Biologics manufacturing or Biomanufacturing is primarily a recombinant DNA technology based complex process of manufacturing biopharmaceuticals using engineered or natural living expression platforms like the mammalian and insect cell cultures, unicellular microbials or the multicellular transgenic plants and animals. The biologics manufacturing is a complex process involving huge capital and sound technical expertise. Many large and small biopharmaceutical companies are turning to outsource their bioprocessing or biomanufacturing activities to reduce capital investments, to accelerate the speed to market of their innovative products and to gain a cost-effective and timely access to flexible and scalable, most appropriate biomanufacturing facilities and technologies along with skilled and technical expertise. The outsourcing process enables large pharmaceutical companies to focus on their core competencies while for small companies and virtual start-ups, it is the only way to get their innovative biological products into the market without making huge investments on building the internal manufacturing capabilities. Contract manufacturing organizations, particularly for R&D and clinical trials, are making product manufacturing process more efficient and often less costly. Also, the use of single-use bioreactors is effectively reducing the manufacturing facility cost.
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The biologics contract manufacturing services global market is expected to reach $57.1 billion by 2028 growing at a low teen CAGR from 2020 to 2028. There is a continued growth of the biopharmaceutical market which is expected to nearly double in the next 10 years. This is attributed to continued new product approvals, expansion of indications for current products, increasing awareness and adoption of these advanced biological products in the less-developed countries and increasing efficient therapeutic products demand from the aging population burdened with various kinds of chronic diseases like cancer, arthritis and genetic diseases in the U.S. and other major pharmaceutical markets. Many blockbuster drugs in the verge of patent expirations is also giving room for many biosimilar (and bio-better) companies to enter into the global biopharmaceuticals market subsequently involving many CROs, CDMOs, and CMOs to enter into the picture to meet the huge volume demand of these biological products. Hence, there is every reason to assume that future growth in biopharmaceutical outsourcing will continue at a minimum of 14% in western countries to about 18% in Asian countries.
Nowadays, CMOs are gaining much prominence to meet the increasing demand for the clinical and commercial supply of biologics. These bioservice providers have become an integral part of the rapidly expanding biopharma industry as they are equipped with the latest technological capabilities and expanded manufacturing capacities. By expanding manufacturing capacities or acquiring new facilities and thus adding novel, advanced and complementary capabilities, increased production capacities and expanded geographical reach to their services portfolio, CDMO’s focus on becoming the single, strategic partner to their customers by providing cost-effective end-to-end biologics development and manufacturing services. In September 2020, Catalent Inc. has invested $130 million for the addition of five additional suites to enhance their late phase clinical to commercial gene therapeutic manufacturing. In August 2020, Samsung Biologics had invested approximately $2 billion to build a fourth Super Plant with an additional 256KL production capacity to offer multi-scale ALSO READ : http://www.marketwatch.com/story/bollard-lights-market-research-rep...
manufacturing services. In January 2020, Cognate BioServices had acquired Cobra Biologics, a leading CDMO specialized in plasmid DNA and viral vector development and manufacturing services to enhance its capabilities in gene therapeutics.
The contract biomanufacturing global market is dominated by North American region which commanded the largest revenue in 2020 and is expected to grow at a low teen CAGR during the forecasted period according to IQ4I estimation. The Asia Pacific region is witnessing huge growth opportunities in terms of biologics outsourcing and many of the local CMOs are leading the way to make the region the most preferred destination for biologics outsourcing. Some of the reasons for countries like China, South Korea and India becoming the favourite destinations for biologic outsourcing projects include the lower labor cost, availability of high technical expertise and huge manufacturing facilities and favorable, supportive government regulations related to contract biomanufacturing in these regions. Asia-Pacific region is the fastest growing region in the contract biomanufacturing global market in 2020 and is expected to grow at high teen CAGR during the forecasted period.
According to IQ4I analysis, even though in-house biomanufacturing capacities still hold a major share of 67.8% in the biomanufacturing market, their capacity utilization rate is less compared to that of CMO’s with a utilization rate of 65.5%. Most of the CMO’s are currently utilizing mammalian culture techniques for the commercial, GMP production of biotherapeutics. Most of the CMO based biomanufacturing capacity is consolidated with major players like Samsung Biologics, Boehringer Ingelheim, Fujifilm and AbbVie. The global medium penetration range of CMO biomanufacturing capacity is expected to increase immensely in the coming years attributed to the vast opportunity in the space and various capacity expansion projects being executed by the CMO’s in response to the elevating biomanufacturing capacity demand.
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The global bio-manufacturing outsourcing market is driven by factors such is driven by the increasing trend of outsourcing among the biopharmaceutical companies, availability of advanced bioprocessing capabilities among the contract bioservice providers and the escalating approval and adoption of biologics and the cost effective biosimilars among the value centric global patient pool leading to huge volume demand for biologics. Emergence of advanced biotherapeutics, increasing R&D investments by the biopharma companies, development of precision and orphan indication therapies and the persistently increasing prevalence of chronic, communicable and autoimmune diseases are also boosting contract biomanufacturing market growth. There are certain restraints and threats as well which could potentially hamper the biomanufacturing outsourcing market. These include requirement of huge capital investment for capacity expansion, setting of cGMP compliant facilities and technology up-gradation, need to be compliant with intellectual property protection rights of biopharma companies, development and expansion of in-house biomanufacturing capacities, the trend of low volume biomanufacturing outsourcing and competition from the established and local CDMO’s and stringent regulatory guidelines to be followed during the biomanufacturing.
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Table of Contents
1.1 EXECUTIVE SUMMARY 14
2 MARKET ANALYSIS 20
2.1 FACTORS INFLUENCING MARKET 20
2.1.1 DRIVERS AND OPPORTUNITIES 21
2.1.1.1 Increasing trend of biomanufacturing outsourcing 21
2.1.1.2 Advanced bioprocessing capabilities of contract biomanufacturers 23
2.1.1.3 Emergence of advanced biotherapeutics 24
2.1.1.4 Escalating approvals and adoption of biologics and biosimilars 26
2.1.1.5 Increasing R&D expenditures of biopharma companies 29
2.1.1.6 Increasing prevalence of chronic, autoimmune and communicable diseases 30
2.1.1.7 Development of personalized and orphan indication therapies 31
2.1.2 RESTRAINTS AND THREATS 33
2.1.2.1 Increasing focus on in-house biologics manufacturing 33
2.1.2.2 Huge capital investment for capacity and capability expansion 34
2.1.2.3 Compliance with stringent regulatory guidelines 35
2.1.2.4 Compliance with intellectual property rights of biopharma companies 37
2.1.2.5 Competition and trend of outsourcing of low volume manufacturing 37
3 CONTRACT BIOMANUFACTURING SERVICES 39
3.1 INTRODUCTION 39
3.2 IN HOUSE VS CMO CAPACITY 42
3.2.1 GLOBAL BIOMANUFACTURING CAPACITY 46
3.2.2 BIOLOGICS CONTRACT MANUFACTURING ORGANIZATIONS, BY PHASE 51
3.3 CONTRACT BIOMANUFACTURING, BY PROCESS 53
3.3.1 BIOMANUFACTURING BY MAMMALIAN CELL CULTURE 54
3.3.2 MAMMALIAN CELL CULTURE BIOMANUFACTURING V/S MICROBIAL AND OTHER CELL CULTURES 58
3.3.3 BIOMANUFACTURING BY MICROBIAL CELL CULTURE 62
3.3.3.1 MICROBIAL CELL CULTURE CMO BIOMANUFACTURING CAPACITY 64
3.3.4 BIOMANUFACTURING BY OTHER CELL CULTURE 65
3.4 CONTRACT BIOMANUFACTURING GLOBAL MARKET, BY END USERS 66
3.4.1 CONTRACT BIOMANUFACTURING OF DIAGNOSTICS 69
3.4.2 CONTRACT BIOMANUFACTURING OF RESEARCH REAGENTS 70
3.4.3 CONTRACT BIOMANUFACTURING OF THERAPEUTICS 71
3.4.3.1 Biomanufacturing of antibodies 72
3.4.3.2 Biomanufacturing of recombinant proteins 77
3.4.3.3 Biomanufacturing of vaccines 79
3.4.3.4 Others (Cell therapy and Gene therapy) 80
3.5 BIOMANUFACTURING OUTSOURCING GLOBAL MARKET, BY REGION 84
3.6 CONTRACT BIOMANUFACTURING ORGANIZATION CAPACITY PENETRATION 89
3.7 COMPETITIVE LANDSCAPE 92
3.7.1 CAPACITY COMPARISON 92
3.7.2 CONTRACT MANUFACTURING GLOBAL MARKET SHARE, BY LEADING PLAYERS 94
3.7.3 COMPANY DEVELOPMENTS 97
3.7.3.1 Agreement 99
3.7.3.1 Expansion 114
3.7.3.1 Acquisition 123
3.7.3.1 Collaboration and partnerships 126
3.7.3.1 Product launch 128
3.7.3.2 Facility approvals 129
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3.7.3.3 Other developments 131
4 COMPANY PROFILES 136
4.1 ABBVIE INC. (ABBVIE CONTRACT MANUFACTURING) 136
4.1.1 OVERVIEW 136
4.1.2 FINANCIALS 138
4.1.3 SERVICE PORTFOLIO 141
4.1.4 KEY DEVELOPMENTS 142
4.1.5 SWOT ANALYSIS 143
4.2 ABZENA PLC 144
4.2.1 OVERVIEW 144
4.2.2 FINANCIALS 145
4.2.3 SERVICE PORTFOLIO 145
4.2.4 KEY DEVELOPMENTS 147
4.2.5 SWOT ANALYSIS 149
4.3 AGC INC. 150
4.3.1 OVERVIEW 150
4.3.2 FINANCIALS 152
4.3.3 SERVICE PORTFOLIO 156
4.3.4 KEY DEVELOPMENTS 156
4.3.5 SWOT ANALYSIS 160
4.4 BOEHRINGER INGELHEIM INTERNATIONAL GMBH 161
4.4.1 OVERVIEW 161
4.4.2 FINANCIALS 163
4.4.3 SERVICE PORTFOLIO 166
4.4.4 KEY DEVELOPMENTS 166
4.4.5 SWOT ANALYSIS 167
4.5 CATALENT INC. 168
4.5.1 OVERVIEW 168
4.5.2 FINANCIALS 170
4.5.3 SERVICE PORTFOLIO 172
4.5.4 KEY DEVELOPMENTS 173
4.5.5 SWOT ANALYSIS 177
4.6 CHARLES RIVER LABORATORIES INTERNATIONAL INC. 178
4.6.1 OVERVIEW 178
4.6.2 FINANCIALS 180
4.6.3 SERVICE PORTFOLIO 183
4.6.4 KEY DEVELOPMENTS 184
4.6.5 SWOT ANALYSIS 185
4.7 COGNATE BIOSERVICES INC. (COBRA BIOLOGICS) 186
4.7.1 OVERVIEW 186
4.7.2 FINANCIALS 186
4.7.3 SERVICE PORTFOLIO 187
4.7.4 KEY DEVELOPMENTS 188
4.7.5 SWOT ANALYSIS 190
4.8 FUJIFILM HOLDINGS CORPORATION (FUJIFILM DIOSYNTH BIOTECHNOL0GIES) 191
4.8.1 OVERVIEW 191
4.8.2 FINANCIALS 193
4.8.3 SERVICE PORTFOLIO 196
4.8.4 KEY DEVELOPMENTS 196
4.8.5 SWOT ANALYSIS 199
4.9 GENSCRIPT BIOTECH CORPORATION 200
4.9.1 OVERVIEW 200
4.9.2 FINANCIALS 202
4.9.3 SERVICE PORTFOLIO 205
4.9.4 KEY DEVELOPMENTS 206
4.9.5 SWOT ANALYSIS 206
4.10 JSR CORPORATION 207
4.10.1 OVERVIEW 207
4.10.2 FINANCIALS 209
4.10.3 SERVICE PORTFOLIO 212
4.10.4 KEY DEVELOPMENTS 213
4.10.5 SWOT ANALYSIS 215
4.11 LONZA GROUP LTD. 216
4.11.1 OVERVIEW 216
4.11.2 FINANCIALS 218
4.11.3 SERVICE PORTFOLIO 221
4.11.4 KEY DEVELOPMENTS 222
4.11.5 SWOT ANALYSIS 226
4.12 MERCK KGAA 227
4.12.1 OVERVIEW 227
4.12.2 FINANCIALS 229
4.12.3 PRODUCT PORTFOLIO 232
4.12.4 KEY DEVELOPMENTS 235
4.12.5 SWOT ANALYSIS 237
4.13 RENTSCHLER BIOPHARMA SE 238
4.13.1 OVERVIEW 238
4.13.2 FINANCIALS 238
4.13.3 SERVICE PORTFOLIO 238
4.13.4 KEY DEVELOPMENTS 240
4.13.5 SWOT ANALYSIS 241
4.14 SAMSUNG BIOLOGICS CO. LTD. 242
4.14.1 OVERVIEW 242
4.14.2 FINANCIALS 244
4.14.3 SERVICE PORTFOLIO 247
4.14.4 KEY DEVELOPMENTS 248
4.14.5 SWOT ANALYSIS 252
4.15 THERMO FISHER SCIENTIFIC INC. 253
4.15.1 OVERVIEW 253
4.15.2 FINANCIALS 255
4.15.3 SERVICE PORTFOLIO 259
4.15.4 KEY DEVELOPMENTS 260
4.15.5 SWOT ANALYSIS 262
4.16 WUXI BIOLOGICS (CAYMAN) INC. 263
4.16.1 OVERVIEW 263
4.16.2 FINANCIALS 265
4.16.3 SERVICE PORTFOLIO 268
4.16.4 KEY DEVELOPMENTS 274
4.16.5 SWOT ANALYSIS 278
LIST OF TABLES

TABLE 1 CAPACITY COMPARISON OF CONTRACT MANUFACTURING ORGANIZATIONS V’S IN-HOUSE CAPACITIES (L) 45
TABLE 2 BIOLOGICS MANUFACTURED IN MAMMALIAN CELL CULTURE 55
TABLE 3 CONTRACT MANUFACTURING ORGANIZATIONS CAPACITY, BY PROCESS (L) 59
TABLE 4 BIOLOGICS MANUFACTURED IN MICROBIAL CELL CULTURE 63
TABLE 5 BIOMANUFACTURING OUTSOURCING GLOBAL MARKET, BY END USERS, (2019 -2028) ($BN) 67
TABLE 6 SELECTED FDA APPROVED THERAPEUTIC PEPTIDES AND PROTEINS 78
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