세계의 바이오의약품 수탁 제조 시장 규모는 2025년 474억 2,000만 달러로 추정되며, 예측 기간 중(2025-2030년) CAGR 13.68%로 확대되어, 2030년에는 900억 2,000만 달러에 달할 것으로 예측됩니다.
COVID-19 팬데믹은 바이오 의약품 수탁 제조 시장에 큰 영향을 미쳤습니다. 2022년 2월 Contract Pharma 잡지의 기사에 따르면, COVID-19 팬데믹은 세계의 바이오 의약품 CMO에서 2 년간의 막대한 일을 빼앗았습니다. 또한 2021년년 6월 BioProcess International에 게재된 기사에 따르면, 유행에 의해 박차가 가해진 CMO의 생산 능력 증가는 산업 전체, 특히 세포 치료와 유전자 치료의 생산에 이익을 가져올 것으로 예상되고 있습니다.
또한 일부 바이오 의약품 CMO는 단백질, 펩타이드, 항체, 백신 및 기타 생물학적 물질의 경우 의약품 제조에서 의약품 제조에 이르는 서비스를 다른 조직에 제공합니다. 2022년 3월 Bharat BIoTech는 스페인 바이오 제약 회사 Biofabri와 제휴하여 새로운 결핵 백신을 개발, 제조 및 판매하기 시작했습니다. 이 새로운 결핵 백신 MTBVAC는 사라고사 대학, 국제 에이즈 백신 이니셔티브(IAVI), 결핵 백신 및 이니셔티브(TBVI)와의 긴밀한 협력하에 Biofabri에 의해 제조 및 개발되고 있습니다. BioPharma Solutions는 Novavax의 COVID-19 재조합 나노입자 백신 후보인 NVX-CoV2373(매트릭스-M 애주번트 포함)의 무균 제조 서비스를 제공하기로 합의했습니다. 약에 따라 영국과 유럽 시장에서의 백신의 제조 및 판매에 필수적인 상업규모의 제조가 진행될 것으로 기대되고 있습니다.
게다가 수탁 제조 파트너십과 같은 시장 진출기업에 의한 전략적 이니셔티브는 조사 대상 시장의 성장을 뒷받침할 것으로 예상됩니다.
그러나 엄격한 규제 요건과 물류 비용 증가가 이 시장의 성장을 방해하는 요인이 되고 있습니다.
바이오 의약품 수탁 제조 시장에서는 백신 부문이 큰 점유율을 차지하고 있습니다.
COVID-19 팬데믹은 백신 제조와 아웃소싱이 이 시장에서 사업을 전개하는 기업에게 서스테인블 수익원이 될 가능성을 나타냈습니다. Novartis는 fizer-BioNTech의 COVID-19 백신을 채우고 마무리하는 지원을 확대하여 COVID-19 팬데믹에 대처하기 위해 제조 능력과 능력을 사용하는 첫 번째 합의를 발표했습니다. Novartis는 슬로베니아의 류블라냐에 있는 Novartis Technical Operations 공장의 무균 제조 능력을 이용하여 2022년에 최소 2,400만 명분을 완성할 예정이었습니다.
게다가, 모든 사람들에게 예방접종을 제공하기 위한 세계의 다양한 정부나 보건기구에 의한 이니셔티브도 조사된 시장의 성장에 기여하고 있습니다. 이에 따라 지부티에서 약 15만 명의 유아에게 백신을 접종하는 5일간의 전국 폴리오 백신 캠페인을 시작했습니다.
제품 출시, 합병, 인수 등 시장 진출 기업이 채용하는 다양한 전략은 이 부문의 성장을 뒷받침할 것으로 예상됩니다.
이와 같이, 이 부문은 상기의 요인으로부터 예측 기간 중에 큰 성장을 이룰 것으로 예상됩니다.
북미 내에서는 미국이 바이오 의약품 수탁 제조 시장에서 큰 시장 점유율을 차지할 것으로 예상됩니다. 미국에서는 2021년 중 결핵 이환율이 전년대비 9.4%(10만명당 2.4명) 증가했습니다.
또한 2021년 3월 Baxter International Inc.는 Baxter BioPharma Solutions(BPS)와 2021년에 약 6,000만-9,000만 용량의 Modernna COVID-19 백신 충전 및 마무리 무균 제조 서비스를 제공하고 포장을 공급하기로 합의했습니다.
이와 같이 위의 요인으로부터 예측기간 동안 이 시장은 이 지역에서 큰 성장이 예상됩니다.
바이오 의약품 수탁 제조 시장은 통합되어 소수의 대기업으로 구성되어 있습니다. 시장 점유율에서는 현재 특정 대기업이 시장을 독점하고 있습니다. 현재 시장을 독점하고 있는 기업에는 Boehringer Ingelheim GmbH, Lonza, Inno Biologics Sdn Bhd, Rentschler Biotechnologies GmbH, JRS Pharma (Celonic), Samsung BioLogics, WuXi Biologics, AGC Biologics, ProBioGen AG, FUJIFILM Diosynth BIoTechnologies USA Inc. 등이 있습니다.
The Biopharmaceuticals Contract Manufacturing Market size is estimated at USD 47.42 billion in 2025, and is expected to reach USD 90.02 billion by 2030, at a CAGR of 13.68% during the forecast period (2025-2030).
The COVID-19 pandemic had a significant impact on the biopharmaceuticals contract manufacturing market. Contracts related to the COVID-19 pandemic immensely benefited the contract development and manufacturing organization (CDMO) industry. According to an article in Contract Pharma, dated February 2022, the COVID-19 pandemic took two years of tremendous work from the world's biopharmaceutical CMO. The industry's resilience is demonstrated by the astonishing speed with which it overcame the obstacles. The article also stated that revenues at biopharmaceutical CDMOs increased for recombinant proteins, vaccines, monoclonal antibodies, and mainstream biologics by an average of 29%. In fact, some have reported a growth of up to 40%-80% in revenue between 2020 and 2021. In addition, according to an article published in June 2021 in BioProcess International, the increases in CMO capacity spurred by the pandemic are anticipated to benefit the entire industry, especially for the production of cell and gene therapies. The COVID-19 pandemic boosted an already upward-trending biopharmaceutical CMO category. The long-term baseline growth pattern is expected to continue.
Furthermore, several biopharmaceutical CMOs offer services from drug production to drug manufacturing for other organizations in the case of proteins/peptides, antibodies, vaccines, and other biological substances. For instance, in March 2022, Bharat Biotech partnered with the Spanish biopharmaceutical firm, Biofabri, to develop, manufacture, and market a new tuberculosis vaccine. The new TB vaccine, 'MTBVAC,' is being manufactured and developed by Biofabri in close collaboration with the University of Zaragoza, the International AIDS Vaccine Initiative (IAVI), and the Tuberculosis Vaccine Initiative (TBVI). In September 2021, Baxter BioPharma Solutions, a CMO specializing in parenteral (injectable) pharmaceuticals, agreed to provide sterile manufacturing services for NVX-CoV2373, Novavax's COVID-19 recombinant nanoparticle vaccine candidate with Matrix-M adjuvant. The agreement is expected to advance commercial-scale manufacturing essential for the vaccine's production and distribution in the UK and European markets. Such activities by the market players are expected to boost the growth of the vaccine contract manufacturing market during the study period.
Moreover, strategic initiatives by the market players, such as contract manufacturing partnerships, are expected to boost the growth of the market studied. For instance, in April 2022, ChimeronBio announced that it had signed a manufacturing agreement with FUJIFILM DiosynthBiotechnologies (FDB) to advance its oncology portfolio to include clinics. ChimeronBio opted for FUJIFILM DiosynthBiotechnologies as its partner for transferring and scaling its drug substance manufacturing process.
However, stringent regulatory requirements and increasing logistics costs are factors hindering the growth of the market studied.
The vaccine segment holds a significant market share in the biopharmaceuticals contract manufacturing market. It is anticipated to showcase a similar trend over the forecast period owing to increasing advancements in monoclonal antibody therapy.
The COVID-19 pandemic indicated the potential of vaccine manufacturing and outsourcing as a sustainable revenue stream for companies operating in the market studied. Following the COVID-19 vaccine, the introduction of boosters is expected to create a favourable landscape for the growth of CMO vendors. For instance, in October 2021, Novartis announced an initial agreement to use its manufacturing capacity and capabilities to address the COVID-19 pandemic by expanding its support of the Pfizer-BioNTech COVID-19 vaccine fill and finish. Novartis was set to complete at least 24 million doses in 2022 using its sterile production capabilities at the Novartis Technical Operations plant in Ljubljana, Slovenia. Thus, the increase in CMO agreement for COVID-19 vaccines is expected to boost the growth of the segment.
Besides, initiatives by various governments and health organizations worldwide to provide vaccinations to all people also contribute to the growth of the market studied. For instance, as per the WHO, in February 2022, Djibouti's Ministry of Health, with technical support from the WHO and UNICEF, launched a five-day national polio vaccination campaign to vaccinate approximately 150,000 children in Djibouti. These vaccine drives focusing on the preventive measures for various diseases are expected to drive the growth of the market studied during the study period.
The various strategies adopted by the market players, such as product launches, mergers, and acquisitions, are expected to boost the growth of the segment. For instance, in January 2022, Recipharm AB reported a deal with a big pharmaceutical company to support vaccine manufacturing from its facility in Kaysersberg, France. The company invested almost EUR 14 million into its vaccine manufacturing offering at the site.
Thus, the segment is expected to witness significant growth over the forecast period due to the above-mentioned factors.
Within North America, the US is expected to hold a major market share in the biopharmaceutical contract manufacturing market due to the presence of several biopharmaceutical companies with large production capacities, leading to the high consumption of biologics in this region. According to January 2022, update from the CDC, tuberculosis incidence rose 9.4% during 2021 (2.4 cases per 100,000 persons) compared to previous years in the United States. As the burden of chronic diseases is expected to rise, so is the need for biological drugs used in treating such conditions. As a result, the need for contract manufacturing products is expected to rise.
Moreover, several market players are engaged in the implementation of strategic initiatives such as mergers and partnership agreements. For instance, in March 2021, Baxter International Inc. agreed on Baxter BioPharma Solutions (BPS) to provide fill/finish sterile manufacturing services and supply packaging for approximately 60-90 million doses of the Moderna COVID-19 Vaccine in 2021.
Thus, due to the above-mentioned factors, the market is expected to witness significant growth in the region during the forecast period.
The biopharmaceuticals contract manufacturing market is consolidated and consists of a few major players. In terms of market share, certain major players are currently dominating the market. Some of the companies currently dominating the market are Boehringer Ingelheim GmbH, Lonza, Inno Biologics Sdn Bhd, Rentschler Biotechnologies GmbH, JRS Pharma (Celonic), Samsung BioLogics, WuXi Biologics, AGC Biologics, ProBioGen AG, and FUJIFILM Diosynth Biotechnologies USA Inc.