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レポート概要
| 本調査資料は、世界の製剤開発アウトソーシング市場について調査し、イントロダクション、調査手法、エグゼクティブサマリー、市場動向、サービス別（プレフォーミュレーション、処方最適化）分析、剤形別（注射、経口、局所、その他）分析、用途別（腫瘍、遺伝性疾患、神経、感染症、呼吸器、その他）分析、エンドユーザー別（製薬・バイオ医薬品企業、政府機関・学術機関）分析、地域別分析、競争状況、市場機会/将来の見通しなどを掲載しています。 ・イントロダクション ・調査手法 ・エグゼクティブサマリー ・市場動向 ・世界の製剤開発アウトソーシング市場規模：サービス別（プレフォーミュレーション、処方最適化） ・世界の製剤開発アウトソーシング市場規模：剤形別（注射、経口、局所、その他） ・世界の製剤開発アウトソーシング市場規模：用途別（腫瘍、遺伝性疾患、神経、感染症、呼吸器、その他） ・世界の製剤開発アウトソーシング市場規模：エンドユーザー別（製薬・バイオ医薬品企業、政府機関・学術機関） ・世界の製剤開発アウトソーシング市場規模：地域別 ・競争状況 ・市場機会/将来の見通し |
The formulation development outsourcing market was valued at approximately USD 8,055 million in 2020, and it is expected to witness a revenue of USD 12,650 million 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 includes 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 observed to show minimal to no impact on COVID-19 patients’ total mortality, need for ventilation, and the number of days of hospitalization. Also, as per the data of the International Federation of Pharmaceuticals Manufacturers and Associations in 2020, there were more than 80 ongoing clinical trials on diagnostic tests, vaccines, and treatments, as well as 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 over the period of 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. Also, an increasing focus on the development of poorly water-soluble compounds that require bioavailability enhancement by commercial drug manufacturers is driving the market. Most of the biopharmaceutical companies are partnering with outsourcing services, in the early phase of drug development to overcome the risk, along with saving them time and money involved in the process of passing the drug through the development pipeline.
Also, globally, the growing burden of chronic diseases surges the demand for the discovery and development of new drugs, which, in turn, leads 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. Also, 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 pertaining to diabetes was estimated to be USD 760 million in 2019, globally.
Thus, owing to the aforementioned factors, 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 estimates from the International Agency for Research on Cancer (IARC) in 2018, by 2040, the global burden of cancer is expected to grow to 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 the important considerations to be looked into during drug development. Hence, most of the 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, owing 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 pertaining to 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 the 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 affect the drug discovery process in Mexico positively, thus driving the market. Also, Canadian biopharmaceutical companies have robust R&D pipelines, within which 5,584 new medicines were in various stages of evaluation and 697 (12%) were in Phase III clinical trials, which were approved by the FDA in 2019, representing a wide range of therapeutic areas.
Also, 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.
Additionally, 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.
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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 Porter’s Five Forces Analysis
4.4.1 Threat of New Entrants
4.4.2 Bargaining Power of Buyers/Consumers
4.4.3 Bargaining Power of Suppliers
4.4.4 Threat of Substitute Products
4.4.5 Intensity of Competitive Rivalry
5 MARKET SEGMENTATION
5.1 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 Dosage Form
5.2.1 Injectable
5.2.2 Oral
5.2.3 Topical
5.2.4 Other Dosage Froms
5.3 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 End User
5.4.1 Pharmaceutical and Biopharmaceutical Companies
5.4.2 Government and Academic Institutes
5.5 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