Global biopharmaceutical production analysis: Overall and sustained growth

Global biopharmaceutical production analysis: Overall and sustained growth

Global biopharmaceutical production analysis: Overall and sustained growth

Since 2018, the global bioprocessing capacity has increased from 16.5 million liters to 17.4 million liters.

Although overall output continues to grow at a rate of about 12%, this rate represents a significant slowdown in capacity growth as the industry moves towards higher productivity and production efficiency.

Our analysis of trends tracked in a biopharmaceutical production capacity and production annual report found that more than 17 years are relevant to this discovery.

Expression titers are increasing; single-use technology reduces the need for large-volume stainless steel; approval of large-volume, blockbuster biological agents reduces the global demand for ultra-large and multiple 10,000-liter facilities.

Optimizing reactor capacity will require planning flexibility and peak demand strategies.

In addition, the generally increased productivity of production companies has led to the commissioning of more facilities, but the total capacity has been reduced.

Although the bioprocessing and production related to COVID-19 has definitely increased the overall global bioproduction, as the industry prioritizes and optimizes available capacity, existing contract manufacturing capacity and internal enterprise capacity may meet most of the capacity related to the COVID-19 epidemic need.

There is no doubt that this strategy will increase overall capacity utilization this year.

Since 2011, the Global Biopharmaceutical Facilities Index database has been tracking global production capacity. In the past 10 years, our index has tracked and ranked the production facilities of 1,643 bioprocessing companies worldwide.

• Known or estimated biological treatment capacity (cumulative on-site bioreactor volume)
• Number of biological products produced on a clinical scale
• Number of commercial scale biologics

Number of personnel involved in bioprocessing.

By summarizing key factors including capacity, staffing, and the number of biologics produced, we have created a biomanufacturing “index” that can be aggregated to assess the concentration of bioprocessing in specific regions and countries.

We also considered the type of facility (for example, contract manufacturing organization, CMO) and the category of products processed, such as monoclonal antibodies (MAb) and gene therapy.

Capacity growth over time

In the past 25 years, the sales and quantity of biological agents have continued to grow at a rate of 12-14% per year.

However, the recent increase in actual capacity and number of facilities illustrates the story of a mature industry focused on improving the productivity of existing infrastructure.

For example, in our 2020 report, we saw that the expression titer of MAb rose from an average of 1.95 g/L in 2008 to 3.5 g/L in 2020.

The 12-year continuous improvement of biomanufacturing productivity (compound annual growth rate of 5.5%, CAGR) shows that nearly half of the annual demand growth can be met by improving titer alone.

Other innovative technologies and process optimization steps are being introduced.

For example, adding perfusion bioreactors to improve seed cultivation performance can limit the need for additional capacity.

Under Table 1 show that, although in the past few years, biological treatment session increased more than 100 facilities, but these increases did not significantly increase the total capacity of the large-scale reactor. This finding suggests that factories are adopting smaller disposable platforms instead of making huge investments in fixed stainless steel capacity as they did more than 10 years ago.

Although advanced therapies such as cell and gene therapies are rapidly gaining a place in the “biopharmaceutical industry,” they still account for a small portion of the total capacity.

For example, gene therapy accounts for only 0.5% of total global production capacity. In contrast, the dominant mammalian platform accounts for more than two-thirds (67.7%) of the market ( Figure 1 below ).

Figure 1: Platform or system as a percentage of total biomanufacturing capacity

When evaluating the global biopharmaceutical industry by scale, we found that more than 1,000 companies have facilities with a capacity of >500 liters, which can be regarded as clinical-scale bioprocessing (see Table 2 below ).

Although most of these facilities produce clinical supplies in developed markets, many are located in emerging regions, especially China and India.

Global production capacity comparison

Of the 17.4 million liters tracked by our database, 5.5 million liters (31.7%) are in the United States and Canada, 5.46 million liters (31.4%) are in Western Europe, 2.2 million liters (12.5%) are in Japan and other Asia-Pacific regions, and China has 180 Ten thousand liters (up from 870,000 liters in 2018), India has 1.1 million liters (up from 941,000 liters in 2018) ( Figure 2 below ).

Figure 2: Global biomanufacturing capabilities by region

Especially for emerging regions, our capacity data is higher than some reported capacity data because we include all active global capacity, including facilities for the production of human and veterinary vaccines and facilities for the production of “biosimilars”-not yet Biologics produced under GMP-used for treatment in less regulated markets.

We include those non-GMP facilities because regions such as China and India may eventually produce biologics (just like they produce small molecule drugs) and active pharmaceutical ingredients (APIs) for the Western market.

Although the growth of biopharmaceutical production capacity in developed and major market countries continues to climb slowly and steadily, the growth rate in developing regions tends to reach double digits. These changes are accompanied by significant strategic significance, especially in emerging and developing regions.

As the production of biologics becomes more global, APIs are produced in one region, filling activities are carried out in another region, and marketing and sales are carried out in another region.

With more and more opportunities outside the US and EU markets, biologics innovators and their suppliers are considering how this growth shift will affect predictive planning.

Measuring regional capacity and using the concentration index over a period of time is an important method to measure the relevance of regional segmentation strategies.

After the COVID-19 epidemic subsides, regional and domestic biological processing may expand, and the importance of supply chain safety to the production of basic raw materials and equipment will increase.

This will lead to more facilities and more suppliers to help alleviate bottlenecks and inventory shortages (for certain raw materials and many disposable equipment) that existed even before the COVID-19 pandemic.

China’s biopharmaceutical CMO production capacity continues to grow, especially after its regulations have changed, allowing third parties to produce clinical and commercial biopharmaceutical products.

The country continues to build capacity and adopt new technologies faster than India, so it will continue to lead in biomanufacturing and related services. These trends continue to translate into massive investment inflows.

In the past three years, China has continued to build biological processing facilities and capabilities. It now has twice as many facilities as India, although the average factory size in China is still about 25% smaller than India.

Most of India’s mature biomanufacturing expertise and capabilities are in vaccine production, while China continues its capacity building and intends to expand on a broader product platform.

We have also observed that with China’s investment in infrastructure and subsequent rapid expansion, China’s overall capacity usage may be lower than the rest of the world.

With the increase in China’s domestic market demand, this over-construction has resulted in idle capacity, which may last for several years.

Non-GMP facilities currently do not sell biologics in regulated Western markets, but they are an increasingly important part of global production capacity.

This emerging global facility requires its own biological manufacturing tools, technologies and services. Non-GMP facilities are competing for global supply chain resources.

As their importance to the local/regional drug market increases, many of these facilities will produce APIs, biosimilars and innovative biologics for the global market.

Tracking this kind of regional growth is crucial. Developing countries initially targeted the domestic market, but this situation is changing as bio-manufacturers achieve production quality goals and target export opportunities in developed markets.

Optimistic future

Although the expansion of biopharmaceutical production capacity may be slowing down, the demand for biopharmaceuticals continues to expand unabated.

As the biological process matures through innovation, process improvement and improved facility use, this gap is being effectively filled.

Compared with production and output, capacity (in liters) is less and less important.

This trend continues to drive the growth of supply and services, and continues to keep pace with the 12-14% annual growth rate of biopharmaceutical revenue.

The rapid expansion of emerging markets and the demand for new technologies such as cell and gene therapy indicate that the market will continue to grow.

We have every reason to assume that biopharmaceutical manufacturing and the demand for raw materials, equipment and services will continue to grow.

Capacity measurement method

The database includes all biological manufacturing facilities at any level.

Products include biotechnology-derived therapies, recombinant and non-recombinant, and fermentation-derived products.

The coverage includes marketed therapeutic proteins, monoclonal antibodies (MAb), vaccines, enzymes, cultured cell products and other biological drugs (human and veterinary), as well as blood-derived cell and plasma protein products.

The capacity of a facility is the cumulative volume of its on-site bioreactors associated with bioprocessing, in liters (L).

Capacity is defined by the facility or estimated based on available information, articles, and online resources.

If the facility uses a single-use system, its capacity is reported as the total bioreactor volume normally used, or if all available kits use the largest relevant bioreactor, the total bioreactor volume is reported.

If the facility reports its capacity, it usually includes only the production bioreactor, so it is usually added up to 15% for the feed-seed sequence, process development, and other bioreactors.

We noticed that the capacity utilization rate was not considered (for example, when the biological treatment is only performed 50% of the time). Instead, use the available capacity.

If perfusion, genetically modified animals, or any method other than direct batch biological treatment is used, then work hard to adjust the capacity to a comparable total volume based on traditional bioreactors (for example, a 500L perfusion bioreactor kit may be considered as compared to a 2000L perfusion bioreactor kit.

Bioreactor kit). Antibiotics and other small molecules (including secondary metabolites) derived from fermentation are not considered biopharmaceuticals and therefore not included.

It also includes a report on the capacity under construction, assuming that it will be put into production within 12-24 months.

Note that this database covers all platforms: mammals, microbes, and other platforms, including advanced therapies such as cell and gene therapy.

In addition, since we report the total capacity, even if it is not used immediately, our estimates are often higher than others.

In addition, our methods include bioprocessing around the world, such as biosimilars in emerging regions serving the domestic population, but may not be considered as GMP conditions for export.

Reference:

Top 1000 Global Biopharmaceutical Facilities IndexDatabase. BioPlan Associates, Inc.: Rockville,MD;https://www.top1000bio.com.

Global biopharmaceutical production analysis: Overall and sustained growth

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