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 coronavirus. This effort is called the Solidarity trial for vaccines. The Coalition for Epidemic Preparedness Innovations announced a ninth worldwide collaboration to develop a COVID-19 vaccine. As per the interim results published on 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 the total mortality, need for ventilation, and the number of days of hospitalization in COVID-19 patients. Also, as per the data of the International Federation of Pharmaceuticals Manufacturers and Associations, 2020, there are 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 Coronavirus. Hence, with the increasing R and D activities, along with clinical trials about the development of therapeutics for COVID-19 treatment, the studied market is expected to witness significant growth over the pandemic.
The growing importance for the innovation of novel drugs because of the increasing patent expirations of the major drugs and the increasing trend of outsourcing the formulation development services by most of the pharmaceutical and biotechnological companies are the major factors driving the growth of the studied market. Cancer Research UK runs the 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, which offers a funding support for 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 the commercial drug manufacturers is driving the market. Most of the biopharmaceutical companies are partnering with the 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, the growing burden of chronic diseases worldwide 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 the Contract Research Organizations (CROs). According to Globocan 2020, the new cancer cases that were diagnosed 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, nearly 463 million population globally are living with diabetes worldwide and are expected to reach 700 million by 2045. Additionally, the total health expenditure caused by 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 studied market growth.
Key Market Trends
The Oncology Sub-Segment is Expected to Witness Significant Growth in the Application Segment 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 of cancer cases globally. According to estimates from the International Agency for Research on Cancer (IARC) 2018, by 2040, the global burden of cancers 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), 2020, the number of clinical trials being performed in the European countries from 2010 to 2018 increase 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 services companies are focused on oncology formulation development to provide end-to-end solutions for oncology drug development. For instance, Quotient sciences had been 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 & Formulation Development. Thus, owing to the high incidence of cancers and the increasing focus on cancer therapeutics by biopharmaceutical companies is expected to aid in the growth of the studied segment over the forecast period.
North America is Holds a Significant Share in the Market and Expected to do Same over the Forecast Period
The North American region is anticipated to witness tremendous growth in the studied 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, the 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, the pharmaceutical companies are outsourcing the formulation development services to CROs which is expected to drive the market growth in the country.
Additionally, in the present COVID-19 pandemic, several collaborative research programs are taking initiatives to fast-track in terms of advancing in therapeutics and vaccines, with institutions, such as Biomedical Advanced Research and Development Authority ( BARDA), and Coalition for Epidemic Preparedness Innovations (CEPI), 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 studied 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 budget each year plays substantial importance in the growth of the drug discovery process. As pe the data published by Organization for Economic Co-operation and Development (OECD), Mexico invested around USD 142.6 billion on healthcare. Owing to this reason, pharmaceutical companies are shifting to discover novel therapies such as personalized medicine. This approach is expected to affect the drug discovery process positively in Mexico, thus driving the studied market. Also, Canadian biopharmaceutical companies have robust R&D pipelines, within which the pipeline contained 5,584 new medicines in various stages of evaluation, 697 (12%) were in Phase III clinical trials which were approved through FDA in 2019, representing a wide range of therapeutic areas.
Also, according to the research article published in Molecules, 2020, between 2015-2019, the U.S. Food Drug Administration (FDA) has 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 also act as a major driver for the market growth in the region over the forecast period.
Additionally, nearly 56 drugs are expected to phase patent expiration in United States between 2020-2022, which include Chantix and Inlyta (Pfizer, Inc.), Dexilant (Takeda Pharmaceuticals USA Inc), Silenor (Currax Pharmaceuticals LLC) among others. Hence, the growing patent expirations is expected to drive theinnovation of novel therapeutics, which in turn boosts the studied market in the North American region.
The Formulation Development Outsourcing market is moderately competitive. In terms of market share, few companies, such as Charles River Laboratories, Aizant Drug Research Solutions Private Limited, Catalent, Inc., Laboratory Corporation of America Holdings, Syngene International Ltd, among others, hold the largest market shares. The key players are evolving through various strategic alliances, such as acquisitions, collaborations, and new product launches, to expand the global product portfolio and secure their positions in the global market.
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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 Major Drugs’ Patent Protection Expiration
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 Outsourcing
4.4 Industry Attractiveness - Porter's Five Forces Analysis
4.4.1 Bargaining Power of Suppliers
4.4.2 Bargaining Power of Consumers
4.4.3 Threat of New Entrants
4.4.4 Threat of Substitute Products/Services
4.4.5 Intensity of Competitive Rivalry
4.5 Analyst’s Perspective - The Impact of COVID-19 on the Market
5. MARKET SEGMENTATION
5.1 By Service
5.1.1 Pre-formulation Services
22.214.171.124 Discovery and Preclinical Services
126.96.36.199 Analytical Services
5.1.2 Formulation Optimization
188.8.131.52 Phase I
184.108.40.206 Phase II
220.127.116.11 Phase III
18.104.22.168 Phase IV
5.2 By Dosage Form
5.2.4 Other Dosage Forms
5.3 By Application
5.3.2 Genetic Disorders
5.3.4 Infectious Diseases
5.3.7 Other Applications
5.4 By End User
5.4.1 Pharmaceutical and Biopharmaceutical Companies
5.4.2 Government and Academic Institutes
5.5.1 North America
22.214.171.124 United States
126.96.36.199 United Kingdom
188.8.131.52 Rest of Europe
184.108.40.206 South Korea
220.127.116.11 Rest of Asia-Pacific
5.5.4 Middle East & Africa
18.104.22.168 South Africa
22.214.171.124 Rest of Middle East & Africa
5.5.5 South America
126.96.36.199 Rest of South America
6. COMPANY PROFILES AND COMPETITIVE LANDSCAPE
6.1 Charles River Laboratories International Inc.
6.2 Aizant Drug Research Solutions Pvt. Limited
6.3 Catalent Inc.
6.4 Laboratory Corporation of America Holdings
6.5 Biocon Limited (Syngene International)
6.6 IRISYS LLC
6.7 Intertek Group PLC
6.8 Piramal Enterprises Ltd
6.9 Qiotient Sciences
6.10 Thermo Fisher Scientific Inc. (Patheon)
6.11 Emergent BioSolutions Inc.
6.12 Lonza Group AG
6.13 Aurigene Pharmaceutical Services Ltd
6.14 PCI Pharma Services
6.15 Hermes Pharma
6.16 Pyramid Laboratories Inc.
7 MARKET OPPORTUNITIES AND FUTURE TRENDS
- Aizant Drug Research Solutions Pvt Limited
- Aurigene Pharmaceutical Services Ltd
- Biocon Limited (Syngene International)
- Catalent Inc
- Charles River Laboratories International Inc
- Emergent BioSolutions Inc
- Hermes Pharma
- Intertek Group PLC
- IRISYS LLC
- Laboratory Corporation of America Holdings
- Lonza Group AG
- PCI Pharma Services
- Piramal Enterprises Ltd
- Pyramid Laboratories Inc
- Qiotient Sciences
- Thermo Fisher Scientific Inc (Patheon)