고효능 원료의약품(HPAPI) 시장 예측(-2030년) : 제품별, 제조업체별, 약물 유형별, 용도별, 지역별 세계 분석

According to Stratistics MRC, the Global High Potency Active Pharmaceutical Ingredient (HPAPI) Market is accounted for $34.51 billion in 2024 and is expected to reach $67.02 billion by 2030 growing at a CAGR of 11.7% during the forecast period. High potency active pharmaceutical ingredients are biologically active compounds that exhibit biological activity at extremely low dose levels. After the human genome was depicted, cancer drugs were produced not only for distinct cancer but also for different patients. The global high potency active ingredient is classified as Generic HPAPI and Innovative HPAPI. The generic HPAPI involve the same chemical agent as a drug that was once secured by chemical patent claims Whereas, Innovative HPAPI involves different chemical molecule.

According to the Alzheimer's Association, roughly 6.2 Million people in the United States over the age of 65 have Alzheimer's dementia, with the number expected to rise to 12.7 Million by 2050.

Market Dynamics:

Driver:

Increasing incidence of cancer

HPAPIs are extremely effective pharmacologically active ingredients. They are highly specific in their action and offer significant efficiency even at low daily therapeutic doses. HPAPIs have the ability to target precise disease cells and are, hence, used in formulations for highly potent drugs. Owing to their target release characteristics, HPAPIs find major applications in target therapies for cancer. Globally, there is a significant growth in the incidence of cancer. This growth in the number of cancer cases has a tremendous impact on the sales of cancer drugs across the globe.

Restraint:

Large initial investments

The cytotoxic nature of HPAPIs presents significant handling challenges and thus requires heavy investments for implementing specialized containment facilities that facilitate the safety of employees from exposure. Although the HPAPIs market is an emerging and growing market, pharmaceutical manufacturers face significant challenges in upgrading their existing facilities that are capable of handling only low- or medium-potency APIs. Contract manufacturers are required to heavily invest in building new facilities that are designed specifically for HPAPI manufacturing apart from the usual GMP production facilities.

Opportunity:

Developments in emerging regions

Developing economies such as India, China, and the Middle East presents high growth opportunities for players in the HPAPIs market. In most of these geographies, the market is expected to show a high growth rate in the coming years owing to their huge population, increasing prosperity, and improving longevity. Diseases like musculoskeletal diseases, glaucoma, and specifically cancer have a significant impact on the health status of people worldwide, with comparatively higher growth rates in developing countries.

Threat:

Continual evolution of industry standards

One of the major challenges faced by the players in this market, especially CMOs that offer HPAPI manufacturing services, is the continual evolution of industry standards, technologies, and regulations. Companies that are willing to enter this marker are required to adopt these newer technologies, which generally translates to huge investments. For instance, SAFC (US) had to upgrade its HPAPI manufacturing facility in the US to include more robust analytical technologies with improved sensitivity and detection levels that allow for the determination of potential API carryover at part-per-billion levels.

Covid-19 Impact:

The COVID-19 pandemic significantly impacted the high-potency active pharmaceutical ingredient (HPAPI) market. The surge in demand for effective treatments and vaccines led to increased investment and production capacity in the pharmaceutical sector, including HPAPIs. Supply chain disruptions and lockdown measures initially posed challenges, causing delays and shortages. However, the crisis also accelerated technological advancements and regulatory approvals, fostering innovation and efficiency in HPAPI manufacturing.

The oncology segment is expected to be the largest during the forecast period

The oncology segment has the largest share of the market because of the greater amount of HPAPIs found in oncology drugs. The rising prevalence of cancer is a major factor driving up demand for HPAPI. And also, some of the factors like rising demand for cancer and initiate of recent target therapy are the main cause of the increase in the development of oncology as compared to other therapeutic applications such as hormonal disorder and glaucoma.

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

The synthetic HPAPI market is growing at a faster rate because, at very low doses, these molecules are very effective in the treatment of a variety of diseases. Many synthetic molecules are also predicted to lose their patents in the years ahead, boosting market growth. The Japanese government has been advocating for the utilize of generic medicines in lowering the overall healthcare costs and the economic burden placed on patients

Region with largest share:

North America is projected to hold the largest market share in the High Potency Active Pharmaceutical Ingredient (HPAPI) market due to its advanced pharmaceutical infrastructure, stringent regulatory standards, and significant investments in R&D. The presence of key pharmaceutical companies and contract manufacturing organizations (CMOs) in the region further drives market growth. Additionally, the increasing prevalence of chronic diseases and the demand for targeted cancer therapies boost the need for HPAPIs, reinforcing North America's leading position in the market.

Region with highest CAGR:

Asia Pacific is projected to have the highest CAGR due to the growth in geriatric population, high prevalence of chronic and lifestyle diseases, increase in disposable income, prevalence of lifestyle- and age-related diseases, government efforts to reform healthcare and encourage the adoption of generics. The growing market for merchant manufacturers in this region is attributed to the low labour and manufacturing costs are driving the growth of the market in Asia.

Key players in the market

Some of the key players in High Potency Active Pharmaceutical Ingredient (HPAPI) market include Abbvie, Alkermes plc, Bristol-Myers Squibb, Cambrex Corporation, Corden Pharma International, Dr. Reddy's Laboratories, Eli Lilly and Company, F. Hoffmann-La Roche, Lonza Group, Merck KGaA, Novartis AG, Novasep, Pfizer, Sanofi, Sigma-Aldrich Co LLC, SK Biotek, Sun Pharmaceutical Industries Ltd, Teva Pharmaceutical Industries, Thermo Fisher Scientific Inc., Viatris Inc. and WuXi AppTec

Key Developments:

In May 2024, Alkermes plc has completed the previously announced sale of its development and manufacturing facility in Athlone, Ireland to Novo Nordisk. In connection with the closing of the transaction, Alkermes will receive a one-time cash payment for the facility and certain related assets of approximately $91 million.

In April 2024, Bio-Techne Corporation announced a significant milestone in its commitment to providing cutting-edge solutions to its customers. Effective May 1, 2024, Bio-Techne will enter into a strategic distribution agreement with Thermo Fisher Scientific, a leading provider of laboratory products and services, in Europe. This partnership marks an important collaboration between two industry leaders in the fields of scientific research, diagnostics, and biotechnology.

Products Covered:

• Biologic
• Biosimilar
• Synthetic
• Biotech

Manufacturers Covered:

• Outsourced/ Contract
• In-House (Captive)

Drug Types Covered:

• Innovative/Novel
• Generic

Applications Covered:

• Metabolic Disorders
• Hormonal Disorders
• Central Nervous System Disorders
• Glaucoma
• Infectious Diseases
• Inflammation
• Musculoskeletal Drugs
• Oncology
• Respiratory Disorders
• Erectile Dysfunction
• Cosmetology
• Cardiovascular Drugs
• Anti-Diabetic Drugs
• Other Applications

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 2022, 2023, 2024, 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 Product Analysis
• 3.7 Application 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 High Potency Active Pharmaceutical Ingredient (HPAPI) Market, By Product

• 5.1 Introduction
• 5.2 Biologic
• 5.3 Biosimilar
• 5.4 Synthetic
• 5.5 Biotech
  • 5.5.1 Vaccines
  • 5.5.2 Recombinant Proteins
  • 5.5.3 Monoclonal Antibodies

6 Global High Potency Active Pharmaceutical Ingredient (HPAPI) Market, By Manufacturer

• 6.1 Introduction
• 6.2 Outsourced/ Contract
• 6.3 In-House (Captive)

7 Global High Potency Active Pharmaceutical Ingredient (HPAPI) Market, By Drug Type

• 7.1 Introduction
• 7.2 Innovative/Novel
• 7.3 Generic

8 Global High Potency Active Pharmaceutical Ingredient (HPAPI) Market, By Application

• 8.1 Introduction
• 8.2 Metabolic Disorders
• 8.3 Hormonal Disorders
• 8.4 Central Nervous System Disorders
• 8.5 Glaucoma
• 8.6 Infectious Diseases
• 8.7 Inflammation
• 8.8 Musculoskeletal Drugs
• 8.9 Oncology
• 8.10 Respiratory Disorders
• 8.11 Erectile Dysfunction
• 8.12 Cosmetology
• 8.13 Cardiovascular Drugs
• 8.14 Anti-Diabetic Drugs
• 8.15 Other Applications

9 Global High Potency Active Pharmaceutical Ingredient (HPAPI) Market, By Geography

• 9.1 Introduction
• 9.2 North America
  • 9.2.1 US
  • 9.2.2 Canada
  • 9.2.3 Mexico
• 9.3 Europe
  • 9.3.1 Germany
  • 9.3.2 UK
  • 9.3.3 Italy
  • 9.3.4 France
  • 9.3.5 Spain
  • 9.3.6 Rest of Europe
• 9.4 Asia Pacific
  • 9.4.1 Japan
  • 9.4.2 China
  • 9.4.3 India
  • 9.4.4 Australia
  • 9.4.5 New Zealand
  • 9.4.6 South Korea
  • 9.4.7 Rest of Asia Pacific
• 9.5 South America
  • 9.5.1 Argentina
  • 9.5.2 Brazil
  • 9.5.3 Chile
  • 9.5.4 Rest of South America
• 9.6 Middle East & Africa
  • 9.6.1 Saudi Arabia
  • 9.6.2 UAE
  • 9.6.3 Qatar
  • 9.6.4 South Africa
  • 9.6.5 Rest of Middle East & Africa

10 Key Developments

• 10.1 Agreements, Partnerships, Collaborations and Joint Ventures
• 10.2 Acquisitions & Mergers
• 10.3 New Product Launch
• 10.4 Expansions
• 10.5 Other Key Strategies

11 Company Profiling

• 11.1 Abbvie
• 11.2 Alkermes plc
• 11.3 Bristol-Myers Squibb
• 11.4 Cambrex Corporation
• 11.5 Corden Pharma International
• 11.6 Dr. Reddy's Laboratories
• 11.7 Eli Lilly and Company
• 11.8 F. Hoffmann-La Roche
• 11.9 Lonza Group
• 11.10 Merck KGaA
• 11.11 Novartis AG
• 11.12 Novasep
• 11.13 Pfizer
• 11.14 Sanofi
• 11.15 Sigma-Aldrich Co LLC
• 11.16 SK Biotek
• 11.17 Sun Pharmaceutical Industries Ltd
• 11.18 Teva Pharmaceutical Industries
• 11.19 Thermo Fisher Scientific Inc.
• 11.20 Viatris Inc.
• 11.21 WuXi AppTec