시장보고서

상품코드

1319149

세계의 API(원료의약품) 시장(2023-2030년)

Global Active Pharmaceutical Ingredients Market - 2023-2030

발행일: 2023년 07월 | 리서치사:

DataM Intelligence | 페이지 정보: 영문 195 Pages | 배송안내 : 1-2일 (영업일 기준)

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시장 개요

세계 API(원료의약품) 시장은 2022년 1,972억 달러, 2030년에는 3,137억 달러에 달할 것으로 예상되며, 수익성 있는 성장을 보일 것으로 예상됩니다. 세계 API(원료의약품) 시장은 예측 기간(2023-2030년) 동안 6.1%의 CAGR을 기록할 것으로 예상됩니다.

API(원료의약품)는 의약품의 중요한 구성요소입니다. API는 생리적 활성 화학제품으로 의약품의 바람직한 치료 효과를 가져오고, API는 천연 유래 또는 화학적으로 합성되며, 안전성과 효능을 보장하기 위해 광범위한 테스트와 품질 관리를 거칩니다.

원료는 의약품의 필수 성분으로 안전하고 효과적인 의약품을 공급하는 데 중요한 역할을 합니다. 원료의약품은 치료 효과, 제조 절차, 연구 개발, 규제 준수 및 신뢰할 수 있는 세계 의약품 공급망 유지에 필수적입니다.

시장 역학

제조 절차의 증가로 시장 성장 견인

의약품 제조 공장의 증가는 시장 성장을 촉진할 것입니다. 예를 들어, 2023년 5월 3일, 베링거인겔하임은 독일 본사에 2억 8,500만 유로(3억 1,500만 달러)를 투자해 임상시험용 API(원료의약품)와 의약품을 생산할 수 있는 새로운 공장 건설을 시작했습니다. 화학 혁신 공장은 2026년 독일 잉겔하임에 위치한 베링거인겔하임 본사에 설립될 예정입니다.

또한 2023년 6월 13일, 노보노디스크는 2023년부터 덴마크 힐레로드에 위치한 제조 시설 확장에 159억 덴마크 크로네(22억 9,000만 달러)를 투자할 계획이라고 밝혔습니다. 이 새로운 투자를 통해 회사는 미래 수요를 충족시킬 수 있는 능력을 확장하고 미래의 후기 임상 제품 포트폴리오를 개발할 수 있게 됩니다. 이 자금은 덴마크의 기존 원료의약품 생산 공장을 개발하여 미래의 중증 만성질환 치료제 포트폴리오를 개발하는 데 사용될 예정입니다. 결과적으로 앞서 언급한 요인들이 시장 확대에 기여할 것으로 보입니다.

기술 발전으로 인한 원료의약품 생산이 시장 성장 촉진

연속 처리와 공정 전산화는 대규모의 비용 효율적이고 효율적인 생산을 가능하게 하는 두 가지 새로운 API 제조 기술입니다. 자동 기계, 컴퓨터 제어 공정 설명(CPD) 시스템 및 디지털 제조 시스템은 현재 원료 의약품의 처방 정확도를 개선하고 전반적인 효율성을 높이고 수작업의 필요성을 없애기 위해 사용되고 있습니다.

예를 들어, 2023년 2월 15일, 피라말 제약의 자회사이자 환자 대상 위탁개발 및 제조수탁기관(CDMO)인 피라말 제약 솔루션즈는 미국 미시간주 리버뷰에 위치한 시설에서 새로운 리액터 스위트를 통해 API(원료의약품)의 첫 번째 배치를 생산하기 시작했다고 발표했습니다. API)의 초기 배치를 생산하기 시작했다고 발표했습니다. 이러한 기술 개발은 시장 확대에 기여하고 있습니다.

높은 제조 비용이 시장 성장에 걸림돌로 작용

다양한 원재료의 비용은 가용성과 수요에 따라 영향을 받을 수 있습니다. 특정 원재료의 공급이 제한적이거나 신약 개발, 시장 역학 변화 등의 이유로 수요가 증가하면 원재료 가격이 상승할 수 있습니다. 환율 변동과 지정학적 고려 사항도 원자재 가격에 영향을 미칠 수 있습니다.

원료의약품의 원재료 비용은 전체 의약품 제조 비용의 구성요소 중 하나에 불과하다는 점에 유의하는 것이 중요합니다. 의약품의 최종 비용에 영향을 미치는 다른 요인으로는 제조 절차, 품질 관리, 규제 준수, 생산 규모 등이 있습니다. 이러한 요인들은 예측 기간 동안 시장 확대를 방해하고 있습니다.

COVID-19 영향 분석

세계 API 시장은 COVID-19 사태로 인해 혜택을 받았습니다. 제약 부문은 고열, 기침, 감기 등 COVID-19 관련 증상 치료의 최전선에 있었습니다. 팬데믹 기간 동안 제약 부문의 인기 상승으로 원료의약품 시장이 성장했습니다. 세계보건기구(WHO)가 COVID-19 사태를 팬데믹(세계적 대유행)으로 선언한 후 유명 제약사, 바이오 제약사, 젊은 스타트업 등 다양한 기업들이 백신 개발에 나섰습니다.

러시아-우크라이나 분쟁의 영향 분석

러시아-우크라이나 분쟁은 이 지역의 주요 시장 기업 수가 적기 때문에 세계 원료의약품 시장에 미치는 영향은 미미할 것으로 추정됩니다. 그러나 원자재 수출입의 영향은 예측 기간 동안 세계 원료의약품 시장 성장에 거의 영향을 미치지 않을 것으로 예상됩니다.

Market Overview

The global active pharmaceutical ingredients market reached US$ 197.2 billion in 2022 and is expected to witness lucrative growth by reaching up to US$ 313.7 billion by 2030. The global active pharmaceutical ingredients market is expected to exhibit a CAGR of 6.1% during the forecast period (2023-2030).

APIs (Active Pharmaceutical Ingredients) are critical components of pharmaceutical products. They are the physiologically active chemicals that are responsible for a drug's desired therapeutic effect. APIs are taken from natural sources or chemically synthesised, and they are subjected to extensive testing and quality control to assure their safety and efficacy.

APIs are essential components in pharmaceutical products, and they play an important role in supplying safe and effective drugs. They are critical for treatment efficacy, manufacturing procedures, research and development, regulatory compliance, and sustaining a dependable global pharmaceutical supply chain.

MarketDynamics

Rising the Manufacturing Procedures will Drive the Market Growth

Increasing the pharma manufacturings plants helps to drive the market growth. For instance, on May 03, 2023, at its German headquarters, Boehringer Ingelheim has begun building on a new 285 million euro ($315 million) plant that will create active pharmaceutical components and medications for clinical trials. The Chemical Innovation Plant is set to open in 2026 at Boehringer's headquarters in Ingelheim, Germany.

Additionally, on June 13, 2023, Novo Nordisk has announced intentions to invest DKr15.9 billion ($2.29 billion) in expanding its manufacturing facility in Hillerod, Denmark, beginning in 2023. The new investment will expand the company's ability to satisfy future demand and allow for the development of its future clinical late-phase product portfolio. The funds will be used to develop its existing Danish API production plant in order to advance its future serious and chronic illness portfolio. As a result, the aforementioned factors contribute to market expansion.

Technological Advancements API Manufacturing Helps to Boost The Market Growth

Continuous processing and computerization of processes are two new API manufacturing technologies that enable large-scale, cost-effective, and efficient production. Automated machinery, computer-controlled process description (CPD) systems, and digital manufacturing systems are currently being used to improve API formulation accuracy, increase overall efficiency, and eliminate the need for manual labour.

For instance, on Feburary 15, 2023, Piramal Pharma Solutions, a patient-focused Contract Development and Manufacturing Organisation (CDMO) and subsidiary of Piramal Pharma Ltd, announced that it had begun of production of initial batches of active pharmaceutical ingredients (APIs) in new reactor suites at its Riverview, Michigan, USA facility. Thus, technical developments contribute to market expansion.

High Manufacturing Costs Will Hamper the Market Growth

The cost of various raw materials can be affected by their availability and demand. Raw material prices can rise if there is a limited supply of a specific raw material or if demand increases owing to reasons such as new drug development or changes in market dynamics. Currency exchange rate fluctuations and geopolitical considerations can also have an impact on raw material prices.

It is crucial to note that the raw material costs of APIs are only one component of the overall pharmaceutical manufacturing expenses. Other factors that influence the final cost of pharmaceutical products include manufacturing procedures, quality control, regulatory compliance, and production scale. These factors are impeding market expansion throughout the predicted period.

COVID-19 Impact Analysis

The global APIs market benefited by the COVID-19 epidemic. The pharmaceutical sector was in the forefront of treating COVID-19-related symptoms such as high fever, cough, and cold. The active pharmaceutical components market grew during the pandemic due to the rising popularity of the pharmaceutical sector. Following the World Health Organization's declaration of the COVID-19 outbreak as a pandemic, a varied group of known pharmaceutical and biopharmaceutical companies, as well as young startups, moved up to develop vaccines.

Russia-Ukraine War Impact Analysis

The Russia-Ukraine conflict is estimated to have a moderate impact on the global active pharmaceutical ingredients market, owing to the low number of key market players in this region. However, the impact of the import and export of raw materials is expected to have little influence over the global active pharmaceutical ingredients market growth over the forecast period.

Segment Analysis

The global active pharmaceutical ingredients market is segmented based on type, application, nature, manufacturing type and region.

Oncology Type Segment Accounts for 21.3% of Market Share

Owing to the high prevalence of cancer in the last few decades, and the disease is expected to affect a higher portion of the population during the forecast period. Key companies are constantly developing new APIs to meet worldwide demand in the oncology segment. For instance, on June 28, 2023, Merck KGaA's North American subsidiary, MilliporeSigma, has opened the doors to its $65 million high-potency active pharmaceutical ingredient (HPAPI) manufacturing plant, which will focus on cancer therapies.

HPAPIs have been discovered to be highly effective at low doses for cell killing, with few side effects for patients. They are currently being employed in innovative cancer therapeutics such as antibody-drug conjugates. As a result, the aforementioned elements contribute to segment growth.

Geographical Analysis

North America Accounted for Approximately 38.4% of the Market Share

The growing prevalence of chronic diseases, as well as increased government incentives to create innovative drugs, characterise the North American market. In addition, the increased adoption of biological pharmaceuticals among patients for the treatment of a variety of chronic illnesses is fuelling demand for the biological API segment in North America.

According to the Alzheimer's Association, roughly 7.5 million persons over the age of 60 in the United States suffer from Alzheimer's dementia, with that number expected to rise to 13 million by 2050. As a result, the rise in such chronic illnesses has fueled the expansion of this market in the North American area.

Competitive Landscape

The major global players in the active pharmaceutical ingredients market include: Aurobindo Pharma, Teva Pharmaceutical Industries Ltd, Pfizer Inc., Novartis AG, BASF SE, Boehringer Ingelheim GmbH, Dr. Reddy's Laboratories Ltd, Lupin Ltd, Mylan NV, Sun Pharmaceutical Industries Ltd among others.

Why Purchase the Report?

To visualize the global active pharmaceutical ingredients market segmentation based on type, application, nature, manufacturing type and region,as well as understand key commercial assets and players.
Identify commercial opportunities by analyzing trends and co-development.
Excel data sheet with numerous data points of active pharmaceutical ingredients market-level with all segments.
PDF report consists of a comprehensive analysis after exhaustive qualitative interviews and an in-depth study.
Product mapping available as excel consisting of key products of all the major players.

The global active pharmaceutical ingredients market report would provide approximately 53 tables, 54 figures and 195 Pages.

Target Audience 2023

Manufacturers/ Buyers
Industry Investors/Investment Bankers
Research Professionals
Emerging Companies

1. Methodology and Scope

1.1. Research Methodology
1.2. Research Objective and Scope of the Report

2. Definition and Overview

3. Executive Summary

3.1. Snippet by Type
3.2. Snippet by Application
3.3. Snippet by Nature
3.4. Snippet by Manufacturing type
3.5. Snippet by Region

4. Dynamics

4.1. Impacting Factors
- 4.1.1. Drivers
  - 4.1.1.1. Rise in the geriatric population around the world
  - 4.1.1.2. The launches of new drugs and approvals
- 4.1.2. Restraints
  - 4.1.2.1. Drug price control policies across various countries
- 4.1.3. Opportunity
  - 4.1.3.1. Rising demand for active pharmaceuticals ingredients
- 4.1.4. Impact Analysis

5. Industry Analysis

5.1. Porter's 5 Forces Analysis
5.2. Supply Chain Analysis
5.3. Pricing Analysis
5.4. Regulatory Analysis

6. COVID-19 Analysis

6.1. Analysis of COVID-19
- 6.1.1. Scenario Before COVID-19
- 6.1.2. Scenario During COVID-19
- 6.1.3. Scenario Post COVID-19
6.2. Pricing Dynamics Amid COVID-19
6.3. Demand-Supply Spectrum
6.4. Government Initiatives Related to the Market During Pandemic
6.5. Manufacturers Strategic Initiatives
6.6. Conclusion

7. Russia Ukraine War Impact Analysis

8. Artificial Intelligence Impact Analysis

9. By Type

9.1. Introduction
- 9.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Type
- 9.1.2. Market Attractiveness Index, By Type
9.2. Synthetic API *
- 9.2.1. Introduction
- 9.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
9.3. Biotech API

10. By Application

10.1. Introduction
- 10.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
- 10.1.2. Market Attractiveness Index, By Application
10.2. Cardiovascular*
- 10.2.1. Introduction
- 10.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
10.3. Diabetes
10.4. Oncology
10.5. Orthopaedics
10.6. Neurology
10.7. NSAIDS
10.8. Others

11. By Nature

11.1. Introduction
- 11.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Nature
- 11.1.2. Market Attractiveness Index, By Nature
11.2. Generic API *
- 11.2.1. Introduction
- 11.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
11.3. Innovator API

12. By Manufacturing type

12.1. Introduction
- 12.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Manufacturing type
- 12.1.2. Market Attractiveness Index, By Manufacturing type
12.2. Captive*
- 12.2.1. Introduction
- 12.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
12.3. Merchant

13. By Region

13.1. Introduction
- 13.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Region
- 13.1.2. Market Attractiveness Index, By Region
13.2. North America
- 13.2.1. Introduction
- 13.2.2. Key Region-Specific Dynamics
- 13.2.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Type
- 13.2.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
- 13.2.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Nature
- 13.2.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Manufacturing type
- 13.2.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
  - 13.2.7.1. U.S.
  - 13.2.7.2. Canada
  - 13.2.7.3. Mexico
13.3. Europe
- 13.3.1. Introduction
- 13.3.2. Key Region-Specific Dynamics
- 13.3.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Type
- 13.3.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
- 13.3.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Nature
- 13.3.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Manufacturing type
- 13.3.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
  - 13.3.7.1. Germany
  - 13.3.7.2. U.K.
  - 13.3.7.3. France
  - 13.3.7.4. Spain
  - 13.3.7.5. Italy
  - 13.3.7.6. Rest of Europe
13.4. South America
- 13.4.1. Introduction
- 13.4.2. Key Region-Specific Dynamics
- 13.4.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Type
- 13.4.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
- 13.4.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Nature
- 13.4.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Manufacturing type
- 13.4.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
  - 13.4.7.1. Brazil
  - 13.4.7.2. Argentina
  - 13.4.7.3. Rest of South America
13.5. Asia-Pacific
- 13.5.1. Introduction
- 13.5.2. Key Region-Specific Dynamics
- 13.5.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Type
- 13.5.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
- 13.5.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Nature
- 13.5.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Manufacturing type
- 13.5.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
  - 13.5.7.1. China
  - 13.5.7.2. India
  - 13.5.7.3. Japan
  - 13.5.7.4. Australia
  - 13.5.7.5. Rest of Asia-Pacific
13.6. Middle East and Africa
- 13.6.1. Introduction
- 13.6.2. Key Region-Specific Dynamics
- 13.6.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Type
- 13.6.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
- 13.6.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Nature
- 13.6.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Manufacturing type

14. Competitive Landscape

14.1. Competitive Scenario
14.2. Market Positioning/Share Analysis
14.3. Mergers and Acquisitions Analysis

15. Company Profiles

15.1. Aurobindo Pharma*
- 15.1.1. Company Overview
- 15.1.2. Product Portfolio and Description
- 15.1.3. Financial Overview
- 15.1.4. Key Developments
15.2. Teva Pharmaceutical Industries Ltd
15.3. Pfizer Inc.
15.4. Novartis AG
15.5. BASF SE
15.6. Boehringer Ingelheim GmbH
15.7. Dr. Reddy's Laboratories Ltd
15.8. Lupin Ltd
15.9. Mylan NV
15.10. Sun Pharmaceutical Industries Ltd.

LIST NOT EXHAUSTIVE

16. Appendix

16.1. About Us and Services
16.2. Contact Us

세계의 API(원료의약품) 시장(2023-2030년)

Global Active Pharmaceutical Ingredients Market - 2023-2030

시장 개요

시장 역학

제조 절차의 증가로 시장 성장 견인

기술 발전으로 인한 원료의약품 생산이 시장 성장 촉진

높은 제조 비용이 시장 성장에 걸림돌로 작용

COVID-19 영향 분석

러시아-우크라이나 분쟁의 영향 분석

목차

제1장 조사 방법과 조사 범위

제2장 정의와 개요

제3장 주요 요약

제4장 시장 역학

제5장 산업 분석

제6장 COVID-19 분석

제7장 러시아·우크라이나 전쟁 영향 분석

제8장 인공지능 영향 분석

제9장 유형별

제10장 용도별

제11장 성질별

제12장 제조 유형별

제13장 지역별

제14장 경쟁 상황

제15장 기업 개요

제16장 부록