세계의 원료의약품(API) 시장 전망(-2030년) : 의약품 유형, 제조업체 유형, API 유형, 용도, 최종 사용자, 지역별 분석

According to Stratistics MRC, the Global Active Pharmaceutical Ingredients Market is accounted for $163.75 billion in 2023 and is expected to reach $323.19 billion by 2030 growing at a CAGR of 10.2% during the forecast period. The essential elements of pharmaceuticals that result in the desired therapeutic effect are known as active pharmaceutical ingredients, or APIs. These chemicals go through rigorous testing and are approved by the government before being used in pharmaceutical formulations. APIs can come from a range of processes, such as fermentation, natural resource isolation, or synthetic processes. Their potency, stability, and purity are essential for guaranteeing the final drug product's safety and effectiveness.

According to the World Health Organization (WHO), access to essential medicines, including Active Pharmaceutical Ingredients (APIs), is a fundamental human right, essential for achieving the highest attainable standard of health.

Market Dynamics:

Driver:

Growing need for prescription drugs

Generic pharmaceutical companies are seeing an opening to enter the market with less expensive alternatives as a result of branded drug patents expiring. The substantial cost savings that generic medications provide to patients and healthcare systems encourage their widespread use. Generic versions of previously patented drugs are being allowed to enter the market thanks to regulatory pathways for approval, such as the US Abbreviated New Drug Applications (ANDAs). Furthermore, when affordable generic substitutes are available, the use of them is encouraged by generic drug substitution policies put in place by healthcare payers and providers.

Restraint:

Price decline and cost constraints

API manufacturers frequently face margin pressure and price erosion as a result of the fierce competition in the pharmaceutical industry, especially in the generic drug segment. Prices are trending lower as a result of price competition between buyers and sellers, industry consolidation, and government programs to control healthcare costs. Additionally, in order to stay profitable in the face of price pressure, API manufacturers need to constantly improve their operations, increase efficiency, and look into ways to cut costs.

Opportunity:

Growth of customized health care

API producers can greatly benefit from personalized medicine strategies, which center on adjusting medical care to the unique needs of each patient. The development of more effective and less side-effect-prone targeted therapies is made possible by developments in genomic sequencing, biomarker identification, and data analytics. Furthermore, personalized medicine applications may employ targeted therapeutics, gene editing technologies, and companion diagnostics as APIs. To create and produce customized medical products, API manufacturers can work with pharmaceutical, diagnostic, and healthcare organizations.

Threat:

Strong rivalry and pricing pressure

There is fierce competition in the API manufacturing sector, both nationally and internationally. As a result of competition among manufacturers for market share, margins are compressed and prices are eroded. In the generic API market, where businesses mainly compete on price, this pressure is especially intense. Moreover, the existence of low-cost manufacturers in areas with cheaper labor and production costs heightens competition, making it difficult for businesses to continue growing and remaining profitable.

Covid-19 Impact:

The COVID-19 pandemic has caused significant disruptions in the pharmaceutical supply chain and has had a significant effect on the API market. Production delays and supply chain bottlenecks have resulted from disruptions in manufacturing operations caused by lockdown measures, travel restrictions, and workforce shortages. The demand for vital drugs, like steroids, antibiotics, and antivirals, has increased. This has put pressure on supply chains and made shortages of finished dosage forms and vital APIs worse. Additionally, pharmaceutical companies have encountered difficulties in locating raw materials, shipping products, and preserving business continuity in the face of uncertainties brought on by pandemics.

The Branded or Innovative Prescription Drugs segment is expected to be the largest during the forecast period

In the Active Pharmaceutical Ingredients (API) market, the branded or innovative prescription drug segment is projected to hold the largest share. Novel compounds and intricate synthesis procedures are in high demand since branded prescription medications frequently need unique and proprietary APIs. One reason for these medications' higher market value and share is that they usually go through lengthy clinical trials, regulatory approval procedures, and research and development before going on sale. Furthermore, to fill gaps in the medical field and set themselves apart from competitors, pharmaceutical companies heavily invest in the development of novel therapies.

The Oncology segment is expected to have the highest CAGR during the forecast period

It is projected that the market for active pharmaceutical ingredients (APIs) will have the highest CAGR in the oncology segment. Due to the rising global incidence of cancer and the ongoing development of novel cancer therapies, oncology APIs are in high demand. The APIs utilized in the treatment of solid tumors and hematologic malignancies fall under the category of oncology. Moreover, novel cancer treatments that rely on specific APIs have been developed as a result of advancements in molecular biology, targeted therapies, and immunotherapy.

Region with largest share:

It is projected that the market for active pharmaceutical ingredients (APIs) will hold the largest share in the North American region. Many factors contribute to this region's dominance, such as a strong pharmaceutical industry, large investments in R&D, sophisticated manufacturing infrastructure, and strict regulatory requirements. Additionally, North America is the market leader due in part to the existence of top pharmaceutical companies, contract manufacturing organizations (CMOs), and API manufacturers. Demand for APIs used in prescription medications is further driven by the region's large patient population, high healthcare expenditures, and advantageous reimbursement policies.

Region with highest CAGR:

It is anticipated that the market for active pharmaceutical ingredients (APIs) will grow at the highest CAGR in Europe. A robust regulatory framework, sophisticated manufacturing capabilities, and a well-established pharmaceutical industry are some of the factors propelling the growth of the API market in Europe. The area gains from a strong ecosystem for research and development, which promotes creativity and the creation of cutting-edge medication treatments that depend on specialized APIs. Furthermore, the emphasis Europe has placed on affordable and accessible healthcare, along with the growing need for generic drugs, all support the growth of the API market.

Key players in the market

Some of the key players in Active Pharmaceutical Ingredients market include BASF SE, Dr. Reddy's Laboratories Ltd, Cambrex Corporation, Abbott, Cipla Inc., GlaxoSmithKline plc, Amgen Inc., Merck & Co., Inc., AbbVie, Inc., Mylan N.V., Bausch Health Companies Inc., Eli Lilly and Company, Biocon Ltd., Johnson & Johnson Private Limited, AstraZeneca, Takeda Pharmaceutical Company Limited, Novartis AG, Teva Pharmaceutical Industries Ltd., Sun Pharmaceutical Industries Ltd and Pfizer, Inc.

Key Developments:

In April 2024, BASF signed a 25-year power purchase agreement (PPA) with China Energy Engineering Group Guangdong Electric Power Design Institute Co., Ltd. (GEDI) to purchase renewable electricity for its Zhanjiang Verbund site. The PPA is a further step in the renewable energy partnership between BASF and GEDI following the Letter of Intent (LOI).

In March 2024, Dr. Reddy's Laboratories said that it has entered into a license agreement with Pharmazz Inc. to commercialise the first-in-class innovative drug Centhaquine in India. Pharmazz is a U.S. based biopharmaceutical company developing and commercializing drug products to treat critically ill patients.

In September 2023, Abbott has entered a definitive agreement for the acquisition of Bigfoot Biomedical, which develops smart insulin management systems for individuals with diabetes. Together, the companies have worked on connected diabetes solutions since 2017.

Drug Types Covered:

• Branded or Innovative Prescription Drugs
• Generic Prescription Drugs
• Over-the-counter (OTC) Drugs
• Other Drug Types

Manufacturer Types Covered:

• In House Manufacturing
• Contract Manufacturing
• Other Manufacturer Types

API Types Covered:

• Synthetic
• Biological
• Plant Extracts
• Other API Types

Applications Covered:

• Anti-infective
• Cardiovascular
• Metabolic Disorder
• Respiratory
• Ophthalmology
• Neurology
• Oncology
• Other Applications

End Users Covered:

• Pharmaceutical & Biotechnological Industry
• CROs
• CMOs
• Other End Users

Regions Covered:

• North America
  • US
  • Canada
  • Mexico
• Europe
  • Germany
  • UK
  • Italy
  • France
  • Spain
  • Rest of Europe
• Asia Pacific
  • Japan
  • China
  • India
  • Australia
  • New Zealand
  • South Korea
  • Rest of Asia Pacific
• South America
  • Argentina
  • Brazil
  • Chile
  • Rest of South America
• Middle East & Africa
  • Saudi Arabia
  • UAE
  • Qatar
  • South Africa
  • Rest of Middle East & Africa

What our report offers:

• Market share assessments for the regional and country-level segments
• Strategic recommendations for the new entrants
• Covers Market data for the years 2021, 2022, 2023, 2026, and 2030
• Market Trends (Drivers, Constraints, Opportunities, Threats, Challenges, Investment Opportunities, and recommendations)
• Strategic recommendations in key business segments based on the market estimations
• Competitive landscaping mapping the key common trends
• Company profiling with detailed strategies, financials, and recent developments
• Supply chain trends mapping the latest technological advancements

Free Customization Offerings:

All the customers of this report will be entitled to receive one of the following free customization options:

• Company Profiling
  • Comprehensive profiling of additional market players (up to 3)
  • SWOT Analysis of key players (up to 3)
• Regional Segmentation
  • Market estimations, Forecasts and CAGR of any prominent country as per the client's interest (Note: Depends on feasibility check)
• Competitive Benchmarking
  • Benchmarking of key players based on product portfolio, geographical presence, and strategic alliances

Table of Contents

1 Executive Summary

2 Preface

• 2.1 Abstract
• 2.2 Stake Holders
• 2.3 Research Scope
• 2.4 Research Methodology
  • 2.4.1 Data Mining
  • 2.4.2 Data Analysis
  • 2.4.3 Data Validation
  • 2.4.4 Research Approach
• 2.5 Research Sources
  • 2.5.1 Primary Research Sources
  • 2.5.2 Secondary Research Sources
  • 2.5.3 Assumptions

3 Market Trend Analysis

• 3.1 Introduction
• 3.2 Drivers
• 3.3 Restraints
• 3.4 Opportunities
• 3.5 Threats
• 3.6 Application Analysis
• 3.7 End User Analysis
• 3.8 Emerging Markets
• 3.9 Impact of Covid-19

4 Porters Five Force Analysis

• 4.1 Bargaining power of suppliers
• 4.2 Bargaining power of buyers
• 4.3 Threat of substitutes
• 4.4 Threat of new entrants
• 4.5 Competitive rivalry

5 Global Active Pharmaceutical Ingredients Market, By Drug Type

• 5.1 Introduction
• 5.2 Branded or Innovative Prescription Drugs
• 5.3 Generic Prescription Drugs
• 5.4 Over-the-counter (OTC) Drugs
• 5.5 Other Drug Types

6 Global Active Pharmaceutical Ingredients Market, By Manufacturer Type

• 6.1 Introduction
• 6.2 In House Manufacturing
• 6.3 Contract Manufacturing
• 6.4 Other Manufacturer Types

7 Global Active Pharmaceutical Ingredients Market, By API Type

• 7.1 Introduction
• 7.2 Synthetic
• 7.3 Biological
• 7.4 Plant Extracts
• 7.5 Other API Types

8 Global Active Pharmaceutical Ingredients Market, By Application

• 8.1 Introduction
• 8.2 Anti-infective
• 8.3 Cardiovascular
• 8.4 Metabolic Disorder
• 8.5 Respiratory
• 8.6 Ophthalmology
• 8.7 Neurology
• 8.8 Oncology
• 8.9 Other Applications

9 Global Active Pharmaceutical Ingredients Market, By End User

• 9.1 Introduction
• 9.2 Pharmaceutical & Biotechnological Industry
• 9.3 CROs
• 9.4 CMOs
• 9.5 Other End Users

10 Global Active Pharmaceutical Ingredients Market, By Geography

• 10.1 Introduction
• 10.2 North America
  • 10.2.1 US
  • 10.2.2 Canada
  • 10.2.3 Mexico
• 10.3 Europe
  • 10.3.1 Germany
  • 10.3.2 UK
  • 10.3.3 Italy
  • 10.3.4 France
  • 10.3.5 Spain
  • 10.3.6 Rest of Europe
• 10.4 Asia Pacific
  • 10.4.1 Japan
  • 10.4.2 China
  • 10.4.3 India
  • 10.4.4 Australia
  • 10.4.5 New Zealand
  • 10.4.6 South Korea
  • 10.4.7 Rest of Asia Pacific
• 10.5 South America
  • 10.5.1 Argentina
  • 10.5.2 Brazil
  • 10.5.3 Chile
  • 10.5.4 Rest of South America
• 10.6 Middle East & Africa
  • 10.6.1 Saudi Arabia
  • 10.6.2 UAE
  • 10.6.3 Qatar
  • 10.6.4 South Africa
  • 10.6.5 Rest of Middle East & Africa

11 Key Developments

• 11.1 Agreements, Partnerships, Collaborations and Joint Ventures
• 11.2 Acquisitions & Mergers
• 11.3 New Product Launch
• 11.4 Expansions
• 11.5 Other Key Strategies

12 Company Profiling

• 12.1 BASF SE
• 12.2 Dr. Reddy's Laboratories Ltd
• 12.3 Cambrex Corporation
• 12.4 Abbott
• 12.5 Cipla Inc.
• 12.6 GlaxoSmithKline plc
• 12.7 Amgen Inc.
• 12.8 Merck & Co., Inc.
• 12.9 AbbVie, Inc.
• 12.10 Mylan N.V.
• 12.11 Bausch Health Companies Inc.
• 12.12 Eli Lilly and Company
• 12.13 Biocon Ltd.
• 12.14 Johnson & Johnson Private Limited
• 12.15 AstraZeneca
• 12.16 Takeda Pharmaceutical Company Limited
• 12.17 Novartis AG
• 12.18 Teva Pharmaceutical Industries Ltd.
• 12.19 Sun Pharmaceutical Industries Ltd
• 12.20 Pfizer, Inc.