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Contract Biomanufacturing Services Global Market - Forecast to 2028

September 2020 | 279 pages | ID: C982A563259EN
IQ4I Research & Consultancy Pvt. Ltd.

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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.

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 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.

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.
1 CONTRACT BIOMANUFACTURING SERVICES GLOBAL MARKET

1.1 EXECUTIVE SUMMARY

2 MARKET ANALYSIS

2.1 FACTORS INFLUENCING MARKET
  2.1.1 DRIVERS AND OPPORTUNITIES
    2.1.1.1 Increasing trend of biomanufacturing outsourcing
    2.1.1.2 Advanced bioprocessing capabilities of contract biomanufacturers
    2.1.1.3 Emergence of advanced biotherapeutics
    2.1.1.4 Escalating approvals and adoption of biologics and biosimilars
    2.1.1.5 Increasing R&D expenditures of biopharma companies
    2.1.1.6 Increasing prevalence of chronic, autoimmune and communicable diseases
    2.1.1.7 Development of personalized and orphan indication therapies
  2.1.2 RESTRAINTS AND THREATS
    2.1.2.1 Increasing focus on in-house biologics manufacturing
    2.1.2.2 Huge capital investment for capacity and capability expansion
    2.1.2.3 Compliance with stringent regulatory guidelines
    2.1.2.4 Compliance with intellectual property rights of biopharma companies
    2.1.2.5 Competition and trend of outsourcing of low volume manufacturing

3 CONTRACT BIOMANUFACTURING SERVICES

3.1 INTRODUCTION
3.2 IN HOUSE VS CMO CAPACITY
  3.2.1 GLOBAL BIOMANUFACTURING CAPACITY
  3.2.2 BIOLOGICS CONTRACT MANUFACTURING ORGANIZATIONS, BY PHASE
3.3 CONTRACT BIOMANUFACTURING, BY PROCESS
  3.3.1 BIOMANUFACTURING BY MAMMALIAN CELL CULTURE
  3.3.2 MAMMALIAN CELL CULTURE BIOMANUFACTURING V/S MICROBIAL AND OTHER CELL CULTURES
  3.3.3 BIOMANUFACTURING BY MICROBIAL CELL CULTURE
    3.3.3.1 MICROBIAL CELL CULTURE CMO BIOMANUFACTURING CAPACITY
  3.3.4 BIOMANUFACTURING BY OTHER CELL CULTURE
3.4 CONTRACT BIOMANUFACTURING GLOBAL MARKET, BY END USERS
  3.4.1 CONTRACT BIOMANUFACTURING OF DIAGNOSTICS
  3.4.2 CONTRACT BIOMANUFACTURING OF RESEARCH REAGENTS
  3.4.3 CONTRACT BIOMANUFACTURING OF THERAPEUTICS
    3.4.3.1 Biomanufacturing of antibodies
    3.4.3.2 Biomanufacturing of recombinant proteins
    3.4.3.3 Biomanufacturing of vaccines
    3.4.3.4 Others (Cell therapy and Gene therapy)
3.5 BIOMANUFACTURING OUTSOURCING GLOBAL MARKET, BY REGION
3.6 CONTRACT BIOMANUFACTURING ORGANIZATION CAPACITY PENETRATION
3.7 COMPETITIVE LANDSCAPE
  3.7.1 CAPACITY COMPARISON
  3.7.2 CONTRACT MANUFACTURING GLOBAL MARKET SHARE, BY LEADING PLAYERS
  3.7.3 COMPANY DEVELOPMENTS
    3.7.3.1 Agreement
    3.7.3.1 Expansion
    3.7.3.1 Acquisition
    3.7.3.1 Collaboration and partnerships
    3.7.3.1 Product launch
    3.7.3.2 Facility approvals
    3.7.3.3 Other developments

4 COMPANY PROFILES

4.1 ABBVIE INC. (ABBVIE CONTRACT MANUFACTURING)
  4.1.1 OVERVIEW
  4.1.2 FINANCIALS
  4.1.3 SERVICE PORTFOLIO
  4.1.4 KEY DEVELOPMENTS
  4.1.5 SWOT ANALYSIS
4.2 ABZENA PLC
  4.2.1 OVERVIEW
  4.2.2 FINANCIALS
  4.2.3 SERVICE PORTFOLIO
  4.2.4 KEY DEVELOPMENTS
  4.2.5 SWOT ANALYSIS
4.3 AGC INC.
  4.3.1 OVERVIEW
  4.3.2 FINANCIALS
  4.3.3 SERVICE PORTFOLIO
  4.3.4 KEY DEVELOPMENTS
  4.3.5 SWOT ANALYSIS
4.4 BOEHRINGER INGELHEIM INTERNATIONAL GMBH
  4.4.1 OVERVIEW
  4.4.2 FINANCIALS
  4.4.3 SERVICE PORTFOLIO
  4.4.4 KEY DEVELOPMENTS
  4.4.5 SWOT ANALYSIS
4.5 CATALENT INC.
  4.5.1 OVERVIEW
  4.5.2 FINANCIALS
  4.5.3 SERVICE PORTFOLIO
  4.5.4 KEY DEVELOPMENTS
  4.5.5 SWOT ANALYSIS
4.6 CHARLES RIVER LABORATORIES INTERNATIONAL INC.
  4.6.1 OVERVIEW
  4.6.2 FINANCIALS
  4.6.3 SERVICE PORTFOLIO
  4.6.4 KEY DEVELOPMENTS
  4.6.5 SWOT ANALYSIS
4.7 COGNATE BIOSERVICES INC. (COBRA BIOLOGICS)
  4.7.1 OVERVIEW
  4.7.2 FINANCIALS
  4.7.3 SERVICE PORTFOLIO
  4.7.4 KEY DEVELOPMENTS
  4.7.5 SWOT ANALYSIS
4.8 FUJIFILM HOLDINGS CORPORATION (FUJIFILM DIOSYNTH BIOTECHNOL0GIES)
  4.8.1 OVERVIEW
  4.8.2 FINANCIALS
  4.8.3 SERVICE PORTFOLIO
  4.8.4 KEY DEVELOPMENTS
  4.8.5 SWOT ANALYSIS
4.9 GENSCRIPT BIOTECH CORPORATION
  4.9.1 OVERVIEW
  4.9.2 FINANCIALS
  4.9.3 SERVICE PORTFOLIO
  4.9.4 KEY DEVELOPMENTS
  4.9.5 SWOT ANALYSIS
4.10 JSR CORPORATION
  4.10.1 OVERVIEW
  4.10.2 FINANCIALS
  4.10.3 SERVICE PORTFOLIO
  4.10.4 KEY DEVELOPMENTS
  4.10.5 SWOT ANALYSIS
4.11 LONZA GROUP LTD.
  4.11.1 OVERVIEW
  4.11.2 FINANCIALS
  4.11.3 SERVICE PORTFOLIO
  4.11.4 KEY DEVELOPMENTS
  4.11.5 SWOT ANALYSIS
4.12 MERCK KGAA
  4.12.1 OVERVIEW
  4.12.2 FINANCIALS
  4.12.3 PRODUCT PORTFOLIO
  4.12.4 KEY DEVELOPMENTS
  4.12.5 SWOT ANALYSIS
4.13 RENTSCHLER BIOPHARMA SE
  4.13.1 OVERVIEW
  4.13.2 FINANCIALS
  4.13.3 SERVICE PORTFOLIO
  4.13.4 KEY DEVELOPMENTS
  4.13.5 SWOT ANALYSIS
4.14 SAMSUNG BIOLOGICS CO. LTD.
  4.14.1 OVERVIEW
  4.14.2 FINANCIALS
  4.14.3 SERVICE PORTFOLIO
  4.14.4 KEY DEVELOPMENTS
  4.14.5 SWOT ANALYSIS
4.15 THERMO FISHER SCIENTIFIC INC.
  4.15.1 OVERVIEW
  4.15.2 FINANCIALS
  4.15.3 SERVICE PORTFOLIO
  4.15.4 KEY DEVELOPMENTS
  4.15.5 SWOT ANALYSIS
4.16 WUXI BIOLOGICS (CAYMAN) INC.
  4.16.1 OVERVIEW
  4.16.2 FINANCIALS
  4.16.3 SERVICE PORTFOLIO
  4.16.4 KEY DEVELOPMENTS
  4.16.5 SWOT ANALYSIS

LIST OF TABLES

TABLE 1 CAPACITY COMPARISON OF CONTRACT MANUFACTURING ORGANIZATIONS V’S IN-HOUSE CAPACITIES (L)
TABLE 2 BIOLOGICS MANUFACTURED IN MAMMALIAN CELL CULTURE
TABLE 3 CONTRACT MANUFACTURING ORGANIZATIONS CAPACITY, BY PROCESS (L)
TABLE 4 BIOLOGICS MANUFACTURED IN MICROBIAL CELL CULTURE
TABLE 5 BIOMANUFACTURING OUTSOURCING GLOBAL MARKET, BY END USERS, (2019 -2028) ($BN)
TABLE 6 SELECTED FDA APPROVED THERAPEUTIC PEPTIDES AND PROTEINS
TABLE 7 BIOMANUFACTURING OUTSOURCING GLOBAL MARKET, BY REGION, (2019-2028) ($BN)
TABLE 8 AGREEMENT
TABLE 9 EXPANSION
TABLE 10 ACQUISITION
TABLE 11 COLLABORATION AND PARTNERSHIPS
TABLE 12 PRODUCT LAUNCH
TABLE 13 FACILITY APPROVALS
TABLE 14 OTHER DEVELOPMENTS
TABLE 15 COMPANY COMPARISON MATRIX, BY MANUFACTURING CAPABILITY
TABLE 16 ABBVIE INC.: TOTAL REVENUE AND R&D EXPENSES, (2018-2020) ($MN)
TABLE 17 ABBVIE INC.: TOTAL REVENUE, BY SEGMENTS, (2018-2020) ($MN)
TABLE 18 ABBVIE INC.: TOTAL REVENUE, BY GEOGRAPHY, (2018-2020) ($MN)
TABLE 19 AGC INC.: TOTAL REVENUE AND R&D EXPENSES, (2018-2020) ($MN)
TABLE 20 AGC INC.: TOTAL REVENUE, BY SEGMENTS, (2018-2020) ($MN)
TABLE 21 AGC INC.: CHEMICALS REVENUE, BY SUB-SEGMENTS, (2018-2020) ($MN)
TABLE 22 AGC INC.: TOTAL REVENUE, BY GEOGRAPHY, (2018-2020) ($MN)
TABLE 23 BOEHRINGER INGELHEIM: TOTAL REVENUE AND R&D EXPENSES, (2018-2020) ($MN)
TABLE 24 BOEHRINGER INGELHEIM: TOTAL REVENUE, BY SEGMENTS, (2018-2020) ($MN)
TABLE 25 BOEHRINGER INGELHEIM: TOTAL REVENUE, BY GEOGRAPHY, (2018-2020) ($MN)
TABLE 26 CATALENT INC: TOTAL REVENUE AND R&D EXPENSES (2018-2020) ($MN)
TABLE 27 CATALENT INC: TOTAL REVENUE, BY SEGMENT, (2018-2020) ($MN)
TABLE 28 CHARLES RIVER LABORATORIES: TOTAL REVENUE AND R&D EXPENSES, (2018-2020) ($MN)
TABLE 29 CHARLES RIVER LABORATORIES: TOTAL REVENUE, BY SEGMENTS, (2018-2020) ($MN)
TABLE 30 CHARLES RIVER LABORATORIES: TOTAL REVENUE, BY GEOGRAPHY, (2018-2020) ($MN)
TABLE 31 FUJIFILM HOLDINGS CORPORATION: TOTAL REVENUE AND R&D EXPENSES, (2018-2020) ($MN)
TABLE 32 FUJIFILM HOLDINGS CORPORATION: TOTAL REVENUE, BY SEGMENTS, (2018-2020) ($MN)
TABLE 33 FUJIFILM HOLDING CORPORATION: TOTAL REVENUE, BY GEOGRAPHY, (2018-2020) ($MN)
TABLE 34 GENSCRIPT BIOTECH CORPORATION: TOTAL REVENUE AND R&D EXPENSES, (2017-2019) ($MN)
TABLE 35 GENSCRIPT BIOTECH CORPORATION: TOTAL REVENUE, BY SEGMENTS, (2017-2019) ($MN)
TABLE 36 GENSCRIPT BIOTECH CORPORATION: TOTAL REVENUE, BY GEOGRAPHY, (2017-2019) ($MN)
TABLE 37 JSR CORPORATION: TOTAL REVENUE AND R&D EXPENSES, (2018-2020 (Q1)) ($MN)
TABLE 38 JSR CORPORATION: TOTAL REVENUE, BY SEGMENTS, (2018-2020 (Q1)) ($MN)
TABLE 39 JSR CORPORATION: TOTAL REVENUE, BY GEOGRAPHY, (2018-2020 (Q1)) ($MN)
TABLE 40 LONZA GROUP: TOTAL REVENUE & R&D EXPENSES (2018-2020) ($MN)
TABLE 41 LONZA GROUP: TOTAL REVENUE, BY SEGMENT, (2018-2020) ($MN)
TABLE 42 LONZA GROUP: TOTAL REVENUE, BY GEOGRAPHY (2018-2020) ($MN)
TABLE 43 MERCK KGAA: TOTAL REVENUE AND R&D EXPENSES, (2018-2020) ($MN)
TABLE 44 MERCK KGAA: TOTAL REVENUE, BY SEGMENTS, (2018-2020) ($MN)
TABLE 45 MERCK KGAA: TOTAL REVENUE, BY GEOGRAPHY, (2018-2020) ($MN)
TABLE 46 SAMSUNG BIOLOGICS CO., LTD: TOTAL REVENUE (2018-2020) ($MN)
TABLE 47 SAMSUNG BIOLOGICS: TOTAL REVENUE, BY GEOGRAPHY (2018-2020) ($MN)
TABLE 48 SAMSUNG BIOLOGICS: CONTRACT MANUFACTURING REVENUE, BY TYPE (2018-2020) ($MN)
TABLE 49 THERMO FISHER SCIENTIFIC INC.: TOTAL REVENUE AND R&D EXPENSES (2018-2020) ($MN)
TABLE 50 THERMO FISHER SCIENTIFIC INC.: TOTAL REVENUE, BY SEGMENT, (2018-2020) ($MN)
TABLE 51 THERMO FISHER SCIENTIFIC INC.: TOTAL REVENUE, BY PRODUCT TYPE, (2018-2020) ($MN)
TABLE 52 THERMO FISHER SCIENTIFIC INC.: TOTAL REVENUE, BY GEOGRAPHY (2018-2020) ($MN)
TABLE 53 WUXI BIOLOGICS: TOTAL REVENUE AND R&D EXPENSES, (2018-2020) ($MN)
TABLE 54 WUXI BIOLOGICS: TOTAL REVENUE, BY SEGMENTS, (2018-2020) ($MN)
TABLE 55 WUXI BIOLOGICS: TOTAL REVENUE, BY GEOGRAPHY, (2018-2020) ($MN)

LIST OF FIGURES

FIGURE 1 MARKET DYNAMICS
FIGURE 2 GLOBAL MANUFACTURING CAPACITY, CGMP V’S NON-CGMP, INHOUSE V’S CMO, (2019-2028)
FIGURE 3 CAPACITY UTILIZATION OF CONTRACT MANUFACTURING ORGANIZATIONS, BY STAGE (MILLION LITERS) (2018-2028)
FIGURE 4 BIOLOGICS CMO GLOBAL MARKET, BY PHASE, (2018-2028) ($BN)
FIGURE 5 BIOLOGICS CMO GLOBAL MARKET, BY PROCESS, (2018-2028) ($BN)
FIGURE 6 GLOBAL CAPACITY COMPARISON OF MAMMALIAN, MICROBIAL AND OTHER CULTURE SYSTEMS (MN L) (2018-2028)
FIGURE 7 CMO CAPACITY COMPARISON OF MAMMALIAN, MICROBIAL AND OTHER CULTURE SYSTEMS (MN L) (2018-2028)
FIGURE 8 BIO-MANUFACTURING OUTSOURCING GLOBAL MARKET, BY END USERS ($BN)
FIGURE 9 ADC PIPELINE FOR CANCER (2020)
FIGURE 10 MONOCLONAL ANTIBODY PIPELINE FOR NON-CANCER INDICATIONS (2020)
FIGURE 11 MONOCLONAL ANTIBODY PIPELINE FOR CANCER (2020)
FIGURE 12 OUTLOOK OF BIOLOGICS CMO GLOBAL MARKET SHARE, BY REGION 2020 (%) AND MANUFACTURING IN METRIC TONS, (2019-2028)
FIGURE 13 CONTRACT BIOMANUFACTURING CAPACITY PENETRATION (2020)
FIGURE 14 CAPACITY COMPARISION OF TOP 15 CONTRACT MANUFACTURING ORGANIZATIONS (L)
FIGURE 15 CONTRACT BIOMANUFACTURING SERVICES GLOBAL MARKET SHARE ANALYSIS, BY MAJOR PLAYERS, 2020 (%)
FIGURE 16 KEY DEALS (2019 – 2020)
FIGURE 17 OVERVIEW: ABBVIE INC.
FIGURE 18 SWOT: ABBVIE CONTRACT MANUFACTURING
FIGURE 19 SWOT: ABZENA PLC
FIGURE 20 OVERVIEW: AGC INC.
FIGURE 21 SWOT: AGC INC.
FIGURE 22 OVERVIEW: BOEHRINGER INGELHEIM
FIGURE 23 SWOT: BOEHRINGER INGELHEIM
FIGURE 24 OVERVIEW: CATALENT INC.
FIGURE 25 SWOT: CATALENT INC.
FIGURE 26 OVERVIEW: CHARLES RIVER LABORATORIES
FIGURE 27 SWOT: CHARLES RIVER LABORATORIES
FIGURE 28 SWOT: COGNATE BIOSERVICES INC.
FIGURE 29 OVERVIEW: FUJIFILM HOLDING CORPORATION
FIGURE 30 SWOT: FUJIFILM HOLDING CORPORATION
FIGURE 31 OVERVIEW: GENSCRIPT BIOTECH CORPORATION
FIGURE 32 SWOT: GENSCRIPT BIOSCIENCES CORPORATION
FIGURE 33 OVERVIEW: JSR CORPORATION
FIGURE 34 SWOT: JSR CORPORATION
FIGURE 35 OVERVIEW: LONZA GROUP
FIGURE 36 SWOT: LONZA GROUP
FIGURE 37 OVERVIEW: MERCK KGAA
FIGURE 38 SWOT: MERCK KGAA
FIGURE 39 SWOT: RENTSCHLER BIOPHARMA
FIGURE 40 OVERVIEW: SAMSUNG BIOLOGICS
FIGURE 41 SWOT: SAMSUNG BIOLOGICS
FIGURE 42 OVERVIEW: THERMO FISHER SCIENTIFIC INC.
FIGURE 43 SWOT: THERMO FISHER SCIENTIFIC
FIGURE 44 OVERVIEW: WUXI BIOLOGICS
FIGURE 45 SWOT: WUXI BIOLOGICS


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