일본의 원료의약품(API) 시장 규모는 2023년 201억 1,000만 달러에서 2024년부터 2031년까지 예측 기간 동안 6.3%의 연평균 복합 성장률(CAGR)로 성장하여 2031년에는 327억 9,000만 달러 규모로 성장할 것으로 예상됩니다.
건강 장애 증가, 의약품 R&D에 대한 대규모 의료비 지출, 생물학적 제제 기술의 발전이 일본의 원료의약품(API) 시장을 주도하고 있습니다. 일본에서는 노인 인구 증가가 만성질환 증가에 큰 영향을 미치고 있습니다. 시장 확대의 주요 요인은 암과 당뇨병에 대한 API의 사용 확대입니다. 일본 API 시장은 고도로 규제되고 있으며, 정부는 산업을 지원하는 데 중요한 역할을 하고 있습니다. 정부는 API 제조업체에 보조금을 지급하고 R&D에 투자하고 있습니다. 정부는 제네릭 의약품의 사용을 촉진하기 위해 여러 가지 이니셔티브를 시행하고 있습니다. 일본 제약회사들은 점점 더 많은 API 제조를 CMO에 위탁하고 있습니다.
일본의 고령 인구가 증가하고 부상, 질병 등 다양한 건강 문제에 노출되기 쉽기 때문에 API에 대한 수요가 크게 급증하고 있습니다. 2022년 9월 15일 현재 일본 총무성 데이터에 따르면 일본의 총 인구는 지난해 1년 동안 82만 명이 감소했습니다. 반면 65세 이상 인구는 6만 명 증가해 역대 최고치인 3,627만 명(2021년 대비 0.03% 증가)을 기록했습니다. 암, 당뇨병, 심혈관 질환 등 만성질환 유병률 증가는 일본 API 시장을 이끄는 주요 요인으로, 국제당뇨병연맹(IDF)에 따르면 일본의 당뇨병 환자는 1,100만 명을 넘어섰다고 합니다.
일본 제약사들은 API 시장 수요 증가에 대응하기 위해 적극적으로 생산 설비를 확장하고 있습니다. 이러한 급증은 안정적인 공급망의 필요성, 의료 요구 사항 증가, 국내 생산에 대한 정부의 지원 등의 요인에 의해 촉진되고 있습니다. 기업들은 엄격한 규제 기준을 준수하고 고품질 API 제조를 보장하기 위해 최첨단 장비에 많은 투자를 하고 있습니다. 이러한 확장은 세계 API 시장에서 일본의 입지를 강화하고, 제약 분야의 혁신과 경제 성장을 가속하며, 세계 제약 산업에서 매우 중요한 위치를 차지하고 있습니다.
일본은 API 시장에서 기술 발전의 최전선에 있으며, 혁신과 품질에 대한 노력을 입증해 왔습니다. 일본 제약사들은 AI, 로봇 공학, 고급 분석 등 혁신적인 기술을 활용하여 신약 개발 및 생산 공정을 가속화하고 R&D에서 큰 진전을 이루었습니다. 이러한 발전은 API 생산의 효율성과 정확성을 향상시켜 새로운 치료법 개발에 기여하고 있습니다.
일본의 API(원료의약품) 시장을 조사했으며, 시장 정의와 개요, 시장 규모 추이와 예측, 각종 분류 및 지역별 상세 분석, 산업 구조, 시장 성장에 영향을 미치는 요인 분석, 사례 연구, 경쟁 구도, 주요 기업 프로파일 등의 정보를 정리하여 전해드립니다.
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.
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.
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.
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.
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 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.
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.
Companies mentioned above DO NOT hold any order as per market share and can be changed as per information available during research work.