생물제제 의약품 수탁제조개발기관(바이오 CDMO) 시장 : 성장, 동향, COVID-19의 영향, 예측(2022-2027년)

※ 본 상품은 영문 자료로 한글과 영문 목차에 불일치하는 내용이 있을 경우 영문을 우선합니다. 정확한 검토를 위해 영문목차를 참고해주시기 바랍니다.

생물제제 의약품 수탁제조개발기관(바이오 CDMO) 시장 규모는 2020년에 99억 3,000만 달러를 기록하고, 2021-2026년 예측기간 중 10.87%의 CAGR로 성장하고, 2026년까지 186억 3,000만 달러에 달할 것으로 예상됩니다.

• 세계의 제약 업계는 지수함수적으로 성장하고 있으며, 2023년까지 연간 매출이 1조 5,200억 달러에 달할 것으로 예상됩니다. 이것은 세계의 경제 성장, 인구 증가와 고령화, 신제품 발매에 의한 것입니다. 소분자는 계속해서 시장에서 압도적인 점유율을 차지하고 있지만, 생물제제, 바이오시밀러, 세포 및 유전자 치료 등의 대분자는 예측기간 중 가장 급속한 성장을 이룰 것으로 예상됩니다.
• 대분자의 볼륨은 축소 경향이 있지만 부문은 보다 빠른 속도로 성장하고 있습니다. 오리지네이터 생물제제, 바이오시밀러, 세포 및 유전자 치료 양방을 포함한 고분자 시장의 절대 성장은 2023년까지 1,330억 달러로 예측됩니다. Results Healthcare에 의하면 오리지네이터 생물제제 시장 규모는 2023년까지 3,710억 달러에 달할 것으로 예상됩니다.
• 암치료는 생물제제 시장 성장 대부분을 견인하는 주요 요인의 하나입니다. 의약품 승인에 관해서는 보다 빠른 성장 예측이 있어도, 소분자는 생물제제를 웃돕니다. 예를 들어 2018년에 FDA는 42개의 새로운 소분자 제품을 승인했지만, 생물제제의 승인은 불과 17개였습니다. 그러나 생물제제 승인수는 과거 몇 년간 꾸준히 증가하고 있습니다.
• CMO/CDMO 서비스 부문은 COVID-19 팬데믹 동안 의약품 개발자가 직면하고 있는 몇 가지 과제에 대처하는 독자적인 입장에 있습니다. 이 팬데믹은 의약품 개발, 임상시험, 공급, 제조부터 공급망 물류까지 바이오의약품 업계의 다양한 측면에 영향을 미치고 있습니다. 그러나 COVID-19에 의한 의약품 부족은 한정되어 있으며, 세계에 의약품이나 API가 비축되고 있기 때문에 단기적으로는 부족이 계속될 것으로 예상됩니다. 공급망 전체에서 직면하고 있는 문제 중에서 중국과 인도는 원료의약품(API)과 제네릭 의약품의 세계 최대 생산업체이기 때문에 가장 큰 영향을 받고 있습니다.
• 봉쇄가 부과되었기 때문에 중국의 제조 시설로부터의 공급은 크게 감소했습니다. 주요 범위는 업무에 복귀할 수 없었던 많은 전형적인 노동력이며, 그것이 업계의 다수의 레벨에 걸쳐서 불충분한 활용 효율로 이어졌습니다. 또한 API 제조 지연으로 2020년 2월 미국 식품의약국(FDA)에 의해 단기적인 부족이 발표되었습니다.

세계의 생물제제 의약품 수탁제조개발기관(바이오 CDMO) 시장을 조사했으며, 시장 개요, 시장 성장 촉진요인 및 저해요인 분석, 시장 기회, COVID-19의 영향, 종류·제품 종류·지역별 시장 규모 추정과 예측, 경쟁 상황, 주요 기업 개요 등 체계적인 정보를 제공합니다.

목차

제1장 서론

제2장 조사 방법

제3장 주요 요약

제4장 시장 역학

• 시장 개요
• 시장 추진력
  • CDMO에 의해 실현된 새로운 테크놀러지로의 액세스와 보다 고속의 실행
  • 능력을 개발하기 위한 고자본 투자 필요성이 기업의 아웃소싱 모델 선택으로 이어져
  • 신흥 의약품 개발 기업의 사내 능력 결여
• 시장 과제
  • IP와 특허 침해에 관한 전송 복잡성과 우려
  • 고분자 약물과 관련된 용량 문제
• 시장 기회
  • 바이오시밀러 공동 개발과 디자이너 세포주 개념의 출현
• 바이오 CDMO 벤더의 선택과 관련된 중요한 고려사항
• 비지니스 모델 분석 - 부가가치, 유연한 용량 위험 공유 및 인타임 제조
• COVID-19가 바이오 CDMO에 미치는 영향의 상세한 평가(새로운 백신 개발 경쟁과 현재 용량에 대한 영향)
• 바이오의약품 업계의 주요 동향
• 다양한 종류의 질환 치료를 위한 생물제제의 현재 사용에 관한 보도 - 종양학, 감염증, 심혈관 등

제5장 시장 세분화

• 종류별
  • 포유류
  • 비포유류(미생물)
• 제품 종류별
  • 생물제제
  • 바이오시밀러
• 지역별
  • 북미
  • 유럽
  • 아시아태평양
  • 라틴아메리카
  • 중동과 아프리카

제6장 경쟁 상황

• 기업 개요
  • Boehringer Ingelheim Group
  • Wuxi Biologics
  • Samsung Biologics
  • Lonza Group
  • Fujifilm Diosynth Biotechnologies USA Inc.
  • Toyobo Co. Limited
  • Parexel International Corporation
  • PRA Health Sciences
  • Binex Co. Limited
  • JRS Pharma
  • Rentschler Biotechnologies
  • AGC Biologics
  • Sandoz Biopharmaceuticals
  • Catalent Inc.
  • AbbVie Contract Manufacturing

제7장 벤더의 시장 점유율

제8장 투자 분석

제9장 시장 기회와 동향

The Global Biologics CDMO Market was valued at USD 9.93 billion in 2020 and is expected to reach USD 18.63 billion by 2026, registering a CAGR of 10.87% during the forecast period (2021-2026).

The CMO/CDMO service sector is uniquely positioned to address some of the challenges that drug developers are facing amid the COVID-19 pandemic. This pandemic has impacted multiple aspects of the biopharma industry, from drug development, clinical trials, supplies, manufacturing to supply chain logistics. However, the drug shortages due to COVID-19 are limited, and they are expected to remain so for the short term due to stockpiles of pharmaceuticals, APIs globally. Among the issues being faced across the supply chains, China and India have been impacted the most due to being the largest global producers of active pharmaceutical ingredients (APIs) and generics.​

Key Highlights

• The global pharmaceutical industry is growing at an exponential rate, which is driven by global economic growth, a growing and aging population, and new product launches. Even though small molecules continue to command the prominent share of the market, large molecules, such as biologics, biosimilars, and cell and gene therapies, are expected to witness the fastest growth over the forecast period.
• Cancer therapies are among the primary drivers for a large proportion of the growth in the biologics market. Even with the faster growth forecast, in terms of drug approvals, small molecules outweigh biologics. For instance, in 2020, the US Food and Drug Administration's Center for Drug Evaluation and Research approved 53 new molecular entities (NMEs), of which 40, or 75%, were small molecules. This continues a recent trend of having approximately three-fourths of NME approvals be small molecules.
• Top pharma companies' propensity toward producing biologic drugs in-house is challenging the growth, as these drugs are high value, high margin products, owing to which large companies are focused on the security of supply, ensuring quality, IP protection of proprietary cell strains, and manufacturing process. For instance, unlike some of its peers in the drug industry, Pfizer has retained significant in-house manufacturing assets. It announced to make raw materials, the mRNA active and finished doses for BNT162b2, the partnership's vaccine, at its own plants in Andover, Massachusetts; Kalamazoo, Michigan, and St. Louis. It will also use its site in Belgium for the European market.
• However, pharma companies are more comfortable and willing to outsource the secondary manufacturing and packaging stages of their biologics products even with the growing tendency to keep the biologic API production in-house. Another major factor influencing the growth in outsourcing biologics to CDMO is the lack of available assets among CDMOs. This is expected to change over the next five years due to the increasing investment from major CDMOs. For instance, Fujifilm Corp. is investing USD 928 million into Fujifilm Diosynth Biotechnologies, a CDMO for biologics and advanced therapies. This will double the Denmark facility's current drug substance manufacturing capacity, thus expanding its fill/finish and enhancing its assembly, labeling, packaging services.
• Further, Fujifilm Diosynth Biotechnologies also aims to build and open a mammalian cell culture facility in the United States in 2025. It will boast eight 20,000 L stainless-steel bioreactor tanks for commercial drug substance manufacturing when the plant opens. It will also offer automated fill-finish and assembly, including packaging and labeling services.
• CDMOs are expected to form alliances and partnerships with pharma companies to expand and enhance their biologic services. For example, in August 2020, HJB, a biologics CDMO, entered a strategic partnership for CMC development and manufacturing with Ansun Biopharma on its therapeutic biologics pipeline.
• Furthermore, for technically difficult to manufacture products, such as biologics, where tech transfer can be a lengthy and expensive process, a single supplier relationship has the potential to reduce the risk of supply issues. The relationship should, in turn, create opportunities for the CDMO to sell more services to the same customer and lock in products at an earlier stage in their life cycle.

Key Market Trends

Biologics to Drive the Market

• Monoclonal antibodies or synthetic versions of antibody have been representative of most successful therapeutic drug classes and attracts huge investment for the biologics industry. The use of monoclonal antibodies to treat diseases is called immunotherapy therapy because each type of monoclonal antibody will target a specifically targeted antigen in the body.
• Mammalian cells are traditionally used for monoclonal antibody production; however, plant-based expression systems have been gaining share due to significant advantages. The advancements in plant glycoengineering have allowed the production of monoclonal antibodies (mAbs) with more homogenous human-like glycans. iBio's proprietary plant-based technology instead of CHO or other mammalian cell technologies led to the development of monoclonal antibody vectors free of any viral transforming functions or contamination from parental lines.
• Recombinant biologics are being developed by processes wherein a genetic code for a specific therapeutic protein is inserted into an expression vector's DNA. The inserted DNA codes lead to recombinant protein being produced through replication in living host cells. Since the first recombinant therapeutic antibody (OKT3) in 1986, biologics products have become a larger pharmaceutical industry percentage.
• Since biologics have been dominating human drug development because of their long-lasting effects and ability to precisely address the molecular causes of disease, only one recombinant protein drug, an antibody, is available for veterinary use in the U.S. or EU.​
• Likewise, in February 2020, Invetx invested USD 15 million in Series A financing and undertook collaborations with WuXi Biologics and AbCellera. This is expected to drive clinical entry of a first therapeutic candidate and preclinical development of Invetx's broader pipeline of protein-based therapeutics for Animal Biopharmaceutical Development.​
• According to the World Health Organization (WHO), as compared to the pharmaceutical market, the vaccine market is relatively small & concentrated on both supply and demand sides. Over time, the largest contract biologics manufacturers have been investing heavily in manufacturing capabilities to address unique product areas, including vaccines. And recently, the number of mergers and acquisitions and partnerships increased in light of new business models for vaccine research and development.
• In April 2020, Cytovance Biologics, a US-based CDMO and a subsidiary of the Shenzhen Hepalink Pharmaceutical Group Co., Ltd., entered into a collaboration agreement with Akshaya Bio, Inc., a Canadian development-stage biotechnology company. The latter would be provided with rapid access to clinical materials using Akshaya's proprietary Chimigen Platform Technology for vaccine development for COVID-19 and HBV.

North America to Dominate the Market

• North America is one of the major markets for the biologics CDMO industry, owing to the presence of two major economies, such as the United States and Canada. The United States is home to one of the major pharmaceutical industries in the world and commands a significant share of the industry revenue; according to AstraZeneca, a major pharma company and one of the COVID-19 vaccine manufacturers, in 2020, the United States pharmaceutical sales were USD 514 billion, and the United States market is seeing a steady growth in the last couple of years.
• In addition to this, the region holds a prominent share of the CDMO market as well. According to Results Healthcare, the region holds about 37% of the CDMO market share and is expected to witness growth in mid-single-digit percentage points over the coming years.
• Moreover, the spending of the US pharmaceutical industry (PhRMA members) on R&D abroad totaled approximately USD 18.7 billion in 2020, according to PhRMA. With such a prominent presence in the market, the biologics CDMO vendors in the region are expected to scale up their presence and expand their capacities as well. For instance, AGC Biologics is looking to invest about USD 100 million into the AstraZeneca plant in Boulder; such developments are expected to increase over the coming years.
• Moreover, in August 2020, AGC Biologics, a global biopharmaceutical CDMO, partnered with Ono Pharmaceutical Co Ltd to manufacture its new biopharmaceutical at the clinical development stage. Such developments are expected to increase over the coming years, further expanding the reach of CDMOs in biologics. Also, in December 2020, AGC Biologics announced its partnership with Laboratoire Pierre Fabre to manufacture ER-004 and intra-amniotic drugs that would pioneer the treatment of a rare and debilitating genetic disorder.
• In addition to this, global biologics CDMO vendors are increasing their investments and are expanding their presence in the region. For example, in March 2020, Bora Pharmaceuticals expanded its footprint in North America. Over the coming years, CDMOs are expected to expand their presence in the region due to the growing health ailments and aging population.

Competitive Landscape

The Biologics Contract Development and Manufacturing Organization (CDMO) Market is highly fragmented and consists of several major players. They have adopted different strategies such as expansions, agreements, new product launches, joint ventures, acquisitions, partnerships, and others to expand their footprints in this market. Major players of the market include Boehringer Ingelheim Group, Wuxi Biologics, Samsung Biologics, Lonza Group, and Fujifilm Diosynth Biotechnologies USA Inc, among others.

• March 2021 - WuXi Biologics has entered into an equity agreement with Pfizer China to acquire its state-of-the-art biologics manufacturing facilities and its labor force in Hangzhou, China. This will boost the commercial Drug Substance (DS) and Drug Product (DP) capacities for WuXi Biologics to address surging manufacturing demands.
• January 2021 - Boehringer Ingelheim entered into a strategic collaboration and licensing agreement with Enara Bio to research and develop novel targeted cancer immunotherapies, leveraging Enara Bio's Dark Antigen discovery platform. The collaboration combines Boehringer Ingelheim's approach to tackling cancer through pairing leading science with innovative immune-oncology platforms, such as oncolytic viruses and cancer vaccines, with Enara Bio's expertise in cancer antigen identification.

Additional Benefits:

• The market estimate (ME) sheet in Excel format
• 3 months of analyst support

TABLE OF CONTENTS

1 INTRODUCTION

• 1.1 Study Assumptions and Market Definition
• 1.2 Scope of the Study

2 RESEARCH METHODOLOGY

3 EXECUTIVE SUMMARY

4 MARKET DYNAMICS

• 4.1 Market Overview
• 4.2 Market Drivers
  • 4.2.1 Access to New Technologies and Higher Speed of Execution Realized by CDMOs
  • 4.2.2 Need for High Capital Investments to Develop Capabilities Has Led to Firms Choosing the Outsourcing Model
  • 4.2.3 Lack of In-house Capacity among the Emerging Drug Development Companies
• 4.3 Market Challenges
  • 4.3.1 Transfer Complexities and Concerns over the Breach of IP and Patents
  • 4.3.2 Capacity Issues Related to Large-molecule Drugs
• 4.4 Market Opportunities (Emergence of the Concept of Biosimilars Co-development and Designer Cell Lines)
• 4.5 Key Considerations Involved in the Selection of a Biologics CDMO Vendor
• 4.6 Business Model Analysis - Value Added, Flexible Capacity Risk Sharing, and In-time Manufacturing
• 4.7 Detailed Assessment of the Impact of COVID-19 on Biologics CDMO (The Race for the Development of a New Vaccine and Impact on the Current Capacities)
• 4.8 Key Trends in Biopharmaceutical Industry
• 4.9 Coverage on the Current Use of Biologics for Different Types of Disease Treatment - Oncology, Infectious, Cardiovascular, Etc.

5 MARKET SEGMENTATION

• 5.1 By Type
  • 5.1.1 Mammalian
  • 5.1.2 Non-mammalian (Microbial)
• 5.2 By Product Type
  • 5.2.1 Biologics
    • 5.2.1.1 Monoclonal (Diagnostic, Therapeutic, and Protein-based)
    • 5.2.1.2 Recombinant Proteins
    • 5.2.1.3 Antisense and Molecular Therapy
    • 5.2.1.4 Vaccines
    • 5.2.1.5 Other Biologics
  • 5.2.2 Biosimilars
• 5.3 By Geography
  • 5.3.1 North America
  • 5.3.2 Europe
  • 5.3.3 Asia Pacific
  • 5.3.4 Middle East and Africa
  • 5.3.5 Latin America

6 COMPETITIVE LANDSCAPE

• 6.1 Company Profiles
  • 6.1.1 Boehringer Ingelheim Group
  • 6.1.2 Wuxi Biologics
  • 6.1.3 Samsung Biologics
  • 6.1.4 Lonza Group
  • 6.1.5 Fujifilm Diosynth Biotechnologies USA Inc.
  • 6.1.6 Toyobo Co. Limited
  • 6.1.7 Parexel International Corporation
  • 6.1.8 PRA Health Sciences
  • 6.1.9 Binex Co. Limited
  • 6.1.10 JRS Pharma
  • 6.1.11 Rentschler Biotechnologies
  • 6.1.12 AGC Biologics
  • 6.1.13 Sandoz Biopharmaceuticals (Novartis AG)
  • 6.1.14 Catalent Inc.
  • 6.1.15 AbbVie Contract Manufacturing

7 VENDOR MARKET SHARE

8 INVESTMENT ANALYSIS

9 FUTURE OUTLOOK OF THE MARKET