The global formulation development outsourcing market size was valued at USD 21.12 billion in 2021. It is expected to reach USD 40.33 billion by 2030, growing at a CAGR of 7.45% during the forecast period (2022–2030). Drug formulation development is a significant area that affects pharmaceutical products' success, durability, and patentability. To improve the solubility of products, it also includes pre-formulation activities like excipient screening and the development and characterization of analytical assays. It is typically outsourced to reduce the time and money needed for the process. Formulation development outsourcing also offers advantages like compressing deadlines, accessing expertise, and providing additional protection against product failure.
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Increasingly Outsourcing from Pharmacies and Biopharmacies
Many pharmaceutical companies have recognized the potential profitability in signing a contract with a CMO (contract manufacturing outsourcing) for formulation development due to the rising demand for generic medications and biologics, the capital-intensive nature of the industry, and the complex manufacturing requirements. To shorten the time and cost of drug development, pharmaceutical companies are progressively outsourcing R&D to academic and commercial contract research organizations (CROs).
According to a 2018 article titled "The Era of Pharma and Biotech Outsourcing," up to 80% of R&D expenditures in the biopharmaceutical sector may be outsourced, opening business opportunities for CROs. This aspect could, in turn, spur market expansion. Companies engaged in contract research and manufacturing are spending money on infrastructure, technology, and human resources to capture a sizeable portion of the healthcare outsourcing market. The market is expected to grow due to the rising number of end-to-end service providers aiming to satisfy the increasing demand for low-cost drug development and manufacturing.
Changes in the Pharmaceutical Industry's Structure
The pharmaceutical industry's structural changes are a significant factor limiting market expansion. Over the previous ten years, several changes have occurred in the global pharmaceutical industry. Large pharmaceutical transnational corporations (TNCs) focusing on research and development (R&D) have been under pressure from these changes to alter how they run their businesses. The large TNCs focusing on R&D are also under pressure from additional factors, such as antitrust and regulatory concerns. The regulatory burden has increased due to more inquiries from drug regulatory agencies regarding clinical data submitted about potential blockbusters. The number of obstacles preventing people from entering the European market has also increased.
Government agencies are paying closer attention to how large pharmaceutical TNCs that rely on R&D conduct their business. In 2008–2009, the EU antitrust authorities conducted four separate but connected antitrust raids on major pharmaceutical firms. The US has swung the antitrust pendulum regarding deals between generic companies and R&D-based TNCs. However, given the uncertainty of patent litigation in the nation today, it is probably resisting such deals. All of this has increased pressure on pipelines for newly patented products. Such structural changes will likely hamper the market growth in the upcoming years.
Development of Novel Therapeutics
Due to the rising demand for the development of novel therapeutics in the market, the formulation development outsourcing market is anticipated to experience healthy growth in the upcoming years. The need for formulation development services is expected to increase as outsourcing is a practical option for these manufacturers due to the increased focus on developing numerous therapeutics that provide effective treatment for various chronic diseases. The development of innovative products is anticipated to gain traction for the outsourcing of formulation development as the blockbuster drugs approach the time when their patents expire. The formulation development outsourcing market is expected to experience steady growth due to the rising demand for formulation development services and outsourcing of the same, as well as the strategic initiatives taken by the major players in the studied market.
The global formulation development outsourcing market is segmented by service, dosage form, application, and end-user.
Based on Service, the global market is bifurcated into pre-formulation service and formulation optimization.
The formulation optimization is the highest contributor to the market and is expected to grow at a CAGR of 7.0% during the forecast period. Studies on solubility and pH profiles, drug/excipient compatibility, preservative screening, selection, and testing, as well as lab-scale and feasibility batches, are all provided by formulation optimization. Phase I trials evaluate the compound’s safety and how it is best metabolized or processed in the body in a small group of healthy volunteers (e.g., 100 or fewer).
The developer must decide how to formulate the product and design the process as they move from phase I studies to phase II. Phase II of the study emphasizes the formulation process regarding designing and optimization. Formula development needs to be implemented correctly to ensure manufacturing scalability and commercialization. Create a suitable formulation for Phase II candidates with a scalable, commercially viable manufacturing process and formulation. Furthermore, market growth is anticipated to be accelerated by the rising trend of collaborations for formulation development and optimization.
The most crucial step in the drug development process is pre-formulation activities. It offers the rationale for scientifically based formulation development. Integrated discovery services spanning synthetic and medicinal chemistry, biology, DMPK, and toxicology are provided to a global clientele across a range of therapeutic areas by Sai Life Sciences, a top contract research organization in India. The introduction of combination products, biosimilars, and other novel drugs has increased the demand for specialized pharmaceutical analytical tests such as bioanalytical testing, method development and validation, active pharmaceutical ingredient testing, and stability testing. Comparing the analytical testing of small-molecule active pharmaceutical ingredients (APIs) and drug products with that of biologics presents unique challenges.
Based on Dosage Form, the global market is bifurcated into injectable, oral, and topical.
The injectable segment is the highest contributor to the market and is expected to grow at a CAGR of 8.38% during the forecast period. The injectable products are typically presented in liquid vials, making them simple to use in a clinical setting. The growing incidence of chronic diseases and rising product approval are the major factors for the growth of the studied segment. Depending on the patient's location and the type of disease that needs to be treated, injectable (parenteral) drug products can range from highly specialized to extremely diverse.
All pharmaceutical products must be formulated in specific dosage forms to deliver medications to patients effectively. Different manufacturing techniques are needed to produce oral tablets, solutions, topical ointments, gels, and other dosage forms, which presents particular technical difficulties for formulation scientists. Due to the growing demand for formulation development and increasing use of oral dosage, the oral route of administration is anticipated to increase over the forecast period. Because of several benefits, oral delivery forms have grown in importance relative to the injectables market. Its advantages include a high level of patient acceptance and long-term compliance, which increases the drug's therapeutic value.
Based on Application, the global market is bifurcated into oncology, genetic disorders, neurology, infectious diseases, respiratory, and cardiovascular.
The oncology segment owns the highest market share and is expected to grow at a CAGR of 9.28% during the forecast period. One of the leading causes of morbidity and mortality worldwide is cancer. The American Cancer Society predicts that among adolescents and young adults (AYAs) aged 15 to 39 in the United States, there will be about 89,500 cancer cases diagnosed and about 9,270 cancer deaths in 2020. In addition, the Globocan Database estimates that between 2020 and 2040, there will be an increase in new cases from 18.1 million to 29.4 million. The rising incidence of cancer is thus discovered to be fueling market expansion in general.
The primary cause of disability and death worldwide is neurological disorders, diseases of the central and peripheral nervous systems. In the United States, more than 930,000 people are anticipated to have Parkinson's disease by 2020, according to the Parkinson's Foundation. In addition, the foundation's report indicates that by 2030, there will be 1.2 million confirmed cases of Parkinson's disease. This is a 1.8-fold increase in Parkinson's prevalence since 2010, underscoring the need for optimized care and treatment solutions for this patient population to lower the healthcare system's financial load and caregivers' duty of care.
Based on The End-User, the global market is bifurcated into pharmaceutical and biopharmaceutical companies and government and academic institutes.
The pharmaceutical and biopharmaceutical companies are the highest contributor to the market and are expected to grow at a CAGR of 7.74% during the forecast period. A growing trend in the biotechnology and pharmaceutical sectors is outsourcing formulation. Most pharmaceutical and biotech companies are outsourcing at least a portion of the development of their potential new drugs due to the rising demand for outsourcing pharmaceutical formulation development among drug developers and the pressure to move potential drug candidates from discovery to human clinical trials as quickly as possible. The task of formulation development frequently resides in one of several departments for smaller, emerging businesses as well as many biotechnology firms. The process of developing a formulation includes a wide variety of tasks.
The early stages of drug development and the future commercial success of an intriguing investigational medicinal product depend critically on formulation development. Academic institutions are becoming more and more critical in the development of both novel and repurposed medications. Pharmaceutical companies are increasingly contracting out their R&D work, including their early-stage research initiatives, to external companies, including academic institutions and private contract research organizations (CROs).
The global formulation development outsourcing market is segmented into North America, Europe, Asia-Pacific, the Middle East and Africa, and South America.
North America Dominates the Global Market
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North America is the most significant revenue contributor and is expected to grow at a CAGR of 6.69% during the forecast period. Due to the rising prevalence of chronic diseases and essential players in the market, the United States formulation development market is predicted to experience tremendous growth in the research market. The key players are developing novel drugs because most stations are nearing the end of their patent protection periods. Pharmaceutical companies are outsourcing formulation development services to CROs in this situation to save time and money on several clinical trials and evaluation studies, which is anticipated to propel market growth in the nation.
Europe is expected to grow at a CAGR of 7.82%, generating USD 11,209.56 million during the forecast period. The extensive expansion of the pharmaceutical and biotechnology sectors, ongoing government support, rising R&D spending, and the rise in chronic diseases in Germany are all factors contributing to the growth of the German formulation development outsourcing market. The number of active development projects for new biopharmaceuticals accounted for 640 in 2019, according to the most recent study, "Pharmaceutical Industry in Germany," for 2020. Additionally, the German pharmaceutical industry spent more than any other European nation in 2018—roughly EUR 7.4 billion—on research and development. Therefore, each of these factors has contributed to the growth of the German market under study.
Japan's formulation development outsourcing market is anticipated to proliferate in the Asia-Pacific region as a result of rising R&D costs and the expanding use of formulation development outsourcing in drug discovery. The drug discovery process is anticipated to be boosted by this increase in healthcare spending, enabling the demand for formulation development outsourcing. Additionally, the UNESCO Institute for Statistics data shows that Japan's research and development spending increased from 3.15 percent of GDP in 2016 to 3.26 percent in 2018. The rising R&D expenditures, particularly in healthcare, are anticipated to boost the overall market growth.
The Gulf Cooperation Council (GCC) region comprises Saudi Arabia, Kuwait, Bahrain, Qatar, the United Arab Emirates, and Oman. The GCC nations share social and economic backgrounds, health problems, and nearly identical health systems and policies. With a robust healthcare infrastructure, the Kingdom of Saudi Arabia and the United Arab Emirates are two of the most developed markets in the Middle East and Africa. This creates a significant opportunity for expanding numerous research projects involving the growth of the healthcare sector.
In South America, rising R&D spending and an increase in clinical trials are two critical factors influencing the market's growth in this nation. Additionally, outsourcing service providers are addressing the complex needs of the pharmaceutical and biotechnological industries, which is predicted to grow Brazil's outsourcing market for formulation development. The Ministry of Science, Technology, Innovation, and Communications (MCTIC) reports that R&D spending increased by over 0.61% in 2018 compared to 2017. In addition, Brazil has a higher percentage of clinical trials than other nations in the same region. For instance, 5,168 clinical trials sponsored by biopharmaceutical companies were being conducted throughout Brazil as of April 30, 2021, according to data from the National Clinical Trial Registry (NCT). These trials are currently in various stages of development. As a result, it is anticipated that the growing number of clinical studies will foster market expansion.
List of key formulation development outsourcing market manufacturers profiled