日本のAPI (原薬) 市場の評価：合成・薬理活性・製造区分・タイプ・薬剤・用途・疾患用途・地域別の機会および予測 (2017-2031年)

日本のAPI (原薬) の市場規模は、2023年の201億1,000万米ドルから、2024年から2031年の予測期間中は6.3%のCAGRで推移し、2031年には327億9,000万米ドルの規模に成長すると予測されています。

健康障害の増加、医薬品のR&Dに対する大規模な医療支出、生物製剤技術の進歩が日本のAPI (原薬) 市場を牽引しています。日本では高齢者人口の増加が慢性疾患の増加に大きな影響を与えています。市場拡大の主な要因は、癌と糖尿病におけるAPIの用途の拡大です。日本のAPI市場は高度に規制されており、政府は業界を支援する上で重要な役割を果たしています。政府はAPIメーカーに補助金を支給し、R&Dに投資しています。政府はジェネリック医薬品の使用を促進するためにいくつかのイニシアチブを行っています。日本の製薬会社は、APIの製造をCMOに委託するケースが増えています。

慢性疾患の負担増と高齢者人口の増加：

日本では高齢者人口が増加しており、怪我や病気などさまざまな健康問題にかかりやすくなっているため、APIの需要が大幅に急増しています。2022年9月15日現在の総務省のデータによると、日本の総人口は昨年1年間で82万人減少しました。一方、65歳以上の人口は6万人増加し、過去最高の3,627万人 (2021年比0.03%増) となっています。癌、糖尿病、心血管疾患などの慢性疾患罹患率の上昇は、日本のAPI市場を牽引する主な要因です。IDF (国際糖尿病連合) によると、日本の糖尿病患者は1,100万人を超えています。

製薬会社による生産設備の拡大：

日本の製薬会社は、API市場の需要拡大に対応するため、積極的に生産設備を拡大しています。この急増は、安定したサプライチェーンの必要性、ヘルスケア要件の増加、国内生産に対する政府の支援といった要因に後押しされています。企業は、厳格な規制基準を遵守して高品質のAPI製造を確保するため、最先端の設備に多額の投資を行っています。この拡大は、世界のAPI市場における日本の地位を強化し、医薬品分野におけるイノベーションと経済成長を促進し、世界の医薬品産業における極めて重要な地位を確立させています。

技術の進歩：

日本はAPI市場における技術の進歩の最前線にあり、革新と品質へのコミットメントを実証してきました。日本の製薬企業は、AI、ロボット工学、高度アナリティクスなどの革新的技術を活用して創薬・生産プロセスを加速化し、R&Dにおいて大きな進歩を遂げてきました。こうした進歩がAPI製造の効率と精度を向上させ、新規治療法の開発に貢献してきました。

当レポートでは、日本のAPI (原薬) の市場を調査し、市場の定義と概要、市場規模の推移・予測、各種区分・地域別の詳細分析、産業構造、市場成長への影響因子の分析、ケーススタディ、競合情勢、主要企業のプロファイルなどをまとめています。

目次

第1章 調査手法

第2章 プロジェクトの範囲と定義

第3章 COVID-19が日本のAPI (原薬) 市場に与える影響

第4章 エグゼクティブサマリー

第5章 日本のAPI (原薬) 市場の展望

• 市場規模・予測
• 合成別
  • バイオテクノロジー
  • 合成
• 薬理活性別
  • 従来型API
  • HPAPI
• 製造区分別
  • キャプティブAPI
  • マーチャントAPI
• タイプ別
  • ジェネリックAPI
  • イノベーティブAPI
• 薬剤別
  • 処方薬
  • OTC薬
• 用途別
  • 臨床
  • 研究
• 疾患用途別
  • 心血管疾患
  • 腫瘍
  • 神経
  • 整形外科
  • 糖尿病
  • 呼吸器科
  • 消化器内科
  • 腎臓
  • 眼科
  • その他
• 地域別
  • 北部 (北海道・東北)
  • 中部 (関東・中部)
  • 南部 (関西・中国・四国・九州・沖縄)
• 企業別市場シェア

第6章 市場マッピング、2023年

• 合成別
• 薬理活性別
• 製造区分別
• タイプ別
• 薬剤別
• 用途別
• 疾患用途別
• 地域別

第7章 マクロ環境と産業構造

• 需給分析
• 輸出入分析
• サプライ/バリューチェーン分析
• PESTEL分析
• ポーターのファイブフォース分析

第8章 市場力学

• 成長促進要因
• 成長抑制要因 (課題と抑制)

第9章 規制枠組みとイノベーション

• 臨床試験
• 特許情勢
• 規制当局の承認
• イノベーション/新興技術

第10章 主要企業の情勢

• 市場リーダー上位5社の競合マトリックス
• 市場リーダー上位5社の市場収益分析
• M&A・ジョイントベンチャー (該当する場合)
• SWOT分析 (参入5社)
• 特許分析 (該当する場合)

第11章 価格分析

第12章 ケーススタディ

第13章 主要企業の展望

• 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14章 戦略的提言

第15章 当社について・免責事項

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

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