Global Biotech API Manufacturing Services Market Size study, by Service Type, by Scale of Operations and Regional Forecasts 2022-2032

Description

Global Biotech API Manufacturing Services Market was valued at USD 41.69 Billion in 2023 and is projected to grow with a robust CAGR of 7.18% over the forecast period 2024-2032. Biotech API manufacturing services play a crucial role in the production of active pharmaceutical ingredients (APIs), which are essential for the therapeutic effects of drugs. These services encompass the entire spectrum of activities, from the design and development of bioprocesses to the manufacturing and quality control of the final API products. Leveraging biotechnology, these services utilize living cells or organisms to produce APIs, highlighting the importance of specialized knowledge and facilities in this domain.

The Global Biotech API Manufacturing market is experiencing significant growth driven by the rising prevalence of chronic diseases, an aging population, and increased healthcare spending. Furthermore, the adoption of biologics and biosimilars and the burgeoning trend of personalized medicine are expected to propel the market forward. Biotech API manufacturing services are predominantly offered by contract development and manufacturing organizations (CDMOs) specializing in biotechnology and pharmaceutical production. These services include API process development and manufacturing, analytical testing and quality control, regulatory support, and scale-up to commercial manufacturing. Moreover, strong focus on R&D activities, the development of new technologies, and increasing demand for biosimilars is anticipated to create lucrative opportunities for the market. However, the high cost associated with biotech API manufacturing services, stringent regulatory requirements, and a shortage of skilled personnel are some challenges restraining market growth.

The key regions considered for the Global Biotech API Manufacturing market study includes Asia Pacific, North America, Europe, Latin America, and Rest of the World. In 2023, North American region currently dominates the market due to its well-established healthcare infrastructure, advanced technologies, and significant investments in R&D. Europe follows closely, benefiting from a robust pharmaceutical industry and favorable regulatory frameworks. Furthermore, Asia-Pacific region is anticipated to exhibit the highest growth rate during the forecast period, driven by increasing healthcare investments, rising disease prevalence, and expanding biopharmaceutical industries.

Major market players included in this report are:

Lonza Group Ltd.
WuXi AppTec Co., Ltd.
Boehringer Ingelheim Biopharmaceuticals GmbH (Boehringer Ingelheim International GmbH)
CordenPharma International
Sterling Pharma Solutions
AbbVie, Inc.
Hikal Ltd.
Almac Group
FUJIFILM Diosynth Biotechnologies
Abzena Ltd.
Regis Technologies, Inc.
Rentschler Biopharma SE
Catalent, Inc.

The detailed segments and sub-segment of the market are explained below:

By Service Type:

API Process Development & Manufacturing
Analytical Testing & Quality Control
Regulatory Support
Scale-up & Commercial Manufacturing

By Scale of Operations:

Small-scale
Mid-scale
Large-scale

By Region:

North America
U.S.
Canada
Europe
UK
Germany
France
Spain
Italy
ROE
Asia Pacific
China
India
Japan
Australia
South Korea
RoAPAC
Latin America
Brazil
Mexico
RoLA
Middle East & Africa
Saudi Arabia
South Africa
RoMEA

Years considered for the study are as follows:

Historical year - 2022
Base year - 2023
Forecast period - 2024 to 2032

Key Takeaways:

Market Estimates & Forecast for 10 years from 2022 to 2032.
Annualized revenues and regional level analysis for each market segment.
Detailed analysis of geographical landscape with Country level analysis of major regions.
Competitive landscape with information on major players in the market.
Analysis of key business strategies and recommendations on future market approach.
Analysis of competitive structure of the market.
Demand side and supply side analysis of the market

Chapter 1. Global Biotech API Manufacturing Services Market Executive Summary

1.1. Global Biotech API Manufacturing Services Market Size & Forecast (2022-2032)
1.2. Regional Summary
1.3. Segmental Summary
- 1.3.1. By Service Type
- 1.3.2. By Scale of Operations
1.4. Key Trends
1.5. Recession Impact
1.6. Analyst Recommendation & Conclusion

Chapter 2. Global Biotech API Manufacturing Services Market Definition and Research Assumptions

2.1. Research Objective
2.2. Market Definition
2.3. Research Assumptions
- 2.3.1. Inclusion & Exclusion
- 2.3.2. Limitations
- 2.3.3. Supply Side Analysis
  - 2.3.3.1. Availability
  - 2.3.3.2. Infrastructure
  - 2.3.3.3. Regulatory Environment
  - 2.3.3.4. Market Competition
  - 2.3.3.5. Economic Viability (Consumer's Perspective)
- 2.3.4. Demand Side Analysis
  - 2.3.4.1. Regulatory frameworks
  - 2.3.4.2. Technological Advancements
  - 2.3.4.3. Environmental Considerations
  - 2.3.4.4. Consumer Awareness & Acceptance
2.4. Estimation Methodology
2.5. Years Considered for the Study
2.6. Currency Conversion Rates

Chapter 3. Global Biotech API Manufacturing Services Market Dynamics

3.1. Market Drivers
- 3.1.1. Rise in Prevalence of Chronic Diseases
- 3.1.2. Increase in Geriatric Population
- 3.1.3. Increase in Healthcare Spending
3.2. Market Challenges
- 3.2.1. High Cost of Biotech API Manufacturing Services
- 3.2.2. Stringent Regulations
- 3.2.3. Lack of Skilled Personnel
3.3. Market Opportunities
- 3.3.1. Increasing Focus on R&D Activities
- 3.3.2. Development of New Technologies
- 3.3.3. Growing Demand for Biosimilars

Chapter 4. Global Biotech API Manufacturing Services Market Industry Analysis

4.1. Porter's 5 Force Model
- 4.1.1. Bargaining Power of Suppliers
- 4.1.2. Bargaining Power of Buyers
- 4.1.3. Threat of New Entrants
- 4.1.4. Threat of Substitutes
- 4.1.5. Competitive Rivalry
- 4.1.6. Futuristic Approach to Porter's 5 Force Model
- 4.1.7. Porter's 5 Force Impact Analysis
4.2. PESTEL Analysis
- 4.2.1. Political
- 4.2.2. Economical
- 4.2.3. Social
- 4.2.4. Technological
- 4.2.5. Environmental
- 4.2.6. Legal
4.3. Top investment opportunity
4.4. Top winning strategies
4.5. Disruptive Trends
4.6. Industry Expert Perspective
4.7. Analyst Recommendation & Conclusion

Chapter 5. Global Biotech API Manufacturing Services Market Size & Forecasts by Service Type 2022-2032

5.1. Segment Dashboard
5.2. Global Biotech API Manufacturing Services Market: Service Type Revenue Trend Analysis, 2022 & 2032 (USD Billion)
- 5.2.1. API Process Development & Manufacturing
- 5.2.2. Analytical Testing & Quality Control
- 5.2.3. Regulatory Support
- 5.2.4. Scale-up & Commercial Manufacturing

Chapter 6. Global Biotech API Manufacturing Services Market Size & Forecasts by Scale of Operations 2022-2032

6.1. Segment Dashboard
6.2. Global Biotech API Manufacturing Services Market: Scale of Operations Revenue Trend Analysis, 2022 & 2032 (USD Billion)
- 6.2.1. Small-scale
- 6.2.2. Mid-scale
- 6.2.3. Large-scale

Chapter 7. Global Biotech API Manufacturing Services Market Size & Forecasts by Region 2022-2032

7.1. North America Biotech API Manufacturing Services Market
- 7.1.1. U.S. Biotech API Manufacturing Services Market
  - 7.1.1.1. Service Type breakdown size & forecasts, 2022-2032
  - 7.1.1.2. Scale of Operations breakdown size & forecasts, 2022-2032
- 7.1.2. Canada Biotech API Manufacturing Services Market
7.2. Europe Biotech API Manufacturing Services Market
- 7.2.1. U.K. Biotech API Manufacturing Services Market
- 7.2.2. Germany Biotech API Manufacturing Services Market
- 7.2.3. France Biotech API Manufacturing Services Market
- 7.2.4. Spain Biotech API Manufacturing Services Market
- 7.2.5. Italy Biotech API Manufacturing Services Market
- 7.2.6. Rest of Europe Biotech API Manufacturing Services Market
7.3. Asia-Pacific Biotech API Manufacturing Services Market
- 7.3.1. China Biotech API Manufacturing Services Market
- 7.3.2. India Biotech API Manufacturing Services Market
- 7.3.3. Japan Biotech API Manufacturing Services Market
- 7.3.4. Australia Biotech API Manufacturing Services Market
- 7.3.5. South Korea Biotech API Manufacturing Services Market
- 7.3.6. Rest of Asia Pacific Biotech API Manufacturing Services Market
7.4. Latin America Biotech API Manufacturing Services Market
- 7.4.1. Brazil Biotech API Manufacturing Services Market
- 7.4.2. Mexico Biotech API Manufacturing Services Market
- 7.4.3. Rest of Latin America Biotech API Manufacturing Services Market
7.5. Middle East & Africa Biotech API Manufacturing Services Market
- 7.5.1. Saudi Arabia Biotech API Manufacturing Services Market
- 7.5.2. South Africa Biotech API Manufacturing Services Market
- 7.5.3. Rest of Middle East & Africa Biotech API Manufacturing Services Market

Chapter 8. Competitive Intelligence

8.1. Key Company SWOT Analysis
8.2. Top Market Strategies
8.3. Company Profiles
- 8.3.1. Lonza Group Ltd.
  - 8.3.1.1. Key Information
  - 8.3.1.2. Overview
  - 8.3.1.3. Financial (Subject to Data Availability)
  - 8.3.1.4. Product Summary
  - 8.3.1.5. Market Strategies
- 8.3.2. WuXi AppTec Co., Ltd.
- 8.3.3. Boehringer Ingelheim Biopharmaceuticals GmbH
- 8.3.4. CordenPharma International
- 8.3.5. Sterling Pharma Solutions
- 8.3.6. AbbVie, Inc.
- 8.3.7. Hikal Ltd.
- 8.3.8. Almac Group
- 8.3.9. FUJIFILM Diosynth Biotechnologies
- 8.3.10. Abzena Ltd.
- 8.3.11. Regis Technologies, Inc.
- 8.3.12. Rentschler Biopharma SE
- 8.3.13. Catalent, Inc.

Chapter 9. Research Process

9.1. Research Process
- 9.1.1. Data Mining
- 9.1.2. Analysis
- 9.1.3. Market Estimation
- 9.1.4. Validation
- 9.1.5. Publishing
9.2. Research Attributes