The objective of this analysis is to compare the relatively rapidly growing biopharma segment in China with that of more experienced regions. Since 2000 China has placed biotechnology prominently in its 5-year Plans (guidelines). And the current guidance makes “Made in China 2025” a priority focus. The country is actively addressing nationally vital technologies, including biopharma, which lack a domestic core platform. In the recent past, Chinese products were perceived internationally to be of inferior quality.
This has been changing, and investments continue to be made to address quality, productivity, and innovation. Both domestic Chinese and global investors have recognized the pattern for sustained growth and a global position for China in biotech. The Chinese government has continued to invest heavily to expand Chinese companies and their innovations. Because biotechnology remains a prominent part of many of China’s Five-Year Plans for strategic economic growth and investment, the segment will continue to receive major investment.
The genesis of the project, based on the analyst's 30+ years of experience and knowledge of the market segment, is the growth in the biopharmaceutical segment, including emerging regions such as China and India. China, in particular, has advanced rapidly, and with those advances comes the need for updated perspectives. Since the publication of the first edition of the analyst's peer-reviewed study, Advances in Biopharmaceutical Technology in China, 1st Ed, in 2004, China has entered the global market for biopharmaceutical manufacturing and is likely to remain a key industry player.
The analyst surveys the global industry annually to identify key trends in the industry. This year, we see the need to compare how the Chinese industry itself perceives the challenges and opportunities, and how these trends compare to the global situation (primarily the leaders in the US and Western Europe). This is timely because so many changes have taken place over the past two decades in China’s biopharma that the industry has now evolved into a stage few could have imagined back then.
Innovation is clearly delivering profitability for this industry which used to be dominated by generic small molecule APIs. Today, many revolutionary changes in bio-manufacturing are occurring, and China is aggressively avoiding legacy technologies in favor of more modern approaches. In China, the awareness that future efficiency and productivity depend on using modern techniques is a strong driver.
Table of Contents
Introduction
Research Methodology
1. Single Most Important Biomanufacturing Trend/Operational Area Industry Must Focus Efforts for 2022
2. Novel Bioprocessing Systems/Innovations Facilities Plan to Evaluate in the Next 12 Months
3. Average Cost for Facility’s Primary Recombinant Protein Manufactured at Facility (per gram)
4. Range and Averages of Titers for mAbs Obtained at Various Production Scales
5. Current Percent of Total Capacity for Facility Operation, by Production System
6. Production Capacity Constraints for Facilities Today
7. Downstream Bioprocessing Steps Creating Overall Capacity Constraints
8. Important Areas to Address for Industry to Avoid Significant Capacity Constraints
9. Budget and Funding Percentage Changes Over the Next 12 Months
10. Actions to Reduce Overall Bioprocessing Costs During the Past 12 Months
11. Percentage of Facilities’ Unit Operations that are “Single-Use or Disposable”
12. Change in Spending on OUTSOURCING for R&D or Manufacturing in the Next 12 Months
13. Current Outsourcing for the Following Activities by Facilities
14. Top NEW Bioprocessing Expenditures in the Past Year
List of Figures
Figure 1: Single Most Important Biomanufacturing Trend or Operational Area Industry Must Focus Efforts (Global)
Figure 2: Novel Bioprocessing Systems/Innovations to Evaluation in Next 12 Months, 2022 (Global)
Figure 3: Average Cost per Gram for PRIMARY Recombinant Protein, 2022 (Global)
Figure 4: Distribution, Average Cost per Gram for PRIMARY Recombinant Protein, 2022 (China)
Figure 5: Range of mAb Titers Obtained at Various Production Scales, Distribution (China)
Figure 6: Average mAb Titer Obtained at the Following Production Scales (Global)
Figure 7: Average Production as % of Operating Capacity, By System, 2022 (Global)
Figure 8: Capacity Constraints, by Stage of Production (China)
Figure 9: Capacity Constraints in Commercial Manufacturing (Global)
Figure 10: Impact on Capacity of Depth, Chromatography and UF Purification Steps (China)
Figure 11: Comparative Impact on Capacity of Downstream Purification Steps, “Severe or Significant” (Global)
Figure 12: Key Areas to Address to Avoid Capacity Constraints (Global)
Figure 13: Percent Expecting “Some” Increase in Budgets for 2022 (Global)
Figure 14: Approximate Average Change in Biomanufacturers’ Budgets, 2022 (Global)
Figure 15: Cost-Cutting Changes: Actions Undertaken During “Past 12 Months”, 2022 (Global)
Figure 16: Cost-Cutting Changes, Outsourced Jobs, by Segment, and Geography, 2022 (Global)
Figure 17: Estimated Percentage of Facilities’ Unit Operations that are “Single-Use or Disposable” (Global)
Figure 18: Change in Spending on Outsourcing for R&D or Manufacturing in Next 12 Months (Global)
Figure 19: Percent of Biomanufacturers Outsourcing at Least Some Activity Today, 2022 (Global)
Figure 20: Estimated Avg Percentage of Activity Outsourced, by Facilities Today, 2022 (Global)
Figure 21: Top 3 New Bioprocessing Expenditure Focus Areas for Facilities, 2022 (Global)
