Biologics Drug Substance Manufacturing - Market Insights, Competitive Landscape, and Market Forecast - 2032
상품코드:1656912
리서치사:DelveInsight
발행일:On Demand Report
페이지 정보:영문 150 Pages
라이선스 & 가격 (부가세 별도)
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한글목차
생물제제 원료의약품 제조 시장 규모는 2024년 4,363억 6,000만 달러에 달했습니다. 이 시장은 2025년부터 2032년까지 예측 기간 동안 10.59%의 연평균 복합 성장률(CAGR)로 성장하여 2032년에는 9억 6,832만 달러에 달할 것으로 예상됩니다. 생물제제 원료의약품 제조 시장은 주로 만성질환의 확산으로 인해 생물제제 개발 및 제조 수요가 증가하면서 큰 성장을 보이고 있습니다. 이러한 긍정적인 성장의 주요 요인으로는 생물제제 제조의 기술적 진보, 연구개발 활동의 활성화, 업계 대기업의 제품 출시 급증 등을 꼽을 수 있습니다. 또한, 생물제제의 채택이 확대되고 있는 것도 시장 확대에 힘을 실어주고 있습니다. 이러한 요인들은 2025년부터 2032년까지 생물제제 원료의약품 제조 시장의 성장에 매우 중요한 역할을 할 것으로 예상됩니다.
GLOBOCAN이 2023년에 제공한 최신 데이터에 따르면, 2022년 신규 암 환자 수는 2,000만 명으로 추정되며, 2045년에는 전 세계적으로 3,260만 명으로 증가할 것으로 예상됩니다.
또한, 2023년 영국 암 조사 최신 데이터에 따르면, 영국에서 연간 38만 5,000명 이상의 신규 암 환자가 보고되고 있습니다. 이 놀라운 통계는 효과적인 치료 옵션의 시급한 필요성을 강조하고 있습니다. 생물제제는 다양한 암종에 대처하기 위한 유망하고 혁신적인 접근법으로 인식되고 있으며, 이는 생물제제에 대한 수요 증가에 크게 기여하고 있습니다.
2023년 국제당뇨병연맹의 데이터에 따르면, 2021년 20세에서 79세 사이의 성인 중 약 5억 3,700만 명이 당뇨병을 앓고 있습니다. 이 수치는 2030년에는 6억 4,300만 명, 2045년에는 7억 8,300만 명으로 증가할 것으로 예측됩니다.
2022년 세계비만연맹의 자료에 따르면, 2023년까지 전 세계적으로 약 10억 명(여성 5명 중 1명, 남성 7명 중 1명)이 비만과 함께 살아갈 것으로 예측되고 있습니다. 이러한 비만 증가는 장기적이고 지속적인 치료가 필요한 만성질환 증가와도 밀접한 관련이 있습니다. 그 결과, 생물제제에 대한 안정적인 수요가 발생하여 시장 성장을 크게 견인하고 있습니다.
2024년 7월 세계보건기구(WHO) 데이터에 따르면, 2023년 전 세계 영유아의 약 84%, 약 1억 800만 명이 디프테리아, 파상풍, 백일해(DTP3) 백신을 3회 접종할 것으로 예상되며, 이는 감염성 질환에 대한 중요한 예방책이 될 것으로 예상됩니다.에 대한 중요한 예방책이 되고 있습니다. 이러한 백신의 이용과 수용 증가는 생물제제의 원료의약품 제조 수요를 촉진하고 시장 확대를 촉진하고 있습니다.
이 시장의 주요 기업들은 생물제제 제조를 강화하기 위한 혁신 기술에 집중하고 있습니다. 예를 들어, 2024년 10월 Forge Biologics는 FUEL(TM) 제조 플랫폼의 출시를 발표했습니다. 이 플랫폼은 AAV 유전자 치료제 개발자들이 새로운 프로그램을 진행하고 더 광범위한 질병을 대상으로 할 때 보다 효율적이고 신속한 제조거점을 제공하도록 설계되었습니다.
세계의 생물제제 원료의약품 제조 시장에 대해 조사했으며, 시장 개요와 함께 생물제제 유형별, 제조별, 제조원료별, 지역별 동향, 시장 진출 기업 프로파일 등의 정보를 전해드립니다.
목차
제1장 생물제제 원료의약품 제조 시장 보고서 서론
제2장 생물제제 원료의약품 제조 시장 주요 요약
제3장 경쟁 구도
제4장 규제 분석
미국
유럽
일본
중국
제5장 생물제제 원료의약품 제조 시장의 주요 요인 분석
생물제제 원료의약품 제조 시장 성장 촉진요인
생물제제 원료의약품 제조 시장 성장 억제요인과 과제
생물제제 원료의약품 제조 시장 기회
제6장 생물제제 원료의약품 제조 시장 : Porter의 Five Forces 분석
제7장 생물제제 원료의약품 제조 시장 평가
생물제제 유형별
단일클론항체
재조합 단백질
성장호르몬
백신
치료용 효소
기타
제조별
사내
아웃소싱
제조 원료별
세포주/세포배양
유전자 공학
미생물 발효
지역별
북미
유럽
아시아태평양
기타 지역
제8장 생물제제 원료의약품 제조 시장 기업과 제품 개요
Lonza
Pfizer Inc.
Catalent, Inc
Boehringer Ingelheim International GmbH
Samsung Biologics
WuXi AppTec
Thermo Fisher Scientific Inc.
Asahi Kasei Corporation
Recipharm AB
Evotec
Novo Nordisk A/S
Siegfried Holding AG
Enzene Biosciences Ltd.
Forge Biologics
BeiGene LTD.
FUJIFILM Holdings Corporation
TOYOBO CO., LTD.
AJINOMOTO CO., INC.
Biocon
Eurofins Scientific
제9장 KOL(Key Opinion Leader)의 견해
제10장 프로젝트 접근
제11장 DelveInsight에 대해
제12장 면책사항과 문의
LSH
영문 목차
영문목차
Biologics Drug Substance Manufacturing Market by Biologics Type (Monoclonal Antibodies, Recombinant Protein, Growth Hormones, Vaccines, Therapeutic Enzyme, and Others), Manufacturing (In-house and Outsourced), Production Source (Cell Line/Cell Culture, Genetic Engineering, and Microbial Fermentation), and Geography (North America, Europe, Asia-Pacific, and Rest of the World) is expected to grow at a steady CAGR forecast till 2032 owing to the growing prevalence chronic diseases and technological advancements in biologics manufacturing
The biologics drug substance manufacturing market was valued at USD 436.36 billion in 2024, growing at a CAGR of 10.59% during the forecast period from 2025 to 2032 to reach USD 968.32 million by 2032. The market for biologics drug substance manufacturing is experiencing significant growth, primarily driven by the increasing prevalence of chronic diseases, which is fueling the demand for biologics development and manufacturing. Key factors contributing to this positive trajectory include technological advancements in biologics manufacturing, a rise in research and development activities, and a surge in product launches by leading industry players. Additionally, the growing adoption of biologic drugs is further propelling market expansion. These factors are expected to play a pivotal role in the growth of the biologics drug substance manufacturing market from 2025 to 2032.
Biologics Drug Substance Manufacturing Market Dynamics:
The growing prevalence of chronic disease is expected to drive the market growth. According to recent data provided by GLOBOCAN in 2023, the estimated new number of cancer cases was 20 million in 2022, and the projection is estimated to increase to 32.6 million by 2045 around the world.
Furthermore, according to recent data from Cancer Research UK in 2023, over 385,000 new cancer cases are reported annually in the United Kingdom. This alarming statistic underscores the urgent need for effective treatment options. Biologics are recognized as a promising and innovative approach for addressing various cancer types, significantly contributing to the growing demand for biologic drugs.
The data from the International Diabetes Federation in 2023, indicates that approximately 537 million adults aged 20 to 79 were living with diabetes in 2021. This figure is projected to escalate to 643 million by 2030 and 783 million by 2045 globally.
According to the data from World Obesity Federation in 2022, it was projected that, approximately 1 billion people, representing 1 in 5 women and 1 in 7 men, will be living with obesity by 2023 across the globe. This rise in obesity is closely linked to the increasing incidence of chronic diseases, which require long-term and continuous treatment. As a result, there is a consistent demand for biologic drugs, significantly driving market growth.
The growing adoption of biologics, particularly vaccines, is expected to significantly propel market growth. According to the data from the World Health Organization in July 2024, approximately 84% of infants worldwide; around 108 million received three doses of the diphtheria-tetanus-pertussis (DTP3) vaccine in 2023, providing crucial protection against infectious diseases. This increasing utilization and acceptance of vaccines is driving demand for biologics drug substance manufacturing, thereby fostering market expansion.
Key players in the market are focusing on innovative technologies to enhance biologics manufacturing. For instance, in October 2024, Forge Biologics announced the launch of its FUEL(TM) manufacturing platform, designed to offer AAV gene therapy developers a more efficient and accelerated foundation for production as they advance new programs and target a broader range of diseases.
Additionally, major players are expanding their capabilities in biologics manufacturing through strategic mergers and acquisitions. For instance, in October 2024, Lonza completed its acquisition of the Genentech large-scale biologics manufacturing site in Vacaville, California, from Roche for USD 1.2 billion. This acquisition significantly enhances Lonza's capacity for mammalian manufacturing in the United States. Such strategic moves by key players are expected to further stimulate market growth.
However, the high development and production costs of biologics and stringent regulatory requirements, among others are some of the key constraints that may limit the growth of the biologics drug substance manufacturing market.
Biologics Drug Substance Manufacturing Market Segment Analysis:
Biologics Drug Substance Manufacturing Market by Biologics Type (Monoclonal Antibodies, Recombinant Protein, Growth Hormones, Vaccines, Therapeutic Enzyme, and Others), Manufacturing (In-house and Outsourced), Production Source (Cell Line/Cell Culture, Genetic Engineering, and Microbial Fermentation), and Geography (North America, Europe, Asia-Pacific, and Rest of the World)
In the biologics type segment of the biologics drug substance manufacturing market, the monoclonal antibodies category is estimated to account for the largest market share in the biologics drug substance manufacturing market in 2024. This can be attributed to the growing prevalence of cancer and infectious diseases, among other factors. According to recent data from the Global Burden of Disease (2023), approximately 1 in 20 people globally suffer from chronic respiratory diseases. Furthermore, data from GLOBOCAN indicates that in 2022, there were an estimated 2.48 million new cases of trachea, bronchus, and lung cancer worldwide, with projections expected to rise to 4.25 million by 2045. Monoclonal antibodies are increasingly utilized in targeted cancer therapy, making the rising prevalence of cancer a significant driver of demand for these biologics. Consequently, this heightened demand is propelling the capabilities of biologics drug substance manufacturing, leading to robust market growth.
Major players in the market are increasingly focusing on the development of innovative technologies to enhance their monoclonal antibody manufacturing capabilities. For instance, in April 2024, Evotec Biologics launched the J.CHO(TM) high expression system, designed for the continuous manufacturing of antibodies. As part of Evotec Biologics' advanced continuous bioprocessing platform, J.CHO(TM) optimizes both clinical and commercial biologics production processes by delivering higher productivity and ensuring the high quality of complex antibody formats, including candidate antibodies, Fc-fusions, and bispecific antibodies. This innovation is expected to significantly contribute to the efficiency and effectiveness of monoclonal antibody manufacturing, thereby promoting market growth.
North America is expected to dominate the overall biologics drug substance manufacturing market:
North America is projected to account for leading market share in the biologics drug substance manufacturing market among all regions, in 2024. The growth of the biologics market in the region is primarily driven by an increasing patient population affected by chronic diseases such as cancer and diabetes. Additionally, the rising geriatric population, which is more susceptible to developing chronic conditions, further fuels this growth. Increased research and development activities by key players, along with the growing adoption of biologic drugs, are also significant contributors. Collectively, these factors are driving the expansion of the biologics drug substance manufacturing market in North America.
According to the American Cancer Society's Cancer Facts & Figures in 2024, nearly 2 million new cancer cases were expected to be diagnosed in the United States in 2024, up from 1.9 million in 2023.
According to the data from the GLOBOCAN in 2024, North America saw an estimated number of 2,673,174 million new cases of cancer in 2022, with forecasts indicating a rise to 3,828,805 million by 2045. Chronic conditions such as cancer and autoimmune diseases can be treated with biologics and specialty drugs, which are complex molecules and require advanced manufacturing processes. Therefore, the increasing prevalence of cancer is driving the market growth.
Also, according to data from the American Diabetes Association (2023), approximately 38.4 million people, or 11.6% of the population, were living with diabetes in 2021 in the United States. Among these individuals, 29.7 million had received a diagnosis, while an estimated 8.7 million were undiagnosed. The rising prevalence of such conditions has driven demand for more effective treatments. Biologics are increasingly used in these areas due to their specificity and lower toxicity compared to small-molecule drugs.
The growing number of chronic diseases such as cancer requires the development of novel biological drugs for effective treatment, which leads to increased biological drug substance manufacturing, thereby driving the market growth.
Key players in the region are actively establishing biological manufacturing facilities to strengthen their market position. For instance, in July 2024, BeiGene Ltd. announced the opening of its flagship U.S. facility in Hopewell, N.J., located at the Princeton West Innovation Campus. This facility boasts state-of-the-art biologics manufacturing capabilities, alongside a clinical research and development center that enhances the company's reputation as an oncology innovator. The site features approximately 400,000 square feet dedicated to commercial-stage biologic pharmaceutical manufacturing, with the capacity for future expansion. Such activities are expected to drive the market growth in the region.
Therefore, the above-mentioned factors will contribute to the growth of the biologics drug substance manufacturing market in North America.
Biologics Drug Substance Manufacturing Market Key Players:
Some of the key market players operating in the biologics drug substance manufacturing market include Lonza, Pfizer Inc., Catalent, Inc., Boehringer Ingelheim International GmbH, Samsung Biologics, WuXi AppTec, Thermo Fisher Scientific Inc., Asahi Kasei Corporation, Recipharm AB, Evotec, Novo Nordisk A/S, Siegfried Holding AG, Enzene Biosciences Ltd., Forge Biologics, BeiGene LTD., FUJIFILM Holdings Corporation, TOYOBO CO., LTD., AJINOMOTO CO., INC., Biocon, Eurofins Scientific, and others.
Recent Developmental Activities in the Biologics Drug Substance Manufacturing Market:
In September 2024, Samsung Biologics launched biologics' innovative development platforms - S-AfuCHOTM and S-OptiChargeTM. S-AfuCHOTM is an innovative cell line platform designed to produce fucosylated antibodies, which demonstrate enhanced antibody-dependent cellular cytotoxicity (ADCC) activity, leading to increased therapeutic efficacy. In parallel, S-OptiChargeTM serves as an upstream process platform capable of modulating a molecule's charge variant distribution.
In June 2024, Bionova Scientific, a U.S.-based biologics contract development and manufacturing organization (CDMO) within the Asahi Kasei Group, announced plans to establish a new facility in Texas. This expansion aims to enhance its capabilities in biologics manufacturing and support the growing demand for biopharmaceutical products.
In January 2024, Enzene Biosciences announced the launch of its first manufacturing site in the United States, situated in Hopewell, near Princeton, New Jersey. The company has leased 54,000 square feet of space to accommodate multiple manufacturing lines utilizing its continuous manufacturing technology platform, EnzeneX(TM). This facility is designed to integrate Enzene's patented EnzeneX(TM) platform, allowing for efficient and scalable production of biologics.
In October 2023, WuXi Biologics announced the launch of its new proprietary bioprocessing platform, WuXiUITM. This ultra-intensified, fed-batch solution is designed to enhance the productivity and quality of various CHO (Chinese Hamster Ovary) and other mammalian cell lines, as well as different product modalities. The WuXiUITM platform significantly improves both productivity and quality while reducing the cost of goods sold (COGS) in commercial manufacturing.
Key Takeaways from the Biologics Drug Substance Manufacturing Market Report Study
Market size analysis for current Biologics Drug Substance Manufacturing Market size (2024), and market forecast for 8 years (2025 to 2032)
Top key product/technology developments, mergers, acquisitions, partnerships, and joint ventures happened for the last 3 years
Key companies dominating the Biologics Drug Substance Manufacturing market.
Various opportunities available for the other competitors in the Biologics Drug Substance Manufacturing Market space.
What are the top-performing segments in 2024? How these segments will perform in 2032?
Which are the top-performing regions and countries in the current Biologics Drug Substance Manufacturing market scenario?
Which are the regions and countries where companies should have concentrated on opportunities for Biologics Drug Substance Manufacturing market growth in the coming future?
Target Audience who can be benefited from this Biologics Drug Substance Manufacturing Market Report Study
Biologics Drug Substance Manufacturing product providers
Research organizations and consulting companies
Biologics Drug Substance Manufacturing related organizations, associations, forums, and other alliances
Government and corporate offices
Start-up companies, venture capitalists, and private equity firms
Distributors and Traders dealing in Biologics Drug Substance Manufacturing
Various end-users who want to know more about the Biologics Drug Substance Manufacturing Market and the latest technological developments in the Biologics Drug Substance Manufacturing Market.
Frequently Asked Questions for the Biologics Drug Substance Manufacturing Market:
1. What are Biologics Drug Substance Manufacturing?
Biologics drug substance manufacturing is the process of producing biologic drugs, which are medicines made from living organisms. This includes growing cells to produce proteins, purifying those proteins, and preparing them for use in treatments, like vaccines or therapies for diseases.
2. What is the market for Biologics Drug Substance Manufacturing?
The biologics drug substance manufacturing market was valued at USD 436.36 billion in 2024, growing at a CAGR of 10.59% during the forecast period from 2025 to 2032 to reach USD 968.32 million by 2032.
3. What are the drivers for the Biologics Drug Substance Manufacturing market?
The biologics drug substance manufacturing market is poised for significant growth, driven by factors such as the rising prevalence of chronic diseases which is fueling the demand for biologics development and manufacturing. Key factors contributing to this positive trajectory include technological advancements in biologics manufacturing, a rise in research and development activities, and a surge in product launches by leading industry players. Additionally, the growing adoption of biologic drugs is further propelling market expansion. These factors are expected to play a pivotal role in the growth of the biologics drug substance manufacturing market from 2025 to 2032.
4. Who are the key players operating in the Biologics Drug Substance Manufacturing market?
Some of the key market players operating in the biologics drug substance manufacturing market include Lonza, Pfizer Inc., Catalent, Inc., Boehringer Ingelheim International GmbH, Samsung Biologics, WuXi AppTec, Thermo Fisher Scientific Inc., Asahi Kasei Corporation, Recipharm AB, Evotec, Novo Nordisk A/S, Siegfried Holding AG, Enzene Biosciences Ltd., Forge Biologics, BeiGene LTD., FUJIFILM Holdings Corporation, TOYOBO CO., LTD., AJINOMOTO CO., INC., Biocon, Eurofins Scientific, and others.
5. Which region has the highest share in the Biologics Drug Substance Manufacturing market?
North America is projected to account for the leading market share in the biologics drug substance manufacturing market among all regions, in 2024. The growth of the biologics market in the region is primarily driven by an increasing patient population affected by chronic diseases such as cancer and diabetes. Additionally, the rising geriatric population, which is more susceptible to developing chronic conditions, further fuels this growth. Increased research and development activities by key players, along with the growing adoption of biologic drugs, are also significant contributors. Collectively, these factors are driving the expansion of the biologics drug substance manufacturing market in North America.
Table of Contents
1. Biologics Drug Substance Manufacturing Market Report Introduction
1.1. Scope of the Study
1.2. Market Segmentation
1.3. Market Assumption
2. Biologics Drug Substance Manufacturing Market Executive Summary
2.1. Market at Glance
3. Competitive Landscape
4. Regulatory Analysis
4.1. The United States
4.2. Europe
4.3. Japan
4.4. China
5. Biologics Drug Substance Manufacturing Market Key Factors Analysis
5.1. Biologics Drug Substance Manufacturing Market Drivers
5.1.1. The growing prevalence of chronic diseases
5.1.2. Technological advancements in biologics manufacturing
5.1.3. Rise in R&D activities and a surge in product launches by leading industry players
5.1.4. The growing adoption of biologic drugs
5.2. Biologics Drug Substance Manufacturing Market Restraints and Challenges
5.2.1. High development and production costs of biologics
5.2.2. Stringent regulatory requirements
5.3. Biologics Drug Substance Manufacturing Market Opportunity
5.3.1. Integration of automation and smart manufacturing
5.3.2. Growing emphasis on personalized medicine
6. Biologics Drug Substance Manufacturing Market Porter's Five Forces Analysis
6.1. Bargaining Power of Suppliers
6.2. Bargaining Power of Consumers
6.3. Threat of New Entrants
6.4. Threat of Substitutes
6.5. Competitive Rivalry
7. Biologics Drug Substance Manufacturing Market Assessment
7.1. By Biologics Type
7.1.1. Monoclonal Antibodies
7.1.2. Recombinant Protein
7.1.3. Growth Hormones
7.1.4. Vaccines
7.1.5. Therapeutic Enzyme
7.1.6. Others
7.2. By Manufacturing
7.2.1. In-house
7.2.2. Outsourced
7.3. By Production Source
7.3.1. Cell Line/Cell Culture
7.3.2. Genetic Engineering
7.3.3. Microbial Fermentation
7.4. By Geography
7.4.1. North America
7.4.1.1. United States Biologics Drug Substance Manufacturing Market Size in USD million (2022-2032)
7.4.1.2. Canada Biologics Drug Substance Manufacturing Market Size in USD million (2022-2032)
7.4.1.3. Mexico Biologics Drug Substance Manufacturing Market Size in USD million (2022-2032)
7.4.2. Europe
7.4.2.1. France Biologics Drug Substance Manufacturing Market Size in USD million (2022-2032)
7.4.2.2. Germany Biologics Drug Substance Manufacturing Market Size in USD million (2022-2032)
7.4.2.3. United Kingdom Biologics Drug Substance Manufacturing Market Size in USD million (2022-2032)
7.4.2.4. Italy Biologics Drug Substance Manufacturing Market Size in USD million (2022-2032)
7.4.2.5. Spain Biologics Drug Substance Manufacturing Market Size in USD million (2022-2032)
7.4.2.6. Rest of Europe Biologics Drug Substance Manufacturing Market Size in USD million (2022-2032)
7.4.3. Asia-Pacific
7.4.3.1. China Biologics Drug Substance Manufacturing Market Size in USD million (2022-2032)
7.4.3.2. Japan Biologics Drug Substance Manufacturing Market Size in USD million (2022-2032)
7.4.3.3. India Biologics Drug Substance Manufacturing Market Size in USD million (2022-2032)
7.4.3.4. Australia Biologics Drug Substance Manufacturing Market Size in USD million (2022-2032)
7.4.3.5. South Korea Biologics Drug Substance Manufacturing Market Size in USD million (2022-2032)
7.4.3.6. Rest of Asia-Pacific Biologics Drug Substance Manufacturing Market Size in USD million (2022-2032)
7.4.4. Rest of the World (RoW)
7.4.4.1. Middle East Biologics Drug Substance Manufacturing Market Size in USD million (2022-2032)
7.4.4.2. Africa Biologics Drug Substance Manufacturing Market Size in USD million (2022-2032)
7.4.4.3. South America Biologics Drug Substance Manufacturing Market Size In USD Million (2022-2032)
8. Biologics Drug Substance Manufacturing Market Company and Product Profiles
