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Pharmaceutical Contract Manufacturing (CMO) Market - Growth, Trends, and Forecast (2020 - 2025)

The market is segmented by CMO Type (Active Pharmaceutical Ingredient (API) Manufacturing, Finished Dosage Formulation (FDF) Development and Manufacturing, and Packaging), and Geography.

Market Snapshot

Study Period:

2019-2025

Base Year:

2019

Fastest Growing Market:

Asia Pacific

Largest Market:

North America

CAGR:

6.4 %

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Market Overview

The global pharmaceutical CMO market (henceforth, referred to as the market studied) was valued USD 109.67 billion in 2019, and it is expected to reach USD 162.1 billion by 2025, registering a CAGR of 6.4%, during the period of 2020-2025. With the growing demand for generic medicines and biologics, the capital-intensive nature of the business, and the complex manufacturing requirements, many pharmaceutical companies have identified the potential profitability in contracting with a CMO (contract manufacturing outsourcing) for both clinical and commercial stage manufacturing. 

  • The biggest factor driving the growth of CMOs in the pharmaceutical industry is the growing need for state-of-the-art processes and production technologies, which have proven highly effective in meeting regulatory requirements.
  • CMOs are consolidating as a means of improving profitability in the competitive market. Through consolidation, the large CMOs can expand their geographical presence and penetrate the niche markets. The small CMOs can leverage the technical expertise and resources of larger CMOs. For instance, in September 2019, SK Holdings, the holding company of South Korea's SK Group, established a US-based consolidated contract manufacturing organization (CMO), SK pharmteco, a collaboration between SK biotek in Korea and AMPAC Fine Chemicals (AFC) in the United States
  • In the pharmaceutical sector, with the ongoing growth, the pharmaceutical innovator companies need to stock their pipelines with new drugs. However, they do not have the resources to discover, develop, and manufacture products. Hence, the requirement for CMOs is quite significant.
  • Novartis International AG, a multinational pharmaceutical company, based in Switzerland, established four in-house facilities across the United States and Europe, in order to build its cell therapy manufacturing network. These CMO facilities are supposed to be commercially ready in the second half of 2020.

Scope of the Report

Contract manufacturing is a form of outsourcing where a manufacturer enters a formal agreement with another manufacturing firm for its parts, products, or components. The former manufacturer uses these in its own manufacturing process for manufacturing its products. A contract manufacturing organization (CMO) is an organization that serves the pharmaceutical industry and provides clients with comprehensive services, from drug development to manufacturing. Outsourcing to a CMO allows the pharmaceutical clients to expand the technical resources, without increased overhead. The client can manage its internal resources and costs by focusing on the core competencies and high-value projects while reducing or not adding infrastructure or technical staff. The study provides a granular view of the current CMO industry, with a further breakdown of each segment by region, as listed in the index.

Service Type
Active Pharmaceutical Ingredient (API) Manufacturing
Small Molecule
Large Molecule
High Potency API (HPAPI)
Finished Dosage Formulation (FDF) Development and Manufacturing
Solid Dose Formulation
Liquid Dose Formulation
Injectable Dose Formulation
Secondary Packaging
Geography
North America
Segmentation by Service Type
Segmentation by Country
US
Canada
Europe
Segmentation by Service Type
Segmentation by Country
UK
Germany
France
Italy
Rest of Europe
Asia-Pacific
Segmentation by Service Type
Segmentation by Country
China
India
Japan
Australia
Rest of Asia-Pacific
Latin America
Segmentation by Service Type
Segmentation by Country
Brazil
Mexica
Argentina
Rest of Latin America
Middle East and Africa
Segmentation by Service Type
Segmentation by Country
UAE
Saudi Arabia
South Africa
Rest of Middle East & Africa

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Key Market Trends

Active Pharmaceutical Ingredient (API) Manufacturing is Expected to Register a Significant Growth

  • The demand for API manufacturing has witnessed a sustained rise over the past few years, and it is expected to continue rising steadily, with further patent expiries expected in the future and a subsequent increase in the global generic production capacities.
  • Most of the companies in this industry are increasingly focusing on the development of biological APIs, which is driving the API manufacturing segment of the market studied. The general prescription drug subsegment has more demand for API manufacturing, as compared to OTC drugs.
  • Other factors driving the growth of the API manufacturing segment include the increasing government initiatives in the healthcare sector, innovation in biologics, and rise in the incidence of cancer and age-related diseases. However, strict regulatory policies in regions like Europe may hinder the segment’s growth.
  • The increasing emphasis on high-potency APIs is driving the growth of the segment. The novel technologies for HPAPIs can potentially change the in-out balance of CMOs in this fast-growing segment.

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Asia Pacific is Expected to Account for a Highest Growth

  • China is becoming the most attractive country for outsourcing. The majority of the CMOs operating in China today offer mainly API and bulk drug products manufacturing for approved branded and generic drugs. Some of the leading API and chemical intermediate CMOs of the country include Beijing Second Pharmaceutical, Asymchem Laboratories, Chongqing Huapont Pharmaceutical, Shandong Xinhua Pharmaceutical, Porton Fine Chemicals, Venturepharm Laboratories, and Tianjin Pharmaceutical.
  • With the advent of multinational pharmaceutical organizations and their rapidly growing presence in India, the concept of contract manufacturing has steadily evolved and quickly adapted to encompass services, such as formulation development, basic manufacturing of medicinal products, stability studies, and various stages of clinical trials.
  • India is also taking advantage of this growth in the domestic CMO market, encouraging the Japanese pharmaceutical industries to set up their locations in the country, either wholly-owned or in partnership with Indian companies.
  • The CMO market in Japan is still immature. However, the country witnessed incremental growth over the past few years. The Japanese CMO market witnessed a growth of about 30%, following the recognition to separate manufacturing and sales by the Pharmaceutical Affairs Act. The growth trend has been continuing ever since. The number of CMO manufacturers of significant size in Japan is low and includes players, like Bushu Pharmaceuticals, Nipro Pharma, and CMIC.

To understand geography trends, Download Sample Report.

Competitive Landscape

The pharmaceutical contract manufacturing market is highly competitive and consists of several major players. In terms of market share, few of the major players currently dominate the market. These major players with a prominent share in the market are focusing on expanding their customer base across foreign countries. These companies are leveraging on strategic collaborative initiatives to increase their market share and increase their profitability.

The companies operating in the market are also acquiring start-ups working on enterprise network equipment technologies to strengthen their product capabilities.

  • February 2020 - Catalent has signed an agreement with Zumutor Biologics, Inc., to manufacture Zumutor’s, ZM008, for the treatment of solid tumors. Zumutor is a biologics company that develops novel immuno-oncotherapeutics to drive transformational improvements in cancer treatment.
  • December 2019 - Thermo Fisher Scientific Inc. opened its new USD 90 million viral vector CDMO (contract development and manufacturing organization) site in Lexington, Mass. The 50,000-square-foot facility will add more than 200 jobs and support the development, testing and manufacture of viral vectors, which are critical to advancing new life-saving gene and cell therapies worldwide.

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Table Of Contents

  1. 1. INTRODUCTION

    1. 1.1 Study Assumptions and Market Definition

    2. 1.2 Scope of the Study

  2. 2. RESEARCH METHODOLOGY

  3. 3. EXECUTIVE SUMMARY

  4. 4. MARKET DYNAMICS

    1. 4.1 Market Overview

    2. 4.2 Market Drivers

      1. 4.2.1 Increasing Outsourcing Volume By Big Pharmaceutical Companies

      2. 4.2.2 Increasing Investments In R&D

    3. 4.3 Market Restraints

      1. 4.3.1 Increasing Lead Time and Logistics Costs

      2. 4.3.2 Stringent Regulatory Requirements

      3. 4.3.3 Capacity Utilisation Issues Affecting The Profitability Of Cmos

    4. 4.4 Industry Attractiveness Porters Five Force Analysis

      1. 4.4.1 Bargaining Power of Suppliers

      2. 4.4.2 Bargaining Power of Buyers/Consumers

      3. 4.4.3 Threat of New Entrants

      4. 4.4.4 Intensity of Competitive Rivalry

      5. 4.4.5 Threat of Substitute Products

    5. 4.5 Value Chain / Supply Chain Analysis

    6. 4.6 Industry Policies

  5. 5. MARKET SEGMENTATION

    1. 5.1 Service Type

      1. 5.1.1 Active Pharmaceutical Ingredient (API) Manufacturing

        1. 5.1.1.1 Small Molecule

        2. 5.1.1.2 Large Molecule

        3. 5.1.1.3 High Potency API (HPAPI)

      2. 5.1.2 Finished Dosage Formulation (FDF) Development and Manufacturing

        1. 5.1.2.1 Solid Dose Formulation

        2. 5.1.2.2 Liquid Dose Formulation

        3. 5.1.2.3 Injectable Dose Formulation

      3. 5.1.3 Secondary Packaging

    2. 5.2 Geography

      1. 5.2.1 North America

        1. 5.2.1.1 Segmentation by Service Type

        2. 5.2.1.2 Segmentation by Country

          1. 5.2.1.2.1 US

          2. 5.2.1.2.2 Canada

      2. 5.2.2 Europe

        1. 5.2.2.1 Segmentation by Service Type

        2. 5.2.2.2 Segmentation by Country

          1. 5.2.2.2.1 UK

          2. 5.2.2.2.2 Germany

          3. 5.2.2.2.3 France

          4. 5.2.2.2.4 Italy

          5. 5.2.2.2.5 Rest of Europe

      3. 5.2.3 Asia-Pacific

        1. 5.2.3.1 Segmentation by Service Type

        2. 5.2.3.2 Segmentation by Country

          1. 5.2.3.2.1 China

          2. 5.2.3.2.2 India

          3. 5.2.3.2.3 Japan

          4. 5.2.3.2.4 Australia

          5. 5.2.3.2.5 Rest of Asia-Pacific

      4. 5.2.4 Latin America

        1. 5.2.4.1 Segmentation by Service Type

        2. 5.2.4.2 Segmentation by Country

          1. 5.2.4.2.1 Brazil

          2. 5.2.4.2.2 Mexica

          3. 5.2.4.2.3 Argentina

          4. 5.2.4.2.4 Rest of Latin America

      5. 5.2.5 Middle East and Africa

        1. 5.2.5.1 Segmentation by Service Type

        2. 5.2.5.2 Segmentation by Country

          1. 5.2.5.2.1 UAE

          2. 5.2.5.2.2 Saudi Arabia

          3. 5.2.5.2.3 South Africa

          4. 5.2.5.2.4 Rest of Middle East & Africa

  6. 6. COMPETITIVE LANDSCAPE

    1. 6.1 Company Profiles

      1. 6.1.1 Catalent Inc.

      2. 6.1.2 Recipharm AB

      3. 6.1.3 Jubilant Life Sciences Ltd

      4. 6.1.4 Thermo Fisher Scientific Inc. (Patheon Inc.)

      5. 6.1.5 Boehringer Ingelheim Group

      6. 6.1.6 Pfizer CentreSource (Pfizer Inc.)

      7. 6.1.7 Aenova Group

      8. 6.1.8 Famar SA

      9. 6.1.9 Baxter Biopharma Solutions (Baxter International Inc.)

      10. 6.1.10 Lonza Group AG

    2. 6.2 Investment Analysis

  7. *List Not Exhaustive
  8. 7. MARKET OPPORTUNITIES AND FUTURE TRENDS

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