Japan Active Pharmaceutical Ingredient Market Assessment, By Synthesis [Biotech, Synthetic], By Potency [Traditional API, HPAPI], By Manufacturer [Captive APIs, Merchant APIs], By Type [Generic APIs, Innovative APIs], By Drug [Prescription Drugs, Over-the

Japan Active Pharmaceutical Ingredient Market Assessment, By Synthesis [Biotech, Synthetic], By Potency [Traditional API, HPAPI], By Manufacturer [Captive APIs, Merchant APIs], By Type [Generic APIs, Innovative APIs], By Drug [Prescription Drugs, Over-the-counter Drugs], By Usage [Clinical, Research], By Application [Cardiovascular diseases, Oncology, Neurology, Orthopedic, Diabetes, Pulmonology, Gastroenterology, Nephrology, Ophthalmology, Others], By Region, Opportunities and Forecast, FY2017-FY2031F



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.


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

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