Global Pharmaceutical Contract Manufacturing Market Research Report 2023-2030: Burgeoning Opportunities with Patent Expiration and Increasing Adoption of 505(B)(2) Pathway of Small Molecules Drugs – ResearchAndMarkets.com

DUBLIN–(BUSINESS WIRE)–The “Global Pharmaceutical Contract Manufacturing Market – Forecast to 2030” report has been added to ResearchAndMarkets.com’s offering.

Pharmaceutical contract manufacturing (PCM) global market is expected to grow at a mid single digit CAGR from 2023 to 2030 to reach $100,102.8 million by 2030.

Global pharmaceutical markets are experiencing rapid growth and are projected to continue evolving in the coming years, particularly in the areas of research and development, manufacturing, and formulation.

This growth can be attributed to various factors, including the increasing global population, a rise in chronic diseases such as infectious diseases, oncology, and cardiovascular disorders, as well as a significant increase in healthcare expenditures. Additionally, the pharmaceutical industry is witnessing a surge in collaborations, mergers, and acquisitions, further driving its expansion.

To keep up with this growing demand and to address various challenges, many pharmaceutical companies are turning to contract manufacturing organizations (CMOs). These companies rely on CMOs for their manufacturing needs, as they may lack well-equipped facilities, advanced technologies, or high containment capabilities. Even when they possess the necessary facilities, they may outsource production to CMOs to save time and have a backup manufacturing option.

This increasing trend of outsourcing manufacturing to CMOs is beneficial for both pharmaceutical companies and the service providers. It allows pharmaceutical companies to focus on their core competencies while leaving the manufacturing responsibilities to specialized CMOs.

This trend is favoring contract manufacturing service providers and is expected to increase the share in the pharmaceutical manufacturing market. Contract pharmaceutical manufacturing services are mainly focused on the manufacturing of Active Pharmaceutical Ingredients (API) and Finished Dosage Formulations (FDF).

The factors such as increased trend of outsourcing and high uptake of small molecules drugs across diverse therapeutics are driving the pharmaceutical contract manufacturing global market. Whereas, patent expiration and increasing adoption of 505(b)(2) pathway of small molecules drugs, advanced technologies in API and FDF manufacturing, increasing R&D expenditures and Capacity and Capability Expansion in advanced Highly Potent APIs and Complex Molecules platforms are providing immense opportunities to the market.

However, contamination of pharmaceutical products (API and FDF), pricing pressure for pharmaceutical contract manufacturing, requirement of highly skilled technicians, increasing biologics approvals and adoption in disease management, stringent regulatory policies, and environmental concerns are some of the factors that are hindering pharmaceutical contract manufacturing global market growth.

North America accounts for the largest revenue of in 2023 and is expected to grow at a mid single digit CAGR from 2023 to 2030 due to growing pharma R&D expenditure, increasing development of new drugs over the time, increasing approval of generics, presence of number of API manufacturing facilities for all regulated drug products, increasing scope of highly potent drugs, government support to expand the domestic pharmaceutical manufacturing facilities, rise in the patient pool with various types of chronic disorders, increasing strategic partnerships among pharma companies & contract manufacturers and launch of advanced CDMO services.

The Asia-Pacific region is expected to grow at a high single digit CAGR from 2023 to 2030. The factors such as increasing generic pharmaceuticals, number of pharma companies with a strong network of manufacturing facilities.

For instance, India is home for more than 3,000 pharma companies with a strong network of over 10,500 manufacturing facilities), increasing outsourcing with number of CMO’s and expanding manufacturing facilities (Europe has outsourced most of its productions to India and China to restrain labor costs and energy expenditure, increasing development of new pharma drugs, increasing government investment to support the pharma industry.

For instance, in June 2021, Government announced an additional outlay of $26,578.3 million for the pharmaceutical PLI scheme in 13 key sectors such as active pharmaceutical ingredients, drug intermediaries and key starting materials, increasing disease population, raising investment by the companies to expand their capabilities are driving the pharmaceutical contract manufacturing market in the region.

Major Companies: Overview, Financials, Product Portfolio, Key Developments, Business Strategy, SWOT Analysis

• Abbvie Inc.
• Asymchem Laboratories (Tianjin) Co. Ltd
• Cambrex Corporation
• Curia
• Delpharm – Delriv
• Lonza Group Ltd
• Porton Pharma Solutions Ltd
• Recipharm Ab
• Thermo Fisher Scientific Inc
• Wuxi Apptec Co. Ltd.

Key Topics Covered:

1 Executive Summary

2 Introduction

2.1 Key Takeaways

2.2 Scope of the Report

2.3 Report Description

2.4 Markets Covered

2.5 Stakeholders

2.6 Research Methodology

3 Market Analysis

3.1 Introduction

3.2 Market Segmentation

3.3 Factors Influencing Market

3.3.1 Drivers and Opportunities

3.3.1.1 Increased Trend of Outsourcing

3.3.1.2 High Uptake of Small Molecules Across Diverse Therapeutics

3.3.1.3 Patent Expiration and Increasing Adoption of 505(B)(2) Pathway of Small Molecules Drugs

3.3.1.4 Increasing R&D Expenditures

3.3.1.5 Capacity and Capability Expansion in Advanced Highly Potent Apis and Complex Molecules Platforms

3.3.1.6 Advanced Technologies in API and Fdf Manufacturing

3.3.2 Restraints and Threats

3.3.2.1 Contamination in the Manufacturing Process

3.3.2.2 Requirement of Highly Skilled Technicians

3.3.2.3 Adoption of Biologics in Disease Management and Increasing Regulatory Approvals

3.3.2.4 Stringent Regulatory Requirements

3.4 Regulatory Affairs

3.5 Porter’s Five Force Analysis

3.6 Supply Chain Analysis

3.7 Market Share Analysis

3.7.1 Pharma Contract Manufacturing Global Market Share Analysis

3.7.2 Market Share Analysis of API Manufacturing by Major Players

3.7.3 Market Share Analysis of Fdf Manufacturing by Major Players

3.8 Technological Advancements

3.8.1 Introduction

3.8.2 Advanced Technologies for API Manufacturing

3.8.3 Advanced Technologies for Fdf Manufacturing

3.9 Differentiated Capabilities

3.9.1 Hpapi

3.9.2 Continuous Flow Manufacturing

3.9.3 Cryogenic Manufacturing Process

3.1 Controlled Substance API Contract Manufacturing Market

3.11 Patent Expiry and Anda Approvals

3.12 Drug Master Filing (Dmf)

3.13 API Pricing

3.14 Cost of Manufacturing Facility

3.15 Fda Approved API Manufacturing Units

3.16 Fda Approval Drugs With Type of Dosage Form

3.17 Deals in Pharmaceutical Companies and Contract Manufacturers

3.18 Acquisition

3.19 Expansion

3.2 Collaboration and Investment

3.21 Global Pharmaceutical API Cmo Production Volume

3.22 China V/S India: Pharmaceutical Contract Manufacturing Market

3.22.1 India

3.22.2 China

3.23 Pharmaceutical Contract Manufacturers Revenue and Capabilities

4 Pharmaceutical Contract Manufacturing Global Market, Based on Product

4.1 Introduction

4.2 API Manufacturing

4.2.1 Branded API Manufacturing

4.2.2 Generic API Manufacturing

4.3 Finished Dosage Form (Fdf) Manufacturing

4.3.1 Solid Dosage Forms

4.3.1.1 Tablets

4.3.1.2 Capsules

4.3.1.3 Other Solid Dosage Forms (Granules and Powders)

4.3.2 Injectables Dosage Forms

4.3.3 Semisolid, Liquid and Gaseous Dosage Forms

4.3.3.1 Semisolids

4.3.3.2 Liquids

4.3.3.3 Gaseous

5 Pharmaceutical Contract Manufacturing Global Market, Based on Phase

5.1 Introduction

5.2 Clinical Manufacturing

5.3 Commercial Manufacturing

6 Pharmaceutical Contract Manufacturing Global Market, Based on Application

6.1 Introduction

6.2 Oncology

6.3 Central Nervous System

6.4 Cardiovascular Diseases

6.5 Infectious Diseases

6.6 Pulmonary Diseases

6.7 Metabolic Disorders

6.8 Gastrointestinal Diseases

6.9 Musculoskeletal Diseases

6.1 Genitourinary Diseases

6.11 Endocrine Diseases

6.12 Other Applications (Anesthesia, Autoimmune Diseases, Opthalmology, Dental, Pain Management, Gynaecology, Dermatology, and Ent)

7 Regional Analysis

7.1 Introduction

7.2 North America

7.2.1 U.S.

7.2.2 Rest of North America

7.3 Europe

7.3.1 Germany

7.3.2 France

7.3.3 Italy

7.3.4 Rest of Europe

7.4 Apac

7.4.1 China

7.4.2 India

7.4.3 Japan

7.4.4 Rest of Apac

7.5 Row

7.5.1 Brazil

7.5.2 Rest of Latam

7.5.3 Middle East & Others

8 Competitive Landscape

8.1 Introduction

8.2 Expansion

8.3 Agreements & Collaboration

8.4 Acquisition

For more information about this report visit https://www.researchandmarkets.com/r/e5xl8y

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