세계의 고효능 원료의약품(HPAPI) : 시장 인사이트, 경쟁 구도, 시장 전망(-2032년)
High Potency Active Pharmaceutical Ingredients (HPAPI) - Market Insights, Competitive Landscape, and Market Forecast - 2032
상품코드 : 1656919
리서치사 : DelveInsight
발행일 : On Demand Report
페이지 정보 : 영문 150 Pages
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한글목차

고효능 원료의약품(HPAPI) 시장 규모는 2024년 244억 362만 달러에서 예측 기간 동안 8.00%의 연평균 복합 성장률(CAGR)로 성장하여 2032년에는 449억 4,439만 달러 규모로 성장할 것으로 예상됩니다.

고효능 원료의약품(HPAPI) 시장은 전 세계 만성질환 유병률 증가에 힘입어 강력한 성장세를 보이고 있습니다. 세계 암 및 당뇨병 유병률 증가, API 개발 및 제조에 대한 정부 지원 강화, 주요 기업의 R&D 노력 강화 등의 요인이 시장 확대를 촉진하는 데 중요한 역할을 할 것으로 예상됩니다. 이러한 역학은 2025년부터 2032년까지의 예측 기간 동안 시장의 긍정적인 성장 모멘텀을 유지할 것으로 예상됩니다.

고효능 원료의약품(HPAPI) 시장 역학:

만성질환 증가로 인해 광범위한 약수처리가 필요해지면서 혁신적인 의약품 유효성분(API)에 대한 수요가 증가하고 있으며, HPAPI는 표적 치료를 위해 특별히 개발된 것으로, 보다 효과적인 질병 관리와 치료를 위해 환자에게 맞춤화된 의약품을 제공할 수 있게 합니다. 세계보건기구(WHO)가 2024년 2월 발표한 자료에 따르면, 2050년까지 새로 발생하는 암 환자는 3,500만 명이 넘을 것으로 추정되며, 이는 2022년 추정치인 2,000만 명에서 77% 증가한 수치입니다. 221만 건, 대장암은 193만 건이었습니다.

국제당뇨병연맹(International Diabetes Federation)이 2021년 발표한 자료에 따르면, 2021년 기준 20-79세 성인 중 약 5억 3,700만 명이 당뇨병을 앓고 있으며, 이 수치는 2030년까지 6억 4,300만 명, 2045년까지 7억 8,300만 명 7억 8,300만 명으로 증가할 것으로 예상됩니다. 따라서 천연 인슐린과 메트포르민과 같은 항당뇨병약이 당뇨병 치료에 널리 사용되고 있으며, 이는 시장 성장을 가속하고 있습니다.

주요 기업들의 연구개발 발전도 HPAPI의 성장을 가속하고 있습니다. 기업들은 고도의 연구와 혁신을 통해 새로운 화합물 개발 및 식별에 적극적으로 나서고 있으며, 만성 질환 치료 옵션을 강화하는 데 주력하고 있습니다.

세계의 고효능 원료의약품(HPAPI) 시장을 조사했으며, 시장 개요, 시장 영향요인 및 시장 기회 분석, 법 및 규제 환경, 시장 규모 추이와 예측, 각종 부문별/지역별/주요 국가별 상세 분석, 경쟁 구도, 주요 기업 개요 등의 정보를 정리하여 전해드립니다.

목차

제1장 고효능 원료의약품(HPAPI) 시장 보고서 : 서론

제2장 고효능 원료의약품(HPAPI) 시장 : 주요 요약

제3장 경쟁 구도

제4장 규제 분석

제5장 고효능 원료의약품(HPAPI) 시장 : 주요 요인 분석

제6장 고효능 원료의약품(HPAPI) 시장 : Porter의 Five Forces 분석

제7장 고효능 원료의약품(HPAPI) 시장 평가

제8장 고효능 원료의약품(HPAPI) 시장 : 기업 및 제품 개요

제9장 KOL(Key Opinion Leader)의 견해

제10장 프로젝트 접근

제11장 DelveInsight에 대해

제12장 면책사항 및 문의

LSH
영문 목차

영문목차

High Potency Active Pharmaceutical Ingredients (HPAPI) Market By Production Method (Natural and Synthetic), Modality (Small Molecule, Biologics, and Others), Application (Oncology, Neurology, Cardiology, Infectious Diseases, Metabolic Diseases, and Others), End-User (Biopharmaceutical and Life Science Companies, Contract Drug Manufacturing Organizations, Research Institutions, and Others), and Geography (North America, Europe, Asia-Pacific, and Rest of the World) is expected to grow at a steady CAGR forecast till 2032 owing to the rising incidence of chronic diseases and the increasing prevalence of cancer and diabetes

The high potency active pharmaceutical ingredients (HPAPI) market was valued at USD 24,403.62 million in 2024, growing at a CAGR of 8.00% during the forecast period from 2025 to 2032 to reach USD 44,944.39 million by 2032. The high-potency active pharmaceutical ingredients (HPAPIs) market is experiencing robust growth, primarily fueled by the rising incidence of chronic diseases globally. Factors such as the increasing prevalence of cancer and diabetes worldwide, enhanced governmental support for API development and manufacturing, and heightened research and development efforts by major industry players are pivotal in driving the market's expansion. These dynamics are expected to sustain positive growth momentum for the high-potency active pharmaceutical ingredients market throughout the forecast period from 2025 to 2032.

High Potency Active Pharmaceutical Ingredients Market Dynamics:

The increasing prevalence of chronic diseases necessitates extensive drug treatments, driving the demand for innovative active pharmaceutical ingredients (APIs). High-potency active pharmaceutical ingredients (HPAPIs) are specifically developed for targeted therapies, enabling the provision of personalized medicines to patients for more effective disease management and treatment. For instance, according to data provided by the World Health Organization (WHO) in February 2024, over 35 million new cancer cases were estimated to occur by 2050, marking a significant 77% increase from the estimated 20 million cases in 2022 across the globe. There were around 2.26 million cases of breast cancer, 2.21 million cases of lung cancer, and 1.93 million cases of colon and rectal cancer, reported in the year 2020 in the world.

According to data published by the International Diabetes Federation in 2021, stated that around 537 million adults aged between 20 and 79 years were suffering from diabetes in 2021 in the world and this number is expected to increase from 643 million by 2030 and 783 million by 2045. Therefore, natural insulin and antidiabetic API such as metformin are being widely used for the treatment of diabetes which is fostering market growth.

Greater domestic production of active pharmaceutical ingredients (APIs) can reduce dependency on global supply chains for critical medications, especially during periods of heightened public health demand. Consequently, government organizations are prioritizing efforts to bolster domestic manufacturing capacity for APIs. For instance, in May 2024, the United States Agency for International Development (USAID), unveiled a new initiative called "Diversifying Asia's Pharmaceutical Supply Chain. The project allocated USD 5 million towards the sustainable production, regulation, and export of high-quality medical products and active pharmaceutical ingredients (APIs) in Uzbekistan and Kazakhstan.

The increasing research and development (R&D) efforts by key players are driving the growth of high-potency active pharmaceutical ingredients (APIs). Key companies are actively engaged in developing and identifying novel compounds through advanced research and technological innovations, focusing on enhancing treatment options for chronic diseases. For instance, in May 2024, Lantern Pharma Inc., an artificial intelligence (AI) company specializing in oncology drug discovery and development, revealed a strategic collaboration driven by AI with French biotechnology firm Oregon Therapeutics. The partnership was established to enhance the development of XCE853, a pioneering protein disulfide isomerase (PDI) inhibitor drug candidate, targeting novel and specific cancer indications. Lantern Pharma utilized its proprietary RADR(R) AI platform to identify biomarkers and efficacy-related signatures of XCE853 across various solid tumors, facilitating precision-focused development strategies.

However, the high development and production costs associated with high-potency active pharmaceutical ingredients, and stringent quality and regulatory requirements, among others are some of the key constraints that may limit the growth of the high-potency active pharmaceutical ingredients market.

High Potency Active Pharmaceutical Ingredients Market Segment Analysis:

High Potency Active Pharmaceutical Ingredients (HPAPI) Market by Production Method (Natural and Synthetic), Modality (Small Molecule, Biologics, and Others), Application (Oncology, Neurology, Cardiology, Infectious Diseases, Metabolic Diseases, and Others), End-User (Biopharmaceutical and Life Science Companies, Contract Drug Manufacturing Organizations, Research Institutions, and Others), and Geography (North America, Europe, Asia-Pacific, and Rest of the World)

In the modality segment, the small molecule category was estimated to account for the largest market share in the high-potency active pharmaceutical ingredients market in 2024. This can be attributed to the wide applications of small molecules in drug discovery and development. From traditional small molecules, which have long served as foundations in drug development, to innovative approaches like PROTACs and zirconium cyclosilicates, small molecules designed for oral administration can engage biological targets through diverse modes of action.

Small molecules can act both intracellularly and extracellularly, with their distribution tailored to achieve systemic exposure, potentially including brain penetration capabilities. This versatility highlights the crucial role of small-molecule drugs in advancing therapeutic strategies across diverse medical conditions. For example, data published by the United States Food and Drug Administration (US FDA) in January 2023, revealed that the FDA approved 37 new drugs in 2022, with 21 of them being small molecules, representing 57% of the total. This statistic underscores the continual relevance, impact, and value of small-molecule drugs in driving innovation and progress in pharmaceutical treatments.

In July 2021, Regeneron Pharmaceuticals, Inc., a US-based biopharmaceutical company, and AstraZeneca, a UK-based pharmaceutical and biotechnology company announced a collaboration aimed at researching, developing, and commercializing small molecule compounds targeting the GPR75 receptor. Through this collaboration, Regeneron joined forces with AstraZeneca to develop small molecule compounds that hold potential for treating obesity and related co-morbidities.

Therefore, the wide use of small molecules in drug discovery and development is expected to contribute to the growth of the segment, thereby driving the growth of the high-potency active pharmaceutical ingredients market during the forecast period.

North America is expected to dominate the High Potency Active Pharmaceutical Ingredients Market:

In 2024, North America is projected to lead the high-potency active pharmaceutical ingredients (HPAPIs) market among all regions, driven by a significant patient population affected by chronic diseases like cancer and diabetes. The region's growth is further fueled by the presence of major pharmaceutical companies and increasing governmental support for active pharmaceutical ingredients (API) production. These factors collectively contribute to the expansion of the high-potency active pharmaceutical ingredients market in North America.

According to the National Cancer Institute in 2020, it was estimated that around 1,806,590 cancer cases were diagnosed in the year 2020 in the United States. The growing number of chronic diseases requires the development of novel active pharmaceutical ingredients for effective treatment, thereby driving market growth.

As per the Centers for Disease Control and Prevention (CDC) in 2021, around 28.7 million people had diabetes in the year 2019 in the United States. Moreover, as per the Centers for Disease Control and Prevention 2022 data, around 96 million people had pre-diabetic conditions in the year 2019 in the US.

Key players in the region are concentrating their efforts on expanding their API production in the United States. For instance, in June 2022, Pfizer Inc. a US-based pharmaceutical and biotechnology company, announced a USD 120 million investment in its Kalamazoo, Michigan facility, emphasizing its commitment to U.S. manufacturing. This investment aims to support the production of its PAXLOVIDTM (nirmatrelvir [PF-07321332] tablets and ritonavir tablets) treatment, by expanding the manufacturing capacity for active pharmaceutical ingredients (API) and registered starting materials (RSMs) necessary for nirmatrelvir production. Therefore, the rising activities by key players in the region is expected to propel the growth of North America high potency active pharmaceutical ingredients market.

High Potency Active Pharmaceutical Ingredients Market Key Players:

Some of the key market players operating in the high potency active pharmaceutical ingredients market include BASF SE, Pfizer Inc., Divi's Laboratories Limited, Teva Pharmaceutical Industries Ltd., Eli Lilly and Company, Merck & Co., Inc., AbbVie Inc., Viatris Inc., Dr. Reddy's Laboratories Ltd., Sun Pharmaceutical Industries Ltd., Evonik Industries AG, CARBOGEN AMCIS, Lonza, WuXi AppTec, Ajinomoto Bio-Pharma, CordenPharma, Lupin Limited, Piramal Enterprises Ltd., Sanofi, Boehringer Ingelheim International GmbH, and others.

Recent Developmental Activities in the High Potency Active Pharmaceutical Ingredients Market:

Key Takeaways from the High Potency Active Pharmaceutical Ingredients Market Report Study

Target Audience who can be benefited from this High Potency Active Pharmaceutical Ingredients Market Report Study

Frequently Asked Questions for the High Potency Active Pharmaceutical Ingredients Market:

1. What are High Potency Active Pharmaceutical Ingredients?

2. What is the market for High Potency Active Pharmaceutical Ingredients?

3. What are the drivers for the global High Potency Active Pharmaceutical Ingredients market?

4. Who are the key players operating in the global High Potency Active Pharmaceutical Ingredients market?)

5. Which region has the highest share in the global High Potency Active Pharmaceutical Ingredients market?

Table of Contents

1. High Potency Active Pharmaceutical Ingredients Market Report Introduction

2. High Potency Active Pharmaceutical Ingredients Market Executive Summary

3. Competitive Landscape

4. Regulatory Analysis

5. High Potency Active Pharmaceutical Ingredients Market Key Factors Analysis

6. High Potency Active Pharmaceutical Ingredients Market Porter's Five Forces Analysis

7. High Potency Active Pharmaceutical Ingredients Market Assessment

8. High Potency Active Pharmaceutical Ingredients Market Company and Product Profiles

9. KOL Views

10. Project Approach

11. About DelveInsight

12. Disclaimer & Contact Us

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