Biopharmaceutical Contract Manufacturing Market Report by 2028

Biopharmaceutical Contract Manufacturing Market Forecast to 2028 - COVID-19 Impact and Global Analysis By Product (Biologics and Biosimilar); Service (Process Development, Fill and Finish Operations, Analytical and Quality Control Studies, and Packaging), and Source (Mammalian and Microbial-Based Biologics/Non-Mammalian), and Geography

Publication Month : Feb 2022

  • Report Code : TIPRE00005512
  • Category : Pharmaceuticals
  • Status : Published
  • No. of Pages : 211
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[Research Report] The biopharmaceutical contract manufacturing market is projected to reach US$ 27,868.50 million by 2028 from US$ 15,735.04 million in 2021; it is expected to grow at a CAGR of 8.5% from 2021 to 2028.

The rising outsourcing by pharmaceutical companies is one of the most key factors driving the growth of the market. A few years ago, the contract manufacturing industry was a niche service market offering additional manufacturing capacity or specific services to pharmaceutical companies. The rise of CMOs was fueled by the increasing number of drug manufacturing failures. In the past, pharmaceutical companies had undertaken manufacturing facilities to develop innovative drugs. However, to reduce the risk of overcapacities, the demand for manufacturing outsourcing has continuously risen. Recently, Revolo Biotherapeutics entered into a partnership with contract development and manufacturing organization (CDMO)—Northway Biotech—to manufacture Revolo’s binding immuno-regulatory protein 1805. The partnership included services from cell line development to manufacturing protein with quality assurance and regulatory compliance support. Similarly, Gland Pharma has been manufacturing Remdesivir for four companies, including Mylan, since 2021. Also, the organization increased its manufacturing quotas due to high demand from the companies. In 2019, Samsung Biologics and GI Innovation signed a contract for immunochemotherapy. Under this agreement, Samsung Biologics was providing services ranging from f-cell lines development to production of Phase-I drug substances. The increasing number of contracts between biopharmaceutical companies and contract manufacturing companies shows an increasing market size for the biopharmaceutical contract manufacturing market.

North America is likely to continue its dominance in the biopharmaceutical contract manufacturing market during 2021–2028. The US holds the largest share of the market in North America and is expected to continue this trend during the forecast period. Increasing demand for clinical trials, growing pharmaceutical and medical device industries, increasing healthcare expenditure, high R&D spending, and the presence of key market players in the region that offer manufacturing, storage, logistic, and other services is likely to enhance the market growth in the country. For instance, Alderley Analytical, Almac, and among others are well-known manufacturing organizations that offer a wide range of integrated services to more than 600 pharmaceutical and biotech companies. The presence and significant impact of biopharmaceutical companies in the region in terms of revenue, technology, and employment opportunities are expected to aid the growth of the market in the region.

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Biopharmaceutical Contract Manufacturing Market: Strategic Insights

Market Size Value inUS$ 15,735.04 million in 2021
Market Size Value byUS$ 27,868.50 million by 2028
Growth rateCAGR of 8.5% from 2021 to 2028.
Forecast Period2021- 2028
Base Year2021
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Lucrative Regions for Biopharmaceutical Contract Manufacturing Market

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Market Insights

Increasing Demand for Biologics Drives Market Growth

The contract manufacturing market for biologics is growing at an unprecedented rate owing to increasing biologics pipeline, manufacturing complexity, and companies shifting their focus towards core activities. Presently, many pharmaceutical and biotechnology companies outsource varied services from early-stage drug development to commercial-scale manufacturing. Outsourcing is required to expedite research and development, speed up market entry, give access to novel technologies, regulatory expertise, and reduce risks at a competitive cost. Complexities in biologics development and production and increasingly stringent quality standards have driven drug manufacturers to prefer contract manufacturer services. Moreover, many companies are opting CMOs services to speed up the development process and lower production costs. For instance, Sanofi has outsourced manufacturing of its biologics pipeline to Boehringer Ingelheim. Moreover, TaiMed Biologics Ibalizumab (the FDA-designated orphan drug) is manufactured by CMO WuXi PharmaTech. Also, in 2021, Samsung Biologics expanded its collaboration with AstraZeneca from 2020. The contract included the production of a drug substance, AstraZeneca’s COVID-19 long-acting antibody combination, and manufacturing of a cancer immunotherapy product started from 2022.

Product-Based Insights

Based on product, biopharmaceuticals contract manufacturing market is segmented into biosimilar and biologics. The biologics segment held the largest share of the market in 2021 owing to increasing demand for biologics, increasing research, and development activities to develop new drugs for chronic indications in the forecast period. The segment is further segmented into monoclonal antibodies, recombinant proteins, vaccines, and others. The market for biosimilar is expected to register the highest CAGR in the market during the forecast period due to patent expiration of blockbuster drugs and increasing pipeline.

Biopharmaceutical Contract Manufacturing Market, by Product– 2021 and 2028

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Service Insights

The biopharmaceuticals contract manufacturing market, by service, is segmented into process development, fill and finish operations, analytical and quality control studies, and packaging. In 2021, the process development accounted for the largest market share in the global biopharmaceuticals contract manufacturing market owing to higher focus on pilot to commercial scale-up process development, cell line development, and other processes. However, analytical and quality control studies are expected to grow at a significant CAGR in the forecast period owing to stringent regulatory regulation and complex manufacturing requirements for biologics.

Companies operating in the biopharmaceutical contract manufacturing market adopt product innovation strategy to meet the evolving customer demands across the world, which also permits them to maintain their brand name in the global market. Also, the companies in the market create partnerships, collaborations, and contracts with biopharmaceutical companies to further drive the revenue of the market.

Biopharmaceutical Contract Manufacturing Market – Segmentation

Based on the product, the biopharmaceutical contract manufacturing market is segmented into biologics and biosimilar. The biologics segment is further segmented into monoclonal antibodies, recombinant proteins, vaccines, and others.

By service, the biopharmaceutical contract manufacturing market is segmented into process development, fill and finish operations, analytical and quality control studies, and packaging.

Based on the source, the biopharmaceutical contract manufacturing market is segmented into mammalian and microbial-based biologics/non-mammalian.

Biopharmaceutical Contract Manufacturing Market – by Geography

Based on geography, the biopharmaceutical contract management market is primarily segmented into North America, Europe, Asia Pacific, the Middle East and Africa, and South and Central America. The market in North America is further segmented into the US, Canada, and Mexico. The European biopharmaceutical contract management market is sub-segmented into Germany, France, the UK, Spain, Italy, and the Rest of Europe. The market in the Asia Pacific is sub-segmented into China, India, Japan, Australia, South Korea, and the Rest of Asia Pacific. The biopharmaceutical contract management market in the Middle East and Africa is further segmented into Saudi Arabia, the UAE, South Africa, and the Rest of the Middle East and Africa. The market in South and Central America is sub-segmented into Brazil, Argentina, and the Rest of South and Central America.

Company Profiles

  • Lonza AG
  • Boehringer Ingelheim Biopharmaceuticals GmbH
  •  Inno Bio Ventures Sdn Bhd
  • Thermo Fisher Scientific, Inc.  
  • AbbVie, Inc.
  • WuXi Biologics, Inc.
  • General Electric Co.
  • Samsung Biologics Co. Ltd.
  • Merck KGaA
  • Ajinomoto Co. Inc.
Report Coverage
Report Coverage

Revenue forecast, Company Analysis, Industry landscape, Growth factors, and Trends

Segment Covered
Segment Covered

Product; Service, and Source, and Geography

Regional Scope
Regional Scope

North America, Europe, Asia Pacific, Middle East & Africa, South & Central America

Country Scope
Country Scope

Argentina, Australia, Brazil, Canada, China, France, Germany, India, Italy, Japan, Mexico, Saudi Arabia, South Africa, South Korea, Spain, United Arab Emirates, United Kingdom, United States

Frequently Asked Questions

What is biopharmaceuticals contract manufacturing?

Biopharmaceuticals contract manufacturing refers to biopharmaceutical companies outsourcing the development and manufacturing of drugs substances and products to contract manufacturers with the necessary resources to manufacture their products. Biopharmaceutical contract manufacturing organizations (CMOs) have become a known name among pharmaceutical companies due to their cost effective services that require minimal capital investments by the biopharmaceutical company. The CMOs offer a wide range of services including process development, analytical and quality control studies, fill and finish operations, and packaging. Moreover, the growing biopharma industry is offering lucrative opportunities for the growth of the market.

What are the driving factors for the biopharmaceuticals contract manufacturing market across the globe?

The factors that are driving the growth of the market are increasing demand for biologics, growing biosimilar pipelines, stringent regulatory guidelines, and increasing outsourcing by pharmaceutical companies. Moreover, emerging markets are offering lucrative opportunities owing to the increasing number of contract manufacturers in developing countries.

Who are the major players in the biopharmaceuticals contract manufacturing market?

The biopharmaceutical contract manufacturing market majorly consists of the players such as Lonza AG, Boehringer Ingelheim Biopharmaceuticals GmbH, Inno Bio Ventures Sdn Bhd, Thermo Fisher Scientific, Inc., AbbVie, Inc., WuXi Biologics, Inc., General Electric Co., Samsung Biologics Co. Ltd., Merck KGaA, and Ajinomoto Co. Inc., among others.

The List of Companies - Biopharmaceuticals Contract Manufacturing Market

  1. Lonza AG
  2. Boehringer Ingelheim Biopharmaceuticals GmbH
  3.  Inno Bio Ventures Sdn Bhd
  4. Thermo Fisher Scientific, Inc.  
  5. AbbVie, Inc.
  6. WuXi Biologics, Inc.
  7. General Electric Co.
  8. Samsung Biologics Co. Ltd.
  9. Merck KGaA
  10. Ajinomoto Co. Inc.

The Insight Partners performs research in 4 major stages: Data Collection & Secondary Research, Primary Research, Data Analysis and Data Triangulation & Final Review.

  1. Data Collection and Secondary Research:

As a market research and consulting firm operating from a decade, we have published many reports and advised several clients across the globe. First step for any study will start with an assessment of currently available data and insights from existing reports. Further, historical and current market information is collected from Investor Presentations, Annual Reports, SEC Filings, etc., and other information related to company’s performance and market positioning are gathered from Paid Databases (Factiva, Hoovers, and Reuters) and various other publications available in public domain.

Several associations trade associates, technical forums, institutes, societies and organizations are accessed to gain technical as well as market related insights through their publications such as research papers, blogs and press releases related to the studies are referred to get cues about the market. Further, white papers, journals, magazines, and other news articles published in the last 3 years are scrutinized and analyzed to understand the current market trends.

  1. Primary Research:

The primarily interview analysis comprise of data obtained from industry participants interview and answers to survey questions gathered by in-house primary team.

For primary research, interviews are conducted with industry experts/CEOs/Marketing Managers/Sales Managers/VPs/Subject Matter Experts from both demand and supply side to get a 360-degree view of the market. The primary team conducts several interviews based on the complexity of the markets to understand the various market trends and dynamics which makes research more credible and precise.

A typical research interview fulfils the following functions:

  • Provides first-hand information on the market size, market trends, growth trends, competitive landscape, and outlook
  • Validates and strengthens in-house secondary research findings
  • Develops the analysis team’s expertise and market understanding

Primary research involves email interactions and telephone interviews for each market, category, segment, and sub-segment across geographies. The participants who typically take part in such a process include, but are not limited to:

  • Industry participants: VPs, business development managers, market intelligence managers and national sales managers
  • Outside experts: Valuation experts, research analysts and key opinion leaders specializing in the electronics and semiconductor industry.

Below is the breakup of our primary respondents by company, designation, and region:

Research Methodology

Once we receive the confirmation from primary research sources or primary respondents, we finalize the base year market estimation and forecast the data as per the macroeconomic and microeconomic factors assessed during data collection.

  1. Data Analysis:

Once data is validated through both secondary as well as primary respondents, we finalize the market estimations by hypothesis formulation and factor analysis at regional and country level.

  • 3.1 Macro-Economic Factor Analysis:

We analyse macroeconomic indicators such the gross domestic product (GDP), increase in the demand for goods and services across industries, technological advancement, regional economic growth, governmental policies, the influence of COVID-19, PEST analysis, and other aspects. This analysis aids in setting benchmarks for various nations/regions and approximating market splits. Additionally, the general trend of the aforementioned components aid in determining the market's development possibilities.

  • 3.2 Country Level Data:

Various factors that are especially aligned to the country are taken into account to determine the market size for a certain area and country, including the presence of vendors, such as headquarters and offices, the country's GDP, demand patterns, and industry growth. To comprehend the market dynamics for the nation, a number of growth variables, inhibitors, application areas, and current market trends are researched. The aforementioned elements aid in determining the country's overall market's growth potential.

  • 3.3 Company Profile:

The “Table of Contents” is formulated by listing and analyzing more than 25 - 30 companies operating in the market ecosystem across geographies. However, we profile only 10 companies as a standard practice in our syndicate reports. These 10 companies comprise leading, emerging, and regional players. Nonetheless, our analysis is not restricted to the 10 listed companies, we also analyze other companies present in the market to develop a holistic view and understand the prevailing trends. The “Company Profiles” section in the report covers key facts, business description, products & services, financial information, SWOT analysis, and key developments. The financial information presented is extracted from the annual reports and official documents of the publicly listed companies. Upon collecting the information for the sections of respective companies, we verify them via various primary sources and then compile the data in respective company profiles. The company level information helps us in deriving the base number as well as in forecasting the market size.

  • 3.4 Developing Base Number:

Aggregation of sales statistics (2020-2022) and macro-economic factor, and other secondary and primary research insights are utilized to arrive at base number and related market shares for 2022. The data gaps are identified in this step and relevant market data is analyzed, collected from paid primary interviews or databases. On finalizing the base year market size, forecasts are developed on the basis of macro-economic, industry and market growth factors and company level analysis.

  1. Data Triangulation and Final Review:

The market findings and base year market size calculations are validated from supply as well as demand side. Demand side validations are based on macro-economic factor analysis and benchmarks for respective regions and countries. In case of supply side validations, revenues of major companies are estimated (in case not available) based on industry benchmark, approximate number of employees, product portfolio, and primary interviews revenues are gathered. Further revenue from target product/service segment is assessed to avoid overshooting of market statistics. In case of heavy deviations between supply and demand side values, all thes steps are repeated to achieve synchronization.

We follow an iterative model, wherein we share our research findings with Subject Matter Experts (SME’s) and Key Opinion Leaders (KOLs) until consensus view of the market is not formulated – this model negates any drastic deviation in the opinions of experts. Only validated and universally acceptable research findings are quoted in our reports.

We have important check points that we use to validate our research findings – which we call – data triangulation, where we validate the information, we generate from secondary sources with primary interviews and then we re-validate with our internal data bases and Subject matter experts. This comprehensive model enables us to deliver high quality, reliable data in shortest possible time.

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