Biologics Contract Manufacturing Market by Type of Service(s) Offered (API, FDF), Type of Biologic Manufactured (Antibodies, Cell Therapies, Vaccines and Other Biologics), Type of Expression System Used (Mammalian, Microbial and Others), Scale of Operatio

Biologics Contract Manufacturing Market by Type of Service(s) Offered (API, FDF), Type of Biologic Manufactured (Antibodies, Cell Therapies, Vaccines and Other Biologics), Type of Expression System Used (Mammalian, Microbial and Others), Scale of Operation (Preclinical / Clinical and Commercial), Company Size (Small, Mid-sized, and Large and Very Large), and Key Geographical Regions (North America, Europe, Asia-Pacific, Latin America and MENA): Industry Trends and Global Forecasts, Till 2035

BIOLOGICS CONTRACT MANUFACTURING MARKET: OVERVIEW

As per Roots Analysis, the global biologics contract manufacturing market is estimated to grow from USD 22.2 billion in the current year to USD 58 billion by 2035, at a CAGR of 9.12% during the forecast period, till 2035.

The market sizing and opportunity analysis has been segmented across the following parameters:

Type of Service Offered

API Manufacturing

FDF Manufacturing

Type of Biologic Manufactured

Antibodies

Cell Therapies

Vaccines

Other Biologics

Type of Expression System Used

Mammalian

Microbial

Others

Scale of Operation

Preclinical / Clinical

Commercial

Company Size

Small

Mid-sized

Large and Very Large

Key Geographical Regions

North America

Europe

Asia-Pacific

Middle East and North Africa

Latin America

BIOLOGICS CONTRACT MANUFACTURING MARKET: GROWTH AND TRENDS

Given the benefits offered by biological products, such as specificity, efficacy and safety, it has captured the attention of both industry stakeholders and patients. In fact, in 2023, the USFDA approved 17 biological products (including monoclonal antibodies and recombinant proteins). In addition, currently, several biologics are being investigated across different geographies for a myriad of disease indications, including immunological, oncological and rare disorders.

Despite the success of biopharmaceutical products, the production of biologics is a complex and cost intensive process coupled with multiple challenges, such as long development timelines, a high rate of attrition of pipeline drugs / therapies, regulatory and compliance-related issues, and inconsistencies related to the quality attributes of the final product. As a result, an increasing number of biopharmaceutical drug developers are relying on contract manufacturers for end-to-end solutions, including bioprocess development and optimization. As outsourcing gains wider acceptance as a practical and advantageous business model in this sector, the global market for biologics contract manufacturing is anticipated to experience significant growth throughout the forecast period.

BIOLOGICS CONTRACT MANUFACTURING MARKET: KEY INSIGHTS

The report delves into the current state of the biologics contract manufacturing market and identifies potential growth opportunities within the industry. Some key findings from the report include:

1. Currently, more than 305 contract manufacturing organizations (CMOs) are engaged in the production of biologics; over 90% of such players provide FDF manufacturing services.

2. Around 70% of the stakeholders operate at all scales of operation to cater to the diverse needs of customers; notably, mammalian cell-based expression systems have emerged as a popular choice among CMOs.

3. The competition among service providers that claim to be focused on the niche and upcoming drug classes is fierce; it is primarily influenced by the success of several blockbuster therapies in the recent past.

4. In the past decade, a shift in trend has been observed in the biopharmaceutical contract manufacturing industry as more players have set up their manufacturing facilities in developing regions across Asia-Pacific.

5. Over the last five years, more than 695 deals have been inked by biologics CMOs; most of the collaborations were inked for the manufacturing of vaccines, antibodies and cell therapies.

6. In order to maintain a competitive edge and establish themselves as one-stop-shops, players are expanding their existing capabilities and service portfolios; the domain has witnessed over 135 mergers and acquisitions.

7. Considering the enormous opportunities associated with biologics contract manufacturing, investors have actively extended funds, amounting to USD 7.5 billion, across more than 90 funding instances in the past eight years.

8. Driven by the growing demand, CMOs have made elaborate investments to expand their existing capacities and capabilities, primarily for niche biologics; this trend is most pronounced in the US and China.

9. More than 215 initiatives were undertaken by big pharma players; more than 80% of such initiatives were focused on partnerships and expansions.

10. Though the existing installed capacity is sufficient to meet the current annual demand for biologics, we anticipate that CMOs are likely to invest in installing incremental capacity to meet the long-term demand.

11. The global installed biopharmaceutical contract manufacturing capacity is spread across various geographies; notably, large players account for 80% of the total capacity.

12. With the growing pipeline of biologics and the increased preference for outsourcing, the biopharmaceutical contract manufacturing services market is anticipated to witness steady growth in the foreseen future.

13. As more developers outsource various aspects of their respective manufacturing operations, we expect the biologics CMOs market to grow at an annualized rate of over 9% in the coming decade.

BIOLOGICS CONTRACT MANUFACTURING MARKET: KEY SEGMENTS

Contract Manufacturing Market for API is Likely to Dominate the Biologics Contract Manufacturing Market During the Forecast Period

Based on the type of service(s) offered, the market is segmented into API and FDF. It is worth highlighting that majority of the current biologics contract manufacturing market is captured by APIs. This can be attributed to the fact that manufacturing of biopharmaceuticals API demand significant capital investments, which include facility costs (development and maintenance), material costs, labor costs and a number of other ancillary expenses. Therefore, stakeholders rely on the expertise of CMOs for API production.

Cell Therapies is the Fastest Growing Segment of the Biologics Contract Manufacturing Market During the Forecast Period

Based on the type of biologic manufactured, the market is segmented into antibodies, cell therapies, vaccines and other biologics. It is worth highlighting the antibodies capture the maximum share within the biopharmaceutical contract manufacturing market. This can be attributed to the fact that more than 100 antibodies have been approved across the globe and an increasing number of clinical trials related to antibodies are also underway.

Mammalian Expression System is Expected to Capture the Highest Share of the Biologics Contract Manufacturing Market During the Forecast Period

Based on the type of expression system used, the market is segmented into mammalian, microbial and others. It is worth highlighting that currently, the market is likely to be driven by revenues generated through biopharmaceutical projects employing mammalian expression systems. This can be attributed to the higher usage of such systems owing to their high protein yielding ability, enhanced folding and post-translational modifications, and improved batch-to-batch uniformity.

By Scale of Operation, Commercial Scale is Likely to Dominate the Biologics Contract Manufacturing Market During the Forecast Period

Based on the scale of operation, the market is segmented into preclinical / clinical and commercial scale. Whilst commercial scale manufacturing is projected to be the primary driver of the overall market, it is worth highlighting that the biologics manufacturing market at preclinical / clinical scale is likely to grow at a relatively higher CAGR.

Large and Very Large Companies Hold Maximum Share within the Biologics Manufacturing Market

Based on company size, the market is segmented into small companies, mid-sized, and large and very large companies. While large and very large companies account for a relatively higher market share, it is worth highlighting that the biologics contract manufacturing market for small companies is likely to witness substantial market growth in the coming years.

North America Accounts for the Largest Share of the Market

Based on key geographical regions, the market is segmented into North America, Europe, Asia-Pacific, Middle East and North Africa, and Latin America. It is worth highlighting that over the years, the market in Asia-Pacific is expected to grow at a higher CAGR.

Example Players in the Biologics Contract Manufacturing Market

AGC Biologics

Boehringer Ingelheim

Catalent

Cell Therapies

Charles River Laboratories

FUJIFILM Diosynth Biotechnologies

KBI Biopharma

Kemwell Biopharma

Lonza

Miltenyi Biotec

Minaris Regenerative Medicine

Samsung Biologics

Sandoz

Vetter Pharma

Wuxi Biologics

Primary Research Overview

The opinions and insights presented in this study were influenced by discussions conducted with multiple stakeholders. The research report features detailed transcripts of interviews held with the following industry stakeholders:

Chief Executive Officer, RoslinCT

Chief Executive Officer and Co-Founder, Jafral Biosolutions

Chief Technical Officer, Cell and Gene Therapy, Discovery Life Sciences

President, Bioworkshops

Senior Director, Global Strategic Marketing, Aldevron

Senior Director of Commercial Strategy and Market Insights, Resilience

Global Head of Sales and Marketing and Head of Business Development (Germany), Minaris Regenerative Medicine

Business Development Manager, 53Biologics

Manager Marketing and Sales, Richter-Helm BioLogics

BIOLOGICS CONTRACT MANUFACTURING MARKET: RESEARCH COVERAGE

The report features an in-depth analysis of the biologics contract manufacturing market, focusing on key market segments, including type of service(s) offered, type of biologic manufactured, type of expression system used, scale of operation, company size and key geographical regions.

The report analyzes various factors such as drivers, restraints, opportunities, and challenges affecting market growth.

A comprehensive evaluation of companies offering contract manufacturing services for biologics, considering various parameters, such as year of establishment, company size (based on number of employees), location of headquarters, type of service offered (API and FDF manufacturing), type of biologic manufactured (antibody drug conjugates, antibodies, biosimilars, cell therapies, gene therapies, nucleic acids / oligonucleotides, plasmid DNA / viral vectors, proteins / peptides, vaccines and others), scale of operation (preclinical, clinical and commercial), type of expression system used (mammalian, microbial and others), type of bioreactor used (single-use and stainless steel) and mode of operation of bioreactor (batch, fed batch and continuous).

A comprehensive analysis of biopharmaceutical manufacturing facilities established across the key geographical regions (North America, Europe, Asia-Pacific and Rest of the World), highlighting the manufacturing hubs for biologics.

In-depth profiles of key biologics contract manufacturers based in North America, focusing on company overviews, service portfolio, manufacturing facilities, recent developments, and an informed future outlook.

In-depth profiles of key biologics contract manufacturers based in Europe, focusing on company overviews, service portfolio, manufacturing facilities, recent developments, and an informed future outlook.

In-depth profiles of key biologics contract manufacturers based in Asia-Pacific, focusing on company overviews, service portfolio, manufacturing facilities, recent developments, and an informed future outlook.

A comprehensive evaluation of the primary enablers within this industry, highlighting specific niche products such as antibody-drug conjugates (ADCs), bispecific antibodies, cell therapies, gene therapies, and viral vectors, which are likely to impact the growth of the contract services market.

A case study comparing the key characteristics of small and large molecule drugs, along with details on the various steps involved in their respective manufacturing processes.

An insightful framework that emphasizes the key indicators and factors that need to be considered by drug / therapy developers to determine whether to manufacture their respective products in-house or outsource the manufacturing operation to contract service providers.

Assessment of the various biopharmaceutical-focused manufacturing initiatives undertaken by big pharma players, based on several relevant parameters, such as number of initiatives, year of initiative, purpose of initiative, type of initiative, scale of operation and type of biologic manufactured.

An analysis of partnerships established in this sector since 2018, based on several relevant parameters, such as year of partnership, type of partnership, type of biologic manufactured, therapeutic area, most active players (in terms of number of deals inked) and regional distribution of partnership activity.

A detailed analysis of the various mergers and acquisitions that have taken place within this industry, since 2018, based on several relevant parameters, such as year of agreement, type of deal, geographical location of companies, type of acquisition, type of biologic manufactured and key value drivers.

An examination of the different expansion efforts made by biologics contract manufacturers in this field to enhance their manufacturing capabilities, since 2016. This analysis considers various factors, including the year of expansion, purpose of expansion, type of biologic manufactured and location of expanded facility.

An analysis of the recent developments within the biologics contract manufacturing market, highlighting information on the funding investments made since 2016, along with information on the technology advancements related to biomanufacturing.

Estimation of global biopharmaceutical manufacturing capacity, derived from data provided by various industry stakeholders in the public domain. This analysis emphasizes the distribution of the available capacity on the basis of size of manufacturer (small, mid-sized, and large and very large), type of expression system used (mammalian, microbial and others) and geography (North America, Europe, Asia-Pacific and Rest of the World).

Informed estimates of the annual demand for biologics, taking into account the top 20 biologics, based on various relevant parameters, such as target patient population, dosing frequency and dose strength of the abovementioned products.

A company size-wise, detailed analysis of the total cost of ownership for biologics CMO for a period of 20 years.

A discussion on key drivers and challenges through a comprehensive SWOT analysis, which is likely to impact the growth of the overall market. This also includes a Harvey ball analysis that illustrates the relative impact of each element of the SWOT analysis on the overall biopharmaceutical industry.

A case study on the virtual business model concept, along with its role in the overall biopharmaceutical industry. It also features a discussion on the advantages and risks / challenges associated with outsourcing operations from virtual service providers.

KEY QUESTIONS ANSWERED IN THIS REPORT

How many companies are currently engaged in this market?

Which are the leading companies in this market?

What kind of partnership models are commonly adopted by industry stakeholders?

What is the current annual demand for biologics?

What kinds of expansion initiatives have been undertaken by industry stakeholders?

What are the factors that are likely to influence the evolution of this market?

What is the current and future market size?

What is the CAGR of this market?

How is the current and future market opportunity likely to be distributed across key market segments?

REASONS TO BUY THIS REPORT

The report provides a comprehensive market analysis, offering detailed revenue projections of the overall market and its specific sub-segments. This information is valuable to both established market leaders and emerging entrants.

Stakeholders can leverage the report to gain a deeper understanding of the competitive dynamics within the market. By analyzing the competitive landscape, businesses can make informed decisions to optimize their market positioning and develop effective go-to-market strategies.

The report offers stakeholders a comprehensive overview of the market, including key drivers, barriers, opportunities, and challenges. This information empowers stakeholders to stay abreast of market trends and make data-driven decisions to capitalize on growth prospects.

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