日本 API (API) 市場評估：依合成、藥理活性、製造領域、類型、藥物、應用、疾病應用和地區劃分的機會和預測（2017-2031 年）

日本原料藥（API）市場規模預計將從2023年的201.1億美元成長到2031年的327.9億美元，預計在2024-2031年期間複合年增長率為6.3%。

健康疾病的增加、醫藥研發方面的大規模醫療保健支出以及生物製劑技術的進步正在推動日本 API（活性藥物成分）市場的發展。在日本，老年人口的增加對慢性病的增加產生了重大影響。市場擴張的主要驅動力是原料藥在癌症和糖尿病領域的日益增長的應用。日本原料藥市場監管嚴格，政府在支持該產業方面發揮重要作用。政府補貼原料藥生產商並投資研發。政府已採取多項措施來促進仿製藥的使用。日本製藥公司越來越多地將 API 製造外包給 CMO。

慢性病負擔增加和老年人口增加：

日本人口老化不斷加劇，使他們更容易受到傷害和疾病等各種健康問題的影響，促使對原料藥的需求大幅激增。根據總務省截至2022年9月15日的數據，過去一年日本總人口減少了82萬人。另一方面，65歲以上人口增加6萬人，達到3,627萬人的歷史新高（與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動日本原料藥市場的主要因素。據IDF（國際糖尿病聯盟）稱，日本有超過1100萬名糖尿病患者。

製藥公司擴大生產設施：

日本製藥公司正在積極擴大其生產設施，以滿足 API 市場不斷增長的需求。這種激增是由穩定供應鏈的需求、醫療保健要求的增加以及政府對國內生產的支持等因素所推動的。公司正在大力投資最先進的設備，以確保高品質的原料藥生產符合嚴格的監管標準。此次擴張加強了日本在全球原料藥市場的地位，促進了製藥業的創新和經濟成長，並確立了在全球製藥業的關鍵地位。

科技的發展：

日本一直處於 API 市場技術進步的前沿，並表現出對創新和品質的承諾。日本製藥公司在研發方面取得了重大進展，利用人工智慧、機器人技術和進階分析等創新技術來加速藥物發現和生產過程。這些進步提高了 API 製造的效率和精確度，並促進了新型療法的開發。

本報告調查了日本API（活性藥物成分）市場，並提供市場定義和概述、市場規模趨勢和預測、各個細分市場和地區的詳細分析、行業結構以及影響市場成長的因素分析、案例研究、競爭格局。

目錄

第一章研究方法論

第二章 專案範圍與定義

第三章 COVID-19 對日本原料藥（API）市場的影響

第 4 章執行摘要

第五章 日本原料藥（API）市場展望

• 市場規模/預測
• 依成分分類
  • 生物技術
  • 合成
• 依藥理活性
  • 傳統API
  • 高壓API
• 依製造類別
  • 專屬API
  • 商家API
• 依類型
  • 一般API
  • 創新API
• 透過藥物
  • 處方藥
  • 非處方藥
• 依用途
  • 臨床
  • 研究
• 依疾病用途
  • 心血管疾病
  • 腫瘤
  • 神經
  • 骨科
  • 糖尿病
  • 呼吸科
  • 胃腸病學
  • 腎
  • 眼科
  • 其他
• 依地區
  • 北（北海道/東北部）
  • 中部（關東/中部）
  • 南部地區（關西、中國、四國、九州、沖繩）
• 依公司劃分的市場佔有率

第六章 市場測繪，2023

• 依成分分類
• 依藥理活性
• 依製造類別
• 依類型
• 透過藥物
• 依用途
• 依疾病用途
• 依地區

第七章 宏觀環境與產業結構

• 供需分析
• 進出口分析
• 供應/價值鏈分析
• PESTEL 分析
• 波特五力分析

第八章市場動態

• 增長動力
• 成長限制因素（課題與限制）

第九章 監理架構與創新

• 臨床試驗
• 專利情況
• 監管審批
• 創新/新興技術

第十章 主要公司情況

• 前 5 名市場領導者的競爭矩陣
• 前 5 名市場領導者的市場收入分析
• 併購/合資（如適用）
• SWOT分析（5家參與企業）
• 專利分析（如果適用）

第11章價格分析

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 戰略建議

第十五章關於我們公司/免責聲明

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