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South America Lyophilized Injectable Market Forecast to 2028 – COVID-19 Impact and Regional Analysis – by Type of Packaging (Single-Use Vials, Point-of-Care Reconstitution, and Specialty Packaging), Type of Delivery (Prefilled Diluent Syringes, Single-Step Devices, Proprietary Reconstitution Devices, and Multi-Step Devices), Indication (Metabolic and Oncology Conditions, Infectious Diseases, Autoimmune Diseases, and Others), and End User (Hospitals, Ambulatory Surgical Centers, Specialty Clinics, and Others)
- Report Code : BMIRE00027600
- Pages : 117
The SAM lyophilized injectable market is expected to grow from US$ 138.84 million in 2022 to US$ 181.45 million by 2028. It is estimated to grow at a CAGR of 4.6% from 2022 to 2028.
Expansion of Pipeline of Lyophilized Injectable Drugs
The continuous research on developing drugs to treat chronic diseases has driven the development of lyophilized injectable drugs in the pharmaceutical industry. Product innovation and strategic activities by critical key players provide opportunities to penetrate a new therapeutic area/market. About 2,400 injectable products are present in the development pipeline. Drug developers are increasingly interested in lyophilization technique as it can extend the shelf life of small and large molecule drugs. The prevalence of formulation stability challenges for complex APIs and biologics resulted in more pharmaceutical and biopharmaceutical manufacturers turning to lyophilization. The use of lyophilization for pharmaceutical and biopharmaceutical product manufacturing has grown around 13.5% per year over the last five years. Because liquids are the preferred formulation for commercial-scale production of many parenteral products, lyophilization is increasingly essential in bringing liquid products to market. Lyophilization is significant for two reasons increasing numbers of new drug applications and decreasing review times for new drug approvals. More than 3,000 drug candidates are in the pipeline in therapeutic areas where parenteral delivery dominates. Of these 3,000 products, about 2,250 are in pre-clinical development/ Phase I. The remaining candidates, around 750 are in Phase II and Phase III. And this pipeline of lyophilized products will only add to the established list of lyophilized drugs in the upcoming period. Thus, it is expected to augment the lyophilized injectable market.
Market Overview
The SAM lyophilized injectable market is segmented into Brazil, Argentina, and the Rest of SAM. Brazil dominated the market in 2022. 70% of the pharmaceutical business in Brazil is dependent on imports of pharmaceutical products. For instance, in 2019, medicines worth US$ 7 billion were imported, among which biological medicines were worth US$ 2 billion, i.e., 30% of the total import. However, the COVID-19 pandemic offered vital growth opportunities for the domestic production of medicines in Brazil and various countries worldwide. Associations in Brazil, such as the Brazilian Association of Generic Medicines Industries (PróGenlicos) and FarmaBrasil Group (GFB), state that the country can produce nearly 75% of the total demand for medicines in the country. Therefore, it is expected to increase the demand for lyophilized injectables in the country. Also, in 2019, the country imported a significant number of biological products or immunotherapeutic drugs worth US$ 1 billion. Therefore, it is expected that investing a huge amount in importing pharmaceutical products. The country can invest in the domestic production of medicines and will only incur in importing lyophilized injectables. In addition, the companies operating in the country that are associated with FarmaBrasil Group have commitments, through the Partnerships for Productive Development (PDPs), to produce medicines domestically, including bevacizumab, palivizumab, infliximab, betainterferone 1A, and insulin. Thus, such strategic moves for domestic production will enhance the demand for lyophilized injectables and eventually lead to market growth in the following years.
SAM Lyophilized Injectable Market Revenue and Forecast to 2028 (US$ Million)
SAM Lyophilized Injectable Market Segmentation
The SAM lyophilized injectable market is segmented based on type of packaging, type of delivery, indication, end user, and country.
Based on type of packaging, the SAM lyophilized injectable market is segmented into single-use vials, point-of-care reconstitution, and specialty packaging. The single-use vials segment held the largest market share in 2022. In terms of type of delivery, the SAM lyophilized injectable market is segmented into prefilled diluent syringes, single-step devices, proprietary reconstitution devices, and multi-step devices. The prefilled diluent syringes segment held the largest market share in 2022.
Based on indication, the SAM lyophilized injectable market is categorized into metabolic and oncology conditions, infectious diseases, autoimmune diseases, and others. The metabolic and oncology conditions segment held the largest market share in 2022. Based on end user, the SAM lyophilized injectable market is segmented into hospitals, ambulatory surgical centers, specialty clinics, and others. The hospitals segment held the largest market share in 2022. Based on country, the SAM lyophilized injectable market is segmented into Brazil, Argentina, and the Rest of SAM. Brazil dominated the market in 2022.
Aristopharma Ltd.; Baxter; Credence MedSystems, Inc.; Jubilant HollisterStier (Jubilant Pharma Limited); Nipro; Recipharm AB; S.G. Biopharm Pvt. Ltd.; and Vetter Pharma are among the leading companies operating in the SAM lyophilized injectable market.
1. Introduction
1.1 Scope of the Study
1.2 The Insight Partners Research Report Guidance
1.3 Market Segmentation
1.3.1 SAM Lyophilized Injectable Market – By Type of Packaging
1.3.2 SAM Lyophilized Injectable Market – By Type of Delivery
1.3.3 SAM Lyophilized Injectable Market – By Indication
1.3.4 SAM Lyophilized Injectable Market – By End User
1.3.5 SAM Lyophilized Injectable Market – By Country
2. Key Takeaways
3. Research Methodology
3.1 Coverage
3.2 Secondary Research
3.3 Primary Research
4. SAM Lyophilized Injectable Market – Market Landscape
4.1 Overview
4.2 SAM PEST Analysis
4.3 Experts Opinion
5. SAM Lyophilized Injectable Market– Key Market Dynamics
5.1 Market Drivers
5.1.1 Increasing Demand for Contract Research Manufacturing Services
5.1.2 Increasing Demand of Biologics
5.2 Market Restraints
5.2.1 Product Recalls
5.3 Market Opportunities
5.3.1 Expansion of Pipeline of Lyophilized Injectable Drugs
5.4 Future Trends
5.4.1 Advancement in Lyophilized Packaging
5.5 Impact Analysis
6. Lyophilized Injectable Market– SAM Analysis
6.1 SAM Lyophilized Injectable Market Revenue Forecast and Analysis
7. SAM Lyophilized Injectable Market Analysis – By Type of Packaging
7.1 Overview
7.2 SAM Lyophilized Injectable Market Revenue Share, by Type of Packaging (2021 and 2028)
7.3 Single-use vials
7.3.1 Overview
7.3.2 Single-use vials: Lyophilized Injectable Market – Revenue and Forecast to 2028 (US$ Million)
7.4 Point-of-Care Reconstitution
7.4.1 Overview
7.4.2 Point-of-Care Reconstitution: Lyophilized Injectable Market – Revenue and Forecast to 2028 (US$ Million)
7.5 Specialty Packaging
7.5.1 Overview
7.5.2 Specialty Packaging: Lyophilized Injectable Market – Revenue and Forecast to 2028 (US$ Million)
8. SAM Lyophilized Injectable Market Analysis – By Type of Delivery
8.1 Overview
8.2 SAM Lyophilized Injectable Market Revenue Share, by Type of Delivery (2021 and 2028)
8.3 Prefilled Diluent Syringes
8.3.1 Overview
8.3.2 Prefilled Diluent Syringes: Lyophilized Injectable Market – Revenue and Forecast to 2028 (US$ Million)
8.4 Single Step Devices
8.4.1 Overview
8.4.2 Single Step Devices: Lyophilized Injectable Market – Revenue and Forecast to 2028 (US$ Million)
8.5 Proprietary Reconstitution Devices
8.5.1 Overview
8.5.2 Proprietary Reconstitution Devices: Lyophilized Injectable Market – Revenue and Forecast to 2028 (US$ Million)
8.6 Multi-Step Devices
8.6.1 Overview
8.6.2 Multi-Step Devices: Lyophilized Injectable Market – Revenue and Forecast to 2028 (US$ Million)
9. SAM Lyophilized Injectable Market Analysis – By Indication
9.1 Overview
9.2 SAM Lyophilized Injectable Market Revenue Share, by Indication (2021 and 2028)
9.3 Metabolic and Oncology Conditions
9.3.1 Overview
9.3.2 Metabolic and Oncology Conditions: Lyophilized Injectable Market – Revenue and Forecast to 2028 (US$ Million)
9.4 Infectious Diseases
9.4.1 Overview
9.4.2 Infectious Diseases: Lyophilized Injectable Market – Revenue and Forecast to 2028 (US$ Million)
9.5 Autoimmune Diseases
9.5.1 Overview
9.5.2 Autoimmune Diseases: Lyophilized Injectable Market – Revenue and Forecast to 2028 (US$ Million)
9.6 Other Indications
9.6.1 Overview
9.6.2 Other Indications: Lyophilized Injectable Market – Revenue and Forecast to 2028 (US$ Million)
10. SAM Lyophilized Injectable Market Analysis – By End User
10.1 Overview
10.2 SAM Lyophilized Injectable Market, by End User, 2021 and 2028 (%)
10.3 Hospitals
10.3.1 Overview
10.3.2 Hospitals: Lyophilized Injectable Market – Revenue and Forecast to 2028 (US$ Million)
10.4 Ambulatory Surgical Centers
10.4.1 Overview
10.4.2 Ambulatory Surgical Centers: Lyophilized Injectable Market – Revenue and Forecast to 2028 (US$ Million)
10.5 Specialty Clinics
10.5.1 Overview
10.5.2 Specialty Clinics: Lyophilized Injectable Market – Revenue and Forecast to 2028 (US$ Million)
10.6 Other End Users
10.6.1 Overview
10.6.2 Other End Users: Lyophilized Injectable Market – Revenue and Forecast to 2028 (US$ Million)
11. SAM Lyophilized Injectable Market – Country Analysis
11.1 Overview
11.1.1 SAM: Lyophilized Injectable Market, by Country, 2021 & 2028 (%)
11.1.1.1 Brazil: Lyophilized Injectable Market – Revenue and Forecast to 2028 (USD Million)
11.1.1.1.1 Overview
11.1.1.1.2 Brazil Lyophilized Injectable Market Revenue and Forecast to 2028 (US$ Million)
11.1.1.1.3 Brazil: Lyophilized Injectable Market Revenue and Forecast to 2028, By Type of Packaging (US$ Million)
11.1.1.1.4 Brazil: Lyophilized Injectable Market Revenue and Forecast To 2028, By Type of Delivery (US$ Million)
11.1.1.1.5 Brazil: Lyophilized Injectable Market Revenue and Forecast to 2028, By Indication (US$ Million)
11.1.1.1.6 Brazil: Lyophilized Injectable Market Revenue and Forecast To 2028, By End User (US$ Million)
11.1.1.2 Argentina: Lyophilized Injectable Market – Revenue and Forecast to 2028 (USD Million)
11.1.1.2.1 Overview
11.1.1.2.2 Argentina Lyophilized Injectable Market Revenue and Forecast to 2028 (US$ Million)
11.1.1.2.3 Argentina: Lyophilized Injectable Market Revenue and Forecast to 2028, By Type of Packaging (US$ Million)
11.1.1.2.4 Argentina: Lyophilized Injectable Market Revenue and Forecast To 2028, By Type of Delivery (US$ Million)
11.1.1.2.5 Argentina: Lyophilized Injectable Market Revenue and Forecast to 2028, By Indication (US$ Million)
11.1.1.2.6 Argentina: Lyophilized Injectable Market Revenue and Forecast To 2028, By End User (US$ Million)
11.1.1.3 Rest of the SAM: Lyophilized Injectable Market – Revenue and Forecast to 2028 (USD Million)
11.1.1.3.1 Overview
11.1.1.3.2 Rest of the SAM Lyophilized Injectable Market Revenue and Forecast to 2028 (US$ Million)
11.1.1.3.3 Rest of the SAM: Lyophilized Injectable Market Revenue and Forecast to 2028, By Type of Packaging (US$ Million)
11.1.1.3.4 Rest of the SAM: Lyophilized Injectable Market Revenue and Forecast To 2028, By Type of Delivery (US$ Million)
11.1.1.3.5 Rest of the SAM: Lyophilized Injectable Market Revenue and Forecast to 2028, By Indication (US$ Million)
11.1.1.3.6 Rest of the SAM: Lyophilized Injectable Market Revenue and Forecast To 2028, By End User (US$ Million)
12. Industry Landscape
12.1 Overview
12.2 Inorganic Growth Strategies
12.2.1 Overview
12.3 Organic Growth Strategies
12.3.1 Overview
13. Company Profiles
13.1 Baxter
13.1.1 Key Facts
13.1.2 Business Description
13.1.3 Products and Services
13.1.4 Financial Overview
13.1.5 SWOT Analysis
13.1.6 Key Developments
13.2 Nipro
13.2.1 Key Facts
13.2.2 Business Description
13.2.3 Products and Services
13.2.4 Financial Overview
13.2.5 SWOT Analysis
13.2.6 Key Developments
13.3 Recipharm AB
13.3.1 Key Facts
13.3.2 Business Description
13.3.3 Products and Services
13.3.4 Financial Overview
13.3.5 SWOT Analysis
13.3.6 Key Developments
13.4 Vetter Pharma
13.4.1 Key Facts
13.4.2 Business Description
13.4.3 Products and Services
13.4.4 Financial Overview
13.4.5 SWOT Analysis
13.4.6 Key Developments
13.5 Jubilant HollisterStier (Jubilant Pharma Limited)
13.5.1 Key Facts
13.5.2 Business Description
13.5.3 Products and Services
13.5.4 Financial Overview
13.5.5 SWOT Analysis
13.5.6 Key Developments
13.6 Aristopharma Ltd.
13.6.1 Key Facts
13.6.2 Business Description
13.6.3 Products and Services
13.6.4 Financial Overview
13.6.5 SWOT Analysis
13.6.6 Key Developments
13.7 Credence MedSystems, Inc.
13.7.1 Key Facts
13.7.2 Business Description
13.7.3 Products and Services
13.7.4 Financial Overview
13.7.5 SWOT Analysis
13.7.6 Key Developments
13.8 S.G. Biopharm Pvt. Ltd.
13.8.1 Key Facts
13.8.2 Business Description
13.8.3 Products and Services
13.8.4 Financial Overview
13.8.5 SWOT Analysis
13.8.6 Key Developments
14. Appendix
14.1 About The Insight Partners
14.2 Glossary of Terms
Table 1. SAM Lyophilized Injectable Market – Revenue and Forecast to 2028 (US$ Million)
Table 2. Brazil: Lyophilized Injectable Market Revenue and Forecast to 2028, By Type of Packaging (US$ Million)
Table 3. Brazil: Lyophilized Injectable Market Revenue and Forecast to 2028, By Type of Delivery (US$ Million)
Table 4. Brazil: Lyophilized Injectable Market Revenue and Forecast to 2028, By Indication (US$ Million)
Table 5. Brazil: Lyophilized Injectable Market Revenue and Forecast to 2028, By End User (US$ Million)
Table 6. Argentina: Lyophilized Injectable Market Revenue and Forecast to 2028, By Type of Packaging (US$ Million)
Table 7. Argentina: Lyophilized Injectable Market Revenue and Forecast to 2028, By Type of Delivery (US$ Million)
Table 8. Argentina: Lyophilized Injectable Market Revenue and Forecast to 2028, By Indication (US$ Million)
Table 9. Argentina: Lyophilized Injectable Market Revenue and Forecast to 2028, By End User (US$ Million)
Table 10. Rest of the SAM: Lyophilized Injectable Market Revenue and Forecast to 2028, By Type of Packaging (US$ Million)
Table 11. Rest of the SAM: Lyophilized Injectable Market Revenue and Forecast to 2028, By Type of Delivery (US$ Million)
Table 12. Rest of the SAM: Lyophilized Injectable Market Revenue and Forecast to 2028, By Indication (US$ Million)
Table 13. Rest of the SAM: Lyophilized Injectable Market Revenue and Forecast to 2028, By End User (US$ Million)
Table 14. Recent Inorganic Growth Strategies
Table 15. Recent Organic Growth Strategies
Table 16. Glossary of Terms
Figure 1. SAM Lyophilized Injectable Market Segmentation
Figure 2. SAM Lyophilized Injectable Market – By Country
Figure 3. SAM Lyophilized Injectable Market Overview
Figure 4. SAM Lyophilized Injectable Market, By Type of Packaging
Figure 5. SAM Lyophilized Injectable Market, By Country
Figure 6. SAM: PEST Analysis
Figure 7. Experts Opinion
Figure 8. SAM Lyophilized Injectable Market Impact Analysis of Drivers and Restraints
Figure 9. SAM Lyophilized Injectable Market– Revenue Forecast and Analysis
Figure 10. SAM Lyophilized Injectable Market Revenue Share, by Type of Packaging (2021 and 2028)
Figure 11. SAM Single-use vials: Lyophilized Injectable Market – Revenue and Forecast to 2028 (US$ Million)
Figure 12. SAM Point-of-Care Reconstitution: Lyophilized Injectable Market – Revenue and Forecast to 2028 (US$ Million)
Figure 13. SAM Specialty Packaging: Lyophilized Injectable Market – Revenue and Forecast to 2028 (US$ Million)
Figure 14. SAM Lyophilized Injectable Market Revenue Share, by Type of Delivery (2021 and 2028)
Figure 15. SAM Prefilled Diluent Syringes: Lyophilized Injectable Market – Revenue and Forecast to 2028 (US$ Million)
Figure 16. SAM Single Step Devices: Lyophilized Injectable Market – Revenue and Forecast to 2028 (US$ Million)
Figure 17. SAM Proprietary Reconstitution Devices: Lyophilized Injectable Market – Revenue and Forecast to 2028 (US$ Million)
Figure 18. SAM Multi-Step Devices: Lyophilized Injectable Market – Revenue and Forecast to 2028 (US$ Million)
Figure 19. SAM Lyophilized Injectable Market Revenue Share, by Indication (2021 and 2028)
Figure 20. SAM Metabolic and Oncology Conditions: Lyophilized Injectable Market – Revenue and Forecast to 2028 (US$ Million)
Figure 21. SAM Infectious Diseases: Lyophilized Injectable Market – Revenue and Forecast to 2028 (US$ Million)
Figure 22. SAM Autoimmune Diseases: Lyophilized Injectable Market – Revenue and Forecast to 2028 (US$ Million)
Figure 23. SAM Other Indications: Lyophilized Injectable Market – Revenue and Forecast to 2028 (US$ Million)
Figure 24. SAM Lyophilized Injectable Market, by End User, 2021 and 2028 (%)
Figure 25. SAM Hospitals: Lyophilized Injectable Market – Revenue and Forecast to 2028 (US$ Million)
Figure 26. SAM Ambulatory Surgical Centers: Lyophilized Injectable Market – Revenue and Forecast to 2028 (US$ Million)
Figure 27. SAM Specialty Clinics: Lyophilized Injectable Market – Revenue and Forecast to 2028 (US$ Million)
Figure 28. SAM Other End Users: Lyophilized Injectable Market – Revenue and Forecast to 2028 (US$ Million)
Figure 29. SAM Lyophilized Injectable Market Revenue Overview, by Country, 2021 (US$ Million)
Figure 30. SAM: Lyophilized Injectable Market, by Country, 2021 & 2028 (%)
Figure 31. Brazil: Lyophilized Injectable Market Revenue and Forecast to 2028 (US$ Million)
Figure 32. Argentina: Lyophilized Injectable Market Revenue and Forecast to 2028 (US$ Million)
Figure 33. Rest of the SAM: Lyophilized Injectable Market Revenue and Forecast to 2028 (US$ Million)
● Save and reduce time carrying out entry-level research by identifying the growth, size, leading players, and segments in the SAM lyophilized injectable market.
● Highlights key business priorities to assist companies to realign their business strategies
● The key findings and recommendations highlight crucial progressive industry trends in the SAM lyophilized injectable market, thereby allowing players across the value chain to develop effective long-term strategies
● Develop/modify business expansion plans by using substantial growth offering developed and emerging markets
● Scrutinize in-depth SAM market trends and outlook coupled with the factors driving the lyophilized injectable market, as well as those hindering it
● Enhance the decision-making process by understanding the strategies that underpin commercial interest with respect to client products, segmentation, pricing, and distribution
● Aristopharma Ltd.
● Baxter
● Credence MedSystems, Inc.
● Jubilant HollisterStier (Jubilant Pharma Limited)
● Nipro
● Recipharm AB
● S.G. Biopharm Pvt. Ltd.
● Vetter Pharma
At 4.6% CAGR, the SAM Lyophilized Injectable Market is speculated to be worth US$ 181.45 million by 2028, says The Insight Partners
According to The Insight Partners’ research, the SAM lyophilized injectable market was valued at US$ 138.84 million in 2022 and is expected to reach US$ 181.45 million by 2028, registering a CAGR of 4.6% from 2022 to 2028. Advancement in lyophilized packaging and expansion of pipeline of lyophilized injectable drugs are the critical factors attributed to the market expansion.
The complexity of drug reconstitution constrained the market potential for lyophilized drugs and vaccines. With multiple pieces of device and long procedures required to reconstitute a lyophilized drug from a vial, thus, most of these products are restricted within healthcare facilities. However, the healthcare transformation toward patient self-injection and the acceleration after biologics flared a new wave of creation for drug reconstitution technology. Dual-chamber syringes represent an enabling technology for both self-injection of lyophilized drugs and for new therapies directing the mixing of two liquid molecules at the time of drug delivery. Prefilled dual chamber devices (DCDs) are combination device containing freeze-dried drugs and diluent in two separate chambers of the device. DCDs have shown many advantages as compared to the traditional drug-delivery systems, such as easy handling, accurate dosing, seal integrity, and high stability, and therefore are promising alternatives to these traditional drug-delivery systems. DCDs are becoming popular choices for physicians and patients needing instant relief and safe delivery, significantly improving drug delivery by quickly applying pressure to the end plunger after mixing and dissolving freeze-dried powder. DCDs can improve long-term pharmaceutical stability by storing them in the lyophilized form before administration and therefore are becoming more popular, especially for those unstable pharmaceutical products. Therefore, advancement in lyophilized packaging is expected to drive the market across the region.
On the contrary, growing rate of product recalls hurdles the growth of SAM lyophilized injectable market.
Based on type of packaging, the SAM lyophilized injectable market is segmented into single-use vials, point-of-care reconstitution, and specialty packaging. The single-use vials segment held 49.3% market share in 2022, amassing US$ 68.42 million. It is projected to garner US$ 89.13 million by 2028 to expand at 4.5% CAGR during 2022–2028. Based on type of delivery, the SAM lyophilized injectable market is segmented into prefilled diluent syringes, single-step devices, proprietary reconstitution devices, and multi-step devices. The prefilled diluent syringes segment held 42.7% market share in 2022, amassing US$ 59.24 million. It is projected to garner US$ 79.80 million by 2028 to expand at 5.1% CAGR during 2022–2028. Based on indication, the SAM lyophilized injectable market is segmented into metabolic and oncology conditions, infectious diseases, autoimmune diseases, and others. The metabolic and oncology conditions segment held 46.5% market share in 2022, amassing US$ 64.53 million. It is projected to garner US$ 86.36 million by 2028 to expand at 5.0% CAGR during 2022–2028. Based on end user, the SAM lyophilized injectable market is segmented into hospitals, ambulatory surgical centers, specialty clinics, and others. The hospitals segment held 47.0% market share in 2022, amassing US$ 65.28 million. It is projected to garner US$ 85.96 million by 2028 to expand at 4.7% CAGR during 2022–2028. Based on country, the SAM lyophilized injectable market has been categorized into Brazil, Argentina, and the Rest of SAM. Our regional analysis states that Brazil captured 55.3% market share in 2022. It was assessed at US$ 76.74 million in 2022 and is likely to hit US$ 104.67 million by 2028, exhibiting a CAGR of 5.3% during the forecast period.
Key players dominating the SAM lyophilized injectable market are Aristopharma Ltd.; Baxter; Credence MedSystems, Inc.; Jubilant HollisterStier (Jubilant Pharma Limited); Nipro; Recipharm AB; S.G. Biopharm Pvt. Ltd.; and Vetter Pharma among others.
In Oct 2020, Credence MedSystems and SCHOTT AG have formed a collaboration for the application of Credence Companion technology with SCHOTT’s pre-fillable syriQ glass and SCHOTT TOPPAC polymer syringe systems. The two companies will work together to integrate the technologies and provide the pharmaceutical industry with an innovative and differentiated offering for the delivery of injectable medications via prefilled syringes.
In Jan 2021, Novartis has invested in Credence, confirming its interest in employing Credence technology for its injectable medicines. The investment is geared towards supporting Credence’s ramp-up of manufacturing capacity for its innovative drug delivery systems and enabling commercial supply of Credence devices to the pharmaceutical market.
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