Report Detail

Other Pharmaceutical Contract Manufacturing Global Market - Forecast to 2025

  • RnM3376141
  • |
  • 12 March, 2020
  • |
  • Global
  • |
  • 429 Pages
  • |
  • IQ4I Research & Consultancy
  • |
  • Other

Globally Pharmaceutical markets are showing rapid growth and in coming years expected to evolve further in the field of research and development, manufacturing and formulation due to rise in population, increasing in diseases like infectious diseases, oncology, cardiovascular disorders, rising healthcare expenditures, collaborations, merger and acquisitions. Pharmaceutical companies are increasing their dependence on contract manufacturing organizations due to lack of having well equipped manufacturing facilities, advanced technologies, high containment capabilities or though they have the facilities, due to insufficient time and to have backup manufacturing, pharmaceutical companies are outsourcing. 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 manufacturing of Active Pharmaceutical Ingredients (API) and Finished Dosage Formulations (FDF). APIs based on molecule size are categorized into biologics/large and synthetic/small molecules. According to IQ4I analysis, synthetic molecules occupy major share of 65% to 70% and the biologics accounts for share of 30% to 35% in API market. One of the major reasons for increasing in synthetic API market is the availability of small molecule drugs for all the major diseases and large number of small molecule drugs in pipeline, which is expected to enter the market in coming years.
According to IQ4I analysis, 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 high profit margin for pharma contract manufacturers and most of the CMO companies in APAC regions are shifting from API to FDF manufacturing.
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 solid dosage form, injectable dosage form, and semi-solid liquid, gaseous dosage form. 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 a fastest growing segment and expected to grow at a CAGR of 11.4% from 2018 to 2025 due to its direct infusion to the body, and 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 commercial manufacturing of API and FDF and increase in outsourcing of generic APIs. Whereas, clinical manufacturing is expected to grow at a high single digit CAGR from 2018 to 2025, due to increase in the number of pipeline drugs where 55-60% of the APIs are synthetic API, 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 play 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, 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 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 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, abundance availability of raw materials, infrastructure facility, rise in generic demands, increased production capabilities, the presence of large number of domestic and international players, and concentration of CMO companies.
The report provides an in-depth market analysis of the above-mentioned segments across the following regions:
• North America
o U.S.
o Rest of North America
• Europe
o Germany
o France
o Italy
o Rest of Europe
• Asia-Pacific
o China
o India
o Japan
o Rest of APAC
• Rest of the World (RoW)
o Brazil
o Rest of Latin America
o Middle East and Others


1 EXECUTIVE SUMMARY 28

    2 INTRODUCTION 34

    • 2.1 KEY TAKEAWAYS 34
    • 2.2 SCOPE OF THE REPORT 35
    • 2.3 REPORT DESCRIPTION 35
    • 2.4 MARKETS COVERED 38
    • 2.5 STAKEHOLDERS 40
    • 2.6 RESEARCH METHODOLOGY 40
      • 2.6.1 MARKET SIZE ESTIMATION 41
      • 2.6.2 MARKET BREAKDOWN AND DATA TRIANGULATION 44
      • 2.6.3 SECONDARY SOURCES 45
      • 2.6.4 PRIMARY SOURCES 46
      • 2.6.5 KEY DATA POINTS FROM SECONDARY SOURCES 47
      • 2.6.6 KEY DATA POINTS FROM PRIMARY SOURCES 48
      • 2.6.7 ASSUMPTIONS 49

    3 MARKET ANALYSIS 51

    • 3.1 INTRODUCTION 51
    • 3.2 MARKET SEGMENTATION 53
    • 3.3 FACTORS INFLUENCING MARKET 55
      • 3.3.1 DRIVERS AND OPPORTUNITIES 56
        • 3.3.1.1 Increased trend of outsourcing 56
        • 3.3.1.2 High uptake of small molecules across diverse therapeutics 56
        • 3.3.1.3 Patent expiration of small molecules drugs 57
        • 3.3.1.4 Advanced technologies in API and FDF manufacturing 58
        • 3.3.1.5 Increasing deals and investments 58
        • 3.3.1.6 Generics drive injectable market opportunity 59
        • 3.3.1.7 Increasing chronic and autoimmune diseases 60
        • 3.3.1.8 Increase in geriatric and aged population 61
      • 3.3.2 RESTRAINTS AND THREATS 62
        • 3.3.2.1 Contamination in the manufacturing 62
        • 3.3.2.2 Pricing pressure for pharmaceutical contract manufacturing 62
        • 3.3.2.3 Requirement of highly skilled technicians 63
        • 3.3.2.4 Increasing biologics approvals and adoption in disease management 64
        • 3.3.2.5 Stringent regulatory requirements 64
    • 3.4 REGULATORY AFFAIRS 66
      • 3.4.1 INTERNATIONAL ORGANIZATION FOR STANDARDIZATION 66
        • 3.4.1.1 ISO 9001: 2015 Quality management system 66
        • 3.4.1.2 ISO 14644-1 Clean room standards 66
      • 3.4.2 U.S. 66
      • 3.4.3 CANADA 69
      • 3.4.4 MEXICO 69
      • 3.4.5 EUROPE 70
      • 3.4.6 JAPAN 70
      • 3.4.7 CHINA 71
      • 3.4.8 INDIA 72
      • 3.4.9 AUSTRALIA 73
      • 3.4.10 SOUTH KOREA 74
      • 3.4.11 LATIN AMERICA 74
      • 3.4.12 MIDDLE EAST 75
    • 3.5 PORTER’S FIVE FORCE ANALYSIS 76
      • 3.5.1 THREAT OF NEW ENTRANTS 77
      • 3.5.2 THREAT OF SUBSTITUTES 77
      • 3.5.3 BARGAINING POWER OF SUPPLIERS 78
      • 3.5.4 BARGAINING POWER OF BUYERS 78
      • 3.5.5 COMPETITIVE RIVALRY 79
    • 3.6 SUPPLY CHAIN ANALYSIS 80
    • 3.7 MARKET SHARE ANALYSIS BY MAJOR PLAYERS 84
      • 3.7.1 PHARMACEUTICAL CONTRACT MANUFACTURING GLOBAL MARKET SHARE ANALYSIS 84
      • 3.7.2 MARKET SHARE ANALYSIS OF API MANUFACTURING

    BY MAJOR PLAYERS 87

    • 3.7.3 MARKET SHARE ANALYSIS OF FDF MANUFACTURING

    BY MAJOR PLAYERS 90

    • 3.8 TECHNOLOGICAL ADVANCEMENTS 93
      • 3.8.1 ADVANCED TECHNOLOGIES FOR API MANUFACTURING 93
      • 3.8.2 ADVANCED TECHNOLOGIES FOR FDF MANUFACTURING 95
    • 3.9 DIFFERENTIATED CAPABILITIES 97
      • 3.9.1 HPAPI 99
        • 3.9.1.1 Selected top selling HPAPI 100
      • 3.9.2 CONTINUOUS FLOW MANUFACTURING 102
      • 3.9.3 CRYOGENIC MANUFACTURING PROCESS 103
    • 3.10 CONTROLLED SUBSTANCE API CONTRACT MANUFACTURING MARKET 104
    • 3.11 PATENT EXPIRY AND ANDA APPROVALS 109
    • 3.12 DRUG MASTER FILING (DMF) 119
    • 3.13 COLLABORATION BETWEEN PHARMACEUTICAL COMPANIES AND CONTRACT MANUFACTURERS 122
    • 3.14 COMPANIES ACQUISITION, MERGER AND INVESTMENTS 126
    • 3.15 API PRICING 135
    • 3.16 GLOBAL PHARMACEUTICAL API CMO PRODUCTION VOLUME 138
    • 3.17 COST OF MANUFACTURING FACILITY 143
    • 3.18 FDA APPROVED MANUFACTURING FACILITY 145
    • 3.19 NOTICE OF INSPECTIONAL OBSERVATIONS (FORM 483) 146
    • 3.20 CHINA V/S INDIA: PHARMACEUTICAL CONTRACT MANUFACTURING

    MARKET 147

    • 3.20.1 INDIA 147
    • 3.20.2 CHINA 148
  • 3.21 PHARMACEUTICAL CONTRACT MANUFACTURERS REVENUE
  • AND CAPABILITIES TABLE 149

      4 PHARMACEUTICAL CONTRACT MANUFACTURING GLOBAL MARKET,

        BY PRODUCT 164

        • 4.1 INTRODUCTION 164
        • 4.2 API MANUFACTURING 169
          • 4.2.1 BRANDED API MANUFACTURING 175
          • 4.2.2 GENERIC API MANUFACTURING 177
        • 4.3 FINISHED DOSAGE FORM (FDF) MANUFACTURING 179
          • 4.3.1 SOLID DOSAGE FORMS 185
          • 4.3.2 INJECTABLES DOSAGE FORMS 187
          • 4.3.3 SEMISOLID, LIQUID AND GASEOUS DOSAGE FORMS 189

        5 PHARMACEUTICAL CONTRACT MANUFACTURING GLOBAL MARKET,

          BY PHASE 191

          • 5.1 INTRODUCTION 191
          • 5.2 CLINICAL MANUFACTURING 194
          • 5.3 COMMERCIAL MANUFACTURING 197

          6 PHARMACEUTICAL CONTRACT MANUFACTURING GLOBAL MARKET,

            BY APPLICATION 200

            • 6.1 INTRODUCTION 200
            • 6.2 ONCOLOGY 203
            • 6.3 CENTRAL NERVOUS SYSTEM 206
            • 6.4 CARDIOVASCULAR DISORDERS 209
            • 6.5 INFECTIOUS DISEASES 213
            • 6.6 PULMONARY DISORDERS 216
            • 6.7 METABOLIC DISORDERS 220
            • 6.8 GASTROINTESTINAL DISORDERS 224
            • 6.9 MUSCULOSKELETAL DISORDERS 228
            • 6.10 GENITOURINARY DISORDERS 231
            • 6.11 ENDOCRINOLOGY 233
            • 6.12 OTHER APPLICATIONS 236

            7 REGIONAL ANALYSIS 241

            • 7.1 INTRODUCTION 241
            • 7.2 NORTH AMERICA 246
              • 7.2.1 U.S. 259
              • 7.2.2 REST OF NORTH AMERICA 264
            • 7.3 EUROPE 269
              • 7.3.1 GERMANY 281
              • 7.3.2 FRANCE 285
              • 7.3.3 ITALY 289
              • 7.3.4 REST OF EUROPE 292
            • 7.4 APAC 296
              • 7.4.1 CHINA 308
              • 7.4.2 INDIA 313
              • 7.4.3 JAPAN 318
              • 7.4.4 REST OF APAC 322
            • 7.5 ROW 326
              • 7.5.1 BRAZIL 337
              • 7.5.2 REST OF LATAM 340
              • 7.5.3 MIDDLE EAST & OTHERS 343

            8 COMPETITIVE LANDSCAPE 346

            • 8.1 INTRODUCTION 346
            • 8.2 ACQUISITION, MERGER & COLLABORATION 347
            • 8.3 EXPANSION AND INVESTMENT 349
            • 8.4 REGULATORY APPROVAL 351
            • 8.5 SERVICE LAUNCH AND OTHERS 351

            9 MAJOR COMPANIES 353

            • 9.1 ABBVIE INC. 353
              • 9.1.1 OVERVIEW 353
              • 9.1.2 FINANCIALS 354
              • 9.1.3 PRODUCT PORTFOLIO 357
              • 9.1.4 KEY DEVELOPMENTS 358
              • 9.1.5 BUSINESS STRATEGY 358
              • 9.1.6 SWOT ANALYSIS 359
            • 9.2 AENOVA HOLDING GMBH 360
              • 9.2.1 OVERVIEW 360
              • 9.2.2 FINANCIAL 360
              • 9.2.3 PRODUCT PORTFOLIO 361
              • 9.2.4 KEY DEVELOPMENTS 361
              • 9.2.5 BUSINESS STRATEGY 362
              • 9.2.6 SWOT ANALYSIS 363
            • 9.3 ALBANY MOLECULAR RESEARCH INC. 364
              • 9.3.1 OVERVIEW 364
              • 9.3.2 FINANCIALS 365
              • 9.3.3 PRODUCT PORTFOLIO 365
              • 9.3.4 KEY DEVELOPMENTS 366
              • 9.3.5 BUSINESS STRATEGY 367
              • 9.3.6 SWOT ANALYSIS 368
            • 9.4 ALMAC GROUP 369
              • 9.4.1 OVERVIEW 369
              • 9.4.2 FINANCIALS 369
              • 9.4.3 PRODUCT PORTFOLIO 370
              • 9.4.4 KEY DEVELOPMENTS 370
              • 9.4.5 BUSINESS STRATEGY 371
              • 9.4.6 SWOT ANALYSIS 372
            • 9.5 CAMBREX CORPORATION 373
              • 9.5.1 OVERVIEW 373
              • 9.5.2 FINANCIALS 374
              • 9.5.3 PRODUCT PORTFOLIO 376
              • 9.5.4 KEY DEVELOPMENTS 378
              • 9.5.5 BUSINESS STRATEGY 379
              • 9.5.6 SWOT ANALYSIS 380
            • 9.6 FAMAR S.A. 381
              • 9.6.1 OVERVIEW 381
              • 9.6.2 FINANCIALS 382
              • 9.6.3 PRODUCT PORTFOLIO 382
              • 9.6.4 KEY DEVELOPMENTS 384
              • 9.6.5 BUSINESS STRATEGY 384
              • 9.6.6 SWOT ANALYSIS 385
            • 9.7 GLAXOSMITHKLINE PLC 386
              • 9.7.1 OVERVIEW 386
              • 9.7.2 FINANCIALS 387
              • 9.7.3 PRODUCT PORTFOLIO 390
              • 9.7.4 KEY DEVELOPMENTS 391
              • 9.7.5 BUSINESS STRATEGY 391
              • 9.7.6 SWOT ANALYSIS 392
            • 9.8 LONZA GROUP LTD 393
              • 9.8.1 OVERVIEW 393
              • 9.8.2 FINANCIALS 394
              • 9.8.3 PRODUCT PORTFOLIO 397
              • 9.8.4 KEY DEVELOPMENTS 398
              • 9.8.5 BUSINESS STRATEGY 398
              • 9.8.6 SWOT ANALYSIS 399
            • 9.9 THERMO FISHER SCIENTIFIC (PATHEON N.V.) 400
              • 9.9.1 OVERVIEW 400
              • 9.9.2 FINANCIALS 401
              • 9.9.3 PRODUCT PORTFOLIO 404
              • 9.9.4 KEY DEVELOPMENTS 405
              • 9.9.5 BUSINESS STRATEGY 406
              • 9.9.6 SWOT ANALYSIS 407
            • 9.10 PFIZET INC (PFIZER CENTERONE) 408
              • 9.10.1 OVERVIEW 408
              • 9.10.2 FINANCIALS 409
              • 9.10.3 PRODUCT PORTFOLIO 412
              • 9.10.4 KEY DEVELOPMENTS 413
              • 9.10.5 BUSINESS STRATEGY 414
              • 9.10.6 SWOT ANALYSIS 415
            • 9.11 RECIPHARM AB 416
              • 9.11.1 OVERVIEW 416
              • 9.11.2 FINANCIALS 417
              • 9.11.3 PRODUCT PORTFOLIO 420
              • 9.11.4 KEY DEVELOPMENTS 421
              • 9.11.5 BUSINESS STRATEGY 421
              • 9.11.6 SWOT ANALYSIS 423
            • 9.12 WUXI STA PHARMACEUTICALS LTD (WUXI APPTEC) 424
              • 9.12.1 OVERVIEW 424
              • 9.12.2 FINANCIALS 424
              • 9.12.3 PRODUCT PORTFOLIO 425
              • 9.12.4 KEY DEVELOPMENTS 426
              • 9.12.5 BUSINESS STRATEGY 427

            Summary:
            Get latest Market Research Reports on Pharmaceutical Contract Manufacturing . Industry analysis & Market Report on Pharmaceutical Contract Manufacturing is a syndicated market report, published as Pharmaceutical Contract Manufacturing Global Market - Forecast to 2025. It is complete Research Study and Industry Analysis of Pharmaceutical Contract Manufacturing market, to understand, Market Demand, Growth, trends analysis and Factor Influencing market.

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