Biopharmaceutical CMO Market Forecasts to 2030 - Global Analysis By Product (Biologics, Biosimilars and Other Products), Source, Service and By Geography

According to Stratistics MRC, the Global Biopharmaceutical CMO Market is accounted for $15.18 billion in 2023 and is expected to reach $39.41 billion by 2030 growing at a CAGR of 14.6% during the forecast period. A biopharmaceutical CMO, often referred to as a contract manufacturing organization, is a business that provides contract services to other businesses in the biopharmaceutical industry, including packaging and drug manufacture. This enables large biopharmaceutical companies to outsource their manufacturing process, allowing them to concentrate on the development and marketing of new drugs. Because they don't have the internal production capacity, many small biotechnology businesses outsource their fill and finish manufacturing requirements, which helps them avoid having to make capital investments.

According to the Indian Drug Manufacturers Association (IDMA), as of July 2021, the cost of raw materials for essential drugs, called APIs in the pharma sector, has seen a steep rise of around 140% since the pre-pandemic levels, posing a challenge for the industry.

Market Dynamics:

Driver:

Growing demand for API production

The manufacture of Active Pharmaceutical Ingredients (API) is experiencing a constant increase in demand. This is due to an increase in the prevalence of age- and cancer-related disorders, increased worldwide generic production capacities, and biologic innovation. As a result, market participants are concentrating on developing biological APIs and expanding their API production capabilities. Better prospects are anticipated as a result, both in the biopharmaceutical and small molecule API sectors, and it is anticipated that this trend will continue throughout the course of the forecast year.

Restraint:

Strict guidelines and requirements

Contract research organizations (CROs) are defined and governed by the Food and Drug Administration (FDA), which also has the authority to hold CROs directly liable for any sponsor responsibilities they take on in connection with an investigational new drug application. It must guarantee that the drug study is correctly run and complies with the standards for good clinical practice and harmonisation. The strict regulatory framework or rules and regulations are one of the main things that are anticipated to impede market expansion.

Opportunity:

Robust biologics pipeline

As pharmaceutical and biotechnology companies spend more on contract manufacturing and development services, this industry will keep expanding. The market for biopharmaceutical contract manufacturing organizations is predicted to increase by double digits, with smaller CMOs anticipating faster growth than bigger CMOs. The high growth rate is mostly attributable to the expanding number of biologics pipelines that are planned for release. The demand for outsourcing services will be significantly increased by the growth in the number of biopharmaceuticals in development.

Threat:

High startup costs and limited outsourcing

The significant challenges limiting the market expansion to some level include the high initial expenditure needed for the creation of manufacturing facilities and investments in additional equipment to start bio manufacturing at a faster rate. The complexity of the service itself and the legal environment have both been recognized to make contract negotiations between CMOs and customers challenging. Because of issues including intellectual property rights, warranties, cost, and timeliness, negotiations between clients and CMOs are difficult.

COVID-19 Impact:

The pandemic has become a huge public health concern around the world. The pandemic's impacts, which were initially discovered in China, are now being felt elsewhere. The healthcare sector's revenue growth was significantly impacted. But the market saw a favorable demand shock all around the world. The sudden increase in growth rate can be largely attributed to the CMOs' increased allocation of biopharmaceutical contracts. The biopharmaceutical sector is concentrating on the development of efficient and safe vaccinations to prevent infection as the impact of COVID-19 grows, as well as on the creation and research of new medicines to treat those who have been infected with the virus.

The mammalian segment is expected to be the largest during the forecast period

The mammalian segment is expected to be the largest during the forecast period owing to the lack of internal expertise in the industry. This is demonstrated by their capacity to enhance complicated protein treatments with post-translational modifications that are human-like. Diverse microorganisms are being identified and their potential is being explored through the use of creative tactics. The segment has also profited significantly from the development of novel and improved expression systems, increased process monitoring solutions, cell line engineering tools, automated screening techniques, and disposable devices.

The contract manufacturing segment is expected to have the highest CAGR during the forecast period

The contract manufacturing segment is expected to have the highest CAGR during the forecast period. The region is home to a sizable number of CMOs that are actively engaged in offering biopharma companies a wide range of services, including end-to-end coverage from cell cultivation to fill/finish services. The manufacturing component of clients' product development programs is also receiving significant investment. It is projected that new market entrants and small businesses who are focused on the development of biopharmaceuticals will choose contract research services for their discovery programs of new candidates, which will accelerate the segment's growth.

Region with largest share:

North America is projected to hold the largest market share during the forecast period. This can be attributed to the local presence of several service providers in the region. Furthermore, CMOs produce a sizeable portion of the approved products in the US. Numerous small- and mid-sized biopharmaceutical companies are present, but they lack the funding and resources necessary to build facilities with adequate resources. As a result, the interdependence between CMOs and SMEs has grown, leading to the market's domination.

Region with highest CAGR:

Asia Pacific is projected to hold the highest CAGR over the forecast period, due to the high volume of large molecule production in this country. The market has been heavily influenced by the lack of global regulatory consistency for biosimilar approval. The region's robust growth is mostly attributable to the rising number of CMOs opening manufacturing facilities across nations. It is projected that the region's high population and rising prevalence of various ailments like diabetes, cancer, and other chronic diseases will present market players with lucrative growth prospects.

Key players in the market:

Some of the key players in Biopharmaceutical CMO market include: JRS Pharma, Toyobo Co., Ltd., Rentschler Biopharma SE, Inno Biologics Sdn Bhd, Fujifilm Diosynth Biotechnologies U.S.A., Inc., Laboratory Corporation of America Holdings, Biomeva GmbH, Samsung Biologics, ProBioGen AG, Boehringer Ingelheim GmbH, Lonza Group AG, CMC Biologics, ICON Plc, AbbVie Inc. and Thermo Fisher Scientific Inc (Patheon & PPD).

Key Developments:

In June 2023, FUJIFILM Corporation announced that it will launch a commercial office*1 in Tokyo to provide enhanced sales support and customer service for Contract Development and Manufacturing services for Biologics and Advanced Therapies to Asia-based pharmaceutical and biotechnology companies.

In June 2023, Lonza to acquired Synaffix and strengthen antibody-drug conjugates offering. Acquisition will further strengthen Lonza's bioconjugates offering through the integration of the industry-leading proprietary Synaffix technology platform and R&D capabilities, including payload and site-specific linker technology

In May 2022, Germany's Boehringer Ingelheim (BI) has announced that it has acquired approval from the Central Drugs Standard Control Organization (CDSCO) to market its medicine Jardiance (empagliflozin) in India, for the whole spectrum of heart failure disorders regardless of ejection fraction.

Products Covered:

• Biologics
• Biosimilars
• Other Products

Sources Covered:

• Non-mammalian
• Mammalian
• Other Sources

Services Covered:

• Contract Manufacturing
• Contract Research
• Other Services

Regions Covered:

• North America
  • US
  • Canada
  • Mexico
• Europe
  • Germany
  • UK
  • Italy
  • France
  • Spain
  • Rest of Europe
• Asia Pacific
  • Japan
  • China
  • India
  • Australia
  • New Zealand
  • South Korea
  • Rest of Asia Pacific
• South America
  • Argentina
  • Brazil
  • Chile
  • Rest of South America
• Middle East & Africa
  • Saudi Arabia
  • UAE
  • Qatar
  • South Africa
  • Rest of Middle East & Africa

What our report offers:

• Market share assessments for the regional and country-level segments
• Strategic recommendations for the new entrants
• Covers Market data for the years 2021, 2022, 2023, 2026, and 2030
• Market Trends (Drivers, Constraints, Opportunities, Threats, Challenges, Investment Opportunities, and recommendations)
• Strategic recommendations in key business segments based on the market estimations
• Competitive landscaping mapping the key common trends
• Company profiling with detailed strategies, financials, and recent developments
• Supply chain trends mapping the latest technological advancements

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