market

4. Executive Summary

5. Japan Active pharmaceutical ingredient Market Outlook, FY2017-FY2031F

• 5.1. Market Size & Forecast
  • 5.1.1. By Value
  • 5.1.2. By Volume
• 5.2. By Synthesis
  • 5.2.1. Biotech
  • 5.2.2. Synthetic
• 5.3. By Potency
  • 5.3.1. Traditional API
  • 5.3.2. HPAPI
• 5.4. By Manufacturer
  • 5.4.1. Captive APIs
  • 5.4.2. Merchant APIs
• 5.5. By Type
  • 5.5.1. Generic APIs
  • 5.5.2. Innovative APIs
• 5.6. By Drug
  • 5.6.1. Prescription Drugs
  • 5.6.2. Over-the-counter Drugs
• 5.7. By Usage
  • 5.7.1. Clinical
  • 5.7.2. Research
• 5.8. By Application
  • 5.8.1. Cardiovascular Diseases
  • 5.8.2. Oncology
  • 5.8.3. Neurology
  • 5.8.4. Orthopaedic
  • 5.8.5. Diabetes
  • 5.8.6. Pulmonology
  • 5.8.7. Gastroenterology
  • 5.8.8. Nephrology
  • 5.8.9. Ophthalmology
  • 5.8.10. Others
• 5.9. By Region
  • 5.9.1. North [Hokkaido and Tohoku]
  • 5.9.2. Central [Kanto and Chubu]
  • 5.9.3. South [Kansai, Chugoku, Shikoku, and Kyushu & Okinawa].
• 5.10 By Company Market Share (%), FY2023

6. Market Mapping, FY2023

• 6.1. By Synthesis
• 6.2. By Potency
• 6.3. By Manufacturer
• 6.4. By Type
• 6.5. By Drug
• 6.6. By Usage
• 6.7. By Application
• 6.8. By Region

7. Macro Environment and Industry Structure

• 7.1. Supply Demand Analysis
• 7.2. Import Export Analysis - Volume and Value
• 7.3. Supply/Value Chain Analysis
• 7.4. PESTEL Analysis
  • 7.4.1. Political Factors
  • 7.4.2. Economic System
  • 7.4.3. Social Implications
  • 7.4.4. Technological Advancements
  • 7.4.5. Environmental Impacts
  • 7.4.6. Legal Compliances and Regulatory Policies (Statutory Bodies Included)
• 7.5. Porter's Five Forces Analysis
  • 7.5.1. Supplier Power
  • 7.5.2. Buyer Power
  • 7.5.3. Substitution Threat
  • 7.5.4. Threat from New Entrant
  • 7.5.5. Competitive Rivalry

8. Market Dynamics

• 8.1. Growth Drivers
• 8.2. Growth Inhibitors (Challenges, Restraints)

9. Regulatory Framework and Innovation

• 9.1. Clinical Trials
• 9.2. Patent Landscape
• 9.3. Regulatory Approvals
• 9.4. Innovations/Emerging Technologies

10. Key Players Landscape

• 10.1. Competition Matrix of Top Five Market Leaders
• 10.2. Market Revenue Analysis of Top Five Market Leaders (in %, FY2023)
• 10.3. Mergers and Acquisitions/Joint Ventures (If Applicable)
• 10.4. SWOT Analysis (For Five Market Players)
• 10.5. Patent Analysis (If Applicable)

11. Pricing Analysis

12. Case Studies

13. Key Players Outlook

• 13.1. Pfizer, Inc.
  • 13.1.1. Company Details
  • 13.1.2. Key Management Personnel
  • 13.1.3. Products & Services
  • 13.1.4. Financials (As reported)
  • 13.1.5. Key Market Focus & Geographical Presence
  • 13.1.6. Recent Developments
• 13.2. Cipla Limited
• 13.3. Sun Pharmaceutical Industries Ltd.
• 13.4. AbbVie Inc.
• 13.5. AstraZeneca plc
• 13.6. GlaxoSmithKline plc
• 13.7. Sanofi S.A.
• 13.8. Teva Pharmaceutical Industries Ltd.
• 13.9. Novartis International AG
• 13.10. Boehringer Ingelheim International GmbH
• 13.11. Piramal Enterprises Ltd.
• 13.12. Aurobindo Pharma

Companies mentioned above DO NOT hold any order as per market share and can be changed as per information available during research work.

14. Strategic Recommendations

15. About Us & Disclaimer

List of Tables

• Table 1. Pricing Analysis of Products from Key Players
• Table 2. Competition Matrix of Top 5 Market Leaders
• Table 3. Mergers & Acquisitions/ Joint Ventures (If Applicable)
• Table 4. About Us - Regions and Countries Where We Have Executed Client Projects

List of Figures

• Figure 1. Japan Active Pharmaceutical Ingredient Market, By Value, In USD Billion, FY2017-FY2031F
• Figure 2. Japan Active Pharmaceutical Ingredient Market, By Volume, In Million Units, FY2017-FY2031F
• Figure 3. Japan Active Pharmaceutical Ingredient Market Share (%), By Synthesis, FY2017-FY2031F
• Figure 4. Japan Active Pharmaceutical Ingredient Market Share (%), By Potency, FY2017-FY2031F
• Figure 5. Japan Active Pharmaceutical Ingredient Market Share (%), By Manufacturer, FY2017-FY2031F
• Figure 6. Japan Active Pharmaceutical Ingredient Market Share (%), By Type, FY2017-FY2031F
• Figure 7. Japan Active Pharmaceutical Ingredient Market Share (%), By Drug, FY2017-FY2031F
• Figure 8. Japan Active Pharmaceutical Ingredient Market Share (%), By Usage, FY2017-FY2031F
• Figure 9. Japan Active Pharmaceutical Ingredient Market Share (%), By Application, FY2017-FY2031F
• Figure 10. Japan Active Pharmaceutical Ingredient Market Share (%), By Region, FY2017-FY2031F
• Figure 11. By Synthesis Map-Market Size (USD Billion) & Growth Rate (%), FY2023
• Figure 12. By Potency Map-Market Size (USD Billion) & Growth Rate (%), FY2023
• Figure 13. By Manufacturer Map-Market Size (USD Billion) & Growth Rate (%), FY2023
• Figure 14. By Type Map-Market Size (USD Billion) & Growth Rate (%), FY2023
• Figure 15. By Drug Map-Market Size (USD Billion) & Growth Rate (%), FY2023
• Figure 16. By Usage Map-Market Size (USD Billion) & Growth Rate (%), FY2023
• Figure 17. By Application Map-Market Size (USD Billion) & Growth Rate (%), FY2023
• Figure 18. By Region Map-Market Size (USD Billion) & Growth Rate (%), FY2023