IVIG stands for intravenous immunoglobulin and refers to a therapy that involves injecting antibodies into a patient’s vein. It is primarily used to boost the immune system in individuals who have a weakened immune system or immunodeficiency disorders.
IVIG injections work by providing the patient with healthy antibodies from donated blood plasma. The injected antibodies help fight infections and diseases that the patient’s immune system cannot handle effectively on its own.
Some of the main uses of IVIG therapy include:
- They treat primary immunodeficiency disorders such as congenital agammaglobulinemia, common variable immunodeficiency, X-linked agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiency.
- Helping patients with blood cancers like chronic lymphocytic leukaemia and multiple myeloma who have a compromised immune system due to the cancer or chemotherapy.
- Managing autoimmune and inflammatory diseases like Guillain-Barre syndrome, Kawasaki disease, chronic inflammatory demyelinating polyneuropathy, and multifocal motor neuropathy.
- Preventing infections in patients who have undergone a bone marrow transplant or organ transplant and are at high risk.
The use of antibodies to treat illness has been recognized for over 100 years. In the 1930s and 1940s, gamma globulin from animal blood was used to prevent and treat measles, hepatitis and other infectious diseases. However, there were high risks of allergic reactions and infections from these early antibody preparations.
It was not until the 1950s that antibody injections made from human blood plasma were developed, paving the way for modern IVIG therapy. In the 1980s and 1990s, IVIG gained FDA approval for an increasing number of medical uses and has become a vital therapy for immunocompromised patients today.
Manufacturing Process for IVIG Injections
IVIG injections go through a complex and highly regulated manufacturing process to ensure safety and efficacy. Here is a summary of the main stages:
Plasma Collection
The starting material for IVIG is human plasma which contains antibodies. Plasma is collected from thousands of screened, healthy donors at plasma donation centres. This plasma pooling helps ensure a broad diversity of antibodies.
Extraction and Purification
Plasma proteins including immunoglobulins are separated from the donated plasma through a process called cold ethanol fractionation. Multiple steps are then taken to isolate the immunoglobulin G (IgG) antibodies:
- Precipitation and filtration to remove lipids, particles, and viruses
- Ion exchange and other chromatography techniques to separate IgG from other proteins
- Treatment with enzymes, detergents, and solvents to inactivate viruses and prions
This yields a highly purified IgG extract.
Formulation
The IgG extract is formulated with stabilizers like sugars or albumin to create a liquid solution for injection. The formulation is tailored to achieve the desired concentration, pH, and osmolarity.
Filling and Packaging
The final IVIG solution is sterile filtered and filled into glass vials or syringes in an aseptic manufacturing environment. The finished drug product undergoes final quarantine and testing.
Regulations and Quality Control
IVIG production must comply with extensive regulations and quality standards including GMP, GTP, GLP, and country-specific regulations. Manufacturing facilities are regularly audited. Each batch of IVIG must pass sterility, purity, and potency tests before release.
This complex manufacturing process ensures that IVIG injections contain concentrated IgG antibodies with proven safety, quality, and clinical effectiveness for patients.
Major IVIG Injection Manufacturers in India
India has emerged as a major global hub for pharmaceutical manufacturing, including intravenous immunoglobulin (IVIG) injections used to treat immunodeficiency disorders. Some of the top IVIG injection manufacturers, suppliers, and exporters in India include:
Florencia Healthcare
– Florencia Healthcare, headquartered in India, is a prominent pharmaceutical company.
– Its product range includes anticancer drugs, antibiotics, and biological pharmaceuticals.
– Established in 2005, it has swiftly gained recognition and trust in the healthcare sector, particularly for its contributions to cancer treatment.
– The company serves both domestic and international markets and is esteemed as a valued partner to healthcare organizations globally.
– Florencia Healthcare operates a modern manufacturing facility certified by the World Health Organization (WHO) for Good Manufacturing Practices (GMP).
– Equipped with advanced technology for production and quality control, the facility ensures the manufacturing of high-quality pharmaceuticals meeting stringent regulatory standards.
Bharat Serums and Vaccines
– One of the oldest and largest IVIG makers, founded in 1971 in Mumbai.
– Manufactures over 500 million doses annually of IVIG and other plasma products.
– Operates one of Asia’s largest automated plants built in technical collaboration with Swiss multinational Octapharma.
– Approved by regulatory authorities in over 30 countries including the US, UK, Brazil, and South Africa.
Biological E
– Leading vaccines and biologics company founded in 1953, based in Hyderabad.
– Manufactures IVIG in a WHO-approved facility, with the capacity to produce over 1 million doses annually.
– Caters to domestic and export markets, with approvals in regulated markets like the EU and Australia.
Intas Pharmaceuticals
– Began in 1977 as a formulations manufacturer, diversified into biologics in the 2000s.
– Built a high-tech IVIG plant approved by MHRA UK, TGA Australia, and ANVISA Brazil.
– Supplies IVIG products to over 50 countries globally.
Kedrion Biopharma
– Italian biopharma company that set up an IVIG plant near Pune in 2013.
– The facility uses a fully automated production line with a capacity of 2 million doses per year.
– Kedrion’s IVIG brands are approved in the USA, EU, and many other markets.
Reliance Life Sciences
– Part of Reliance group, entered biologics in 2011 with IVIG focus.
– Constructed a biologics plant in Mumbai with capacity to make over 500,000 doses of IVIG annually.
– Received approvals from regulated agencies like the US FDA and ANVISA Brazil.
Evaluating and Selecting an IVIG Manufacturer
When looking for an IVIG manufacturer, there are several key factors to consider:
Product Quality and Safety
- IVIG is a biological product derived from human blood plasma, so stringent quality control and safety standards are essential. Reputable IVIG companies should follow cGMP practices and be ISO-certified.
- Review the manufacturer’s quality track record, recall history, and any regulatory actions. Request to see their quality audit reports and certifications.
- Ensure the manufacturing facilities are modern and meet high standards of hygiene and sterility. Many companies offer virtual tours or videos.
- Look for IVIG products approved by major regulatory agencies like the US FDA, EMA, WHO, etc.
Reliability and Consistency
- Choose an established manufacturer with years of experience producing IVIG to global standards. This ensures dependable quality batch after batch.
- Review their supply chain and inventory management system. Seasonal shortages of IVIG can occur, so pick a company that can maintain ample stocks.
- Ask about how they prevent disruptions, such as backup power, climate-controlled warehouses, and contingency plans.
Range of IVIG Products
– Look for a broad catalogue of IVIG products in different concentrations, vial sizes, and delivery methods. This allows for selecting the optimal product per application.
– Inquire if they offer speciality IVIG products like pH neutral, sucrose-free, IgA depleted, etc. These can benefit patients with sensitivities.
– Ask if they can provide custom formulations, private labelling, or contract manufacturing if needed.
Order Fulfillment and Lead Times
– Discuss expected lead times for orders and how quickly inventory can be replenished. Shorter lead times allow better response to urgent orders.
– Understand their ordering and shipping process. Do they export directly or through distributors? Is door-to-door delivery available?
– Check if they can handle small trial orders to large bulk orders of IVIG. Having flexibility helps manage demand fluctuations.
Pricing and Payment Terms
– Request quotes from multiple IVIG suppliers to compare pricing. Get detailed breakdowns including taxes, duties, and shipping costs.
– Negotiate pricing for large or long-term supply contracts. Discounts may be offered on high-volume orders.
– Discuss payment terms and financing options if needed. Many suppliers accept instalments or offer payment plans.
Responsiveness and Customer Service
– Look for manufacturers that provide dedicated support contacts and timely responses to inquiries.
– Check reviews and feedback from existing customers on their service quality.
– Request samples and literature to gauge how well they support customers.
Regulatory Expertise and Support
- The manufacturer should assist with documentation needed for regulatory submissions and import licenses.
- They should be updated on the latest regulations in your target markets and guidance on meeting them.
- For markets like EU, US, etc. they should have appropriate international approvals for their IVIG already.
Becoming an Authorized IVIG Distributor
Becoming an authorized distributor for IVIG injections involves establishing relationships with manufacturers and demonstrating capabilities in key areas like sourcing, inventory management, logistics, and quality assurance.
Overview of Process to Become a Distributor
The first step is identifying manufacturers of IVIG willing to work with new distributors. Developing partnerships with manufacturers requires a strong value proposition – distributors must prove they can reliably handle product distribution while meeting all regulatory requirements. Most manufacturers have a formal process that includes due diligence on the distributor’s operations, finances, and expertise.
Once a manufacturer relationship is established, the distributor and manufacturer sign distribution agreements stipulating terms like minimum order quantities, geographic territory, marketing support, and more. The distributor is responsible for forecasting demand and placing purchase orders to maintain adequate IVIG stock.
Sourcing and Inventory Management
To ensure consistent availability of IVIG for customers, distributors must develop robust inventory management and sourcing capabilities. Key factors include:
– Maintaining a just-in-time inventory with adequate safety stock based on demand forecasts and lead times. This prevents stockouts or expiration of products.
– Diversifying sources by partnering with multiple manufacturers. This mitigates the risk if one manufacturer faces production issues.
– Monitoring product shelf life and rotating stock using first-expiry-first-out methods.
– Developing the infrastructure to handle proper storage conditions for IVIG, including cold chain logistics if required.
Logistics and Transportation
Efficient transportation and logistics operations are vital for the timely delivery of IVIG injections from manufacturers to end-users. Distributors should implement:
– Climate-controlled transportation methods to maintain product integrity.
– Tracking and monitoring capabilities to pinpoint shipment locations and preempt potential delays.
– Contingency plans for disruptions like labour strikes or natural disasters that may impact supply chains.
– Management of regulatory documentation like certificates of analysis and material safety data sheets.
Quality Assurance and Control
Robust quality management is imperative – IVIG is a highly regulated drug product. Key quality assurance steps include:
– Inspecting shipments to confirm intact, unexpired product that meets specifications.
– Testing of random samples for purity, sterility, and other critical quality attributes.
– Tracking batch numbers and expiration dates to enable recalls if needed.
– Developing the ability to investigate and resolve any customer complaints related to product quality.
Following cGMP guidelines and implementing strong QA systems is mandatory for becoming an authorized IVIG distributor. This ensures patient safety while also satisfying regulators and manufacturer partners.
Pricing Trends for IVIG Injections
The pricing for IVIG injections can vary significantly depending on the manufacturer, brand, dosage, and other factors. Here is an overview of typical IVIG pricing trends in India:
The average price per gram of IVIG generally ranges from Rs. 6000 – Rs. 10,000. However, prices can be as low as Rs. 4000 per gram for some brands and formulations.
For a typical adult dose of 2 grams, the cost per IVIG treatment often ranges from Rs. 12,000 – Rs. 20,000.
Some of the factors impacting IVIG pricing include:
- Brand – Established brands from major pharma companies like Bharat Serums and Vaccines, Biological E, Intas Pharmaceuticals, etc. are usually priced at a premium over lesser-known brands.
- Formulation – Liquid formulations are more expensive than lyophilized powder formulations that need to be reconstituted.
- Vial Size – The per-gram pricing reduces with an increase in vial size due to economies of scale. A 10-gram vial is priced lower per gram than a 2.5-gram vial.
- Immunoglobulin Type – IVIG products derived from only human plasma are costlier than those derived from human and animal plasma blends.
- Order Quantity – Distributors offer better pricing for bulk order quantities due to discounts.
- Location – Prices are impacted by distributor margins, transportation costs and local taxes based on geographic location. Metro cities see higher pricing.
IVIG pricing has been on a downward trend in recent years due to an increase in local manufacturing and competition among Indian pharma companies. However, prices continue to be high due to complex manufacturing processes and high raw material costs.
Prominent End-Users of IVIG in India
India’s healthcare sector has seen rapid growth and modernization in recent years, leading to rising demand for intravenous immunoglobulin (IVIG) from major end-user segments. Some of the key end-users and applications of IVIG in India include:
Primary Immunodeficiency Diseases
Primary immunodeficiency diseases like common variable immunodeficiency and X-linked agammaglobulinemia are key conditions where IVIG is used. There are estimated to be over 50,000 diagnosed cases of primary immunodeficiency in India, and many more remain undiagnosed. IVIG helps boost antibody levels and prevent infections in this patient population.
Neurological Disorders
IVIG is emerging as an important therapy for certain neurological conditions like Guillain-Barré syndrome, chronic inflammatory demyelinating polyneuropathy, and multifocal motor neuropathy where it can help reduce inflammation and neurological damage. The use of IVIG in these indications is rising steadily.
Hematological Disorders
Hematological disorders like idiopathic thrombocytopenic purpura (ITP), Kawasaki disease, and certain cases of thrombocytopenia see IVIG being administered regularly for its immunomodulatory effects. This is a major application area.
Transplant Medicine
IVIG is given to prevent graft rejection and graft-versus-host disease in bone marrow and solid organ transplant patients. Its use is now standard protocol in most transplant centres.
Autoimmune Diseases
Several autoimmune conditions may warrant IVIG therapy – these include systemic lupus erythematosus, dermatomyositis, stiff person syndrome, and autoimmune encephalitis. IVIG helps calm down the hyperactive immune system.
The rising cases of such diseases requiring immunoglobulin therapy is fueling demand from hospitals, speciality clinics and nursing homes across India. With improving diagnosis, the end-user base for IVIG is likely to expand further.
Growth Outlook for IVIG Market
The Indian IVIG market has seen steady growth over the past decade, driven by rising demand and favourable demographic trends. As per industry estimates, the current size of the IVIG market in India stands at around $150 million.
India’s expanding population and improving healthcare access is expected to drive continued growth in the IVIG market. The Indian pharmaceutical market is projected to reach $65 billion by 2024 from $38 billion in 2019, growing at a CAGR of 11-12%. Within this, biologics and biosimilars are forecast to be the fastest-growing segment.
Some key factors that will propel growth in the IVIG market in India:
- The rising prevalence of immunodeficiency disorders, autoimmune diseases, and neurological disorders creates demand for IVIG therapy.
- Improving diagnosis rates and physician awareness about the benefits of IVIG.
- Increasing health insurance penetration makes IVIG treatment more affordable.
- A growing number of speciality hospitals and clinics provide immunoglobulin therapy.
- Rising per capita income enables patients to spend on advanced biologic drugs.
Given these positive trends, the Indian IVIG market is projected to grow at a CAGR of 12-15% over the next 5 years. The market is expected to reach around $250 million by 2025.
Leading domestic manufacturers are expanding production capacities to meet the increasing demand. At the same time, global IVIG brands are also targeting India as a high-growth market and launching new products.
Going forward, widening indications, rising immunoglobulin usage, and improving access will continue to stimulate growth in the Indian IVIG market. Domestic manufacturers with advanced fractionation capabilities and strong distribution networks are well-poised to capitalize on this growth.
Opportunities and Challenges
India’s IVIG market presents exciting opportunities as well as challenges for manufacturers and distributors.
Key Opportunities
– Increasing diagnosis of immunodeficiency disorders and autoimmune diseases is driving demand for IVIG in India. The market is expected to grow at over 12% CAGR through 2025.
– Rising incomes and healthcare spending enable access to IVIG therapy for more patients in Tier 2 and 3 cities. This expands the addressable market.
– Contract manufacturing opportunities as global IVIG demand rises. Indian facilities can provide cost advantages.
– Distribution tie-ups with major hospital chains across India to supply IVIG injections. The rising hospital network presents partnership potential.
– Launch of new, innovative IVIG products such as subcutaneous IG and recombinant IG. These can obtain premium pricing.
– Export opportunities to serve demand in emerging markets and low-cost IVIG requirements in Africa and Asia.
Key Challenges
– High capital investment is required for advanced IVIG manufacturing facilities as per regulatory standards.
– Strict quality control and assurance are needed to ensure the highest product purity and safety. This increases overheads.
– Cold chain logistics are essential to maintain product integrity during transportation and storage. Adds cost.
– Pricing pressure from tender contracts and competition from new entrants. Requires economies of scale.
– Regular plasma supply chain must be ensured for stable IVIG production. Collection centres have to be expanded.
– Doctors can be hesitant to adopt new IVIG brands. Extensive marketing and medical education are required.
Conclusion
India’s IVIG industry is poised for strong growth in the coming years as demand rises for these critical medications. Key factors driving growth include:
- Increasing diagnosis and treatment of immunodeficiency disorders, autoimmune diseases, and neurological conditions that rely on IVIG therapy.
- Rising healthcare spending and access enable more patients to afford IVIG.
- Growth of medical infrastructure and clinical facilities providing IVIG infusions.
- Favorable demographic trends like growing population and life expectancy.
Major Indian manufacturers are ramping up IVIG production capacities through facility expansions, technology upgrades, and process improvements. As volumes increase, prices are expected to become more competitive as well.
Going forward, ensuring stringent quality standards, expanding plasma collection networks, and regulatory compliance will be vital for IVIG companies to succeed in India. Partnerships between manufacturers, hospitals, diagnostic chains, blood banks and policymakers will also catalyze growth.
Overall, India’s expanding patient pool, increasing healthcare expenditure, improved clinical practice and favourable business environment will stimulate rapid growth in IVIG demand and production. IVIG manufacturers and distributors will need to tap this opportunity through strategic investments. Companies that can consistently supply high-quality and cost-effective IVIG on scale will emerge as industry leaders.
FAQs:
1. What is IVIG therapy, and how does it work?
IVIG stands for intravenous immunoglobulin therapy, which involves injecting antibodies into a patient’s vein. These antibodies are derived from donated blood plasma and help boost the patient’s immune system to fight infections and diseases.
2. What are the main uses of IVIG therapy?
IVIG therapy is primarily used to treat primary immunodeficiency disorders, blood cancers, autoimmune and inflammatory diseases, and to prevent infections in transplant patients.
3. How are IVIG injections manufactured?
IVIG injections undergo a complex process that involves plasma collection, extraction, purification, formulation, filling, and packaging, all adhering to stringent regulations and quality control measures.
4. What are some major IVIG manufacturers in India?
Some prominent IVIG manufacturers in India include Bharat Serums and Vaccines, Biological E, Intas Pharmaceuticals, Kedrion Biopharma, and Reliance Life Sciences.
5. What factors should be considered when selecting an IVIG manufacturer?
Key factors to consider when choosing an IVIG manufacturer include product quality and safety, reliability, range of products, order fulfilment, pricing, responsiveness, regulatory expertise, and customer service.
6. How can one become an authorized IVIG distributor?
To become an authorized IVIG distributor, one needs to establish relationships with manufacturers, demonstrate capabilities in sourcing, inventory management, logistics, and quality assurance, and adhere to regulatory requirements.
7. What are the pricing trends for IVIG injections in India?
IVIG prices in India vary based on factors such as brand, formulation, vial size, immunoglobulin type, order quantity, and location, typically ranging from Rs. 6000 to Rs. 10,000 per gram.
8. Who are the prominent end-users of IVIG in India?
Major end-users of IVIG in India include patients with primary immunodeficiency diseases, neurological disorders, haematological disorders, transplant recipients, and autoimmune diseases.
9. What is the growth outlook for the IVIG market in India?
The IVIG market in India is expected to grow at a CAGR of 12-15% over the next five years, driven by increasing demand, improving healthcare access, rising incomes, and expanding medical infrastructure.
10. What are some challenges faced by the IVIG industry in India?
Challenges for the IVIG industry in India include high capital investment for manufacturing facilities, strict quality control requirements, cold chain logistics, pricing pressure, plasma supply chain management, and the need for extensive marketing and medical education.