; Formulation Development Outsourcing Market size, share 2034

Formulation Development Outsourcing Market

Formulation Development Outsourcing Market Size, Share, and Analysis, By Service (Pre-formulations and Formulation Development), By Formulation (Oral, Injectable, Topical, and Inhaled), By Application (Oncology, Infectious Diseases, Neurology, Hematology, Respiratory, Cardiovascular, and Dermatology), By End-User (Pharmaceutical Industries, Research and Academic Institutes, and Others), and By Region (North America, Europe, Asia-Pacific, And Rest of the World) And Regional Forecast 2024-2034

Published on: Feb-2024
Report Code: FG HC 01860
No. of Pages: 170-350
Report Format: PDF

Formulation Development Outsourcing Market is anticipated to exhibit a Compound Annual Growth Rate (CAGR) of 7% during the forecast span from 2024 to 2034. In 2023, the market size was assessed at USD 33.9 billion and is projected to reach USD 71.5 billion by the completion of 2034.

Product Overview

Formulation Development Outsourcing refers to the process of hiring external entities or contract research & development firms to manage the development of pharmaceutical or chemical formulations. This outsourcing method enables businesses to utilize the specific expertise of external partners while developing medicine or product compositions. These outsourcing organizations conduct extensive research to discover the ideal combination of ingredients and formulation, which ensures a product's stability and manufacturability. Additionally, companies that outsource formulation development can simplify processes, decrease expenses, and accelerate the time-to-market for new products. Therefore, outsourcing formulation development allows businesses to focus on their core capabilities while benefiting from expertise knowledge and resources for efficient formulation procedures.

Market Highlights

Formulation Development Outsourcing Market is expected to grow at a compound annual growth rate (CAGR) of 7% from 2024 to 2034

Formulation Development Outsourcing Market is projected to reach USD 71.5 billion over the forecast period, due to the rising complexity of drug formulations, combined with high demand for innovative pharmaceuticals and the adoption of affordable strategies by pharmaceutical and biotechnology firms. There has been a considerable increase in outsourcing cooperation as companies are seeking external expertise to improve their formulation methods. Moreover, the global landscape is defined by an abundance of Contract Research Organizations (CROs) and Contract Development and Manufacturing Organizations (CDMOs) that provide specialized formulation services. Furthermore, strict regulatory needs and rapid improvements in pharmaceutical tech are contributing to the growth of formulation development outsourcing market. Consequently, the market is expected to rise steadily, owing to continuous focus of the industry on research & development activities.

Source: Fatpos Global

Formulation Development Outsourcing Market Segmentation

Formulation Development segment will lead due to its important role in drug development process

Based on Service, the Formulation development outsourcing market is segmented into Pre-formulations and Formulation Development. The formulation development segment is expected to dominate the market owing to its crucial role in navigating the challenges of drug development. With the increasing complications of pharmaceutical formulations, companies are seeking external expertise to navigate the difficult phases of pre-formulation evaluations. Moreover, contract research organizations and contract development & manufacturing organizations are in charge of the optimization process, which is an essential component of formulation development outsourcing. These external partners are armed with modern technologies and function as industry experts in refining the drug components to reach the necessary potency and stability. Besides, external partners serve as auditors and ensures that formulations meet the regulatory standards. Therefore, outsourcing formulation development is a strategic collaboration, which ensures a symphony of success in the pharmaceutical and biotechnological realms.

Oral segment will dominate owing to its popularity as common dosage form

By Formulation, Formulation Development Outsourcing Market is divided into Oral, Injectable, Topical, and Inhaled. The oral segment is expected to lead the formulation development outsourcing market due to several significant factors. The vast usage of tablets and capsules, which is the most commonly prescribed and consumed dosage forms, substantially contributes to the dominance of this segment. The strong demand for formulation development services for oral medications helps in sustaining a consistent growth trajectory. Moreover, oral drugs have a well-established and uncomplicated regulatory approval process. The simplified regulatory environment accelerates the development timeline, which provides a significant advantage over other dosage forms. This regulatory simplicity enhances the attractiveness of oral segment for outsourcing and reducing uncertainties associated with approvals.

Source: Fatpos Global

Market Dynamics

Growth Drivers

Growing Demand for Specialized Expertise will Create Growth Opportunities

Expansion of the formulation development outsourcing market is driven by the growing demand for specialized expertise. The need for expertise increases as the biotechnology and pharmaceutical sectors explore deeper into complicated medication formulations and modern therapeutic techniques. Moreover, contract research organizations (CROs) and contract development and manufacturing organizations (CDMOs) are sources of specialized knowledge and advanced technology, which makes them appealing to companies that are looking to improve their internal capabilities. The ability of outsourcing partners to navigate complicated formulation issues positions them as an important contributor to the pharmaceutical development pipeline. This surge in demand reflects the vital significance of specialized skills and resources in accomplishing efficient formulation development.

Increased Focus on R&D Efficiency will Lead to Market Expansion

Increasing emphasis in the pharmaceutical and biotechnology sectors on enhancing R&D efficiency is responsible for the growth of formulation development outsourcing market. Companies strategically depend on outsourcing formulation methods to optimize operational effectiveness, along with reducing costs and accelerate the entry of new products in the market. This efficiency-oriented approach aligns with the wider industry objective of accelerating drug development timelines while upholding strict quality standards. Furthermore, external partners provide essential expertise, which enable companies to allocate resources strategically and focus on their core competencies and research initiatives. Thus, the growth of the market is driven by the acknowledgment that outsourcing formulation development offers a strategic avenue to improve overall R&D efficiency and provide a competitive benefit in the pharmaceutical sector.

Restraints

Regulatory and Compliance Issues may Impede Industry Growth

Formulation development outsourcing industry has significant obstacles due to regulatory constraints and compliance issues, even with its strong expansion. The pharmaceutical sector operates in a highly regulated setting with strict restrictions that vary by region. Thus, navigating this complex regulatory framework presents significant obstacles for outsourcing organizations and service providers. Additionally, ensuring compliance with diverse regulatory frameworks demands a thorough understanding and continuous adaptation to changing requirements. Thus, effectively addressing these compliance challenges requires vigilance, along with investment in regulatory expertise and smooth communication between outsourcing partners and their clients.

Recent Developments

  • In August 2023, Catalent, Inc. acquired Pharmaceutics International, Inc. (Pii), expanding its global FDO capabilities and adding expertise in complex formulations.
  • In March 2023, Patheon launched its PATheon On-Demand™ service, offering flexible and scalable FDO solutions for early-stage development programs.
  • In September 2023, Lonza Group announced plans to invest CHF 50 million in expanding its small molecule FDO capabilities at its Visp, Switzerland site. The company also entered into a collaboration with Evotec to offer integrated drug discovery and development services, including FDO.
  • In December 2023, Recipharm AB acquired LianBio, a Chinese contract development and manufacturing organization (CDMO) with strong FDO capabilities.
  • In October 2023, Evonik Industries AG launched its EVOTEC® DosiSol™ platform, offering customized formulation development solutions for poorly soluble drugs. The company is looking to expand its collaboration with Pfizer on the development and manufacturing of mRNA-based vaccines, leveraging its FDO expertise.

Formulation Development Outsourcing Market

Key Players:

  • Catalent, Inc.
  • Lonza Group
  • Recipharm AB
  • Evonik Industries AG
  • Patheon
  • Cambrex Corporation
  • Jubilant Life Sciences
  • Aptuit
  • Metrics Contract Services
  • AMRI (Albany Molecular Research Inc.)
  • Curia
  • Charles River Laboratories
  • WuXi AppTec
  • PPD, Inc.
  • Pharmaceutics International, Inc.
  • Other Prominent Players (Company Overview, Business Strategy, Key Product Offerings, Financial Performance, Key Performance Indicators, Risk Analysis, Recent Development, Regional Presence, SWOT Analysis)

Regional Analysis

Formulation Development Outsourcing Market is segmented based on regional analysis into five key regions: North America, Latin America, Europe, Asia Pacific and the Middle East and Africa. North America region stands at the forefront of the formulation development outsourcing market owing to its strong pharmaceutical industry, combined with modern research infrastructure, and high concentration of contract research organizations (CROs) and contract development and manufacturing organizations (CDMOs). For instance, Catalent, Inc., a prominent player headquartered in the United States, offers a comprehensive suite of services including formulation development and analytical solutions, which attracts global clients with its expertise and modern facilities. Moreover, North America benefits from a supportive regulatory ecosystem and strong intellectual property protections, which instills confidence in international clients. The skilled workforce in North America and access to advanced technologies further solidify its position. These factors collectively establish North America as a preferred destination for companies which are seeking efficient and high-quality solutions for their formulation development needs.

Source: Fatpos Global

Impact of Covid-19 on Formulation Development Outsourcing Market

COVID-19 pandemic had a multifaceted impact on the formulation development outsourcing market. Initially, the market witnessed disruptions in global supply chains and restrictions on movement resulted in delays and logistical challenges which affected project timelines and increased costs. Furthermore, the importance of funds to combat the pandemic caused a delay in non-essential research & development efforts, that temporarily lowered the demand for outsourcing services. However, the pandemic highlighted the necessity of agility and resilience in the pharmaceutical sector, which forced corporations to reconsider their outsourcing strategy. Furthermore, demand for formulation expertise grew due to the renewed focus on vaccine and therapeutic research. This rising demand for special services encouraged fast adaptation and innovation in the formulation development outsourcing market to address the evolving needs of the pharmaceutical and biotechnology sectors in combating COVID-19.

Formulation Development Outsourcing Market is further segmented by region into:

  • North America Market Size, Share, Trends, Opportunities, Y-o-Y Growth, CAGR – United States and Canada
  • Latin America Market Size, Share, Trends, Opportunities, Y-o-Y Growth, CAGR – Mexico, Argentina, Brazil, and Rest of Latin America
  • Europe Market Size, Share, Trends, Opportunities, Y-o-Y Growth, CAGR – United Kingdom, France, Germany, Italy, Spain, Belgium, Hungary, Luxembourg, Netherlands, Poland, NORDIC, Russia, Turkey, and Rest of Europe
  • Asia Pacific Market Size, Share, Trends, Opportunities, Y-o-Y Growth, CAGR – India, China, South Korea, Japan, Malaysia, Indonesia, New Zealand, Australia, and Rest of APAC
  • Middle East and Africa Market Size, Share, Trends, Opportunities, Y-o-Y Growth, CAGR – North Africa, Israel, GCC, South Africa, and Rest of MENA

Formulation Development Outsourcing Market Scope and Segments:

ATTRIBUTE

  DETAILS

Study Period

2018-2034

Base Year

2023

Forecast Period

2024-2034

Historical Period

2019-2022

Growth Rate

CAGR of 7% from 2024-2034

Unit

Value (USD Billion)

Segmentation

Main Segments List

By Service

  • Pre-formulations
  • 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
  • Others

By Region

  • North America
    • U.S.
    • Canada
  • Europe
    • Germany
    • U.K.
    • France
    • Rest of Europe
  • Asia Pacific
    • China
    • Japan
    • India
    • Australia
    • Southeast Asia
    • Rest of Asia Pacific
  • Latin America
    • Brazil
    • Mexico
    • Rest of Latin America
  • Middle East & Africa
    • GCC
    • South Africa
    • Rest of Middle East & Africa

Frequently Asked Questions (FAQ):

Formulation Development Outsourcing Market size was values at USD 33.9 billion in 2023 and is projected to reach the value of USD 71.5 billion in 2034, exhibiting a CAGR of 7% during the forecast period.

The Formulation Development Outsourcing Market refers to the practice of pharmaceutical and biotechnology companies contracting external organizations or contract research and development (R&D) firms to handle the process of developing formulations for drugs or other products.

Formulation Development segment and the Oral segment accounted for the largest Formulation Development Outsourcing Market share.

Key players in the Formulation Development Outsourcing Market include Catalent, Inc., Lonza Group, Recipharm AB, Evonik Industries AG, Jubilant Life Sciences, Patheon, Cambrex Corporation, Aptuit, Metrics Contract Services, AMRI (Albany Molecular Research Inc.), Curia, Charles River Laboratories, WuXi AppTec, PPD, Inc., Pharmaceutics International, Inc., and Other Prominent Players.

Growing demand for specialized expertise and increased focus on R&D efficiency are the factors driving the formulation development outsourcing market.

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