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제제 개발 아웃소싱 시장 : 성장, 동향, COVID-19의 영향 및 예측(2021-2026년)

Formulation Development Outsourcing Market - Growth, Size, Trends, COVID-19 Impact, and Forecasts (2022 - 2027)

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제제 개발 아웃소싱 시장 : 성장, 동향, COVID-19의 영향 및 예측(2021-2026년) Formulation Development Outsourcing Market - Growth, Size, Trends, COVID-19 Impact, and Forecasts (2022 - 2027)
발행일 : 2022년 01월 페이지 정보 : 영문

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

제제 개발 아웃소싱 시장 규모는 2020년에 약 80억 5,500만 달러를 기록했습니다.

이 시장은 예측 기간 중 7.2%의 CAGR로 확대하며, 2026년에 126억 5,000만 달러의 매출에 달할 것으로 예측됩니다.

COVID-19의 위협이 급속히 확대하는 가운데 전 세계의 생활, 커뮤니티, 비지니스 및 산업이 영향을 받고 있습니다. 세계보건기구(WHO)는 2020년에 COVID-19에 대한 효과적인 치료법을 찾기 위한 국제 임상시험 'Solidarity'를 개시했습니다. 이 시험에는 4개의 치료 옵션을 표준 치료와 비교하여 COVID-19에 대한 유효성을 평가하는 것이 포함됩니다. WHO는 코로나바이러스의 만연을 막기 위해 다수의 후보 백신을 동시에 개발하기 위한 국제 동맹을 발표했습니다. 이 작업은 백신의 연대 시험으로 불리고 있습니다. Coalition for Epidemic Preparedness Innovations는 COVID-19 백신을 개발하기 위한 9번째의 세계 제휴를 발표했습니다. 2020년 10월의 연대 시험에서 발표된 중간 결과에 따르면 렘데시비르, 하이드록시클로로퀸, lopinavir/ritonavir 및 인터페론에 기반한 4개의 치료 시험은 모두 총사망률, 환기의 필요성 및 COVID-19 환자의 입원 일수에 대한 영향이 최소 또는 전혀 없는 것으로 보이는 것으로 관찰되었습니다. 또한 2020년 IFPMA(International Federation of Pharmaceuticals Manufacturers and Associations)의 데이터에 따르면 코로나바이러스에 이미 감염된 환자를 대상으로 한 진단 테스트, 백신, 치료에 관한 80개 이상의 진행중인 임상시험과 기존 의약품에 관한 연구가 시행되고 있습니다. 따라서 COVID-19의 치료법 개발에 관한 임상시험과 함께 연구개발 활동의 증가에 의해 이 시장은 팬데믹을 초월하여 대폭적인 성장을 달성할 것으로 예상됩니다.

제제 개발 아웃소싱 시장에 대해 조사했으며, 시장의 개요와 서비스별, 제형별, 용도별, 최종사용자별, 지역별 동향 및 시장에 참여하는 기업의 개요 등을 정리하여 전해드립니다.

목차

제1장 서론

제2장 조사 방법

제3장 주요 요약

제4장 시장 역학

  • 시장 개요
  • 시장 촉진요인
    • 주요 의약품의 특허 보호 만료의 증가 동향
    • 서비스를 아웃소싱하는 제약회사 및 바이오의약품 기업의 증가
  • 시장 억제요인
    • 제약 업계의 구조 변화
    • 제제 개발 아웃소싱을 통해 의약품 개발 프로세스를 시행하기 위한 불충분한 자금
  • Porter's Five Forces 분석

제5장 시장 세분화

  • 서비스별
    • 제제전 서비스
    • 제제의 최적화
  • 제형별
    • 주사
    • 경구
    • 국소
    • 기타
  • 용도별
    • 종양학
    • 유전성 질환
    • 신경학
    • 감염증
    • 호흡기
    • 심장혈관
    • 기타
  • 최종사용자별
    • 제약회사 및 바이오의약품 기업
    • 정부 및 학술기관
  • 지역별
    • 북미
    • 유럽
    • 아시아태평양
    • 기타 지역

제6장 경쟁 구도

  • 기업 개요
    • Charles River Laboratories
    • Aizant Drug Research Solutions Private Limited
    • Catalent, Inc
    • Laboratory Corporation of America Holdings
    • Syngene International Ltd
    • IRISYS, LLC
    • Intertek Group plc
    • Piramal Pharma Solutions
    • Qiotient Sciences
    • Patheon(Thermo Fisher Scientific Inc.)
    • Emergent BioSolutions, Inc.
    • Lonza Group AG
    • Dr. Reddy's Laboratories Ltd
    • PCI Pharma Services
    • Hermes Pharma
    • Pyramid Laboratories, Inc.

제7장 시장 기회 및 향후 전망

KSA 21.03.23

The formulation development outsourcing market was valued at approximately USD 8.05 billion in 2020, and it is expected to witness a revenue of USD 12.650 billion in 2026, with a CAGR of 7.2% over the forecast period.

The rapidly evolving threat of COVID-19 is impacting lives, communities, businesses, and industries around the world. The World Health Organization (WHO) launched 'Solidarity', an international clinical trial to find an effective treatment against COVID-19 in 2020. The trial included comparing four treatment options against the standard of care to evaluate their effectiveness against COVID-19. The WHO announced an international alliance for simultaneously developing numerous candidate vaccines to prevent the spread of the SARS-CoV-2 virus. This effort is called the 'Solidarity Trial for Vaccines'. The Coalition for Epidemic Preparedness Innovations announced the ninth worldwide collaboration to develop a COVID-19 vaccine. As per the interim results published for the Solidarity Trial in October 2020, all the four treatment trials based on remdesivir, hydroxychloroquine, lopinavir/ritonavir, and interferon were observed to show minimal to no impact on COVID-19 patients' total mortality, need for ventilation, and the number of days of hospitalization. Additionally, as per the data of the International Federation of Pharmaceuticals Manufacturers and Associations in 2020, more than 80 ongoing clinical trials on diagnostic tests, vaccines, and treatments, and studies on the existing medicines for the patients already infected with the SARS-CoV-2 virus. Hence, with the increasing R&D activities, along with clinical trials about the development of therapeutics for COVID-19 treatment, the market is expected to witness significant growth throughout the ongoing pandemic.

The growing importance of the innovation of novel drugs because of the increasing patent expirations of major drugs and the increasing trend of outsourcing formulation development services by most pharmaceutical and biotechnological companies are the major factors driving the growth of the market. Cancer Research UK runs initiatives to promote small molecule drug discovery. It runs a program called 'Small Molecule Drug Discovery Project Award' and funds milestone-driven projects at all stages of drug discovery, from target identification/validation to early preclinical studies. It offers funding support worth approximately 12-36 months, with an amount of GBP 100,000 per annum. Additionally, an increasing focus on developing poorly water-soluble compounds that require bioavailability enhancement by commercial drug manufacturers is driving the market. Most biopharmaceutical companies are partnering with outsourcing services in the early phase of drug development to overcome the risk and save them time and money involved in passing the drug through the development pipeline.

Globally, the growing burden of chronic diseases surges the demand for the discovery and development of new drugs, leading to the growth of formulation development services being outsourced to contract research organizations (CROs). According to GLOBOCAN 2020, newly diagnosed cancer cases accounted for 19,292,789 in 2020, worldwide, with 9,958,133 deaths due to cancers, globally. Moreover, as per the International Diabetes Federation Diabetes' Altas Ninth Edition 2019, globally, nearly 463 million population were living with diabetes, and this number is expected to reach 700 million by 2045. Additionally, the total health expenditure on diabetes was estimated to be USD 760 million in 2019, globally.

Thus, due to the factors mentioned above, the formulation development outsourcing market is expected to register tremendous growth over the forecast period. However, the lack of funding to carry out the drug development process through formulation development outsourcing is expected to hamper the market growth.

Key Market Trends

The Oncology Sub-segment is Expected to Witness Significant Growth over the Forecast Period

The application of formulation development outsourcing in the area of oncology is predicted to register healthy growth due to the rising incidence rates of cancer cases, globally. According to the International Agency for Research on Cancer (IARC) estimates, in 2018, by 2040, the global burden of cancer is expected to witness 27.5 million new cancer cases and 16.3 million deaths, worldwide. According to the research article published in the European Society for Medical Oncology (ESMO) in 2020, the number of clinical trials performed in the European countries from 2010 to 2018 increased by 33%, among which the early phase trials increased by 61% in Phase I-II trials, whereas late-phase trials showed an increase by 7% in Phase II-III trials.

Formulation development plays a vital role in anti-cancer drugs, as formulation issues, including stability, solubility, and bioavailability, are important considerations for drug development. Hence, most pharma service companies are focused on oncology formulation development to provide end-to-end solutions for oncology drug development. For instance, Quotient Sciences is involved in providing nearly 300 oncology development projects for 91 different oncology drug candidates across approximately 34 different disease indications, which primarily involves pre-formulation assessment and formulation development. Thus, the high incidence rates of cancer cases and the increasing focus on cancer therapeutics by biopharmaceutical companies are expected to aid in the growth of the segment over the forecast period.

North America is Expected to Hold Significant Market Share over the Forecast Period

North America is anticipated to witness tremendous growth in the market, due to the growing burden of chronic diseases and the presence of key players in the region, especially in the United States. As most of the major drugs are in the stage of patent expiration, key players are involved in novel drug development. In this context, to save time and investment on a series of clinical trials and evaluation studies in formulation development, pharmaceutical companies are outsourcing formulation development services to CROs, which may drive market growth in the region.

Additionally, amid the present COVID-19 pandemic, several collaborative research programs are looking to fast-track their process, in terms of advancing in therapeutics and vaccines, by joining hands with institutions, such as Biomedical Advanced Research and Development Authority (BARDA), Coalition for Epidemic Preparedness Innovations (CEPI), and Europe's Innovative Medicines Initiative (IMI). In May 2020, the US Department of Commerce's National Institute of Standards and Technology (NIST) funded around USD 8.9 million to the highly impacted biopharmaceutical manufacturing projects in response to the emerged outbreak. Hence, the COVID-19 pandemic is also expected to boost market growth.

Since the pharmaceutical industry has a significant role in the healthcare system, in terms of providing medicines and vaccines for several health interventions, the healthcare expenditure from business enterprises and government budgets, each year, plays a substantial role in the growth of the drug discovery process. As per the data published by the Organization for Economic Co-operation and Development (OECD), Mexico invested around USD 142.6 billion in healthcare. Hence, pharmaceutical companies are shifting to discover novel therapies, such as personalized medicine. This approach is expected to positively affect the drug discovery process in Mexico, thus, driving the market. Additionally, Canadian biopharmaceutical companies have robust R&D pipelines, within which 5,584 new medicines were in various evaluation stages, and 697 (12%) were in Phase III clinical trials approved by the FDA in 2019, representing a wide range of therapeutic areas.

Moreover, according to the research article published in Molecules in 2020, between 2015 and 2019, the US Food Drug Administration (FDA) authorized a total of 208 new drugs (150 new chemical entities and 58 biologics). Thus, the increasing healthcare expenditure and the growing number of product approvals may also act as major drivers for market growth in the region over the forecast period.​

Furthermore, nearly 56 drugs are expected to undergo patent expiration in the United States between 2020 and 2022, which include Chantix and Inlyta (Pfizer Inc.), Dexilant (Takeda Pharmaceuticals USA Inc.), and Silenor (Currax Pharmaceuticals LLC), among others. Hence, increasing patent expirations may drive innovations pertaining to novel therapeutics, which, in turn, may boost the market in the North American region.

Competitive Landscape

The formulation development outsourcing market is moderately competitive. In terms of market share, a few companies, such as Charles River Laboratories, Aizant Drug Research Solutions Private Limited, Catalent Inc., Laboratory Corporation of America Holdings, and Syngene International Ltd, among others, hold the largest market shares. Key market players are evolving through various strategic alliances, such as acquisitions, collaborations, and new product launches, to expand their global product portfolios and secure their positions in the global market.

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 Increasing Trend of Patent Protection Expiration of Major Drugs
    • 4.2.2 Rising Number of Pharmaceutical and Biopharmaceutical Companies Outsourcing Their Services
  • 4.3 Market Restraints
    • 4.3.1 Structural Changes in the Pharmaceutical Industry
    • 4.3.2 Insufficient Funding to Perform the Drug Development Process Through Formulation Development
  • 4.4 Industry Attractiveness - Porter's Five Forces Analysis
    • 4.4.1 Bargaining Power of Buyers/Consumers
    • 4.4.2 Bargaining Power of Suppliers
    • 4.4.3 Threat of New Entrants
    • 4.4.4 Threat of Substitute Products
    • 4.4.5 Intensity of Competitive Rivalry

5 MARKET SEGMENTATION

  • 5.1 By Service
    • 5.1.1 Pre-formulation Services
      • 5.1.1.1 Discovery and Preclinical Services
      • 5.1.1.2 Analytical Services
    • 5.1.2 Formulation Optimization
      • 5.1.2.1 Phase I
      • 5.1.2.2 Phase II
      • 5.1.2.3 Phase III
      • 5.1.2.4 Phase IV
  • 5.2 By Dosage Form
    • 5.2.1 Injectable
    • 5.2.2 Oral
    • 5.2.3 Topical
    • 5.2.4 Other Dosage Forms
  • 5.3 By Application
    • 5.3.1 Oncology
    • 5.3.2 Genetic Disorders
    • 5.3.3 Neurology
    • 5.3.4 Infectious Diseases
    • 5.3.5 Respiratory
    • 5.3.6 Cardiovascular
    • 5.3.7 Other Applications
  • 5.4 By End User
    • 5.4.1 Pharmaceutical and Biopharmaceutical Companies
    • 5.4.2 Government and Academic Institutes
  • 5.5 By Geography
    • 5.5.1 North America
      • 5.5.1.1 United States
      • 5.5.1.2 Canada
      • 5.5.1.3 Mexico
    • 5.5.2 Europe
      • 5.5.2.1 Germany
      • 5.5.2.2 United Kingdom
      • 5.5.2.3 France
      • 5.5.2.4 Italy
      • 5.5.2.5 Spain
      • 5.5.2.6 Rest of Europe
    • 5.5.3 Asia Pacific
      • 5.5.3.1 China
      • 5.5.3.2 Japan
      • 5.5.3.3 India
      • 5.5.3.4 Australia
      • 5.5.3.5 South Korea
      • 5.5.3.6 Rest of Asia Pacific
    • 5.5.4 Middle-East and Africa
      • 5.5.4.1 GCC
      • 5.5.4.2 South Africa
      • 5.5.4.3 Rest of Middle-East and Africa
    • 5.5.5 South America
      • 5.5.5.1 Brazil
      • 5.5.5.2 Argentina
      • 5.5.5.3 Rest of South America

6 COMPETITIVE LANDSCAPE

  • 6.1 Company Profiles
    • 6.1.1 Charles River Laboratories
    • 6.1.2 Aizant Drug Research Solutions Private Limited
    • 6.1.3 Catalent Inc.
    • 6.1.4 Laboratory Corporation of America Holdings
    • 6.1.5 Syngene International Ltd
    • 6.1.6 Irisys LLC
    • 6.1.7 Intertek Group PLC
    • 6.1.8 Piramal Pharma Solutions
    • 6.1.9 Qiotient Sciences
    • 6.1.10 Patheon (Thermo Fisher Scientific Inc.)
    • 6.1.11 Emergent BioSolutions Inc.
    • 6.1.12 Lonza Group AG
    • 6.1.13 Dr. Reddy's Laboratories Ltd

7 MARKET OPPORTUNITIES AND FUTURE TRENDS

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