원료의약품 시장 : 합성, 역가, 제조사, 유형, 약물, 용도, 지역별, 기회 및 예측(2017-2031년)

Global active pharmaceutical ingredient market size was valued at USD 211.75 billion in 2023, expected to reach USD 369.3 billion in 2031, with a CAGR of 7.2% for the forecast period between 2024 and 2031F. The global active pharmaceutical ingredient market is influenced by factors such as rising pharmaceutical demand, growing incidence of chronic illnesses, widespread adoption of biotechnology and biopharmaceuticals, thriving market for generic drugs, and advancements in technologies like artificial intelligence.

The global active pharmaceutical ingredient market functions as the fundamental pillar of the pharmaceutical sector, providing the essential components required for the formulation and manufacturing of crucial medicines, which are indispensable for enhancing and maintaining global health standards. With the healthcare landscape evolving continuously, the active pharmaceutical ingredient (API) market's significance grows more pronounced. The global active pharmaceutical ingredient market is predominantly led by Asia-Pacific, with India and China at the forefront, benefiting from cost advantages and a highly skilled workforce. In contrast, North America and Europe remain significant API consumers, largely due to their thriving pharmaceutical industries.

Global active pharmaceutical ingredient market is greatly influenced by rising demand for pharmaceuticals, largely driven by aging populations and emerging markets striving to improve healthcare accessibility. The utilization of biotechnology and biopharmaceuticals has amplified the request for biologically derived APIs, primarily due to their inventive and precise therapeutic applications. The expiration of patents for blockbuster drugs continues to energize the generic drug sector, which heavily depends on APIs to achieve cost-effective production. Meanwhile, artificial intelligence (AI) and other technological advancements are ushering in a transformation in drug research, development, and production, enhancing the efficiency and cost-effectiveness of APIs, leading to growth in the global active pharmaceutical ingredient market.

Increasing Global Demand for Pharmaceuticals

Shifting demographics, particularly the aging of populations across various regions, contribute significantly to the heightened need for healthcare interventions, consequently driving pharmaceutical demand upwards. Additionally, the rising prevalence of chronic diseases, often linked to shifts in lifestyle and urbanization, amplifies the requirement for medications aimed at managing and treating these health issues. With expanding economies and improved healthcare accessibility, more individuals can afford and access essential medications, thereby further stimulating the global pharmaceutical market.

Furthermore, the persistent pursuit of groundbreaking therapies and treatments, coupled with the rapid expansion of biotechnology and personalized medicine, sustains a continuous demand for pharmaceutical products. The demand encompasses traditional drugs and extends to biopharmaceuticals and novel therapeutic approaches, thus broadening the pharmaceutical market's scope. In essence, the mounting global demand for pharmaceuticals results from an intricate interplay among demographic, economic, and technological factors, with healthcare requirements standing as the central driver of the burgeoning trend.

Technological Progress is Propelling the Market Forward

Breakthroughs in cutting-edge technologies like Artificial Intelligence (AI) and Machine Learning (ML) are instigating a profound transformation in the production of active pharmaceutical ingredients (APIs). Within the global active pharmaceutical ingredient market, AI and ML systems are increasingly harnessed for their capacity to streamline processes, minimize errors, and augment operational efficiency. These innovations enable real-time monitoring and predictive analytics, thereby facilitating manufacturers in maintaining consistent quality and yield standards. By scrutinizing extensive datasets and recognizing underlying patterns, AI and ML algorithms contribute to developing more effective and precise production methodologies that indirectly boost the global active pharmaceutical ingredient market.

As an incidence of AI and ML's impact, a recent study, featured in a publication of May 2023 of Nature Communications, authored by MIT and Takeda researchers, introduced a groundbreaking approach that combines physics principles with machine learning to classify the irregular surfaces characterizing particles within mixtures. Employing a physics-enhanced autocorrelation-based estimator (PEACE), the technique can potentially revolutionize pharmaceutical manufacturing processes for tablets and powders. It promises heightened efficiency, precision, and a reduction in the occurrence of failed batches, thereby elevating the overall productivity and accuracy of pharmaceutical product manufacturing.

Government Initiatives

Governments worldwide are implementing a range of strategies to attain self-reliance in active pharmaceutical ingredient (API) production, boosting growth in the global active pharmaceutical ingredient market. The strategic endeavor stems from acknowledging the pivotal role APIs play in ensuring a steady supply of essential medications, particularly during global crises, like the COVID-19 pandemic. Governments are actively promoting the growth of domestic API manufacturing capabilities to reduce reliance on foreign sources, fortify national healthcare security, and mitigate potential vulnerabilities in the supply chain. These efforts often encompass investments in research and development, providing incentives for domestic production, streamlining regulatory procedures, and fostering collaboration between public and private sectors to bolster the resilience and capacity of domestic API production.

For instance, in March 2023, a minister of Canada unveiled a federal investment initiative to boost the country's capability to research and produce essential medications. The initiative, backed by over USD 80.5 million in federal funding and based in Edmonton, will empower emerging pharmaceutical companies to introduce new products to the market and cultivate talent in Alberta's life sciences sector. The Canadian Critical Drug Initiative is designed to augment Canada's manufacturing capacity and supply chain, thus reducing the nation's reliance on foreign sources for active pharmaceutical ingredients. Simultaneously, it supports the commercialization of crucial medicines, contributing to healthcare self-sufficiency.

High Demand for HPAPIs

The demand for High Potency Active Pharmaceutical Ingredients (HPAPIs) is substantial in the global active pharmaceutical ingredient market due to their pivotal role in pharmaceutical formulations. Approximately one-quarter of pharmaceutical drugs worldwide feature HPAPIs, recognized for their exceptional effectiveness. HPAPIs are compounds that demonstrate potent pharmacological activity at low concentrations, making them indispensable for addressing intricate health conditions like cancer and autoimmune disorders. Their precision and strength enable precise therapeutic targeting, reducing adverse effects while optimizing treatment outcomes.

Given their fundamental contribution to contemporary healthcare, the demand for HPAPIs remains robust, as researchers and pharmaceutical firms continuously explore their potential for innovating advanced and highly efficacious medicines. For instance, in July 2023, Evonik and Heraeus Precious Metals joined hands to broaden their respective portfolios of services pertaining to highly potent active pharmaceutical ingredients (HPAPIs). The collaboration harnesses unique HPAPI expertise of both firms to deliver a comprehensive solution, spanning from the early preclinical phases to full-scale commercial production. The integrated offering includes a seamless transition between small-scale and large-scale manufacturing processes, enabling a more efficient and versatile approach to HPAPI development and production.

Growing Demand for Therapeutic Enzymes

The global active pharmaceutical ingredient market is witnessing a notable increase in the demand for APIs that rely on enzymes. Enzymes are crucial in formulating pharmaceuticals by facilitating targeted drug delivery and improving therapeutic effectiveness. The upsurge in demand is driven by several factors, including the growing adoption of biotechnology in drug research, the emergence of precision medicine, and the pharmaceutical industry's increasing emphasis on sustainable and eco-friendly manufacturing practices. Enzyme-based APIs offer significant benefits like precise action, reduced side effects, and environmentally conscious production methods. Consequently, they have become an essential component in developing cutting-edge pharmaceuticals, effectively addressing both therapeutic requirements and sustainability objectives within the evolving pharmaceutical sector. For instance, in October 2022, Gingko Bioworks unveiled a partnership with Merck, with the goal of enhancing the production of active pharmaceutical ingredients. The initiative involves the genetic engineering of potentially four enzymes to serve as biocatalysts in Merck's API production endeavors.

Future Market Scenario

The global active pharmaceutical ingredient market's future is characterized by optimistic growth prospects driven by several key factors. To begin with, the pharmaceutical industry's dedication to innovation and substantial investments in research and development are poised to stimulate the demand for specialized APIs. The trend is particularly pertinent as pursuing precision medicine and targeted therapies gains traction, necessitating novel APIs with unique attributes.

Additionally, sustainability will be pivotal in shaping the API market's trajectory. The adoption of green chemistry practices and eco-friendly production methods aligns with global environmental initiatives and resonates with a growing number of environmentally conscious consumers and regulatory bodies. Furthermore, cultivating international collaborations and partnerships will provide access to diverse markets and resources, thereby augmenting the API market's growth potential. To summarize, the bright future of the API market hinges on innovation, sustainability, regulatory compliance, and robust supply chain strategies.

Key Players Landscape and Outlook

Prominent pharmaceutical firms are progressively joining forces to produce APIs. The cooperative initiative is geared towards boosting operational efficiency, cost reduction, and expediting the creation of vital drugs. These corporations can consolidate their capabilities, simplify manufacturing procedures, and secure a consistent API supply through the exchange of resources, research findings, and expertise.

Furthermore, such partnerships help them lessen the vulnerabilities linked to depending solely on one supplier, thus reinforcing their adaptability when confronted with unexpected difficulties. Ultimately, these collaborations play a crucial role in advancing the global active pharmaceutical ingredient market, ensuring the availability of essential medications, and improving patient access to life-saving treatments.

A recent example involved the cooperation of four companies in July 2022, to offer a dedicated service for the rapid development of mobile units for API production, known as the Production Intelligente de Principes Actifs (PIPAc) project. The initiative aims to streamline the complex and lengthy supply chains associated with API production. PIPAc encompasses synthesis, continuous flow chemistry, in-flow analysis, and leverages artificial intelligence (AI) to design efficient production units equipped with autonomous capabilities.

Table of Contents

1. Research Methodology

2. Project Scope & Definitions

3. Executive Summary

4. Global Active Pharmaceutical Ingredient Market Outlook, 2017-2031F

• 4.1. Market Size & Forecast
  • 4.1.1. Value
  • 4.1.2. Volume
• 4.2. By Synthesis
  • 4.2.1. Biotech
    • 4.2.1.1. Monoclonal Antibodies
    • 4.2.1.2. Hormones
    • 4.2.1.3. Cytokines
    • 4.2.1.4. Recombinant Proteins
    • 4.2.1.5. Therapeutic Enzymes
    • 4.2.1.6. Vaccines
    • 4.2.1.7. Blood Factors
  • 4.2.2. Synthetic
• 4.3. By Potency
  • 4.3.1. Traditional API
  • 4.3.2. HPAPI
• 4.4. By Manufacturer
  • 4.4.1. Captive APIs
  • 4.4.2. Merchant APIs
• 4.5. By Type
  • 4.5.1. Generic APIs
  • 4.5.2. Innovative APIs
• 4.6. By Drugs
  • 4.6.1. Prescription Drugs
  • 4.6.2. Over-the-counter Drugs
• 4.7. By Usage
  • 4.7.1. Clinical
  • 4.7.2. Research
• 4.8. By Application
  • 4.8.1. Cardiovascular Diseases
  • 4.8.2. Oncology
  • 4.8.3. CNS and Neurology
  • 4.8.4. Orthopedic
  • 4.8.5. Endocrinology
  • 4.8.6. Pulmonology
  • 4.8.7. Gastroenterology
  • 4.8.8. Nephrology
  • 4.8.9. Ophthalmology
  • 4.8.10. Communicable Diseases
  • 4.8.11. Diabetes
  • 4.8.12. Pain Management
  • 4.8.13. Others
• 4.9. By Region
  • 4.9.1. North America
  • 4.9.2. Europe
  • 4.9.3. South America
  • 4.9.4. Asia-Pacific
  • 4.9.5. Middle East and Africa
• 4.10. By Company Market Share (%), 2023

5. Global Active Pharmaceutical Ingredient Market Outlook, By Region, 2017-2031F

• 5.1. North America*
  • 5.1.1. Market Size & Forecast
    • 5.1.1.1. Value
    • 5.1.1.2. Volume
  • 5.1.2. By Synthesis
    • 5.1.2.1. Biotech
    • 5.1.2.1.1. Monoclonal Antibodies
    • 5.1.2.1.2. Hormones
    • 5.1.2.1.3. Cytokines
    • 5.1.2.1.4. Recombinant Proteins
    • 5.1.2.1.5. Therapeutic Enzymes
    • 5.1.2.1.6. Vaccines
    • 5.1.2.1.7. Blood Factors
    • 5.1.2.2. Synthetic
  • 5.1.3. By Potency
    • 5.1.3.1. Traditional API
    • 5.1.3.2. HPAPI
  • 5.1.4. By Manufacturer
    • 5.1.4.1. Captive APIs
    • 5.1.4.2. Merchant APIs
  • 5.1.5. By Type
    • 5.1.5.1. Generic APIs
    • 5.1.5.2. Innovative APIs
  • 5.1.6. By Drugs
    • 5.1.6.1. Prescription Drugs
    • 5.1.6.2. Over-the-counter Drugs
  • 5.1.7. By Usage
    • 5.1.7.1. Clinical
    • 5.1.7.2. Research
  • 5.1.8. By Application
    • 5.1.8.1. Cardiovascular Diseases
    • 5.1.8.2. Oncology
    • 5.1.8.3. CNS and Neurology
    • 5.1.8.4. Orthopedic
    • 5.1.8.5. Endocrinology
    • 5.1.8.6. Pulmonology
    • 5.1.8.7. Gastroenterology
    • 5.1.8.8. Nephrology
    • 5.1.8.9. Ophthalmology
    • 5.1.8.10. Communicable Diseases
    • 5.1.8.11. Diabetes
    • 5.1.8.12. Pain Management
    • 5.1.8.13. Others
  • 5.1.9. United States*
    • 5.1.9.1. Market Size & Forecast
    • 5.1.9.1.1. Value
    • 5.1.9.1.2. Volume
    • 5.1.9.2. By Synthesis
    • 5.1.9.2.1. Biotech
    • 5.1.9.2.1.1. Monoclonal Antibodies
    • 5.1.9.2.1.2. Hormones
    • 5.1.9.2.1.3. Cytokines
    • 5.1.9.2.1.4. Recombinant Proteins
    • 5.1.9.2.1.5. Therapeutic Enzymes
    • 5.1.9.2.1.6. Vaccines
    • 5.1.9.2.1.7. Blood Factors
    • 5.1.9.2.2. Synthetic
    • 5.1.9.3. By Potency
    • 5.1.9.3.1. Traditional API
    • 5.1.9.3.2. HPAPI
    • 5.1.9.4. By Manufacturer
    • 5.1.9.4.1. Captive APIs
    • 5.1.9.4.2. Merchant APIs
    • 5.1.9.5. By Type
    • 5.1.9.5.1. Generic APIs
    • 5.1.9.5.2. Innovative APIs
    • 5.1.9.6. By Drugs
    • 5.1.9.6.1. Prescription Drugs
    • 5.1.9.6.2. Over-the-counter Drugs
    • 5.1.9.7. By Usage
    • 5.1.9.7.1. Clinical
    • 5.1.9.7.2. Research
    • 5.1.9.8. By Application
    • 5.1.9.8.1. Cardiovascular Diseases
    • 5.1.9.8.2. Oncology
    • 5.1.9.8.3. CNS and Neurology
    • 5.1.9.8.4. Orthopedic
    • 5.1.9.8.5. Endocrinology
    • 5.1.9.8.6. Pulmonology
    • 5.1.9.8.7. Gastroenterology
    • 5.1.9.8.8. Nephrology
    • 5.1.9.8.9. Ophthalmology
    • 5.1.9.8.10. Communicable Diseases
    • 5.1.9.8.11. Diabetes
    • 5.1.9.8.12. Pain Management
    • 5.1.9.8.13. Others
  • 5.1.10. Canada
  • 5.1.11. Mexico

All segments will be provided for all regions and countries covered:

• 5.2. Europe
  • 5.2.1. Germany
  • 5.2.2. France
  • 5.2.3. Italy
  • 5.2.4. United Kingdom
  • 5.2.5. Russia
  • 5.2.6. Netherlands
  • 5.2.7. Spain
  • 5.2.8. Turkey
  • 5.2.9. Poland
• 5.3. South America
  • 5.3.1. Brazil
  • 5.3.2. Argentina
• 5.4. Asia-Pacific
  • 5.4.1. India
  • 5.4.2. China
  • 5.4.3. Japan
  • 5.4.4. Australia
  • 5.4.5. Vietnam
  • 5.4.6. South Korea
  • 5.4.7. Indonesia
  • 5.4.8. Philippines
• 5.5. Middle East & Africa
  • 5.5.1. Saudi Arabia
  • 5.5.2. UAE
  • 5.5.3. South Africa

6. Market Mapping, 2023

• 6.1. Synthesis
• 6.2. Potency
• 6.3. Manufacturer
• 6.4. Type
• 6.5. Drug
• 6.6. Usage
• 6.7. Application
• 6.8. By Region

7. Macro Environment and Industry Structure

• 7.1. Supply Demand Analysis
• 7.2. Import Export Analysis
• 7.3. 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 and 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 %, 2023)
• 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. Abbvie, Inc.
• 13.3. Novartis AG
• 13.4. Sanofi S.A.
• 13.5. F. Hoffmann-La Roche AG
• 13.6. Bristol-Myers Squibb Company
• 13.7. Merck & Co., Inc.
• 13.8. GlaxoSmithKline plc.
• 13.9. AstraZeneca plc
• 13.10. Eli Lilly International Corp.
• 13.11. Teva Pharmaceutical Industries Ltd.
• 13.12. Boehringer Ingelheim International GmbH
• 13.13. Johnson & Johnson Services, Inc.

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