Global Formulation Development Outsourcing Market by Service (Preformulations, Formulation Development), By Formulation (Oral, Injectable, Topical, Inhaled), By Application (Oncology, Infectious Diseases, Neurology, Hematology, Respiratory, Cardiovascular, Dermatology), By End-User (Pharmaceutical Industries, Research and Academic Institutes, Other End-Users), By Region and Companies - Industry Segment Outlook, Market Assessment, Competition Scenario, Trends, and Forecast 2023-2032

Report Overview

In 2022, the global formulation development outsourcing market accounted for USD 34.7 billion and is expected to grow to around USD 67.7 billion in 2032. Between 2023 and 2032, this market is estimated to register the highest CAGR of 7.1%.

Formulation development outsourcing refers to the industry involved in providing formulation development services to pharmaceutical, biotech, and medical device companies. It includes companies which are specialized in developing and optimizing formulations for drug candidates and companies that provide related services such as analytical testing, regulatory support, and process development. The formulation development outsourcing market growing rapidly due to the increasing complexity of drug formulations.

Market Scope

Service Analysis

The Formulation Development Segment is The Most Lucrative Segment in The Product Type of Formulation Development Outsourcing Market.

Based on service, the market for formulation development outsourcing is segmented into formulations and formulation development. Among these types, the formulation development segment is the most lucrative in the global formulation development outsourcing market, with a projected CAGR of 7.5%. The total revenue share of formulation development type formulation development outsourcing is 76.8% in 2022. It involves designing and optimizing the final dosage form of a drug, like capsules, tablets, and injectables, to ensure drug delivery and bioavailability. This can also include activities such as optimizing formulation parameters.

The Pre-Formulation Service is Expected to Grow in the Projected Period in Formulation Development Outsourcing Market.

Followed by pre-formulation service, which accounted for the fastest-growing type segment in the formulation development outsourcing market, and its estimated market share is 23.2% in 2022. The pre-formulation is often conducted early in the drug development process to evaluate the physicochemical properties of a drug candidate and determine the optimal formulation strategy.

Formulation Analysis

The Oral Segment Holds the Majority Share in the Technology Segment of the Formulation Development Outsourcing Market.

By formulation, the market is further divided into oral, injectable, topical, and inhaled. Among these, the oral segment is estimated to be the most lucrative segment in the global formulation development outsourcing market, with a market share of 62.4% and a projected CAGR of 7.8%, in 2022. Owing to oral delivery being the most common route of administration for pharmaceuticals, oral formulations are relatively easy to develop compared to other routes of administration like inhalation or injection.

The Injectable Segment is Expected as Fastest Growing Technological Segment in Formulation Development Outsourcing Market.

Also, the injectable segment is estimated as the fastest-growing segment in technology with a CAGR of 7.2. Owing to its increasing demand for biologics, growing demand for targeted delivery, technological advancements, and favorable regulatory environments.

Application Analysis

The Oncology Segment Accounted for the Largest Revenue Share in Formulation Development Outsourcing Market in 2022.

Based on application, the market is segmented into oncology, infectious diseases, neurology, hematology, respiratory, cardiovascular, and dermatology. Among these, the oncology segment is estimated to be the most lucrative segment in the global formulation development outsourcing market, with the largest revenue share of 28.8% and a projected CAGR of 7.6% during the forecast period. Owing to its high demand, complex formulations, regulatory requirements, high-profit margins, and increasing prevalence of cancer worldwide.

The Infectious Diseases Segment is Expected to be the Fastest Growing Application Segment in Formulation Development Outsourcing Market.

The infectious diseases segment is projected as the fastest-growing application segment in the Formulation Development Outsourcing market, with a revenue share of 22.4% in 2022, and registering a CAGR of 7.2% from 2022 to 2031. This segment has gained importance due to the COVID-19 pandemic. The pandemic has led to an increase in demand for antiviral drugs, vaccines, and other treatments for infectious diseases is continue to grow due to the need for innovative solutions to tackle viral and bacterial infections.

End-User Analysis

The Pharmaceutical Industries Development Outsourcing Companies Hold the Significant Share of the End-User Segment in Formulation Development Outsourcing Market.

Based on end-user, the market is divided into pharmaceutical industries and research and academic institutes. Among these end-users, pharmaceutical industries are dominant in the end-user segment in the formulation development outsourcing market, with a market share of 71.5% and a CAGR of 7.8. This is due to the pharmaceutical industries being the largest consumers of formulation development outsourcing services. There is also high demand for new drugs and pharmaceutical industries are focused on developing new drugs to tackle a number of diseases and conditions.

Research and Academic Institute is Identified as Fastest Growing End-User Segment in Projected Period.

Research and academic institutes is also important end-user segment in the formulation development outsourcing market and it is expected to grow faster in the end-user segment in the Formulation Development Outsourcing market with a CAGR of 7.3 and a market value is 22.8%. This is the fastest-growing end-user segment because of its increasing focus on translational research, budget constraints, and collaboration with industry.

Key Market Segments

Based on Service

• Preformulations
• Formulation Development

Based on Formulation

• Oral
• Injectable
• Topical
• Inhaled
• Other Outlooks

Based on Application

• Oncology
• Infectious Diseases
• Neurology
• Hematology
• Respiratory
• Cardiovascular
• Dermatology
• Other Applications

Based on End-User

• Pharmaceutical Industries
• Research and Academic Institutes
• Other End-Users

Drivers

Growing Demand for New and Innovative Drugs, Cost Reduction, and Increasing Prevalence of Chronic Diseases Drive the Market Growth of the Formulation Development Outsourcing Market.

The factors which drive the formulation development outsourcing market includes, increasing demand for new and innovative drugs to tackle a wide range of diseases and conditions, the formulation development outsourcing services help pharmaceutical companies to increase the drug development process and introduce new drugs to market quickly and efficiently.

Drug development is a complex and costly process that requires significant investment in R&D, formulation development outsourcing services can help pharmaceutical industries reduce costs. Advancements in technology such as 3D printing, biotechnology, and nanotechnology have revolutionized drug development and formulation, formulation development outsourcing can help pharmaceutical industries to take advantage of these advancements to develop new drugs.

The increasing prevalence of chronic diseases like diabetes, cancer, and cardiovascular diseases, are driving the demand for new and improved treatments. Drug development is subject to strict regulatory requirements and ensuring compliance with these requirements is vital for introducing new drugs into the market. Biologics and biosimilars are complex drugs that require hence formulation development outsourcing services that can help pharmaceutical industries to develop drugs more cost-effectively.

Restraints

Intellectual Property Concerns, Quality Concerns, Communication and Coordination Issues, and Political and Economic Instability are Some Restraints to Formulation Development Outsourcing Market.

Formulation development outsourcing also has some restraints in the global market, which affect the growth of the formulation development outsourcing market. The factors include intellectual property concerns, as it is critical to maintaining a competitive advantage. Lack of control over the drug development process. Quality concerns occur when a provider does not have the necessary expertise.

Communication and coordination issues occur when the service provider is located in another country. Political and economic instability may increase the risk of supply chain disruptions, which can negatively impact the growth of the Formulation Development Outsourcing market.

Opportunity

Increasing Demand for Specialized Expertise, Cost-effective solutions, and access to cutting-edge technologies Creates Opportunities in the Formulation Development Outsourcing market.

The formulation development outsourcing industry is also boosted due to growing healthcare industries in several emerging economies such as Brazil, India, South Africa, and China. There are some opportunities in this sector like increasing demand for specialized expertise such as drug delivery, controlled release systems, and nanoparticle formulation.

Pharmaceutical industries are playing a vital role in the formulation development outsourcing market by focusing and innovating on oncology formulation development and other drug development. Moreover, the adoption of new methods availability and pharmaceutical services by key market players increase the market size during the forecasted period.

However, key players are capturing maximum profit in the market by accepting some marketing tactics and methodologies. The pharmaceutical company’s hunt for novel and efficient medicines continues to be longer-term growth and clinical research for both existing COVID-19 and new medications.

Trends

An increase in Demand for Complex and Specialized Formulations, Growing Focus on Risk-Sharing Partnerships are Some Recent Trends in Formulation Development Outsourcing Market.

The growing prevalence of chronic diseases like cancer, arthritis, asthma, diabetes, chronic obstructive pulmonary disease, and Alzheimer’s is producing the demand for the finding and development of new drugs. This represents one of the major factors resulting in the formulation development services being outsourced to contract research organizations around the world.

Outside of this, there is an increase in the requirement to overcome the risk and save the money and time invested in passing the drug through the development pipeline. Growing focus on risk-sharing partnerships which allows pharmaceutical companies to share the cost and risk of drug development with outsourcing partners. Expansion of services offered by CROs and CDMOs to provide end-to-end solutions from drug finding to commercialization.

COVID-19 Impact Analysis

Delayed Clinical Trials, Increased Demand for Virtual Collaborations, Focus on COVID-19 Treatments and Vaccines Impacts on Formulation Development Outsourcing Market.

As pharmaceuticals fell under the category of essential services, and these were spread from the limits imposed by the statewide lockdown. Hence COVID-19 pandemic has slowed down many key pharmaceutical companies’ production, supply chains, and export. It also shows the world’s dependence on China for various pharmaceuticals.

Due to the lockdown implemented by the Chinese government during outbroke, nearly 44 Chinese firms were marked to be inactive. It had an effect on China’s exports of essential materials. The pandemic has caused several countries to launch plans for domestic API production.

The pandemic has disrupted clinical trial timelines, which led to delays in drug development. Many pharmaceutical and biotech companies have to pause or delay clinical trials due to restrictions on travel and face-to-face communications. The pandemic has increased the shift towards digitalization in the pharmaceutical industry. Many firms are investing in digital tools and platforms to streamline drug development processes.

The pandemic had led to a rush in demand for COVID-19 treatments and vaccines, which diverted resources and attention from other drug development projects. With in-person meetings prohibited, there has been a rush in virtual collaborations and remote working. This has led to an increased demand for virtual formulation development outsourcing services, like virtual meetings, remote monitoring of trials, and data analysis.

Regional Analysis

North America Accounted for the Largest Revenue Share in Formulation Development Outsourcing Market in 2022.

North America is estimated to be the most lucrative market in the global formulation development outsourcing market, with the largest market share of 37.2%, and is expected to register a CAGR of 7.1% during the forecast period.

Owing to the presence of a large number of pharmaceutical and biotechnology industries, well-established health infrastructure, availability of specialized expertise in drug delivery, and favorable regulatory environment. The region’s expectations for formulation development outsourcing are expanding because of an increase in the number of approved drugs and the development of the vaccine.

APAC is expected as Fastest Growing Region in Projected Period in Formulation Development Outsourcing Market.

Asia Pacific is expected as fastest growing region in the Formulation Development Outsourcing market with a CAGR of 6.5% and a market value of 25.3%. Owing to its increase in the number of biotechnology and pharmaceutical companies. Rising healthcare expenditure, and growing demand for generic drugs. Also, countries like India and China have become charming destinations due to the availability of skilled labor, supportive regulatory environment, and lower costs.

Key Regions

• North America
  • o The US
  • o Canada
  • o Mexico
• Western Europe
  • o Germany
  • o France
  • o The UK
  • o Spain
  • o Italy
  • o Portugal
  • o Ireland
  • o Austria
  • o Switzerland
  • o Benelux
  • o Nordic
  • o Rest of Western Europe
• Eastern Europe
  • o Russia
  • o Poland
  • o The Czech Republic
  • o Greece
  • o Rest of Eastern Europe
• APAC
  • o China
  • o Japan
  • o South Korea
  • o India
  • o Australia & New Zealand
  • o Indonesia
  • o Malaysia
  • o Philippines
  • o Singapore
  • o Thailand
  • o Vietnam
  • o Rest of APAC
• Latin America
  • o Brazil
  • o Colombia
  • o Chile
  • o Argentina
  • o Costa Rica
  • o Rest of Latin America
• Middle East & Africa
  • o Algeria
  • o Egypt
  • o Israel
  • o Kuwait
  • o Nigeria
  • o Saudi Arabia
  • o South Africa
  • o Turkey
  • o United Arab Emirates
  • o Rest of MEA

Key Players Analysis

Emerging key players are focused on the development and commercialization of new and innovative drugs. For example, Catalent Inc. is leading advanced delivery technologies, manufacturing solutions for drugs, gene therapies, consumer health products, and development. Lonza Group Ltd. is a Swiss MNC that provides products and series to the biotechnology, specialty ingredients market, and pharmaceutical. Thermo Fisher Scientific is a global leader in the development and manufacture of analytical instruments, consumables, and services for research, diagnostic, analysis, software, and reagents.

Market Key Players

• SGS S.A.
• Intertek Group plc.
• Recipharm AB
• Lonza Group AG
• Charles River Laboratories International Inc.
• Eurofins Scientific SE
• Element
• Labcorp
• Thermo Fisher Scientific Inc.
• Catalent Inc.
• Laboratory Corporation of America
• Intertek
• Quotient Sciences
• Reddy’s Laboratories
• Emergent Biosolutions Inc.
• Aizant Drug Research Solutions Pvt. Ltd.
• Other Key Players

Recent Developments

• In June 2022, Lonza started a new R&D facility in Bend dedicated to supporting early-phase clinical trials.
• In April 2022, Labcorp collaborated with a developer of cell and gene therapy technologies to expand its research capabilities in cell and gene therapies.
• In January 2021, Lonza announced the expansion of its formulation development capabilities in Europe by starting a new facility in Basel, Switzerland. The facility can strengthen the firm’s expertise in lipid nanoparticle technology for the delivery of RNA-based therapeutics.

Report Scope