DUBLIN, March 21, 2019 /PRNewswire/ — The “Pharmaceutical Contract Manufacturing Global Market – Forecast to 2025” report has been added to ResearchAndMarkets.com’s offering.
The Pharmaceutical contract manufacturing global market is expected to grow at mid-single-digit CAGR to reach $95,904.9 million by 2025.
Pharmaceutical contract manufacturing market based on product is segmented into API manufacturing and FDF manufacturing. API manufacturing market holds the largest share in 2018 and is expected to grow at mid-single-digit CAGR from 2018 to 2025 due to government initiatives, increase in a number of API manufacturers, increasing availability of APIs for all the diseases, aging population, rise in chronic diseases, research and manufacturing of new drugs and demand for generics. FDF manufacturing is the fastest growing segment with strong CAGR from 2018 to 2025, due to the high profit margins for pharma contract manufacturers and most of the CMO companies in APAC regions are shifting from API to FDF manufacturing.
Globally, pharmaceutical markets are showing rapid growth and in the coming years are expected to evolve further in the field of research and development, manufacturing and formulation, due to a rise in population, the increasing incidence of disease, rising healthcare expenditures, collaborations, merger, and acquisitions. Pharmaceutical companies are increasing their dependence on contract manufacturing organizations because they lack well-equipped manufacturing facilities, advanced technologies, high containment capabilities – or, though they have the facilities, they are outsourcing due to insufficient time, and in order to have backup.
This trend is favoring contract manufacturing service providers and is expected to increase their 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). One of the major reasons for the increase in synthetic API market is the availability of small molecule drugs for all the major diseases and a large number of small molecule drugs in the pipeline, which is expected to enter the market in coming years.
The API manufacturing market by customer base is sub-segmented into Branded API manufacturing and Generic API manufacturing. The generic API manufacturing segment is accounted for the largest revenue in 2018 and is expected to grow at a strong CAGR from 2018 to 2025, due to the patent expiries of branded drugs, low cost of generic medicines. The branded API segment is projected to grow at a CAGR of 4.0% from 2018 to 2025.
The FDF manufacturing market by dosage form is classified into a solid dosage form, injectable dosage form, and semi-solid liquid, gaseous dosage form. The solid dosage form is accounted for the largest revenue in 2018 and is expected to grow at a CAGR of 4.0% from 2018 to 2025, due to changing consumer demands, advent, and progress of newer dosage forms and ever-evolving regulations. The injectable dosage form is the fastest growing segment and expected to grow at a CAGR from 2018 to 2025 due to its direct infusion to the body, and the onset of action of drugs is faster. Hence, it is suitable for emergency conditions.
Pharmaceutical contract manufacturing by phase is segmented into commercial manufacturing and clinical manufacturing. Commercial manufacturing holds the highest revenue in 2018 and expected to grow at a mid-single- digit CAGR from 2018 to 2025, due to huge demand for commercial API production, patent expiry increases, the commercial manufacturing of API and FDF, and an increase in outsourcing of generic APIs. Whereas, clinical manufacturing is expected to grow at a high single-digit CAGR from 2018 to 2025, clinical phase 2 and 3 projects requiring cGMP facilities and increase in outsourcing by innovator pharma companies due to low-cost manufacturing and shorter timelines. Also, clinical manufacturing plays a significant role in securing client relationships that can lead to commercial scale manufacturing contracts.
Pharmaceutical contract manufacturing market by application is segmented as Oncology, Central nervous system, Cardiovascular disorder, Infectious diseases, Pulmonary disorders, Metabolic disorder, Gastrointestinal disorders, Musculoskeletal disorders, Genitourinary disorders, Endocrinology and other applications (acute pain, chronic pain and post-surgical, dental, ENT, autoimmune disorder). Among these applications, Infectious disease segment accounted for the largest revenue in 2018 due to increase in global HIV pandemic causes about one million deaths every year, the emergence of severe acute respiratory syndrome (SARs) and viral hemorrhagic fever. The Oncology segment is a fastest growing application market during the forecasting period, due to increase in the incidence of breast and lung cancer, increase in the usage of synthetic HPAPIs for cancer treatment, increase in geriatric population and FDA approvals.
Pharmaceutical contract manufacturing market by region is segmented as North America (U.S. and Rest of North America), Europe (Germany, France, Italy and Rest of Europe), Asia-Pacific (China, India, Japan, and Others) and Rest of the World (Brazil, Rest of Latin America and Middle East & others). North America accounts for the largest revenue in 2018 and is expected to grow at a mid-single-digit CAGR from 2018 to 2025. In North America, U.S. and Canada are the most prominent countries in which the U.S. occupies the largest revenue, due to expansion of regional market includes developed healthcare sector, availability of funds, increasing clinical trials, rising burden of cancer, increasing government focus on generic drugs, rising demands for specialty of drugs and technological advancements.
Asia-Pacific region is expected to grow at a strong CAGR of 8.4% from 2018 to 2025. Mainly India and China are concentrated more due to low labor cost, regulatory relaxation, abundant availability of raw materials, infrastructure facilities, a rise in generic demands, increased production capabilities, the presence of a large number of domestic and international players, and concentration of CMO companies.
Key Topics Covered:
1 Executive Summary
3 Market Analysis
3.2 Market Segmentation
3.3 Factors Influencing Market
3.3.1 Drivers And Opportunities
184.108.40.206 Increased Trend Of Outsourcing
220.127.116.11 High Uptake Of Small Molecules Across Diverse Therapeutics
18.104.22.168 Patent Expiration Of Small Molecules Drugs
22.214.171.124 Advanced Technologies In API And FDF Manufacturing
126.96.36.199 Increasing Deals And Investments
188.8.131.52 Generics Drive Injectable Market Opportunity
184.108.40.206 Increasing Chronic And Autoimmune Diseases
220.127.116.11 Increase In Geriatric And Aged Population
3.3.2 Restraints And Threats
18.104.22.168 Contamination In The Manufacturing
22.214.171.124 Pricing Pressure For Pharmaceutical Contract Manufacturing
126.96.36.199 Requirement Of Highly Skilled Technicians
188.8.131.52 Increasing Biologics Approvals And Adoption In Disease Management
184.108.40.206 Stringent Regulatory Requirements
3.4 Regulatory Affairs
3.4.1 International Organization For Standardization
220.127.116.11 ISO 9001: 2015 Quality Management System
18.104.22.168 ISO 14644-1 Clean Room Standards
3.5 Porter’s Five Force Analysis
3.6 Supply Chain Analysis
3.7 Market Share Analysis By Major Players
3.7.1 Pharmaceutical 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 Advanced Technologies For API Manufacturing
3.8.2 Advanced Technologies For Fdf Manufacturing
3.9 Differentiated Capabilities
22.214.171.124 Selected Top Selling HPAPI
3.9.2 Continuous Flow Manufacturing
3.9.3 Cryogenic Manufacturing Process
3.10 Controlled Substance API Contract Manufacturing Market
3.11 Patent Expiry And Anda Approvals
3.12 Drug Master Filing (DMF)
3.13 Collaboration Between Pharmaceutical Companies And Contract Manufacturers
3.14 Companies Acquisition, Merger And Investments
3.15 API Pricing
3.16 Global Pharmaceutical API CMO Production Volume
3.17 Cost Of Manufacturing Facility
3.18 FDA Approved Manufacturing Facility
3.19 Notice Of Inspectional Observations (Form 483)
3.20 China V/S India: Pharmaceutical Contract Manufacturing Market
3.21 Pharmaceutical Contract Manufacturers Revenue And Capabilities Table
4 Pharmaceutical Contract Manufacturing Global Market, By Product
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
4.3.2 Injectables Dosage Forms
4.3.3 Semisolid, Liquid And Gaseous Dosage Forms
5 Pharmaceutical Contract Manufacturing Global Market, By Phase
5.2 Clinical Manufacturing
5.3 Commercial Manufacturing
6 Pharmaceutical Contract Manufacturing Global Market, By Application
6.3 Central Nervous System
6.4 Cardiovascular Disorders
6.5 Infectious Diseases
6.6 Pulmonary Disorders
6.7 Metabolic Disorders
6.8 Gastrointestinal Disorders
6.9 Musculoskeletal Disorders
6.1 Genitourinary Disorders
6.12 Other Applications
7 Regional Analysis
8 Competitive Landscape
8.2 Acquisition, Merger & Collaboration
8.3 Expansion And Investment
8.4 Regulatory Approval
8.5 Service Launch And Others
9 Major Companies
9.1 Abbvie Inc.
9.2 Aenova Holding Gmbh
9.3 Albany Molecular Research Inc.
9.4 Almac Group
9.5 Cambrex Corporation
9.6 Famar S.A.
9.7 GlaxoSmithKline Plc
9.8 Lonza Group Ltd
9.9 Thermo Fisher Scientific (Patheon N.V.)
9.1 Pfizet Inc (Pfizer Centerone)
9.11 Recipharm AB
9.12 Wuxi Sta Pharmaceuticals Ltd (Wuxi Apptec)
- Aarthi Drugs Ltd.
- Abbvie Contract Manufacturing
- Accupac, Inc. (J.H Whitney Capital Partners Llc)
- Acic Pharmaceutical Inc.
- Aenova Holding Gmbh
- Aesica Pharmaceuticals Ltd (Consort Medical)
- Ajinomoto Bio-Pharma Services
- Akorn, Inc.
- Albany Molecular Research Inc. (Carlyle Group & Gtcr)
- Alcami Corporation
- Alliance Contract Pharma Llc
- Almac Group
- Alpex Pharma S.A.
- Ambio Pharma
- Ampac Fine Chemicals
- A.M.S.A. S.P.A.
- Amr Pharma India Private Limited
- Ani Pharmaceuticals, Inc.
- Ardena Group
- Artesan Pharma Gmbh
- Asymchem Laboratories, Inc.
- Avara Pharmaceutical Services
- Bachem Holding AG
- Biocon Limited
- Cadila Pharmaceuticals Ltd.
- Cambrex Corporation
- Cerbios Pharma S.A.
- Chambio Co., Ltd.
- Chemcon Gmbh
- China Chemical & Pharmaceutical Co., Ltd. (CCPC)
- Ciron Drugs And Pharmaceuticals Pvt Ltd.
- Corden Pharma Gmbh
- Core Rx, Inc.
- Custom Pharma Services
- Daito Pharmaceutical Co., Ltd.
- Dalton Pharma Service
- Delpharm Sas
- DPT Laboratories, Ltd. (Mylan N.V.)
- Dr. Reddy’s Laboratories Ltd.
- Elpen Pharmaceutical Co. Inc.
- Elysium Pharmaceuticals Ltd.
- Ever Neuro Pharma Gmbh
- Evonik Industries Ag
- Famar S.A.
- Fareva Group
- Fermion Oy.
- Flamma S.P.A
- Fuji Chemical Industry Co.,Ltd
- Galenicum Health, S.L.
- GP Pharm SA
- Groupe Parima Inc.
- GSK Contract Manufacturing
- GVK Biosciences Pvt Ltd.
- HBM Pharma S.R.O
- Heraues Holding Gmbh
- Hetero Drugs
- Icrom S.P.A
- Ind-Swift Laboratories Ltd.
- Johnson Matthey Pharma Servicesinc.
- Jubilant Lifesciences
- Kern Pharma, S.L.
- Kleos Pharmaceutical Inc.
- Koak Farma Pharmaceutical
- Kolmar Korea Co., Ltd.
- Kwizda Pharma Gmbh.
- Logos Pharma
- Lonza Group Ltd
- Lotus Pharmaceutical Co., Ltd.
- LSNE Contract Manufacturing
- Madras Pharmaceuticals Pvt Ltd
- McGuff Pharmaceuticals
- Merck SAFC (Merck & Co. Inc)
- Metrics Contract Services (Mayne Pharma Inc)
- Mint Lifesciences Pvt Ltd.
- MSN Laboratories Pvt Ltd.
- Nautilus Pharma
- Nectar Lifesciences Ltd.
- Neolpharma Inc.
- Nextar Chempharma Solutions Ltd.
- Nextpharma Technologies Holding Limited
- Nipro Pharma Corporation
- Olon S.P.A
- Orion Pharma Ltd
- Patheon N.V. (Thermofisher)
- Pfizer Centreone (Pfizer Inc.)
- Pharma Synth Formulations Limited
- Pharmapac Uk Ltd., (Inyx, Inc.)
- Pillar5 Pharma Inc.
- Piramal Pharma Solutions
- Polpharma Sa Pharmaceutical.
- Porton Pharma Solutions Ltd.
- Recipharm Ab
- Sai Life Science Ltd.
- Sain Medicaments Pvt Ltd.
- Saneca Pharmaceutical A.S.
- Sanofi Cepia
- Scinopharm Taiwan Ltd.
- Seqens (Novacap)
- Siegfried AG
- SK Biotek Co.,Ltd
- Soigner Pharma
- Sopharma Pharma Plc.
- Stason Pharmaceuticals, Inc.
- Sterling Pharma Solutions
- Supriya Lifescience Ltd.
- Surepharma Services Ltd.
- Synokem Pharmaceuticals Ltd.
- Taj Ando Pharmaceuticals
- Temad Co.
- Tapi (Teva Pharmaceutical Industries Ltd.)
- Ubi Pharma Inc.
- Valpharma S.P.A
- Venus Pharma Gmbh
- Vivimed Labs Ltd
- Wockhardt Ltd.
- Woodfield Pharmaceutical Llc
- Wuxi Sta Pharmaceutical (Wuxi Apptec+Sta Pharmaceutical)
- Yash Pharma Laboratories Pvt Ltd.
- Zach System (Zambon Company S.P.A.)
- ZCL Chemicals Ltd
- Zhejiang Hisun Pharmaceutical Co., Ltd.
- Zhejiang Huahai Pharmaceutical Co., Ltd.
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